79C3C34C52B45572883A05D425EB0F82
National Ethical Guidelines for Health Research
https://www.pogsinc.org/files/research/pnhrs-national-ethical-guidelines.pdf
http://leaux.net/URLS/ConvertAPI Text Files/76CEA9A1F6F3E862FEF715DC856930A1.en.txt
Examining the file media/Synopses/76CEA9A1F6F3E862FEF715DC856930A1.html:
This file was generated: 2020-12-01 07:45:18
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator unlawful:
(return to top)
p.000073:
p.000073: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000073:
p.000073: disclosure of data – the giving of information in connection with proposed research undertaking or the sharing of
p.000073: the results of the study especially as they pertain to the individual’s of the family’s health situation
p.000073:
p.000073: disease allele – one of the variant forms of a disease gene at a particular locus, or location, on a chromosome.
p.000073: Different alleles produce variation in inherited characteristics such as hair color or blood type. In an individual,
p.000073: one form of the allele (the dominant one) may be expressed more than another form (the recessive one)
p.000073:
p.000073: disease susceptibility/predisposition – the pathophysiological conditions and genetic inclination that favor the
p.000073: development of a disease condition
p.000073:
p.000073: domestic violence – violence committed by one family or household member against another (Merriam-Webster’s Dictionary
p.000073: of Law (c) 1996)
p.000073:
p.000073: double blinding – is one in which neither the subject nor any of the investigator or sponsor staff who are involved in
p.000073: the treatment or clinical evaluation of the subjects are aware of the treatment received (ICH Harmonized Tripartite
p.000073: Guideline, Statistical Principles for Clinical Trials (E9) p8)
p.000073:
p.000073: drugs – a substance used as medication or used in the diagnosis, cure, mitigation, treatment or prevention
p.000073: of disease
p.000073:
p.000073: duress – wrongful and usually unlawful compulsion (as threats of physical violence) that induces a person to act
p.000073: against his or her will: ‘coercion” (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000073:
p.000073: efficacy – is the ability of a treatment modality to produce an effect to alleviate a disease
p.000073:
p.000073: embryo – the stage of human development following implantation (starting 10- 14 days), when the primitive streak begins
p.000073: to form up to fetal stage
p.000073:
p.000073: epidemiologic research – investigative studies intended to establish “the distribution and determinants of
p.000073: disease frequency in human populations”
p.000073:
p.000073: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the determinants of the
p.000073: incidence of diseases as well as their related risk factors, etiology and causation
p.000073:
p.000073: epidemiology – the basic medical science that focuses on the distribution and determinants of disease frequency in
p.000073: human populations (Raymond Greenberg, Medical Epidemiology, 1993)
p.000073:
p.000074: 74
p.000074:
p.000074: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000074:
p.000074: ethical clearance – a certification that a research proposal has complied with ethical requirements
p.000074:
p.000074: – action of an ethics review committee on a research protocol that signifies approval and permission to proceed with
p.000074: the research.
p.000074:
p.000074: ethical principles – rules or codes conforming to accepted professional standards of conduct (Merriam-Webster’s
p.000074: Dictionary of Law (c) 1996)
p.000074:
...
Political / Indigenous
Searching for indicator indigenous:
(return to top)
p.000035:
p.000035: 18. Preliminary reports that raise false hopes and expectations of product safety, efficacy, and immediate
p.000035: use shall not be made public.
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036:
p.000036: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000036:
p.000036: 19. The plan for publication and the actual publication of trial results shall not expose the identity of the
p.000036: participants or their family and community, or imperil their privacy or confidentiality as individuals,
p.000036: family, or community. As necessary, a clear consent to publication shall be obtained not only at the start of the
p.000036: trial but also at its completion.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037:
p.000037:
p.000037: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000037:
p.000037: ETHICAL GUIDELINES FOR HERBAL RESEARCH
p.000037:
p.000037:
p.000037: Introduction
p.000037:
p.000037: The use of herbal remedies can provide a practical and inexpensive way of alleviating illness in countries like the
p.000037: Philippines that is rich in natural resources and has a fecund pool of indigenous healing practices.
p.000037:
p.000037: Philippine Republic Act No. 8423, the Traditional and Alternative Medicine Act of 1997 declared the policy of the state
p.000037: “to improve the quality and delivery of health care services to the Filipino people through the development
p.000037: of traditional and alternative health care and its integration into the national health care delivery system.” This law
p.000037: aims to 1) encourage scientific research on and develop traditional and alternative health care systems that have
p.000037: direct impact on public health care; and 2) promote and advocate the use of traditional, alternative, preventive, and
p.000037: curative health care modalities that have been proven safe, effective, cost-effective, and consistent with government
p.000037: standards of medical practice.
p.000037:
p.000037: These legislated objectives have generated research activities on herbal remedies or preparations to evaluate
p.000037: their safety and effectiveness. Necessarily, these researches involve human participants for which ethics review is
p.000037: mandated.
p.000037:
p.000037: Advocates of herbal medicine are convinced that herbal products can be used without subjecting them to the same
p.000037: rigorous scientific evaluation (e.g., requirement for pre-clinical trials) required in Western medicine. It is argued
p.000037: that the current universal scientific procedures and standards are not applicable to remedies with a long history of
p.000037: use in and have been accepted by communities.
p.000037:
p.000037: This set of ethical guidelines will not dwell on the aforementioned issues surrounding herbal research. In this regard,
...
p.000039: Operational Guidance: Information needed to support clinical trials of herbal products, 2005).
p.000039:
p.000039: Recruitment 10. When normal volunteers are recruited, participants of volunteers must preferably
p.000039: come from the community where
p.000039: the herbal preparations are frequently used.
p.000039:
p.000039: Participation 11. Cultural settings and expectations must be of traditional considered in
p.000039: the review of the proposal and this healers may require inviting a traditional healer or a known
p.000039: scholar of herbal medicines in the ethics review
p.000039: board.
p.000039:
p.000039: Research 12. Placebo-controlled trials may be accommodated design in consonance
p.000039: with the guidelines on the use of placebo as indicated in Ethical Guidelines for
p.000039: Clinical Trials on Drugs, Devices, and Diagnostics
p.000039: - 13b, 13d, and 13f.
p.000039:
p.000039: 13. Effectiveness of herbal preparations may not only be measured with improvements in health or disappearance of
p.000039: physical symptoms and other
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040:
p.000040: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000040:
p.000040: disease-related variables. It may also be measured in terms of overall health and well- being.
p.000040:
p.000040: Transport 14. No indigenous materials used in the research may of materials be
p.000040: transported outside the country unless the
p.000040: source (represented by the community leader, government agency or institution) of the material and the recipient
p.000040: sign a material transfer agreement.
p.000040:
p.000040: 15. Researchers must comply with the transfer agreement if plant products or herbal preparations will be tested
p.000040: outside the country.
p.000040:
p.000040: Benefit sharing 16. Where possible, the community from where the
p.000040: medicine originates should be consulted during the course of the research, and the results and benefits of the research
p.000040: should be shared with this community (WHO Operational Guidance: Information needed to support clinical trials
p.000040: of herbal products, 2005).
p.000040:
p.000040: 17. A memorandum of agreement regarding benefit sharing and patenting conditions especially for indigenous plant
p.000040: products must be set as early as the planning stage of the research.
p.000040:
p.000040: Commercialization 18. Researchers must include provisions for of herbal conditions when the
p.000040: herbal preparations may likely preparations be commercialized. They should be guided by
p.000040: existing laws and regulations of the Philippine Intellectual Property Rights Office.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000041:
p.000041: ETHICAL GUIDELINES FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH
p.000041:
p.000041: Introduction
p.000041:
p.000041: Worldwide, there is a continuing popular interest in and utilization of complementary and alternative medicine
p.000041: (CAM). In the Philippines, promotion of the utilization of CAM is embodied in Republic Act No. 8423, the Traditional
p.000041: and Alternative Medicine Act of 1997 which declared that the state shall “improve the quality and delivery of
p.000041: health care services to the Filipino people through the development of traditional and alternative health care and its
p.000041: integration into the national health care delivery system.”
p.000041:
p.000041: The World Health Organization and national health authorities have looked to CAM as a welcome wellspring of
p.000041: accessible, cost-effective, and beneficial alternative to the expensive conventional methods of treatment.
p.000041: Scientists, however, call for the application of the rigors of scientific investigation before specific CAM modalities
p.000041: could be promoted for widespread use.
p.000041:
p.000041: Complementary and alternative medicine is defined as a group of diverse medical and health care systems, practices, and
p.000041: products that is not presently considered to be part of conventional medicine. Complementary medicine is
p.000041: used together with conventional medicine, while alternative medicine is used in place of conventional medicine (NCCAM,
p.000041: 2006). As opposed to CAM, traditional medicine (TM) is defined as the sum total of the knowledge, skills, and practices
p.000041: based on the theories, beliefs, and experiences indigenous to a particular culture, whether explicable or not,
p.000041: used in the maintenance of health, and in the prevention, diagnosis, improvement, or treatment of illnesses. However,
p.000041: the term complementary/alternative/non-conventional medicine is used interchangeably with traditional medicine in some
p.000041: countries (WHO, 2000). It will also be so used in this guidelines.
p.000041:
p.000041: CAM therapies include (NCCAM):
p.000041:
p.000041: 1. Biologically-based therapies such as dietary supplements, herbal products, animal products, and aromatherapy;
p.000041:
p.000041:
p.000042: 42
p.000042:
p.000042:
p.000042:
p.000042: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000042:
p.000042: 2. Manipulative body-based methods such as massage, acupressure, chiropractic, and osteopathic manipulation;
p.000042:
p.000042: 3. Mind-body interventions such as meditation, prayer, mental healing, art or music therapy;
p.000042:
p.000042: 4. Energy therapies such as qi gong, reiki, therapeutic touch, pranic healing, electromagnetic fields methods; and
p.000042:
p.000042: 5. Other methods used in alternative medical systems such as in medical traditions that developed in the West (e.g.,
p.000042: naturopathy and homeopathy), and in Oriental traditional medicine (e.g., ayurveda, unani, and traditional
p.000042: Chinese medicine).
p.000042:
p.000042: While some scientific evidence exists regarding some CAM therapies, for most there are key questions that have yet to
p.000042: be answered through well-designed scientific studies—questions such as whether these therapies are safe and
p.000042: whether they work for the diseases or medical conditions for which they are used.
p.000042:
p.000042: General 1. All research involving human subjects should be
p.000042: guidelines conducted in accordance with the ethical
...
p.000058: as individuals.
p.000058:
p.000058: 8. In cases where identities of groups or communities may be linked with genetic traits under study, informed
p.000058: consent for the whole group may be obtained from an elected or recognized leader who will be responsible
p.000058: for making decisions on the participation of the group in the study.
p.000058:
p.000059: 59
p.000059:
p.000059:
p.000059:
p.000059: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000059:
p.000059: 9. Informed consent shall not be required for those protocols for genetic research that use anonymous samples or
p.000059: samples that have no identifiers. Any sample that can be linked to an individual through an identifier, or through any
p.000059: person or institution that has the capability to link the sample with its source, is not to be considered anonymous.
p.000059:
p.000059: 10. Stored biological samples collected for purposes other than those stated in No. 3 above may be used to produce
p.000059: human genetic or proteomic data with the prior, free, informed, and express consent of the person concerned.
p.000059:
p.000059: 11. In case informed consent is withdrawn, the samples and data should be irretrievably unlinked from their
p.000059: source. This will be accomplished by the destruction of all identifiers.
p.000059:
p.000059: Informed 12. Genetic studies involving indigenous groups shall consent of be guided
p.000059: by domestic and international vulnerable regulations on respect for human rights and groups
p.000059: privacy, and protection from exploitation.
p.000059:
p.000059: Genetic 13. The informed consent shall include statements counseling and on the disclosure
p.000059: and sharing of the results and disclosure findings of the study, i.e., to whom should the
p.000059: information be revealed, etc.
p.000059:
p.000059: 14. Genetic counseling (pre- and post-test) shall be provided when there is a need to disclose the findings of
p.000059: the genetic study.
p.000059:
p.000059: Privacy, 15. Researchers must ensure the confidentiality and confidentiality, privacy of
p.000059: stored genetic information or research and security results relating to identified or potentially
p.000059: identifiable participants in accordance with domestic and international laws on human rights. Researchers should
p.000059: also ensure that safeguards are in place to avoid accidental disclosure of sensitive information.
p.000059:
p.000060: 60
p.000060:
p.000060:
p.000060:
p.000060: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000060:
p.000060: 16. Disclosure of genetic information is sometimes impossible to avoid. Such information should be dealt with
p.000060: sensitively, and the possibility that such a disclosure may occur should be considered in the initial process of
...
p.000067:
p.000067: GLOSSARY
p.000067:
p.000067: active principle (in medicinal preparations) – the substance in a medicinal preparation that is bringing
p.000067: about the clinical effects expected or observed
p.000067:
p.000067: adverse events – any untoward medical occurrence in a patient or clinical investigation participant
p.000067: administered an investigational product and which does not necessarily have a causal relationship with this treatment.
p.000067:
p.000067: serious adverse event – the adverse event is serious and should be reported when the outcome is death,
p.000067: life-threatening, hospitalization, disability, congenital anomaly and requires intervention to prevent permanent
p.000067: impairment or damage
p.000067:
p.000067: serious and unexpected adverse event – the unexpected adverse drug reaction is an adverse reaction, the nature or
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
p.000067: The assent is a requirement for research in addition to consent given by a parent or legal guardian
p.000067:
p.000067: child’s assent – is the expressed willingness of a minor to participate in a study
p.000067:
p.000068: 68
p.000068:
p.000068: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000068:
p.000068: assisted reproductive technology – all treatment or procedures that include the in-vitro handling of human oocytes and
p.000068: human sperm or embryos for the purpose of establishing a pregnancy (e.g., in vitro fertilization and transcervical
...
p.000079:
p.000079: HIV/AIDS research – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the
p.000079: prevention or treatment of HIV/ AIDS
p.000079:
p.000079: HIV test – immunology-based laboratory test that establishes the presence of HIV infection in an individual
p.000079:
p.000079: human subjects – see research participants
p.000079:
p.000079: hypothesis – a tentative explanation for an observation, phenomenon, or scientific problem that can be tested by
p.000079: further investigation
p.000079:
p.000079: independent consultant – An expert who gives advice comments and suggestions upon review of the study protocols with no
p.000079: affiliation to the institute or investigators proposing the research proposals
p.000079:
p.000079: information in the public domain – data or information available and open to public observation like the list of names
p.000079: in the telephone directory, or events in streets and public transportation
p.000079:
p.000079: informed consent (verbal, video, written) – the process of obtaining approval to participate in an investigative
p.000079: study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An
p.000079: important part of the process is the adequacy, appropriateness, and timeliness of the information for decision-making
p.000079:
p.000079: intellectual property rights – the legal basis by which indigenous communities exercise their rights to have access to,
p.000079: protection, and control over their cultural knowledge and products, including but not limited to traditional medicines,
p.000079: and includes the right to receive compensation for it
p.000079:
p.000080: 80
p.000080:
p.000080: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000080:
p.000080: intellectual property sharing – to participate in, use, enjoy, or experience jointly or in turns the property that
p.000080: derives from the work of the mind or intellect or an idea, invention, trade secret, process, program, data, formula,
p.000080: patent, copyright, or trademark or application, right, or registration relating thereto (Merriam-Webster’s Dictionary
p.000080: of Law (c) 1996)
p.000080:
p.000080: interaction – the chemical or biological reactivity of the active principle or herbal preparation with other
p.000080: administered substances
p.000080:
p.000080: international collaborative research – joint or shared conduct of research by at least two countries or governments
p.000080: (e.g. Philippines and one other foreign government/country)
p.000080:
p.000080: – investigative work conducted at an international level, with involvement by investigators coming from different
p.000080: countries
p.000080:
p.000080: interventional study – research that includes measures or technology that may affect the course of an illness
p.000080:
p.000080: invasive procedure – biological sampling using a method involving intrusion into the human body, such as obtaining a
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
...
p.000071: control – the standard by which experimental observation are evaluated. In many clinical trials, one group of patients
p.000071: will be given an experimental drug or treatment, while the control group is either given a standard treatment for the
p.000071: illness or a placebo (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000071:
p.000071: controlled trials – a trial in which one group of participants is given an experimental drug, while another group (the
p.000071: control group) is given either a standard treatment for the disease or a placebo
p.000071:
p.000072: 72
p.000072:
p.000072: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000072:
p.000072: conventional medicine – (see Western medicine) that discipline of medical care advocating therapy with remedies that
p.000072: produce effects differing from those of the disease treated
p.000072:
p.000072: counseling – non-coercive interaction between a health professional and a patient/ client and/or family that is meant
p.000072: to clarify personal values and priorities, health care options, expectations, risks, benefits, and resources in
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
p.000072: cultural bias – prejudice based on community values and traditions
p.000072:
p.000072: culture – the way of life of groups of people that is defined by mores, shared values, traditions and sociopolitical
p.000072: structures and institutions
p.000072:
p.000072: debriefing – the process of obtaining information about an experience from an individual who has participated in, or
p.000072: observed particular events
p.000072:
p.000072: deception – an act characterized by dishonesty, fraud, trickery or sham for the purpose of manipulating another person
p.000072: into making a decision that he or she would not have made otherwise
p.000072:
p.000072: deoxyribonucleic acid (DNA) – an antiparallel double helix of nucleotides (having deoxyribose as their sugars) linked
p.000072: by phosphodiester (sugar-phosphate) bonds to adjacent nucleotides in the same chain and by hydrogen bonds to
p.000072: complementary nucleotides in the opposite chain. The fundamental substance of which genes are composed.
p.000072:
p.000072: deoxyribonucleic acid sequencing – method of analyzing the base sequence composition and order of a DNA sample using
p.000072: chemical tagging and physical measurements
p.000072: devices – a piece of equipment designed to served a clinical purpose diagnostics – procedure or technique used in the
p.000072: identification of a disease or
...
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
p.000090: Philippines, providing for a Traditional and Alternative Health Care Development Fund and for other purposes
p.000090:
p.000090: traditional healer – the relatively old, highly placed respected person in the community, with a profound knowledge of
p.000090: traditional remedies
p.000090:
p.000090: traditional medicine – the sum total of knowledge, skills, and practices in health care, not necessarily explicable in
p.000090: the context of modern, scientific, philosophical framework, but recognized by the people to help maintain and improve
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
p.000090: traditional medicine expert – a health care provider employing traditional medicine modalities to give a cure
p.000090: traumatized populations – are individuals who live in communities that have experienced extreme forms of life-
p.000090: threatening stress due to natural calamities or human atrocities such as armed conflict, political repression as well
p.000090: as criminal and domestic violence.
p.000090:
p.000090: trial-related expenses – costs incurred in the course of litigation
p.000090:
p.000090: – Expenses incurred by study participants related to their participation in a research study such as transportation,
p.000090: meals, loss of income.
p.000090:
p.000090: undue influence – improper influence that deprives a person of freedom of choice or substitutes another’s choice or
p.000090: desire for the person’s own. Note: It is a doctrine of equity that a contract, deed, donation. Or
p.000090: testamentary disposition can be set aside if the court finds that someone has exercised undue influence over the
p.000090: maker at the time that the contrast, conveyance, or will was made. To establish a prima facie case it is usually
p.000090: necessary to show a susceptibility to undue influence (as from mental impairment), the opportunity and
p.000090: disposition on someone’s part to exercise such influence, and that the transaction
p.000090:
p.000091: 91
p.000091:
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
...
p.000095: Case-control studies,46, 69
p.000095: Cellular metabolites, 57, 70 Children,20,23 Chiropractic,43
p.000095: Clinical epidemiology,45 Clinical equipoise,31, 70 Clinical indication,30 Clinical research, 70
p.000095: Clinical trial,30, 70
p.000095: Phase I, 30, 83
p.000095: Phase II,30, 83
p.000095: Phase III,30, 84
p.000095: Phase IV, 30, 84
p.000095: Closure activities,51
p.000095: Cluster Ethics Review Committees (CERCs), 5, 87
p.000095: coercion,48
p.000095: cohort studies,46,71 collaborative research, externally
p.000095: sponsored,29 commercialization,41 commercial products,19 commercial purpose/s,55 community, -ies, 46,49,50,52,59
p.000095: community
p.000095: advocate,51 leader, 59
p.000095: community participation,28 community priorities,51 comparator product,32, 71 compensation,20,23,47,72 complementary and
p.000095: alternative
p.000095: medicine, 42, 72
p.000095: Completion, 15,18
p.000095: Conception,56, 71
p.000095: Confidentiality,18,19,45,48, 61, 72 Conflict of interest,50,51,72 Consent,46, 61
p.000095: Consent agreement, 62 Contraceptive methods,25
p.000095:
p.000096: 96
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096:
p.000096: Contraceptive implant,36 Control, 72
p.000096: Controlled trials, 17, 72
p.000096: Conventional medicine,42, 73
p.000096: Counseling,49,54,73
p.000096: Gender-sensitive, 56, 77
p.000096: Genetic, 60, 77 Criminal violence,50,73 Cultural beliefs,51 Cultural sensitivity,50,53 Culture bias,54,73
p.000096: Data, administrative, 46
p.000096: Debriefing,49, 73
p.000096: Deception,21,46,49, 73
p.000096: devices, 73
p.000096: biomedical, 59
p.000096: medical, 35
p.000096: Diagnostic/s, 59 ,73 procedures,35,36
p.000096: Dietary supplements,42 Disapproval, 13,14, 73 Discontinuation,33 Disclosure,22,45, 60, 61,
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
...
Political / political affiliation
Searching for indicator political:
(return to top)
p.000004:
p.000004:
p.000004: Cluster Ethics Review Committees (CERCs)
p.000004:
p.000004: Several institutions may form a common ethics review committee if it is not feasible to form their own committees.
p.000004:
p.000004: The management of CERCs and its areas of responsibility should be covered by a memorandum of agreement among the
p.000004: involved institutions.
p.000004:
p.000004: The CERC’s functions shall be similar to that of an institutional ethics review committee.
p.000004:
p.000004:
p.000004: The Institutional Ethics Review Committees (IERCs)
p.000004:
p.000004: Philippine institutions that engage in biomedical and behavioral research shall establish an institutional ethics
p.000004: review committee which shall provide
p.000004:
p.000005: 5
p.000005:
p.000005: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000005:
p.000005: independent, competent, and timely review of the ethics of proposed studies. The main purpose of the IERC is to help
p.000005: “safeguard the dignity, rights, safety, and well-being of all actual or potential human participants” (WHO Operational
p.000005: Guidelines for Ethics Committees that Review Biomedical Research, 2000). To this end, it is important
p.000005: that “in its composition, procedures, and decision-making, the IERC shall be independent of political,
p.000005: institutional, professional, and market influences” (WHO Operational Guidelines for Ethics Committees that
p.000005: Review Biomedical Research, 2000).
p.000005:
p.000005: The IERC should consider both the scientific and ethical aspects of the proposed research even when the IERC is
p.000005: distinct from the technical review committee (Council for International Organizations of Medical Sciences).
p.000005:
p.000005: Data from a recent survey of local institutions conducted by the Philippine National Health Research System Technical
p.000005: Working Group on Ethics (2003-04) show that only 50 percent of these institutions have an IERC (Reyes, 2004). Of the 80
p.000005: reported IERCs in the country, almost half (36) are in the National Capital Region. Lack of training in research ethics
p.000005: was cited as a major flaw of many IERCs. The efforts of DOST-PCHRD, DOH, and University of the Philippines
p.000005: Fogarty Group in organizing intensive training courses in research ethics may answer the need for capacity building
p.000005: in this field.
p.000005:
p.000005: Standardization of ethics review is an area of concern that the IERC should address. In this regard, the IERC may use
p.000005: as references the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000), and
p.000005: the 2006 General Ethical Guidelines for Health Research (pp16-29). However, it should develop a manual of standard
p.000005: operating procedures.
p.000005:
...
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
p.000024: c. Investigators and ethics review committees shall ensure that prospective subjects who are pregnant are
p.000024: adequately informed about the risks and benefits to themselves, their pregnancy, the fetus and their
p.000024: subsequent offspring, and their fertility.
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
p.000025: political or medical disadvantages, are liable to give consent under duress or without the benefit of adequate
p.000025: information.
p.000025:
p.000025: Absence of 23. When there is ethical and scientific justification direct benefit to conduct
p.000025: research with individuals capable of
p.000025: giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000025: the individual subject should be no more likely and no greater than the risk attached to routine medical or
p.000025: psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an
p.000025: overriding scientific or medical rationale for such increases and when an ethics review committee has approved
p.000025: them (Guideline 9 – CIOMS, 2002).
p.000025:
p.000025:
p.000025: II. Ensuring Quality Research
p.000025:
p.000025: Role of the 24. The ERC shall:
p.000025: ethics review
p.000025: committee (ERC) a. Review the scientific merit and ethical
p.000025: acceptability of any research involving human participants;
p.000025:
p.000025: b. Conduct further reviews as necessary in the course of the research as well as monitor the study’s progress
p.000025: (Guideline 2 – CIOMS, 2002);
p.000025:
p.000025:
p.000026: 26
p.000026:
...
p.000037:
p.000037: Philippine Republic Act No. 8423, the Traditional and Alternative Medicine Act of 1997 declared the policy of the state
p.000037: “to improve the quality and delivery of health care services to the Filipino people through the development
p.000037: of traditional and alternative health care and its integration into the national health care delivery system.” This law
p.000037: aims to 1) encourage scientific research on and develop traditional and alternative health care systems that have
p.000037: direct impact on public health care; and 2) promote and advocate the use of traditional, alternative, preventive, and
p.000037: curative health care modalities that have been proven safe, effective, cost-effective, and consistent with government
p.000037: standards of medical practice.
p.000037:
p.000037: These legislated objectives have generated research activities on herbal remedies or preparations to evaluate
p.000037: their safety and effectiveness. Necessarily, these researches involve human participants for which ethics review is
p.000037: mandated.
p.000037:
p.000037: Advocates of herbal medicine are convinced that herbal products can be used without subjecting them to the same
p.000037: rigorous scientific evaluation (e.g., requirement for pre-clinical trials) required in Western medicine. It is argued
p.000037: that the current universal scientific procedures and standards are not applicable to remedies with a long history of
p.000037: use in and have been accepted by communities.
p.000037:
p.000037: This set of ethical guidelines will not dwell on the aforementioned issues surrounding herbal research. In this regard,
p.000037: these ethical guidelines were formulated with the Traditional and Alternative Medicine Act as its political framework
p.000037: and Good Clinical Practice for its scientific underpinning.
p.000037:
p.000037: These guidelines shall serve as parameters in the conduct of research on herbal remedies based on universally accepted
p.000037: ethical principles such as respect for persons, beneficence, and justice. Thus, it is expected that these principles
p.000037: will be considered in all reviews to ensure the safety
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038:
p.000038: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000038:
p.000038: and rights of all human participants in research. Aside from this substantive type of ethical requirement,
p.000038: ethically sound research must satisfy a number of important procedural requirements of which the most important is a
p.000038: prior review by an independent and competent ethics review committee. The latter requirement is what these ethical
p.000038: guidelines will attempt to describe.
p.000038:
p.000038: General 1. All research involving human subjects should be
p.000038: guidelines conducted in accordance with the ethical
p.000038: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000038:
p.000038: 2. There must be proof of long history of use of the herbal plant/remedy to be tested. An exhaustive literature
p.000038: search on prior studies must introduce the research proposal. Any documents supporting its putative actions and
p.000038: traditional use in the community must be incorporated in the research proposal.
p.000038:
p.000038: 3. The original herbal preparations and manner of use by people in the community must be similar to that intended in
p.000038: the proposed research.
p.000038:
...
p.000044: epidemiologic research involving humans, focusing primarily on non- experimental studies. Its main difference from
p.000044: other researches is in the nature and extent of the informed consent process.
p.000044:
p.000044: General 1. All research involving human subjects should be
p.000044: guidelines conducted in accordance with the ethical
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000045:
p.000045: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000045:
p.000045: Specific guidelines
p.000045:
p.000045: Informed 2. For case-control and cohort studies, non- consent disclosure of
p.000045: all the study objectives may be permissible if full disclosure of the study
p.000045: hypothesis could bias the investigation.
p.000045:
p.000045: 3. Consent may not be required for collection of information in the public domain. Public domain information
p.000045: may include common general data such as address, marital status, educational attainment, and number of
p.000045: children among others.
p.000045:
p.000045: It should be realized that communities differ in their definition of what type of information about citizens is
p.000045: regarded as public.
p.000045:
p.000045: 4. Data regarding income, personal habits, preferences, personal opinions, political and religious
p.000045: inclinations, among others, may be considered confidential and will require consent prior to collection.
p.000045:
p.000045: 5. Collection of data by questionable means, such as deception, should not be condoned.
p.000045:
p.000045: 6. Data gathered for administrative purposes (as long as the information is not sensitive) do not require consent and
p.000045: may be waived if getting consent is considered impractical or too expensive.
p.000045:
p.000045: 7. Review of medical records may be done without requiring consent if anonymity can be maintained and if
p.000045: information sought is considered non- sensitive (Gordis and Gold, 1980).
p.000045:
p.000045: 8. The appropriate permission for storing biological material for research must be obtained from
p.000045:
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000046:
p.000046: individuals. If the samples are to be used for research not covered by the original consent, an ethics
p.000046: committee should decide whether renewed consent is needed or if the analyses may be done on anonymized samples.
p.000046: Details regarding the collection and storage of biological material are covered in the document on ethical guidelines
p.000046: for genetics research.
p.000046:
...
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
p.000049: gender and cultural sensitivity, and the need for research to contribute to the healing and re-empowerment of the
p.000049: traumatized community.
p.000049:
p.000049: General 1. All research involving human subjects should be
p.000049: guidelines conducted in accordance with the ethical
p.000049: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000049:
p.000050: 50
...
p.000087: ordinary circumstances and development
p.000087:
p.000087: risk factors – determinants of disease development
p.000087:
p.000087: scientific review – also called technical review, is the evaluation of the research protocol to ascertain scientific
p.000087: soundness and appropriateness of the objectives and design of the proposed study and the qualifications of the
p.000087: researcher
p.000087:
p.000087: selective disclosure of information – deliberate withholding of certain information from a patient or from a research
p.000087: participant usually justified by the principle of non-maleficence or, in the case of research, avoiding the
p.000087: introduction of bias on the part of the patient
p.000087:
p.000087: single-gene diseases – a disorder that is determined by mutant alleles at a single locus
p.000087:
p.000087: social and behavioral research – study undertaken on a systematic and rigorous basis to generate new knowledge
p.000087: regarding he impact of sociological, psychological, anthropological and other social factors on health and well being
p.000087:
p.000088: 88
p.000088:
p.000088: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000088:
p.000088: Critical Perspective
p.000088: This perspective is recursive and focused on bringing about change in practices. Researchers utilizing this
p.000088: perspective generally have an agenda for social change. Studies under this perspective begin with an important
p.000088: stance about social issues and is aimed at creating political debate and discussion to bring about change. It
p.000088: is practical and collaborative
p.000088:
p.000088: Interpretive perspective
p.000088: This perspective holds that in seeking to understand their world, people develop subjective meanings of their
p.000088: experiences which are varied and multiple. The researcher then looks into the complexity of views rather than reducing
p.000088: them to a few ideas. Open-ended questions suit this perspective. Historical and social contexts are important to
p.000088: consider. The assumption is that the basic generation of meaning is always social resulting from the interaction within
p.000088: social groups.
p.000088:
p.000088: Positivist perspective
p.000088: This is sometimes referred to as the “scientific method” and is likewise called quantitative research, empirical
p.000088: science or postivist/postpositivist research. This reflects a deterministic philosophy which says that causes probably
p.000088: determine effects or outcomes. It is reductionistic because it reduces ideas into discrete sets to test in hypotheses
p.000088: and research questions. It utilizes careful observation and measurement of objective reality. Most of research in this
p.000088: perspective starts with test of a theory.
p.000088:
p.000088: Social Research
p.000088: Social research covers a broad range of disciplines and perspectives. Sociology, anthropology, political science,
p.000088: economics, psychology, population studies, history, geography and linguistics are specific areas within social science
p.000088: which are directly concerned with health issues. Interdisciplinary social research involves two or more of these
p.000088: disciplines utilizing both quantitative and qualitative approaches which are consistent with either positivist
p.000088: interpretive or critical perspectives.
p.000088:
p.000088: sponsor – an individual, a company, an institution or an organization which take responsibility for the initiation,
p.000088: management and/or financing of a clinical trial (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical
p.000088: Practice [E6, R1])
p.000088:
p.000088: – an individual, company, institution or organization that takes responsibility fort eh initiation,
p.000088: management and /or financing of a research project
p.000088:
p.000088: – an individual, a company, an institution or an organization that takes
p.000088:
p.000089: 89
p.000089:
p.000089: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000089:
p.000089: responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates
p.000089: and takes full for a trial, the investigator then also assumes the role of the sponsor responsibility (WHO
p.000089: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000089:
p.000089: standard of care – health care intervention or regimen that is generally accepted by health practitioners and experts
p.000089: as beneficial to an individual needing such care
p.000089:
p.000089: prophylactic – professionally accepted level and type of preventive management to prevent the occurrence
p.000089: of a particular health condition
p.000089:
...
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
p.000090: Philippines, providing for a Traditional and Alternative Health Care Development Fund and for other purposes
p.000090:
p.000090: traditional healer – the relatively old, highly placed respected person in the community, with a profound knowledge of
p.000090: traditional remedies
p.000090:
p.000090: traditional medicine – the sum total of knowledge, skills, and practices in health care, not necessarily explicable in
p.000090: the context of modern, scientific, philosophical framework, but recognized by the people to help maintain and improve
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
p.000090: traditional medicine expert – a health care provider employing traditional medicine modalities to give a cure
p.000090: traumatized populations – are individuals who live in communities that have experienced extreme forms of life-
p.000090: threatening stress due to natural calamities or human atrocities such as armed conflict, political repression as well
p.000090: as criminal and domestic violence.
p.000090:
p.000090: trial-related expenses – costs incurred in the course of litigation
p.000090:
p.000090: – Expenses incurred by study participants related to their participation in a research study such as transportation,
p.000090: meals, loss of income.
p.000090:
p.000090: undue influence – improper influence that deprives a person of freedom of choice or substitutes another’s choice or
p.000090: desire for the person’s own. Note: It is a doctrine of equity that a contract, deed, donation. Or
p.000090: testamentary disposition can be set aside if the court finds that someone has exercised undue influence over the
p.000090: maker at the time that the contrast, conveyance, or will was made. To establish a prima facie case it is usually
p.000090: necessary to show a susceptibility to undue influence (as from mental impairment), the opportunity and
p.000090: disposition on someone’s part to exercise such influence, and that the transaction
p.000090:
p.000091: 91
p.000091:
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
...
p.000097: Art, 43
p.000097: Music therapy, 43 minutes of meeting,13 medical rationale, 26
p.000097: medical records, 46 medical services,19
p.000097: memorandum of agreement, 41 monitoring mechanism, 51
p.000097: moral agent, 55
p.000097: multifactorial inheritance, 57, 82
p.000097: mutagenicity, 26, 82
p.000097: National Ethics Committee, 3, 5, 87
p.000097: National Unified Health Agenda, 29, 83
p.000097: Natural calamities, 50
p.000097: Naturopathy, 43
p.000097: North-south research collaboration, 64, 83
p.000097: Non-disclosure, 52, 83
p.000097:
p.000098: 98
p.000098:
p.000098: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000098:
p.000098:
p.000098: Nuremberg Code, 3
p.000098: Observational studies, 45, 48 Oriental traditional medicine, 43
p.000098: Ayurveda Unani
p.000098: Traditional Chinese medicine Osteopathic manipulation Ovulatory rates
p.000098: Ovum/ ova, 55, 56
p.000098: Photographs, 67
p.000098: Pain, 17
p.000098: Parallel design, 33 Participant
p.000098: Observation, 48
p.000098: Selection, 33
p.000098: Withdrawal, 33
p.000098: Participatory research, 52, 83
p.000098: Patenting, 41
p.000098: Personal data, 47 Person of authority, 47 pharmacogenetics, 83
p.000098: Philippine Health Research Ethics Board (PHREB), 3-4
p.000098: Functions, 4
p.000098: Philippine National Health Research System, 3
p.000098: Philippine Obstetrical and Gynecological Society (POGS), 55
p.000098: Philippine Society of Reproductive Endocrinology and Infertility, 55
p.000098: Placebo, 31, 33, 34, 84
p.000098: Placebo-controlled, 33, 40, 85
p.000098: Political repression, 50
p.000098: Post-marketing surveillance, 30
p.000098: Practitioner, qualified, 55
p.000098: Preclinical studies, 32, 85
p.000098: Predictive testing, 57, 59, 85
p.000098: Predisposition, 57, 85
p.000098: Pregnancy test, 25
p.000098: Pre-marketing phase, 30
p.000098: Prenatal testing, 57, 85
p.000098: Privacy,18,22,45,48, 61, 85
p.000098: Procedures, invasive, 28
p.000098: Product toxicities, 31
p.000098: Protein, 57, 58
p.000098: Protocol, 32, (see also research protocol), 85
p.000098: Psychocultural aspects, 53, 55
p.000098: Psychosocial needs, 51, 86
p.000098: Publication, 36, 54, 67
p.000098: Impediments to, 67 Qualifications of investigators, 28 Quality of life, 43, 86
p.000098: Quasi-experimental design, 49, 86
p.000098: Questionnaire, 47
p.000098: Quorum, 12
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
p.000098: Reprisals, 50
p.000098: Research agreement, 65
p.000098: Rescue medication, 44, 87
p.000098: Research capacity, Investment, 64
p.000098: Local, 64
p.000098: strengthening, 29
p.000098: Research design, 17
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
p.000098: Review procedure, 12-13 Right of access, 18 Risks, 17, 88
p.000098: RNA, 57, 58, 88
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.002006: light to emerging public health threats, which especially hit low-income populations against human rights not to be
p.002006: misused when these poor people are chosen as research subjects We must therefore adapt with the times and revolutionize
p.002006: ways in which we conduct local research by becoming more responsive to these scientific, technological, and
p.002006: social advances.
p.002006:
p.002006: The Philippine Health Research Ethics Board (PHREB) under the Philippine National Health Research System (PNHRS) is now
p.002006: bringing out the updated National Ethical Guidelines for Health Research in response to these changing needs. This is
p.002006: indeed a welcome development for the DOH as we continuously seek better information and evidence and explore new ways,
p.002006: approaches, and technologies, which can enhance the performance of the entire health system. Critical reform strategies
p.002006: on service delivery, regulation, financing, and governance under the Fourmula 1 for Health implementation strategy
p.002006: shall surely benefit from these developments as we devote ourselves more to conducting researches built on a foundation
p.002006: of public trust, scientific integrity, and social responsibility.
p.002006:
p.002006: While we accelerate our actions for health through speedier ways of testing new drugs, tools, strategies, and
p.002006: approaches in health research, we must all take care to uphold the values associated with ethical research conduct. We
p.002006: need to safeguard the rights of the participants, particularly those who are vulnerable or disadvantaged. The national
p.002006: guidelines shall ensure that more research institutions and researches from the biomedical and behavioral
p.002006: fields of discipline will be able to support and protect the dignity and rights of the human person as a research
p.002006: participant. I understand also that this initiative is pointing to one of the goals of the Philippine National Health
p.002006: Research System (PNHRS) - that of fostering high performing research organizations relative to technical and ethical
p.002006: standards.
p.002006:
p.002006: We therefore laud the tireless efforts and admirable dedication of the members of the Ad Hoc Committee for
p.002006: accomplishing the revised ethical guidelines for the conduct of health research in the country.
p.002006:
p.002006: Congratulations and more power to the Philippine National Health Research System!
p.002006:
p.002006:
p.002006:
p.002006: FRANCISCO T. DUQUE III, M.D., M.Sc.
p.002006: Secretary of Health
p.002006:
p.002006: 30 June, 2006
p.002006: iv
p.002006:
p.002006: ACKNOWLEDGMENTS
p.002006:
p.002006: The Ad Hoc Committee for the revision of the National Ethical Guidelines for Health Research patiently and carefully
p.002006: reviewed and revised the old guidelines, and formulated new ones in order to provide researchers and ethics review
p.002006: committees a new set of guidelines that is responsive to the needs of an evolving and growing national health research
p.002006: system. The committee was composed of:
p.002006:
p.002006: Dr. Leonardo D. de Castro Professor, Department of Philosophy
...
p.000022: are disclosed to its subjects. Appropriate medical advice or referral should be provided.
p.000022:
p.000022: Standard of care 14. The particular needs of the economically and
p.000022: medically disadvantaged must be recognized in determining the standard of care that must be provided them as
p.000022: research subjects.
p.000022:
p.000022: 15. The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best
p.000022: current prophylactic, diagnostic, or therapeutic methods. Placebo, or no treatment, may be used in studies
p.000022: where no proven prophylactic, diagnostic, or therapeutic method exists (Principle 29 – Declaration of Helsinki,
p.000022: 2004).
p.000022:
p.000022: Compensation 16. Compensation given to subjects for lost earnings, for research travel costs, and
p.000022: other expenses incurred in taking subjects part in a study; free medical services; and
p.000022: compensation for the inconvenience and time spent by those who do not have direct benefit from the research should
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
...
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
...
p.000058: as individuals.
p.000058:
p.000058: 8. In cases where identities of groups or communities may be linked with genetic traits under study, informed
p.000058: consent for the whole group may be obtained from an elected or recognized leader who will be responsible
p.000058: for making decisions on the participation of the group in the study.
p.000058:
p.000059: 59
p.000059:
p.000059:
p.000059:
p.000059: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000059:
p.000059: 9. Informed consent shall not be required for those protocols for genetic research that use anonymous samples or
p.000059: samples that have no identifiers. Any sample that can be linked to an individual through an identifier, or through any
p.000059: person or institution that has the capability to link the sample with its source, is not to be considered anonymous.
p.000059:
p.000059: 10. Stored biological samples collected for purposes other than those stated in No. 3 above may be used to produce
p.000059: human genetic or proteomic data with the prior, free, informed, and express consent of the person concerned.
p.000059:
p.000059: 11. In case informed consent is withdrawn, the samples and data should be irretrievably unlinked from their
p.000059: source. This will be accomplished by the destruction of all identifiers.
p.000059:
p.000059: Informed 12. Genetic studies involving indigenous groups shall consent of be guided
p.000059: by domestic and international vulnerable regulations on respect for human rights and groups
p.000059: privacy, and protection from exploitation.
p.000059:
p.000059: Genetic 13. The informed consent shall include statements counseling and on the disclosure
p.000059: and sharing of the results and disclosure findings of the study, i.e., to whom should the
p.000059: information be revealed, etc.
p.000059:
p.000059: 14. Genetic counseling (pre- and post-test) shall be provided when there is a need to disclose the findings of
p.000059: the genetic study.
p.000059:
p.000059: Privacy, 15. Researchers must ensure the confidentiality and confidentiality, privacy of
p.000059: stored genetic information or research and security results relating to identified or potentially
p.000059: identifiable participants in accordance with domestic and international laws on human rights. Researchers should
p.000059: also ensure that safeguards are in place to avoid accidental disclosure of sensitive information.
p.000059:
p.000060: 60
p.000060:
p.000060:
p.000060:
p.000060: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000060:
p.000060: 16. Disclosure of genetic information is sometimes impossible to avoid. Such information should be dealt with
p.000060: sensitively, and the possibility that such a disclosure may occur should be considered in the initial process of
p.000060: seeking consent.
p.000060:
...
p.000090: as criminal and domestic violence.
p.000090:
p.000090: trial-related expenses – costs incurred in the course of litigation
p.000090:
p.000090: – Expenses incurred by study participants related to their participation in a research study such as transportation,
p.000090: meals, loss of income.
p.000090:
p.000090: undue influence – improper influence that deprives a person of freedom of choice or substitutes another’s choice or
p.000090: desire for the person’s own. Note: It is a doctrine of equity that a contract, deed, donation. Or
p.000090: testamentary disposition can be set aside if the court finds that someone has exercised undue influence over the
p.000090: maker at the time that the contrast, conveyance, or will was made. To establish a prima facie case it is usually
p.000090: necessary to show a susceptibility to undue influence (as from mental impairment), the opportunity and
p.000090: disposition on someone’s part to exercise such influence, and that the transaction
p.000090:
p.000091: 91
p.000091:
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: vulnerable groups – classes of individuals who have characteristics that lessen their capacity to protect their own
p.000091: interests or promote their own welfare
p.000091:
p.000091: waiver of informed consent – the act of intentionally or knowingly relinquishing or abandoning the right to consent to
p.000091: medical treatment by a patient or to participation in a medical experiment by a subject after achieving an
p.000091: understanding of what is involved and especially for the risks (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: – Permission given by an Ethics Review Committee for research to be conducted without the informed consent of subjects,
p.000091: under exceptional circumstances, such as when research has to be undertaken in an emergencyXsituation
p.000091:
p.000091: Western medicine – or biomedicine, allopathy, regular medicine, conventional medicine, mainstream medicine, orthodox
p.000091: medicine or cosmopolitan medicine, refers to medical care that advocates therapy that produces effects differing from
p.000091: those of the diseases treated (TAMA 1997)
p.000091:
p.000091: zygote – the product of the biological union of the human sperm and egg (process of fertilization) until the
p.000091: blastocyst (32-cell) stage prior to implantation in the endometrium (0 to 4-5 days)
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
...
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000100:
p.000100: APPENDIX A
p.000100: TEMPLATE FOR PATIENT INFORMATION AND INFORMED CONSENT FORM
p.000100:
p.000100: Project Title:
p.000100:
p.000100: Sponsor:
p.000100:
p.000100: Investigator/s:
p.000100:
p.000100:
p.000100:
p.000100: Purpose and conduct of study:
p.000100: • Why is the study being done?
p.000100: • What has been done previously?
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
p.000100: Compensation
p.000100: • Will there be reimbursement of travel expenses? Compensation for loss of income? Meal expenses?
...
Searching for indicator vulnerability:
(return to top)
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
...
p.000098: RNA, 57, 58, 88
p.000098: Safety information, 11-12
p.000098: Safety parameters, 34
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000100:
p.000100: APPENDIX A
p.000100: TEMPLATE FOR PATIENT INFORMATION AND INFORMED CONSENT FORM
p.000100:
p.000100: Project Title:
p.000100:
p.000100: Sponsor:
p.000100:
p.000100: Investigator/s:
p.000100:
p.000100:
p.000100:
p.000100: Purpose and conduct of study:
p.000100: • Why is the study being done?
p.000100: • What has been done previously?
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
...
Health / Cognitive Impairment
Searching for indicator impaired:
(return to top)
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
...
Searching for indicator impairment:
(return to top)
p.000066: b. Acknowledgment of contributors other than the authors; and
p.000066: c. Statement that the authors observed ethics review committee requirements, the National Ethical Guidelines for
p.000066: Health Research, and pertinent guidelines on the care and use of animals.
p.000066:
p.000066: 8. The authors shall obtain the informed consent of subjects as a condition for the publication of photographs
p.000066: or identifiable information.
p.000066:
p.000066: 9. Sponsors or other interested parties may not impose impediments to the publication of research outcomes.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000067:
p.000067: GLOSSARY
p.000067:
p.000067: active principle (in medicinal preparations) – the substance in a medicinal preparation that is bringing
p.000067: about the clinical effects expected or observed
p.000067:
p.000067: adverse events – any untoward medical occurrence in a patient or clinical investigation participant
p.000067: administered an investigational product and which does not necessarily have a causal relationship with this treatment.
p.000067:
p.000067: serious adverse event – the adverse event is serious and should be reported when the outcome is death,
p.000067: life-threatening, hospitalization, disability, congenital anomaly and requires intervention to prevent permanent
p.000067: impairment or damage
p.000067:
p.000067: serious and unexpected adverse event – the unexpected adverse drug reaction is an adverse reaction, the nature or
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
...
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
p.000090: traditional medicine expert – a health care provider employing traditional medicine modalities to give a cure
p.000090: traumatized populations – are individuals who live in communities that have experienced extreme forms of life-
p.000090: threatening stress due to natural calamities or human atrocities such as armed conflict, political repression as well
p.000090: as criminal and domestic violence.
p.000090:
p.000090: trial-related expenses – costs incurred in the course of litigation
p.000090:
p.000090: – Expenses incurred by study participants related to their participation in a research study such as transportation,
p.000090: meals, loss of income.
p.000090:
p.000090: undue influence – improper influence that deprives a person of freedom of choice or substitutes another’s choice or
p.000090: desire for the person’s own. Note: It is a doctrine of equity that a contract, deed, donation. Or
p.000090: testamentary disposition can be set aside if the court finds that someone has exercised undue influence over the
p.000090: maker at the time that the contrast, conveyance, or will was made. To establish a prima facie case it is usually
p.000090: necessary to show a susceptibility to undue influence (as from mental impairment), the opportunity and
p.000090: disposition on someone’s part to exercise such influence, and that the transaction
p.000090:
p.000091: 91
p.000091:
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: vulnerable groups – classes of individuals who have characteristics that lessen their capacity to protect their own
p.000091: interests or promote their own welfare
p.000091:
p.000091: waiver of informed consent – the act of intentionally or knowingly relinquishing or abandoning the right to consent to
p.000091: medical treatment by a patient or to participation in a medical experiment by a subject after achieving an
p.000091: understanding of what is involved and especially for the risks (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: – Permission given by an Ethics Review Committee for research to be conducted without the informed consent of subjects,
p.000091: under exceptional circumstances, such as when research has to be undertaken in an emergencyXsituation
p.000091:
p.000091: Western medicine – or biomedicine, allopathy, regular medicine, conventional medicine, mainstream medicine, orthodox
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000028: informed consent, protection of condidentiality and right of dissent, and community involvement in the conduct of
p.000028: research (Wejer & Emmanuel, 2000).
p.000028:
p.000028:
p.000028: Externally- 36. In externally sponsored collaborative research, sponsored sponsors
p.000028: and investigators have an ethical collaborative obligation to ensure that biomedical research
p.000028: research projects for which they are responsible shall
p.000028: contribute effectively to capacity building which may include, but is not limited to the following activities:
p.000028:
p.000028: a. Designing and conducting biomedical research
p.000028:
p.000028: b. Strengthening research capacity to develop technologies appropriate to healthcare and biomedical research
p.000028: training of research and healthcare staff
p.000028:
p.000028: c. Educating the community from which research subjects will be drawn (Guideline 20 – CIOMS, 2002)
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000029:
p.000029: ETHICAL GUIDELINES FOR CLINICAL TRIALS ON DRUGS, DEVICES, AND DIAGNOSTICS
p.000029:
p.000029: Introduction
p.000029:
p.000029: A clinical trial is a scientifically designed experiment that evaluates the safety and efficacy of a treatment. There
p.000029: are four phases of clinical trials
p.000029:
p.000029: Phase I study refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000029: determine the levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in
p.000029: patients for safety and, in some cases, early evidence of effectiveness.
p.000029:
p.000029: Phase II investigation consists of controlled clinical trials designed to demonstrate efficacy and relative safety.
p.000029: Normally, these are performed on a limited number of closely monitored patients.
p.000029:
p.000029: Phase III trial is performed after a reasonable probability of a drug’s effectiveness has been established. This type
p.000029: of trial is intended to gather additional evidence of effectiveness for specific indications and more precise
p.000029: definition of drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000029:
p.000029: Phase IV trial is conducted after the national drug registration authority (i.e. BFAD) has approved a drug for
p.000029: distribution or marketing. This trial may include research designed to explore a specific pharmacological effect,
p.000029: establish the incidence of adverse reactions, or determine the effects of a long-term drug administration. It may also
p.000029: be designed to evaluate a drug in a population (such as children or the elderly) not studied adequately in the
p.000029: pre-marketing phases, or to establish a new clinical indication for a drug. Such research is to be distinguished from
p.000029: marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug reactions in that
p.000029: these categories ordinarily need not be reviewed by ethics review committees.
p.000029:
p.000029: The four conventional phases in clinical drug development present different ethical issues. Careful
p.000029: consideration should be noted and addressed in each phase as indicated in the International Conference on
p.000029: Harmonization (ICH) Harmonized Tripartite Guidelines for Good
p.000029:
p.000030: 30
p.000030:
p.000030:
p.000030:
p.000030: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000030:
p.000030: Clinical Practice, General Consideration for Clinical Trials (E8).
p.000030:
p.000030: General 1. All research involving human subjects should be guidelines conducted in
p.000030: accordance with the ethical
p.000030: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000030:
p.000030: 2. All clinical trials must have scientific and social value and, therefore, shall be adequately justified.
p.000030:
p.000030: 3. The various phases of the pharmaceutical trial present different ethical issues that should be keenly looked
p.000030: into by the institutional ethics review committee (IERC). These issues include product toxicities in Phase I, use of
p.000030: placebo in Phases II and III, and professional integrity and conflict of interest in post-marketing activities in Phase
p.000030: IV.
p.000030:
p.000030: Clinical 4. Investigator/s involved in clinical trials shall be equipoise
p.000030: governed by clinical equipoise. A state of clinical
p.000030: equipoise means that on the basis of available data, a condition of genuine uncertainty on the part of the clinical
p.000030: investigator/s and/or a community of medical experts exists regarding the comparative therapeutic merits of each
...
p.000033: there are standard treatments available to a patient population. Thus, a placebo control may be used only when –
p.000033:
p.000033: a. Standard therapy is unavailable
p.000033: b. Existing treatment is of unproven efficacy, or possesses unacceptable side-effects
p.000033: c. The placebo itself is an effective therapy
p.000033: d. The disease has little adverse effect on the patient
p.000033: e. Testing an add-on treatment to a standard therapy when all subjects get all treatments that would normally
p.000033: be given
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034:
p.000034: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000034:
p.000034: f. The patient has provided informed rejection or refusal of standard therapy for a minor condition for
p.000034: which the patient refuses treatment, and when such refusal for therapy will not lead to unjustified affliction
p.000034: or irreparable damage or harm
p.000034:
p.000034: Informed 14. Refer to section on Informed Consent in the consent General
p.000034: Ethical Guidelines for Health Research
p.000034: (pp16-29).
p.000034:
p.000034: Therapy versus 15. The difference between therapy and research research shall be upheld
p.000034: throughout a clinical trial. The
p.000034: investigator/s shall ensure that participants comprehend and keep in mind that in a clinical trial, the drug is
p.000034: experimental and that its benefits are currently being proven.
p.000034:
p.000034: Research on 16. Clinical trials of medical devices, diagnostic medical devices, procedures, and
p.000034: preventive measures, including diagnostic vaccines, raise similar ethical concerns especially
p.000034: procedures and on free and informed consent, and potential preventive measures conflict of interest.
p.000034:
p.000034: a. Trials of critical medical devices such as implants which may present a potential serious risk to health,
p.000034: safety or welfare of the subject shall not be conducted on healthy volunteers. The current safety data on the medical
p.000034: device shall be gathered and the risks posed by the device considered and evaluated. Safety procedures in the
p.000034: introduction of such medical device in the patient shall be followed. The patient information sheet shall contain
p.000034: information on procedures to be adopted should the patient decide to withdraw from the trial. Medical devices
p.000034: that are not used regularly have less risk- potential than those used regularly. Likewise, devices used outside the
p.000034: body have less risk than those used inside the body.
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035:
p.000035: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000035:
p.000035: b. In the case of contraceptive implant trials, adequate monitoring for removal of the implant shall be done
...
p.000066: Health Research, and pertinent guidelines on the care and use of animals.
p.000066:
p.000066: 8. The authors shall obtain the informed consent of subjects as a condition for the publication of photographs
p.000066: or identifiable information.
p.000066:
p.000066: 9. Sponsors or other interested parties may not impose impediments to the publication of research outcomes.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000067:
p.000067: GLOSSARY
p.000067:
p.000067: active principle (in medicinal preparations) – the substance in a medicinal preparation that is bringing
p.000067: about the clinical effects expected or observed
p.000067:
p.000067: adverse events – any untoward medical occurrence in a patient or clinical investigation participant
p.000067: administered an investigational product and which does not necessarily have a causal relationship with this treatment.
p.000067:
p.000067: serious adverse event – the adverse event is serious and should be reported when the outcome is death,
p.000067: life-threatening, hospitalization, disability, congenital anomaly and requires intervention to prevent permanent
p.000067: impairment or damage
p.000067:
p.000067: serious and unexpected adverse event – the unexpected adverse drug reaction is an adverse reaction, the nature or
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
...
p.000071: care systems, practices and products that are not presently considered to be part of conventional medicine
p.000071:
p.000071: complementary medicine – a health treatment modality that is used together in a conventional or mainstream medicine
p.000071:
p.000071: conception – pregnancy beginning from the process of fertilization to form a zygote or its implantation
p.000071:
p.000071: conditional approval – approval of the protocol by the Ethics Committee to proceed after certain conditions or
p.000071: modifications set by the EC are met
p.000071:
p.000071: confidentiality – a duty of health care providers and health researchers toward patients and research participants to
p.000071: protect privacy and to refrain from unauthorized disclosure of information pertaining to them
p.000071:
p.000071: – prevention of disclosure of the IEC/IRB information, deliberations and documents to other than authorized individuals
p.000071:
p.000071: conflict of interest – a conflict of interest arises when a member (or members) of the Ethics Committee holds
p.000071: interests with respect to specific applications for review that may jeopardize his/her ability to provide a
p.000071: free and independent evaluation of the research focused on the protection of the research participants. Conflict of
p.000071: interests may arise when an EC member has financial, material, institutional or social ties to the research.
p.000071:
p.000071: control – the standard by which experimental observation are evaluated. In many clinical trials, one group of patients
p.000071: will be given an experimental drug or treatment, while the control group is either given a standard treatment for the
p.000071: illness or a placebo (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000071:
p.000071: controlled trials – a trial in which one group of participants is given an experimental drug, while another group (the
p.000071: control group) is given either a standard treatment for the disease or a placebo
p.000071:
p.000072: 72
p.000072:
p.000072: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000072:
p.000072: conventional medicine – (see Western medicine) that discipline of medical care advocating therapy with remedies that
p.000072: produce effects differing from those of the disease treated
p.000072:
p.000072: counseling – non-coercive interaction between a health professional and a patient/ client and/or family that is meant
p.000072: to clarify personal values and priorities, health care options, expectations, risks, benefits, and resources in
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
p.000072: cultural bias – prejudice based on community values and traditions
p.000072:
p.000072: culture – the way of life of groups of people that is defined by mores, shared values, traditions and sociopolitical
p.000072: structures and institutions
p.000072:
...
p.000077: standard provides public assurance that the rights, safety, and well- being of trial subjects are protected,
p.000077: consistent with the principles that have their origin in the International Declaration of Helsinki, and that the
p.000077: clinical trial data are credible (CPMP/ICH/135/95)
p.000077:
p.000077: – standards and procedures for clinical trials that encompass the design, protocol approval, monitoring,
p.000077: termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and
p.000077: activities of the sponsor, principal investigators and monitor involved in the clinical trials. The code GCP
p.000077: ensures that the studies are scientifically and ethically sound, and all the clinical properties of the product under
p.000077: investigation are properly documented. For compete information, reference is made to the published WHO and
p.000077: International Conference on Harmonization Code of Good Clinical Practice (Department of Health Administrative
p.000077: Order No. 47-A series of 2001 [August 30, 2001])
p.000077:
p.000077: – a standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses,
p.000077: reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound
p.000077: and that the clinical properties of the pharmaceutical products (diagnostic, therapeutic or prophylactic) under
p.000077: investigation are properly documented (World Health Organization, Guidelines for Good Clinical Practice (GCP) for
p.000077: trials of pharmaceutical products)
p.000077:
p.000077: – set of principles and rules that define the responsibilities of the sponsor, the researcher and participants in a
p.000077: clinical drug trial that ensures ethical conduct of research and integrity of research data
p.000077:
p.000077: good laboratory practices – are standards and procedures whereby a laboratory achieves a defined, consistent, and
p.000077: reliable standard in performing laboratory tests and activities (Department of Health Administrative Order No. 47-A
p.000077: series of 2001 [August 30, 2001])
p.000077:
p.000077: Good Manufacturing Practice Guidelines – national standards and regulations for licensing of laboratories engaged in
p.000077: the manufacture and production of drugs, vaccines and other pharmaceuticals intended for human administration
p.000077: or consumption
p.000077:
p.000077: – that part of quality assurance which ensures that products, including vaccines and biologics are consistently
p.000077: produced and controlled to quality standards appropriate for their intended use, including all phases of vaccine
p.000077: clinical trials, and as required by registration and marketing authorization. For supplementary guidelines for the
p.000077: manufacture of investigational pharmaceutical products for human studies, refer to
p.000077:
p.000078: 78
p.000078:
p.000078: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000078:
p.000078: WHO/Pharm/94.571 (Department of Health Administrative Order No. 47-A series of 2001 [August 30, 2001])
p.000078:
p.000078: – the part of pharmaceutical quality assurance which ensures that products are consistently produced and
p.000078: controlled to the quality standards appropriate to their intended use and as required by marketing
p.000078: authorization (World Health Organization, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000078: products. WHO Technical Report Series, No. 850, 1995, Annex 3)
p.000078:
...
p.000081:
p.000081: mutagenicity – the capacity of a chemical or physical agent to cause genetic alterations
p.000081:
p.000081: national health care delivery system – the total structures – private and public organizations, agencies, and
p.000081: individuals, including policies and mechanisms
p.000081: – that provide health care to individuals and communities in the country
p.000081:
p.000081:
p.000082: 82
p.000082:
p.000082: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000082:
p.000082: National Unified Health Research Agenda (NUHRA) – national health research priorities identified by major stakeholders
p.000082:
p.000082: non-disclosure of data – the withholding of or refusal to reveal information derived from research
p.000082:
p.000082: non-invasive procedure – biological sampling using a method which does not involve intrusion into the human body (e.g.,
p.000082: oral smears)
p.000082:
p.000082: North-South research collaboration – in the broad sense, would refer to the relationship or interaction between the
p.000082: developed and developing countries or rich and poor countries
p.000082:
p.000082: participatory research – research that involves the participation of the investigator in the activities of the research
p.000082: population. It could also involve involves research subjects in the definition of the research agenda, the conduct of
p.000082: research, monitoring and evaluation, and dissemination of results.
p.000082:
p.000082: patent – government instrument that assigns ownership of a product or creative work that is accompanied by certain
p.000082: rights
p.000082: pharmacodynamics – the study of what a drug does to the body pharmacogenetics – the field of biochemical genetics
p.000082: concerned with drug
p.000082: responses due to genetically-controlled variations
p.000082:
p.000082: pharmacokinetics – the study of what the body does to a drug
p.000082:
p.000082: Phase I clinical trial – the first trials of a new active ingredient or new formulations in man, often carried out
p.000082: in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a first outline of
p.000082: the pharmacokinetic and, where possible, a phramacodynamic profile of the active ingredients in humans. (WHO,
p.000082: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000082: Phase II clinical trial –trials performed in a limited number of subjects, often at a later stage of a comparative
p.000082: (e.g., placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and assess short-term safety of
p.000082: the active ingredient in patients suffering from a disease or condition for which the active ingredient is intended.
p.000082: This phase also aims at the determination of appropriate dose ranges or regimens and (if possible) clarification of
p.000082: dose-response relationships in order to provide an optimal background for the design of extensive therapeutic
p.000082: trials (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000083: 83
p.000083:
p.000083: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000083:
p.000083: Phase III clinical trial – trials in larger (and possibly varied) patient groups with the purpose of determining
p.000083: the short- and long-term safety/efficacy balance of formulation/s of the active ingredient, and of assessing its
p.000083: overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated
p.000083: and special features of the product must be explored (e.g., clinically relevant drug interactions, factors leading to
p.000083: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000083: designs may be acceptable (e.g., long-term safety studies). Generally, the conditions under which these trials
p.000083: are carried out should be as close as possible to normal conditions of use. (WHO Guidelines for Good Clinical Practice
p.000083: (GCP) for trials of pharmaceutical products)
p.000083:
p.000083: Phase IV clinical trial – studies performed after marketing of the pharmaceutical product. Trials in this phase are
p.000083: carried out on the basis of the product characteristics on which the marketing authorization was granted and are
p.000083: normally in the form of the post-marketing surveillance, or assessment of therapeutic value or treatment
p.000083: strategies. Although methods may differ, these studies should use the same scientific and ethical standards as applied
p.000083: in pre-marketing studies. After a product has been placed on the market, clinical trials designed to explore new
p.000083: indications, new methods of administration or new combinations, etc., are normality considered as trials for new
p.000083: pharmaceutical products. (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000083: products)
p.000083:
p.000083: Philippine Health Research Ethics Board – was created on March 1, 2006 through DOST Special Order No. 091 series of
p.000083: 2006 as a policy-making body for research ethics in the Philippines
p.000083:
p.000083: Philippine National Health Research System – formally organized in 2004, it was conceptualized in support of a
p.000083: vibrant, dynamic, and responsible health research community working on a unified health research agenda with enhanced
p.000083: cooperation between the Department of Health, the Department of Science and Technology, and the Commission on Higher
p.000083: Education. The Philippine Health Research Ethics Board is one of the six groups working under its Governing Council.
p.000083:
p.000083: placebo – a substance that is not biologically active, does not interact with other substances nor is it expected to
p.000083: affect the health status of an individual
p.000083:
p.000083: – an inactive pill, liquid, or powder that has no treatment value. In clinical trial, experimental treatments are
p.000083: often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the
p.000083: participants in the control group will receive a placebo instead of an
p.000083:
p.000084: 84
p.000084:
p.000084: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000084:
p.000084: active drug or experimental treatment (http://www.Clinicaltrials.gov/ct/ info/whatis. Retrieved May 17, 2006)
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
p.000084: pre-clinical trials – investigation of the pharmacologic properties of a drug or preparation done in animals prior to
p.000084: human studies. Pre-clinical studies shall include pharmacodynamics, pharmacokinetics, and toxicity studies (BFAD
p.000084: Guidelines for Registration of Pharmaceutical Products, 1997)
p.000084:
p.000084: predictive testing – determination of the presence of disease-associated genes prior to the onset or manifestation of
p.000084: the disease
p.000084:
p.000084: predisposition or risk testing – determination of genetic parameters in an individual associated with increased risk of
p.000084: disease
p.000084:
p.000084: prenatal testing – determination of whether a fetus has (or probably has) a designated condition for which an increased
p.000084: risk is indicated by later maternal age, family history, or other well-defined risk factors
p.000084:
p.000084: prior dose finding – quantity or dosage of the herbal medicine established in earlier studies or practice to be
p.000084: effective
p.000084:
p.000084: privacy – a conceptual space defining the individual’s boundary as a person, intrusion of which is limited human rights
p.000084: and by law
p.000084:
p.000084: – the assurance of the secrecy of the identity of or information about research participants
p.000084:
p.000084: product adulteration – presence of foreign substances or impurities in the drug preparation that results in dilution or
p.000084: loss of its efficacy
p.000084:
p.000084: protein – a macromolecule composed of subunits of linear chains of amino acids attached to each other by peptide bonds
p.000084:
p.000084: proteomic data – information from the comprehensive analysis and cataloguing of the structure and function of all the
p.000084: proteins present in a given cell or tissue
p.000084:
p.000084: protocol – is the documentary record of the research undertaking that includes
p.000084:
p.000085: 85
p.000085:
p.000085: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000085:
p.000085: the background of the study, research question and objectives, the conceptual design, the methodology and data
p.000085: collection, and planned analysis of data.
p.000085:
p.000085: – a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of
p.000085: participants as well as answers specific research questions. The protocol describes what types of people may
p.000085: participate in the trial; the schedule of tests, procedures, medications, and dosages; and length of the study. In a
p.000085: clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and
p.000085: determine the safety and effectiveness of their treatment (http:// www.Clinicaltrials.gov/ct/info/whatis. Retrieved May
p.000085: 17, 2006)
p.000085:
p.000085: protocol amendment- a written description of a change to, or formal clarification of a protocol.
p.000085:
p.000085: psychosocial needs – the needs of an individual pertaining to her social and psychological well being
p.000085:
p.000085: quality of life – a state or condition in ones being wherein he/she is able to live as one normal person wants to live
p.000085: it
p.000085:
p.000085: quasi-experimental design – the structure of a research project that does not make use of random assignment to groups
p.000085:
p.000085: randomization – the process of assigning trial subjects to treatment or control groups using an element of chance to
p.000085: determine the assignments in order to reduce bias (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical
p.000085: Practice [E6, R1])
p.000085:
p.000085: Regional Health Research Ethics Board – proposed policy-making body for research ethics in a particular region in the
p.000085: Philippines
p.000085:
p.000085: regulatory requirements – approval of clinical trial by a regulatory agency. For example, for pharmaceutical and
p.000085: biologic products it means obtaining a “permit for clinical investigational use” which is a “registration document
p.000085: issued by the Bureau of Food and Drugs for the purpose of allowing the conduct of Phase I, Phase II, and Phase III
p.000085: clinical trials of investigational biologic products in the country” (Department of Health Administrative Order No.
p.000085: 47-A series of 2001 [August 30, 2001])
p.000085:
p.000085: reportability (of test results) – the inclusion of an event (e.g., a diagnosis, evidence of violence against persons)
p.000085: in a list of items that are mandated by law to be reported to the Department of Health by designated individuals or
p.000085: health professionals because of their impact on public health and safety
p.000085:
p.000086: 86
p.000086:
p.000086: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000086:
p.000086: rescue medication – the drug or procedure used in applying conventional medicine intended to manage a disease
p.000086:
p.000086: research – organized set of activities intended to generate data that are generalizable into new knowledge,
p.000086: principle or technology
p.000086:
p.000086: – Investigative work undertaken on a systematic and rigorous basis using quantitative and qualitative methods to
p.000086: generate new knowledge
p.000086:
p.000086: research ethics review committees
p.000086:
p.000086: National Ethics Committee – organized in 1984 through a Special Order No. 84-053 issued by the Executive Director of
p.000086: the PCHRD to ensure that health research involving human participants is conducted in accordance to
p.000086: international ethical principles. The seven-member committee reviews protocols of researches to be done in sites
p.000086: without functioning Ethics Review Committees
p.000086:
p.000086: Cluster Ethics Review Committee – an ethics review committee shared by (common to) several institutions where the
p.000086: volume of researches and resources do not make it feasible to have an ethics committee in each institution. The
p.000086: functions of the cluster committee and the respective institutional responsibilities shall be contained in a
p.000086: memorandum of agreement amongst the institutions concerned
p.000086:
...
p.000093: medicine. Retrieved (month day, year) from http://www.paho.org/Spanish/AD/THS/EV/PM-WHO
p.000093: Traditional-medicines-research-evaluation.pdf.
p.000093:
p.000093: World Health Organization. (2000). Operational guidelines for ethics committees that review biomedical research.
p.000093: Geneva.
p.000093:
p.000093:
p.000094: 94
p.000094:
p.000094: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000094:
p.000094: World Health Organization. (2005). Operational guidelines for the establishment and functioning of data and safety
p.000094: monitoring boards. Geneva.
p.000094:
p.000094: World Health Organization. (2005). Special Programme for Research and Training in Tropical Diseases (TDR).
p.000094: Geneva.
p.000094:
p.000094: World Health Organization. (2005). Special Programme for Research and Training in Tropical Diseases (TDR).
p.000094: Operational guidance: Information needed to support clinical trials of herbal products. Geneva.
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000095: 95
p.000095:
p.000095: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000095:
p.000095: SUBJECT INDEX
p.000095:
p.000095:
p.000095: Accountability procedures,33 Acknowledgement of contributors, 67 Action on proposals,13
p.000095: Active principle, 39, 68
p.000095: Acupressure,43
p.000095: Adverse drug reaction,30 Adverse events, 68 Adverse reactions,39,52 Advertisements,12 Affiliation, 19
p.000095: Aftercare, 51
p.000095: AIDS, 68
p.000095: Alternative interventions,18 Alternative medicine, 68
p.000095: Amendments, 27,34 Animal products,42 Animal Welfare Act,28 Anonymity,46,49
p.000095: Anonymized samples, 61, 68
p.000095: Approval,13, 68
p.000095: Conditional, 13-14, 71
p.000095: Archival work,48, 68 Aromatherapy,42 Armed conflict,50 Assent, 24,48, 68
p.000095: Assisted reproductive technology, 55, 69
p.000095: Association studies, 57
p.000095: Authorship,29, 66
p.000095: Availability of research product,22 Behavioral research,48, 69
p.000095: Benefits, 69
p.000095: direct, 18,21,26 Benefit sharing,41 Bias, 69
p.000095: Bioethics, capacity in, 64 Biological
p.000095: Samples, 60
p.000095: specimens, 19,45,46
p.000095: Biopsy, -ies, 58 Biosafety,28 Blinding,33,43 ,69
p.000095: see also double blinding
p.000095: Body fluids, 58
p.000095: Bureau of Food and Drug, 30, 32,34 Capacity to give informed consent, 24 Carrier testing, 57, 69
p.000095: Case-control studies,46, 69
p.000095: Cellular metabolites, 57, 70 Children,20,23 Chiropractic,43
p.000095: Clinical epidemiology,45 Clinical equipoise,31, 70 Clinical indication,30 Clinical research, 70
p.000095: Clinical trial,30, 70
p.000095: Phase I, 30, 83
p.000095: Phase II,30, 83
p.000095: Phase III,30, 84
p.000095: Phase IV, 30, 84
p.000095: Closure activities,51
p.000095: Cluster Ethics Review Committees (CERCs), 5, 87
p.000095: coercion,48
p.000095: cohort studies,46,71 collaborative research, externally
p.000095: sponsored,29 commercialization,41 commercial products,19 commercial purpose/s,55 community, -ies, 46,49,50,52,59
p.000095: community
p.000095: advocate,51 leader, 59
p.000095: community participation,28 community priorities,51 comparator product,32, 71 compensation,20,23,47,72 complementary and
p.000095: alternative
p.000095: medicine, 42, 72
p.000095: Completion, 15,18
p.000095: Conception,56, 71
p.000095: Confidentiality,18,19,45,48, 61, 72 Conflict of interest,50,51,72 Consent,46, 61
p.000095: Consent agreement, 62 Contraceptive methods,25
p.000095:
p.000096: 96
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096:
p.000096: Contraceptive implant,36 Control, 72
p.000096: Controlled trials, 17, 72
p.000096: Conventional medicine,42, 73
p.000096: Counseling,49,54,73
p.000096: Gender-sensitive, 56, 77
p.000096: Genetic, 60, 77 Criminal violence,50,73 Cultural beliefs,51 Cultural sensitivity,50,53 Culture bias,54,73
p.000096: Data, administrative, 46
p.000096: Debriefing,49, 73
p.000096: Deception,21,46,49, 73
p.000096: devices, 73
p.000096: biomedical, 59
p.000096: medical, 35
p.000096: Diagnostic/s, 59 ,73 procedures,35,36
p.000096: Dietary supplements,42 Disapproval, 13,14, 73 Discontinuation,33 Disclosure,22,45, 60, 61,
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
...
Searching for indicator influence:
(return to top)
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
p.000019: 5. The participation of children in research requires extra protection, as children cannot volunteer to participate
p.000019: in a research study in the same way as an adult can. While they cannot give informed consent, they can participate in
p.000019: the process of
p.000019:
p.000020: 20
p.000020:
p.000020: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000020:
p.000020: obtaining consent by being asked for their assent to participate. When appropriate, both a child’s assent and the
p.000020: parent’s or guardian’s permission should be obtained prior to enrolling a child in a research study.
p.000020:
p.000020: 6. In obtaining informed consent, sponsors and investigators have a duty to:
p.000020:
p.000020: a. avoid deception, undue influence, or intimidation;
p.000020:
p.000020: b. seek consent only after ascertaining that the prospective subject has adequate understanding of the
p.000020: relevant facts and the consequences of participation, and has had sufficient opportunity to consider whether to
p.000020: participate;
p.000020:
p.000020: c. as a general rule, obtain from each prospective subject a signed form as evidence of informed consent;
p.000020: investigators shall justify any exceptions to this general rule and obtain the approval of the ethics review committee;
p.000020:
p.000020: d. renew the informed consent of each subject if there are any significant changes in the conditions or
p.000020: procedures of the research, or if new information becomes available that could affect the willingness of
p.000020: subjects to continue to participate;
p.000020:
p.000020: e. renew the informed consent of each subject in long-term studies at pre-determined intervals even if there are
p.000020: no changes in the design or objectives of the research (Guideline 6 - CIOMS, 2002).
p.000020:
p.000020: Risks, benefits, 7. Health research is only justified if there is a and safety
p.000020: reasonable likelihood that the populations in which
p.000020: the research is carried out stand to benefit from
p.000020:
p.000021: 21
p.000021:
p.000021: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000021:
p.000021: the research results (Principle 19 – Declaration of Helsinki, 2004).
p.000021:
...
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
p.000090: Philippines, providing for a Traditional and Alternative Health Care Development Fund and for other purposes
p.000090:
p.000090: traditional healer – the relatively old, highly placed respected person in the community, with a profound knowledge of
p.000090: traditional remedies
p.000090:
p.000090: traditional medicine – the sum total of knowledge, skills, and practices in health care, not necessarily explicable in
p.000090: the context of modern, scientific, philosophical framework, but recognized by the people to help maintain and improve
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
p.000090: traditional medicine expert – a health care provider employing traditional medicine modalities to give a cure
p.000090: traumatized populations – are individuals who live in communities that have experienced extreme forms of life-
p.000090: threatening stress due to natural calamities or human atrocities such as armed conflict, political repression as well
p.000090: as criminal and domestic violence.
p.000090:
p.000090: trial-related expenses – costs incurred in the course of litigation
p.000090:
p.000090: – Expenses incurred by study participants related to their participation in a research study such as transportation,
p.000090: meals, loss of income.
p.000090:
p.000090: undue influence – improper influence that deprives a person of freedom of choice or substitutes another’s choice or
p.000090: desire for the person’s own. Note: It is a doctrine of equity that a contract, deed, donation. Or
p.000090: testamentary disposition can be set aside if the court finds that someone has exercised undue influence over the
p.000090: maker at the time that the contrast, conveyance, or will was made. To establish a prima facie case it is usually
p.000090: necessary to show a susceptibility to undue influence (as from mental impairment), the opportunity and
p.000090: disposition on someone’s part to exercise such influence, and that the transaction
p.000090:
p.000091: 91
p.000091:
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: vulnerable groups – classes of individuals who have characteristics that lessen their capacity to protect their own
p.000091: interests or promote their own welfare
p.000091:
p.000091: waiver of informed consent – the act of intentionally or knowingly relinquishing or abandoning the right to consent to
p.000091: medical treatment by a patient or to participation in a medical experiment by a subject after achieving an
p.000091: understanding of what is involved and especially for the risks (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: – Permission given by an Ethics Review Committee for research to be conducted without the informed consent of subjects,
p.000091: under exceptional circumstances, such as when research has to be undertaken in an emergencyXsituation
p.000091:
p.000091: Western medicine – or biomedicine, allopathy, regular medicine, conventional medicine, mainstream medicine, orthodox
p.000091: medicine or cosmopolitan medicine, refers to medical care that advocates therapy that produces effects differing from
p.000091: those of the diseases treated (TAMA 1997)
p.000091:
...
Searching for indicator substance:
(return to top)
p.000065:
p.000065: 5. The list of authors shall include a guarantor who will assume responsibility for the integrity of the whole
p.000065: scientific paper.
p.000065:
p.000066: 66
p.000066:
p.000066: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000066:
p.000066: Publication 6. Every listed author must share part of the
p.000066: responsibility for -
p.000066:
p.000066: a. Drafting the article or revising it for intellectual content, and
p.000066: b. The final approval of the version to be published.
p.000066:
p.000066: 7. In submitting articles for publication, the authors must provide the following to the editor:
p.000066:
p.000066: a. Contribution of each author to the paper;
p.000066: b. Acknowledgment of contributors other than the authors; and
p.000066: c. Statement that the authors observed ethics review committee requirements, the National Ethical Guidelines for
p.000066: Health Research, and pertinent guidelines on the care and use of animals.
p.000066:
p.000066: 8. The authors shall obtain the informed consent of subjects as a condition for the publication of photographs
p.000066: or identifiable information.
p.000066:
p.000066: 9. Sponsors or other interested parties may not impose impediments to the publication of research outcomes.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000067:
p.000067: GLOSSARY
p.000067:
p.000067: active principle (in medicinal preparations) – the substance in a medicinal preparation that is bringing
p.000067: about the clinical effects expected or observed
p.000067:
p.000067: adverse events – any untoward medical occurrence in a patient or clinical investigation participant
p.000067: administered an investigational product and which does not necessarily have a causal relationship with this treatment.
p.000067:
p.000067: serious adverse event – the adverse event is serious and should be reported when the outcome is death,
p.000067: life-threatening, hospitalization, disability, congenital anomaly and requires intervention to prevent permanent
p.000067: impairment or damage
p.000067:
p.000067: serious and unexpected adverse event – the unexpected adverse drug reaction is an adverse reaction, the nature or
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
...
p.000067: The assent is a requirement for research in addition to consent given by a parent or legal guardian
p.000067:
p.000067: child’s assent – is the expressed willingness of a minor to participate in a study
p.000067:
p.000068: 68
p.000068:
p.000068: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000068:
p.000068: assisted reproductive technology – all treatment or procedures that include the in-vitro handling of human oocytes and
p.000068: human sperm or embryos for the purpose of establishing a pregnancy (e.g., in vitro fertilization and transcervical
p.000068: embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, gamete
p.000068: and embryo cryopreservation, oocyte and embryo donation, gestational surrogacy)
p.000068:
p.000068: behavioral research – studies regarding the actions or reactions of persons in response to external or internal stimuli
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
p.000068: bias – the systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the
p.000068: results of a clinical trial to make the estimate of a treatment effect deviate from its true value (ICH Harmonized
p.000068: Tripartite Guideline, General Considerations for Clinical Trial (E8)
p.000068:
p.000068: blinding/masking – a procedure in which one or more parties of the trial are kept unaware of the treatment
p.000068: assignment/s. Single blinding usually refers to the subject/s being unaware, and double-blinding usually refers to the
p.000068: subject/s, investigator/s, monitor, and, in some cases, data analyst/ s being unaware of the treatment
p.000068: assignment/s (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000068:
p.000068: carrier testing – testing to identify individuals who carry recessive genes; testing designed for healthy people who
p.000068: have no symptoms of disease, but who are known to be at high risk because of family history
p.000068:
p.000068: case-control study – type of investigation that attempts to look backward in time to identify characteristics that
p.000068: may have contributed to disease development by comparing responses of cases (those affected with the disease) and
p.000068: controls (the unaffected persons)
p.000068:
p.000068:
p.000069: 69
p.000069:
p.000069: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000069:
...
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
p.000072: cultural bias – prejudice based on community values and traditions
p.000072:
p.000072: culture – the way of life of groups of people that is defined by mores, shared values, traditions and sociopolitical
p.000072: structures and institutions
p.000072:
p.000072: debriefing – the process of obtaining information about an experience from an individual who has participated in, or
p.000072: observed particular events
p.000072:
p.000072: deception – an act characterized by dishonesty, fraud, trickery or sham for the purpose of manipulating another person
p.000072: into making a decision that he or she would not have made otherwise
p.000072:
p.000072: deoxyribonucleic acid (DNA) – an antiparallel double helix of nucleotides (having deoxyribose as their sugars) linked
p.000072: by phosphodiester (sugar-phosphate) bonds to adjacent nucleotides in the same chain and by hydrogen bonds to
p.000072: complementary nucleotides in the opposite chain. The fundamental substance of which genes are composed.
p.000072:
p.000072: deoxyribonucleic acid sequencing – method of analyzing the base sequence composition and order of a DNA sample using
p.000072: chemical tagging and physical measurements
p.000072: devices – a piece of equipment designed to served a clinical purpose diagnostics – procedure or technique used in the
p.000072: identification of a disease or
p.000072: determination of the health status of an individual
p.000072:
p.000072: disapproval – a negative action of the Ethics Committee on the protocol. The study cannot be implemented if it has been
p.000072: disapproved by the Ethics Committee
p.000072:
p.000073: 73
p.000073:
p.000073: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000073:
p.000073: disclosure of data – the giving of information in connection with proposed research undertaking or the sharing of
p.000073: the results of the study especially as they pertain to the individual’s of the family’s health situation
p.000073:
p.000073: disease allele – one of the variant forms of a disease gene at a particular locus, or location, on a chromosome.
p.000073: Different alleles produce variation in inherited characteristics such as hair color or blood type. In an individual,
p.000073: one form of the allele (the dominant one) may be expressed more than another form (the recessive one)
p.000073:
p.000073: disease susceptibility/predisposition – the pathophysiological conditions and genetic inclination that favor the
p.000073: development of a disease condition
p.000073:
p.000073: domestic violence – violence committed by one family or household member against another (Merriam-Webster’s Dictionary
p.000073: of Law (c) 1996)
p.000073:
p.000073: double blinding – is one in which neither the subject nor any of the investigator or sponsor staff who are involved in
p.000073: the treatment or clinical evaluation of the subjects are aware of the treatment received (ICH Harmonized Tripartite
p.000073: Guideline, Statistical Principles for Clinical Trials (E9) p8)
p.000073:
p.000073: drugs – a substance used as medication or used in the diagnosis, cure, mitigation, treatment or prevention
p.000073: of disease
p.000073:
p.000073: duress – wrongful and usually unlawful compulsion (as threats of physical violence) that induces a person to act
p.000073: against his or her will: ‘coercion” (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000073:
p.000073: efficacy – is the ability of a treatment modality to produce an effect to alleviate a disease
p.000073:
p.000073: embryo – the stage of human development following implantation (starting 10- 14 days), when the primitive streak begins
p.000073: to form up to fetal stage
p.000073:
p.000073: epidemiologic research – investigative studies intended to establish “the distribution and determinants of
p.000073: disease frequency in human populations”
p.000073:
p.000073: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the determinants of the
p.000073: incidence of diseases as well as their related risk factors, etiology and causation
p.000073:
p.000073: epidemiology – the basic medical science that focuses on the distribution and determinants of disease frequency in
p.000073: human populations (Raymond Greenberg, Medical Epidemiology, 1993)
p.000073:
p.000074: 74
p.000074:
p.000074: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000074:
p.000074: ethical clearance – a certification that a research proposal has complied with ethical requirements
p.000074:
...
p.000083: carried out on the basis of the product characteristics on which the marketing authorization was granted and are
p.000083: normally in the form of the post-marketing surveillance, or assessment of therapeutic value or treatment
p.000083: strategies. Although methods may differ, these studies should use the same scientific and ethical standards as applied
p.000083: in pre-marketing studies. After a product has been placed on the market, clinical trials designed to explore new
p.000083: indications, new methods of administration or new combinations, etc., are normality considered as trials for new
p.000083: pharmaceutical products. (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000083: products)
p.000083:
p.000083: Philippine Health Research Ethics Board – was created on March 1, 2006 through DOST Special Order No. 091 series of
p.000083: 2006 as a policy-making body for research ethics in the Philippines
p.000083:
p.000083: Philippine National Health Research System – formally organized in 2004, it was conceptualized in support of a
p.000083: vibrant, dynamic, and responsible health research community working on a unified health research agenda with enhanced
p.000083: cooperation between the Department of Health, the Department of Science and Technology, and the Commission on Higher
p.000083: Education. The Philippine Health Research Ethics Board is one of the six groups working under its Governing Council.
p.000083:
p.000083: placebo – a substance that is not biologically active, does not interact with other substances nor is it expected to
p.000083: affect the health status of an individual
p.000083:
p.000083: – an inactive pill, liquid, or powder that has no treatment value. In clinical trial, experimental treatments are
p.000083: often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the
p.000083: participants in the control group will receive a placebo instead of an
p.000083:
p.000084: 84
p.000084:
p.000084: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000084:
p.000084: active drug or experimental treatment (http://www.Clinicaltrials.gov/ct/ info/whatis. Retrieved May 17, 2006)
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
p.000084: pre-clinical trials – investigation of the pharmacologic properties of a drug or preparation done in animals prior to
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.002006: Foreword
p.002006: Estrella F. Alabastro, Ph.D. iii
p.002006: Message
p.002006: Francisco T. Duque III, MD, M.Sc iv
p.002006: Acknowledgments v
p.002006: How to Use the Guidelines viii
p.002006: Abbreviations
p.002006: x
p.002006: Introduction
p.000001: 1
p.000001: Ethics Review Authorities 3
p.000001: The Research Ethics Review Process 11
p.000001: General Ethical Guidelines for Health Research 16
p.000001: Special Guidelines
p.000001: Ethical Guidelines for Clinical Trials on Drugs, Devices, and Diagnostics 30
p.000001: Ethical Guidelines for Herbal Research 38
p.000001: Ethical Guidelines for Complementary and Alternative Medicine Research 42
p.000001: Ethical Guidelines for Epidemiologic Research 45
p.000001: Ethical Guidelines for Social and Behavioral Research 48
p.000001: Ethical Guidelines for the Conduct of Research on Populations
p.000001: Traumatized in Emergencies and Disasters 50
p.000001: Ethical Guidelines for HIV/AIDS Research 53
p.000001: Ethical Guidelines for Research on Assisted Reproductive Technology 55
p.000001: Ethical Guidelines for Genetic Research with a Section
p.000001: on Stem Cell Research 57
p.000001: Ethical Guidelines for International Collaborative Research 64
p.000001: Guidelines on Authorship and Publication 66
p.000001: Glossary
p.000068: 68
p.000068: Bibliography
p.000093: 93
p.000093: Index
p.000096: 96
p.000096: Appendices
p.000096: Appendix A – Template for Patient Information and Informed
p.000096: Consent Form 101
p.000096: Appendix B – Standard Application Form for Ethical Evaluation of Proposal 103
p.000096: Appendix C – List of Documents that Proponent/s Should Provide
p.000096: an Ethics Review Committee 104
p.000096: Appendix D – Composition of the National Ethics Commiittee 105
p.000096: Appendix E – Composition of the Philippine Health
p.000096: Research Ethics Board 106
p.000096: vii
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: HOW TO USE THE GUIDELINES
p.000096:
p.000096: This set of Guidelines is divided into two major topics: 1) the General Guidelines on ethical review of health
p.000096: research, and 2) the Special Guidelines on specific research areas, namely a) clinical trials on drugs, devices,
p.000096: and diagnostics; b) herbal medicine research; c) complementary and alternative medicine research; d) epidemiological
p.000096: research; e) social and behavioral research; f) research involving traumatized populations;
p.000096: g) HIV/AIDS research; h) research on assisted reproductive technology; and i) genetic research that includes a section
p.000096: on stem cell research. Guidelines on international collaborations and authorship and publications complete this new set
p.000096: of ethical guidelines.
p.000096:
p.000096: In the past few years, the use of the term “human subjects” in reference to individuals involved in the research has
p.000096: been criticized especially by social scientist as an objectification of persons. The recommendation is to use the term
p.000096: “human participants”. However, participation in research includes involvement in the different phases of
p.000096: research including identification of objectives and designing the protocol. In practice, many of health researches are
p.000096: conceptualized without the input of the potential “participants” and therefore, the use of the latter term is
p.000096: inaccurate. In this set of guidelines, therefore the terms “human subjects” and “human participants” are used
p.000096: interchangeably.
p.000096:
p.000096: Three appendices are provided in these guidelines. Appendix A is a template for patient information and informed
p.000096: consent forms. The template lists the essential information that should be reflected in the patient information and
p.000096: informed consent forms. By answering each question under each heading, the proponent/s would be able to make the
p.000096: potential study participant understand the nature, risks, and benefits of his/her participation in the study, and
p.000096: thus be able to decide to participate or not. Appendix B is the standard application form for ethical evaluation
...
p.000096: the reader to all the sections where a particular item appears.
p.000096:
p.000096: Much effort was exerted to make this guidebook easy to use by researchers, by members of the ERCs and
p.000096: funding agencies, by research policy makers and even by young students in health research.
p.000096:
p.000096: For questions, please call/ email –
p.000096:
p.000096: The Secretariat, Philippine Health Research Ethics Board (PHREB) Philippine Council for Health Research and Development
p.000096: Department of Science and Technology
p.000096: General Santos Avenue, Bicutan, Taguig City Telephone Number(s): 837-7535/36
p.000096: Fax Number: 837-2924
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096: ix
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: ABBREVIATIONS
p.000096: AO - administrative order
p.000096: BFAD - Bureau of Food and Drugs
p.000096: CAM - complementary and alternative medicine CERC - Cluster Ethics Review Committee
p.000096: CIOMS - Council of International Organizations of Medical Sciences DA - Department of
p.000096: Agriculture
p.000096: DNA - deoxyribonucleic acid DOH - Department of Health
p.000096: DOST - Department of Science and Technology ERC - Ethics Review Committee
p.000096: HIV/AIDS - human immunodeficiency virus / acquired immune deficiency syndrome
p.000096: ICH - International Conference on Harmonization IERC - institutional ethics review committee
p.000096: NCCAM - National Center for Complementary and Alternative Medicine
p.000096: NEC - National Ethics Committee
p.000096: PALAS - Philippine Association for Laboratory Animal Science PCHRD - Philippine Council for Health
p.000096: Research and Development PHREB - Philippine Health Research Ethics Board
p.000096: PNHRS - Philippine National Health Research System POGS - Philippine Obstetrical and Gynecological
p.000096: Society RNA - ribonucleic acid
p.000096: SAE - serious adverse event TM - traditional medicine TWG - Technical Working
p.000096: Group
p.000096: WHO - World Health Organization
p.000096:
p.000096: x
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: INTRODUCTION
p.000096:
p.000096: “Research investigators should be aware of the ethical, legal, and regulatory requirements for research on human
p.000096: subjects in their own countries as well as applicable international requirements. No national ethical, legal or
p.000096: regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in
p.000096: the Declaration of Helsinki” (Helsinki, 2004, 9).
p.000096:
...
p.000006: officially appointed by the administrative head of the institution.
p.000006:
p.000006: 4. The appointing official shall indicate their functions, terms of office, scope of work, conditions of
p.000006: appointment, and compensation, if any.
p.000006:
p.000006: 5. Procedures for renewal of appointment, resignation, replacement; grounds for disqualification;
p.000006: and procedures in regard to conflict of interest due to financial gains shall be included in the manual of
p.000006: standard operating procedures.
p.000006:
p.000006: 6. Prior to serving as a regular member, each member of the IERC shall sign a disclosure document which
p.000006: states that he/she has no conflict of interest (e.g., financial interests in a pharmaceutical company) as a
p.000006: reviewer, and a confidentiality agreement.
p.000006:
p.000006: 7. The appointing official should consider “a fixed rotation system for members that allows for continuity, the
p.000006: development and maintenance of expertise within the committee, and the regular input of fresh ideas and
p.000006: approaches” (WHO Operational Guidelines for Ethics Committees that Review Biomedical Research, 2000).
p.000006:
p.000006: External 8. The committee shall establish a list of external consultants consultants
p.000006: who can provide special expertise
p.000006:
p.000007: 7
p.000007:
p.000007: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000007:
p.000007: regarding ethical, scientific, psychological or social aspects of researches for review.
p.000007:
p.000007: 9. In deliberations on research involving special subject groups or concerns (e.g., HIV/AIDS, the physically
p.000007: challenged), best efforts must be exerted to include participation of advocates.
p.000007:
p.000007: Functions and 10. The IERC is responsible for “acting in the full Responsibilities interest of
p.000007: potential research participants and
p.000007: affected communities, taking into account the interests and needs of the researchers, and having due regard
p.000007: for the requirements of relevant regulatory agencies and applicable laws” (WHO Operational Guidelines for Ethics
p.000007: Committees that Review Biomedical Research, 2000). In the Philippines, the regulatory agencies include
p.000007: PNHRS-PHREB, DOH-BFAD, and the National Committee on Biosafety.
p.000007:
p.000007: 11. The IERC’s functions are as follows:
p.000007:
p.000007: a. To evaluate the conduct of research in their institutions in accordance with international and national
p.000007: guidelines; local laws; standards of professional conduct and practice; and community mores, values, and needs;
p.000007: b. To promote research integrity by identifying and resolving conflicts of interest;
p.000007: c. To establish appropriate mechanisms in all stages of the research in order to:
p.000007: 1) ensure the safety, protect the rights, and promote the welfare and well-being of human participants,
p.000007: 2) provide counsel to human participants, including proponents and researchers,
p.000007: 3) ensure prompt reporting of changes in the protocol and unanticipated problems,
...
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000014:
p.000014: Completion of 15. Upon completion of the research, the investigator the research shall inform the
p.000014: ERC in writing that the study has
p.000014: been completed, and shall furnish the committee a copy of the final report.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000015:
p.000015: GENERAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000015:
p.000015: Introduction
p.000015:
p.000015: For the purposes of these guidelines, an activity is deemed to be “research” if it aims to develop or
p.000015: contribute to generalizable knowledge (including theories, principles, relationships, or any accumulation of
p.000015: information using scientific methods, observation, and inference).
p.000015:
p.000015: These general guidelines shall govern all health researches involving human subjects. Additionally, special guidelines
p.000015: on clinical trials (pp30- 37), herbal medicine research (pp38-41), complementary and alternative medicine research
p.000015: (pp42-44), epidemiological research (pp45-47), social and behavioral research (pp48-49), research involving
p.000015: traumatized populations (pp50-52), HIV/AIDS research (pp53-54), research on assisted reproductive technology
p.000015: (pp55-56), and genetic research (pp57- 63), international/collaborative research (pp64-65), have been formulated
p.000015: because of special concerns that have been identified by practitioners.
p.000015:
p.000015: Health research involving human subjects includes research on identifiable human material or identifiable data
p.000015: (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: Considerations related to the well-being of the human subject should take precedence over the interests of science and
p.000015: society (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: It is the duty of the researcher to protect the life, health, privacy, and dignity of the human subjects, and to
p.000015: safeguard scientific integrity.
p.000015:
p.000015:
p.000015: I. Elements of Research Ethics
p.000015:
p.000015: Informed consent 1. For all biomedical research involving humans, the
p.000015: investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who
p.000015: is incapable of giving informed consent, the permission of a legally authorized representative in accordance with
p.000015: applicable laws.
p.000015:
p.000016: 16
p.000016:
p.000016: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000016:
...
p.000051: and the mechanisms that are being put in place to address them.
p.000051:
p.000051: Recruitment 11. The researchers must consult the community and and informed secure its
p.000051: permission before approaching consent individuals for their informed consent.
p.000051:
p.000051: 12. The research team must identify factors that serve as a barrier to the freedom of individual members of the
p.000051: subject population to give consent, and provide effective mechanisms to address them.
p.000051:
p.000051: Community 13. The study design must demonstrate the principles participation of participatory
p.000051: research and describe the
p.000051: involvement of the community participants in research planning, design, conduct, analysis,
p.000051: validation/feedback, and utilization.
p.000051:
p.000051: Non-disclosure 14. The withholding or non-disclosure of pertinent of information information
p.000051: must be justified in the context of
p.000051: protecting the participants from specific harm or risks and must be done according to the ethical guidelines for social
p.000051: science research (pp48-49), and with the approval of the ethics review committee.
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000052: 52
p.000052:
p.000052:
p.000052:
p.000052: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000052:
p.000052: ETHICAL GUIDELINES FOR HIV/AIDS RESEARCH
p.000052:
p.000052:
p.000052: Introduction
p.000052:
p.000052: HIV/AIDS research encompasses a wide range of health research that includes basic research on the infectious
p.000052: agent and its effect on individuals, clinical trials on vaccines and other therapeutic protocols, and
p.000052: investigations on the psychosociocultural aspect of HIV/AIDS. The basic principles of research ethics shall, therefore,
p.000052: apply in all these activities as they apply to other health research activities. However, institutional
p.000052: research ethics committees, researchers, and funding agencies should pay special attention to the issues of
p.000052: justice and respect for groups and individuals affected by HIV/AIDS as their condition gives them distinct
p.000052: vulnerabilities because of the cultural sensitivity of reproductive health issues.
p.000052:
p.000052: For a more detailed discussion of ethical issues, the reader is referred to the Ethical Guidelines in AIDS
p.000052: Investigations in the Philippines published by the Philippine National AIDS Council and the AIDS Society of the
p.000052: Philippines, and the Philippine AIDS Prevention and Control Act of 1998.
p.000052:
p.000052: General 1. All research involving human subjects should be
p.000052: guidelines conducted in accordance with the ethical
p.000052: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000052:
p.000052: Special guidelines
p.000052:
p.000052: Identification 2. The recruitment process shall be sensitive to the consent social
p.000052: implications of being identified as a potential HIV/AIDS case or of belonging to a high-risk
p.000052: group. Specific mechanisms to protect the privacy of individuals shall be described and put in place.
p.000052:
p.000052: 3. Special attention shall be given to the possible sensitive nature of the information to be extracted from the
p.000052: research participants and, if applicable, the necessity of undergoing an HIV test. It is also important to determine
p.000052: the participant’s willingness to be informed of the test result, the test’s
p.000052:
p.000053: 53
p.000053:
p.000053:
p.000053:
p.000053: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000053:
p.000053: reportability, and the implication on his/her sexual activities if found positive.
p.000053:
p.000053: The participant must also be informed that he/ she is free to withdraw from the study anytime.
p.000053:
p.000053: Pre- and 4. Pre- and post-test counseling by well-trained, post-test
p.000053: culture- and gender-sensitive research personnel counseling shall be put in place as part of
p.000053: the research
p.000053: protocol.
p.000053:
p.000053: Standard 5. In an interventional study, the control group shall of care receive
p.000053: the standard of care accepted by the larger community. It is unethical to subject the
p.000053: control group of affected individuals to placebo treatment or be withdrawn from the current mode of treatment before
p.000053: the start of the study.
p.000053:
p.000053: Research 6. Special effort shall be exerted to make the benefits beneficial
p.000053: findings of the research project accessible and available to participants under
p.000053: reasonable circumstances.
p.000053:
p.000053: Use of 7. Special care shall be taken in the public use of research data research data
...
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000067:
p.000067: GLOSSARY
p.000067:
p.000067: active principle (in medicinal preparations) – the substance in a medicinal preparation that is bringing
p.000067: about the clinical effects expected or observed
p.000067:
p.000067: adverse events – any untoward medical occurrence in a patient or clinical investigation participant
p.000067: administered an investigational product and which does not necessarily have a causal relationship with this treatment.
p.000067:
p.000067: serious adverse event – the adverse event is serious and should be reported when the outcome is death,
p.000067: life-threatening, hospitalization, disability, congenital anomaly and requires intervention to prevent permanent
p.000067: impairment or damage
p.000067:
p.000067: serious and unexpected adverse event – the unexpected adverse drug reaction is an adverse reaction, the nature or
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
p.000067: The assent is a requirement for research in addition to consent given by a parent or legal guardian
p.000067:
p.000067: child’s assent – is the expressed willingness of a minor to participate in a study
p.000067:
p.000068: 68
p.000068:
p.000068: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000068:
p.000068: assisted reproductive technology – all treatment or procedures that include the in-vitro handling of human oocytes and
...
p.000078: environment, energy and agricultural policies (PNHRS TWG Chairs, Feb 2004)
p.000078:
p.000078: – investigational activities that aim to generate data that shall contribute to improvement in the diagnosis,
p.000078: prevention and management of diseases, and in the delivery of care and for the enhancement of the quality of
p.000078: life of individuals and health conditions in communities
p.000078:
p.000078: herbal medicine research – study undertaken to generate new knowledge regarding the use of herbs and plants
p.000078: to prevent and treat diseases and ailments or to promote health and healing
p.000078:
p.000078: herbal medicines – finished, labeled medicinal products that contain as active ingredient/s serial or underground
p.000078: part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations
p.000078:
p.000079: 79
p.000079:
p.000079: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000079:
p.000079: (TAMA of 1997). Plant materials include juices, gums, fatty oils, essential oils, and other substances of this nature.
p.000079: Herbal medicines, however, may contain excipients in addition to the active ingredient/s. Medicines containing plant
p.000079: material/s combined with chemically defined active substances, including chemically defined isolated constituents of
p.000079: plants, are not considered herbal medicines
p.000079:
p.000079: high-risk group – social group known to have a high prevalence of a health problem because of shared environmental,
p.000079: occupational, nutritional or genetic factors including practices that contribute to ill-health
p.000079:
p.000079: HIV (human immunodeficiency virus – type 1) – viral infectious agent that causes destruction of cellular immunity in
p.000079: individuals acquired through tissue fluid transmission from infected persons
p.000079:
p.000079: HIV/AIDS research – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the
p.000079: prevention or treatment of HIV/ AIDS
p.000079:
p.000079: HIV test – immunology-based laboratory test that establishes the presence of HIV infection in an individual
p.000079:
p.000079: human subjects – see research participants
p.000079:
p.000079: hypothesis – a tentative explanation for an observation, phenomenon, or scientific problem that can be tested by
p.000079: further investigation
p.000079:
p.000079: independent consultant – An expert who gives advice comments and suggestions upon review of the study protocols with no
p.000079: affiliation to the institute or investigators proposing the research proposals
p.000079:
p.000079: information in the public domain – data or information available and open to public observation like the list of names
p.000079: in the telephone directory, or events in streets and public transportation
p.000079:
p.000079: informed consent (verbal, video, written) – the process of obtaining approval to participate in an investigative
p.000079: study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An
p.000079: important part of the process is the adequacy, appropriateness, and timeliness of the information for decision-making
p.000079:
p.000079: intellectual property rights – the legal basis by which indigenous communities exercise their rights to have access to,
p.000079: protection, and control over their cultural knowledge and products, including but not limited to traditional medicines,
p.000079: and includes the right to receive compensation for it
p.000079:
p.000080: 80
p.000080:
p.000080: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000080:
...
p.000096: medical, 35
p.000096: Diagnostic/s, 59 ,73 procedures,35,36
p.000096: Dietary supplements,42 Disapproval, 13,14, 73 Discontinuation,33 Disclosure,22,45, 60, 61,
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
p.000096: Feasibility, 27, 76
p.000096: Feedback session, 49
p.000096: Fertilization success, 55
p.000096: Fetus, 76
p.000096:
p.000097: 97
p.000097:
p.000097: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000097:
p.000097:
p.000097: aborted, 63
p.000097: Forensic medicine, 59
p.000097: Gender, 77
p.000097: Gender bias,54, 77
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
...
Searching for indicator hiv/aids:
(return to top)
Health / Healthy People
Searching for indicator healthy people:
(return to top)
p.000068:
p.000068: behavioral research – studies regarding the actions or reactions of persons in response to external or internal stimuli
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
p.000068: bias – the systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the
p.000068: results of a clinical trial to make the estimate of a treatment effect deviate from its true value (ICH Harmonized
p.000068: Tripartite Guideline, General Considerations for Clinical Trial (E8)
p.000068:
p.000068: blinding/masking – a procedure in which one or more parties of the trial are kept unaware of the treatment
p.000068: assignment/s. Single blinding usually refers to the subject/s being unaware, and double-blinding usually refers to the
p.000068: subject/s, investigator/s, monitor, and, in some cases, data analyst/ s being unaware of the treatment
p.000068: assignment/s (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000068:
p.000068: carrier testing – testing to identify individuals who carry recessive genes; testing designed for healthy people who
p.000068: have no symptoms of disease, but who are known to be at high risk because of family history
p.000068:
p.000068: case-control study – type of investigation that attempts to look backward in time to identify characteristics that
p.000068: may have contributed to disease development by comparing responses of cases (those affected with the disease) and
p.000068: controls (the unaffected persons)
p.000068:
p.000068:
p.000069: 69
p.000069:
p.000069: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000069:
p.000069: cellular metabolites – the molecular substrates and products of various cellular processes
p.000069:
p.000069: chief/principal investigator – the person primarily responsible for the implementation of a research project
p.000069:
p.000069: clinical equipoise – “The ethics of medical practice grants no ethical or normative meaning to a treatment preference,
p.000069: however powerful, that is, based on a hunch or anything less than evidence publicly presented and convincing
p.000069: to the clinical community. Persons are licensed as physicians after they demonstrate the acquisition of this
p.000069: professionally validated knowledge, not after they reveal a superior capacity for guessing.” (Freedman, 1987)
p.000069:
p.000069: – a state of clinical equipoise means that on the basis of available data, a condition of genuine uncertainty on the
p.000069: part of the clinical investigator/ s and/or a community of medical experts exists regarding the comparative therapeutic
p.000069: merits of each arm in a trial. Thus they would be content to have their patients/clients pursue any of the treatment
...
Searching for indicator healthy volunteers:
(return to top)
p.000034: which the patient refuses treatment, and when such refusal for therapy will not lead to unjustified affliction
p.000034: or irreparable damage or harm
p.000034:
p.000034: Informed 14. Refer to section on Informed Consent in the consent General
p.000034: Ethical Guidelines for Health Research
p.000034: (pp16-29).
p.000034:
p.000034: Therapy versus 15. The difference between therapy and research research shall be upheld
p.000034: throughout a clinical trial. The
p.000034: investigator/s shall ensure that participants comprehend and keep in mind that in a clinical trial, the drug is
p.000034: experimental and that its benefits are currently being proven.
p.000034:
p.000034: Research on 16. Clinical trials of medical devices, diagnostic medical devices, procedures, and
p.000034: preventive measures, including diagnostic vaccines, raise similar ethical concerns especially
p.000034: procedures and on free and informed consent, and potential preventive measures conflict of interest.
p.000034:
p.000034: a. Trials of critical medical devices such as implants which may present a potential serious risk to health,
p.000034: safety or welfare of the subject shall not be conducted on healthy volunteers. The current safety data on the medical
p.000034: device shall be gathered and the risks posed by the device considered and evaluated. Safety procedures in the
p.000034: introduction of such medical device in the patient shall be followed. The patient information sheet shall contain
p.000034: information on procedures to be adopted should the patient decide to withdraw from the trial. Medical devices
p.000034: that are not used regularly have less risk- potential than those used regularly. Likewise, devices used outside the
p.000034: body have less risk than those used inside the body.
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035:
p.000035: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000035:
p.000035: b. In the case of contraceptive implant trials, adequate monitoring for removal of the implant shall be done
p.000035: when the trial is over or the subject has withdrawn from the trial. Children born as a result of failure
p.000035: of the contraceptive being investigated shall be followed up for any abnormalities and properly reported to
p.000035: monitoring authorities.
p.000035:
p.000035: c. For vaccine trials using active or live attenuated microorganisms, the subject may be exposed to the
p.000035: specific infection for which the vaccine is being tested. As such, the vaccinated subject shall be
p.000035: informed accordingly and properly cared for.
p.000035:
p.000035: d. Clinical trials involving diagnostic agents using radioactive materials and X-ray should not necessarily
p.000035: expose subjects to more radiation than normal and shall be undertaken on patients undergoing the procedure
...
Searching for indicator volunteers:
(return to top)
p.000038: Conference on Harmonization Good Clinical Practice Guidelines and Good Manufacturing Practice guidelines.
p.000038:
p.000038: 5. Although efficacy of herbal preparations is a major objective of herbal researches, adverse reactions such as
p.000038: side effects, tolerance profile, and interaction with other administered preparations should always be part of
p.000038: herbal research.
p.000038:
p.000038: 6. Research in herbal remedies should include standardization of the preparation and identification of markers
p.000038: to ensure that the ingredients being
p.000038:
p.000039: 39
p.000039:
p.000039:
p.000039:
p.000039: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000039:
p.000039: studied and assessed are the same.
p.000039:
p.000039: 7. In the absence of a standard for the test preparation, the geographic area, maturity of collection
p.000039: of the plant, and the method of its preparation must be clearly described.
p.000039:
p.000039: 8. Priority should be given to clinical trials that are responsive to the country’s health/economic needs.
p.000039:
p.000039: Special guidelines
p.000039:
p.000039: Informed 9. Uncertainty regarding product adulteration, consent interactions
p.000039: between herbal remedies and other entities, minimal toxicity data, and incomplete prior
p.000039: dose finding must be clearly disclosed to all concerned, particularly in the informed consent process (WHO
p.000039: Operational Guidance: Information needed to support clinical trials of herbal products, 2005).
p.000039:
p.000039: Recruitment 10. When normal volunteers are recruited, participants of volunteers must preferably
p.000039: come from the community where
p.000039: the herbal preparations are frequently used.
p.000039:
p.000039: Participation 11. Cultural settings and expectations must be of traditional considered in
p.000039: the review of the proposal and this healers may require inviting a traditional healer or a known
p.000039: scholar of herbal medicines in the ethics review
p.000039: board.
p.000039:
p.000039: Research 12. Placebo-controlled trials may be accommodated design in consonance
p.000039: with the guidelines on the use of placebo as indicated in Ethical Guidelines for
p.000039: Clinical Trials on Drugs, Devices, and Diagnostics
p.000039: - 13b, 13d, and 13f.
p.000039:
p.000039: 13. Effectiveness of herbal preparations may not only be measured with improvements in health or disappearance of
p.000039: physical symptoms and other
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040:
p.000040: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000040:
p.000040: disease-related variables. It may also be measured in terms of overall health and well- being.
p.000040:
p.000040: Transport 14. No indigenous materials used in the research may of materials be
p.000040: transported outside the country unless the
p.000040: source (represented by the community leader, government agency or institution) of the material and the recipient
p.000040: sign a material transfer agreement.
p.000040:
...
p.000068:
p.000068: case-control study – type of investigation that attempts to look backward in time to identify characteristics that
p.000068: may have contributed to disease development by comparing responses of cases (those affected with the disease) and
p.000068: controls (the unaffected persons)
p.000068:
p.000068:
p.000069: 69
p.000069:
p.000069: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000069:
p.000069: cellular metabolites – the molecular substrates and products of various cellular processes
p.000069:
p.000069: chief/principal investigator – the person primarily responsible for the implementation of a research project
p.000069:
p.000069: clinical equipoise – “The ethics of medical practice grants no ethical or normative meaning to a treatment preference,
p.000069: however powerful, that is, based on a hunch or anything less than evidence publicly presented and convincing
p.000069: to the clinical community. Persons are licensed as physicians after they demonstrate the acquisition of this
p.000069: professionally validated knowledge, not after they reveal a superior capacity for guessing.” (Freedman, 1987)
p.000069:
p.000069: – a state of clinical equipoise means that on the basis of available data, a condition of genuine uncertainty on the
p.000069: part of the clinical investigator/ s and/or a community of medical experts exists regarding the comparative therapeutic
p.000069: merits of each arm in a trial. Thus they would be content to have their patients/clients pursue any of the treatment
p.000069: strategies being tested since none of them has been clearly established as preferable.
p.000069:
p.000069: clinical research – is a study done with human volunteers to answer specific health questions. Carefully conducted
p.000069: clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.
p.000069: Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and safe
p.000069: and effective under controlled environments. Observational trials address health issues in large groups of people or
p.000069: population in natural settings. The different types of clinical researches are: Treatment trials test
p.000069: experimental treatments, new combination of drugs, or new approaches to surgery or radiation therapy; prevention trials
p.000069: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from
p.000069: returning. These approaches may include medicines, vitamins, vaccines, minerals or lifestyle changes. Diagnostic trials
p.000069: are conducted to find a better test or procedures for diagnosing a particular disease or conditions. Screening trials
p.000069: test the best way to detect certain diseases or health conditions. Quality of life trials or supportive care trials
p.000069: explore ways to improve comfort and the quality of life for individuals with a chronic illness.
p.000069: (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000069:
p.000069: clinical trials – is a research study in human volunteers to answer specific health questions. Carefully conducted
p.000069: clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.
p.000069: Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and safe
p.000069: and effective under
p.000069:
p.000070: 70
p.000070:
p.000070: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000070:
p.000070: controlled environments. Observational trials address health issues in large groups of people or population in
p.000070: natural settings. The different types of clinical trials are: Treatment trials test experimental treatments, new
p.000070: combination of drugs, or new approaches to surgery or radiation therapy; prevention trials look for better ways to
p.000070: prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may
p.000070: include medicines, vitamins, vaccines, minerals or lifestyle changes. Diagnostic trials are conducted to find a better
p.000070: test or procedures for diagnosing a particular disease or conditions. Screening trials test the best way to
p.000070: detect certain diseases or health conditions. Quality of life trials or supportive care trials explore ways to improve
p.000070: comfort and the quality of life for individuals with a chronic illness.
p.000070: (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000070:
p.000070: – a systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to
p.000070: discover or verify the effects of and/or identify any adverse reactions to investigational products, and/or to study
p.000070: the absorption, distribution, metabolism, and excretion of the products with the object of ascertaining their efficacy
p.000070: and safety (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000070:
p.000070: – Investigative work to evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly
p.000070: scientifically controlled settings. Clinical trials may be designed to assess the safety and efficacy of an
p.000070: experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the
p.000070: efficacy of two standard or marketed interventions
p.000070:
p.000070: cloning human genes – transfer of human DNA sequences of interest into nonhuman cells with the purpose of
p.000070: expression, genetic manipulation, and amplification
p.000070:
p.000070: cohort study – type of investigation in which exposure is assessed among unaffected persons and subjects are
p.000070: then observed for subsequent development of the disease
p.000070:
p.000070: comparator (product) – an investigational or marketed product (i.e., active control), or placebo, used as
p.000070: reference in a clinical trial (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000070:
p.000070: – a pharmaceutical or other product (which may be a placebo) used as a reference in a clinical trials (WHO Guidelines
p.000070: for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000070:
p.000071: 71
p.000071:
p.000071: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000071:
p.000071: compensation – payments received by the research participants as reimbursement for lost earnings, travel costs and
p.000071: other expenses incurred as a study participant, as reparation for inconvenience and time spent
p.000071:
p.000071: complementary and alternative medicine research – study done in human volunteers to determine the effects
p.000071: of and/or identify any adverse reactions to maneuvers word in complementary and alternative medicine
p.000071:
p.000071: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding diverse medical and health
p.000071: care systems, practices and products that are not presently considered to be part of conventional medicine
p.000071:
p.000071: complementary medicine – a health treatment modality that is used together in a conventional or mainstream medicine
p.000071:
p.000071: conception – pregnancy beginning from the process of fertilization to form a zygote or its implantation
p.000071:
p.000071: conditional approval – approval of the protocol by the Ethics Committee to proceed after certain conditions or
p.000071: modifications set by the EC are met
p.000071:
p.000071: confidentiality – a duty of health care providers and health researchers toward patients and research participants to
p.000071: protect privacy and to refrain from unauthorized disclosure of information pertaining to them
p.000071:
p.000071: – prevention of disclosure of the IEC/IRB information, deliberations and documents to other than authorized individuals
p.000071:
p.000071: conflict of interest – a conflict of interest arises when a member (or members) of the Ethics Committee holds
p.000071: interests with respect to specific applications for review that may jeopardize his/her ability to provide a
p.000071: free and independent evaluation of the research focused on the protection of the research participants. Conflict of
...
p.000082: National Unified Health Research Agenda (NUHRA) – national health research priorities identified by major stakeholders
p.000082:
p.000082: non-disclosure of data – the withholding of or refusal to reveal information derived from research
p.000082:
p.000082: non-invasive procedure – biological sampling using a method which does not involve intrusion into the human body (e.g.,
p.000082: oral smears)
p.000082:
p.000082: North-South research collaboration – in the broad sense, would refer to the relationship or interaction between the
p.000082: developed and developing countries or rich and poor countries
p.000082:
p.000082: participatory research – research that involves the participation of the investigator in the activities of the research
p.000082: population. It could also involve involves research subjects in the definition of the research agenda, the conduct of
p.000082: research, monitoring and evaluation, and dissemination of results.
p.000082:
p.000082: patent – government instrument that assigns ownership of a product or creative work that is accompanied by certain
p.000082: rights
p.000082: pharmacodynamics – the study of what a drug does to the body pharmacogenetics – the field of biochemical genetics
p.000082: concerned with drug
p.000082: responses due to genetically-controlled variations
p.000082:
p.000082: pharmacokinetics – the study of what the body does to a drug
p.000082:
p.000082: Phase I clinical trial – the first trials of a new active ingredient or new formulations in man, often carried out
p.000082: in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a first outline of
p.000082: the pharmacokinetic and, where possible, a phramacodynamic profile of the active ingredients in humans. (WHO,
p.000082: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000082: Phase II clinical trial –trials performed in a limited number of subjects, often at a later stage of a comparative
p.000082: (e.g., placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and assess short-term safety of
p.000082: the active ingredient in patients suffering from a disease or condition for which the active ingredient is intended.
p.000082: This phase also aims at the determination of appropriate dose ranges or regimens and (if possible) clarification of
p.000082: dose-response relationships in order to provide an optimal background for the design of extensive therapeutic
p.000082: trials (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000083: 83
p.000083:
p.000083: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000083:
p.000083: Phase III clinical trial – trials in larger (and possibly varied) patient groups with the purpose of determining
p.000083: the short- and long-term safety/efficacy balance of formulation/s of the active ingredient, and of assessing its
p.000083: overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated
p.000083: and special features of the product must be explored (e.g., clinically relevant drug interactions, factors leading to
...
p.000086:
p.000086: Cluster Ethics Review Committee – an ethics review committee shared by (common to) several institutions where the
p.000086: volume of researches and resources do not make it feasible to have an ethics committee in each institution. The
p.000086: functions of the cluster committee and the respective institutional responsibilities shall be contained in a
p.000086: memorandum of agreement amongst the institutions concerned
p.000086:
p.000086: Institutional Ethics Review Committee – ethics review committee organized in a particular institution to ensure that
p.000086: health research is conducted according to international ethical principles, national and institutional guidelines
p.000086:
p.000086: research involving traumatized populations – study undertaken on a systematic and rigorous basis to generate new
p.000086: knowledge regarding groups living in communities that have experienced hardships and stress due to natural
p.000086: calamities or human atrocities
p.000086:
p.000086: research on assisted reproductive technology – study undertaken on a systematic and rigorous basis to generate new
p.000086: knowledge regarding reproduction that makes use of modern technology
p.000086:
p.000086: research participants/subjects – an individual who participates in a biomedical research project, either as the
p.000086: direct recipient of an intervention (e.g. study product or invasive procedure), as a control, or through
p.000086: observation. The individual may be a healthy person who volunteers to participate in the research or a person with a
p.000086: condition unrelated to the research carried out who volunteers to participate or a person (usually
p.000086:
p.000087: 87
p.000087:
p.000087: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000087:
p.000087: a patient) whose condition is relevant to the use of the study product or questions being investigated
p.000087:
p.000087: research protocol - A document that provides the background rationale and objective(s) of a biomedical research
p.000087: project and describes its design, methodology and organization, including ethical and statistical considerations.
p.000087: Some of these considerations may be provided in other documents referred to in the protocol
p.000087:
p.000087: respondent – one who answers or defends in various proceedings (Merriam- Webster’s Dictionary of Law (c) 1996)
p.000087:
p.000087: ribonucleic acid (RNA) - A single-stranded nucleic acid similar to DNA but having ribose sugar rather than deoxyribose
p.000087: sugar and uracil rather than thymine as one of the pyrimidine bases
p.000087:
p.000087: risk – the probability of harm or discomfort to study participants
p.000087:
p.000087: – the probability of harm or discomfort to study participants. Acceptable risk differs depending on the conditions for
p.000087: which the product is being tested.
p.000087:
p.000087: minimal risk – harm or discomfort comparable to those experienced in the daily existence of people living under
p.000087: ordinary circumstances and development
p.000087:
...
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
p.000100: Compensation
p.000100: • Will there be reimbursement of travel expenses? Compensation for loss of income? Meal expenses?
p.000100: • Are there other financial considerations?
p.000100:
p.000100: Provision for injury or related illness
p.000100: • Will the participant be given free treatment in case of injury or illness incurred as a result of participating
p.000100: in the study?
p.000100:
p.000100: Contact person
p.000100: • Who is the person knowledgeable about the research and rights of the participant? How can he/she be contacted?
p.000100:
p.000100: Voluntariness of participation
p.000100: • Is the participant free of any coercion in participating?
p.000100: • Is there assurance that the participant can withdraw anytime without affecting treatment/care due him/her?
p.000100: • Is there provision for obtaining the informed consent from the legal
p.000100:
p.000101: 101
p.000101:
p.000101: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000101:
p.000101: representative in case of minors, the mentally handicapped or the incapacitated?
p.000101:
p.000101: Confidentiality
p.000101: • Is there a statement that describes the measures that will be taken to keep and ensure the confidentiality of the
p.000101: participant’s records?
p.000101:
p.000101:
p.000101: CONSENT FORM
p.000101:
p.000101: I have read and understood the above information and had been given the opportunity to consider and ask questions on
p.000101: the information regarding the involvement in this study. I have spoken directly to my doctor who has answered to my
p.000101: satisfaction all my questions. I have received a copy of this Patient Information and Informed Consent Form.
p.000101: I voluntarily agree to participate.
p.000101:
p.000101:
p.000101:
p.000101: Patient’s Signature:
p.000101:
p.000101:
p.000101:
p.000101: Name of Patient Signature of Patient Date
p.000101:
p.000101:
p.000101: Witness or Legal Guardian’s Signature:
p.000101: (Only when patient cannot read or sign this Informed Consent)
p.000101:
p.000101:
p.000101:
p.000101: Name of Witness/ Signature of Witness/ Date Legal Guardian Legal
p.000101: Guardian
p.000101:
p.000101:
p.000101: Physician’s Signature:
p.000101:
p.000101: I, the undersigned, certify that to the best of my knowledge, the patient signing this consent form has read the above
p.000101: information sheet fully, that this has been carefully explained to him/her, and that he/she clearly understands the
p.000101: nature, risks, and benefits of his/her participation in this study.
p.000101:
...
Searching for indicator disability:
(return to top)
p.000018: funding for the research;
p.000018:
p.000018: q. The possible research uses, direct or secondary, of the subject’s medical records; and the possible
p.000018: future use and final disposition of biological specimens;
p.000018:
p.000018: r. If the specimens collected will not be destroyed, where, how, and for how long they are going to be stored;
p.000018:
p.000018: s. That the subjects have the right to decide about such future use, continued storage, or destruction of
p.000018: collected specimens;
p.000018:
p.000018: t. Whether commercial products may be developed from biological specimens, and whether the participant will
p.000018: receive monetary or other benefits from the development of such products;
p.000018:
p.000018: u. Whether the investigator is serving only as an investigator or as both investigator and the subject’s
p.000018: physician;
p.000018:
p.000018: v. The extent of the investigator’s responsibility to provide medical services to the participant;
p.000018:
p.000018: w. That treatment will be provided free of charge for specified types of research-related injury or for
p.000018: complications associated with the
p.000018:
p.000019: 19
p.000019:
p.000019: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000019:
p.000019: research, the nature and duration of such care, the name of the organization or individual that will provide the
p.000019: treatment, and whether there is any uncertainty regarding funding of such treatment;
p.000019:
p.000019: x. In what way, and by what organization the subject or the subject’s family or dependents will be
p.000019: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to
p.000019: provide such compensation);
p.000019:
p.000019: y. That an ethics review committee has approved or cleared the research protocol (Guideline 5
p.000019: – CIOMS, 2002).
p.000019:
p.000019: 3. After ensuring that the subject has understood the information, the physician should then obtain the
p.000019: subject’s freely given informed consent, preferably in writing. If the consent cannot be obtained in
p.000019: writing, the non-written consent must be formally documented and witnessed (Principle 22 – Declaration of Helsinki,
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
...
p.000066:
p.000066: a. Contribution of each author to the paper;
p.000066: b. Acknowledgment of contributors other than the authors; and
p.000066: c. Statement that the authors observed ethics review committee requirements, the National Ethical Guidelines for
p.000066: Health Research, and pertinent guidelines on the care and use of animals.
p.000066:
p.000066: 8. The authors shall obtain the informed consent of subjects as a condition for the publication of photographs
p.000066: or identifiable information.
p.000066:
p.000066: 9. Sponsors or other interested parties may not impose impediments to the publication of research outcomes.
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000067:
p.000067: GLOSSARY
p.000067:
p.000067: active principle (in medicinal preparations) – the substance in a medicinal preparation that is bringing
p.000067: about the clinical effects expected or observed
p.000067:
p.000067: adverse events – any untoward medical occurrence in a patient or clinical investigation participant
p.000067: administered an investigational product and which does not necessarily have a causal relationship with this treatment.
p.000067:
p.000067: serious adverse event – the adverse event is serious and should be reported when the outcome is death,
p.000067: life-threatening, hospitalization, disability, congenital anomaly and requires intervention to prevent permanent
p.000067: impairment or damage
p.000067:
p.000067: serious and unexpected adverse event – the unexpected adverse drug reaction is an adverse reaction, the nature or
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
...
p.000088: Practice [E6, R1])
p.000088:
p.000088: – an individual, company, institution or organization that takes responsibility fort eh initiation,
p.000088: management and /or financing of a research project
p.000088:
p.000088: – an individual, a company, an institution or an organization that takes
p.000088:
p.000089: 89
p.000089:
p.000089: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000089:
p.000089: responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates
p.000089: and takes full for a trial, the investigator then also assumes the role of the sponsor responsibility (WHO
p.000089: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000089:
p.000089: standard of care – health care intervention or regimen that is generally accepted by health practitioners and experts
p.000089: as beneficial to an individual needing such care
p.000089:
p.000089: prophylactic – professionally accepted level and type of preventive management to prevent the occurrence
p.000089: of a particular health condition
p.000089:
p.000089: diagnostic – professionally accepted level and type of examination to determine a patient’s health condition
p.000089:
p.000089: therapeutic – professionally accepted level and type of treatment or assistance for a particular health condition
p.000089:
p.000089: stem cell research – the study of the properties, development, and transformation of primordial progenitor cells prior
p.000089: to establishment of specialized cells
p.000089:
p.000089: stigma – the negative regard (e.g., shame and dishonor) of the community or society to particular groups because of
p.000089: disability, illness, occupation, poverty, etc. as dictated by culture
p.000089:
p.000089: study/investigational product – a pharmaceutical form of an active ingredient or placebo being tested or used as a
p.000089: reference in a clinical trial, including a product with marketing authorization when used or assembled
p.000089: (formulated or packaged) in a way different from the approved form, or when used fro an unapproved indication, or when
p.000089: used to gain further information about an approved use (ICH Harmonized Tripartite Guideline, Guideline for Good
p.000089: Clinical Practice [E6,R1])
p.000089:
p.000089: susceptibility – genetic condition leading to the development of a disease technical review – see scientific review
p.000089: teratogenicity – the degree or measure of the ability to cause malformations of an embryo or fetus
p.000089:
p.000089: termination of the research – the research study may be ended before its scheduled completion when the safety or
p.000089: benefit of the study participants is doubtful or at risk.
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000015: on clinical trials (pp30- 37), herbal medicine research (pp38-41), complementary and alternative medicine research
p.000015: (pp42-44), epidemiological research (pp45-47), social and behavioral research (pp48-49), research involving
p.000015: traumatized populations (pp50-52), HIV/AIDS research (pp53-54), research on assisted reproductive technology
p.000015: (pp55-56), and genetic research (pp57- 63), international/collaborative research (pp64-65), have been formulated
p.000015: because of special concerns that have been identified by practitioners.
p.000015:
p.000015: Health research involving human subjects includes research on identifiable human material or identifiable data
p.000015: (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: Considerations related to the well-being of the human subject should take precedence over the interests of science and
p.000015: society (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: It is the duty of the researcher to protect the life, health, privacy, and dignity of the human subjects, and to
p.000015: safeguard scientific integrity.
p.000015:
p.000015:
p.000015: I. Elements of Research Ethics
p.000015:
p.000015: Informed consent 1. For all biomedical research involving humans, the
p.000015: investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who
p.000015: is incapable of giving informed consent, the permission of a legally authorized representative in accordance with
p.000015: applicable laws.
p.000015:
p.000016: 16
p.000016:
p.000016: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000016:
p.000016: Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an
p.000016: ethics review committee (Guideline 4 – Council for International Organi- zations of Medical Sciences [CIOMS], 2002).
p.000016:
p.000016: 2. The investigator shall provide the following information to the potential subject, using language that
p.000016: can be understood:
p.000016:
p.000016: a. That the individual is invited to participate in the research, the reasons for considering the individual
p.000016: suitable for the study, and that participation is voluntary;
p.000016:
p.000016: b. That the individual is free to refuse to participate and is free to withdraw from the research at any time
p.000016: without penalty or loss of benefits to which he/she is entitled;
p.000016:
p.000016: c. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000016: explanation of how the research differs from routine medical care;
p.000016:
p.000016: d. For controlled trials, an explanation of features of the research design (e.g., randomization, double blinding),
p.000016: and that the subject will not be told of the assigned treatment until the study has been completed and the blind
p.000016: has been broken;
p.000016:
...
p.000080: investigator (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6, R1)
p.000080:
p.000080: – a person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The
p.000080: investigator should have qualifications and competence in accordance with local laws and regulations as
p.000080: evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and to provisions of,
p.000080: medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice
p.000080: medicine or dentistry (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000080:
p.000080: – a qualified scientist who undertakes scientific and ethical responsibility, either on his/her behalf or on behalf of
p.000080: an organization, for the ethical and scientific integrity of a research project at a specific site or group of sites
p.000080:
p.000080: legally authorized representative – one that represents another or others, upon their permission in accordance with
p.000080: law, in a special capacity (Merriam- Webster’s Dictionary of Law (c)1996)
p.000080:
p.000081: 81
p.000081:
p.000081: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000081:
p.000081: – A person who has authority, under the law, to stand for, or make decisions in behalf of another
p.000081:
p.000081: legally competent person – qualified or fit to perform an act, in accordance with law, free from addiction or mental
p.000081: defects that renders one incapable of taking care or oneself or one’s property (Merriam-Webster’s Dictionary of Law
p.000081: (c)1996)
p.000081:
p.000081: linkage analysis – gene hunting technique that traces patterns of disease in high risk families for the purpose of
p.000081: locating a disease-causing gene by identifying genetic markers of known chromosomal location that are co-inherited with
p.000081: the trait of interest
p.000081:
p.000081: material transfer agreement – an agreement between the source institution (or community) and the recipient institution
p.000081: (agency or community) that defines responsibilities and ownership of the material under study
p.000081:
p.000081: minimal toxicity data – the lowest dose of the preparation that shall elicit toxicity signs and symptoms in the
p.000081: participants or in animals
p.000081: minors – persons who have not yet reached the age of majority, 18 years old monitor – a person appointed by and
p.000081: responsible to the sponsor or contract
p.000081: research organization for monitoring and reporting progress of the trial
p.000081: and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000081:
p.000081: moral agent – a sentient individual whose acts impact on others and are affected by the act of others
p.000081:
p.000081: multicenter trial – a clinical trial conducted according to a single protocol but at more that one site, and
p.000081: therefore, carried out by more than one investigator (ICH Harmonized Tripartite Guideline, General
p.000081: Considerations for Clinical Trial (E8)
p.000081:
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000018: consequences of breaches of confidentiality;
p.000018:
p.000018: p. The sponsors of the research, the institutional affiliation of the investigators, and the nature and sources of
p.000018: funding for the research;
p.000018:
p.000018: q. The possible research uses, direct or secondary, of the subject’s medical records; and the possible
p.000018: future use and final disposition of biological specimens;
p.000018:
p.000018: r. If the specimens collected will not be destroyed, where, how, and for how long they are going to be stored;
p.000018:
p.000018: s. That the subjects have the right to decide about such future use, continued storage, or destruction of
p.000018: collected specimens;
p.000018:
p.000018: t. Whether commercial products may be developed from biological specimens, and whether the participant will
p.000018: receive monetary or other benefits from the development of such products;
p.000018:
p.000018: u. Whether the investigator is serving only as an investigator or as both investigator and the subject’s
p.000018: physician;
p.000018:
p.000018: v. The extent of the investigator’s responsibility to provide medical services to the participant;
p.000018:
p.000018: w. That treatment will be provided free of charge for specified types of research-related injury or for
p.000018: complications associated with the
p.000018:
p.000019: 19
p.000019:
p.000019: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000019:
p.000019: research, the nature and duration of such care, the name of the organization or individual that will provide the
p.000019: treatment, and whether there is any uncertainty regarding funding of such treatment;
p.000019:
p.000019: x. In what way, and by what organization the subject or the subject’s family or dependents will be
p.000019: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to
p.000019: provide such compensation);
p.000019:
p.000019: y. That an ethics review committee has approved or cleared the research protocol (Guideline 5
p.000019: – CIOMS, 2002).
p.000019:
p.000019: 3. After ensuring that the subject has understood the information, the physician should then obtain the
p.000019: subject’s freely given informed consent, preferably in writing. If the consent cannot be obtained in
p.000019: writing, the non-written consent must be formally documented and witnessed (Principle 22 – Declaration of Helsinki,
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
...
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
...
p.000035: specific infection for which the vaccine is being tested. As such, the vaccinated subject shall be
p.000035: informed accordingly and properly cared for.
p.000035:
p.000035: d. Clinical trials involving diagnostic agents using radioactive materials and X-ray should not necessarily
p.000035: expose subjects to more radiation than normal and shall be undertaken on patients undergoing the procedure
p.000035: for diagnostic or therapeutic purposes. Radiation limits for the use of such materials and X-rays shall be within the
p.000035: medically acceptable limits. Measures to safeguard research subjects and others who may be exposed to radiation shall
p.000035: be taken. Adequate provisions for detecting pregnancies to avoid risks of exposure to the embryo shall be given.
p.000035: Subjects shall also be provided information on possible genetic damage to their offspring.
p.000035:
p.000035: Publication 17. Clinical trial results shall be communicated in a of clinical timely
p.000035: fashion and published regardless of results trial results or findings. Findings shall be brought
p.000035: into the
p.000035: public domain and generally made known through scientific and other publications.
p.000035:
p.000035: 18. Preliminary reports that raise false hopes and expectations of product safety, efficacy, and immediate
p.000035: use shall not be made public.
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036:
p.000036: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000036:
p.000036: 19. The plan for publication and the actual publication of trial results shall not expose the identity of the
p.000036: participants or their family and community, or imperil their privacy or confidentiality as individuals,
p.000036: family, or community. As necessary, a clear consent to publication shall be obtained not only at the start of the
p.000036: trial but also at its completion.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037:
p.000037:
p.000037: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000037:
p.000037: ETHICAL GUIDELINES FOR HERBAL RESEARCH
p.000037:
p.000037:
p.000037: Introduction
p.000037:
p.000037: The use of herbal remedies can provide a practical and inexpensive way of alleviating illness in countries like the
p.000037: Philippines that is rich in natural resources and has a fecund pool of indigenous healing practices.
p.000037:
p.000037: Philippine Republic Act No. 8423, the Traditional and Alternative Medicine Act of 1997 declared the policy of the state
p.000037: “to improve the quality and delivery of health care services to the Filipino people through the development
p.000037: of traditional and alternative health care and its integration into the national health care delivery system.” This law
p.000037: aims to 1) encourage scientific research on and develop traditional and alternative health care systems that have
p.000037: direct impact on public health care; and 2) promote and advocate the use of traditional, alternative, preventive, and
...
p.000056:
p.000056: Introduction
p.000056:
p.000056: A person’s current and future health is the interaction of many factors, including environment, lifestyle, and genes.
p.000056: Genes are the biochemical instructions for the development and growth of individuals. When a gene is altered, it may
p.000056: cause or contribute to a disease. Genes themselves do not cause disease, but alterations in the normal gene sequence
p.000056: may lead to a disease.
p.000056:
p.000056: The presence of a “disease allele” usually leads to an increased predisposition or susceptibility for
p.000056: developing a disease, with no certainty that disease will actually happen. There are various reasons for genetic
p.000056: testing: diagnosis, carrier testing, prenatal testing, predictive testing, susceptibility, predisposition or risk
p.000056: testing, genetic screening, and research testing. This raises a new set of issues, particularly on how this information
p.000056: is interpreted by those who might be affected in the future. Even for some single-gene diseases, not everyone with the
p.000056: gene develops the disease. This variability in gene expression further complicates multifactorial inheritance.
p.000056: Many counselors find it difficult to explain the uncertainty associated with genetic testing.
p.000056:
p.000056: Human genetic research aims to identify genes associated with health and disease, and elucidate their functions. The
p.000056: ultimate goal is to use the knowledge gained through research to discover ways of better diagnosis and
p.000056: treatment. The main types of genetic research are: cloning human genes, family studies, linkage analysis, DNA
p.000056: sequencing and association studies, pharmacogenetics, behavioral genetics, population- based genetics, and stem cell
p.000056: research. Genetic information may be obtained in several ways. One of the most important ways is from a family
p.000056: medical history, which is a kind of genetic test that are commonly used by good doctors. Genetic information is also
p.000056: available from clinical examination, and testing of DNA, RNA, proteins, or cellular metabolites that indicate gene
p.000056: activity.
p.000056:
p.000056: Human stem cell research holds enormous potential for contributing to an understanding of fundamental human biology,
p.000056: leading to the possibility of novel treatments and, ultimately, cures for many diseases for which adequate therapies do
p.000056: not exist. It is essential that the public be educated
p.000056:
p.000057: 57
p.000057:
p.000057:
p.000057:
p.000057: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000057:
p.000057: and informed about ethical and policy issues raised by stem cell research and its applications. Informed public
p.000057: discussions of these issues should be based on an understanding of the science associated with stem cell research and
p.000057: should involve a broad cross-section of society. Special efforts should be made to promote equitable access to the
p.000057: benefits of stem cell research. Intellectual property regulations for stem cell research should set conditions that do
p.000057: not restrict basic research or encumber future product development.
p.000057:
p.000057: The ethical considerations in reviewing genetic research are no different from those that arise when reviewing other
p.000057: types of research. However, in addition to those that apply to all research involving humans, there are ethical issues
p.000057: unique to genetic research. These arise from the nature of genes and genetic information which, though personal, are
p.000057: also shared with other family members and with unrelated individuals in the population.
p.000057:
p.000057: These guidelines shall be used by research institutions, scientists, pharmaceutical companies, health
p.000057: researchers, and institutional review boards for the ethical pursuit of genetic research so that the expected benefits
p.000057: in the improvement of health and healthcare will be attained.
p.000057:
p.000057: General 1. All research involving human subjects should be
p.000057: guidelines conducted in accordance with the ethical
p.000057: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000057:
p.000057: 2. Given the familial nature of genetic research, confidentiality, privacy, and security are important
p.000057: considerations in the ethics review of a genetic study.
p.000057:
p.000057: Specific guidelines
p.000057:
p.000057: Collection of 3. Human biological samples for genetic research samples include samples
p.000057: that can serve as DNA, RNA, from humans and protein sources: solid tissues, biopsies,
p.000057: aspirates, scrapings, and body fluids such as blood, saliva, ocular fluids, and excretions. Samples may be
p.000057: collected, processed, used and stored only for the following purposes:
p.000057:
p.000058: 58
p.000058:
p.000058:
p.000058:
p.000058: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000058:
p.000058: a. Diagnosis and healthcare, including screening and predictive testing
p.000058: b. Medical and other scientific research (i.e., epidemiological, prognostication, population- based genetic
p.000058: studies, anthropological or archeological studies)
p.000058: c. Forensic medicine, in which case, use of samples shall be in accordance with domestic laws and consistent
p.000058: with laws on human rights
p.000058: d. Development of drugs, biomedical devices, molecular diagnostics, and medical technologies
p.000058: e. Others as dictated by local and/or international interests, or in the event of global health and technology
p.000058: trends, or other reasons of public interest
p.000058:
p.000058: Informed 4. Prior, voluntary, informed, and expressed consent, consent without
p.000058: inducement by financial or personal gain, should be obtained for the collection of biological
p.000058: samples, human genetic and proteomic data, and for their subsequent processing, use, and storage.
p.000058:
p.000058: 5. Informed consent shall be required for all research protocols that propose the use of any kind of human
p.000058: tissue sample for genetic research.
p.000058:
p.000058: 6. Potential research subjects should be adequately informed about what will happen to any genetic material or
p.000058: information obtained as part of the study.
p.000058:
p.000058: 7. Subjects should be recruited as individuals in their own right rather than as a family group, and should consent
p.000058: as individuals.
p.000058:
p.000058: 8. In cases where identities of groups or communities may be linked with genetic traits under study, informed
p.000058: consent for the whole group may be obtained from an elected or recognized leader who will be responsible
p.000058: for making decisions on the participation of the group in the study.
p.000058:
p.000059: 59
p.000059:
p.000059:
p.000059:
p.000059: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000059:
p.000059: 9. Informed consent shall not be required for those protocols for genetic research that use anonymous samples or
p.000059: samples that have no identifiers. Any sample that can be linked to an individual through an identifier, or through any
p.000059: person or institution that has the capability to link the sample with its source, is not to be considered anonymous.
p.000059:
p.000059: 10. Stored biological samples collected for purposes other than those stated in No. 3 above may be used to produce
p.000059: human genetic or proteomic data with the prior, free, informed, and express consent of the person concerned.
p.000059:
p.000059: 11. In case informed consent is withdrawn, the samples and data should be irretrievably unlinked from their
p.000059: source. This will be accomplished by the destruction of all identifiers.
p.000059:
p.000059: Informed 12. Genetic studies involving indigenous groups shall consent of be guided
...
p.000059: information be revealed, etc.
p.000059:
p.000059: 14. Genetic counseling (pre- and post-test) shall be provided when there is a need to disclose the findings of
p.000059: the genetic study.
p.000059:
p.000059: Privacy, 15. Researchers must ensure the confidentiality and confidentiality, privacy of
p.000059: stored genetic information or research and security results relating to identified or potentially
p.000059: identifiable participants in accordance with domestic and international laws on human rights. Researchers should
p.000059: also ensure that safeguards are in place to avoid accidental disclosure of sensitive information.
p.000059:
p.000060: 60
p.000060:
p.000060:
p.000060:
p.000060: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000060:
p.000060: 16. Disclosure of genetic information is sometimes impossible to avoid. Such information should be dealt with
p.000060: sensitively, and the possibility that such a disclosure may occur should be considered in the initial process of
p.000060: seeking consent.
p.000060:
p.000060: 17. There is potential harm to participants arising from the use of genetic information, including stigmatization
p.000060: or unfair discrimination. Researchers should take special care to protect the privacy and confidentiality of
p.000060: this information.
p.000060:
p.000060: 18. Identifying genetic information must not be released to others, including family members, without the
p.000060: written consent of the individual to whom the information relates, or a person or institution which may
p.000060: legally provide consent for that person.
p.000060:
p.000060: 19. The patient’s right to privacy (researcher’s duty for confidentiality) continues after the patient’s death so
p.000060: that confidential information may be revealed after death only with proper legal authority. The only
p.000060: exception is the right to disclose information to a family member if there is a clear and urgent need to provide
p.000060: information to avoid a serious health risk.
p.000060:
p.000060: Handling of 20. Genetic research often involves the storage of biological DNA or
p.000060: other biological samples in “tissue” or specimens “sample” collections. In some cases, samples
p.000060: can
p.000060: be anonymized so that the donors cannot be identified. This raises problems in cases where the information
p.000060: from research might be of value to the individuals or families. Most genetic research studies will require linking of
p.000060: DNA samples to health records, family pedigrees, and individual results.
p.000060:
p.000060: 21. Handling and preservation of biological samples shall be in accordance with standard scientific procedures.
p.000060:
p.000061: 61
p.000061:
p.000061:
p.000061:
p.000061: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000061:
p.000061: 22. Disposal of stored biological specimens shall be in accordance with standards for handling biohazardous and
p.000061: infectious materials.
p.000061:
p.000061: 23. Transport, transfer, and disposal of all stored biological samples shall be properly documented and filed.
p.000061:
p.000061: 24. Retention time for stored biological samples shall be determined by the respective institution.
p.000061:
p.000061: 25. All specimens in a tissue bank must be accompanied by a copy of the consent agreement signed by the donor.
p.000061:
p.000061: 26. No specimen shall be removed from a tissue bank for research purposes without an approved research protocol.
p.000061:
p.000061: 27. A researcher must not transfer genetic material or related information to another research group, unless
p.000061:
p.000061: a. The researcher and the other research group are collaborating on research which has been approved by their
p.000061: respective institutional ethics review committee
p.000061: b. The genetic material and information are provided in a form that ensures that participants cannot be
p.000061: identified
p.000061:
p.000061: Ethical 28. Securing stem cells for research, whether from considerations children, adults
...
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
p.000068: bias – the systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the
p.000068: results of a clinical trial to make the estimate of a treatment effect deviate from its true value (ICH Harmonized
p.000068: Tripartite Guideline, General Considerations for Clinical Trial (E8)
p.000068:
p.000068: blinding/masking – a procedure in which one or more parties of the trial are kept unaware of the treatment
p.000068: assignment/s. Single blinding usually refers to the subject/s being unaware, and double-blinding usually refers to the
p.000068: subject/s, investigator/s, monitor, and, in some cases, data analyst/ s being unaware of the treatment
p.000068: assignment/s (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000068:
p.000068: carrier testing – testing to identify individuals who carry recessive genes; testing designed for healthy people who
p.000068: have no symptoms of disease, but who are known to be at high risk because of family history
p.000068:
p.000068: case-control study – type of investigation that attempts to look backward in time to identify characteristics that
p.000068: may have contributed to disease development by comparing responses of cases (those affected with the disease) and
p.000068: controls (the unaffected persons)
p.000068:
p.000068:
p.000069: 69
p.000069:
p.000069: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000069:
p.000069: cellular metabolites – the molecular substrates and products of various cellular processes
p.000069:
p.000069: chief/principal investigator – the person primarily responsible for the implementation of a research project
p.000069:
p.000069: clinical equipoise – “The ethics of medical practice grants no ethical or normative meaning to a treatment preference,
p.000069: however powerful, that is, based on a hunch or anything less than evidence publicly presented and convincing
p.000069: to the clinical community. Persons are licensed as physicians after they demonstrate the acquisition of this
p.000069: professionally validated knowledge, not after they reveal a superior capacity for guessing.” (Freedman, 1987)
p.000069:
p.000069: – a state of clinical equipoise means that on the basis of available data, a condition of genuine uncertainty on the
p.000069: part of the clinical investigator/ s and/or a community of medical experts exists regarding the comparative therapeutic
p.000069: merits of each arm in a trial. Thus they would be content to have their patients/clients pursue any of the treatment
p.000069: strategies being tested since none of them has been clearly established as preferable.
p.000069:
...
p.000071: interests with respect to specific applications for review that may jeopardize his/her ability to provide a
p.000071: free and independent evaluation of the research focused on the protection of the research participants. Conflict of
p.000071: interests may arise when an EC member has financial, material, institutional or social ties to the research.
p.000071:
p.000071: control – the standard by which experimental observation are evaluated. In many clinical trials, one group of patients
p.000071: will be given an experimental drug or treatment, while the control group is either given a standard treatment for the
p.000071: illness or a placebo (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000071:
p.000071: controlled trials – a trial in which one group of participants is given an experimental drug, while another group (the
p.000071: control group) is given either a standard treatment for the disease or a placebo
p.000071:
p.000072: 72
p.000072:
p.000072: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000072:
p.000072: conventional medicine – (see Western medicine) that discipline of medical care advocating therapy with remedies that
p.000072: produce effects differing from those of the disease treated
p.000072:
p.000072: counseling – non-coercive interaction between a health professional and a patient/ client and/or family that is meant
p.000072: to clarify personal values and priorities, health care options, expectations, risks, benefits, and resources in
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
p.000072: cultural bias – prejudice based on community values and traditions
p.000072:
p.000072: culture – the way of life of groups of people that is defined by mores, shared values, traditions and sociopolitical
p.000072: structures and institutions
p.000072:
p.000072: debriefing – the process of obtaining information about an experience from an individual who has participated in, or
p.000072: observed particular events
p.000072:
p.000072: deception – an act characterized by dishonesty, fraud, trickery or sham for the purpose of manipulating another person
p.000072: into making a decision that he or she would not have made otherwise
p.000072:
p.000072: deoxyribonucleic acid (DNA) – an antiparallel double helix of nucleotides (having deoxyribose as their sugars) linked
p.000072: by phosphodiester (sugar-phosphate) bonds to adjacent nucleotides in the same chain and by hydrogen bonds to
p.000072: complementary nucleotides in the opposite chain. The fundamental substance of which genes are composed.
p.000072:
p.000072: deoxyribonucleic acid sequencing – method of analyzing the base sequence composition and order of a DNA sample using
p.000072: chemical tagging and physical measurements
p.000072: devices – a piece of equipment designed to served a clinical purpose diagnostics – procedure or technique used in the
p.000072: identification of a disease or
p.000072: determination of the health status of an individual
p.000072:
p.000072: disapproval – a negative action of the Ethics Committee on the protocol. The study cannot be implemented if it has been
p.000072: disapproved by the Ethics Committee
p.000072:
p.000073: 73
p.000073:
p.000073: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000073:
p.000073: disclosure of data – the giving of information in connection with proposed research undertaking or the sharing of
p.000073: the results of the study especially as they pertain to the individual’s of the family’s health situation
p.000073:
p.000073: disease allele – one of the variant forms of a disease gene at a particular locus, or location, on a chromosome.
p.000073: Different alleles produce variation in inherited characteristics such as hair color or blood type. In an individual,
p.000073: one form of the allele (the dominant one) may be expressed more than another form (the recessive one)
p.000073:
p.000073: disease susceptibility/predisposition – the pathophysiological conditions and genetic inclination that favor the
p.000073: development of a disease condition
p.000073:
p.000073: domestic violence – violence committed by one family or household member against another (Merriam-Webster’s Dictionary
p.000073: of Law (c) 1996)
p.000073:
p.000073: double blinding – is one in which neither the subject nor any of the investigator or sponsor staff who are involved in
p.000073: the treatment or clinical evaluation of the subjects are aware of the treatment received (ICH Harmonized Tripartite
p.000073: Guideline, Statistical Principles for Clinical Trials (E9) p8)
p.000073:
p.000073: drugs – a substance used as medication or used in the diagnosis, cure, mitigation, treatment or prevention
p.000073: of disease
p.000073:
p.000073: duress – wrongful and usually unlawful compulsion (as threats of physical violence) that induces a person to act
p.000073: against his or her will: ‘coercion” (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000073:
p.000073: efficacy – is the ability of a treatment modality to produce an effect to alleviate a disease
p.000073:
p.000073: embryo – the stage of human development following implantation (starting 10- 14 days), when the primitive streak begins
p.000073: to form up to fetal stage
p.000073:
p.000073: epidemiologic research – investigative studies intended to establish “the distribution and determinants of
p.000073: disease frequency in human populations”
p.000073:
p.000073: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the determinants of the
p.000073: incidence of diseases as well as their related risk factors, etiology and causation
p.000073:
...
p.000075: Horde=85a91621422a63bcc765ef05290c2baf)
p.000075:
p.000075: ethics review – the evaluation of a research protocol by an ethics review committee that promotes the
p.000075: safety and protection of the dignity of human participants
p.000075:
p.000075: – a systematic process by which an independent committee evaluates a study protocol to determine if it follows ethical
p.000075: and scientific standards for carrying out biomedical research on human participants. Compliance with these guidelines
p.000075: helps ensure that the dignity, rights, safety and well-being of research participants are promoted.
p.000075:
p.000075: ethics review committee – a Committee constituted to review the ethical aspects of a research proposal and its possible
p.000075: implementation
p.000075:
p.000075: Ethics Committee (IEC/IRB) – Independent Ethics Committee / Institutional Review Board is an independent body
p.000075: (either a review board or committee) whose responsibility is to ensure the protection of the rights, safety and
p.000075: well-being of human participants involved in a trial and to provide public assurance of that protection.
p.000075:
p.000075: experimental design – the structure of research, identifying the various elements of a research project and how they
p.000075: relate to one another
p.000075:
p.000075: family studies – mapping of disease genes through the establishment of genetic linkage within a family
p.000075:
p.000075: feasibility – capability to be accomplished or implemented
p.000075:
p.000075: fetus – stage of human development when the first neural cells start differentiating (starting from 6-8 weeks up to
p.000075: birth)
p.000075:
p.000076: 76
p.000076:
p.000076: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000076:
p.000076: gender – socially defined feminine or masculine roles, attitudes, and values
p.000076:
p.000076: gender bias – partiality, unfairness, prejudice manifested towards an individual or group of individuals based on sex
p.000076: and sexual orientation
p.000076:
p.000076: gender-sensitive counseling – counseling that includes awareness of existing gender differences, issues and inequality
p.000076: in its framework for interaction with the patient/client
p.000076:
p.000076: gender sensitivity – the ability to perceive existing gender differences, issues, and inequality and to incorporate
p.000076: these into strategies and actions
p.000076:
p.000076: genes – the functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA,
p.000076: and most genes contain the information for making a specific protein
p.000076:
p.000076: gene activity – refers to the degree of expression of a particular gene or levels of transcription
p.000076:
p.000076: genetic association studies – describes a situation in which a particular allele is found either significantly more or
p.000076: less frequently in a group of affected individuals than would be expected from the frequency of the allele in the
p.000076: general population from which the affected individuals were drawn
p.000076:
p.000076: genetic counseling – the provision of information and assistance to affected individuals or family members at risk of a
p.000076: disorder that may be genetic, concerning the consequences of the disorder, the probability or developing or
p.000076: transmitting it, and the ways in which it may be prevented or ameliorated
p.000076:
p.000076: genetic research – the study of the structure and functions of individual genes, genetic variation in human
p.000076: populations, and the applications of genetics in diagnosis and patient care
p.000076:
p.000076: genetic screening – a population-based method for identifying a subset of individuals at risk of developing
p.000076: or of transmitting a specific genetic disease or disorder
p.000076:
p.000076: gene testing – analysis done on affected persons or carriers within family already identified because of a history of
p.000076: high risk for having or transmitting a specific genetic disorder
p.000076:
p.000076: Good Clinical Practice Guidelines (GCP) – an international ethical and scientific quality standard for designing,
p.000076: conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this
p.000076:
p.000077: 77
p.000077:
p.000077: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000077:
p.000077: standard provides public assurance that the rights, safety, and well- being of trial subjects are protected,
p.000077: consistent with the principles that have their origin in the International Declaration of Helsinki, and that the
p.000077: clinical trial data are credible (CPMP/ICH/135/95)
p.000077:
p.000077: – standards and procedures for clinical trials that encompass the design, protocol approval, monitoring,
p.000077: termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and
p.000077: activities of the sponsor, principal investigators and monitor involved in the clinical trials. The code GCP
p.000077: ensures that the studies are scientifically and ethically sound, and all the clinical properties of the product under
p.000077: investigation are properly documented. For compete information, reference is made to the published WHO and
p.000077: International Conference on Harmonization Code of Good Clinical Practice (Department of Health Administrative
p.000077: Order No. 47-A series of 2001 [August 30, 2001])
p.000077:
p.000077: – a standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses,
...
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
p.000084: pre-clinical trials – investigation of the pharmacologic properties of a drug or preparation done in animals prior to
p.000084: human studies. Pre-clinical studies shall include pharmacodynamics, pharmacokinetics, and toxicity studies (BFAD
p.000084: Guidelines for Registration of Pharmaceutical Products, 1997)
p.000084:
p.000084: predictive testing – determination of the presence of disease-associated genes prior to the onset or manifestation of
p.000084: the disease
p.000084:
p.000084: predisposition or risk testing – determination of genetic parameters in an individual associated with increased risk of
p.000084: disease
p.000084:
p.000084: prenatal testing – determination of whether a fetus has (or probably has) a designated condition for which an increased
p.000084: risk is indicated by later maternal age, family history, or other well-defined risk factors
p.000084:
p.000084: prior dose finding – quantity or dosage of the herbal medicine established in earlier studies or practice to be
p.000084: effective
p.000084:
p.000084: privacy – a conceptual space defining the individual’s boundary as a person, intrusion of which is limited human rights
p.000084: and by law
p.000084:
p.000084: – the assurance of the secrecy of the identity of or information about research participants
p.000084:
p.000084: product adulteration – presence of foreign substances or impurities in the drug preparation that results in dilution or
p.000084: loss of its efficacy
p.000084:
p.000084: protein – a macromolecule composed of subunits of linear chains of amino acids attached to each other by peptide bonds
p.000084:
p.000084: proteomic data – information from the comprehensive analysis and cataloguing of the structure and function of all the
p.000084: proteins present in a given cell or tissue
p.000084:
p.000084: protocol – is the documentary record of the research undertaking that includes
p.000084:
p.000085: 85
p.000085:
p.000085: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000085:
p.000085: the background of the study, research question and objectives, the conceptual design, the methodology and data
p.000085: collection, and planned analysis of data.
p.000085:
p.000085: – a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of
p.000085: participants as well as answers specific research questions. The protocol describes what types of people may
p.000085: participate in the trial; the schedule of tests, procedures, medications, and dosages; and length of the study. In a
...
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
p.000096: Feasibility, 27, 76
p.000096: Feedback session, 49
p.000096: Fertilization success, 55
p.000096: Fetus, 76
p.000096:
p.000097: 97
p.000097:
p.000097: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000097:
p.000097:
p.000097: aborted, 63
p.000097: Forensic medicine, 59
p.000097: Gender, 77
p.000097: Gender bias,54, 77
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
p.000097: Genetic traits, 59
p.000097: Good clinical practice, 38, 77
p.000097: Good laboratory practices, 32, 78 Good manufacturing practice, 32 Good Manufacturing Practice
p.000097: Guidelines, 39, 78
p.000097: Health equity, 64, 79
p.000097: Health research involving human Subjects, 16, 22
p.000097: Helsinki Declaration, 3,16
p.000097: Herbal products, 42
p.000097: Herbal remedies, 38
p.000097: Homeopathy, 43
p.000097: Human atrocities, 50
p.000097: Identifiable information, 67
p.000097: Inconvenience, 17 Indicators of success, 64 Inducement, 59
p.000097: Information in the public domain,46 Informed Consent, 11, 20, 21, 33, 40, 48,
p.000097: 52, 59, 67, 80
p.000097: Alternative methods, 47
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000035: into the
p.000035: public domain and generally made known through scientific and other publications.
p.000035:
p.000035: 18. Preliminary reports that raise false hopes and expectations of product safety, efficacy, and immediate
p.000035: use shall not be made public.
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036:
p.000036: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000036:
p.000036: 19. The plan for publication and the actual publication of trial results shall not expose the identity of the
p.000036: participants or their family and community, or imperil their privacy or confidentiality as individuals,
p.000036: family, or community. As necessary, a clear consent to publication shall be obtained not only at the start of the
p.000036: trial but also at its completion.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037:
p.000037:
p.000037: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000037:
p.000037: ETHICAL GUIDELINES FOR HERBAL RESEARCH
p.000037:
p.000037:
p.000037: Introduction
p.000037:
p.000037: The use of herbal remedies can provide a practical and inexpensive way of alleviating illness in countries like the
p.000037: Philippines that is rich in natural resources and has a fecund pool of indigenous healing practices.
p.000037:
p.000037: Philippine Republic Act No. 8423, the Traditional and Alternative Medicine Act of 1997 declared the policy of the state
p.000037: “to improve the quality and delivery of health care services to the Filipino people through the development
p.000037: of traditional and alternative health care and its integration into the national health care delivery system.” This law
p.000037: aims to 1) encourage scientific research on and develop traditional and alternative health care systems that have
p.000037: direct impact on public health care; and 2) promote and advocate the use of traditional, alternative, preventive, and
p.000037: curative health care modalities that have been proven safe, effective, cost-effective, and consistent with government
p.000037: standards of medical practice.
p.000037:
p.000037: These legislated objectives have generated research activities on herbal remedies or preparations to evaluate
p.000037: their safety and effectiveness. Necessarily, these researches involve human participants for which ethics review is
p.000037: mandated.
p.000037:
p.000037: Advocates of herbal medicine are convinced that herbal products can be used without subjecting them to the same
p.000037: rigorous scientific evaluation (e.g., requirement for pre-clinical trials) required in Western medicine. It is argued
p.000037: that the current universal scientific procedures and standards are not applicable to remedies with a long history of
p.000037: use in and have been accepted by communities.
p.000037:
p.000037: This set of ethical guidelines will not dwell on the aforementioned issues surrounding herbal research. In this regard,
...
p.000069: part of the clinical investigator/ s and/or a community of medical experts exists regarding the comparative therapeutic
p.000069: merits of each arm in a trial. Thus they would be content to have their patients/clients pursue any of the treatment
p.000069: strategies being tested since none of them has been clearly established as preferable.
p.000069:
p.000069: clinical research – is a study done with human volunteers to answer specific health questions. Carefully conducted
p.000069: clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.
p.000069: Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and safe
p.000069: and effective under controlled environments. Observational trials address health issues in large groups of people or
p.000069: population in natural settings. The different types of clinical researches are: Treatment trials test
p.000069: experimental treatments, new combination of drugs, or new approaches to surgery or radiation therapy; prevention trials
p.000069: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from
p.000069: returning. These approaches may include medicines, vitamins, vaccines, minerals or lifestyle changes. Diagnostic trials
p.000069: are conducted to find a better test or procedures for diagnosing a particular disease or conditions. Screening trials
p.000069: test the best way to detect certain diseases or health conditions. Quality of life trials or supportive care trials
p.000069: explore ways to improve comfort and the quality of life for individuals with a chronic illness.
p.000069: (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000069:
p.000069: clinical trials – is a research study in human volunteers to answer specific health questions. Carefully conducted
p.000069: clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.
p.000069: Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and safe
p.000069: and effective under
p.000069:
p.000070: 70
p.000070:
p.000070: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000070:
p.000070: controlled environments. Observational trials address health issues in large groups of people or population in
p.000070: natural settings. The different types of clinical trials are: Treatment trials test experimental treatments, new
p.000070: combination of drugs, or new approaches to surgery or radiation therapy; prevention trials look for better ways to
p.000070: prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may
p.000070: include medicines, vitamins, vaccines, minerals or lifestyle changes. Diagnostic trials are conducted to find a better
p.000070: test or procedures for diagnosing a particular disease or conditions. Screening trials test the best way to
p.000070: detect certain diseases or health conditions. Quality of life trials or supportive care trials explore ways to improve
p.000070: comfort and the quality of life for individuals with a chronic illness.
p.000070: (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000070:
p.000070: – a systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to
p.000070: discover or verify the effects of and/or identify any adverse reactions to investigational products, and/or to study
p.000070: the absorption, distribution, metabolism, and excretion of the products with the object of ascertaining their efficacy
p.000070: and safety (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000070:
p.000070: – Investigative work to evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly
p.000070: scientifically controlled settings. Clinical trials may be designed to assess the safety and efficacy of an
p.000070: experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the
p.000070: efficacy of two standard or marketed interventions
p.000070:
p.000070: cloning human genes – transfer of human DNA sequences of interest into nonhuman cells with the purpose of
p.000070: expression, genetic manipulation, and amplification
p.000070:
p.000070: cohort study – type of investigation in which exposure is assessed among unaffected persons and subjects are
p.000070: then observed for subsequent development of the disease
p.000070:
p.000070: comparator (product) – an investigational or marketed product (i.e., active control), or placebo, used as
p.000070: reference in a clinical trial (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000070:
...
p.000071:
p.000071: conception – pregnancy beginning from the process of fertilization to form a zygote or its implantation
p.000071:
p.000071: conditional approval – approval of the protocol by the Ethics Committee to proceed after certain conditions or
p.000071: modifications set by the EC are met
p.000071:
p.000071: confidentiality – a duty of health care providers and health researchers toward patients and research participants to
p.000071: protect privacy and to refrain from unauthorized disclosure of information pertaining to them
p.000071:
p.000071: – prevention of disclosure of the IEC/IRB information, deliberations and documents to other than authorized individuals
p.000071:
p.000071: conflict of interest – a conflict of interest arises when a member (or members) of the Ethics Committee holds
p.000071: interests with respect to specific applications for review that may jeopardize his/her ability to provide a
p.000071: free and independent evaluation of the research focused on the protection of the research participants. Conflict of
p.000071: interests may arise when an EC member has financial, material, institutional or social ties to the research.
p.000071:
p.000071: control – the standard by which experimental observation are evaluated. In many clinical trials, one group of patients
p.000071: will be given an experimental drug or treatment, while the control group is either given a standard treatment for the
p.000071: illness or a placebo (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000071:
p.000071: controlled trials – a trial in which one group of participants is given an experimental drug, while another group (the
p.000071: control group) is given either a standard treatment for the disease or a placebo
p.000071:
p.000072: 72
p.000072:
p.000072: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000072:
p.000072: conventional medicine – (see Western medicine) that discipline of medical care advocating therapy with remedies that
p.000072: produce effects differing from those of the disease treated
p.000072:
p.000072: counseling – non-coercive interaction between a health professional and a patient/ client and/or family that is meant
p.000072: to clarify personal values and priorities, health care options, expectations, risks, benefits, and resources in
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
...
p.000079: intellectual property rights – the legal basis by which indigenous communities exercise their rights to have access to,
p.000079: protection, and control over their cultural knowledge and products, including but not limited to traditional medicines,
p.000079: and includes the right to receive compensation for it
p.000079:
p.000080: 80
p.000080:
p.000080: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000080:
p.000080: intellectual property sharing – to participate in, use, enjoy, or experience jointly or in turns the property that
p.000080: derives from the work of the mind or intellect or an idea, invention, trade secret, process, program, data, formula,
p.000080: patent, copyright, or trademark or application, right, or registration relating thereto (Merriam-Webster’s Dictionary
p.000080: of Law (c) 1996)
p.000080:
p.000080: interaction – the chemical or biological reactivity of the active principle or herbal preparation with other
p.000080: administered substances
p.000080:
p.000080: international collaborative research – joint or shared conduct of research by at least two countries or governments
p.000080: (e.g. Philippines and one other foreign government/country)
p.000080:
p.000080: – investigative work conducted at an international level, with involvement by investigators coming from different
p.000080: countries
p.000080:
p.000080: interventional study – research that includes measures or technology that may affect the course of an illness
p.000080:
p.000080: invasive procedure – biological sampling using a method involving intrusion into the human body, such as obtaining a
p.000080: blood sample by using a needle and syringe (UNESCO International Declaration on Human Genetic Data)
p.000080:
p.000080: investigator – a person responsible for the conduct of the critical trial at a trial site. If trial is conducted by a
p.000080: team of individuals at a trial site, the investigator is the responsible leader of the team and be called the principal
p.000080: investigator (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6, R1)
p.000080:
p.000080: – a person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The
p.000080: investigator should have qualifications and competence in accordance with local laws and regulations as
p.000080: evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and to provisions of,
p.000080: medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice
p.000080: medicine or dentistry (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000080:
p.000080: – a qualified scientist who undertakes scientific and ethical responsibility, either on his/her behalf or on behalf of
p.000080: an organization, for the ethical and scientific integrity of a research project at a specific site or group of sites
p.000080:
p.000080: legally authorized representative – one that represents another or others, upon their permission in accordance with
p.000080: law, in a special capacity (Merriam- Webster’s Dictionary of Law (c)1996)
p.000080:
p.000081: 81
p.000081:
...
p.000088: Practice [E6, R1])
p.000088:
p.000088: – an individual, company, institution or organization that takes responsibility fort eh initiation,
p.000088: management and /or financing of a research project
p.000088:
p.000088: – an individual, a company, an institution or an organization that takes
p.000088:
p.000089: 89
p.000089:
p.000089: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000089:
p.000089: responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates
p.000089: and takes full for a trial, the investigator then also assumes the role of the sponsor responsibility (WHO
p.000089: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000089:
p.000089: standard of care – health care intervention or regimen that is generally accepted by health practitioners and experts
p.000089: as beneficial to an individual needing such care
p.000089:
p.000089: prophylactic – professionally accepted level and type of preventive management to prevent the occurrence
p.000089: of a particular health condition
p.000089:
p.000089: diagnostic – professionally accepted level and type of examination to determine a patient’s health condition
p.000089:
p.000089: therapeutic – professionally accepted level and type of treatment or assistance for a particular health condition
p.000089:
p.000089: stem cell research – the study of the properties, development, and transformation of primordial progenitor cells prior
p.000089: to establishment of specialized cells
p.000089:
p.000089: stigma – the negative regard (e.g., shame and dishonor) of the community or society to particular groups because of
p.000089: disability, illness, occupation, poverty, etc. as dictated by culture
p.000089:
p.000089: study/investigational product – a pharmaceutical form of an active ingredient or placebo being tested or used as a
p.000089: reference in a clinical trial, including a product with marketing authorization when used or assembled
p.000089: (formulated or packaged) in a way different from the approved form, or when used fro an unapproved indication, or when
p.000089: used to gain further information about an approved use (ICH Harmonized Tripartite Guideline, Guideline for Good
p.000089: Clinical Practice [E6,R1])
p.000089:
p.000089: susceptibility – genetic condition leading to the development of a disease technical review – see scientific review
p.000089: teratogenicity – the degree or measure of the ability to cause malformations of an embryo or fetus
p.000089:
p.000089: termination of the research – the research study may be ended before its scheduled completion when the safety or
p.000089: benefit of the study participants is doubtful or at risk.
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
...
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000100:
p.000100: APPENDIX A
p.000100: TEMPLATE FOR PATIENT INFORMATION AND INFORMED CONSENT FORM
p.000100:
p.000100: Project Title:
p.000100:
p.000100: Sponsor:
p.000100:
p.000100: Investigator/s:
p.000100:
p.000100:
p.000100:
p.000100: Purpose and conduct of study:
p.000100: • Why is the study being done?
p.000100: • What has been done previously?
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
p.000100: Compensation
p.000100: • Will there be reimbursement of travel expenses? Compensation for loss of income? Meal expenses?
p.000100: • Are there other financial considerations?
p.000100:
p.000100: Provision for injury or related illness
p.000100: • Will the participant be given free treatment in case of injury or illness incurred as a result of participating
p.000100: in the study?
p.000100:
p.000100: Contact person
p.000100: • Who is the person knowledgeable about the research and rights of the participant? How can he/she be contacted?
p.000100:
p.000100: Voluntariness of participation
p.000100: • Is the participant free of any coercion in participating?
p.000100: • Is there assurance that the participant can withdraw anytime without affecting treatment/care due him/her?
p.000100: • Is there provision for obtaining the informed consent from the legal
p.000100:
p.000101: 101
p.000101:
p.000101: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000101:
p.000101: representative in case of minors, the mentally handicapped or the incapacitated?
p.000101:
p.000101: Confidentiality
p.000101: • Is there a statement that describes the measures that will be taken to keep and ensure the confidentiality of the
p.000101: participant’s records?
p.000101:
p.000101:
p.000101: CONSENT FORM
p.000101:
p.000101: I have read and understood the above information and had been given the opportunity to consider and ask questions on
p.000101: the information regarding the involvement in this study. I have spoken directly to my doctor who has answered to my
p.000101: satisfaction all my questions. I have received a copy of this Patient Information and Informed Consent Form.
p.000101: I voluntarily agree to participate.
p.000101:
p.000101:
p.000101:
p.000101: Patient’s Signature:
p.000101:
p.000101:
p.000101:
...
Searching for indicator physically:
(return to top)
p.000006: officially appointed by the administrative head of the institution.
p.000006:
p.000006: 4. The appointing official shall indicate their functions, terms of office, scope of work, conditions of
p.000006: appointment, and compensation, if any.
p.000006:
p.000006: 5. Procedures for renewal of appointment, resignation, replacement; grounds for disqualification;
p.000006: and procedures in regard to conflict of interest due to financial gains shall be included in the manual of
p.000006: standard operating procedures.
p.000006:
p.000006: 6. Prior to serving as a regular member, each member of the IERC shall sign a disclosure document which
p.000006: states that he/she has no conflict of interest (e.g., financial interests in a pharmaceutical company) as a
p.000006: reviewer, and a confidentiality agreement.
p.000006:
p.000006: 7. The appointing official should consider “a fixed rotation system for members that allows for continuity, the
p.000006: development and maintenance of expertise within the committee, and the regular input of fresh ideas and
p.000006: approaches” (WHO Operational Guidelines for Ethics Committees that Review Biomedical Research, 2000).
p.000006:
p.000006: External 8. The committee shall establish a list of external consultants consultants
p.000006: who can provide special expertise
p.000006:
p.000007: 7
p.000007:
p.000007: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000007:
p.000007: regarding ethical, scientific, psychological or social aspects of researches for review.
p.000007:
p.000007: 9. In deliberations on research involving special subject groups or concerns (e.g., HIV/AIDS, the physically
p.000007: challenged), best efforts must be exerted to include participation of advocates.
p.000007:
p.000007: Functions and 10. The IERC is responsible for “acting in the full Responsibilities interest of
p.000007: potential research participants and
p.000007: affected communities, taking into account the interests and needs of the researchers, and having due regard
p.000007: for the requirements of relevant regulatory agencies and applicable laws” (WHO Operational Guidelines for Ethics
p.000007: Committees that Review Biomedical Research, 2000). In the Philippines, the regulatory agencies include
p.000007: PNHRS-PHREB, DOH-BFAD, and the National Committee on Biosafety.
p.000007:
p.000007: 11. The IERC’s functions are as follows:
p.000007:
p.000007: a. To evaluate the conduct of research in their institutions in accordance with international and national
p.000007: guidelines; local laws; standards of professional conduct and practice; and community mores, values, and needs;
p.000007: b. To promote research integrity by identifying and resolving conflicts of interest;
p.000007: c. To establish appropriate mechanisms in all stages of the research in order to:
p.000007: 1) ensure the safety, protect the rights, and promote the welfare and well-being of human participants,
p.000007: 2) provide counsel to human participants, including proponents and researchers,
p.000007: 3) ensure prompt reporting of changes in the protocol and unanticipated problems,
p.000007: 4) ensure the proper documentation of and adherence to the confidentiality rule and policy on informed consent, and
p.000007:
p.000008: 8
p.000008:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
p.000024: access is not possible for legal or religious reasons, investigators shall not recruit for such possibly hazardous
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
p.000024: c. Investigators and ethics review committees shall ensure that prospective subjects who are pregnant are
p.000024: adequately informed about the risks and benefits to themselves, their pregnancy, the fetus and their
p.000024: subsequent offspring, and their fertility.
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
p.000025: political or medical disadvantages, are liable to give consent under duress or without the benefit of adequate
p.000025: information.
p.000025:
p.000025: Absence of 23. When there is ethical and scientific justification direct benefit to conduct
p.000025: research with individuals capable of
p.000025: giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000025: the individual subject should be no more likely and no greater than the risk attached to routine medical or
p.000025: psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an
p.000025: overriding scientific or medical rationale for such increases and when an ethics review committee has approved
p.000025: them (Guideline 9 – CIOMS, 2002).
p.000025:
p.000025:
p.000025: II. Ensuring Quality Research
p.000025:
...
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000100:
p.000100: APPENDIX A
p.000100: TEMPLATE FOR PATIENT INFORMATION AND INFORMED CONSENT FORM
p.000100:
p.000100: Project Title:
p.000100:
p.000100: Sponsor:
p.000100:
p.000100: Investigator/s:
p.000100:
p.000100:
p.000100:
p.000100: Purpose and conduct of study:
p.000100: • Why is the study being done?
p.000100: • What has been done previously?
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
p.000100: Compensation
p.000100: • Will there be reimbursement of travel expenses? Compensation for loss of income? Meal expenses?
p.000100: • Are there other financial considerations?
p.000100:
p.000100: Provision for injury or related illness
p.000100: • Will the participant be given free treatment in case of injury or illness incurred as a result of participating
p.000100: in the study?
p.000100:
...
Health / ill
Searching for indicator ill:
(return to top)
p.000078: problems, health systems and policies as well as those that impact on health such as socioeconomic,
p.000078: environment, energy and agricultural policies (PNHRS TWG Chairs, Feb 2004)
p.000078:
p.000078: – investigational activities that aim to generate data that shall contribute to improvement in the diagnosis,
p.000078: prevention and management of diseases, and in the delivery of care and for the enhancement of the quality of
p.000078: life of individuals and health conditions in communities
p.000078:
p.000078: herbal medicine research – study undertaken to generate new knowledge regarding the use of herbs and plants
p.000078: to prevent and treat diseases and ailments or to promote health and healing
p.000078:
p.000078: herbal medicines – finished, labeled medicinal products that contain as active ingredient/s serial or underground
p.000078: part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations
p.000078:
p.000079: 79
p.000079:
p.000079: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000079:
p.000079: (TAMA of 1997). Plant materials include juices, gums, fatty oils, essential oils, and other substances of this nature.
p.000079: Herbal medicines, however, may contain excipients in addition to the active ingredient/s. Medicines containing plant
p.000079: material/s combined with chemically defined active substances, including chemically defined isolated constituents of
p.000079: plants, are not considered herbal medicines
p.000079:
p.000079: high-risk group – social group known to have a high prevalence of a health problem because of shared environmental,
p.000079: occupational, nutritional or genetic factors including practices that contribute to ill-health
p.000079:
p.000079: HIV (human immunodeficiency virus – type 1) – viral infectious agent that causes destruction of cellular immunity in
p.000079: individuals acquired through tissue fluid transmission from infected persons
p.000079:
p.000079: HIV/AIDS research – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the
p.000079: prevention or treatment of HIV/ AIDS
p.000079:
p.000079: HIV test – immunology-based laboratory test that establishes the presence of HIV infection in an individual
p.000079:
p.000079: human subjects – see research participants
p.000079:
p.000079: hypothesis – a tentative explanation for an observation, phenomenon, or scientific problem that can be tested by
p.000079: further investigation
p.000079:
p.000079: independent consultant – An expert who gives advice comments and suggestions upon review of the study protocols with no
p.000079: affiliation to the institute or investigators proposing the research proposals
p.000079:
p.000079: information in the public domain – data or information available and open to public observation like the list of names
p.000079: in the telephone directory, or events in streets and public transportation
p.000079:
p.000079: informed consent (verbal, video, written) – the process of obtaining approval to participate in an investigative
p.000079: study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.002006: vi
p.002006:
p.002006: Page
p.002006: TABLE OF CONTENTS vii
p.002006: Foreword
p.002006: Estrella F. Alabastro, Ph.D. iii
p.002006: Message
p.002006: Francisco T. Duque III, MD, M.Sc iv
p.002006: Acknowledgments v
p.002006: How to Use the Guidelines viii
p.002006: Abbreviations
p.002006: x
p.002006: Introduction
p.000001: 1
p.000001: Ethics Review Authorities 3
p.000001: The Research Ethics Review Process 11
p.000001: General Ethical Guidelines for Health Research 16
p.000001: Special Guidelines
p.000001: Ethical Guidelines for Clinical Trials on Drugs, Devices, and Diagnostics 30
p.000001: Ethical Guidelines for Herbal Research 38
p.000001: Ethical Guidelines for Complementary and Alternative Medicine Research 42
p.000001: Ethical Guidelines for Epidemiologic Research 45
p.000001: Ethical Guidelines for Social and Behavioral Research 48
p.000001: Ethical Guidelines for the Conduct of Research on Populations
p.000001: Traumatized in Emergencies and Disasters 50
p.000001: Ethical Guidelines for HIV/AIDS Research 53
p.000001: Ethical Guidelines for Research on Assisted Reproductive Technology 55
p.000001: Ethical Guidelines for Genetic Research with a Section
p.000001: on Stem Cell Research 57
p.000001: Ethical Guidelines for International Collaborative Research 64
p.000001: Guidelines on Authorship and Publication 66
p.000001: Glossary
p.000068: 68
p.000068: Bibliography
p.000093: 93
p.000093: Index
p.000096: 96
p.000096: Appendices
p.000096: Appendix A – Template for Patient Information and Informed
p.000096: Consent Form 101
p.000096: Appendix B – Standard Application Form for Ethical Evaluation of Proposal 103
p.000096: Appendix C – List of Documents that Proponent/s Should Provide
p.000096: an Ethics Review Committee 104
p.000096: Appendix D – Composition of the National Ethics Commiittee 105
p.000096: Appendix E – Composition of the Philippine Health
p.000096: Research Ethics Board 106
p.000096: vii
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: HOW TO USE THE GUIDELINES
...
p.000048:
p.000048: Access to 5. In carrying out experimental or quasi-experimental services or designs in
p.000048: field research, access to services or benefits benefits provided to the experimental group shall
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
...
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
p.000096: Feasibility, 27, 76
p.000096: Feedback session, 49
p.000096: Fertilization success, 55
p.000096: Fetus, 76
p.000096:
p.000097: 97
p.000097:
p.000097: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000097:
p.000097:
p.000097: aborted, 63
p.000097: Forensic medicine, 59
p.000097: Gender, 77
p.000097: Gender bias,54, 77
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
p.000097: Genetic traits, 59
p.000097: Good clinical practice, 38, 77
p.000097: Good laboratory practices, 32, 78 Good manufacturing practice, 32 Good Manufacturing Practice
p.000097: Guidelines, 39, 78
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000060: from research might be of value to the individuals or families. Most genetic research studies will require linking of
p.000060: DNA samples to health records, family pedigrees, and individual results.
p.000060:
p.000060: 21. Handling and preservation of biological samples shall be in accordance with standard scientific procedures.
p.000060:
p.000061: 61
p.000061:
p.000061:
p.000061:
p.000061: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000061:
p.000061: 22. Disposal of stored biological specimens shall be in accordance with standards for handling biohazardous and
p.000061: infectious materials.
p.000061:
p.000061: 23. Transport, transfer, and disposal of all stored biological samples shall be properly documented and filed.
p.000061:
p.000061: 24. Retention time for stored biological samples shall be determined by the respective institution.
p.000061:
p.000061: 25. All specimens in a tissue bank must be accompanied by a copy of the consent agreement signed by the donor.
p.000061:
p.000061: 26. No specimen shall be removed from a tissue bank for research purposes without an approved research protocol.
p.000061:
p.000061: 27. A researcher must not transfer genetic material or related information to another research group, unless
p.000061:
p.000061: a. The researcher and the other research group are collaborating on research which has been approved by their
p.000061: respective institutional ethics review committee
p.000061: b. The genetic material and information are provided in a form that ensures that participants cannot be
p.000061: identified
p.000061:
p.000061: Ethical 28. Securing stem cells for research, whether from considerations children, adults
p.000061: or naturally aborted fetuses, must in stem cell be done under conditions of the most rigorous research
p.000061: integrity for several reasons:
p.000061:
p.000061: • To protect the interests of the donors
p.000061: • To reassure the public that important boundaries are not being overstepped
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000062:
p.000062: • To enable those who are ethically uncomfort- able with elements of this research to partici- pate to the greatest
p.000062: extent possible
p.000062: • To ensure the highest quality of research and outcomes
p.000062:
p.000062: 29. Obtaining adult stem cells and hematopoietic stem cells presents no ethical problems. Whether from adults or from
p.000062: children, protection of donors is the same as in research on human subjects where adequate protection and
p.000062: regulation exist.
p.000062:
p.000062: 30. Research with aborted fetuses and pre- implantation embryos is highly controversial and may be unacceptable to
p.000062: several sectors of society. Thus, where the research benefits may be obtained using adult and cord blood stem
p.000062: cells, the use of these acceptable alternative sources is strongly recommended.
p.000062:
p.000062: 31. Patients and researchers should be able to avoid participating in stem cell use if the cells were derived
p.000062: in a way they consider unethical.
p.000062:
p.000062: 32. Documentation of the original source of the stem cells should be made readily available to researchers and
p.000062: potential recipients of stem cell- based therapies.
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063:
p.000063:
p.000063: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000063:
p.000063: ETHICAL GUIDELINES FOR INTERNATIONAL COLLABORATIVE RESEARCHES
p.000063:
p.000063: Introduction
p.000063:
p.000063: Health research is a public good whose burdens and benefits should be shared equally by all the concerned populations
p.000063: (Torres-Edejer, 1999). However, North-South research collaboration is currently plagued by differing interpretations of
p.000063: ethical standards of doing research in developing countries. Should new treatments be compared against Western
p.000063: standards of care or against local existing standards? Can communities benefit from research they have taken part in
p.000063: when they may not be able to afford the new interventions they have helped prove efficacious? How can
p.000063: researchers and institutions in developing countries be strengthened through international collaboration (Lansang and
p.000063: Crawley, 2000)?
p.000063:
p.000063: One other major issue is that of inequitable funding, with only 10 percent of global research funding going to diseases
p.000063: which make up 90 percent of the global burden. For this, three guideposts - Think action - Think local - Think long
p.000063: term - can be used (Torres-Edejer, 1999).
p.000063:
p.000063: Scientific advances are not the only yardstick to measure success of North-South research collaboration: the choice of
...
Health / visual impairment
Searching for indicator blind:
(return to top)
p.000015: applicable laws.
p.000015:
p.000016: 16
p.000016:
p.000016: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000016:
p.000016: Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an
p.000016: ethics review committee (Guideline 4 – Council for International Organi- zations of Medical Sciences [CIOMS], 2002).
p.000016:
p.000016: 2. The investigator shall provide the following information to the potential subject, using language that
p.000016: can be understood:
p.000016:
p.000016: a. That the individual is invited to participate in the research, the reasons for considering the individual
p.000016: suitable for the study, and that participation is voluntary;
p.000016:
p.000016: b. That the individual is free to refuse to participate and is free to withdraw from the research at any time
p.000016: without penalty or loss of benefits to which he/she is entitled;
p.000016:
p.000016: c. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000016: explanation of how the research differs from routine medical care;
p.000016:
p.000016: d. For controlled trials, an explanation of features of the research design (e.g., randomization, double blinding),
p.000016: and that the subject will not be told of the assigned treatment until the study has been completed and the blind
p.000016: has been broken;
p.000016:
p.000016: e. The expected duration of the individual’s participation (including number and duration of visits to the
p.000016: research center and the total time involved) and the possibility of early termination of the trial or of the
p.000016: individual’s participation in it;
p.000016:
p.000016: f. Any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others)
p.000016:
p.000017: 17
p.000017:
p.000017: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000017:
p.000017: associated with participation in the research, (in both the control and experimental group), including risks to the
p.000017: health or well-being of a subject’s spouse or partner;
p.000017:
p.000017: g. The direct benefits, if any, expected to result to subjects from participating in the research;
p.000017:
p.000017: h. Whether money or other forms of material goods will be provided in return for the individual’s
p.000017: participation and, if so, the kind and amount;
p.000017:
p.000017: i. That the subjects have the right of access to data on demand even if these data lack immediate clinical
p.000017: utility (unless the ethics review committee has approved temporary or permanent non-disclosure of data, in which
p.000017: case the subject should be informed and given the reasons for such non-disclosure);
p.000017:
p.000017: j. That after the completion of the study the subject will be informed (if he/she so desires) of any findings
p.000017: related to his/her health status;
p.000017:
p.000017: k. The expected benefits of the research to the community or to society at large, or contribution to scientific
p.000017: knowledge;
p.000017:
...
p.000031: the product shall be made available for review.
p.000031:
p.000031: 9. Good laboratory practices shall be strictly observed when a clinical trial requires laboratory assay.
p.000031:
p.000031: Agreement 10. The investigator/s shall establish with the sponsor with sponsor an agreement on
p.000031: the protocol, standard operating
p.000031: procedures, monitoring, and auditing of the trial and allocation of trial-related responsibilities including
p.000031: publication and authorship.
p.000031:
p.000031: Protocol 11. The protocol shall at least contain the following:
p.000031:
p.000031: a. General information about the trial such as investigator/s, sponsor/s, monitor/s, other qualified medical
p.000031: expert/s, diagnostic laboratories, and research institutions involved.
p.000031:
p.000031: b. Background information regarding the product under investigation, relevant current research findings and
p.000031: references to such information and data, potential risks and benefits, reasons for the indicated route of
p.000031: administration, dosage, periods of treatment, population to be studied, a declaration regarding
p.000031:
p.000032: 32
p.000032:
p.000032:
p.000032:
p.000032: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000032:
p.000032: compliance with good clinical practice, and regulatory requirements.
p.000032:
p.000032: c. Objectives and purpose.
p.000032:
p.000032: d. Trial design, which substantially determines the scientific integrity of the trial and reliability of the data,
p.000032: and which shall include the following:
p.000032:
p.000032: 1) Description of the type of design and trial plan (double-blind, placebo controlled, parallel design) and
p.000032: diagram of procedures and stages
p.000032: 2) Primary and secondary endpoints to be measured
p.000032: 3) Measures to minimize or avoid bias, such as randomization and blinding
p.000032: 4) Trial treatments and investigation product’s dosage, packaging, labeling, and storage
p.000032: 5) Estimated duration of subjects’ participation in the trial
p.000032: 6) Discontinuation rules for the subjects and the trial
p.000032: 7) Treatment randomization codes maintenance and rules on breaking the code
p.000032: 8) Procedures for accountability for product being investigated, placebos, and comparators
p.000032: 9) Other sources of data
p.000032:
p.000032: e. Selection and withdrawal of participants, which include inclusion, exclusion, and withdrawal criteria
p.000032:
p.000032: f. Informed consent
p.000032:
p.000032: g. Subjects’ therapy or treatment, and monitoring procedures
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033:
p.000033: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000033:
p.000033: h. Efficacy parameters, methods, and timing
p.000033:
p.000033: i. Safety parameters, methods, timing, and procedures for recording and reporting as well as monitoring adverse
p.000033: reactions
p.000033:
p.000033: j. Plan for data and statistical analysis
p.000033:
p.000033: k. Statement regarding direct access to trial data and documents for monitoring, audits, institutional ethics
p.000033: committee reviews, and regulatory inspections
p.000033:
p.000033: l. Ethical considerations
p.000033:
...
p.000082: the pharmacokinetic and, where possible, a phramacodynamic profile of the active ingredients in humans. (WHO,
p.000082: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000082: Phase II clinical trial –trials performed in a limited number of subjects, often at a later stage of a comparative
p.000082: (e.g., placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and assess short-term safety of
p.000082: the active ingredient in patients suffering from a disease or condition for which the active ingredient is intended.
p.000082: This phase also aims at the determination of appropriate dose ranges or regimens and (if possible) clarification of
p.000082: dose-response relationships in order to provide an optimal background for the design of extensive therapeutic
p.000082: trials (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000083: 83
p.000083:
p.000083: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000083:
p.000083: Phase III clinical trial – trials in larger (and possibly varied) patient groups with the purpose of determining
p.000083: the short- and long-term safety/efficacy balance of formulation/s of the active ingredient, and of assessing its
p.000083: overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated
p.000083: and special features of the product must be explored (e.g., clinically relevant drug interactions, factors leading to
p.000083: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000083: designs may be acceptable (e.g., long-term safety studies). Generally, the conditions under which these trials
p.000083: are carried out should be as close as possible to normal conditions of use. (WHO Guidelines for Good Clinical Practice
p.000083: (GCP) for trials of pharmaceutical products)
p.000083:
p.000083: Phase IV clinical trial – studies performed after marketing of the pharmaceutical product. Trials in this phase are
p.000083: carried out on the basis of the product characteristics on which the marketing authorization was granted and are
p.000083: normally in the form of the post-marketing surveillance, or assessment of therapeutic value or treatment
p.000083: strategies. Although methods may differ, these studies should use the same scientific and ethical standards as applied
p.000083: in pre-marketing studies. After a product has been placed on the market, clinical trials designed to explore new
p.000083: indications, new methods of administration or new combinations, etc., are normality considered as trials for new
p.000083: pharmaceutical products. (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000083: products)
p.000083:
p.000083: Philippine Health Research Ethics Board – was created on March 1, 2006 through DOST Special Order No. 091 series of
p.000083: 2006 as a policy-making body for research ethics in the Philippines
p.000083:
p.000083: Philippine National Health Research System – formally organized in 2004, it was conceptualized in support of a
p.000083: vibrant, dynamic, and responsible health research community working on a unified health research agenda with enhanced
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.002006: sharing and intellectual property, and culture and informed/misinformed consent.
p.002006:
p.002006: Given the increasing universality of what were once region-specific health concerns, these Guidelines have also
p.002006: identified issues/topics that are commonly addressed by the four international ethics guidelines, namely the
p.002006: International Declaration on Human Genetic Data, the Council for International Organizations of Medical Sciences,
p.002006: UNAIDS, and the Declaration of Helsinki.
p.002006:
p.002006: Written in simple, concise, and reader-friendly style, the 2006 National Ethical Guidelines for Health Research will
p.002006: hopefully encourage more studies conducted by Filipinos on local health concerns, thereby addressing the problem of
p.002006: under-representation of the Philippines in high-impact general medical journals, which is another key ethical issue in
p.002006: health research.
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: Estrella F. Alabastro, Ph. D.
p.002006: Secretary
p.002006: Department of Science and Technology 23 June, 2006
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: iii
p.002006:
p.002006:
p.002006: Republic of the Philippines Department of Health
p.002006: OFFICE OF THE SECRETARY
p.002006: MANILA, PHILIPPINES
p.002006: Tel Nos. (632) 743-83-01 local 1107,1111
p.002006: MESSAGE
p.002006:
p.002006: The landscape of health research has immensely changed with the explosion of new information, the ease of exchange of
p.002006: scientific knowledge, and information technology (IT) that allows for the quick and downloadable access of the outputs
p.002006: of research. There are also challenges being posed by new ethical considerations such as in balancing the need to shed
p.002006: light to emerging public health threats, which especially hit low-income populations against human rights not to be
p.002006: misused when these poor people are chosen as research subjects We must therefore adapt with the times and revolutionize
p.002006: ways in which we conduct local research by becoming more responsive to these scientific, technological, and
p.002006: social advances.
p.002006:
p.002006: The Philippine Health Research Ethics Board (PHREB) under the Philippine National Health Research System (PNHRS) is now
p.002006: bringing out the updated National Ethical Guidelines for Health Research in response to these changing needs. This is
p.002006: indeed a welcome development for the DOH as we continuously seek better information and evidence and explore new ways,
p.002006: approaches, and technologies, which can enhance the performance of the entire health system. Critical reform strategies
p.002006: on service delivery, regulation, financing, and governance under the Fourmula 1 for Health implementation strategy
p.002006: shall surely benefit from these developments as we devote ourselves more to conducting researches built on a foundation
p.002006: of public trust, scientific integrity, and social responsibility.
p.002006:
p.002006: While we accelerate our actions for health through speedier ways of testing new drugs, tools, strategies, and
p.002006: approaches in health research, we must all take care to uphold the values associated with ethical research conduct. We
...
p.000016:
p.000016: b. That the individual is free to refuse to participate and is free to withdraw from the research at any time
p.000016: without penalty or loss of benefits to which he/she is entitled;
p.000016:
p.000016: c. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000016: explanation of how the research differs from routine medical care;
p.000016:
p.000016: d. For controlled trials, an explanation of features of the research design (e.g., randomization, double blinding),
p.000016: and that the subject will not be told of the assigned treatment until the study has been completed and the blind
p.000016: has been broken;
p.000016:
p.000016: e. The expected duration of the individual’s participation (including number and duration of visits to the
p.000016: research center and the total time involved) and the possibility of early termination of the trial or of the
p.000016: individual’s participation in it;
p.000016:
p.000016: f. Any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others)
p.000016:
p.000017: 17
p.000017:
p.000017: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000017:
p.000017: associated with participation in the research, (in both the control and experimental group), including risks to the
p.000017: health or well-being of a subject’s spouse or partner;
p.000017:
p.000017: g. The direct benefits, if any, expected to result to subjects from participating in the research;
p.000017:
p.000017: h. Whether money or other forms of material goods will be provided in return for the individual’s
p.000017: participation and, if so, the kind and amount;
p.000017:
p.000017: i. That the subjects have the right of access to data on demand even if these data lack immediate clinical
p.000017: utility (unless the ethics review committee has approved temporary or permanent non-disclosure of data, in which
p.000017: case the subject should be informed and given the reasons for such non-disclosure);
p.000017:
p.000017: j. That after the completion of the study the subject will be informed (if he/she so desires) of any findings
p.000017: related to his/her health status;
p.000017:
p.000017: k. The expected benefits of the research to the community or to society at large, or contribution to scientific
p.000017: knowledge;
p.000017:
p.000017: l. Whether, when, and how, any products or interventions proven by the research to be safe and effective
p.000017: will be made available to the subjects after they have completed their participation in the research, and whether they
p.000017: will be expected to pay for them;
p.000017:
p.000017: m. Any currently available alternative interventions or courses of treatment;
p.000017:
p.000017: n. The provisions that will be made to ensure respect for the privacy of subjects and the
p.000017:
p.000018: 18
p.000018:
p.000018: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000018:
p.000018: confidentiality of records in which the subjects are identified;
p.000018:
p.000018: o. The limits, legal or other, to the investigator’s ability to safeguard confidentiality, and the possible
p.000018: consequences of breaches of confidentiality;
p.000018:
p.000018: p. The sponsors of the research, the institutional affiliation of the investigators, and the nature and sources of
p.000018: funding for the research;
p.000018:
p.000018: q. The possible research uses, direct or secondary, of the subject’s medical records; and the possible
...
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
p.000024: access is not possible for legal or religious reasons, investigators shall not recruit for such possibly hazardous
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
p.000024: c. Investigators and ethics review committees shall ensure that prospective subjects who are pregnant are
p.000024: adequately informed about the risks and benefits to themselves, their pregnancy, the fetus and their
p.000024: subsequent offspring, and their fertility.
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
...
p.000032: and which shall include the following:
p.000032:
p.000032: 1) Description of the type of design and trial plan (double-blind, placebo controlled, parallel design) and
p.000032: diagram of procedures and stages
p.000032: 2) Primary and secondary endpoints to be measured
p.000032: 3) Measures to minimize or avoid bias, such as randomization and blinding
p.000032: 4) Trial treatments and investigation product’s dosage, packaging, labeling, and storage
p.000032: 5) Estimated duration of subjects’ participation in the trial
p.000032: 6) Discontinuation rules for the subjects and the trial
p.000032: 7) Treatment randomization codes maintenance and rules on breaking the code
p.000032: 8) Procedures for accountability for product being investigated, placebos, and comparators
p.000032: 9) Other sources of data
p.000032:
p.000032: e. Selection and withdrawal of participants, which include inclusion, exclusion, and withdrawal criteria
p.000032:
p.000032: f. Informed consent
p.000032:
p.000032: g. Subjects’ therapy or treatment, and monitoring procedures
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033:
p.000033: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000033:
p.000033: h. Efficacy parameters, methods, and timing
p.000033:
p.000033: i. Safety parameters, methods, timing, and procedures for recording and reporting as well as monitoring adverse
p.000033: reactions
p.000033:
p.000033: j. Plan for data and statistical analysis
p.000033:
p.000033: k. Statement regarding direct access to trial data and documents for monitoring, audits, institutional ethics
p.000033: committee reviews, and regulatory inspections
p.000033:
p.000033: l. Ethical considerations
p.000033:
p.000033: m. Data management and record keeping
p.000033:
p.000033: n. Financing and insurance
p.000033:
p.000033: o. Publication plans and procedures
p.000033:
p.000033: p. Clinical trial participants’ information sheet/ brochure
p.000033:
p.000033: 12. Any amendment/s to the protocol should be resubmitted to the IERC and BFAD.
p.000033:
p.000033: Use of placebo 13. Use of placebo is generally not acceptable when
p.000033: there are standard treatments available to a patient population. Thus, a placebo control may be used only when –
p.000033:
p.000033: a. Standard therapy is unavailable
p.000033: b. Existing treatment is of unproven efficacy, or possesses unacceptable side-effects
p.000033: c. The placebo itself is an effective therapy
p.000033: d. The disease has little adverse effect on the patient
p.000033: e. Testing an add-on treatment to a standard therapy when all subjects get all treatments that would normally
p.000033: be given
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034:
p.000034: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000034:
p.000034: f. The patient has provided informed rejection or refusal of standard therapy for a minor condition for
p.000034: which the patient refuses treatment, and when such refusal for therapy will not lead to unjustified affliction
...
p.000047: or written consent. Verbal consent must be attested to in the absence of a written consent. Coercion in any form
p.000047: may not be used to force individuals to participate. If participants are minors, consent of the parent/
p.000047: guardian must be obtained. Assent of the minor must also be obtained, properly documented, and attested to by an
p.000047: impartial witness of legal age.
p.000047:
p.000047: Privacy and 3. The researcher shall respect the respondent’s confidentiality right to
p.000047: privacy and preserve the confidentiality of of information information. He/She shall make provisions
p.000047: to
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048:
p.000048: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000048:
p.000048: render the participants anonymous to those not directly involved in the research.
p.000048:
p.000048: 4. The researcher shall not release information that permits linking specific individuals to specific
p.000048: information. In cases where information pertaining to groups or specific communities exposes them to possible harm or
p.000048: abuse, the researcher shall refrain from identifying such groups or communities unless required by law.
p.000048:
p.000048: Access to 5. In carrying out experimental or quasi-experimental services or designs in
p.000048: field research, access to services or benefits benefits provided to the experimental group shall
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
...
p.000056:
p.000056: Human genetic research aims to identify genes associated with health and disease, and elucidate their functions. The
p.000056: ultimate goal is to use the knowledge gained through research to discover ways of better diagnosis and
p.000056: treatment. The main types of genetic research are: cloning human genes, family studies, linkage analysis, DNA
p.000056: sequencing and association studies, pharmacogenetics, behavioral genetics, population- based genetics, and stem cell
p.000056: research. Genetic information may be obtained in several ways. One of the most important ways is from a family
p.000056: medical history, which is a kind of genetic test that are commonly used by good doctors. Genetic information is also
p.000056: available from clinical examination, and testing of DNA, RNA, proteins, or cellular metabolites that indicate gene
p.000056: activity.
p.000056:
p.000056: Human stem cell research holds enormous potential for contributing to an understanding of fundamental human biology,
p.000056: leading to the possibility of novel treatments and, ultimately, cures for many diseases for which adequate therapies do
p.000056: not exist. It is essential that the public be educated
p.000056:
p.000057: 57
p.000057:
p.000057:
p.000057:
p.000057: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000057:
p.000057: and informed about ethical and policy issues raised by stem cell research and its applications. Informed public
p.000057: discussions of these issues should be based on an understanding of the science associated with stem cell research and
p.000057: should involve a broad cross-section of society. Special efforts should be made to promote equitable access to the
p.000057: benefits of stem cell research. Intellectual property regulations for stem cell research should set conditions that do
p.000057: not restrict basic research or encumber future product development.
p.000057:
p.000057: The ethical considerations in reviewing genetic research are no different from those that arise when reviewing other
p.000057: types of research. However, in addition to those that apply to all research involving humans, there are ethical issues
p.000057: unique to genetic research. These arise from the nature of genes and genetic information which, though personal, are
p.000057: also shared with other family members and with unrelated individuals in the population.
p.000057:
p.000057: These guidelines shall be used by research institutions, scientists, pharmaceutical companies, health
p.000057: researchers, and institutional review boards for the ethical pursuit of genetic research so that the expected benefits
p.000057: in the improvement of health and healthcare will be attained.
p.000057:
p.000057: General 1. All research involving human subjects should be
p.000057: guidelines conducted in accordance with the ethical
p.000057: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000057:
p.000057: 2. Given the familial nature of genetic research, confidentiality, privacy, and security are important
p.000057: considerations in the ethics review of a genetic study.
p.000057:
p.000057: Specific guidelines
p.000057:
p.000057: Collection of 3. Human biological samples for genetic research samples include samples
...
p.000079: prevention or treatment of HIV/ AIDS
p.000079:
p.000079: HIV test – immunology-based laboratory test that establishes the presence of HIV infection in an individual
p.000079:
p.000079: human subjects – see research participants
p.000079:
p.000079: hypothesis – a tentative explanation for an observation, phenomenon, or scientific problem that can be tested by
p.000079: further investigation
p.000079:
p.000079: independent consultant – An expert who gives advice comments and suggestions upon review of the study protocols with no
p.000079: affiliation to the institute or investigators proposing the research proposals
p.000079:
p.000079: information in the public domain – data or information available and open to public observation like the list of names
p.000079: in the telephone directory, or events in streets and public transportation
p.000079:
p.000079: informed consent (verbal, video, written) – the process of obtaining approval to participate in an investigative
p.000079: study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An
p.000079: important part of the process is the adequacy, appropriateness, and timeliness of the information for decision-making
p.000079:
p.000079: intellectual property rights – the legal basis by which indigenous communities exercise their rights to have access to,
p.000079: protection, and control over their cultural knowledge and products, including but not limited to traditional medicines,
p.000079: and includes the right to receive compensation for it
p.000079:
p.000080: 80
p.000080:
p.000080: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000080:
p.000080: intellectual property sharing – to participate in, use, enjoy, or experience jointly or in turns the property that
p.000080: derives from the work of the mind or intellect or an idea, invention, trade secret, process, program, data, formula,
p.000080: patent, copyright, or trademark or application, right, or registration relating thereto (Merriam-Webster’s Dictionary
p.000080: of Law (c) 1996)
p.000080:
p.000080: interaction – the chemical or biological reactivity of the active principle or herbal preparation with other
p.000080: administered substances
p.000080:
p.000080: international collaborative research – joint or shared conduct of research by at least two countries or governments
p.000080: (e.g. Philippines and one other foreign government/country)
p.000080:
p.000080: – investigative work conducted at an international level, with involvement by investigators coming from different
p.000080: countries
p.000080:
p.000080: interventional study – research that includes measures or technology that may affect the course of an illness
p.000080:
p.000080: invasive procedure – biological sampling using a method involving intrusion into the human body, such as obtaining a
p.000080: blood sample by using a needle and syringe (UNESCO International Declaration on Human Genetic Data)
p.000080:
...
p.000098: Political repression, 50
p.000098: Post-marketing surveillance, 30
p.000098: Practitioner, qualified, 55
p.000098: Preclinical studies, 32, 85
p.000098: Predictive testing, 57, 59, 85
p.000098: Predisposition, 57, 85
p.000098: Pregnancy test, 25
p.000098: Pre-marketing phase, 30
p.000098: Prenatal testing, 57, 85
p.000098: Privacy,18,22,45,48, 61, 85
p.000098: Procedures, invasive, 28
p.000098: Product toxicities, 31
p.000098: Protein, 57, 58
p.000098: Protocol, 32, (see also research protocol), 85
p.000098: Psychocultural aspects, 53, 55
p.000098: Psychosocial needs, 51, 86
p.000098: Publication, 36, 54, 67
p.000098: Impediments to, 67 Qualifications of investigators, 28 Quality of life, 43, 86
p.000098: Quasi-experimental design, 49, 86
p.000098: Questionnaire, 47
p.000098: Quorum, 12
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
p.000098: Reprisals, 50
p.000098: Research agreement, 65
p.000098: Rescue medication, 44, 87
p.000098: Research capacity, Investment, 64
p.000098: Local, 64
p.000098: strengthening, 29
p.000098: Research design, 17
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
p.000098: Review procedure, 12-13 Right of access, 18 Risks, 17, 88
p.000098: RNA, 57, 58, 88
p.000098: Safety information, 11-12
p.000098: Safety parameters, 34
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
...
Social / Age
Searching for indicator age:
(return to top)
p.000003:
p.000003: 2. Develop guidelines for the establishment and management of ethics review committees and standardization of
p.000003: research ethics review;
p.000003:
p.000003: 3. Monitor and evaluate the performance of institutional ethics review committees in accordance with procedures
p.000003: outlined in a prior agreement;
p.000003:
p.000003: 4. Promote the establishment of functional and effective ethics review committees;
p.000003:
p.000003: 5. Provide advice and make recommenda- tions to the PNHRS Governing Council and other appropriate entities
p.000003: (including the Bureau of Food and Drugs [BFAD]) regarding programs, policies, and regula- tions as they relate to
p.000003: ethical issues in human health research;
p.000003:
p.000003: 6. Initiate and contribute to discourse and discussions of ethical issues in human health research; and
p.000003:
p.000003: 7. Network with relevant local, national, and international organizations.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000004:
p.000004: Regional Research Ethics Boards
p.000004:
p.000004: Composition The regional research ethics boards will be
p.000004: constituted by the PNHRS Governing Council and will have a multidisciplinary, multisectoral, gender- and age-balanced
p.000004: membership that reflects the cultural and social milieu obtaining in the region they are in. They will be under the
p.000004: supervision of PHREB.
p.000004:
p.000004: Functions The regional research ethics boards will be
p.000004: established in key regions to act as a regional research ethics review policy-making authority. Their functions will,
p.000004: therefore, be similar to that of PHREB with the region as their area of responsibility.
p.000004:
p.000004:
p.000004: Ethics Review Committees (ERCs)
p.000004:
p.000004: The Ethics Review Committees include the Cluster Ethics Review Committees, the Institutional Ethics Review
p.000004: Committees and the erstwhile National Ethics Committee. The latter has for several years conducted initial review for
p.000004: researches done in institutions without a functional research ethics review committee.
p.000004:
p.000004:
p.000004: Cluster Ethics Review Committees (CERCs)
p.000004:
p.000004: Several institutions may form a common ethics review committee if it is not feasible to form their own committees.
p.000004:
p.000004: The management of CERCs and its areas of responsibility should be covered by a memorandum of agreement among the
...
p.000005: was cited as a major flaw of many IERCs. The efforts of DOST-PCHRD, DOH, and University of the Philippines
p.000005: Fogarty Group in organizing intensive training courses in research ethics may answer the need for capacity building
p.000005: in this field.
p.000005:
p.000005: Standardization of ethics review is an area of concern that the IERC should address. In this regard, the IERC may use
p.000005: as references the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000), and
p.000005: the 2006 General Ethical Guidelines for Health Research (pp16-29). However, it should develop a manual of standard
p.000005: operating procedures.
p.000005:
p.000005: Composition 1. The membership of the institutional ethics review
p.000005: committee should be multidisciplinary and multisectoral, including the relevant expertise, e.g., medicine and
p.000005: research, theology, social or behavioral science, law, philosophy, environmental science, and public
p.000005: health. It is recommended that the IERC should include a person without disciplinal constraints who will
p.000005: represent the interests and concerns of the
p.000005:
p.000006: 6
p.000006:
p.000006: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000006:
p.000006: community. At least one member should be independent of the institution or research site. The IERC should have
p.000006: at least five members and should consider age and gender distribution.
p.000006:
p.000006: 2. In addition to the committee members, there should be adequate support staff for carrying out the IERC’s
p.000006: responsibilities.
p.000006:
p.000006: Appointment 3. The officers and members of the IERC shall be
p.000006: officially appointed by the administrative head of the institution.
p.000006:
p.000006: 4. The appointing official shall indicate their functions, terms of office, scope of work, conditions of
p.000006: appointment, and compensation, if any.
p.000006:
p.000006: 5. Procedures for renewal of appointment, resignation, replacement; grounds for disqualification;
p.000006: and procedures in regard to conflict of interest due to financial gains shall be included in the manual of
p.000006: standard operating procedures.
p.000006:
p.000006: 6. Prior to serving as a regular member, each member of the IERC shall sign a disclosure document which
p.000006: states that he/she has no conflict of interest (e.g., financial interests in a pharmaceutical company) as a
p.000006: reviewer, and a confidentiality agreement.
p.000006:
p.000006: 7. The appointing official should consider “a fixed rotation system for members that allows for continuity, the
p.000006: development and maintenance of expertise within the committee, and the regular input of fresh ideas and
p.000006: approaches” (WHO Operational Guidelines for Ethics Committees that Review Biomedical Research, 2000).
p.000006:
p.000006: External 8. The committee shall establish a list of external consultants consultants
p.000006: who can provide special expertise
p.000006:
p.000007: 7
p.000007:
p.000007: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
...
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
p.000024: access is not possible for legal or religious reasons, investigators shall not recruit for such possibly hazardous
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
...
p.000047: autonomy.
p.000047:
p.000047: The guidelines below are consistent with existing ones on research on human subjects but are made more specific for
p.000047: social research.
p.000047:
p.000047: General 1. All research involving human subjects should be
p.000047: guidelines conducted in accordance with the ethical
p.000047: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000047:
p.000047: Special guidelines
p.000047:
p.000047: Informed 2. Informed consent shall be obtained, with the consent possible
p.000047: exception of research involving archival work, participant observation, and observation in
p.000047: public places. The researcher shall inform his/ her participants as to the nature of the research and obtain verbal
p.000047: or written consent. Verbal consent must be attested to in the absence of a written consent. Coercion in any form
p.000047: may not be used to force individuals to participate. If participants are minors, consent of the parent/
p.000047: guardian must be obtained. Assent of the minor must also be obtained, properly documented, and attested to by an
p.000047: impartial witness of legal age.
p.000047:
p.000047: Privacy and 3. The researcher shall respect the respondent’s confidentiality right to
p.000047: privacy and preserve the confidentiality of of information information. He/She shall make provisions
p.000047: to
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048:
p.000048: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000048:
p.000048: render the participants anonymous to those not directly involved in the research.
p.000048:
p.000048: 4. The researcher shall not release information that permits linking specific individuals to specific
p.000048: information. In cases where information pertaining to groups or specific communities exposes them to possible harm or
p.000048: abuse, the researcher shall refrain from identifying such groups or communities unless required by law.
p.000048:
p.000048: Access to 5. In carrying out experimental or quasi-experimental services or designs in
p.000048: field research, access to services or benefits benefits provided to the experimental group shall
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
...
p.000080:
p.000080: legally authorized representative – one that represents another or others, upon their permission in accordance with
p.000080: law, in a special capacity (Merriam- Webster’s Dictionary of Law (c)1996)
p.000080:
p.000081: 81
p.000081:
p.000081: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000081:
p.000081: – A person who has authority, under the law, to stand for, or make decisions in behalf of another
p.000081:
p.000081: legally competent person – qualified or fit to perform an act, in accordance with law, free from addiction or mental
p.000081: defects that renders one incapable of taking care or oneself or one’s property (Merriam-Webster’s Dictionary of Law
p.000081: (c)1996)
p.000081:
p.000081: linkage analysis – gene hunting technique that traces patterns of disease in high risk families for the purpose of
p.000081: locating a disease-causing gene by identifying genetic markers of known chromosomal location that are co-inherited with
p.000081: the trait of interest
p.000081:
p.000081: material transfer agreement – an agreement between the source institution (or community) and the recipient institution
p.000081: (agency or community) that defines responsibilities and ownership of the material under study
p.000081:
p.000081: minimal toxicity data – the lowest dose of the preparation that shall elicit toxicity signs and symptoms in the
p.000081: participants or in animals
p.000081: minors – persons who have not yet reached the age of majority, 18 years old monitor – a person appointed by and
p.000081: responsible to the sponsor or contract
p.000081: research organization for monitoring and reporting progress of the trial
p.000081: and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000081:
p.000081: moral agent – a sentient individual whose acts impact on others and are affected by the act of others
p.000081:
p.000081: multicenter trial – a clinical trial conducted according to a single protocol but at more that one site, and
p.000081: therefore, carried out by more than one investigator (ICH Harmonized Tripartite Guideline, General
p.000081: Considerations for Clinical Trial (E8)
p.000081:
p.000081: multifactorial inheritance – heredity characterized by the involvement of several genes and environmental factors
p.000081:
p.000081: mutagenicity – the capacity of a chemical or physical agent to cause genetic alterations
p.000081:
p.000081: national health care delivery system – the total structures – private and public organizations, agencies, and
p.000081: individuals, including policies and mechanisms
p.000081: – that provide health care to individuals and communities in the country
p.000081:
p.000081:
p.000082: 82
p.000082:
p.000082: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000082:
p.000082: National Unified Health Research Agenda (NUHRA) – national health research priorities identified by major stakeholders
p.000082:
p.000082: non-disclosure of data – the withholding of or refusal to reveal information derived from research
p.000082:
p.000082: non-invasive procedure – biological sampling using a method which does not involve intrusion into the human body (e.g.,
p.000082: oral smears)
p.000082:
...
p.000082: the pharmacokinetic and, where possible, a phramacodynamic profile of the active ingredients in humans. (WHO,
p.000082: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000082: Phase II clinical trial –trials performed in a limited number of subjects, often at a later stage of a comparative
p.000082: (e.g., placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and assess short-term safety of
p.000082: the active ingredient in patients suffering from a disease or condition for which the active ingredient is intended.
p.000082: This phase also aims at the determination of appropriate dose ranges or regimens and (if possible) clarification of
p.000082: dose-response relationships in order to provide an optimal background for the design of extensive therapeutic
p.000082: trials (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000083: 83
p.000083:
p.000083: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000083:
p.000083: Phase III clinical trial – trials in larger (and possibly varied) patient groups with the purpose of determining
p.000083: the short- and long-term safety/efficacy balance of formulation/s of the active ingredient, and of assessing its
p.000083: overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated
p.000083: and special features of the product must be explored (e.g., clinically relevant drug interactions, factors leading to
p.000083: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000083: designs may be acceptable (e.g., long-term safety studies). Generally, the conditions under which these trials
p.000083: are carried out should be as close as possible to normal conditions of use. (WHO Guidelines for Good Clinical Practice
p.000083: (GCP) for trials of pharmaceutical products)
p.000083:
p.000083: Phase IV clinical trial – studies performed after marketing of the pharmaceutical product. Trials in this phase are
p.000083: carried out on the basis of the product characteristics on which the marketing authorization was granted and are
p.000083: normally in the form of the post-marketing surveillance, or assessment of therapeutic value or treatment
p.000083: strategies. Although methods may differ, these studies should use the same scientific and ethical standards as applied
p.000083: in pre-marketing studies. After a product has been placed on the market, clinical trials designed to explore new
p.000083: indications, new methods of administration or new combinations, etc., are normality considered as trials for new
p.000083: pharmaceutical products. (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000083: products)
p.000083:
p.000083: Philippine Health Research Ethics Board – was created on March 1, 2006 through DOST Special Order No. 091 series of
p.000083: 2006 as a policy-making body for research ethics in the Philippines
p.000083:
p.000083: Philippine National Health Research System – formally organized in 2004, it was conceptualized in support of a
p.000083: vibrant, dynamic, and responsible health research community working on a unified health research agenda with enhanced
...
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
p.000084: pre-clinical trials – investigation of the pharmacologic properties of a drug or preparation done in animals prior to
p.000084: human studies. Pre-clinical studies shall include pharmacodynamics, pharmacokinetics, and toxicity studies (BFAD
p.000084: Guidelines for Registration of Pharmaceutical Products, 1997)
p.000084:
p.000084: predictive testing – determination of the presence of disease-associated genes prior to the onset or manifestation of
p.000084: the disease
p.000084:
p.000084: predisposition or risk testing – determination of genetic parameters in an individual associated with increased risk of
p.000084: disease
p.000084:
p.000084: prenatal testing – determination of whether a fetus has (or probably has) a designated condition for which an increased
p.000084: risk is indicated by later maternal age, family history, or other well-defined risk factors
p.000084:
p.000084: prior dose finding – quantity or dosage of the herbal medicine established in earlier studies or practice to be
p.000084: effective
p.000084:
p.000084: privacy – a conceptual space defining the individual’s boundary as a person, intrusion of which is limited human rights
p.000084: and by law
p.000084:
p.000084: – the assurance of the secrecy of the identity of or information about research participants
p.000084:
p.000084: product adulteration – presence of foreign substances or impurities in the drug preparation that results in dilution or
p.000084: loss of its efficacy
p.000084:
p.000084: protein – a macromolecule composed of subunits of linear chains of amino acids attached to each other by peptide bonds
p.000084:
p.000084: proteomic data – information from the comprehensive analysis and cataloguing of the structure and function of all the
p.000084: proteins present in a given cell or tissue
p.000084:
p.000084: protocol – is the documentary record of the research undertaking that includes
p.000084:
p.000085: 85
p.000085:
p.000085: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000085:
p.000085: the background of the study, research question and objectives, the conceptual design, the methodology and data
p.000085: collection, and planned analysis of data.
p.000085:
p.000085: – a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of
p.000085: participants as well as answers specific research questions. The protocol describes what types of people may
p.000085: participate in the trial; the schedule of tests, procedures, medications, and dosages; and length of the study. In a
...
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000100:
p.000100: APPENDIX A
p.000100: TEMPLATE FOR PATIENT INFORMATION AND INFORMED CONSENT FORM
p.000100:
p.000100: Project Title:
p.000100:
p.000100: Sponsor:
p.000100:
p.000100: Investigator/s:
p.000100:
p.000100:
p.000100:
p.000100: Purpose and conduct of study:
p.000100: • Why is the study being done?
p.000100: • What has been done previously?
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
p.000100: Compensation
p.000100: • Will there be reimbursement of travel expenses? Compensation for loss of income? Meal expenses?
p.000100: • Are there other financial considerations?
p.000100:
p.000100: Provision for injury or related illness
...
Social / Child
Searching for indicator child:
(return to top)
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
p.000019: 5. The participation of children in research requires extra protection, as children cannot volunteer to participate
p.000019: in a research study in the same way as an adult can. While they cannot give informed consent, they can participate in
p.000019: the process of
p.000019:
p.000020: 20
p.000020:
p.000020: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000020:
p.000020: obtaining consent by being asked for their assent to participate. When appropriate, both a child’s assent and the
p.000020: parent’s or guardian’s permission should be obtained prior to enrolling a child in a research study.
p.000020:
p.000020: 6. In obtaining informed consent, sponsors and investigators have a duty to:
p.000020:
p.000020: a. avoid deception, undue influence, or intimidation;
p.000020:
p.000020: b. seek consent only after ascertaining that the prospective subject has adequate understanding of the
p.000020: relevant facts and the consequences of participation, and has had sufficient opportunity to consider whether to
p.000020: participate;
p.000020:
p.000020: c. as a general rule, obtain from each prospective subject a signed form as evidence of informed consent;
p.000020: investigators shall justify any exceptions to this general rule and obtain the approval of the ethics review committee;
p.000020:
p.000020: d. renew the informed consent of each subject if there are any significant changes in the conditions or
p.000020: procedures of the research, or if new information becomes available that could affect the willingness of
p.000020: subjects to continue to participate;
p.000020:
p.000020: e. renew the informed consent of each subject in long-term studies at pre-determined intervals even if there are
p.000020: no changes in the design or objectives of the research (Guideline 6 - CIOMS, 2002).
p.000020:
p.000020: Risks, benefits, 7. Health research is only justified if there is a and safety
p.000020: reasonable likelihood that the populations in which
...
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
...
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
p.000067: The assent is a requirement for research in addition to consent given by a parent or legal guardian
p.000067:
p.000067: child’s assent – is the expressed willingness of a minor to participate in a study
p.000067:
p.000068: 68
p.000068:
p.000068: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000068:
p.000068: assisted reproductive technology – all treatment or procedures that include the in-vitro handling of human oocytes and
p.000068: human sperm or embryos for the purpose of establishing a pregnancy (e.g., in vitro fertilization and transcervical
p.000068: embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, gamete
p.000068: and embryo cryopreservation, oocyte and embryo donation, gestational surrogacy)
p.000068:
p.000068: behavioral research – studies regarding the actions or reactions of persons in response to external or internal stimuli
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
p.000068: bias – the systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the
...
p.000098: Parallel design, 33 Participant
p.000098: Observation, 48
p.000098: Selection, 33
p.000098: Withdrawal, 33
p.000098: Participatory research, 52, 83
p.000098: Patenting, 41
p.000098: Personal data, 47 Person of authority, 47 pharmacogenetics, 83
p.000098: Philippine Health Research Ethics Board (PHREB), 3-4
p.000098: Functions, 4
p.000098: Philippine National Health Research System, 3
p.000098: Philippine Obstetrical and Gynecological Society (POGS), 55
p.000098: Philippine Society of Reproductive Endocrinology and Infertility, 55
p.000098: Placebo, 31, 33, 34, 84
p.000098: Placebo-controlled, 33, 40, 85
p.000098: Political repression, 50
p.000098: Post-marketing surveillance, 30
p.000098: Practitioner, qualified, 55
p.000098: Preclinical studies, 32, 85
p.000098: Predictive testing, 57, 59, 85
p.000098: Predisposition, 57, 85
p.000098: Pregnancy test, 25
p.000098: Pre-marketing phase, 30
p.000098: Prenatal testing, 57, 85
p.000098: Privacy,18,22,45,48, 61, 85
p.000098: Procedures, invasive, 28
p.000098: Product toxicities, 31
p.000098: Protein, 57, 58
p.000098: Protocol, 32, (see also research protocol), 85
p.000098: Psychocultural aspects, 53, 55
p.000098: Psychosocial needs, 51, 86
p.000098: Publication, 36, 54, 67
p.000098: Impediments to, 67 Qualifications of investigators, 28 Quality of life, 43, 86
p.000098: Quasi-experimental design, 49, 86
p.000098: Questionnaire, 47
p.000098: Quorum, 12
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
p.000098: Reprisals, 50
p.000098: Research agreement, 65
p.000098: Rescue medication, 44, 87
p.000098: Research capacity, Investment, 64
p.000098: Local, 64
p.000098: strengthening, 29
p.000098: Research design, 17
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
p.000098: Review procedure, 12-13 Right of access, 18 Risks, 17, 88
p.000098: RNA, 57, 58, 88
p.000098: Safety information, 11-12
p.000098: Safety parameters, 34
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
...
Searching for indicator children:
(return to top)
p.000019: provide such compensation);
p.000019:
p.000019: y. That an ethics review committee has approved or cleared the research protocol (Guideline 5
p.000019: – CIOMS, 2002).
p.000019:
p.000019: 3. After ensuring that the subject has understood the information, the physician should then obtain the
p.000019: subject’s freely given informed consent, preferably in writing. If the consent cannot be obtained in
p.000019: writing, the non-written consent must be formally documented and witnessed (Principle 22 – Declaration of Helsinki,
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
p.000019: 5. The participation of children in research requires extra protection, as children cannot volunteer to participate
p.000019: in a research study in the same way as an adult can. While they cannot give informed consent, they can participate in
p.000019: the process of
p.000019:
p.000020: 20
p.000020:
p.000020: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000020:
p.000020: obtaining consent by being asked for their assent to participate. When appropriate, both a child’s assent and the
p.000020: parent’s or guardian’s permission should be obtained prior to enrolling a child in a research study.
p.000020:
p.000020: 6. In obtaining informed consent, sponsors and investigators have a duty to:
p.000020:
p.000020: a. avoid deception, undue influence, or intimidation;
p.000020:
p.000020: b. seek consent only after ascertaining that the prospective subject has adequate understanding of the
p.000020: relevant facts and the consequences of participation, and has had sufficient opportunity to consider whether to
p.000020: participate;
p.000020:
p.000020: c. as a general rule, obtain from each prospective subject a signed form as evidence of informed consent;
...
p.000022: current prophylactic, diagnostic, or therapeutic methods. Placebo, or no treatment, may be used in studies
p.000022: where no proven prophylactic, diagnostic, or therapeutic method exists (Principle 29 – Declaration of Helsinki,
p.000022: 2004).
p.000022:
p.000022: Compensation 16. Compensation given to subjects for lost earnings, for research travel costs, and
p.000022: other expenses incurred in taking subjects part in a study; free medical services; and
p.000022: compensation for the inconvenience and time spent by those who do not have direct benefit from the research should
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
...
p.000029: determine the levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in
p.000029: patients for safety and, in some cases, early evidence of effectiveness.
p.000029:
p.000029: Phase II investigation consists of controlled clinical trials designed to demonstrate efficacy and relative safety.
p.000029: Normally, these are performed on a limited number of closely monitored patients.
p.000029:
p.000029: Phase III trial is performed after a reasonable probability of a drug’s effectiveness has been established. This type
p.000029: of trial is intended to gather additional evidence of effectiveness for specific indications and more precise
p.000029: definition of drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000029:
p.000029: Phase IV trial is conducted after the national drug registration authority (i.e. BFAD) has approved a drug for
p.000029: distribution or marketing. This trial may include research designed to explore a specific pharmacological effect,
p.000029: establish the incidence of adverse reactions, or determine the effects of a long-term drug administration. It may also
p.000029: be designed to evaluate a drug in a population (such as children or the elderly) not studied adequately in the
p.000029: pre-marketing phases, or to establish a new clinical indication for a drug. Such research is to be distinguished from
p.000029: marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug reactions in that
p.000029: these categories ordinarily need not be reviewed by ethics review committees.
p.000029:
p.000029: The four conventional phases in clinical drug development present different ethical issues. Careful
p.000029: consideration should be noted and addressed in each phase as indicated in the International Conference on
p.000029: Harmonization (ICH) Harmonized Tripartite Guidelines for Good
p.000029:
p.000030: 30
p.000030:
p.000030:
p.000030:
p.000030: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000030:
p.000030: Clinical Practice, General Consideration for Clinical Trials (E8).
p.000030:
p.000030: General 1. All research involving human subjects should be guidelines conducted in
p.000030: accordance with the ethical
p.000030: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000030:
p.000030: 2. All clinical trials must have scientific and social value and, therefore, shall be adequately justified.
p.000030:
p.000030: 3. The various phases of the pharmaceutical trial present different ethical issues that should be keenly looked
...
p.000034: Research on 16. Clinical trials of medical devices, diagnostic medical devices, procedures, and
p.000034: preventive measures, including diagnostic vaccines, raise similar ethical concerns especially
p.000034: procedures and on free and informed consent, and potential preventive measures conflict of interest.
p.000034:
p.000034: a. Trials of critical medical devices such as implants which may present a potential serious risk to health,
p.000034: safety or welfare of the subject shall not be conducted on healthy volunteers. The current safety data on the medical
p.000034: device shall be gathered and the risks posed by the device considered and evaluated. Safety procedures in the
p.000034: introduction of such medical device in the patient shall be followed. The patient information sheet shall contain
p.000034: information on procedures to be adopted should the patient decide to withdraw from the trial. Medical devices
p.000034: that are not used regularly have less risk- potential than those used regularly. Likewise, devices used outside the
p.000034: body have less risk than those used inside the body.
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035:
p.000035: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000035:
p.000035: b. In the case of contraceptive implant trials, adequate monitoring for removal of the implant shall be done
p.000035: when the trial is over or the subject has withdrawn from the trial. Children born as a result of failure
p.000035: of the contraceptive being investigated shall be followed up for any abnormalities and properly reported to
p.000035: monitoring authorities.
p.000035:
p.000035: c. For vaccine trials using active or live attenuated microorganisms, the subject may be exposed to the
p.000035: specific infection for which the vaccine is being tested. As such, the vaccinated subject shall be
p.000035: informed accordingly and properly cared for.
p.000035:
p.000035: d. Clinical trials involving diagnostic agents using radioactive materials and X-ray should not necessarily
p.000035: expose subjects to more radiation than normal and shall be undertaken on patients undergoing the procedure
p.000035: for diagnostic or therapeutic purposes. Radiation limits for the use of such materials and X-rays shall be within the
p.000035: medically acceptable limits. Measures to safeguard research subjects and others who may be exposed to radiation shall
p.000035: be taken. Adequate provisions for detecting pregnancies to avoid risks of exposure to the embryo shall be given.
p.000035: Subjects shall also be provided information on possible genetic damage to their offspring.
p.000035:
p.000035: Publication 17. Clinical trial results shall be communicated in a of clinical timely
p.000035: fashion and published regardless of results trial results or findings. Findings shall be brought
p.000035: into the
p.000035: public domain and generally made known through scientific and other publications.
p.000035:
p.000035: 18. Preliminary reports that raise false hopes and expectations of product safety, efficacy, and immediate
p.000035: use shall not be made public.
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036:
...
p.000044: biological materials collected in epidemiologic researches.
p.000044:
p.000044: These guidelines are for consideration of ethics committees for the protection of participants in
p.000044: epidemiologic research involving humans, focusing primarily on non- experimental studies. Its main difference from
p.000044: other researches is in the nature and extent of the informed consent process.
p.000044:
p.000044: General 1. All research involving human subjects should be
p.000044: guidelines conducted in accordance with the ethical
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000045:
p.000045: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000045:
p.000045: Specific guidelines
p.000045:
p.000045: Informed 2. For case-control and cohort studies, non- consent disclosure of
p.000045: all the study objectives may be permissible if full disclosure of the study
p.000045: hypothesis could bias the investigation.
p.000045:
p.000045: 3. Consent may not be required for collection of information in the public domain. Public domain information
p.000045: may include common general data such as address, marital status, educational attainment, and number of
p.000045: children among others.
p.000045:
p.000045: It should be realized that communities differ in their definition of what type of information about citizens is
p.000045: regarded as public.
p.000045:
p.000045: 4. Data regarding income, personal habits, preferences, personal opinions, political and religious
p.000045: inclinations, among others, may be considered confidential and will require consent prior to collection.
p.000045:
p.000045: 5. Collection of data by questionable means, such as deception, should not be condoned.
p.000045:
p.000045: 6. Data gathered for administrative purposes (as long as the information is not sensitive) do not require consent and
p.000045: may be waived if getting consent is considered impractical or too expensive.
p.000045:
p.000045: 7. Review of medical records may be done without requiring consent if anonymity can be maintained and if
p.000045: information sought is considered non- sensitive (Gordis and Gold, 1980).
p.000045:
p.000045: 8. The appropriate permission for storing biological material for research must be obtained from
p.000045:
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000046:
p.000046: individuals. If the samples are to be used for research not covered by the original consent, an ethics
p.000046: committee should decide whether renewed consent is needed or if the analyses may be done on anonymized samples.
p.000046: Details regarding the collection and storage of biological material are covered in the document on ethical guidelines
p.000046: for genetics research.
p.000046:
p.000046: 9. A person of authority may be allowed to give consent for collection of data among children and other
p.000046: individuals who are temporarily or permanently unable to give informed consent by themselves, provided that the
p.000046: research does not involve more than minimal risks to the participants.
p.000046:
p.000046: 10. If the information is obtained by means of a questionnaire, and adequate information has been given to
p.000046: the research subject, there is no need for a written informed consent, since answering the questionnaire implies
p.000046: consent.
p.000046:
p.000046: 11. There are alternative methods of obtaining informed consent (e.g., verbal consent). These are covered by the
p.000046: document on Ethical Guidelines for Social and Behavioral Research (pp48-49).
p.000046:
p.000046: Privacy and 12. Working with personal data is a privilege that calls confidentiality for a high
p.000046: degree of data protection, especially in
p.000046: situations where data are used without personal consent. A working standard for data protection that secures as little
p.000046: risk of disclosure as possible should be developed.
p.000046:
p.000046: Information 13. Important findings from the research should be shared with made available to
p.000046: all the participants in a suitable participants form.
p.000046:
...
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055:
p.000055: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000055:
p.000055: 3. The intentional creation of human zygotes, embryos or fetuses for study, research, and experimentation
p.000055: or for commercial and industrial purposes is unacceptable (POGS, 1995).
p.000055:
p.000055: 4. Research may be conducted on a human embryo only for the purpose of improving that particular embryo’s chances of
p.000055: being born alive and healthy.
p.000055:
p.000055: 5. The sale of human zygotes is unacceptable.
p.000055:
p.000055: Research 6. Special effort shall be exerted to ascertain the participants
p.000055: emotional stability and maturity of research
p.000055: subjects. Gender-sensitive counseling shall be made available and offered as an adjunct service to research
p.000055: participants.
p.000055:
p.000055: Informed 7. It shall be the responsibility of the attending consent
p.000055: physician to ensure that consent of research subjects is given freely and on the basis of
p.000055: adequate information and that potential conflict of interest is resolved. The investigator must be sensitive to the
p.000055: coercive and unfair pressure on women to bear children.
p.000055:
p.000055: Privacy and 8. Researchers shall uphold the dignity of confidentiality participants
p.000055: and protect their privacy by putting in
p.000055: place adequate mechanisms for upholding the confidentiality especially of the circumstances of conception of
p.000055: children born out of assisted reproductive technology.
p.000055:
p.000055: Embryos from 9. Embryos formed by in vitro fertilization shall be in vitro given
p.000055: respect commensurate to their status fertilization (POGS,1995). Extreme care shall be exercised
p.000055: in the handling of human embryos.
p.000055:
p.000055: 10. Arrangements regarding unused embryos, sperms, and ova shall be agreed upon by the investigator and the
p.000055: source/s prior to the research, and shall be an important part of the research protocol.
p.000056: 56
p.000056:
p.000056:
p.000056:
p.000056: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000056:
p.000056: ETHICAL GUIDELINES FOR GENETIC RESEARCH WITH A SECTION ON STEM CELL RESEARCH
p.000056:
p.000056: Introduction
p.000056:
p.000056: A person’s current and future health is the interaction of many factors, including environment, lifestyle, and genes.
p.000056: Genes are the biochemical instructions for the development and growth of individuals. When a gene is altered, it may
p.000056: cause or contribute to a disease. Genes themselves do not cause disease, but alterations in the normal gene sequence
p.000056: may lead to a disease.
p.000056:
p.000056: The presence of a “disease allele” usually leads to an increased predisposition or susceptibility for
p.000056: developing a disease, with no certainty that disease will actually happen. There are various reasons for genetic
p.000056: testing: diagnosis, carrier testing, prenatal testing, predictive testing, susceptibility, predisposition or risk
p.000056: testing, genetic screening, and research testing. This raises a new set of issues, particularly on how this information
...
p.000060: DNA samples to health records, family pedigrees, and individual results.
p.000060:
p.000060: 21. Handling and preservation of biological samples shall be in accordance with standard scientific procedures.
p.000060:
p.000061: 61
p.000061:
p.000061:
p.000061:
p.000061: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000061:
p.000061: 22. Disposal of stored biological specimens shall be in accordance with standards for handling biohazardous and
p.000061: infectious materials.
p.000061:
p.000061: 23. Transport, transfer, and disposal of all stored biological samples shall be properly documented and filed.
p.000061:
p.000061: 24. Retention time for stored biological samples shall be determined by the respective institution.
p.000061:
p.000061: 25. All specimens in a tissue bank must be accompanied by a copy of the consent agreement signed by the donor.
p.000061:
p.000061: 26. No specimen shall be removed from a tissue bank for research purposes without an approved research protocol.
p.000061:
p.000061: 27. A researcher must not transfer genetic material or related information to another research group, unless
p.000061:
p.000061: a. The researcher and the other research group are collaborating on research which has been approved by their
p.000061: respective institutional ethics review committee
p.000061: b. The genetic material and information are provided in a form that ensures that participants cannot be
p.000061: identified
p.000061:
p.000061: Ethical 28. Securing stem cells for research, whether from considerations children, adults
p.000061: or naturally aborted fetuses, must in stem cell be done under conditions of the most rigorous research
p.000061: integrity for several reasons:
p.000061:
p.000061: • To protect the interests of the donors
p.000061: • To reassure the public that important boundaries are not being overstepped
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000062:
p.000062: • To enable those who are ethically uncomfort- able with elements of this research to partici- pate to the greatest
p.000062: extent possible
p.000062: • To ensure the highest quality of research and outcomes
p.000062:
p.000062: 29. Obtaining adult stem cells and hematopoietic stem cells presents no ethical problems. Whether from adults or from
p.000062: children, protection of donors is the same as in research on human subjects where adequate protection and
p.000062: regulation exist.
p.000062:
p.000062: 30. Research with aborted fetuses and pre- implantation embryos is highly controversial and may be unacceptable to
p.000062: several sectors of society. Thus, where the research benefits may be obtained using adult and cord blood stem
p.000062: cells, the use of these acceptable alternative sources is strongly recommended.
p.000062:
p.000062: 31. Patients and researchers should be able to avoid participating in stem cell use if the cells were derived
p.000062: in a way they consider unethical.
p.000062:
p.000062: 32. Documentation of the original source of the stem cells should be made readily available to researchers and
p.000062: potential recipients of stem cell- based therapies.
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063:
p.000063:
p.000063: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000063:
p.000063: ETHICAL GUIDELINES FOR INTERNATIONAL COLLABORATIVE RESEARCHES
p.000063:
p.000063: Introduction
p.000063:
p.000063: Health research is a public good whose burdens and benefits should be shared equally by all the concerned populations
p.000063: (Torres-Edejer, 1999). However, North-South research collaboration is currently plagued by differing interpretations of
...
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000095: 95
p.000095:
p.000095: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000095:
p.000095: SUBJECT INDEX
p.000095:
p.000095:
p.000095: Accountability procedures,33 Acknowledgement of contributors, 67 Action on proposals,13
p.000095: Active principle, 39, 68
p.000095: Acupressure,43
p.000095: Adverse drug reaction,30 Adverse events, 68 Adverse reactions,39,52 Advertisements,12 Affiliation, 19
p.000095: Aftercare, 51
p.000095: AIDS, 68
p.000095: Alternative interventions,18 Alternative medicine, 68
p.000095: Amendments, 27,34 Animal products,42 Animal Welfare Act,28 Anonymity,46,49
p.000095: Anonymized samples, 61, 68
p.000095: Approval,13, 68
p.000095: Conditional, 13-14, 71
p.000095: Archival work,48, 68 Aromatherapy,42 Armed conflict,50 Assent, 24,48, 68
p.000095: Assisted reproductive technology, 55, 69
p.000095: Association studies, 57
p.000095: Authorship,29, 66
p.000095: Availability of research product,22 Behavioral research,48, 69
p.000095: Benefits, 69
p.000095: direct, 18,21,26 Benefit sharing,41 Bias, 69
p.000095: Bioethics, capacity in, 64 Biological
p.000095: Samples, 60
p.000095: specimens, 19,45,46
p.000095: Biopsy, -ies, 58 Biosafety,28 Blinding,33,43 ,69
p.000095: see also double blinding
p.000095: Body fluids, 58
p.000095: Bureau of Food and Drug, 30, 32,34 Capacity to give informed consent, 24 Carrier testing, 57, 69
p.000095: Case-control studies,46, 69
p.000095: Cellular metabolites, 57, 70 Children,20,23 Chiropractic,43
p.000095: Clinical epidemiology,45 Clinical equipoise,31, 70 Clinical indication,30 Clinical research, 70
p.000095: Clinical trial,30, 70
p.000095: Phase I, 30, 83
p.000095: Phase II,30, 83
p.000095: Phase III,30, 84
p.000095: Phase IV, 30, 84
p.000095: Closure activities,51
p.000095: Cluster Ethics Review Committees (CERCs), 5, 87
p.000095: coercion,48
p.000095: cohort studies,46,71 collaborative research, externally
p.000095: sponsored,29 commercialization,41 commercial products,19 commercial purpose/s,55 community, -ies, 46,49,50,52,59
p.000095: community
p.000095: advocate,51 leader, 59
p.000095: community participation,28 community priorities,51 comparator product,32, 71 compensation,20,23,47,72 complementary and
p.000095: alternative
p.000095: medicine, 42, 72
p.000095: Completion, 15,18
p.000095: Conception,56, 71
p.000095: Confidentiality,18,19,45,48, 61, 72 Conflict of interest,50,51,72 Consent,46, 61
p.000095: Consent agreement, 62 Contraceptive methods,25
p.000095:
p.000096: 96
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096:
p.000096: Contraceptive implant,36 Control, 72
p.000096: Controlled trials, 17, 72
p.000096: Conventional medicine,42, 73
p.000096: Counseling,49,54,73
p.000096: Gender-sensitive, 56, 77
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000029: determine the levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in
p.000029: patients for safety and, in some cases, early evidence of effectiveness.
p.000029:
p.000029: Phase II investigation consists of controlled clinical trials designed to demonstrate efficacy and relative safety.
p.000029: Normally, these are performed on a limited number of closely monitored patients.
p.000029:
p.000029: Phase III trial is performed after a reasonable probability of a drug’s effectiveness has been established. This type
p.000029: of trial is intended to gather additional evidence of effectiveness for specific indications and more precise
p.000029: definition of drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000029:
p.000029: Phase IV trial is conducted after the national drug registration authority (i.e. BFAD) has approved a drug for
p.000029: distribution or marketing. This trial may include research designed to explore a specific pharmacological effect,
p.000029: establish the incidence of adverse reactions, or determine the effects of a long-term drug administration. It may also
p.000029: be designed to evaluate a drug in a population (such as children or the elderly) not studied adequately in the
p.000029: pre-marketing phases, or to establish a new clinical indication for a drug. Such research is to be distinguished from
p.000029: marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug reactions in that
p.000029: these categories ordinarily need not be reviewed by ethics review committees.
p.000029:
p.000029: The four conventional phases in clinical drug development present different ethical issues. Careful
p.000029: consideration should be noted and addressed in each phase as indicated in the International Conference on
p.000029: Harmonization (ICH) Harmonized Tripartite Guidelines for Good
p.000029:
p.000030: 30
p.000030:
p.000030:
p.000030:
p.000030: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000030:
p.000030: Clinical Practice, General Consideration for Clinical Trials (E8).
p.000030:
p.000030: General 1. All research involving human subjects should be guidelines conducted in
p.000030: accordance with the ethical
p.000030: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000030:
p.000030: 2. All clinical trials must have scientific and social value and, therefore, shall be adequately justified.
p.000030:
p.000030: 3. The various phases of the pharmaceutical trial present different ethical issues that should be keenly looked
p.000030: into by the institutional ethics review committee (IERC). These issues include product toxicities in Phase I, use of
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000020: no changes in the design or objectives of the research (Guideline 6 - CIOMS, 2002).
p.000020:
p.000020: Risks, benefits, 7. Health research is only justified if there is a and safety
p.000020: reasonable likelihood that the populations in which
p.000020: the research is carried out stand to benefit from
p.000020:
p.000021: 21
p.000021:
p.000021: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000021:
p.000021: the research results (Principle 19 – Declaration of Helsinki, 2004).
p.000021:
p.000021: 8. Every health research project involving human subjects should be preceded by a careful assessment of
p.000021: predictable risks and burdens in comparison with foreseeable benefits to the subject or to others (Principle 16 –
p.000021: Declaration of Helsinki, 2004).
p.000021:
p.000021: 9. Every precaution should be taken to minimize the negative impact of the study on the subject’s physical
p.000021: and mental integrity (Principle 21 – Declaration of Helsinki, 2004).
p.000021:
p.000021: 10. There must be an assurance of reasonable availability of a research product within the local market.
p.000021:
p.000021: Community 11. The conclusion or termination of the research care activity
p.000021: should not preclude the possibility of administering extended community care. This
p.000021: should be especially considered in researches involving depressed communities, ethnic groups or in international
p.000021: collaborative protocols (Bhutta, 2000).
p.000021:
p.000021: Privacy and 12. Every precaution should be taken to respect the confidentiality privacy of the
p.000021: participant and the confidentiality
p.000021: of the participant’s information.
p.000021:
p.000021:
p.000021: Disclosure of 13. Disclosure of research results to subjects should research results occur only when
p.000021: all of the following apply:
p.000021:
p.000021: a. the findings are scientifically valid and confirmed;
p.000021:
p.000021: b. the findings have significant implications for the subject’s health concerns; and
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000022:
p.000022: c. the course of action to ameliorate or treat these concerns is readily available when research results
p.000022: are disclosed to its subjects. Appropriate medical advice or referral should be provided.
p.000022:
p.000022: Standard of care 14. The particular needs of the economically and
p.000022: medically disadvantaged must be recognized in determining the standard of care that must be provided them as
p.000022: research subjects.
p.000022:
p.000022: 15. The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best
p.000022: current prophylactic, diagnostic, or therapeutic methods. Placebo, or no treatment, may be used in studies
p.000022: where no proven prophylactic, diagnostic, or therapeutic method exists (Principle 29 – Declaration of Helsinki,
p.000022: 2004).
p.000022:
p.000022: Compensation 16. Compensation given to subjects for lost earnings, for research travel costs, and
...
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
p.000049: gender and cultural sensitivity, and the need for research to contribute to the healing and re-empowerment of the
p.000049: traumatized community.
p.000049:
p.000049: General 1. All research involving human subjects should be
p.000049: guidelines conducted in accordance with the ethical
p.000049: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000050:
p.000050: 2. In deliberations on research involving traumatized populations, a community advocate or representative
p.000050: must be present.
p.000050:
p.000050: 3. In the course of research, the psychosocial needs of the community must be taken into account.
p.000050:
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
p.000024: access is not possible for legal or religious reasons, investigators shall not recruit for such possibly hazardous
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
p.000024: c. Investigators and ethics review committees shall ensure that prospective subjects who are pregnant are
p.000024: adequately informed about the risks and benefits to themselves, their pregnancy, the fetus and their
p.000024: subsequent offspring, and their fertility.
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
p.000025: political or medical disadvantages, are liable to give consent under duress or without the benefit of adequate
p.000025: information.
p.000025:
p.000025: Absence of 23. When there is ethical and scientific justification direct benefit to conduct
p.000025: research with individuals capable of
p.000025: giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000025: the individual subject should be no more likely and no greater than the risk attached to routine medical or
p.000025: psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an
p.000025: overriding scientific or medical rationale for such increases and when an ethics review committee has approved
p.000025: them (Guideline 9 – CIOMS, 2002).
p.000025:
p.000025:
...
p.000075: safety and protection of the dignity of human participants
p.000075:
p.000075: – a systematic process by which an independent committee evaluates a study protocol to determine if it follows ethical
p.000075: and scientific standards for carrying out biomedical research on human participants. Compliance with these guidelines
p.000075: helps ensure that the dignity, rights, safety and well-being of research participants are promoted.
p.000075:
p.000075: ethics review committee – a Committee constituted to review the ethical aspects of a research proposal and its possible
p.000075: implementation
p.000075:
p.000075: Ethics Committee (IEC/IRB) – Independent Ethics Committee / Institutional Review Board is an independent body
p.000075: (either a review board or committee) whose responsibility is to ensure the protection of the rights, safety and
p.000075: well-being of human participants involved in a trial and to provide public assurance of that protection.
p.000075:
p.000075: experimental design – the structure of research, identifying the various elements of a research project and how they
p.000075: relate to one another
p.000075:
p.000075: family studies – mapping of disease genes through the establishment of genetic linkage within a family
p.000075:
p.000075: feasibility – capability to be accomplished or implemented
p.000075:
p.000075: fetus – stage of human development when the first neural cells start differentiating (starting from 6-8 weeks up to
p.000075: birth)
p.000075:
p.000076: 76
p.000076:
p.000076: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000076:
p.000076: gender – socially defined feminine or masculine roles, attitudes, and values
p.000076:
p.000076: gender bias – partiality, unfairness, prejudice manifested towards an individual or group of individuals based on sex
p.000076: and sexual orientation
p.000076:
p.000076: gender-sensitive counseling – counseling that includes awareness of existing gender differences, issues and inequality
p.000076: in its framework for interaction with the patient/client
p.000076:
p.000076: gender sensitivity – the ability to perceive existing gender differences, issues, and inequality and to incorporate
p.000076: these into strategies and actions
p.000076:
p.000076: genes – the functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA,
p.000076: and most genes contain the information for making a specific protein
p.000076:
p.000076: gene activity – refers to the degree of expression of a particular gene or levels of transcription
p.000076:
p.000076: genetic association studies – describes a situation in which a particular allele is found either significantly more or
p.000076: less frequently in a group of affected individuals than would be expected from the frequency of the allele in the
...
p.000083:
p.000084: 84
p.000084:
p.000084: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000084:
p.000084: active drug or experimental treatment (http://www.Clinicaltrials.gov/ct/ info/whatis. Retrieved May 17, 2006)
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
p.000084: pre-clinical trials – investigation of the pharmacologic properties of a drug or preparation done in animals prior to
p.000084: human studies. Pre-clinical studies shall include pharmacodynamics, pharmacokinetics, and toxicity studies (BFAD
p.000084: Guidelines for Registration of Pharmaceutical Products, 1997)
p.000084:
p.000084: predictive testing – determination of the presence of disease-associated genes prior to the onset or manifestation of
p.000084: the disease
p.000084:
p.000084: predisposition or risk testing – determination of genetic parameters in an individual associated with increased risk of
p.000084: disease
p.000084:
p.000084: prenatal testing – determination of whether a fetus has (or probably has) a designated condition for which an increased
p.000084: risk is indicated by later maternal age, family history, or other well-defined risk factors
p.000084:
p.000084: prior dose finding – quantity or dosage of the herbal medicine established in earlier studies or practice to be
p.000084: effective
p.000084:
p.000084: privacy – a conceptual space defining the individual’s boundary as a person, intrusion of which is limited human rights
p.000084: and by law
p.000084:
p.000084: – the assurance of the secrecy of the identity of or information about research participants
p.000084:
p.000084: product adulteration – presence of foreign substances or impurities in the drug preparation that results in dilution or
p.000084: loss of its efficacy
p.000084:
p.000084: protein – a macromolecule composed of subunits of linear chains of amino acids attached to each other by peptide bonds
p.000084:
p.000084: proteomic data – information from the comprehensive analysis and cataloguing of the structure and function of all the
p.000084: proteins present in a given cell or tissue
p.000084:
p.000084: protocol – is the documentary record of the research undertaking that includes
p.000084:
p.000085: 85
p.000085:
p.000085: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000085:
p.000085: the background of the study, research question and objectives, the conceptual design, the methodology and data
p.000085: collection, and planned analysis of data.
p.000085:
p.000085: – a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of
...
p.000089: of a particular health condition
p.000089:
p.000089: diagnostic – professionally accepted level and type of examination to determine a patient’s health condition
p.000089:
p.000089: therapeutic – professionally accepted level and type of treatment or assistance for a particular health condition
p.000089:
p.000089: stem cell research – the study of the properties, development, and transformation of primordial progenitor cells prior
p.000089: to establishment of specialized cells
p.000089:
p.000089: stigma – the negative regard (e.g., shame and dishonor) of the community or society to particular groups because of
p.000089: disability, illness, occupation, poverty, etc. as dictated by culture
p.000089:
p.000089: study/investigational product – a pharmaceutical form of an active ingredient or placebo being tested or used as a
p.000089: reference in a clinical trial, including a product with marketing authorization when used or assembled
p.000089: (formulated or packaged) in a way different from the approved form, or when used fro an unapproved indication, or when
p.000089: used to gain further information about an approved use (ICH Harmonized Tripartite Guideline, Guideline for Good
p.000089: Clinical Practice [E6,R1])
p.000089:
p.000089: susceptibility – genetic condition leading to the development of a disease technical review – see scientific review
p.000089: teratogenicity – the degree or measure of the ability to cause malformations of an embryo or fetus
p.000089:
p.000089: termination of the research – the research study may be ended before its scheduled completion when the safety or
p.000089: benefit of the study participants is doubtful or at risk.
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
p.000090: Philippines, providing for a Traditional and Alternative Health Care Development Fund and for other purposes
p.000090:
p.000090: traditional healer – the relatively old, highly placed respected person in the community, with a profound knowledge of
p.000090: traditional remedies
p.000090:
p.000090: traditional medicine – the sum total of knowledge, skills, and practices in health care, not necessarily explicable in
p.000090: the context of modern, scientific, philosophical framework, but recognized by the people to help maintain and improve
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
p.000090: traditional medicine expert – a health care provider employing traditional medicine modalities to give a cure
...
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
p.000096: Feasibility, 27, 76
p.000096: Feedback session, 49
p.000096: Fertilization success, 55
p.000096: Fetus, 76
p.000096:
p.000097: 97
p.000097:
p.000097: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000097:
p.000097:
p.000097: aborted, 63
p.000097: Forensic medicine, 59
p.000097: Gender, 77
p.000097: Gender bias,54, 77
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
p.000097: Genetic traits, 59
p.000097: Good clinical practice, 38, 77
p.000097: Good laboratory practices, 32, 78 Good manufacturing practice, 32 Good Manufacturing Practice
p.000097: Guidelines, 39, 78
p.000097: Health equity, 64, 79
p.000097: Health research involving human Subjects, 16, 22
p.000097: Helsinki Declaration, 3,16
p.000097: Herbal products, 42
p.000097: Herbal remedies, 38
p.000097: Homeopathy, 43
p.000097: Human atrocities, 50
p.000097: Identifiable information, 67
p.000097: Inconvenience, 17 Indicators of success, 64 Inducement, 59
p.000097: Information in the public domain,46 Informed Consent, 11, 20, 21, 33, 40, 48,
p.000097: 52, 59, 67, 80
p.000097: Alternative methods, 47
p.000097: Verbal consent, 47, 48 Injury, research related, 19
p.000097: Institutional Ethics Review Committees (IERCs), 5-10, 87
...
Searching for indicator fetuses:
(return to top)
p.000054:
p.000054: The Philippine Obstetrical and Gynecological Society (POGS) and the Philippine Society of Reproductive Endocrinology
p.000054: and Infertility have set requirements that must be satisfied by medical hospitals, clinics, centers, and/or other
p.000054: facilities that conduct assisted reproductive techniques/ technologies and related research. Additionally, it is
p.000054: emphasized that clinical and biological research involving assisted reproductive technology shall be carried out under
p.000054: the supervision of a qualified practitioner who has acquired adequate and up-to-date training in, and is sensitive to
p.000054: the technical aspects of using technology for assisted reproduction.
p.000054:
p.000054: General 1. All research involving human subjects should be
p.000054: guidelines conducted in accordance with the ethical
p.000054: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000054:
p.000054: Specific guidelines
p.000054:
p.000054: Research on 2. The use of gametes in fertility research shall be gametes, subject to
p.000054: ethical review with special attention to human zygotes the harm and risks involved in the collection of and
p.000054: embryos specimens and its cultural implications.
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055:
p.000055: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000055:
p.000055: 3. The intentional creation of human zygotes, embryos or fetuses for study, research, and experimentation
p.000055: or for commercial and industrial purposes is unacceptable (POGS, 1995).
p.000055:
p.000055: 4. Research may be conducted on a human embryo only for the purpose of improving that particular embryo’s chances of
p.000055: being born alive and healthy.
p.000055:
p.000055: 5. The sale of human zygotes is unacceptable.
p.000055:
p.000055: Research 6. Special effort shall be exerted to ascertain the participants
p.000055: emotional stability and maturity of research
p.000055: subjects. Gender-sensitive counseling shall be made available and offered as an adjunct service to research
p.000055: participants.
p.000055:
p.000055: Informed 7. It shall be the responsibility of the attending consent
p.000055: physician to ensure that consent of research subjects is given freely and on the basis of
p.000055: adequate information and that potential conflict of interest is resolved. The investigator must be sensitive to the
p.000055: coercive and unfair pressure on women to bear children.
p.000055:
p.000055: Privacy and 8. Researchers shall uphold the dignity of confidentiality participants
p.000055: and protect their privacy by putting in
...
p.000060:
p.000060: 21. Handling and preservation of biological samples shall be in accordance with standard scientific procedures.
p.000060:
p.000061: 61
p.000061:
p.000061:
p.000061:
p.000061: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000061:
p.000061: 22. Disposal of stored biological specimens shall be in accordance with standards for handling biohazardous and
p.000061: infectious materials.
p.000061:
p.000061: 23. Transport, transfer, and disposal of all stored biological samples shall be properly documented and filed.
p.000061:
p.000061: 24. Retention time for stored biological samples shall be determined by the respective institution.
p.000061:
p.000061: 25. All specimens in a tissue bank must be accompanied by a copy of the consent agreement signed by the donor.
p.000061:
p.000061: 26. No specimen shall be removed from a tissue bank for research purposes without an approved research protocol.
p.000061:
p.000061: 27. A researcher must not transfer genetic material or related information to another research group, unless
p.000061:
p.000061: a. The researcher and the other research group are collaborating on research which has been approved by their
p.000061: respective institutional ethics review committee
p.000061: b. The genetic material and information are provided in a form that ensures that participants cannot be
p.000061: identified
p.000061:
p.000061: Ethical 28. Securing stem cells for research, whether from considerations children, adults
p.000061: or naturally aborted fetuses, must in stem cell be done under conditions of the most rigorous research
p.000061: integrity for several reasons:
p.000061:
p.000061: • To protect the interests of the donors
p.000061: • To reassure the public that important boundaries are not being overstepped
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062:
p.000062:
p.000062: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000062:
p.000062: • To enable those who are ethically uncomfort- able with elements of this research to partici- pate to the greatest
p.000062: extent possible
p.000062: • To ensure the highest quality of research and outcomes
p.000062:
p.000062: 29. Obtaining adult stem cells and hematopoietic stem cells presents no ethical problems. Whether from adults or from
p.000062: children, protection of donors is the same as in research on human subjects where adequate protection and
p.000062: regulation exist.
p.000062:
p.000062: 30. Research with aborted fetuses and pre- implantation embryos is highly controversial and may be unacceptable to
p.000062: several sectors of society. Thus, where the research benefits may be obtained using adult and cord blood stem
p.000062: cells, the use of these acceptable alternative sources is strongly recommended.
p.000062:
p.000062: 31. Patients and researchers should be able to avoid participating in stem cell use if the cells were derived
p.000062: in a way they consider unethical.
p.000062:
p.000062: 32. Documentation of the original source of the stem cells should be made readily available to researchers and
p.000062: potential recipients of stem cell- based therapies.
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063:
p.000063:
p.000063: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000063:
p.000063: ETHICAL GUIDELINES FOR INTERNATIONAL COLLABORATIVE RESEARCHES
p.000063:
p.000063: Introduction
p.000063:
p.000063: Health research is a public good whose burdens and benefits should be shared equally by all the concerned populations
p.000063: (Torres-Edejer, 1999). However, North-South research collaboration is currently plagued by differing interpretations of
p.000063: ethical standards of doing research in developing countries. Should new treatments be compared against Western
p.000063: standards of care or against local existing standards? Can communities benefit from research they have taken part in
p.000063: when they may not be able to afford the new interventions they have helped prove efficacious? How can
...
Social / Laboratory Staff
Searching for indicator research staff:
(return to top)
p.000084:
p.000084: prior dose finding – quantity or dosage of the herbal medicine established in earlier studies or practice to be
p.000084: effective
p.000084:
p.000084: privacy – a conceptual space defining the individual’s boundary as a person, intrusion of which is limited human rights
p.000084: and by law
p.000084:
p.000084: – the assurance of the secrecy of the identity of or information about research participants
p.000084:
p.000084: product adulteration – presence of foreign substances or impurities in the drug preparation that results in dilution or
p.000084: loss of its efficacy
p.000084:
p.000084: protein – a macromolecule composed of subunits of linear chains of amino acids attached to each other by peptide bonds
p.000084:
p.000084: proteomic data – information from the comprehensive analysis and cataloguing of the structure and function of all the
p.000084: proteins present in a given cell or tissue
p.000084:
p.000084: protocol – is the documentary record of the research undertaking that includes
p.000084:
p.000085: 85
p.000085:
p.000085: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000085:
p.000085: the background of the study, research question and objectives, the conceptual design, the methodology and data
p.000085: collection, and planned analysis of data.
p.000085:
p.000085: – a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of
p.000085: participants as well as answers specific research questions. The protocol describes what types of people may
p.000085: participate in the trial; the schedule of tests, procedures, medications, and dosages; and length of the study. In a
p.000085: clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and
p.000085: determine the safety and effectiveness of their treatment (http:// www.Clinicaltrials.gov/ct/info/whatis. Retrieved May
p.000085: 17, 2006)
p.000085:
p.000085: protocol amendment- a written description of a change to, or formal clarification of a protocol.
p.000085:
p.000085: psychosocial needs – the needs of an individual pertaining to her social and psychological well being
p.000085:
p.000085: quality of life – a state or condition in ones being wherein he/she is able to live as one normal person wants to live
p.000085: it
p.000085:
p.000085: quasi-experimental design – the structure of a research project that does not make use of random assignment to groups
p.000085:
p.000085: randomization – the process of assigning trial subjects to treatment or control groups using an element of chance to
p.000085: determine the assignments in order to reduce bias (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical
p.000085: Practice [E6, R1])
p.000085:
p.000085: Regional Health Research Ethics Board – proposed policy-making body for research ethics in a particular region in the
p.000085: Philippines
p.000085:
p.000085: regulatory requirements – approval of clinical trial by a regulatory agency. For example, for pharmaceutical and
p.000085: biologic products it means obtaining a “permit for clinical investigational use” which is a “registration document
p.000085: issued by the Bureau of Food and Drugs for the purpose of allowing the conduct of Phase I, Phase II, and Phase III
p.000085: clinical trials of investigational biologic products in the country” (Department of Health Administrative Order No.
p.000085: 47-A series of 2001 [August 30, 2001])
p.000085:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000015:
p.000015: Considerations related to the well-being of the human subject should take precedence over the interests of science and
p.000015: society (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: It is the duty of the researcher to protect the life, health, privacy, and dignity of the human subjects, and to
p.000015: safeguard scientific integrity.
p.000015:
p.000015:
p.000015: I. Elements of Research Ethics
p.000015:
p.000015: Informed consent 1. For all biomedical research involving humans, the
p.000015: investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who
p.000015: is incapable of giving informed consent, the permission of a legally authorized representative in accordance with
p.000015: applicable laws.
p.000015:
p.000016: 16
p.000016:
p.000016: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000016:
p.000016: Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an
p.000016: ethics review committee (Guideline 4 – Council for International Organi- zations of Medical Sciences [CIOMS], 2002).
p.000016:
p.000016: 2. The investigator shall provide the following information to the potential subject, using language that
p.000016: can be understood:
p.000016:
p.000016: a. That the individual is invited to participate in the research, the reasons for considering the individual
p.000016: suitable for the study, and that participation is voluntary;
p.000016:
p.000016: b. That the individual is free to refuse to participate and is free to withdraw from the research at any time
p.000016: without penalty or loss of benefits to which he/she is entitled;
p.000016:
p.000016: c. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000016: explanation of how the research differs from routine medical care;
p.000016:
p.000016: d. For controlled trials, an explanation of features of the research design (e.g., randomization, double blinding),
p.000016: and that the subject will not be told of the assigned treatment until the study has been completed and the blind
p.000016: has been broken;
p.000016:
p.000016: e. The expected duration of the individual’s participation (including number and duration of visits to the
p.000016: research center and the total time involved) and the possibility of early termination of the trial or of the
p.000016: individual’s participation in it;
p.000016:
p.000016: f. Any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others)
p.000016:
p.000017: 17
p.000017:
p.000017: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000017:
p.000017: associated with participation in the research, (in both the control and experimental group), including risks to the
p.000017: health or well-being of a subject’s spouse or partner;
p.000017:
p.000017: g. The direct benefits, if any, expected to result to subjects from participating in the research;
p.000017:
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000055: respect commensurate to their status fertilization (POGS,1995). Extreme care shall be exercised
p.000055: in the handling of human embryos.
p.000055:
p.000055: 10. Arrangements regarding unused embryos, sperms, and ova shall be agreed upon by the investigator and the
p.000055: source/s prior to the research, and shall be an important part of the research protocol.
p.000056: 56
p.000056:
p.000056:
p.000056:
p.000056: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000056:
p.000056: ETHICAL GUIDELINES FOR GENETIC RESEARCH WITH A SECTION ON STEM CELL RESEARCH
p.000056:
p.000056: Introduction
p.000056:
p.000056: A person’s current and future health is the interaction of many factors, including environment, lifestyle, and genes.
p.000056: Genes are the biochemical instructions for the development and growth of individuals. When a gene is altered, it may
p.000056: cause or contribute to a disease. Genes themselves do not cause disease, but alterations in the normal gene sequence
p.000056: may lead to a disease.
p.000056:
p.000056: The presence of a “disease allele” usually leads to an increased predisposition or susceptibility for
p.000056: developing a disease, with no certainty that disease will actually happen. There are various reasons for genetic
p.000056: testing: diagnosis, carrier testing, prenatal testing, predictive testing, susceptibility, predisposition or risk
p.000056: testing, genetic screening, and research testing. This raises a new set of issues, particularly on how this information
p.000056: is interpreted by those who might be affected in the future. Even for some single-gene diseases, not everyone with the
p.000056: gene develops the disease. This variability in gene expression further complicates multifactorial inheritance.
p.000056: Many counselors find it difficult to explain the uncertainty associated with genetic testing.
p.000056:
p.000056: Human genetic research aims to identify genes associated with health and disease, and elucidate their functions. The
p.000056: ultimate goal is to use the knowledge gained through research to discover ways of better diagnosis and
p.000056: treatment. The main types of genetic research are: cloning human genes, family studies, linkage analysis, DNA
p.000056: sequencing and association studies, pharmacogenetics, behavioral genetics, population- based genetics, and stem cell
p.000056: research. Genetic information may be obtained in several ways. One of the most important ways is from a family
p.000056: medical history, which is a kind of genetic test that are commonly used by good doctors. Genetic information is also
p.000056: available from clinical examination, and testing of DNA, RNA, proteins, or cellular metabolites that indicate gene
p.000056: activity.
p.000056:
p.000056: Human stem cell research holds enormous potential for contributing to an understanding of fundamental human biology,
p.000056: leading to the possibility of novel treatments and, ultimately, cures for many diseases for which adequate therapies do
p.000056: not exist. It is essential that the public be educated
p.000056:
p.000057: 57
p.000057:
p.000057:
p.000057:
p.000057: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000057:
p.000057: and informed about ethical and policy issues raised by stem cell research and its applications. Informed public
...
p.000068: human sperm or embryos for the purpose of establishing a pregnancy (e.g., in vitro fertilization and transcervical
p.000068: embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, gamete
p.000068: and embryo cryopreservation, oocyte and embryo donation, gestational surrogacy)
p.000068:
p.000068: behavioral research – studies regarding the actions or reactions of persons in response to external or internal stimuli
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
p.000068: bias – the systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the
p.000068: results of a clinical trial to make the estimate of a treatment effect deviate from its true value (ICH Harmonized
p.000068: Tripartite Guideline, General Considerations for Clinical Trial (E8)
p.000068:
p.000068: blinding/masking – a procedure in which one or more parties of the trial are kept unaware of the treatment
p.000068: assignment/s. Single blinding usually refers to the subject/s being unaware, and double-blinding usually refers to the
p.000068: subject/s, investigator/s, monitor, and, in some cases, data analyst/ s being unaware of the treatment
p.000068: assignment/s (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000068:
p.000068: carrier testing – testing to identify individuals who carry recessive genes; testing designed for healthy people who
p.000068: have no symptoms of disease, but who are known to be at high risk because of family history
p.000068:
p.000068: case-control study – type of investigation that attempts to look backward in time to identify characteristics that
p.000068: may have contributed to disease development by comparing responses of cases (those affected with the disease) and
p.000068: controls (the unaffected persons)
p.000068:
p.000068:
p.000069: 69
p.000069:
p.000069: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000069:
p.000069: cellular metabolites – the molecular substrates and products of various cellular processes
p.000069:
p.000069: chief/principal investigator – the person primarily responsible for the implementation of a research project
p.000069:
p.000069: clinical equipoise – “The ethics of medical practice grants no ethical or normative meaning to a treatment preference,
p.000069: however powerful, that is, based on a hunch or anything less than evidence publicly presented and convincing
p.000069: to the clinical community. Persons are licensed as physicians after they demonstrate the acquisition of this
...
p.000081:
p.000081: legally competent person – qualified or fit to perform an act, in accordance with law, free from addiction or mental
p.000081: defects that renders one incapable of taking care or oneself or one’s property (Merriam-Webster’s Dictionary of Law
p.000081: (c)1996)
p.000081:
p.000081: linkage analysis – gene hunting technique that traces patterns of disease in high risk families for the purpose of
p.000081: locating a disease-causing gene by identifying genetic markers of known chromosomal location that are co-inherited with
p.000081: the trait of interest
p.000081:
p.000081: material transfer agreement – an agreement between the source institution (or community) and the recipient institution
p.000081: (agency or community) that defines responsibilities and ownership of the material under study
p.000081:
p.000081: minimal toxicity data – the lowest dose of the preparation that shall elicit toxicity signs and symptoms in the
p.000081: participants or in animals
p.000081: minors – persons who have not yet reached the age of majority, 18 years old monitor – a person appointed by and
p.000081: responsible to the sponsor or contract
p.000081: research organization for monitoring and reporting progress of the trial
p.000081: and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000081:
p.000081: moral agent – a sentient individual whose acts impact on others and are affected by the act of others
p.000081:
p.000081: multicenter trial – a clinical trial conducted according to a single protocol but at more that one site, and
p.000081: therefore, carried out by more than one investigator (ICH Harmonized Tripartite Guideline, General
p.000081: Considerations for Clinical Trial (E8)
p.000081:
p.000081: multifactorial inheritance – heredity characterized by the involvement of several genes and environmental factors
p.000081:
p.000081: mutagenicity – the capacity of a chemical or physical agent to cause genetic alterations
p.000081:
p.000081: national health care delivery system – the total structures – private and public organizations, agencies, and
p.000081: individuals, including policies and mechanisms
p.000081: – that provide health care to individuals and communities in the country
p.000081:
p.000081:
p.000082: 82
p.000082:
p.000082: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000082:
p.000082: National Unified Health Research Agenda (NUHRA) – national health research priorities identified by major stakeholders
p.000082:
p.000082: non-disclosure of data – the withholding of or refusal to reveal information derived from research
p.000082:
p.000082: non-invasive procedure – biological sampling using a method which does not involve intrusion into the human body (e.g.,
p.000082: oral smears)
p.000082:
p.000082: North-South research collaboration – in the broad sense, would refer to the relationship or interaction between the
p.000082: developed and developing countries or rich and poor countries
p.000082:
p.000082: participatory research – research that involves the participation of the investigator in the activities of the research
p.000082: population. It could also involve involves research subjects in the definition of the research agenda, the conduct of
...
p.000086: research involving traumatized populations – study undertaken on a systematic and rigorous basis to generate new
p.000086: knowledge regarding groups living in communities that have experienced hardships and stress due to natural
p.000086: calamities or human atrocities
p.000086:
p.000086: research on assisted reproductive technology – study undertaken on a systematic and rigorous basis to generate new
p.000086: knowledge regarding reproduction that makes use of modern technology
p.000086:
p.000086: research participants/subjects – an individual who participates in a biomedical research project, either as the
p.000086: direct recipient of an intervention (e.g. study product or invasive procedure), as a control, or through
p.000086: observation. The individual may be a healthy person who volunteers to participate in the research or a person with a
p.000086: condition unrelated to the research carried out who volunteers to participate or a person (usually
p.000086:
p.000087: 87
p.000087:
p.000087: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000087:
p.000087: a patient) whose condition is relevant to the use of the study product or questions being investigated
p.000087:
p.000087: research protocol - A document that provides the background rationale and objective(s) of a biomedical research
p.000087: project and describes its design, methodology and organization, including ethical and statistical considerations.
p.000087: Some of these considerations may be provided in other documents referred to in the protocol
p.000087:
p.000087: respondent – one who answers or defends in various proceedings (Merriam- Webster’s Dictionary of Law (c) 1996)
p.000087:
p.000087: ribonucleic acid (RNA) - A single-stranded nucleic acid similar to DNA but having ribose sugar rather than deoxyribose
p.000087: sugar and uracil rather than thymine as one of the pyrimidine bases
p.000087:
p.000087: risk – the probability of harm or discomfort to study participants
p.000087:
p.000087: – the probability of harm or discomfort to study participants. Acceptable risk differs depending on the conditions for
p.000087: which the product is being tested.
p.000087:
p.000087: minimal risk – harm or discomfort comparable to those experienced in the daily existence of people living under
p.000087: ordinary circumstances and development
p.000087:
p.000087: risk factors – determinants of disease development
p.000087:
p.000087: scientific review – also called technical review, is the evaluation of the research protocol to ascertain scientific
p.000087: soundness and appropriateness of the objectives and design of the proposed study and the qualifications of the
p.000087: researcher
p.000087:
p.000087: selective disclosure of information – deliberate withholding of certain information from a patient or from a research
p.000087: participant usually justified by the principle of non-maleficence or, in the case of research, avoiding the
p.000087: introduction of bias on the part of the patient
p.000087:
p.000087: single-gene diseases – a disorder that is determined by mutant alleles at a single locus
p.000087:
p.000087: social and behavioral research – study undertaken on a systematic and rigorous basis to generate new knowledge
p.000087: regarding he impact of sociological, psychological, anthropological and other social factors on health and well being
p.000087:
p.000088: 88
p.000088:
p.000088: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000088:
p.000088: Critical Perspective
p.000088: This perspective is recursive and focused on bringing about change in practices. Researchers utilizing this
p.000088: perspective generally have an agenda for social change. Studies under this perspective begin with an important
p.000088: stance about social issues and is aimed at creating political debate and discussion to bring about change. It
p.000088: is practical and collaborative
p.000088:
p.000088: Interpretive perspective
p.000088: This perspective holds that in seeking to understand their world, people develop subjective meanings of their
p.000088: experiences which are varied and multiple. The researcher then looks into the complexity of views rather than reducing
p.000088: them to a few ideas. Open-ended questions suit this perspective. Historical and social contexts are important to
p.000088: consider. The assumption is that the basic generation of meaning is always social resulting from the interaction within
p.000088: social groups.
p.000088:
p.000088: Positivist perspective
p.000088: This is sometimes referred to as the “scientific method” and is likewise called quantitative research, empirical
p.000088: science or postivist/postpositivist research. This reflects a deterministic philosophy which says that causes probably
p.000088: determine effects or outcomes. It is reductionistic because it reduces ideas into discrete sets to test in hypotheses
...
p.000098: Product toxicities, 31
p.000098: Protein, 57, 58
p.000098: Protocol, 32, (see also research protocol), 85
p.000098: Psychocultural aspects, 53, 55
p.000098: Psychosocial needs, 51, 86
p.000098: Publication, 36, 54, 67
p.000098: Impediments to, 67 Qualifications of investigators, 28 Quality of life, 43, 86
p.000098: Quasi-experimental design, 49, 86
p.000098: Questionnaire, 47
p.000098: Quorum, 12
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
p.000098: Reprisals, 50
p.000098: Research agreement, 65
p.000098: Rescue medication, 44, 87
p.000098: Research capacity, Investment, 64
p.000098: Local, 64
p.000098: strengthening, 29
p.000098: Research design, 17
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
p.000098: Review procedure, 12-13 Right of access, 18 Risks, 17, 88
p.000098: RNA, 57, 58, 88
p.000098: Safety information, 11-12
p.000098: Safety parameters, 34
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
...
Social / Occupation
Searching for indicator occupation:
(return to top)
p.000088:
p.000088: – an individual, company, institution or organization that takes responsibility fort eh initiation,
p.000088: management and /or financing of a research project
p.000088:
p.000088: – an individual, a company, an institution or an organization that takes
p.000088:
p.000089: 89
p.000089:
p.000089: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000089:
p.000089: responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates
p.000089: and takes full for a trial, the investigator then also assumes the role of the sponsor responsibility (WHO
p.000089: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000089:
p.000089: standard of care – health care intervention or regimen that is generally accepted by health practitioners and experts
p.000089: as beneficial to an individual needing such care
p.000089:
p.000089: prophylactic – professionally accepted level and type of preventive management to prevent the occurrence
p.000089: of a particular health condition
p.000089:
p.000089: diagnostic – professionally accepted level and type of examination to determine a patient’s health condition
p.000089:
p.000089: therapeutic – professionally accepted level and type of treatment or assistance for a particular health condition
p.000089:
p.000089: stem cell research – the study of the properties, development, and transformation of primordial progenitor cells prior
p.000089: to establishment of specialized cells
p.000089:
p.000089: stigma – the negative regard (e.g., shame and dishonor) of the community or society to particular groups because of
p.000089: disability, illness, occupation, poverty, etc. as dictated by culture
p.000089:
p.000089: study/investigational product – a pharmaceutical form of an active ingredient or placebo being tested or used as a
p.000089: reference in a clinical trial, including a product with marketing authorization when used or assembled
p.000089: (formulated or packaged) in a way different from the approved form, or when used fro an unapproved indication, or when
p.000089: used to gain further information about an approved use (ICH Harmonized Tripartite Guideline, Guideline for Good
p.000089: Clinical Practice [E6,R1])
p.000089:
p.000089: susceptibility – genetic condition leading to the development of a disease technical review – see scientific review
p.000089: teratogenicity – the degree or measure of the ability to cause malformations of an embryo or fetus
p.000089:
p.000089: termination of the research – the research study may be ended before its scheduled completion when the safety or
p.000089: benefit of the study participants is doubtful or at risk.
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.002006: limitless possibilities of new technologies and of the modern scientific mind. Yet researches, no matter how impressive
p.002006: or noble the end, must never be allowed to prosper at the cost of the health and well-being of people, particularly the
p.002006: disadvantaged.
p.002006:
p.002006: This revised edition of the National Ethical Guidelines for Health Research aims to provide the safeguards
p.002006: in the conduct of researches, particularly those involving human participants. It also aims to establish the needed
p.002006: structures for the ethical conduct of biomedical and behavioral research by setting off the scope, functions, and
p.002006: composition of the Philippine Health Research Ethics Board (PHREB) as a national body, as well as that of institutional
p.002006: ethics review committees.
p.002006:
p.002006: The 2006 National Ethical Guidelines for Health Research likewise seeks to address the role of research and the various
p.002006: issues and gaps relating to research in the context of developing countries. These include ethical issues pertaining to
p.002006: international collaborative research funded by industrialized countries and carried out in developing countries. Such
p.002006: issues include difficulties in creating ethical guidelines and review processes in developing countries, the standard
p.002006: of care to be provided during and after clinical trials, traditional medicines, genomics and global health, benefit
p.002006: sharing and intellectual property, and culture and informed/misinformed consent.
p.002006:
p.002006: Given the increasing universality of what were once region-specific health concerns, these Guidelines have also
p.002006: identified issues/topics that are commonly addressed by the four international ethics guidelines, namely the
p.002006: International Declaration on Human Genetic Data, the Council for International Organizations of Medical Sciences,
p.002006: UNAIDS, and the Declaration of Helsinki.
p.002006:
p.002006: Written in simple, concise, and reader-friendly style, the 2006 National Ethical Guidelines for Health Research will
p.002006: hopefully encourage more studies conducted by Filipinos on local health concerns, thereby addressing the problem of
p.002006: under-representation of the Philippines in high-impact general medical journals, which is another key ethical issue in
p.002006: health research.
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: Estrella F. Alabastro, Ph. D.
p.002006: Secretary
p.002006: Department of Science and Technology 23 June, 2006
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: iii
p.002006:
p.002006:
p.002006: Republic of the Philippines Department of Health
p.002006: OFFICE OF THE SECRETARY
p.002006: MANILA, PHILIPPINES
p.002006: Tel Nos. (632) 743-83-01 local 1107,1111
p.002006: MESSAGE
p.002006:
p.002006: The landscape of health research has immensely changed with the explosion of new information, the ease of exchange of
p.002006: scientific knowledge, and information technology (IT) that allows for the quick and downloadable access of the outputs
...
p.000039: physical symptoms and other
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040:
p.000040: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000040:
p.000040: disease-related variables. It may also be measured in terms of overall health and well- being.
p.000040:
p.000040: Transport 14. No indigenous materials used in the research may of materials be
p.000040: transported outside the country unless the
p.000040: source (represented by the community leader, government agency or institution) of the material and the recipient
p.000040: sign a material transfer agreement.
p.000040:
p.000040: 15. Researchers must comply with the transfer agreement if plant products or herbal preparations will be tested
p.000040: outside the country.
p.000040:
p.000040: Benefit sharing 16. Where possible, the community from where the
p.000040: medicine originates should be consulted during the course of the research, and the results and benefits of the research
p.000040: should be shared with this community (WHO Operational Guidance: Information needed to support clinical trials
p.000040: of herbal products, 2005).
p.000040:
p.000040: 17. A memorandum of agreement regarding benefit sharing and patenting conditions especially for indigenous plant
p.000040: products must be set as early as the planning stage of the research.
p.000040:
p.000040: Commercialization 18. Researchers must include provisions for of herbal conditions when the
p.000040: herbal preparations may likely preparations be commercialized. They should be guided by
p.000040: existing laws and regulations of the Philippine Intellectual Property Rights Office.
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041:
p.000041:
p.000041: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000041:
p.000041: ETHICAL GUIDELINES FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH
p.000041:
p.000041: Introduction
p.000041:
p.000041: Worldwide, there is a continuing popular interest in and utilization of complementary and alternative medicine
p.000041: (CAM). In the Philippines, promotion of the utilization of CAM is embodied in Republic Act No. 8423, the Traditional
p.000041: and Alternative Medicine Act of 1997 which declared that the state shall “improve the quality and delivery of
p.000041: health care services to the Filipino people through the development of traditional and alternative health care and its
p.000041: integration into the national health care delivery system.”
p.000041:
p.000041: The World Health Organization and national health authorities have looked to CAM as a welcome wellspring of
p.000041: accessible, cost-effective, and beneficial alternative to the expensive conventional methods of treatment.
p.000041: Scientists, however, call for the application of the rigors of scientific investigation before specific CAM modalities
p.000041: could be promoted for widespread use.
p.000041:
p.000041: Complementary and alternative medicine is defined as a group of diverse medical and health care systems, practices, and
p.000041: products that is not presently considered to be part of conventional medicine. Complementary medicine is
p.000041: used together with conventional medicine, while alternative medicine is used in place of conventional medicine (NCCAM,
p.000041: 2006). As opposed to CAM, traditional medicine (TM) is defined as the sum total of the knowledge, skills, and practices
...
p.000056: ultimate goal is to use the knowledge gained through research to discover ways of better diagnosis and
p.000056: treatment. The main types of genetic research are: cloning human genes, family studies, linkage analysis, DNA
p.000056: sequencing and association studies, pharmacogenetics, behavioral genetics, population- based genetics, and stem cell
p.000056: research. Genetic information may be obtained in several ways. One of the most important ways is from a family
p.000056: medical history, which is a kind of genetic test that are commonly used by good doctors. Genetic information is also
p.000056: available from clinical examination, and testing of DNA, RNA, proteins, or cellular metabolites that indicate gene
p.000056: activity.
p.000056:
p.000056: Human stem cell research holds enormous potential for contributing to an understanding of fundamental human biology,
p.000056: leading to the possibility of novel treatments and, ultimately, cures for many diseases for which adequate therapies do
p.000056: not exist. It is essential that the public be educated
p.000056:
p.000057: 57
p.000057:
p.000057:
p.000057:
p.000057: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000057:
p.000057: and informed about ethical and policy issues raised by stem cell research and its applications. Informed public
p.000057: discussions of these issues should be based on an understanding of the science associated with stem cell research and
p.000057: should involve a broad cross-section of society. Special efforts should be made to promote equitable access to the
p.000057: benefits of stem cell research. Intellectual property regulations for stem cell research should set conditions that do
p.000057: not restrict basic research or encumber future product development.
p.000057:
p.000057: The ethical considerations in reviewing genetic research are no different from those that arise when reviewing other
p.000057: types of research. However, in addition to those that apply to all research involving humans, there are ethical issues
p.000057: unique to genetic research. These arise from the nature of genes and genetic information which, though personal, are
p.000057: also shared with other family members and with unrelated individuals in the population.
p.000057:
p.000057: These guidelines shall be used by research institutions, scientists, pharmaceutical companies, health
p.000057: researchers, and institutional review boards for the ethical pursuit of genetic research so that the expected benefits
p.000057: in the improvement of health and healthcare will be attained.
p.000057:
p.000057: General 1. All research involving human subjects should be
p.000057: guidelines conducted in accordance with the ethical
p.000057: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000057:
p.000057: 2. Given the familial nature of genetic research, confidentiality, privacy, and security are important
p.000057: considerations in the ethics review of a genetic study.
p.000057:
p.000057: Specific guidelines
p.000057:
p.000057: Collection of 3. Human biological samples for genetic research samples include samples
p.000057: that can serve as DNA, RNA, from humans and protein sources: solid tissues, biopsies,
...
p.000064: 4. Share responsibility;
p.000064: 5. Create transparency;
p.000064: 6. Monitor and evaluate the collaboration;
p.000064: 7. Disseminate the results;
p.000064: 8. Apply the results;
p.000064: 9. Share the profits equitably;
p.000064: 10. Increase research capacity; and
p.000064: 11. Build on achievements.
p.000064:
p.000064: Finally, the above considerations should result into a clear agreement on the conduct of collaborative research
p.000064: including data management and research outputs (e.g., storage and utilization of data, publication strategy, dispute
p.000064: settlement, nature of benefits and their distribution) (South African Medical Research Council, 2005).
p.000064:
p.000064: General 1. All research involving human subjects should be
p.000064: guidelines conducted in accordance with the ethical
p.000064: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000064:
p.000064: Special 2. Research approved for implementation by an ethics
p.000064: guidelines review committee (ERC) in a foreign country must
p.000064: also be subjected to ethics review in the country of implementation. When the research is intended for implementation
p.000064: in several communities, the ERC that has jurisdiction over a particular community has the right to conduct its
p.000064: own review before giving approval for the research to be carried out.
p.000064:
p.000064: 3. There shall be clear agreements on all aspects of the research. These include intellectual property
p.000064: sharing, management of the research process, division of responsibilities, finances, spreading of benefits
p.000064: and burdens and other appropriate aspects.
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000065: 65
p.000065:
p.000065: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000065:
p.000065: GUIDELINES ON AUTHORSHIP AND PUBLICATION
p.000065:
p.000065:
p.000065: The publication of research results gives rise to ethical problems and controversies when there are ambiguities
p.000065: regarding credit for authorship and uncertainty on the responsibility for various aspects of the research and the
p.000065: subsequent publication. These ambiguities and uncertainties have made it imperative for the Philippine Health Research
p.000065: Ethics Board to provide guidelines to clarify when researchers may be recognized as authors, and to elucidate the scope
p.000065: of their accountability.
p.000065:
p.000065:
p.000065: Authorship 1. All qualified authors must be given due recognition
p.000065: by being included in the list of authors.
p.000065:
p.000065: 2. Scientists may be listed as authors of a scientific paper only if they have made substantive intellectual
p.000065: contributions to the pertinent research. Each listed author must have participated sufficiently in the research
p.000065: to be publicly responsible for specific parts of the publication.
p.000065:
p.000065: 3. To be recognized as an author, a contributor must have provided substantial input to one of the following:
p.000065:
p.000065: a. Conception and design
p.000065: b. Acquisition of data
p.000065: c. Analysis and interpretation of data
p.000065:
p.000065: 4. The following shall not be regarded solely as grounds for recognizing research contributors as authors:
...
p.000077: reliable standard in performing laboratory tests and activities (Department of Health Administrative Order No. 47-A
p.000077: series of 2001 [August 30, 2001])
p.000077:
p.000077: Good Manufacturing Practice Guidelines – national standards and regulations for licensing of laboratories engaged in
p.000077: the manufacture and production of drugs, vaccines and other pharmaceuticals intended for human administration
p.000077: or consumption
p.000077:
p.000077: – that part of quality assurance which ensures that products, including vaccines and biologics are consistently
p.000077: produced and controlled to quality standards appropriate for their intended use, including all phases of vaccine
p.000077: clinical trials, and as required by registration and marketing authorization. For supplementary guidelines for the
p.000077: manufacture of investigational pharmaceutical products for human studies, refer to
p.000077:
p.000078: 78
p.000078:
p.000078: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000078:
p.000078: WHO/Pharm/94.571 (Department of Health Administrative Order No. 47-A series of 2001 [August 30, 2001])
p.000078:
p.000078: – the part of pharmaceutical quality assurance which ensures that products are consistently produced and
p.000078: controlled to the quality standards appropriate to their intended use and as required by marketing
p.000078: authorization (World Health Organization, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000078: products. WHO Technical Report Series, No. 850, 1995, Annex 3)
p.000078:
p.000078: government-sponsored health research – health research that is undertaken using government funds or resources
p.000078:
p.000078: guardian – one who has or is entitled or legally appointed to the care and management of the person or property of
p.000078: another (Merriam-Webster’s Dictionary of Law (c)1996)
p.000078:
p.000078: – one who is legally responsible for the care and management of the person or property of an incompetent or a minor
p.000078:
p.000078: guidelines – a set of rules or recommendations intended to effect a course of action
p.000078:
p.000078: health equity – is the absence of systematic disparities in health (or in major social determinants of health) between
p.000078: groups with different levels of underlying advantage/disadvantages e.g. wealth, power, prestige
p.000078:
p.000078: health research – generation of new knowledge (biomedical, clinical, social) to identify and deal with health
p.000078: problems, health systems and policies as well as those that impact on health such as socioeconomic,
p.000078: environment, energy and agricultural policies (PNHRS TWG Chairs, Feb 2004)
p.000078:
p.000078: – investigational activities that aim to generate data that shall contribute to improvement in the diagnosis,
p.000078: prevention and management of diseases, and in the delivery of care and for the enhancement of the quality of
p.000078: life of individuals and health conditions in communities
p.000078:
p.000078: herbal medicine research – study undertaken to generate new knowledge regarding the use of herbs and plants
p.000078: to prevent and treat diseases and ailments or to promote health and healing
p.000078:
p.000078: herbal medicines – finished, labeled medicinal products that contain as active ingredient/s serial or underground
p.000078: part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations
p.000078:
p.000079: 79
p.000079:
p.000079: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000079:
p.000079: (TAMA of 1997). Plant materials include juices, gums, fatty oils, essential oils, and other substances of this nature.
...
p.000079: individuals acquired through tissue fluid transmission from infected persons
p.000079:
p.000079: HIV/AIDS research – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the
p.000079: prevention or treatment of HIV/ AIDS
p.000079:
p.000079: HIV test – immunology-based laboratory test that establishes the presence of HIV infection in an individual
p.000079:
p.000079: human subjects – see research participants
p.000079:
p.000079: hypothesis – a tentative explanation for an observation, phenomenon, or scientific problem that can be tested by
p.000079: further investigation
p.000079:
p.000079: independent consultant – An expert who gives advice comments and suggestions upon review of the study protocols with no
p.000079: affiliation to the institute or investigators proposing the research proposals
p.000079:
p.000079: information in the public domain – data or information available and open to public observation like the list of names
p.000079: in the telephone directory, or events in streets and public transportation
p.000079:
p.000079: informed consent (verbal, video, written) – the process of obtaining approval to participate in an investigative
p.000079: study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An
p.000079: important part of the process is the adequacy, appropriateness, and timeliness of the information for decision-making
p.000079:
p.000079: intellectual property rights – the legal basis by which indigenous communities exercise their rights to have access to,
p.000079: protection, and control over their cultural knowledge and products, including but not limited to traditional medicines,
p.000079: and includes the right to receive compensation for it
p.000079:
p.000080: 80
p.000080:
p.000080: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000080:
p.000080: intellectual property sharing – to participate in, use, enjoy, or experience jointly or in turns the property that
p.000080: derives from the work of the mind or intellect or an idea, invention, trade secret, process, program, data, formula,
p.000080: patent, copyright, or trademark or application, right, or registration relating thereto (Merriam-Webster’s Dictionary
p.000080: of Law (c) 1996)
p.000080:
p.000080: interaction – the chemical or biological reactivity of the active principle or herbal preparation with other
p.000080: administered substances
p.000080:
p.000080: international collaborative research – joint or shared conduct of research by at least two countries or governments
p.000080: (e.g. Philippines and one other foreign government/country)
p.000080:
p.000080: – investigative work conducted at an international level, with involvement by investigators coming from different
p.000080: countries
p.000080:
p.000080: interventional study – research that includes measures or technology that may affect the course of an illness
p.000080:
p.000080: invasive procedure – biological sampling using a method involving intrusion into the human body, such as obtaining a
p.000080: blood sample by using a needle and syringe (UNESCO International Declaration on Human Genetic Data)
p.000080:
p.000080: investigator – a person responsible for the conduct of the critical trial at a trial site. If trial is conducted by a
p.000080: team of individuals at a trial site, the investigator is the responsible leader of the team and be called the principal
p.000080: investigator (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6, R1)
p.000080:
p.000080: – a person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The
p.000080: investigator should have qualifications and competence in accordance with local laws and regulations as
p.000080: evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and to provisions of,
p.000080: medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice
p.000080: medicine or dentistry (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000080:
p.000080: – a qualified scientist who undertakes scientific and ethical responsibility, either on his/her behalf or on behalf of
p.000080: an organization, for the ethical and scientific integrity of a research project at a specific site or group of sites
p.000080:
p.000080: legally authorized representative – one that represents another or others, upon their permission in accordance with
p.000080: law, in a special capacity (Merriam- Webster’s Dictionary of Law (c)1996)
p.000080:
p.000081: 81
p.000081:
p.000081: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000081:
p.000081: – A person who has authority, under the law, to stand for, or make decisions in behalf of another
p.000081:
p.000081: legally competent person – qualified or fit to perform an act, in accordance with law, free from addiction or mental
p.000081: defects that renders one incapable of taking care or oneself or one’s property (Merriam-Webster’s Dictionary of Law
p.000081: (c)1996)
p.000081:
p.000081: linkage analysis – gene hunting technique that traces patterns of disease in high risk families for the purpose of
p.000081: locating a disease-causing gene by identifying genetic markers of known chromosomal location that are co-inherited with
p.000081: the trait of interest
p.000081:
p.000081: material transfer agreement – an agreement between the source institution (or community) and the recipient institution
p.000081: (agency or community) that defines responsibilities and ownership of the material under study
p.000081:
p.000081: minimal toxicity data – the lowest dose of the preparation that shall elicit toxicity signs and symptoms in the
p.000081: participants or in animals
p.000081: minors – persons who have not yet reached the age of majority, 18 years old monitor – a person appointed by and
p.000081: responsible to the sponsor or contract
p.000081: research organization for monitoring and reporting progress of the trial
p.000081: and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000081:
p.000081: moral agent – a sentient individual whose acts impact on others and are affected by the act of others
p.000081:
p.000081: multicenter trial – a clinical trial conducted according to a single protocol but at more that one site, and
p.000081: therefore, carried out by more than one investigator (ICH Harmonized Tripartite Guideline, General
p.000081: Considerations for Clinical Trial (E8)
p.000081:
p.000081: multifactorial inheritance – heredity characterized by the involvement of several genes and environmental factors
p.000081:
...
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
p.000097: Genetic traits, 59
p.000097: Good clinical practice, 38, 77
p.000097: Good laboratory practices, 32, 78 Good manufacturing practice, 32 Good Manufacturing Practice
p.000097: Guidelines, 39, 78
p.000097: Health equity, 64, 79
p.000097: Health research involving human Subjects, 16, 22
p.000097: Helsinki Declaration, 3,16
p.000097: Herbal products, 42
p.000097: Herbal remedies, 38
p.000097: Homeopathy, 43
p.000097: Human atrocities, 50
p.000097: Identifiable information, 67
p.000097: Inconvenience, 17 Indicators of success, 64 Inducement, 59
p.000097: Information in the public domain,46 Informed Consent, 11, 20, 21, 33, 40, 48,
p.000097: 52, 59, 67, 80
p.000097: Alternative methods, 47
p.000097: Verbal consent, 47, 48 Injury, research related, 19
p.000097: Institutional Ethics Review Committees (IERCs), 5-10, 87
p.000097: Appointment of members, 7
p.000097: Composition, 6-7
p.000097: Continuing education, 10
p.000097: External consultants, 7-8
p.000097: Functions and Responsibilities, 8-10 Meetings and Deliberations, 10 Training, 10
p.000097: Intellectual property sharing, 65, 81
p.000097: International collaborative research/es, 64, 81
p.000097: International Conference on Harmonization (ICH), 30, 39
p.000097: Interventional study, 54, 81
p.000097: Intervention programs, 51
p.000097: Intimidation, 21
p.000097: In vitro fertilization, 56 Investigator, principal/chief, 69, 70
p.000097: Animals, care and use of laboratory, 28 Legal representative, 24,25
p.000097: Linkage analysis, 57, 82
p.000097: Linking DNA samples to health records, 61
p.000097: Markers, 39
p.000097: Massage, 43
p.000097: Material transfer agreement, 41 Mind-body interventions, 43
p.000097: Meditation, 43
p.000097: Prayer, 43
p.000097: Mental healing, 43
p.000097: Art, 43
p.000097: Music therapy, 43 minutes of meeting,13 medical rationale, 26
p.000097: medical records, 46 medical services,19
p.000097: memorandum of agreement, 41 monitoring mechanism, 51
p.000097: moral agent, 55
p.000097: multifactorial inheritance, 57, 82
p.000097: mutagenicity, 26, 82
p.000097: National Ethics Committee, 3, 5, 87
p.000097: National Unified Health Agenda, 29, 83
p.000097: Natural calamities, 50
p.000097: Naturopathy, 43
p.000097: North-south research collaboration, 64, 83
p.000097: Non-disclosure, 52, 83
p.000097:
p.000098: 98
p.000098:
p.000098: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000098:
p.000098:
p.000098: Nuremberg Code, 3
p.000098: Observational studies, 45, 48 Oriental traditional medicine, 43
p.000098: Ayurveda Unani
p.000098: Traditional Chinese medicine Osteopathic manipulation Ovulatory rates
p.000098: Ovum/ ova, 55, 56
p.000098: Photographs, 67
p.000098: Pain, 17
p.000098: Parallel design, 33 Participant
p.000098: Observation, 48
p.000098: Selection, 33
p.000098: Withdrawal, 33
p.000098: Participatory research, 52, 83
p.000098: Patenting, 41
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
p.000049: gender and cultural sensitivity, and the need for research to contribute to the healing and re-empowerment of the
p.000049: traumatized community.
p.000049:
p.000049: General 1. All research involving human subjects should be
...
Searching for indicator racial:
(return to top)
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
p.000049: gender and cultural sensitivity, and the need for research to contribute to the healing and re-empowerment of the
p.000049: traumatized community.
p.000049:
p.000049: General 1. All research involving human subjects should be
p.000049: guidelines conducted in accordance with the ethical
p.000049: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000050:
p.000050: 2. In deliberations on research involving traumatized populations, a community advocate or representative
p.000050: must be present.
p.000050:
p.000050: 3. In the course of research, the psychosocial needs of the community must be taken into account.
...
Social / Religion
Searching for indicator belief:
(return to top)
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
p.000049: gender and cultural sensitivity, and the need for research to contribute to the healing and re-empowerment of the
p.000049: traumatized community.
p.000049:
p.000049: General 1. All research involving human subjects should be
p.000049: guidelines conducted in accordance with the ethical
p.000049: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
...
Searching for indicator religious:
(return to top)
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
p.000024: access is not possible for legal or religious reasons, investigators shall not recruit for such possibly hazardous
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
p.000024: c. Investigators and ethics review committees shall ensure that prospective subjects who are pregnant are
p.000024: adequately informed about the risks and benefits to themselves, their pregnancy, the fetus and their
p.000024: subsequent offspring, and their fertility.
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
...
p.000044: epidemiologic research involving humans, focusing primarily on non- experimental studies. Its main difference from
p.000044: other researches is in the nature and extent of the informed consent process.
p.000044:
p.000044: General 1. All research involving human subjects should be
p.000044: guidelines conducted in accordance with the ethical
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000045:
p.000045: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000045:
p.000045: Specific guidelines
p.000045:
p.000045: Informed 2. For case-control and cohort studies, non- consent disclosure of
p.000045: all the study objectives may be permissible if full disclosure of the study
p.000045: hypothesis could bias the investigation.
p.000045:
p.000045: 3. Consent may not be required for collection of information in the public domain. Public domain information
p.000045: may include common general data such as address, marital status, educational attainment, and number of
p.000045: children among others.
p.000045:
p.000045: It should be realized that communities differ in their definition of what type of information about citizens is
p.000045: regarded as public.
p.000045:
p.000045: 4. Data regarding income, personal habits, preferences, personal opinions, political and religious
p.000045: inclinations, among others, may be considered confidential and will require consent prior to collection.
p.000045:
p.000045: 5. Collection of data by questionable means, such as deception, should not be condoned.
p.000045:
p.000045: 6. Data gathered for administrative purposes (as long as the information is not sensitive) do not require consent and
p.000045: may be waived if getting consent is considered impractical or too expensive.
p.000045:
p.000045: 7. Review of medical records may be done without requiring consent if anonymity can be maintained and if
p.000045: information sought is considered non- sensitive (Gordis and Gold, 1980).
p.000045:
p.000045: 8. The appropriate permission for storing biological material for research must be obtained from
p.000045:
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000046:
p.000046: individuals. If the samples are to be used for research not covered by the original consent, an ethics
p.000046: committee should decide whether renewed consent is needed or if the analyses may be done on anonymized samples.
p.000046: Details regarding the collection and storage of biological material are covered in the document on ethical guidelines
p.000046: for genetics research.
p.000046:
...
p.000053: reasonable circumstances.
p.000053:
p.000053: Use of 7. Special care shall be taken in the public use of research data research data
p.000053: and the publication of reports so and publication that participant groups are not further stigmatized of
p.000053: reports or become blameworthy targets. Reports shall be
p.000053: carefully examined for gender and culture bias.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054:
p.000054: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000054:
p.000054: ETHICAL GUIDELINES FOR RESEARCH ON ASSISTED REPRODUCTIVE TECHNOLOGY
p.000054:
p.000054: Introduction
p.000054:
p.000054: Research in assisted reproductive technology includes studies to improve ovulatory rates, ejaculatory efficiency,
p.000054: embryo viability, fertilization success, and uterine hospitability. It may also involve studies on the
p.000054: psychosociocultural aspects of reproductive technology. Research in the reproductive health field in general is studded
p.000054: with gender issues.
p.000054:
p.000054: In general, assisted reproductive technology is ethically complex. This is because the research participants, in
p.000054: contrast to other health researches, include two individuals (i.e., the source of the ovum and the source of the
p.000054: sperm) and the fertilized egg in various stages of development, whose status as a moral agent has religious and
p.000054: ethical implications. This means that the ethical principles enunciated for health research in general must be
p.000054: equitably and equally applied to the research participants with special consideration for gender and religious issues.
p.000054:
p.000054: The Philippine Obstetrical and Gynecological Society (POGS) and the Philippine Society of Reproductive Endocrinology
p.000054: and Infertility have set requirements that must be satisfied by medical hospitals, clinics, centers, and/or other
p.000054: facilities that conduct assisted reproductive techniques/ technologies and related research. Additionally, it is
p.000054: emphasized that clinical and biological research involving assisted reproductive technology shall be carried out under
p.000054: the supervision of a qualified practitioner who has acquired adequate and up-to-date training in, and is sensitive to
p.000054: the technical aspects of using technology for assisted reproduction.
p.000054:
p.000054: General 1. All research involving human subjects should be
p.000054: guidelines conducted in accordance with the ethical
p.000054: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000054:
p.000054: Specific guidelines
p.000054:
p.000054: Research on 2. The use of gametes in fertility research shall be gametes, subject to
p.000054: ethical review with special attention to human zygotes the harm and risks involved in the collection of and
p.000054: embryos specimens and its cultural implications.
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055:
p.000055: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000055:
p.000055: 3. The intentional creation of human zygotes, embryos or fetuses for study, research, and experimentation
...
p.000098: Philippine Health Research Ethics Board (PHREB), 3-4
p.000098: Functions, 4
p.000098: Philippine National Health Research System, 3
p.000098: Philippine Obstetrical and Gynecological Society (POGS), 55
p.000098: Philippine Society of Reproductive Endocrinology and Infertility, 55
p.000098: Placebo, 31, 33, 34, 84
p.000098: Placebo-controlled, 33, 40, 85
p.000098: Political repression, 50
p.000098: Post-marketing surveillance, 30
p.000098: Practitioner, qualified, 55
p.000098: Preclinical studies, 32, 85
p.000098: Predictive testing, 57, 59, 85
p.000098: Predisposition, 57, 85
p.000098: Pregnancy test, 25
p.000098: Pre-marketing phase, 30
p.000098: Prenatal testing, 57, 85
p.000098: Privacy,18,22,45,48, 61, 85
p.000098: Procedures, invasive, 28
p.000098: Product toxicities, 31
p.000098: Protein, 57, 58
p.000098: Protocol, 32, (see also research protocol), 85
p.000098: Psychocultural aspects, 53, 55
p.000098: Psychosocial needs, 51, 86
p.000098: Publication, 36, 54, 67
p.000098: Impediments to, 67 Qualifications of investigators, 28 Quality of life, 43, 86
p.000098: Quasi-experimental design, 49, 86
p.000098: Questionnaire, 47
p.000098: Quorum, 12
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
p.000098: Reprisals, 50
p.000098: Research agreement, 65
p.000098: Rescue medication, 44, 87
p.000098: Research capacity, Investment, 64
p.000098: Local, 64
p.000098: strengthening, 29
p.000098: Research design, 17
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
p.000098: Review procedure, 12-13 Right of access, 18 Risks, 17, 88
p.000098: RNA, 57, 58, 88
p.000098: Safety information, 11-12
p.000098: Safety parameters, 34
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
...
Social / Threat of Stigma
Searching for indicator stigmatization:
(return to top)
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
p.000049: gender and cultural sensitivity, and the need for research to contribute to the healing and re-empowerment of the
p.000049: traumatized community.
p.000049:
p.000049: General 1. All research involving human subjects should be
p.000049: guidelines conducted in accordance with the ethical
p.000049: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000050:
p.000050: 2. In deliberations on research involving traumatized populations, a community advocate or representative
p.000050: must be present.
p.000050:
p.000050: 3. In the course of research, the psychosocial needs of the community must be taken into account.
p.000050:
p.000050: 4. The different roles of the researchers, caregivers, and volunteer workers must always be clarified and the
p.000050: potential conflicts of interest identified.
p.000050:
...
p.000059: privacy, and protection from exploitation.
p.000059:
p.000059: Genetic 13. The informed consent shall include statements counseling and on the disclosure
p.000059: and sharing of the results and disclosure findings of the study, i.e., to whom should the
p.000059: information be revealed, etc.
p.000059:
p.000059: 14. Genetic counseling (pre- and post-test) shall be provided when there is a need to disclose the findings of
p.000059: the genetic study.
p.000059:
p.000059: Privacy, 15. Researchers must ensure the confidentiality and confidentiality, privacy of
p.000059: stored genetic information or research and security results relating to identified or potentially
p.000059: identifiable participants in accordance with domestic and international laws on human rights. Researchers should
p.000059: also ensure that safeguards are in place to avoid accidental disclosure of sensitive information.
p.000059:
p.000060: 60
p.000060:
p.000060:
p.000060:
p.000060: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000060:
p.000060: 16. Disclosure of genetic information is sometimes impossible to avoid. Such information should be dealt with
p.000060: sensitively, and the possibility that such a disclosure may occur should be considered in the initial process of
p.000060: seeking consent.
p.000060:
p.000060: 17. There is potential harm to participants arising from the use of genetic information, including stigmatization
p.000060: or unfair discrimination. Researchers should take special care to protect the privacy and confidentiality of
p.000060: this information.
p.000060:
p.000060: 18. Identifying genetic information must not be released to others, including family members, without the
p.000060: written consent of the individual to whom the information relates, or a person or institution which may
p.000060: legally provide consent for that person.
p.000060:
p.000060: 19. The patient’s right to privacy (researcher’s duty for confidentiality) continues after the patient’s death so
p.000060: that confidential information may be revealed after death only with proper legal authority. The only
p.000060: exception is the right to disclose information to a family member if there is a clear and urgent need to provide
p.000060: information to avoid a serious health risk.
p.000060:
p.000060: Handling of 20. Genetic research often involves the storage of biological DNA or
p.000060: other biological samples in “tissue” or specimens “sample” collections. In some cases, samples
p.000060: can
p.000060: be anonymized so that the donors cannot be identified. This raises problems in cases where the information
p.000060: from research might be of value to the individuals or families. Most genetic research studies will require linking of
...
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
p.000098: Reprisals, 50
p.000098: Research agreement, 65
p.000098: Rescue medication, 44, 87
p.000098: Research capacity, Investment, 64
p.000098: Local, 64
p.000098: strengthening, 29
p.000098: Research design, 17
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
p.000098: Review procedure, 12-13 Right of access, 18 Risks, 17, 88
p.000098: RNA, 57, 58, 88
p.000098: Safety information, 11-12
p.000098: Safety parameters, 34
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
...
Searching for indicator stigmatized:
(return to top)
p.000052:
p.000053: 53
p.000053:
p.000053:
p.000053:
p.000053: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000053:
p.000053: reportability, and the implication on his/her sexual activities if found positive.
p.000053:
p.000053: The participant must also be informed that he/ she is free to withdraw from the study anytime.
p.000053:
p.000053: Pre- and 4. Pre- and post-test counseling by well-trained, post-test
p.000053: culture- and gender-sensitive research personnel counseling shall be put in place as part of
p.000053: the research
p.000053: protocol.
p.000053:
p.000053: Standard 5. In an interventional study, the control group shall of care receive
p.000053: the standard of care accepted by the larger community. It is unethical to subject the
p.000053: control group of affected individuals to placebo treatment or be withdrawn from the current mode of treatment before
p.000053: the start of the study.
p.000053:
p.000053: Research 6. Special effort shall be exerted to make the benefits beneficial
p.000053: findings of the research project accessible and available to participants under
p.000053: reasonable circumstances.
p.000053:
p.000053: Use of 7. Special care shall be taken in the public use of research data research data
p.000053: and the publication of reports so and publication that participant groups are not further stigmatized of
p.000053: reports or become blameworthy targets. Reports shall be
p.000053: carefully examined for gender and culture bias.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054:
p.000054: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000054:
p.000054: ETHICAL GUIDELINES FOR RESEARCH ON ASSISTED REPRODUCTIVE TECHNOLOGY
p.000054:
p.000054: Introduction
p.000054:
p.000054: Research in assisted reproductive technology includes studies to improve ovulatory rates, ejaculatory efficiency,
p.000054: embryo viability, fertilization success, and uterine hospitability. It may also involve studies on the
p.000054: psychosociocultural aspects of reproductive technology. Research in the reproductive health field in general is studded
p.000054: with gender issues.
p.000054:
p.000054: In general, assisted reproductive technology is ethically complex. This is because the research participants, in
p.000054: contrast to other health researches, include two individuals (i.e., the source of the ovum and the source of the
p.000054: sperm) and the fertilized egg in various stages of development, whose status as a moral agent has religious and
p.000054: ethical implications. This means that the ethical principles enunciated for health research in general must be
...
Social / Threat of Violence
Searching for indicator violence:
(return to top)
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
...
p.000071: will be given an experimental drug or treatment, while the control group is either given a standard treatment for the
p.000071: illness or a placebo (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000071:
p.000071: controlled trials – a trial in which one group of participants is given an experimental drug, while another group (the
p.000071: control group) is given either a standard treatment for the disease or a placebo
p.000071:
p.000072: 72
p.000072:
p.000072: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000072:
p.000072: conventional medicine – (see Western medicine) that discipline of medical care advocating therapy with remedies that
p.000072: produce effects differing from those of the disease treated
p.000072:
p.000072: counseling – non-coercive interaction between a health professional and a patient/ client and/or family that is meant
p.000072: to clarify personal values and priorities, health care options, expectations, risks, benefits, and resources in
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
p.000072: cultural bias – prejudice based on community values and traditions
p.000072:
p.000072: culture – the way of life of groups of people that is defined by mores, shared values, traditions and sociopolitical
p.000072: structures and institutions
p.000072:
p.000072: debriefing – the process of obtaining information about an experience from an individual who has participated in, or
p.000072: observed particular events
p.000072:
p.000072: deception – an act characterized by dishonesty, fraud, trickery or sham for the purpose of manipulating another person
p.000072: into making a decision that he or she would not have made otherwise
p.000072:
p.000072: deoxyribonucleic acid (DNA) – an antiparallel double helix of nucleotides (having deoxyribose as their sugars) linked
p.000072: by phosphodiester (sugar-phosphate) bonds to adjacent nucleotides in the same chain and by hydrogen bonds to
p.000072: complementary nucleotides in the opposite chain. The fundamental substance of which genes are composed.
p.000072:
p.000072: deoxyribonucleic acid sequencing – method of analyzing the base sequence composition and order of a DNA sample using
p.000072: chemical tagging and physical measurements
p.000072: devices – a piece of equipment designed to served a clinical purpose diagnostics – procedure or technique used in the
p.000072: identification of a disease or
p.000072: determination of the health status of an individual
p.000072:
p.000072: disapproval – a negative action of the Ethics Committee on the protocol. The study cannot be implemented if it has been
p.000072: disapproved by the Ethics Committee
p.000072:
p.000073: 73
p.000073:
p.000073: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000073:
p.000073: disclosure of data – the giving of information in connection with proposed research undertaking or the sharing of
p.000073: the results of the study especially as they pertain to the individual’s of the family’s health situation
p.000073:
p.000073: disease allele – one of the variant forms of a disease gene at a particular locus, or location, on a chromosome.
p.000073: Different alleles produce variation in inherited characteristics such as hair color or blood type. In an individual,
p.000073: one form of the allele (the dominant one) may be expressed more than another form (the recessive one)
p.000073:
p.000073: disease susceptibility/predisposition – the pathophysiological conditions and genetic inclination that favor the
p.000073: development of a disease condition
p.000073:
p.000073: domestic violence – violence committed by one family or household member against another (Merriam-Webster’s Dictionary
p.000073: of Law (c) 1996)
p.000073:
p.000073: double blinding – is one in which neither the subject nor any of the investigator or sponsor staff who are involved in
p.000073: the treatment or clinical evaluation of the subjects are aware of the treatment received (ICH Harmonized Tripartite
p.000073: Guideline, Statistical Principles for Clinical Trials (E9) p8)
p.000073:
p.000073: drugs – a substance used as medication or used in the diagnosis, cure, mitigation, treatment or prevention
p.000073: of disease
p.000073:
p.000073: duress – wrongful and usually unlawful compulsion (as threats of physical violence) that induces a person to act
p.000073: against his or her will: ‘coercion” (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000073:
p.000073: efficacy – is the ability of a treatment modality to produce an effect to alleviate a disease
p.000073:
p.000073: embryo – the stage of human development following implantation (starting 10- 14 days), when the primitive streak begins
p.000073: to form up to fetal stage
p.000073:
p.000073: epidemiologic research – investigative studies intended to establish “the distribution and determinants of
p.000073: disease frequency in human populations”
p.000073:
p.000073: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the determinants of the
p.000073: incidence of diseases as well as their related risk factors, etiology and causation
p.000073:
p.000073: epidemiology – the basic medical science that focuses on the distribution and determinants of disease frequency in
p.000073: human populations (Raymond Greenberg, Medical Epidemiology, 1993)
p.000073:
p.000074: 74
p.000074:
p.000074: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000074:
p.000074: ethical clearance – a certification that a research proposal has complied with ethical requirements
p.000074:
p.000074: – action of an ethics review committee on a research protocol that signifies approval and permission to proceed with
p.000074: the research.
p.000074:
p.000074: ethical principles – rules or codes conforming to accepted professional standards of conduct (Merriam-Webster’s
p.000074: Dictionary of Law (c) 1996)
p.000074:
...
p.000085: 17, 2006)
p.000085:
p.000085: protocol amendment- a written description of a change to, or formal clarification of a protocol.
p.000085:
p.000085: psychosocial needs – the needs of an individual pertaining to her social and psychological well being
p.000085:
p.000085: quality of life – a state or condition in ones being wherein he/she is able to live as one normal person wants to live
p.000085: it
p.000085:
p.000085: quasi-experimental design – the structure of a research project that does not make use of random assignment to groups
p.000085:
p.000085: randomization – the process of assigning trial subjects to treatment or control groups using an element of chance to
p.000085: determine the assignments in order to reduce bias (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical
p.000085: Practice [E6, R1])
p.000085:
p.000085: Regional Health Research Ethics Board – proposed policy-making body for research ethics in a particular region in the
p.000085: Philippines
p.000085:
p.000085: regulatory requirements – approval of clinical trial by a regulatory agency. For example, for pharmaceutical and
p.000085: biologic products it means obtaining a “permit for clinical investigational use” which is a “registration document
p.000085: issued by the Bureau of Food and Drugs for the purpose of allowing the conduct of Phase I, Phase II, and Phase III
p.000085: clinical trials of investigational biologic products in the country” (Department of Health Administrative Order No.
p.000085: 47-A series of 2001 [August 30, 2001])
p.000085:
p.000085: reportability (of test results) – the inclusion of an event (e.g., a diagnosis, evidence of violence against persons)
p.000085: in a list of items that are mandated by law to be reported to the Department of Health by designated individuals or
p.000085: health professionals because of their impact on public health and safety
p.000085:
p.000086: 86
p.000086:
p.000086: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000086:
p.000086: rescue medication – the drug or procedure used in applying conventional medicine intended to manage a disease
p.000086:
p.000086: research – organized set of activities intended to generate data that are generalizable into new knowledge,
p.000086: principle or technology
p.000086:
p.000086: – Investigative work undertaken on a systematic and rigorous basis using quantitative and qualitative methods to
p.000086: generate new knowledge
p.000086:
p.000086: research ethics review committees
p.000086:
p.000086: National Ethics Committee – organized in 1984 through a Special Order No. 84-053 issued by the Executive Director of
p.000086: the PCHRD to ensure that health research involving human participants is conducted in accordance to
p.000086: international ethical principles. The seven-member committee reviews protocols of researches to be done in sites
p.000086: without functioning Ethics Review Committees
p.000086:
p.000086: Cluster Ethics Review Committee – an ethics review committee shared by (common to) several institutions where the
...
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
p.000090: Philippines, providing for a Traditional and Alternative Health Care Development Fund and for other purposes
p.000090:
p.000090: traditional healer – the relatively old, highly placed respected person in the community, with a profound knowledge of
p.000090: traditional remedies
p.000090:
p.000090: traditional medicine – the sum total of knowledge, skills, and practices in health care, not necessarily explicable in
p.000090: the context of modern, scientific, philosophical framework, but recognized by the people to help maintain and improve
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
p.000090: traditional medicine expert – a health care provider employing traditional medicine modalities to give a cure
p.000090: traumatized populations – are individuals who live in communities that have experienced extreme forms of life-
p.000090: threatening stress due to natural calamities or human atrocities such as armed conflict, political repression as well
p.000090: as criminal and domestic violence.
p.000090:
p.000090: trial-related expenses – costs incurred in the course of litigation
p.000090:
p.000090: – Expenses incurred by study participants related to their participation in a research study such as transportation,
p.000090: meals, loss of income.
p.000090:
p.000090: undue influence – improper influence that deprives a person of freedom of choice or substitutes another’s choice or
p.000090: desire for the person’s own. Note: It is a doctrine of equity that a contract, deed, donation. Or
p.000090: testamentary disposition can be set aside if the court finds that someone has exercised undue influence over the
p.000090: maker at the time that the contrast, conveyance, or will was made. To establish a prima facie case it is usually
p.000090: necessary to show a susceptibility to undue influence (as from mental impairment), the opportunity and
p.000090: disposition on someone’s part to exercise such influence, and that the transaction
p.000090:
p.000091: 91
p.000091:
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: vulnerable groups – classes of individuals who have characteristics that lessen their capacity to protect their own
...
p.000095: Case-control studies,46, 69
p.000095: Cellular metabolites, 57, 70 Children,20,23 Chiropractic,43
p.000095: Clinical epidemiology,45 Clinical equipoise,31, 70 Clinical indication,30 Clinical research, 70
p.000095: Clinical trial,30, 70
p.000095: Phase I, 30, 83
p.000095: Phase II,30, 83
p.000095: Phase III,30, 84
p.000095: Phase IV, 30, 84
p.000095: Closure activities,51
p.000095: Cluster Ethics Review Committees (CERCs), 5, 87
p.000095: coercion,48
p.000095: cohort studies,46,71 collaborative research, externally
p.000095: sponsored,29 commercialization,41 commercial products,19 commercial purpose/s,55 community, -ies, 46,49,50,52,59
p.000095: community
p.000095: advocate,51 leader, 59
p.000095: community participation,28 community priorities,51 comparator product,32, 71 compensation,20,23,47,72 complementary and
p.000095: alternative
p.000095: medicine, 42, 72
p.000095: Completion, 15,18
p.000095: Conception,56, 71
p.000095: Confidentiality,18,19,45,48, 61, 72 Conflict of interest,50,51,72 Consent,46, 61
p.000095: Consent agreement, 62 Contraceptive methods,25
p.000095:
p.000096: 96
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096:
p.000096: Contraceptive implant,36 Control, 72
p.000096: Controlled trials, 17, 72
p.000096: Conventional medicine,42, 73
p.000096: Counseling,49,54,73
p.000096: Gender-sensitive, 56, 77
p.000096: Genetic, 60, 77 Criminal violence,50,73 Cultural beliefs,51 Cultural sensitivity,50,53 Culture bias,54,73
p.000096: Data, administrative, 46
p.000096: Debriefing,49, 73
p.000096: Deception,21,46,49, 73
p.000096: devices, 73
p.000096: biomedical, 59
p.000096: medical, 35
p.000096: Diagnostic/s, 59 ,73 procedures,35,36
p.000096: Dietary supplements,42 Disapproval, 13,14, 73 Discontinuation,33 Disclosure,22,45, 60, 61,
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: vulnerable groups – classes of individuals who have characteristics that lessen their capacity to protect their own
p.000091: interests or promote their own welfare
p.000091:
p.000091: waiver of informed consent – the act of intentionally or knowingly relinquishing or abandoning the right to consent to
p.000091: medical treatment by a patient or to participation in a medical experiment by a subject after achieving an
p.000091: understanding of what is involved and especially for the risks (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: – Permission given by an Ethics Review Committee for research to be conducted without the informed consent of subjects,
p.000091: under exceptional circumstances, such as when research has to be undertaken in an emergencyXsituation
p.000091:
p.000091: Western medicine – or biomedicine, allopathy, regular medicine, conventional medicine, mainstream medicine, orthodox
p.000091: medicine or cosmopolitan medicine, refers to medical care that advocates therapy that produces effects differing from
p.000091: those of the diseases treated (TAMA 1997)
p.000091:
p.000091: zygote – the product of the biological union of the human sperm and egg (process of fertilization) until the
p.000091: blastocyst (32-cell) stage prior to implantation in the endometrium (0 to 4-5 days)
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000092: 92
p.000092:
p.000092: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000092:
p.000092: BIBLIOGRAPHY
p.000092:
p.000092: Bhutta, Z. A. (2000). Ethics in international health research: a perspective from the developing world. Bulletin of the
p.000092: World Health Organization 80(3), 114-120.
p.000092:
p.000092: Braveman, P. & Gruskin, S. (2003). Defining equity in health. Journal of Epidemiology of Community Health
p.000092: 57(4), 254-258.
p.000092:
p.000092: Council for International Organizations of Medical Sciences. (2002). International ethical guidelines for biomedical
p.000092: research involving human subjects. Guideline 4.
p.000092:
p.000092: Department of Health. (2001). Administrative Order 47-A s 2001. Rules and regulations on the registration including
p.000092: approval and conduct of clinical trials, and lot or batch release certification of vaccines and biologic products.
p.000092:
p.000092: Freedman, R. (1987). Equipose and the ethics of clinical research. New England Journal of Medicine 317(3), 141-145.
p.000092:
p.000092: Gordis, L. & Gold, E. (1980). Privacy, confidentiality, and the use of medical records in research. Science 207, 153-6.
p.000092:
p.000092: International Conference on Harmonization. (1996). Guidance for industry; E6 Good clinical practice: Consolidated
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000047: public places. The researcher shall inform his/ her participants as to the nature of the research and obtain verbal
p.000047: or written consent. Verbal consent must be attested to in the absence of a written consent. Coercion in any form
p.000047: may not be used to force individuals to participate. If participants are minors, consent of the parent/
p.000047: guardian must be obtained. Assent of the minor must also be obtained, properly documented, and attested to by an
p.000047: impartial witness of legal age.
p.000047:
p.000047: Privacy and 3. The researcher shall respect the respondent’s confidentiality right to
p.000047: privacy and preserve the confidentiality of of information information. He/She shall make provisions
p.000047: to
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048:
p.000048: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000048:
p.000048: render the participants anonymous to those not directly involved in the research.
p.000048:
p.000048: 4. The researcher shall not release information that permits linking specific individuals to specific
p.000048: information. In cases where information pertaining to groups or specific communities exposes them to possible harm or
p.000048: abuse, the researcher shall refrain from identifying such groups or communities unless required by law.
p.000048:
p.000048: Access to 5. In carrying out experimental or quasi-experimental services or designs in
p.000048: field research, access to services or benefits benefits provided to the experimental group shall
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
...
Social / Women
Searching for indicator women:
(return to top)
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
p.000024: access is not possible for legal or religious reasons, investigators shall not recruit for such possibly hazardous
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
p.000024: c. Investigators and ethics review committees shall ensure that prospective subjects who are pregnant are
p.000024: adequately informed about the risks and benefits to themselves, their pregnancy, the fetus and their
p.000024: subsequent offspring, and their fertility.
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
p.000025: political or medical disadvantages, are liable to give consent under duress or without the benefit of adequate
p.000025: information.
p.000025:
p.000025: Absence of 23. When there is ethical and scientific justification direct benefit to conduct
p.000025: research with individuals capable of
p.000025: giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000025: the individual subject should be no more likely and no greater than the risk attached to routine medical or
p.000025: psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an
p.000025: overriding scientific or medical rationale for such increases and when an ethics review committee has approved
p.000025: them (Guideline 9 – CIOMS, 2002).
p.000025:
p.000025:
p.000025: II. Ensuring Quality Research
p.000025:
p.000025: Role of the 24. The ERC shall:
...
p.000054: embryos specimens and its cultural implications.
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055:
p.000055: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000055:
p.000055: 3. The intentional creation of human zygotes, embryos or fetuses for study, research, and experimentation
p.000055: or for commercial and industrial purposes is unacceptable (POGS, 1995).
p.000055:
p.000055: 4. Research may be conducted on a human embryo only for the purpose of improving that particular embryo’s chances of
p.000055: being born alive and healthy.
p.000055:
p.000055: 5. The sale of human zygotes is unacceptable.
p.000055:
p.000055: Research 6. Special effort shall be exerted to ascertain the participants
p.000055: emotional stability and maturity of research
p.000055: subjects. Gender-sensitive counseling shall be made available and offered as an adjunct service to research
p.000055: participants.
p.000055:
p.000055: Informed 7. It shall be the responsibility of the attending consent
p.000055: physician to ensure that consent of research subjects is given freely and on the basis of
p.000055: adequate information and that potential conflict of interest is resolved. The investigator must be sensitive to the
p.000055: coercive and unfair pressure on women to bear children.
p.000055:
p.000055: Privacy and 8. Researchers shall uphold the dignity of confidentiality participants
p.000055: and protect their privacy by putting in
p.000055: place adequate mechanisms for upholding the confidentiality especially of the circumstances of conception of
p.000055: children born out of assisted reproductive technology.
p.000055:
p.000055: Embryos from 9. Embryos formed by in vitro fertilization shall be in vitro given
p.000055: respect commensurate to their status fertilization (POGS,1995). Extreme care shall be exercised
p.000055: in the handling of human embryos.
p.000055:
p.000055: 10. Arrangements regarding unused embryos, sperms, and ova shall be agreed upon by the investigator and the
p.000055: source/s prior to the research, and shall be an important part of the research protocol.
p.000056: 56
p.000056:
p.000056:
p.000056:
p.000056: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000056:
p.000056: ETHICAL GUIDELINES FOR GENETIC RESEARCH WITH A SECTION ON STEM CELL RESEARCH
p.000056:
p.000056: Introduction
p.000056:
p.000056: A person’s current and future health is the interaction of many factors, including environment, lifestyle, and genes.
p.000056: Genes are the biochemical instructions for the development and growth of individuals. When a gene is altered, it may
p.000056: cause or contribute to a disease. Genes themselves do not cause disease, but alterations in the normal gene sequence
p.000056: may lead to a disease.
p.000056:
p.000056: The presence of a “disease allele” usually leads to an increased predisposition or susceptibility for
...
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000100:
p.000100: APPENDIX A
p.000100: TEMPLATE FOR PATIENT INFORMATION AND INFORMED CONSENT FORM
p.000100:
p.000100: Project Title:
p.000100:
p.000100: Sponsor:
p.000100:
p.000100: Investigator/s:
p.000100:
p.000100:
p.000100:
p.000100: Purpose and conduct of study:
p.000100: • Why is the study being done?
p.000100: • What has been done previously?
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
p.000100: Compensation
p.000100: • Will there be reimbursement of travel expenses? Compensation for loss of income? Meal expenses?
p.000100: • Are there other financial considerations?
p.000100:
p.000100: Provision for injury or related illness
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
p.000025: political or medical disadvantages, are liable to give consent under duress or without the benefit of adequate
p.000025: information.
p.000025:
p.000025: Absence of 23. When there is ethical and scientific justification direct benefit to conduct
p.000025: research with individuals capable of
p.000025: giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000025: the individual subject should be no more likely and no greater than the risk attached to routine medical or
p.000025: psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an
p.000025: overriding scientific or medical rationale for such increases and when an ethics review committee has approved
p.000025: them (Guideline 9 – CIOMS, 2002).
p.000025:
p.000025:
p.000025: II. Ensuring Quality Research
p.000025:
p.000025: Role of the 24. The ERC shall:
p.000025: ethics review
p.000025: committee (ERC) a. Review the scientific merit and ethical
p.000025: acceptability of any research involving human participants;
p.000025:
p.000025: b. Conduct further reviews as necessary in the course of the research as well as monitor the study’s progress
p.000025: (Guideline 2 – CIOMS, 2002);
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000026:
p.000026: c. Research approved by a foreign ERC for implementation in the Philippines shall also be subjected to ethics
p.000026: review.
p.000026:
p.000026: Ensure that the ethical standards applied are no less stringent than they would be if the research were to be
p.000026: carried out in the country of the sponsoring agency;
p.000026:
p.000026: d. Ensure that the proposed research is responsive to the health needs and priorities of the Philippines and
p.000026: meets the requisite ethical standards (Guideline 3 - CIOMS, 2002);
p.000026:
p.000026: e. Issue the ethical clearance required for the implementation of any research it has reviewed and approved; and
p.000026:
...
p.000033:
p.000033: k. Statement regarding direct access to trial data and documents for monitoring, audits, institutional ethics
p.000033: committee reviews, and regulatory inspections
p.000033:
p.000033: l. Ethical considerations
p.000033:
p.000033: m. Data management and record keeping
p.000033:
p.000033: n. Financing and insurance
p.000033:
p.000033: o. Publication plans and procedures
p.000033:
p.000033: p. Clinical trial participants’ information sheet/ brochure
p.000033:
p.000033: 12. Any amendment/s to the protocol should be resubmitted to the IERC and BFAD.
p.000033:
p.000033: Use of placebo 13. Use of placebo is generally not acceptable when
p.000033: there are standard treatments available to a patient population. Thus, a placebo control may be used only when –
p.000033:
p.000033: a. Standard therapy is unavailable
p.000033: b. Existing treatment is of unproven efficacy, or possesses unacceptable side-effects
p.000033: c. The placebo itself is an effective therapy
p.000033: d. The disease has little adverse effect on the patient
p.000033: e. Testing an add-on treatment to a standard therapy when all subjects get all treatments that would normally
p.000033: be given
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034:
p.000034: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000034:
p.000034: f. The patient has provided informed rejection or refusal of standard therapy for a minor condition for
p.000034: which the patient refuses treatment, and when such refusal for therapy will not lead to unjustified affliction
p.000034: or irreparable damage or harm
p.000034:
p.000034: Informed 14. Refer to section on Informed Consent in the consent General
p.000034: Ethical Guidelines for Health Research
p.000034: (pp16-29).
p.000034:
p.000034: Therapy versus 15. The difference between therapy and research research shall be upheld
p.000034: throughout a clinical trial. The
p.000034: investigator/s shall ensure that participants comprehend and keep in mind that in a clinical trial, the drug is
p.000034: experimental and that its benefits are currently being proven.
p.000034:
p.000034: Research on 16. Clinical trials of medical devices, diagnostic medical devices, procedures, and
p.000034: preventive measures, including diagnostic vaccines, raise similar ethical concerns especially
p.000034: procedures and on free and informed consent, and potential preventive measures conflict of interest.
p.000034:
p.000034: a. Trials of critical medical devices such as implants which may present a potential serious risk to health,
p.000034: safety or welfare of the subject shall not be conducted on healthy volunteers. The current safety data on the medical
...
p.000047: knowledge and concerns for the participants’ rights for privacy as well as preserving their integrity, dignity, and
p.000047: autonomy.
p.000047:
p.000047: The guidelines below are consistent with existing ones on research on human subjects but are made more specific for
p.000047: social research.
p.000047:
p.000047: General 1. All research involving human subjects should be
p.000047: guidelines conducted in accordance with the ethical
p.000047: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000047:
p.000047: Special guidelines
p.000047:
p.000047: Informed 2. Informed consent shall be obtained, with the consent possible
p.000047: exception of research involving archival work, participant observation, and observation in
p.000047: public places. The researcher shall inform his/ her participants as to the nature of the research and obtain verbal
p.000047: or written consent. Verbal consent must be attested to in the absence of a written consent. Coercion in any form
p.000047: may not be used to force individuals to participate. If participants are minors, consent of the parent/
p.000047: guardian must be obtained. Assent of the minor must also be obtained, properly documented, and attested to by an
p.000047: impartial witness of legal age.
p.000047:
p.000047: Privacy and 3. The researcher shall respect the respondent’s confidentiality right to
p.000047: privacy and preserve the confidentiality of of information information. He/She shall make provisions
p.000047: to
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048:
p.000048: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000048:
p.000048: render the participants anonymous to those not directly involved in the research.
p.000048:
p.000048: 4. The researcher shall not release information that permits linking specific individuals to specific
p.000048: information. In cases where information pertaining to groups or specific communities exposes them to possible harm or
p.000048: abuse, the researcher shall refrain from identifying such groups or communities unless required by law.
p.000048:
p.000048: Access to 5. In carrying out experimental or quasi-experimental services or designs in
p.000048: field research, access to services or benefits benefits provided to the experimental group shall
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
...
p.000067: impairment or damage
p.000067:
p.000067: serious and unexpected adverse event – the unexpected adverse drug reaction is an adverse reaction, the nature or
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
p.000067: The assent is a requirement for research in addition to consent given by a parent or legal guardian
p.000067:
p.000067: child’s assent – is the expressed willingness of a minor to participate in a study
p.000067:
p.000068: 68
p.000068:
p.000068: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000068:
p.000068: assisted reproductive technology – all treatment or procedures that include the in-vitro handling of human oocytes and
p.000068: human sperm or embryos for the purpose of establishing a pregnancy (e.g., in vitro fertilization and transcervical
p.000068: embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, gamete
p.000068: and embryo cryopreservation, oocyte and embryo donation, gestational surrogacy)
p.000068:
p.000068: behavioral research – studies regarding the actions or reactions of persons in response to external or internal stimuli
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
p.000068: bias – the systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the
p.000068: results of a clinical trial to make the estimate of a treatment effect deviate from its true value (ICH Harmonized
...
p.000077: or consumption
p.000077:
p.000077: – that part of quality assurance which ensures that products, including vaccines and biologics are consistently
p.000077: produced and controlled to quality standards appropriate for their intended use, including all phases of vaccine
p.000077: clinical trials, and as required by registration and marketing authorization. For supplementary guidelines for the
p.000077: manufacture of investigational pharmaceutical products for human studies, refer to
p.000077:
p.000078: 78
p.000078:
p.000078: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000078:
p.000078: WHO/Pharm/94.571 (Department of Health Administrative Order No. 47-A series of 2001 [August 30, 2001])
p.000078:
p.000078: – the part of pharmaceutical quality assurance which ensures that products are consistently produced and
p.000078: controlled to the quality standards appropriate to their intended use and as required by marketing
p.000078: authorization (World Health Organization, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000078: products. WHO Technical Report Series, No. 850, 1995, Annex 3)
p.000078:
p.000078: government-sponsored health research – health research that is undertaken using government funds or resources
p.000078:
p.000078: guardian – one who has or is entitled or legally appointed to the care and management of the person or property of
p.000078: another (Merriam-Webster’s Dictionary of Law (c)1996)
p.000078:
p.000078: – one who is legally responsible for the care and management of the person or property of an incompetent or a minor
p.000078:
p.000078: guidelines – a set of rules or recommendations intended to effect a course of action
p.000078:
p.000078: health equity – is the absence of systematic disparities in health (or in major social determinants of health) between
p.000078: groups with different levels of underlying advantage/disadvantages e.g. wealth, power, prestige
p.000078:
p.000078: health research – generation of new knowledge (biomedical, clinical, social) to identify and deal with health
p.000078: problems, health systems and policies as well as those that impact on health such as socioeconomic,
p.000078: environment, energy and agricultural policies (PNHRS TWG Chairs, Feb 2004)
p.000078:
p.000078: – investigational activities that aim to generate data that shall contribute to improvement in the diagnosis,
p.000078: prevention and management of diseases, and in the delivery of care and for the enhancement of the quality of
p.000078: life of individuals and health conditions in communities
p.000078:
p.000078: herbal medicine research – study undertaken to generate new knowledge regarding the use of herbs and plants
p.000078: to prevent and treat diseases and ailments or to promote health and healing
p.000078:
p.000078: herbal medicines – finished, labeled medicinal products that contain as active ingredient/s serial or underground
p.000078: part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations
p.000078:
p.000079: 79
p.000079:
p.000079: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000079:
p.000079: (TAMA of 1997). Plant materials include juices, gums, fatty oils, essential oils, and other substances of this nature.
p.000079: Herbal medicines, however, may contain excipients in addition to the active ingredient/s. Medicines containing plant
...
Searching for indicator youth:
(return to top)
p.000002:
p.000002: In 2003, the Philippine National Health Research System (PNHRS) led to the creation of the Philippine Health Research
p.000002: Ethics Board (PHREB), a national policymaking body on health research ethics. In the different regions, policymaking
p.000002: boards shall also be established as Regional Health Research Ethics Boards.
p.000002:
p.000002:
p.000002: The Philippine Health Research Ethics Board (PHREB)
p.000002:
p.000002: Composition The Philippine Health Research Ethics Board has
p.000002: 13 members, including two ex-officio members: the Department of Science and Technology (DOST)-PCHRD Executive
p.000002: Director, and the Department of Health (DOH) Research Ethics Committee Chair. Except for the ex-officio
p.000002: members, appointments shall be for a term of three years (initially, however, five were appointed for three
p.000002: years, and six members for two years). The members represent a balance of background, gender, and disciplines (e.g.,
p.000002: health research,
p.000002:
p.000003: 3
p.000003:
p.000003: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000003:
p.000003: philosophy, law, academe, medicine, public health/ epidemiology, theology, social science, allied health
p.000003: sciences, people’s organizations, and the youth). The Chair and Co-Chair have two-year terms.
p.000003:
p.000003: Functions PHREB shall have the following functions:
p.000003:
p.000003: 1. Formulate/Update guidelines for the ethical conduct of human health research;
p.000003:
p.000003: 2. Develop guidelines for the establishment and management of ethics review committees and standardization of
p.000003: research ethics review;
p.000003:
p.000003: 3. Monitor and evaluate the performance of institutional ethics review committees in accordance with procedures
p.000003: outlined in a prior agreement;
p.000003:
p.000003: 4. Promote the establishment of functional and effective ethics review committees;
p.000003:
p.000003: 5. Provide advice and make recommenda- tions to the PNHRS Governing Council and other appropriate entities
p.000003: (including the Bureau of Food and Drugs [BFAD]) regarding programs, policies, and regula- tions as they relate to
p.000003: ethical issues in human health research;
p.000003:
p.000003: 6. Initiate and contribute to discourse and discussions of ethical issues in human health research; and
p.000003:
p.000003: 7. Network with relevant local, national, and international organizations.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000004:
p.000004: Regional Research Ethics Boards
p.000004:
p.000004: Composition The regional research ethics boards will be
...
p.000104:
p.000104:
p.000104: Members
p.000104:
p.000104: LEONARDO D. DE CASTRO, Ph.D.
p.000104: Professor, Department of Philosophy UP Diliman
p.000104:
p.000104: MILAGROS L. FERNANDEZ, M.D.
p.000104: Undersecretary Department of Health
p.000104:
p.000104: JAIME C. MONTOYA, M.D., M.Sc.
p.000104: Executive Director
p.000104: Philippine Council for Health Research and Development
p.000104:
p.000104: FILIPINAS F. NATIVIDAD, Ph.D.
p.000104: Assistant Vice-President and Director Research and Biotechnology Division St. Luke’s Medical Center
p.000104:
p.000104: ARSENIO C. PASCUAL, M.D. Ll.B
p.000104: General Surgeon and Attorney-at-Law Professor, Legal Medicine and Medical Jurisprudence
p.000104:
p.000104: PACITA R. SALCEDA, M.D.
p.000104: Makati Medical Center
p.000104:
p.000104: FR. DANILO C. TIONG
p.000104: Professor, Bioethics Department
p.000104: Dela Salle University Health Sciences Center
p.000104:
p.000104: BENJAMIN C. VITASA, M.D., M.P.H., Ph.D.
p.000104: Professor, Department of Environmental and Occupational Health College of Public Health, UP-Manila
p.000104:
p.000104:
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000105:
p.000105: APPENDIX E
p.000105: PHILIPPINE HEALTH RESEARCH ETHICS BOARD
p.000105:
p.000105: Chair
p.000105: MARITA V.T. REYES, M.D.
p.000105: Health Research
p.000105:
p.000105: Co-Chair
p.000105: LEONARDO D. DE CASTRO, Ph.D.
p.000105: Philosophy
p.000105:
p.000105:
p.000105: Members
p.000105:
p.000105: MARIA ARLISSA D. AGUILUZ, D.M.D.
p.000105: Allied Health
p.000105:
p.000105: ABDULRAHIM M. BAGUNDANG
p.000105: Youth
p.000105:
p.000105: GILBERT P. HOGGANG, D.V.M.
p.000105: People’s Organization
p.000105:
p.000105: ROMEO INTENGAN, S.J.
p.000105: Theology
p.000105:
p.000105: JAIME C. MONTOYA, M.D., M.Sc.
p.000105: Executive Director, PCHRD (Ex-officio)
p.000105:
p.000105: ALBERT D. REBOSA, M.D., Ll.B.
p.000105: Law
p.000105:
p.000105: ANGELES TAN-ALORA, M.D.
p.000105: Academe
p.000105:
p.000105: MA. CARMEN C. TOLABING, Ph.D.
p.000105: Public Health/Epidemiology
p.000105:
p.000105: CECILIA V. TOMAS, M.D.
p.000105: Medicine
p.000105:
p.000105: CRISPINITA A. VALDEZ
p.000105: Chair, DOH-Research Ethics Committee (Ex-officio)
p.000105:
p.000105: ELIZABETH R. VENTURA, Ph.D.
p.000105: Social Science
p.000105:
p.000106: 106
p.000106:
p.000106: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
...
Social / education
Searching for indicator education:
(return to top)
p.000008:
p.000008: 4) Number of researches reviewed by the IERC during the year categorized as follows:
p.000008:
p.000008: • Researches approved without changes
p.000008: • Researches for which the IERC required modifications or revisions before approval
p.000008: • Researches disapproved
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000009:
p.000009: 5) Such other information as may be required by PHREB
p.000009:
p.000009: Meetings and 12. The IERC shall regularly meet as a committee on deliberations a schedule that
p.000009: is determined based on the
p.000009: research cycle of the institution. There shall be a provision for holding special meetings to consider urgent matters
p.000009: as decided by the chairperson.
p.000009:
p.000009: 13. More than half the members shall constitute a quorum, which should include one with expertise in a
p.000009: non-scientific area and at least one member who is independent of the institution or research site.
p.000009:
p.000009: 14. Deliberations of the IERC shall be characterized by transparency and collegiality. A member who is involved in
p.000009: whatever capacity in the study/ project under consideration should so inform the committee and his/her further
p.000009: participation in the deliberations must be determined accordingly.
p.000009:
p.000009: 15. As much as possible, decisions shall be made by consensus.
p.000009:
p.000009: Training and 16. Members of the IERC shall undergo continuing continuing training on the
p.000009: ethics and science of biomedical education of research. Initial training must be required of new ethics
p.000009: members. Continuing educational activities must committee be held at least
p.000009: once a year. These may be linked members with those of other ethics committees within the
p.000009: province or region.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000010:
p.000010: THE RESEARCH ETHICS REVIEW PROCESS
p.000010:
p.000010: All proposals for the conduct of biomedical and behavioral researches involving human subjects shall be clearly
p.000010: formulated in a research protocol to be submitted to an ethics review committee (ERC) for consideration,
p.000010: comment, guidance, and approval.
p.000010:
p.000010: The review must be transparent, timely, and reasonable. Each ethics review committee shall indicate a time frame for
p.000010: completing the review process, and provide the proponent initial feedback within four weeks after receipt of the
p.000010: complete documents.
p.000010:
p.000010: Required 1. The research investigator/proponent shall be documents required to
p.000010: submit the following documents:
p.000010:
p.000010: a. Application for review;
p.000010:
...
p.000083: are carried out should be as close as possible to normal conditions of use. (WHO Guidelines for Good Clinical Practice
p.000083: (GCP) for trials of pharmaceutical products)
p.000083:
p.000083: Phase IV clinical trial – studies performed after marketing of the pharmaceutical product. Trials in this phase are
p.000083: carried out on the basis of the product characteristics on which the marketing authorization was granted and are
p.000083: normally in the form of the post-marketing surveillance, or assessment of therapeutic value or treatment
p.000083: strategies. Although methods may differ, these studies should use the same scientific and ethical standards as applied
p.000083: in pre-marketing studies. After a product has been placed on the market, clinical trials designed to explore new
p.000083: indications, new methods of administration or new combinations, etc., are normality considered as trials for new
p.000083: pharmaceutical products. (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000083: products)
p.000083:
p.000083: Philippine Health Research Ethics Board – was created on March 1, 2006 through DOST Special Order No. 091 series of
p.000083: 2006 as a policy-making body for research ethics in the Philippines
p.000083:
p.000083: Philippine National Health Research System – formally organized in 2004, it was conceptualized in support of a
p.000083: vibrant, dynamic, and responsible health research community working on a unified health research agenda with enhanced
p.000083: cooperation between the Department of Health, the Department of Science and Technology, and the Commission on Higher
p.000083: Education. The Philippine Health Research Ethics Board is one of the six groups working under its Governing Council.
p.000083:
p.000083: placebo – a substance that is not biologically active, does not interact with other substances nor is it expected to
p.000083: affect the health status of an individual
p.000083:
p.000083: – an inactive pill, liquid, or powder that has no treatment value. In clinical trial, experimental treatments are
p.000083: often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the
p.000083: participants in the control group will receive a placebo instead of an
p.000083:
p.000084: 84
p.000084:
p.000084: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000084:
p.000084: active drug or experimental treatment (http://www.Clinicaltrials.gov/ct/ info/whatis. Retrieved May 17, 2006)
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
...
p.000097: aborted, 63
p.000097: Forensic medicine, 59
p.000097: Gender, 77
p.000097: Gender bias,54, 77
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
p.000097: Genetic traits, 59
p.000097: Good clinical practice, 38, 77
p.000097: Good laboratory practices, 32, 78 Good manufacturing practice, 32 Good Manufacturing Practice
p.000097: Guidelines, 39, 78
p.000097: Health equity, 64, 79
p.000097: Health research involving human Subjects, 16, 22
p.000097: Helsinki Declaration, 3,16
p.000097: Herbal products, 42
p.000097: Herbal remedies, 38
p.000097: Homeopathy, 43
p.000097: Human atrocities, 50
p.000097: Identifiable information, 67
p.000097: Inconvenience, 17 Indicators of success, 64 Inducement, 59
p.000097: Information in the public domain,46 Informed Consent, 11, 20, 21, 33, 40, 48,
p.000097: 52, 59, 67, 80
p.000097: Alternative methods, 47
p.000097: Verbal consent, 47, 48 Injury, research related, 19
p.000097: Institutional Ethics Review Committees (IERCs), 5-10, 87
p.000097: Appointment of members, 7
p.000097: Composition, 6-7
p.000097: Continuing education, 10
p.000097: External consultants, 7-8
p.000097: Functions and Responsibilities, 8-10 Meetings and Deliberations, 10 Training, 10
p.000097: Intellectual property sharing, 65, 81
p.000097: International collaborative research/es, 64, 81
p.000097: International Conference on Harmonization (ICH), 30, 39
p.000097: Interventional study, 54, 81
p.000097: Intervention programs, 51
p.000097: Intimidation, 21
p.000097: In vitro fertilization, 56 Investigator, principal/chief, 69, 70
p.000097: Animals, care and use of laboratory, 28 Legal representative, 24,25
p.000097: Linkage analysis, 57, 82
p.000097: Linking DNA samples to health records, 61
p.000097: Markers, 39
p.000097: Massage, 43
p.000097: Material transfer agreement, 41 Mind-body interventions, 43
p.000097: Meditation, 43
p.000097: Prayer, 43
p.000097: Mental healing, 43
p.000097: Art, 43
p.000097: Music therapy, 43 minutes of meeting,13 medical rationale, 26
p.000097: medical records, 46 medical services,19
p.000097: memorandum of agreement, 41 monitoring mechanism, 51
p.000097: moral agent, 55
p.000097: multifactorial inheritance, 57, 82
p.000097: mutagenicity, 26, 82
p.000097: National Ethics Committee, 3, 5, 87
p.000097: National Unified Health Agenda, 29, 83
p.000097: Natural calamities, 50
p.000097: Naturopathy, 43
p.000097: North-south research collaboration, 64, 83
p.000097: Non-disclosure, 52, 83
p.000097:
p.000098: 98
p.000098:
p.000098: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000098:
p.000098:
p.000098: Nuremberg Code, 3
p.000098: Observational studies, 45, 48 Oriental traditional medicine, 43
p.000098: Ayurveda Unani
p.000098: Traditional Chinese medicine Osteopathic manipulation Ovulatory rates
p.000098: Ovum/ ova, 55, 56
p.000098: Photographs, 67
p.000098: Pain, 17
...
Searching for indicator educational:
(return to top)
p.000007: b. To promote research integrity by identifying and resolving conflicts of interest;
p.000007: c. To establish appropriate mechanisms in all stages of the research in order to:
p.000007: 1) ensure the safety, protect the rights, and promote the welfare and well-being of human participants,
p.000007: 2) provide counsel to human participants, including proponents and researchers,
p.000007: 3) ensure prompt reporting of changes in the protocol and unanticipated problems,
p.000007: 4) ensure the proper documentation of and adherence to the confidentiality rule and policy on informed consent, and
p.000007:
p.000008: 8
p.000008:
p.000008: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000008:
p.000008: 5) monitor the progress of ongoing research.
p.000008:
p.000008: d. To report to the institutional or national authorities any matter that affects the conduct and ethics of
p.000008: research which in its view may affect the rights and safety of research participants;
p.000008:
p.000008: e. To keep a systematic and organized record of all proposals reviewed, including actions taken and other pertinent
p.000008: information; and
p.000008:
p.000008: f. To submit an annual report to the Philippine Health Research Ethics Board c/o DOST- PCHRD.
p.000008:
p.000008: The IERC annual report shall contain the following:
p.000008:
p.000008: 1) The composition of the IERC, including a short curriculum vitae (name of the person, educational attainment, most
p.000008: recent ethics training/seminars attended), and term of office of each member
p.000008:
p.000008: 2) Members of the IERC secretariat, office/ email addresses, and contact numbers
p.000008:
p.000008: 3) Number of meetings held during the year, including the date and venue
p.000008:
p.000008: 4) Number of researches reviewed by the IERC during the year categorized as follows:
p.000008:
p.000008: • Researches approved without changes
p.000008: • Researches for which the IERC required modifications or revisions before approval
p.000008: • Researches disapproved
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000009:
p.000009: 5) Such other information as may be required by PHREB
p.000009:
p.000009: Meetings and 12. The IERC shall regularly meet as a committee on deliberations a schedule that
p.000009: is determined based on the
p.000009: research cycle of the institution. There shall be a provision for holding special meetings to consider urgent matters
p.000009: as decided by the chairperson.
p.000009:
p.000009: 13. More than half the members shall constitute a quorum, which should include one with expertise in a
p.000009: non-scientific area and at least one member who is independent of the institution or research site.
p.000009:
p.000009: 14. Deliberations of the IERC shall be characterized by transparency and collegiality. A member who is involved in
p.000009: whatever capacity in the study/ project under consideration should so inform the committee and his/her further
p.000009: participation in the deliberations must be determined accordingly.
p.000009:
p.000009: 15. As much as possible, decisions shall be made by consensus.
p.000009:
p.000009: Training and 16. Members of the IERC shall undergo continuing continuing training on the
p.000009: ethics and science of biomedical education of research. Initial training must be required of new ethics
p.000009: members. Continuing educational activities must committee be held at least
p.000009: once a year. These may be linked members with those of other ethics committees within the
p.000009: province or region.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000010:
p.000010: THE RESEARCH ETHICS REVIEW PROCESS
p.000010:
p.000010: All proposals for the conduct of biomedical and behavioral researches involving human subjects shall be clearly
p.000010: formulated in a research protocol to be submitted to an ethics review committee (ERC) for consideration,
p.000010: comment, guidance, and approval.
p.000010:
p.000010: The review must be transparent, timely, and reasonable. Each ethics review committee shall indicate a time frame for
p.000010: completing the review process, and provide the proponent initial feedback within four weeks after receipt of the
p.000010: complete documents.
p.000010:
p.000010: Required 1. The research investigator/proponent shall be documents required to
p.000010: submit the following documents:
p.000010:
p.000010: a. Application for review;
p.000010:
p.000010: b. Research protocol that includes the title of the proposal, background of the study, rationale, objectives,
p.000010: research design, inclusion and exclusion criteria, and safety information. (For general guidelines on the research
p.000010: protocol, refer to the General Ethical Guidelines for Health Research on pp16-29);
p.000010:
...
p.000044:
p.000044: Ethics committees and other appropriate authorities should set the conditions for the use of genetic and other
p.000044: biological materials collected in epidemiologic researches.
p.000044:
p.000044: These guidelines are for consideration of ethics committees for the protection of participants in
p.000044: epidemiologic research involving humans, focusing primarily on non- experimental studies. Its main difference from
p.000044: other researches is in the nature and extent of the informed consent process.
p.000044:
p.000044: General 1. All research involving human subjects should be
p.000044: guidelines conducted in accordance with the ethical
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000045:
p.000045: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000045:
p.000045: Specific guidelines
p.000045:
p.000045: Informed 2. For case-control and cohort studies, non- consent disclosure of
p.000045: all the study objectives may be permissible if full disclosure of the study
p.000045: hypothesis could bias the investigation.
p.000045:
p.000045: 3. Consent may not be required for collection of information in the public domain. Public domain information
p.000045: may include common general data such as address, marital status, educational attainment, and number of
p.000045: children among others.
p.000045:
p.000045: It should be realized that communities differ in their definition of what type of information about citizens is
p.000045: regarded as public.
p.000045:
p.000045: 4. Data regarding income, personal habits, preferences, personal opinions, political and religious
p.000045: inclinations, among others, may be considered confidential and will require consent prior to collection.
p.000045:
p.000045: 5. Collection of data by questionable means, such as deception, should not be condoned.
p.000045:
p.000045: 6. Data gathered for administrative purposes (as long as the information is not sensitive) do not require consent and
p.000045: may be waived if getting consent is considered impractical or too expensive.
p.000045:
p.000045: 7. Review of medical records may be done without requiring consent if anonymity can be maintained and if
p.000045: information sought is considered non- sensitive (Gordis and Gold, 1980).
p.000045:
p.000045: 8. The appropriate permission for storing biological material for research must be obtained from
p.000045:
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000046:
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000034: that are not used regularly have less risk- potential than those used regularly. Likewise, devices used outside the
p.000034: body have less risk than those used inside the body.
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035:
p.000035: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000035:
p.000035: b. In the case of contraceptive implant trials, adequate monitoring for removal of the implant shall be done
p.000035: when the trial is over or the subject has withdrawn from the trial. Children born as a result of failure
p.000035: of the contraceptive being investigated shall be followed up for any abnormalities and properly reported to
p.000035: monitoring authorities.
p.000035:
p.000035: c. For vaccine trials using active or live attenuated microorganisms, the subject may be exposed to the
p.000035: specific infection for which the vaccine is being tested. As such, the vaccinated subject shall be
p.000035: informed accordingly and properly cared for.
p.000035:
p.000035: d. Clinical trials involving diagnostic agents using radioactive materials and X-ray should not necessarily
p.000035: expose subjects to more radiation than normal and shall be undertaken on patients undergoing the procedure
p.000035: for diagnostic or therapeutic purposes. Radiation limits for the use of such materials and X-rays shall be within the
p.000035: medically acceptable limits. Measures to safeguard research subjects and others who may be exposed to radiation shall
p.000035: be taken. Adequate provisions for detecting pregnancies to avoid risks of exposure to the embryo shall be given.
p.000035: Subjects shall also be provided information on possible genetic damage to their offspring.
p.000035:
p.000035: Publication 17. Clinical trial results shall be communicated in a of clinical timely
p.000035: fashion and published regardless of results trial results or findings. Findings shall be brought
p.000035: into the
p.000035: public domain and generally made known through scientific and other publications.
p.000035:
p.000035: 18. Preliminary reports that raise false hopes and expectations of product safety, efficacy, and immediate
p.000035: use shall not be made public.
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036:
p.000036: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000036:
p.000036: 19. The plan for publication and the actual publication of trial results shall not expose the identity of the
p.000036: participants or their family and community, or imperil their privacy or confidentiality as individuals,
p.000036: family, or community. As necessary, a clear consent to publication shall be obtained not only at the start of the
p.000036: trial but also at its completion.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037:
p.000037:
...
p.000053: the standard of care accepted by the larger community. It is unethical to subject the
p.000053: control group of affected individuals to placebo treatment or be withdrawn from the current mode of treatment before
p.000053: the start of the study.
p.000053:
p.000053: Research 6. Special effort shall be exerted to make the benefits beneficial
p.000053: findings of the research project accessible and available to participants under
p.000053: reasonable circumstances.
p.000053:
p.000053: Use of 7. Special care shall be taken in the public use of research data research data
p.000053: and the publication of reports so and publication that participant groups are not further stigmatized of
p.000053: reports or become blameworthy targets. Reports shall be
p.000053: carefully examined for gender and culture bias.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054:
p.000054: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000054:
p.000054: ETHICAL GUIDELINES FOR RESEARCH ON ASSISTED REPRODUCTIVE TECHNOLOGY
p.000054:
p.000054: Introduction
p.000054:
p.000054: Research in assisted reproductive technology includes studies to improve ovulatory rates, ejaculatory efficiency,
p.000054: embryo viability, fertilization success, and uterine hospitability. It may also involve studies on the
p.000054: psychosociocultural aspects of reproductive technology. Research in the reproductive health field in general is studded
p.000054: with gender issues.
p.000054:
p.000054: In general, assisted reproductive technology is ethically complex. This is because the research participants, in
p.000054: contrast to other health researches, include two individuals (i.e., the source of the ovum and the source of the
p.000054: sperm) and the fertilized egg in various stages of development, whose status as a moral agent has religious and
p.000054: ethical implications. This means that the ethical principles enunciated for health research in general must be
p.000054: equitably and equally applied to the research participants with special consideration for gender and religious issues.
p.000054:
p.000054: The Philippine Obstetrical and Gynecological Society (POGS) and the Philippine Society of Reproductive Endocrinology
p.000054: and Infertility have set requirements that must be satisfied by medical hospitals, clinics, centers, and/or other
p.000054: facilities that conduct assisted reproductive techniques/ technologies and related research. Additionally, it is
p.000054: emphasized that clinical and biological research involving assisted reproductive technology shall be carried out under
p.000054: the supervision of a qualified practitioner who has acquired adequate and up-to-date training in, and is sensitive to
p.000054: the technical aspects of using technology for assisted reproduction.
p.000054:
p.000054: General 1. All research involving human subjects should be
p.000054: guidelines conducted in accordance with the ethical
p.000054: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000054:
p.000054: Specific guidelines
p.000054:
p.000054: Research on 2. The use of gametes in fertility research shall be gametes, subject to
p.000054: ethical review with special attention to human zygotes the harm and risks involved in the collection of and
p.000054: embryos specimens and its cultural implications.
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055:
p.000055: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000055:
p.000055: 3. The intentional creation of human zygotes, embryos or fetuses for study, research, and experimentation
p.000055: or for commercial and industrial purposes is unacceptable (POGS, 1995).
p.000055:
p.000055: 4. Research may be conducted on a human embryo only for the purpose of improving that particular embryo’s chances of
p.000055: being born alive and healthy.
p.000055:
p.000055: 5. The sale of human zygotes is unacceptable.
p.000055:
p.000055: Research 6. Special effort shall be exerted to ascertain the participants
p.000055: emotional stability and maturity of research
p.000055: subjects. Gender-sensitive counseling shall be made available and offered as an adjunct service to research
p.000055: participants.
p.000055:
p.000055: Informed 7. It shall be the responsibility of the attending consent
p.000055: physician to ensure that consent of research subjects is given freely and on the basis of
p.000055: adequate information and that potential conflict of interest is resolved. The investigator must be sensitive to the
p.000055: coercive and unfair pressure on women to bear children.
p.000055:
p.000055: Privacy and 8. Researchers shall uphold the dignity of confidentiality participants
p.000055: and protect their privacy by putting in
p.000055: place adequate mechanisms for upholding the confidentiality especially of the circumstances of conception of
p.000055: children born out of assisted reproductive technology.
p.000055:
p.000055: Embryos from 9. Embryos formed by in vitro fertilization shall be in vitro given
...
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
p.000067: The assent is a requirement for research in addition to consent given by a parent or legal guardian
p.000067:
p.000067: child’s assent – is the expressed willingness of a minor to participate in a study
p.000067:
p.000068: 68
p.000068:
p.000068: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000068:
p.000068: assisted reproductive technology – all treatment or procedures that include the in-vitro handling of human oocytes and
p.000068: human sperm or embryos for the purpose of establishing a pregnancy (e.g., in vitro fertilization and transcervical
p.000068: embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, gamete
p.000068: and embryo cryopreservation, oocyte and embryo donation, gestational surrogacy)
p.000068:
p.000068: behavioral research – studies regarding the actions or reactions of persons in response to external or internal stimuli
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
p.000068: bias – the systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the
p.000068: results of a clinical trial to make the estimate of a treatment effect deviate from its true value (ICH Harmonized
p.000068: Tripartite Guideline, General Considerations for Clinical Trial (E8)
p.000068:
p.000068: blinding/masking – a procedure in which one or more parties of the trial are kept unaware of the treatment
p.000068: assignment/s. Single blinding usually refers to the subject/s being unaware, and double-blinding usually refers to the
p.000068: subject/s, investigator/s, monitor, and, in some cases, data analyst/ s being unaware of the treatment
p.000068: assignment/s (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000068:
p.000068: carrier testing – testing to identify individuals who carry recessive genes; testing designed for healthy people who
...
p.000073: Different alleles produce variation in inherited characteristics such as hair color or blood type. In an individual,
p.000073: one form of the allele (the dominant one) may be expressed more than another form (the recessive one)
p.000073:
p.000073: disease susceptibility/predisposition – the pathophysiological conditions and genetic inclination that favor the
p.000073: development of a disease condition
p.000073:
p.000073: domestic violence – violence committed by one family or household member against another (Merriam-Webster’s Dictionary
p.000073: of Law (c) 1996)
p.000073:
p.000073: double blinding – is one in which neither the subject nor any of the investigator or sponsor staff who are involved in
p.000073: the treatment or clinical evaluation of the subjects are aware of the treatment received (ICH Harmonized Tripartite
p.000073: Guideline, Statistical Principles for Clinical Trials (E9) p8)
p.000073:
p.000073: drugs – a substance used as medication or used in the diagnosis, cure, mitigation, treatment or prevention
p.000073: of disease
p.000073:
p.000073: duress – wrongful and usually unlawful compulsion (as threats of physical violence) that induces a person to act
p.000073: against his or her will: ‘coercion” (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000073:
p.000073: efficacy – is the ability of a treatment modality to produce an effect to alleviate a disease
p.000073:
p.000073: embryo – the stage of human development following implantation (starting 10- 14 days), when the primitive streak begins
p.000073: to form up to fetal stage
p.000073:
p.000073: epidemiologic research – investigative studies intended to establish “the distribution and determinants of
p.000073: disease frequency in human populations”
p.000073:
p.000073: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the determinants of the
p.000073: incidence of diseases as well as their related risk factors, etiology and causation
p.000073:
p.000073: epidemiology – the basic medical science that focuses on the distribution and determinants of disease frequency in
p.000073: human populations (Raymond Greenberg, Medical Epidemiology, 1993)
p.000073:
p.000074: 74
p.000074:
p.000074: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000074:
p.000074: ethical clearance – a certification that a research proposal has complied with ethical requirements
p.000074:
p.000074: – action of an ethics review committee on a research protocol that signifies approval and permission to proceed with
p.000074: the research.
p.000074:
p.000074: ethical principles – rules or codes conforming to accepted professional standards of conduct (Merriam-Webster’s
p.000074: Dictionary of Law (c) 1996)
p.000074:
p.000074: – usually refer to the ex prima facie universal principles of respect for persons, beneficence, non-maleficence and
p.000074: justice
p.000074:
p.000074: respect for persons – involves a recognition of the personal dignity and autonomy of individuals, and special
...
p.000089: of a particular health condition
p.000089:
p.000089: diagnostic – professionally accepted level and type of examination to determine a patient’s health condition
p.000089:
p.000089: therapeutic – professionally accepted level and type of treatment or assistance for a particular health condition
p.000089:
p.000089: stem cell research – the study of the properties, development, and transformation of primordial progenitor cells prior
p.000089: to establishment of specialized cells
p.000089:
p.000089: stigma – the negative regard (e.g., shame and dishonor) of the community or society to particular groups because of
p.000089: disability, illness, occupation, poverty, etc. as dictated by culture
p.000089:
p.000089: study/investigational product – a pharmaceutical form of an active ingredient or placebo being tested or used as a
p.000089: reference in a clinical trial, including a product with marketing authorization when used or assembled
p.000089: (formulated or packaged) in a way different from the approved form, or when used fro an unapproved indication, or when
p.000089: used to gain further information about an approved use (ICH Harmonized Tripartite Guideline, Guideline for Good
p.000089: Clinical Practice [E6,R1])
p.000089:
p.000089: susceptibility – genetic condition leading to the development of a disease technical review – see scientific review
p.000089: teratogenicity – the degree or measure of the ability to cause malformations of an embryo or fetus
p.000089:
p.000089: termination of the research – the research study may be ended before its scheduled completion when the safety or
p.000089: benefit of the study participants is doubtful or at risk.
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
p.000090: Philippines, providing for a Traditional and Alternative Health Care Development Fund and for other purposes
p.000090:
p.000090: traditional healer – the relatively old, highly placed respected person in the community, with a profound knowledge of
p.000090: traditional remedies
p.000090:
p.000090: traditional medicine – the sum total of knowledge, skills, and practices in health care, not necessarily explicable in
p.000090: the context of modern, scientific, philosophical framework, but recognized by the people to help maintain and improve
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
...
p.000096:
p.000096:
p.000096: Contraceptive implant,36 Control, 72
p.000096: Controlled trials, 17, 72
p.000096: Conventional medicine,42, 73
p.000096: Counseling,49,54,73
p.000096: Gender-sensitive, 56, 77
p.000096: Genetic, 60, 77 Criminal violence,50,73 Cultural beliefs,51 Cultural sensitivity,50,53 Culture bias,54,73
p.000096: Data, administrative, 46
p.000096: Debriefing,49, 73
p.000096: Deception,21,46,49, 73
p.000096: devices, 73
p.000096: biomedical, 59
p.000096: medical, 35
p.000096: Diagnostic/s, 59 ,73 procedures,35,36
p.000096: Dietary supplements,42 Disapproval, 13,14, 73 Discontinuation,33 Disclosure,22,45, 60, 61,
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
p.000096: Feasibility, 27, 76
p.000096: Feedback session, 49
p.000096: Fertilization success, 55
p.000096: Fetus, 76
p.000096:
p.000097: 97
p.000097:
...
Social / gender
Searching for indicator gender:
(return to top)
p.000002: Romualdez, Jr., then Executive Director of the Philippine Council for Health Research and Development (PCHRD).
p.000002:
p.000002: The NEC was created to ensure that all health research and development proposals conformed with ethical standards.
p.000002: It also promoted the establishment of ethics review committees in various localities and institutions.
p.000002:
p.000002: In 2003, the Philippine National Health Research System (PNHRS) led to the creation of the Philippine Health Research
p.000002: Ethics Board (PHREB), a national policymaking body on health research ethics. In the different regions, policymaking
p.000002: boards shall also be established as Regional Health Research Ethics Boards.
p.000002:
p.000002:
p.000002: The Philippine Health Research Ethics Board (PHREB)
p.000002:
p.000002: Composition The Philippine Health Research Ethics Board has
p.000002: 13 members, including two ex-officio members: the Department of Science and Technology (DOST)-PCHRD Executive
p.000002: Director, and the Department of Health (DOH) Research Ethics Committee Chair. Except for the ex-officio
p.000002: members, appointments shall be for a term of three years (initially, however, five were appointed for three
p.000002: years, and six members for two years). The members represent a balance of background, gender, and disciplines (e.g.,
p.000002: health research,
p.000002:
p.000003: 3
p.000003:
p.000003: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000003:
p.000003: philosophy, law, academe, medicine, public health/ epidemiology, theology, social science, allied health
p.000003: sciences, people’s organizations, and the youth). The Chair and Co-Chair have two-year terms.
p.000003:
p.000003: Functions PHREB shall have the following functions:
p.000003:
p.000003: 1. Formulate/Update guidelines for the ethical conduct of human health research;
p.000003:
p.000003: 2. Develop guidelines for the establishment and management of ethics review committees and standardization of
p.000003: research ethics review;
p.000003:
p.000003: 3. Monitor and evaluate the performance of institutional ethics review committees in accordance with procedures
p.000003: outlined in a prior agreement;
p.000003:
p.000003: 4. Promote the establishment of functional and effective ethics review committees;
p.000003:
p.000003: 5. Provide advice and make recommenda- tions to the PNHRS Governing Council and other appropriate entities
p.000003: (including the Bureau of Food and Drugs [BFAD]) regarding programs, policies, and regula- tions as they relate to
p.000003: ethical issues in human health research;
p.000003:
p.000003: 6. Initiate and contribute to discourse and discussions of ethical issues in human health research; and
p.000003:
p.000003: 7. Network with relevant local, national, and international organizations.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000004:
p.000004: Regional Research Ethics Boards
p.000004:
p.000004: Composition The regional research ethics boards will be
p.000004: constituted by the PNHRS Governing Council and will have a multidisciplinary, multisectoral, gender- and age-balanced
p.000004: membership that reflects the cultural and social milieu obtaining in the region they are in. They will be under the
p.000004: supervision of PHREB.
p.000004:
p.000004: Functions The regional research ethics boards will be
p.000004: established in key regions to act as a regional research ethics review policy-making authority. Their functions will,
p.000004: therefore, be similar to that of PHREB with the region as their area of responsibility.
p.000004:
p.000004:
p.000004: Ethics Review Committees (ERCs)
p.000004:
p.000004: The Ethics Review Committees include the Cluster Ethics Review Committees, the Institutional Ethics Review
p.000004: Committees and the erstwhile National Ethics Committee. The latter has for several years conducted initial review for
p.000004: researches done in institutions without a functional research ethics review committee.
p.000004:
p.000004:
p.000004: Cluster Ethics Review Committees (CERCs)
p.000004:
p.000004: Several institutions may form a common ethics review committee if it is not feasible to form their own committees.
p.000004:
...
p.000005: Fogarty Group in organizing intensive training courses in research ethics may answer the need for capacity building
p.000005: in this field.
p.000005:
p.000005: Standardization of ethics review is an area of concern that the IERC should address. In this regard, the IERC may use
p.000005: as references the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000), and
p.000005: the 2006 General Ethical Guidelines for Health Research (pp16-29). However, it should develop a manual of standard
p.000005: operating procedures.
p.000005:
p.000005: Composition 1. The membership of the institutional ethics review
p.000005: committee should be multidisciplinary and multisectoral, including the relevant expertise, e.g., medicine and
p.000005: research, theology, social or behavioral science, law, philosophy, environmental science, and public
p.000005: health. It is recommended that the IERC should include a person without disciplinal constraints who will
p.000005: represent the interests and concerns of the
p.000005:
p.000006: 6
p.000006:
p.000006: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000006:
p.000006: community. At least one member should be independent of the institution or research site. The IERC should have
p.000006: at least five members and should consider age and gender distribution.
p.000006:
p.000006: 2. In addition to the committee members, there should be adequate support staff for carrying out the IERC’s
p.000006: responsibilities.
p.000006:
p.000006: Appointment 3. The officers and members of the IERC shall be
p.000006: officially appointed by the administrative head of the institution.
p.000006:
p.000006: 4. The appointing official shall indicate their functions, terms of office, scope of work, conditions of
p.000006: appointment, and compensation, if any.
p.000006:
p.000006: 5. Procedures for renewal of appointment, resignation, replacement; grounds for disqualification;
p.000006: and procedures in regard to conflict of interest due to financial gains shall be included in the manual of
p.000006: standard operating procedures.
p.000006:
p.000006: 6. Prior to serving as a regular member, each member of the IERC shall sign a disclosure document which
p.000006: states that he/she has no conflict of interest (e.g., financial interests in a pharmaceutical company) as a
p.000006: reviewer, and a confidentiality agreement.
p.000006:
p.000006: 7. The appointing official should consider “a fixed rotation system for members that allows for continuity, the
p.000006: development and maintenance of expertise within the committee, and the regular input of fresh ideas and
p.000006: approaches” (WHO Operational Guidelines for Ethics Committees that Review Biomedical Research, 2000).
p.000006:
p.000006: External 8. The committee shall establish a list of external consultants consultants
p.000006: who can provide special expertise
p.000006:
p.000007: 7
p.000007:
p.000007: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000007:
...
p.000011: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000011:
p.000011: adverse events, contact telephone numbers);
p.000011:
p.000011: f. Procedure for participant recruitment, including advertisements;
p.000011:
p.000011: g. A section on ethical considerations (e.g., anticipated risks and why they are outweighed by potential
p.000011: benefits, how the risks will be minimized, how confidentiality of data and privacy of participants are
p.000011: going to be protected);
p.000011:
p.000011: h. Investigators’ qualifications (e.g., curriculum vitae). If a conflict of interest exists, the investigator
p.000011: shall formally disclose this; and
p.000011:
p.000011: i. Information regarding funding, sponsors, institutional affiliations, other potential conflict of interest, and
p.000011: compensation for the subjects.
p.000011:
p.000011:
p.000011: Review 2. The ERC should have a standard operating procedure process that
p.000011: should be made available to the
p.000011: researchers and stakeholders. It is advisable for the ethics review committee to have a standard application form
p.000011: (Appendix B).
p.000011:
p.000011: 3. The ERC Chairperson shall schedule a research review meeting reasonably within four weeks after submission of the
p.000011: required documents.
p.000011:
p.000011: 4. ERC members shall be provided with a copy of the documents to be reviewed well ahead of the meeting to give them
p.000011: sufficient time to study the documents and ready their comments.
p.000011:
p.000011: 5. The quorum shall be set and attendance of members recorded. The rule on quorum shall not only specify
p.000011: numbers but shall also require a balanced composition (e.g., gender, expertise).
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000012:
p.000012: 6. The minutes of the meeting, including actions taken, shall be properly documented. Minutes and other records
p.000012: shall be properly secured at least three years after the completion of the study or as required by the official
p.000012: agencies or institutions.
p.000012:
p.000012: 7. The ERC may invite the investigator/proponent to clarify certain issues. The latter shall leave the room
p.000012: immediately after the clarification has been made.
p.000012:
p.000012:
p.000012: Action on 8. The ERC shall inform the investigator/proponent proposals in writing of
p.000012: the committee’s action. The ERC’s
p.000012: action may be one of the following:
p.000012:
p.000012: a. Approval
p.000012: b. Conditional approval with modifications
p.000012: c. Disapproval
p.000012:
p.000012: 9. The ERC shall include in its letter to the investigator the a) title of the proposal reviewed
p.000012: (revision/amendment, date, version number); b) name and title of applicant; c) documents reviewed; d) name of
p.000012: review site; e) date and place of decision; and f) the name of the ERC making the decision.
p.000012:
p.000012: 10. In case of approval, the ERC shall inform the investigator in writing of the ERC’s requirements for approved
p.000012: researches that must be complied with during the conduct of the research. These include the following:
p.000012:
p.000012: a. Report of serious and/or unexpected adverse event/s (SAEs) related to the conduct of the research within a
p.000012: timeframe required by the ERC (e.g., 24 or 48 hours after occurrence).
p.000012:
p.000012: b. Report of SAEs from other study sites or centers,
p.000012:
p.000013: 13
p.000013:
...
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
p.000049: sociopolitical implications, the potential for the exploitation of subjects, conflicts of researchers’ interest with
p.000049: that of the community being studied, the recruitment of participants and obtaining of valid informed consent, ensuring
p.000049: gender and cultural sensitivity, and the need for research to contribute to the healing and re-empowerment of the
p.000049: traumatized community.
p.000049:
p.000049: General 1. All research involving human subjects should be
p.000049: guidelines conducted in accordance with the ethical
p.000049: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000050:
p.000050: 2. In deliberations on research involving traumatized populations, a community advocate or representative
p.000050: must be present.
p.000050:
p.000050: 3. In the course of research, the psychosocial needs of the community must be taken into account.
p.000050:
p.000050: 4. The different roles of the researchers, caregivers, and volunteer workers must always be clarified and the
p.000050: potential conflicts of interest identified.
p.000050:
p.000050: 5. The ethics review committee must put in place a monitoring mechanism to ensure that the above guidelines are
p.000050: followed.
p.000050:
p.000050: Special guidelines
p.000050:
p.000050: Research 6. The research proposal must explain how its protocol objectives
p.000050: relate to the priorities of the community.
p.000050:
p.000050: 7. The research methodology must ensure that the research process will not impede the healing or recovery of the
p.000050: community. It must contribute to the process of designing intervention programs.
p.000050:
p.000050: 8. The protocol must include provisions for aftercare, including closure activities and a proper referral
...
p.000052: guidelines conducted in accordance with the ethical
p.000052: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000052:
p.000052: Special guidelines
p.000052:
p.000052: Identification 2. The recruitment process shall be sensitive to the consent social
p.000052: implications of being identified as a potential HIV/AIDS case or of belonging to a high-risk
p.000052: group. Specific mechanisms to protect the privacy of individuals shall be described and put in place.
p.000052:
p.000052: 3. Special attention shall be given to the possible sensitive nature of the information to be extracted from the
p.000052: research participants and, if applicable, the necessity of undergoing an HIV test. It is also important to determine
p.000052: the participant’s willingness to be informed of the test result, the test’s
p.000052:
p.000053: 53
p.000053:
p.000053:
p.000053:
p.000053: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000053:
p.000053: reportability, and the implication on his/her sexual activities if found positive.
p.000053:
p.000053: The participant must also be informed that he/ she is free to withdraw from the study anytime.
p.000053:
p.000053: Pre- and 4. Pre- and post-test counseling by well-trained, post-test
p.000053: culture- and gender-sensitive research personnel counseling shall be put in place as part of
p.000053: the research
p.000053: protocol.
p.000053:
p.000053: Standard 5. In an interventional study, the control group shall of care receive
p.000053: the standard of care accepted by the larger community. It is unethical to subject the
p.000053: control group of affected individuals to placebo treatment or be withdrawn from the current mode of treatment before
p.000053: the start of the study.
p.000053:
p.000053: Research 6. Special effort shall be exerted to make the benefits beneficial
p.000053: findings of the research project accessible and available to participants under
p.000053: reasonable circumstances.
p.000053:
p.000053: Use of 7. Special care shall be taken in the public use of research data research data
p.000053: and the publication of reports so and publication that participant groups are not further stigmatized of
p.000053: reports or become blameworthy targets. Reports shall be
p.000053: carefully examined for gender and culture bias.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054:
p.000054: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000054:
p.000054: ETHICAL GUIDELINES FOR RESEARCH ON ASSISTED REPRODUCTIVE TECHNOLOGY
p.000054:
p.000054: Introduction
p.000054:
p.000054: Research in assisted reproductive technology includes studies to improve ovulatory rates, ejaculatory efficiency,
p.000054: embryo viability, fertilization success, and uterine hospitability. It may also involve studies on the
p.000054: psychosociocultural aspects of reproductive technology. Research in the reproductive health field in general is studded
p.000054: with gender issues.
p.000054:
p.000054: In general, assisted reproductive technology is ethically complex. This is because the research participants, in
p.000054: contrast to other health researches, include two individuals (i.e., the source of the ovum and the source of the
p.000054: sperm) and the fertilized egg in various stages of development, whose status as a moral agent has religious and
p.000054: ethical implications. This means that the ethical principles enunciated for health research in general must be
p.000054: equitably and equally applied to the research participants with special consideration for gender and religious issues.
p.000054:
p.000054: The Philippine Obstetrical and Gynecological Society (POGS) and the Philippine Society of Reproductive Endocrinology
p.000054: and Infertility have set requirements that must be satisfied by medical hospitals, clinics, centers, and/or other
p.000054: facilities that conduct assisted reproductive techniques/ technologies and related research. Additionally, it is
p.000054: emphasized that clinical and biological research involving assisted reproductive technology shall be carried out under
p.000054: the supervision of a qualified practitioner who has acquired adequate and up-to-date training in, and is sensitive to
p.000054: the technical aspects of using technology for assisted reproduction.
p.000054:
p.000054: General 1. All research involving human subjects should be
p.000054: guidelines conducted in accordance with the ethical
p.000054: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000054:
p.000054: Specific guidelines
p.000054:
p.000054: Research on 2. The use of gametes in fertility research shall be gametes, subject to
p.000054: ethical review with special attention to human zygotes the harm and risks involved in the collection of and
p.000054: embryos specimens and its cultural implications.
p.000054:
p.000055: 55
p.000055:
p.000055:
p.000055:
p.000055: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000055:
p.000055: 3. The intentional creation of human zygotes, embryos or fetuses for study, research, and experimentation
p.000055: or for commercial and industrial purposes is unacceptable (POGS, 1995).
p.000055:
p.000055: 4. Research may be conducted on a human embryo only for the purpose of improving that particular embryo’s chances of
p.000055: being born alive and healthy.
p.000055:
p.000055: 5. The sale of human zygotes is unacceptable.
p.000055:
p.000055: Research 6. Special effort shall be exerted to ascertain the participants
p.000055: emotional stability and maturity of research
p.000055: subjects. Gender-sensitive counseling shall be made available and offered as an adjunct service to research
p.000055: participants.
p.000055:
p.000055: Informed 7. It shall be the responsibility of the attending consent
p.000055: physician to ensure that consent of research subjects is given freely and on the basis of
p.000055: adequate information and that potential conflict of interest is resolved. The investigator must be sensitive to the
p.000055: coercive and unfair pressure on women to bear children.
p.000055:
p.000055: Privacy and 8. Researchers shall uphold the dignity of confidentiality participants
p.000055: and protect their privacy by putting in
p.000055: place adequate mechanisms for upholding the confidentiality especially of the circumstances of conception of
p.000055: children born out of assisted reproductive technology.
p.000055:
p.000055: Embryos from 9. Embryos formed by in vitro fertilization shall be in vitro given
p.000055: respect commensurate to their status fertilization (POGS,1995). Extreme care shall be exercised
p.000055: in the handling of human embryos.
p.000055:
p.000055: 10. Arrangements regarding unused embryos, sperms, and ova shall be agreed upon by the investigator and the
p.000055: source/s prior to the research, and shall be an important part of the research protocol.
p.000056: 56
p.000056:
...
p.000075: and scientific standards for carrying out biomedical research on human participants. Compliance with these guidelines
p.000075: helps ensure that the dignity, rights, safety and well-being of research participants are promoted.
p.000075:
p.000075: ethics review committee – a Committee constituted to review the ethical aspects of a research proposal and its possible
p.000075: implementation
p.000075:
p.000075: Ethics Committee (IEC/IRB) – Independent Ethics Committee / Institutional Review Board is an independent body
p.000075: (either a review board or committee) whose responsibility is to ensure the protection of the rights, safety and
p.000075: well-being of human participants involved in a trial and to provide public assurance of that protection.
p.000075:
p.000075: experimental design – the structure of research, identifying the various elements of a research project and how they
p.000075: relate to one another
p.000075:
p.000075: family studies – mapping of disease genes through the establishment of genetic linkage within a family
p.000075:
p.000075: feasibility – capability to be accomplished or implemented
p.000075:
p.000075: fetus – stage of human development when the first neural cells start differentiating (starting from 6-8 weeks up to
p.000075: birth)
p.000075:
p.000076: 76
p.000076:
p.000076: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000076:
p.000076: gender – socially defined feminine or masculine roles, attitudes, and values
p.000076:
p.000076: gender bias – partiality, unfairness, prejudice manifested towards an individual or group of individuals based on sex
p.000076: and sexual orientation
p.000076:
p.000076: gender-sensitive counseling – counseling that includes awareness of existing gender differences, issues and inequality
p.000076: in its framework for interaction with the patient/client
p.000076:
p.000076: gender sensitivity – the ability to perceive existing gender differences, issues, and inequality and to incorporate
p.000076: these into strategies and actions
p.000076:
p.000076: genes – the functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA,
p.000076: and most genes contain the information for making a specific protein
p.000076:
p.000076: gene activity – refers to the degree of expression of a particular gene or levels of transcription
p.000076:
p.000076: genetic association studies – describes a situation in which a particular allele is found either significantly more or
p.000076: less frequently in a group of affected individuals than would be expected from the frequency of the allele in the
p.000076: general population from which the affected individuals were drawn
p.000076:
p.000076: genetic counseling – the provision of information and assistance to affected individuals or family members at risk of a
p.000076: disorder that may be genetic, concerning the consequences of the disorder, the probability or developing or
p.000076: transmitting it, and the ways in which it may be prevented or ameliorated
p.000076:
p.000076: genetic research – the study of the structure and functions of individual genes, genetic variation in human
p.000076: populations, and the applications of genetics in diagnosis and patient care
p.000076:
p.000076: genetic screening – a population-based method for identifying a subset of individuals at risk of developing
p.000076: or of transmitting a specific genetic disease or disorder
p.000076:
...
p.000095: Case-control studies,46, 69
p.000095: Cellular metabolites, 57, 70 Children,20,23 Chiropractic,43
p.000095: Clinical epidemiology,45 Clinical equipoise,31, 70 Clinical indication,30 Clinical research, 70
p.000095: Clinical trial,30, 70
p.000095: Phase I, 30, 83
p.000095: Phase II,30, 83
p.000095: Phase III,30, 84
p.000095: Phase IV, 30, 84
p.000095: Closure activities,51
p.000095: Cluster Ethics Review Committees (CERCs), 5, 87
p.000095: coercion,48
p.000095: cohort studies,46,71 collaborative research, externally
p.000095: sponsored,29 commercialization,41 commercial products,19 commercial purpose/s,55 community, -ies, 46,49,50,52,59
p.000095: community
p.000095: advocate,51 leader, 59
p.000095: community participation,28 community priorities,51 comparator product,32, 71 compensation,20,23,47,72 complementary and
p.000095: alternative
p.000095: medicine, 42, 72
p.000095: Completion, 15,18
p.000095: Conception,56, 71
p.000095: Confidentiality,18,19,45,48, 61, 72 Conflict of interest,50,51,72 Consent,46, 61
p.000095: Consent agreement, 62 Contraceptive methods,25
p.000095:
p.000096: 96
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096:
p.000096: Contraceptive implant,36 Control, 72
p.000096: Controlled trials, 17, 72
p.000096: Conventional medicine,42, 73
p.000096: Counseling,49,54,73
p.000096: Gender-sensitive, 56, 77
p.000096: Genetic, 60, 77 Criminal violence,50,73 Cultural beliefs,51 Cultural sensitivity,50,53 Culture bias,54,73
p.000096: Data, administrative, 46
p.000096: Debriefing,49, 73
p.000096: Deception,21,46,49, 73
p.000096: devices, 73
p.000096: biomedical, 59
p.000096: medical, 35
p.000096: Diagnostic/s, 59 ,73 procedures,35,36
p.000096: Dietary supplements,42 Disapproval, 13,14, 73 Discontinuation,33 Disclosure,22,45, 60, 61,
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
p.000096: Feasibility, 27, 76
p.000096: Feedback session, 49
p.000096: Fertilization success, 55
p.000096: Fetus, 76
p.000096:
p.000097: 97
p.000097:
p.000097: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000097:
p.000097:
p.000097: aborted, 63
p.000097: Forensic medicine, 59
p.000097: Gender, 77
p.000097: Gender bias,54, 77
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
p.000097: Genetic traits, 59
p.000097: Good clinical practice, 38, 77
p.000097: Good laboratory practices, 32, 78 Good manufacturing practice, 32 Good Manufacturing Practice
p.000097: Guidelines, 39, 78
p.000097: Health equity, 64, 79
p.000097: Health research involving human Subjects, 16, 22
p.000097: Helsinki Declaration, 3,16
p.000097: Herbal products, 42
p.000097: Herbal remedies, 38
p.000097: Homeopathy, 43
p.000097: Human atrocities, 50
p.000097: Identifiable information, 67
p.000097: Inconvenience, 17 Indicators of success, 64 Inducement, 59
p.000097: Information in the public domain,46 Informed Consent, 11, 20, 21, 33, 40, 48,
p.000097: 52, 59, 67, 80
p.000097: Alternative methods, 47
p.000097: Verbal consent, 47, 48 Injury, research related, 19
p.000097: Institutional Ethics Review Committees (IERCs), 5-10, 87
p.000097: Appointment of members, 7
p.000097: Composition, 6-7
p.000097: Continuing education, 10
p.000097: External consultants, 7-8
p.000097: Functions and Responsibilities, 8-10 Meetings and Deliberations, 10 Training, 10
p.000097: Intellectual property sharing, 65, 81
p.000097: International collaborative research/es, 64, 81
p.000097: International Conference on Harmonization (ICH), 30, 39
...
Social / parents
Searching for indicator parent:
(return to top)
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
p.000019: 5. The participation of children in research requires extra protection, as children cannot volunteer to participate
p.000019: in a research study in the same way as an adult can. While they cannot give informed consent, they can participate in
p.000019: the process of
p.000019:
p.000020: 20
p.000020:
p.000020: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000020:
p.000020: obtaining consent by being asked for their assent to participate. When appropriate, both a child’s assent and the
p.000020: parent’s or guardian’s permission should be obtained prior to enrolling a child in a research study.
p.000020:
p.000020: 6. In obtaining informed consent, sponsors and investigators have a duty to:
p.000020:
p.000020: a. avoid deception, undue influence, or intimidation;
p.000020:
p.000020: b. seek consent only after ascertaining that the prospective subject has adequate understanding of the
p.000020: relevant facts and the consequences of participation, and has had sufficient opportunity to consider whether to
p.000020: participate;
p.000020:
p.000020: c. as a general rule, obtain from each prospective subject a signed form as evidence of informed consent;
p.000020: investigators shall justify any exceptions to this general rule and obtain the approval of the ethics review committee;
p.000020:
p.000020: d. renew the informed consent of each subject if there are any significant changes in the conditions or
p.000020: procedures of the research, or if new information becomes available that could affect the willingness of
p.000020: subjects to continue to participate;
p.000020:
p.000020: e. renew the informed consent of each subject in long-term studies at pre-determined intervals even if there are
p.000020: no changes in the design or objectives of the research (Guideline 6 - CIOMS, 2002).
p.000020:
...
p.000022: other expenses incurred in taking subjects part in a study; free medical services; and
p.000022: compensation for the inconvenience and time spent by those who do not have direct benefit from the research should
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
...
p.000047: individual researcher, social and behavioral research involves the basic dilemma of balancing the pursuit of valid
p.000047: knowledge and concerns for the participants’ rights for privacy as well as preserving their integrity, dignity, and
p.000047: autonomy.
p.000047:
p.000047: The guidelines below are consistent with existing ones on research on human subjects but are made more specific for
p.000047: social research.
p.000047:
p.000047: General 1. All research involving human subjects should be
p.000047: guidelines conducted in accordance with the ethical
p.000047: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000047:
p.000047: Special guidelines
p.000047:
p.000047: Informed 2. Informed consent shall be obtained, with the consent possible
p.000047: exception of research involving archival work, participant observation, and observation in
p.000047: public places. The researcher shall inform his/ her participants as to the nature of the research and obtain verbal
p.000047: or written consent. Verbal consent must be attested to in the absence of a written consent. Coercion in any form
p.000047: may not be used to force individuals to participate. If participants are minors, consent of the parent/
p.000047: guardian must be obtained. Assent of the minor must also be obtained, properly documented, and attested to by an
p.000047: impartial witness of legal age.
p.000047:
p.000047: Privacy and 3. The researcher shall respect the respondent’s confidentiality right to
p.000047: privacy and preserve the confidentiality of of information information. He/She shall make provisions
p.000047: to
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048:
p.000048: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000048:
p.000048: render the participants anonymous to those not directly involved in the research.
p.000048:
p.000048: 4. The researcher shall not release information that permits linking specific individuals to specific
p.000048: information. In cases where information pertaining to groups or specific communities exposes them to possible harm or
p.000048: abuse, the researcher shall refrain from identifying such groups or communities unless required by law.
p.000048:
p.000048: Access to 5. In carrying out experimental or quasi-experimental services or designs in
p.000048: field research, access to services or benefits benefits provided to the experimental group shall
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
...
p.000067: severity of which is not consistent with the informed consent / information sheets or applicable product information
p.000067: (e.g investigator’s brochure for the unapproved investigational product or package insert/ summary of
p.000067: product characteristic for an approved product
p.000067:
p.000067: AIDS (acquired immune deficiency syndrome) – the clinical manifestations in the advanced stages of HIV infection
p.000067: characterized by the breakdown of the immune system
p.000067:
p.000067: alternative medicine – a health treatment modality which is non-allopathic, occasionally non-indigenous or
p.000067: imported healing method, though not necessarily practiced for centuries nor handed down from one generation to
p.000067: another
p.000067:
p.000067: anonymized sample or data – biological sample or data that cannot be linked to an identifiable person through
p.000067: destruction of that link to any identifying information about the person who provided the sample or data
p.000067:
p.000067: approval – favorable decision of the Ethics Committee following a review of the application
p.000067: archival work – research involving the examination of records or documents assent – authorization for one’s own
p.000067: participation in research given by a minor
p.000067: or another subject who lacks the capability to give informed consent.
p.000067: The assent is a requirement for research in addition to consent given by a parent or legal guardian
p.000067:
p.000067: child’s assent – is the expressed willingness of a minor to participate in a study
p.000067:
p.000068: 68
p.000068:
p.000068: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000068:
p.000068: assisted reproductive technology – all treatment or procedures that include the in-vitro handling of human oocytes and
p.000068: human sperm or embryos for the purpose of establishing a pregnancy (e.g., in vitro fertilization and transcervical
p.000068: embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, gamete
p.000068: and embryo cryopreservation, oocyte and embryo donation, gestational surrogacy)
p.000068:
p.000068: behavioral research – studies regarding the actions or reactions of persons in response to external or internal stimuli
p.000068:
p.000068: behavioral genetics – The study of genes that determine behavioral traits and phenotypes
p.000068:
p.000068: benefits – any direct or indirect good effect of the research study to the participants
p.000068:
p.000068: – something that promotes or enhances well-being; an advantage
p.000068:
p.000068: direct benefits – derived by a research subject if it arises from the use of an experimental substance or device
p.000068:
p.000068: indirect benefits – is derived when it comes about as an unintended or unlikely consequence of research participation
p.000068:
...
p.000075: relate to one another
p.000075:
p.000075: family studies – mapping of disease genes through the establishment of genetic linkage within a family
p.000075:
p.000075: feasibility – capability to be accomplished or implemented
p.000075:
p.000075: fetus – stage of human development when the first neural cells start differentiating (starting from 6-8 weeks up to
p.000075: birth)
p.000075:
p.000076: 76
p.000076:
p.000076: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000076:
p.000076: gender – socially defined feminine or masculine roles, attitudes, and values
p.000076:
p.000076: gender bias – partiality, unfairness, prejudice manifested towards an individual or group of individuals based on sex
p.000076: and sexual orientation
p.000076:
p.000076: gender-sensitive counseling – counseling that includes awareness of existing gender differences, issues and inequality
p.000076: in its framework for interaction with the patient/client
p.000076:
p.000076: gender sensitivity – the ability to perceive existing gender differences, issues, and inequality and to incorporate
p.000076: these into strategies and actions
p.000076:
p.000076: genes – the functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA,
p.000076: and most genes contain the information for making a specific protein
p.000076:
p.000076: gene activity – refers to the degree of expression of a particular gene or levels of transcription
p.000076:
p.000076: genetic association studies – describes a situation in which a particular allele is found either significantly more or
p.000076: less frequently in a group of affected individuals than would be expected from the frequency of the allele in the
p.000076: general population from which the affected individuals were drawn
p.000076:
p.000076: genetic counseling – the provision of information and assistance to affected individuals or family members at risk of a
p.000076: disorder that may be genetic, concerning the consequences of the disorder, the probability or developing or
p.000076: transmitting it, and the ways in which it may be prevented or ameliorated
p.000076:
p.000076: genetic research – the study of the structure and functions of individual genes, genetic variation in human
p.000076: populations, and the applications of genetics in diagnosis and patient care
p.000076:
p.000076: genetic screening – a population-based method for identifying a subset of individuals at risk of developing
p.000076: or of transmitting a specific genetic disease or disorder
p.000076:
p.000076: gene testing – analysis done on affected persons or carriers within family already identified because of a history of
...
Searching for indicator parents:
(return to top)
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
...
Social / philosophical differences/differences of opinion
Searching for indicator philosophy:
(return to top)
p.002006: need to safeguard the rights of the participants, particularly those who are vulnerable or disadvantaged. The national
p.002006: guidelines shall ensure that more research institutions and researches from the biomedical and behavioral
p.002006: fields of discipline will be able to support and protect the dignity and rights of the human person as a research
p.002006: participant. I understand also that this initiative is pointing to one of the goals of the Philippine National Health
p.002006: Research System (PNHRS) - that of fostering high performing research organizations relative to technical and ethical
p.002006: standards.
p.002006:
p.002006: We therefore laud the tireless efforts and admirable dedication of the members of the Ad Hoc Committee for
p.002006: accomplishing the revised ethical guidelines for the conduct of health research in the country.
p.002006:
p.002006: Congratulations and more power to the Philippine National Health Research System!
p.002006:
p.002006:
p.002006:
p.002006: FRANCISCO T. DUQUE III, M.D., M.Sc.
p.002006: Secretary of Health
p.002006:
p.002006: 30 June, 2006
p.002006: iv
p.002006:
p.002006: ACKNOWLEDGMENTS
p.002006:
p.002006: The Ad Hoc Committee for the revision of the National Ethical Guidelines for Health Research patiently and carefully
p.002006: reviewed and revised the old guidelines, and formulated new ones in order to provide researchers and ethics review
p.002006: committees a new set of guidelines that is responsive to the needs of an evolving and growing national health research
p.002006: system. The committee was composed of:
p.002006:
p.002006: Dr. Leonardo D. de Castro Professor, Department of Philosophy
p.002006: (Chair) College of Social Science and Philosophy University of the
p.002006: Philippines Diliman
p.002006:
p.002006: Dr. Sonny Matias E. Habacon Professor, Department of Pharmacology
p.002006: College of Medicine
p.002006: Far Eastern University- Nicanor Reyes Memorial Medical Foundation
p.002006:
p.002006: Fr. J. Cesar R. Marin, SJ Parish Priest
p.002006: Mary the Queen Parish
p.002006:
p.002006: Dr. Jaime C. Montoya Executive Director
p.002006: Philippine Council for Health Research and Development
p.002006: Department of Science and Technology
p.002006:
p.002006: Dr. Filipinas F. Natividad Vice President and Director
p.002006: Research and Biotechnology Division St. Luke’s Medical Center
p.002006:
p.002006: Atty. Elizabeth A. Pangalangan Professor, College of Law
p.002006: University of the Philippines Diliman
p.002006:
p.002006: Dr. Marita V. T. Reyes Professor, Department of Biochemistry and
p.002006: Molecular Biology College of Medicine
p.002006: University of the Philippines Manila
p.002006:
p.002006: Dr. Cecilia V. Tomas Dean, College of Medicine University of the Philippines Manila
p.002006:
p.002006: Ms. Crispinita A. Valdez Director, Information Management Service
p.002006: Department of Health
p.002006:
p.002006:
p.002006: The following brought in their technical expertise to bear on the writing of specific sections of these guidelines:
p.002006:
p.002006: Dr. Godofreda V. Dalmacion Professor, Department of Clinical
p.002006: Epidemiology
p.002006: College of Medicine, UP Manila
p.002006: v
p.002006:
p.002006: Dr. Jacinto Blas Mantaring Associate Professor, Department of Pediatrics
p.002006: College of Medicine, UP Manila
p.002006:
p.002006: Dr. June Pagaduan-Lopez Associate Professor, Department of Psychiatry
p.002006: College of Medicine, UP Manila
p.002006:
p.002006: Dr. Isidro C. Sia Professor, Department of Pharmacology College of Medicine, UP Manila
p.002006:
p.002006: Prof. Elizabeth R. Ventura Professor, Department of Social Science
p.002006: College of Social Science and Philosophy University of the Philippines Diliman
p.002006:
p.002006: They also facilitated the group discussions on the guidelines during the 24th Anniversary Conference of the Philippine
p.002006: Council for Health Research and Development.
p.002006:
p.002006: Imelda B. Mutuc and Guidditta L. Gelera of the Philippine Council for Health Research and Development, and Adelaida
p.002006: P. Mendoza of the Department of Health provided critical organizational and coordinative support in all stages
p.002006: of this project. The editorial assistance of Saniata P. Masulit has been invaluable.
p.002006:
p.002006: Finally, the ultimate credit must be given to all those who actively participated and gave insightful comments and
p.002006: suggestions during the roundtable discussions and consultations and, thus, helped make this set of guidelines
p.002006: appropriate to Philippine health research.
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: vi
p.002006:
p.002006: Page
p.002006: TABLE OF CONTENTS vii
p.002006: Foreword
p.002006: Estrella F. Alabastro, Ph.D. iii
p.002006: Message
p.002006: Francisco T. Duque III, MD, M.Sc iv
p.002006: Acknowledgments v
p.002006: How to Use the Guidelines viii
p.002006: Abbreviations
p.002006: x
...
p.000002: The NEC was created to ensure that all health research and development proposals conformed with ethical standards.
p.000002: It also promoted the establishment of ethics review committees in various localities and institutions.
p.000002:
p.000002: In 2003, the Philippine National Health Research System (PNHRS) led to the creation of the Philippine Health Research
p.000002: Ethics Board (PHREB), a national policymaking body on health research ethics. In the different regions, policymaking
p.000002: boards shall also be established as Regional Health Research Ethics Boards.
p.000002:
p.000002:
p.000002: The Philippine Health Research Ethics Board (PHREB)
p.000002:
p.000002: Composition The Philippine Health Research Ethics Board has
p.000002: 13 members, including two ex-officio members: the Department of Science and Technology (DOST)-PCHRD Executive
p.000002: Director, and the Department of Health (DOH) Research Ethics Committee Chair. Except for the ex-officio
p.000002: members, appointments shall be for a term of three years (initially, however, five were appointed for three
p.000002: years, and six members for two years). The members represent a balance of background, gender, and disciplines (e.g.,
p.000002: health research,
p.000002:
p.000003: 3
p.000003:
p.000003: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000003:
p.000003: philosophy, law, academe, medicine, public health/ epidemiology, theology, social science, allied health
p.000003: sciences, people’s organizations, and the youth). The Chair and Co-Chair have two-year terms.
p.000003:
p.000003: Functions PHREB shall have the following functions:
p.000003:
p.000003: 1. Formulate/Update guidelines for the ethical conduct of human health research;
p.000003:
p.000003: 2. Develop guidelines for the establishment and management of ethics review committees and standardization of
p.000003: research ethics review;
p.000003:
p.000003: 3. Monitor and evaluate the performance of institutional ethics review committees in accordance with procedures
p.000003: outlined in a prior agreement;
p.000003:
p.000003: 4. Promote the establishment of functional and effective ethics review committees;
p.000003:
p.000003: 5. Provide advice and make recommenda- tions to the PNHRS Governing Council and other appropriate entities
p.000003: (including the Bureau of Food and Drugs [BFAD]) regarding programs, policies, and regula- tions as they relate to
p.000003: ethical issues in human health research;
p.000003:
p.000003: 6. Initiate and contribute to discourse and discussions of ethical issues in human health research; and
p.000003:
p.000003: 7. Network with relevant local, national, and international organizations.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000004:
...
p.000005:
p.000005: Data from a recent survey of local institutions conducted by the Philippine National Health Research System Technical
p.000005: Working Group on Ethics (2003-04) show that only 50 percent of these institutions have an IERC (Reyes, 2004). Of the 80
p.000005: reported IERCs in the country, almost half (36) are in the National Capital Region. Lack of training in research ethics
p.000005: was cited as a major flaw of many IERCs. The efforts of DOST-PCHRD, DOH, and University of the Philippines
p.000005: Fogarty Group in organizing intensive training courses in research ethics may answer the need for capacity building
p.000005: in this field.
p.000005:
p.000005: Standardization of ethics review is an area of concern that the IERC should address. In this regard, the IERC may use
p.000005: as references the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (2000), and
p.000005: the 2006 General Ethical Guidelines for Health Research (pp16-29). However, it should develop a manual of standard
p.000005: operating procedures.
p.000005:
p.000005: Composition 1. The membership of the institutional ethics review
p.000005: committee should be multidisciplinary and multisectoral, including the relevant expertise, e.g., medicine and
p.000005: research, theology, social or behavioral science, law, philosophy, environmental science, and public
p.000005: health. It is recommended that the IERC should include a person without disciplinal constraints who will
p.000005: represent the interests and concerns of the
p.000005:
p.000006: 6
p.000006:
p.000006: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000006:
p.000006: community. At least one member should be independent of the institution or research site. The IERC should have
p.000006: at least five members and should consider age and gender distribution.
p.000006:
p.000006: 2. In addition to the committee members, there should be adequate support staff for carrying out the IERC’s
p.000006: responsibilities.
p.000006:
p.000006: Appointment 3. The officers and members of the IERC shall be
p.000006: officially appointed by the administrative head of the institution.
p.000006:
p.000006: 4. The appointing official shall indicate their functions, terms of office, scope of work, conditions of
p.000006: appointment, and compensation, if any.
p.000006:
p.000006: 5. Procedures for renewal of appointment, resignation, replacement; grounds for disqualification;
p.000006: and procedures in regard to conflict of interest due to financial gains shall be included in the manual of
p.000006: standard operating procedures.
p.000006:
p.000006: 6. Prior to serving as a regular member, each member of the IERC shall sign a disclosure document which
p.000006: states that he/she has no conflict of interest (e.g., financial interests in a pharmaceutical company) as a
p.000006: reviewer, and a confidentiality agreement.
p.000006:
...
p.000087:
p.000087: social and behavioral research – study undertaken on a systematic and rigorous basis to generate new knowledge
p.000087: regarding he impact of sociological, psychological, anthropological and other social factors on health and well being
p.000087:
p.000088: 88
p.000088:
p.000088: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000088:
p.000088: Critical Perspective
p.000088: This perspective is recursive and focused on bringing about change in practices. Researchers utilizing this
p.000088: perspective generally have an agenda for social change. Studies under this perspective begin with an important
p.000088: stance about social issues and is aimed at creating political debate and discussion to bring about change. It
p.000088: is practical and collaborative
p.000088:
p.000088: Interpretive perspective
p.000088: This perspective holds that in seeking to understand their world, people develop subjective meanings of their
p.000088: experiences which are varied and multiple. The researcher then looks into the complexity of views rather than reducing
p.000088: them to a few ideas. Open-ended questions suit this perspective. Historical and social contexts are important to
p.000088: consider. The assumption is that the basic generation of meaning is always social resulting from the interaction within
p.000088: social groups.
p.000088:
p.000088: Positivist perspective
p.000088: This is sometimes referred to as the “scientific method” and is likewise called quantitative research, empirical
p.000088: science or postivist/postpositivist research. This reflects a deterministic philosophy which says that causes probably
p.000088: determine effects or outcomes. It is reductionistic because it reduces ideas into discrete sets to test in hypotheses
p.000088: and research questions. It utilizes careful observation and measurement of objective reality. Most of research in this
p.000088: perspective starts with test of a theory.
p.000088:
p.000088: Social Research
p.000088: Social research covers a broad range of disciplines and perspectives. Sociology, anthropology, political science,
p.000088: economics, psychology, population studies, history, geography and linguistics are specific areas within social science
p.000088: which are directly concerned with health issues. Interdisciplinary social research involves two or more of these
p.000088: disciplines utilizing both quantitative and qualitative approaches which are consistent with either positivist
p.000088: interpretive or critical perspectives.
p.000088:
p.000088: sponsor – an individual, a company, an institution or an organization which take responsibility for the initiation,
p.000088: management and/or financing of a clinical trial (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical
p.000088: Practice [E6, R1])
p.000088:
p.000088: – an individual, company, institution or organization that takes responsibility fort eh initiation,
p.000088: management and /or financing of a research project
p.000088:
p.000088: – an individual, a company, an institution or an organization that takes
p.000088:
p.000089: 89
p.000089:
p.000089: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000089:
p.000089: responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates
p.000089: and takes full for a trial, the investigator then also assumes the role of the sponsor responsibility (WHO
...
p.000102: Signature
p.000102:
p.000102: 10. Date:
p.000102:
p.000102:
p.000103: 103
p.000103:
p.000103: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000103:
p.000103: APPENDIX C
p.000103: List of Documents that the Proponent/s Should Provide the Ethics Review Committee
p.000103:
p.000103: 1) Ten (10) copies of the final protocol and, if applicable, amendments
p.000103:
p.000103: 2) Ten (10) copies of informed consent (written in English and Filipino or dialect spoken and understood by research
p.000103: participants)
p.000103:
p.000103: 3) Ten (10) copies of Information Sheet (written in English and Filipino or dialect spoken and understood by research
p.000103: participants)
p.000103:
p.000103: 4) Curriculum vitae of project investigator/s
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000104: 104
p.000104:
p.000104: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000104:
p.000104: APPENDIX D NATIONAL ETHICS COMMITTEE
p.000104:
p.000104: Chair
p.000104:
p.000104: MARITA V.T. REYES, M.D.
p.000104: Professor, Department of Biochemistry and Molecular Biology College of Medicine, UP-Manila
p.000104:
p.000104:
p.000104: Members
p.000104:
p.000104: LEONARDO D. DE CASTRO, Ph.D.
p.000104: Professor, Department of Philosophy UP Diliman
p.000104:
p.000104: MILAGROS L. FERNANDEZ, M.D.
p.000104: Undersecretary Department of Health
p.000104:
p.000104: JAIME C. MONTOYA, M.D., M.Sc.
p.000104: Executive Director
p.000104: Philippine Council for Health Research and Development
p.000104:
p.000104: FILIPINAS F. NATIVIDAD, Ph.D.
p.000104: Assistant Vice-President and Director Research and Biotechnology Division St. Luke’s Medical Center
p.000104:
p.000104: ARSENIO C. PASCUAL, M.D. Ll.B
p.000104: General Surgeon and Attorney-at-Law Professor, Legal Medicine and Medical Jurisprudence
p.000104:
p.000104: PACITA R. SALCEDA, M.D.
p.000104: Makati Medical Center
p.000104:
p.000104: FR. DANILO C. TIONG
p.000104: Professor, Bioethics Department
p.000104: Dela Salle University Health Sciences Center
p.000104:
p.000104: BENJAMIN C. VITASA, M.D., M.P.H., Ph.D.
p.000104: Professor, Department of Environmental and Occupational Health College of Public Health, UP-Manila
p.000104:
p.000104:
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000105:
p.000105: APPENDIX E
p.000105: PHILIPPINE HEALTH RESEARCH ETHICS BOARD
p.000105:
p.000105: Chair
p.000105: MARITA V.T. REYES, M.D.
p.000105: Health Research
p.000105:
p.000105: Co-Chair
p.000105: LEONARDO D. DE CASTRO, Ph.D.
p.000105: Philosophy
p.000105:
p.000105:
p.000105: Members
p.000105:
p.000105: MARIA ARLISSA D. AGUILUZ, D.M.D.
p.000105: Allied Health
p.000105:
p.000105: ABDULRAHIM M. BAGUNDANG
p.000105: Youth
p.000105:
p.000105: GILBERT P. HOGGANG, D.V.M.
p.000105: People’s Organization
p.000105:
p.000105: ROMEO INTENGAN, S.J.
p.000105: Theology
p.000105:
p.000105: JAIME C. MONTOYA, M.D., M.Sc.
p.000105: Executive Director, PCHRD (Ex-officio)
p.000105:
p.000105: ALBERT D. REBOSA, M.D., Ll.B.
p.000105: Law
p.000105:
p.000105: ANGELES TAN-ALORA, M.D.
p.000105: Academe
p.000105:
p.000105: MA. CARMEN C. TOLABING, Ph.D.
p.000105: Public Health/Epidemiology
p.000105:
p.000105: CECILIA V. TOMAS, M.D.
p.000105: Medicine
p.000105:
p.000105: CRISPINITA A. VALDEZ
p.000105: Chair, DOH-Research Ethics Committee (Ex-officio)
p.000105:
p.000105: ELIZABETH R. VENTURA, Ph.D.
p.000105: Social Science
p.000105:
p.000106: 106
p.000106:
p.000106: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.002006: International Declaration on Human Genetic Data, the Council for International Organizations of Medical Sciences,
p.002006: UNAIDS, and the Declaration of Helsinki.
p.002006:
p.002006: Written in simple, concise, and reader-friendly style, the 2006 National Ethical Guidelines for Health Research will
p.002006: hopefully encourage more studies conducted by Filipinos on local health concerns, thereby addressing the problem of
p.002006: under-representation of the Philippines in high-impact general medical journals, which is another key ethical issue in
p.002006: health research.
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: Estrella F. Alabastro, Ph. D.
p.002006: Secretary
p.002006: Department of Science and Technology 23 June, 2006
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: iii
p.002006:
p.002006:
p.002006: Republic of the Philippines Department of Health
p.002006: OFFICE OF THE SECRETARY
p.002006: MANILA, PHILIPPINES
p.002006: Tel Nos. (632) 743-83-01 local 1107,1111
p.002006: MESSAGE
p.002006:
p.002006: The landscape of health research has immensely changed with the explosion of new information, the ease of exchange of
p.002006: scientific knowledge, and information technology (IT) that allows for the quick and downloadable access of the outputs
p.002006: of research. There are also challenges being posed by new ethical considerations such as in balancing the need to shed
p.002006: light to emerging public health threats, which especially hit low-income populations against human rights not to be
p.002006: misused when these poor people are chosen as research subjects We must therefore adapt with the times and revolutionize
p.002006: ways in which we conduct local research by becoming more responsive to these scientific, technological, and
p.002006: social advances.
p.002006:
p.002006: The Philippine Health Research Ethics Board (PHREB) under the Philippine National Health Research System (PNHRS) is now
p.002006: bringing out the updated National Ethical Guidelines for Health Research in response to these changing needs. This is
p.002006: indeed a welcome development for the DOH as we continuously seek better information and evidence and explore new ways,
p.002006: approaches, and technologies, which can enhance the performance of the entire health system. Critical reform strategies
p.002006: on service delivery, regulation, financing, and governance under the Fourmula 1 for Health implementation strategy
p.002006: shall surely benefit from these developments as we devote ourselves more to conducting researches built on a foundation
p.002006: of public trust, scientific integrity, and social responsibility.
p.002006:
p.002006: While we accelerate our actions for health through speedier ways of testing new drugs, tools, strategies, and
p.002006: approaches in health research, we must all take care to uphold the values associated with ethical research conduct. We
p.002006: need to safeguard the rights of the participants, particularly those who are vulnerable or disadvantaged. The national
p.002006: guidelines shall ensure that more research institutions and researches from the biomedical and behavioral
p.002006: fields of discipline will be able to support and protect the dignity and rights of the human person as a research
...
p.000081:
p.000081: moral agent – a sentient individual whose acts impact on others and are affected by the act of others
p.000081:
p.000081: multicenter trial – a clinical trial conducted according to a single protocol but at more that one site, and
p.000081: therefore, carried out by more than one investigator (ICH Harmonized Tripartite Guideline, General
p.000081: Considerations for Clinical Trial (E8)
p.000081:
p.000081: multifactorial inheritance – heredity characterized by the involvement of several genes and environmental factors
p.000081:
p.000081: mutagenicity – the capacity of a chemical or physical agent to cause genetic alterations
p.000081:
p.000081: national health care delivery system – the total structures – private and public organizations, agencies, and
p.000081: individuals, including policies and mechanisms
p.000081: – that provide health care to individuals and communities in the country
p.000081:
p.000081:
p.000082: 82
p.000082:
p.000082: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000082:
p.000082: National Unified Health Research Agenda (NUHRA) – national health research priorities identified by major stakeholders
p.000082:
p.000082: non-disclosure of data – the withholding of or refusal to reveal information derived from research
p.000082:
p.000082: non-invasive procedure – biological sampling using a method which does not involve intrusion into the human body (e.g.,
p.000082: oral smears)
p.000082:
p.000082: North-South research collaboration – in the broad sense, would refer to the relationship or interaction between the
p.000082: developed and developing countries or rich and poor countries
p.000082:
p.000082: participatory research – research that involves the participation of the investigator in the activities of the research
p.000082: population. It could also involve involves research subjects in the definition of the research agenda, the conduct of
p.000082: research, monitoring and evaluation, and dissemination of results.
p.000082:
p.000082: patent – government instrument that assigns ownership of a product or creative work that is accompanied by certain
p.000082: rights
p.000082: pharmacodynamics – the study of what a drug does to the body pharmacogenetics – the field of biochemical genetics
p.000082: concerned with drug
p.000082: responses due to genetically-controlled variations
p.000082:
p.000082: pharmacokinetics – the study of what the body does to a drug
p.000082:
p.000082: Phase I clinical trial – the first trials of a new active ingredient or new formulations in man, often carried out
p.000082: in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a first outline of
p.000082: the pharmacokinetic and, where possible, a phramacodynamic profile of the active ingredients in humans. (WHO,
p.000082: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000082: Phase II clinical trial –trials performed in a limited number of subjects, often at a later stage of a comparative
p.000082: (e.g., placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and assess short-term safety of
...
Searching for indicator poverty:
(return to top)
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
p.000049: violence. The severe stress on these populations may have lingering physical, social, and psychological consequences,
p.000049: including chronic poverty, deprivation of basic needs, violation of basic rights, vulnerability, and a profound
p.000049: sense of hopelessness and disempowerment.
p.000049:
p.000049: Research involving traumatized populations must be guided by principles applicable to the practice of humanitarian
p.000049: assistance in general and work with vulnerable groups in particular. Of relevance are universal humanitarian
p.000049: imperatives of alleviating human suffering, preserving human dignity as well as protecting and respecting
p.000049: human rights regardless of race, creed, nationality or political belief. More specifically, work with traumatized
p.000049: populations must place special attention on the unique needs and special concerns of survivors, including those
p.000049: of specific cultural, racial, and ethnic group members, so that services and opportunities are appropriate and
p.000049: acceptable to these individuals (where feasible and appropriate to the study question). Issues of possible repeat
p.000049: traumatization and potential risks (e.g., stigmatization and reprisals) for the study population should likewise be
p.000049: fully addressed.
p.000049:
p.000049: These guidelines address the following issues: the potential for harm resulting from the research process and its
...
p.000088: management and /or financing of a research project
p.000088:
p.000088: – an individual, a company, an institution or an organization that takes
p.000088:
p.000089: 89
p.000089:
p.000089: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000089:
p.000089: responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates
p.000089: and takes full for a trial, the investigator then also assumes the role of the sponsor responsibility (WHO
p.000089: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000089:
p.000089: standard of care – health care intervention or regimen that is generally accepted by health practitioners and experts
p.000089: as beneficial to an individual needing such care
p.000089:
p.000089: prophylactic – professionally accepted level and type of preventive management to prevent the occurrence
p.000089: of a particular health condition
p.000089:
p.000089: diagnostic – professionally accepted level and type of examination to determine a patient’s health condition
p.000089:
p.000089: therapeutic – professionally accepted level and type of treatment or assistance for a particular health condition
p.000089:
p.000089: stem cell research – the study of the properties, development, and transformation of primordial progenitor cells prior
p.000089: to establishment of specialized cells
p.000089:
p.000089: stigma – the negative regard (e.g., shame and dishonor) of the community or society to particular groups because of
p.000089: disability, illness, occupation, poverty, etc. as dictated by culture
p.000089:
p.000089: study/investigational product – a pharmaceutical form of an active ingredient or placebo being tested or used as a
p.000089: reference in a clinical trial, including a product with marketing authorization when used or assembled
p.000089: (formulated or packaged) in a way different from the approved form, or when used fro an unapproved indication, or when
p.000089: used to gain further information about an approved use (ICH Harmonized Tripartite Guideline, Guideline for Good
p.000089: Clinical Practice [E6,R1])
p.000089:
p.000089: susceptibility – genetic condition leading to the development of a disease technical review – see scientific review
p.000089: teratogenicity – the degree or measure of the ability to cause malformations of an embryo or fetus
p.000089:
p.000089: termination of the research – the research study may be ended before its scheduled completion when the safety or
p.000089: benefit of the study participants is doubtful or at risk.
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
...
Searching for indicator low-income:
(return to top)
p.002006: identified issues/topics that are commonly addressed by the four international ethics guidelines, namely the
p.002006: International Declaration on Human Genetic Data, the Council for International Organizations of Medical Sciences,
p.002006: UNAIDS, and the Declaration of Helsinki.
p.002006:
p.002006: Written in simple, concise, and reader-friendly style, the 2006 National Ethical Guidelines for Health Research will
p.002006: hopefully encourage more studies conducted by Filipinos on local health concerns, thereby addressing the problem of
p.002006: under-representation of the Philippines in high-impact general medical journals, which is another key ethical issue in
p.002006: health research.
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: Estrella F. Alabastro, Ph. D.
p.002006: Secretary
p.002006: Department of Science and Technology 23 June, 2006
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: iii
p.002006:
p.002006:
p.002006: Republic of the Philippines Department of Health
p.002006: OFFICE OF THE SECRETARY
p.002006: MANILA, PHILIPPINES
p.002006: Tel Nos. (632) 743-83-01 local 1107,1111
p.002006: MESSAGE
p.002006:
p.002006: The landscape of health research has immensely changed with the explosion of new information, the ease of exchange of
p.002006: scientific knowledge, and information technology (IT) that allows for the quick and downloadable access of the outputs
p.002006: of research. There are also challenges being posed by new ethical considerations such as in balancing the need to shed
p.002006: light to emerging public health threats, which especially hit low-income populations against human rights not to be
p.002006: misused when these poor people are chosen as research subjects We must therefore adapt with the times and revolutionize
p.002006: ways in which we conduct local research by becoming more responsive to these scientific, technological, and
p.002006: social advances.
p.002006:
p.002006: The Philippine Health Research Ethics Board (PHREB) under the Philippine National Health Research System (PNHRS) is now
p.002006: bringing out the updated National Ethical Guidelines for Health Research in response to these changing needs. This is
p.002006: indeed a welcome development for the DOH as we continuously seek better information and evidence and explore new ways,
p.002006: approaches, and technologies, which can enhance the performance of the entire health system. Critical reform strategies
p.002006: on service delivery, regulation, financing, and governance under the Fourmula 1 for Health implementation strategy
p.002006: shall surely benefit from these developments as we devote ourselves more to conducting researches built on a foundation
p.002006: of public trust, scientific integrity, and social responsibility.
p.002006:
p.002006: While we accelerate our actions for health through speedier ways of testing new drugs, tools, strategies, and
p.002006: approaches in health research, we must all take care to uphold the values associated with ethical research conduct. We
p.002006: need to safeguard the rights of the participants, particularly those who are vulnerable or disadvantaged. The national
p.002006: guidelines shall ensure that more research institutions and researches from the biomedical and behavioral
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000018: complications associated with the
p.000018:
p.000019: 19
p.000019:
p.000019: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000019:
p.000019: research, the nature and duration of such care, the name of the organization or individual that will provide the
p.000019: treatment, and whether there is any uncertainty regarding funding of such treatment;
p.000019:
p.000019: x. In what way, and by what organization the subject or the subject’s family or dependents will be
p.000019: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to
p.000019: provide such compensation);
p.000019:
p.000019: y. That an ethics review committee has approved or cleared the research protocol (Guideline 5
p.000019: – CIOMS, 2002).
p.000019:
p.000019: 3. After ensuring that the subject has understood the information, the physician should then obtain the
p.000019: subject’s freely given informed consent, preferably in writing. If the consent cannot be obtained in
p.000019: writing, the non-written consent must be formally documented and witnessed (Principle 22 – Declaration of Helsinki,
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
p.000019: 5. The participation of children in research requires extra protection, as children cannot volunteer to participate
p.000019: in a research study in the same way as an adult can. While they cannot give informed consent, they can participate in
p.000019: the process of
p.000019:
p.000020: 20
p.000020:
p.000020: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000020:
p.000020: obtaining consent by being asked for their assent to participate. When appropriate, both a child’s assent and the
p.000020: parent’s or guardian’s permission should be obtained prior to enrolling a child in a research study.
p.000020:
p.000020: 6. In obtaining informed consent, sponsors and investigators have a duty to:
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000073: to form up to fetal stage
p.000073:
p.000073: epidemiologic research – investigative studies intended to establish “the distribution and determinants of
p.000073: disease frequency in human populations”
p.000073:
p.000073: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the determinants of the
p.000073: incidence of diseases as well as their related risk factors, etiology and causation
p.000073:
p.000073: epidemiology – the basic medical science that focuses on the distribution and determinants of disease frequency in
p.000073: human populations (Raymond Greenberg, Medical Epidemiology, 1993)
p.000073:
p.000074: 74
p.000074:
p.000074: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000074:
p.000074: ethical clearance – a certification that a research proposal has complied with ethical requirements
p.000074:
p.000074: – action of an ethics review committee on a research protocol that signifies approval and permission to proceed with
p.000074: the research.
p.000074:
p.000074: ethical principles – rules or codes conforming to accepted professional standards of conduct (Merriam-Webster’s
p.000074: Dictionary of Law (c) 1996)
p.000074:
p.000074: – usually refer to the ex prima facie universal principles of respect for persons, beneficence, non-maleficence and
p.000074: justice
p.000074:
p.000074: respect for persons – involves a recognition of the personal dignity and autonomy of individuals, and special
p.000074: protection of those persons with diminished autonomy (Institutional Review Board Guidebook, US Department of
p.000074: Health and Human Services http://kartero.pchrd.dost.gov.ph
p.000074: /horde/utilgo.php?url=http%3A%2F%2Fwww.hhs.gov%2Fohrp% 2Firb%2Firb_introduction.htm &Horde=85a91621422a63bcc765
p.000074: ef05290c2baf )
p.000074:
p.000074: beneficence – the quality or state of doing or producing good especially performing acts of kindness and charity
p.000074: (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000074:
p.000074: – the requirement to serve the interests and well being of others, including respect for their rights. It
p.000074: is the principle of doing good in the widest sense (http://kartero.pchrd.dost.gov.ph/horde/util/
p.000074: go.php?url=http%3A%2F%2Fwww.arts.ac.2FCode_of_Practice_on_Research_ Ethics.pdf&Horde=85a91621422a63bcc765ef05290c2baf )
p.000074:
p.000074: – is the professional duty to do or produce good. By “good” is meant the performance of acts of kindness and
p.000074: charity (http://kartero. pchrd.dost.gov.ph/horde/util/go.php?url=http%3A%2F%2F health.enotes.com%2Fpublic health
p.000074: encyclopedia&Horde= 85a91621422a63bcc765 ef05290c2baf)
p.000074:
p.000074: – entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing anticipated
p.000074: benefits and minimizing possible risks of harm. (Institutional Review Board Guidebook, US Department of Health
p.000074: and Human Services http://kartero.pchrd.dost.gov.ph
p.000074: /horde/util/go.php?url= http%3A%2F%2Fwww.hhs.gov%2Fohrp%2
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000046: degree of data protection, especially in
p.000046: situations where data are used without personal consent. A working standard for data protection that secures as little
p.000046: risk of disclosure as possible should be developed.
p.000046:
p.000046: Information 13. Important findings from the research should be shared with made available to
p.000046: all the participants in a suitable participants form.
p.000046:
p.000046: Compensation 14. Compensation commensurate to the time given for participants and effort exerted by
p.000046: participation is encouraged
p.000046: while taking care not to use this as a form of coercion.
p.000046:
p.000047: 47
p.000047:
p.000047:
p.000047:
p.000047: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000047:
p.000047: ETHICAL GUIDELINES FOR SOCIAL AND BEHAVIORAL RESEARCH
p.000047:
p.000047: Introduction
p.000047:
p.000047: Social and behavioral research necessarily involves individuals, groups, organizations or societies, and for a great
p.000047: part are conducted in the field. There are several perspectives that one may bring to bear on such research:
p.000047: positivist, interpretive, or critical (see Glossary, pp.88-89). Regardless of the preferred perspective of an
p.000047: individual researcher, social and behavioral research involves the basic dilemma of balancing the pursuit of valid
p.000047: knowledge and concerns for the participants’ rights for privacy as well as preserving their integrity, dignity, and
p.000047: autonomy.
p.000047:
p.000047: The guidelines below are consistent with existing ones on research on human subjects but are made more specific for
p.000047: social research.
p.000047:
p.000047: General 1. All research involving human subjects should be
p.000047: guidelines conducted in accordance with the ethical
p.000047: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000047:
p.000047: Special guidelines
p.000047:
p.000047: Informed 2. Informed consent shall be obtained, with the consent possible
p.000047: exception of research involving archival work, participant observation, and observation in
p.000047: public places. The researcher shall inform his/ her participants as to the nature of the research and obtain verbal
p.000047: or written consent. Verbal consent must be attested to in the absence of a written consent. Coercion in any form
p.000047: may not be used to force individuals to participate. If participants are minors, consent of the parent/
p.000047: guardian must be obtained. Assent of the minor must also be obtained, properly documented, and attested to by an
p.000047: impartial witness of legal age.
p.000047:
...
p.000073:
p.000073: embryo – the stage of human development following implantation (starting 10- 14 days), when the primitive streak begins
p.000073: to form up to fetal stage
p.000073:
p.000073: epidemiologic research – investigative studies intended to establish “the distribution and determinants of
p.000073: disease frequency in human populations”
p.000073:
p.000073: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding the determinants of the
p.000073: incidence of diseases as well as their related risk factors, etiology and causation
p.000073:
p.000073: epidemiology – the basic medical science that focuses on the distribution and determinants of disease frequency in
p.000073: human populations (Raymond Greenberg, Medical Epidemiology, 1993)
p.000073:
p.000074: 74
p.000074:
p.000074: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000074:
p.000074: ethical clearance – a certification that a research proposal has complied with ethical requirements
p.000074:
p.000074: – action of an ethics review committee on a research protocol that signifies approval and permission to proceed with
p.000074: the research.
p.000074:
p.000074: ethical principles – rules or codes conforming to accepted professional standards of conduct (Merriam-Webster’s
p.000074: Dictionary of Law (c) 1996)
p.000074:
p.000074: – usually refer to the ex prima facie universal principles of respect for persons, beneficence, non-maleficence and
p.000074: justice
p.000074:
p.000074: respect for persons – involves a recognition of the personal dignity and autonomy of individuals, and special
p.000074: protection of those persons with diminished autonomy (Institutional Review Board Guidebook, US Department of
p.000074: Health and Human Services http://kartero.pchrd.dost.gov.ph
p.000074: /horde/utilgo.php?url=http%3A%2F%2Fwww.hhs.gov%2Fohrp% 2Firb%2Firb_introduction.htm &Horde=85a91621422a63bcc765
p.000074: ef05290c2baf )
p.000074:
p.000074: beneficence – the quality or state of doing or producing good especially performing acts of kindness and charity
p.000074: (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000074:
p.000074: – the requirement to serve the interests and well being of others, including respect for their rights. It
p.000074: is the principle of doing good in the widest sense (http://kartero.pchrd.dost.gov.ph/horde/util/
p.000074: go.php?url=http%3A%2F%2Fwww.arts.ac.2FCode_of_Practice_on_Research_ Ethics.pdf&Horde=85a91621422a63bcc765ef05290c2baf )
p.000074:
p.000074: – is the professional duty to do or produce good. By “good” is meant the performance of acts of kindness and
p.000074: charity (http://kartero. pchrd.dost.gov.ph/horde/util/go.php?url=http%3A%2F%2F health.enotes.com%2Fpublic health
p.000074: encyclopedia&Horde= 85a91621422a63bcc765 ef05290c2baf)
p.000074:
p.000074: – entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing anticipated
p.000074: benefits and minimizing possible risks of harm. (Institutional Review Board Guidebook, US Department of Health
p.000074: and Human Services http://kartero.pchrd.dost.gov.ph
p.000074: /horde/util/go.php?url= http%3A%2F%2Fwww.hhs.gov%2Fohrp%2
p.000074: Firb%2Firb_introduction.htm&Horde=85a91621422a63bcc765ef05290c2 baf )
p.000074:
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
p.000100: • Will there be risks? Are these explained fully?
p.000100: • Are there other effects the participants need to know in order to make a decision?
p.000100:
p.000100: Possible benefits for the participants
p.000100: • What benefits can the participants expect?
p.000100:
p.000100: Compensation
p.000100: • Will there be reimbursement of travel expenses? Compensation for loss of income? Meal expenses?
p.000100: • Are there other financial considerations?
p.000100:
p.000100: Provision for injury or related illness
p.000100: • Will the participant be given free treatment in case of injury or illness incurred as a result of participating
p.000100: in the study?
p.000100:
p.000100: Contact person
p.000100: • Who is the person knowledgeable about the research and rights of the participant? How can he/she be contacted?
p.000100:
p.000100: Voluntariness of participation
p.000100: • Is the participant free of any coercion in participating?
p.000100: • Is there assurance that the participant can withdraw anytime without affecting treatment/care due him/her?
p.000100: • Is there provision for obtaining the informed consent from the legal
p.000100:
p.000101: 101
p.000101:
p.000101: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000101:
p.000101: representative in case of minors, the mentally handicapped or the incapacitated?
p.000101:
p.000101: Confidentiality
p.000101: • Is there a statement that describes the measures that will be taken to keep and ensure the confidentiality of the
p.000101: participant’s records?
p.000101:
p.000101:
p.000101: CONSENT FORM
p.000101:
p.000101: I have read and understood the above information and had been given the opportunity to consider and ask questions on
p.000101: the information regarding the involvement in this study. I have spoken directly to my doctor who has answered to my
p.000101: satisfaction all my questions. I have received a copy of this Patient Information and Informed Consent Form.
p.000101: I voluntarily agree to participate.
p.000101:
p.000101:
p.000101:
p.000101: Patient’s Signature:
p.000101:
p.000101:
p.000101:
p.000101: Name of Patient Signature of Patient Date
p.000101:
p.000101:
p.000101: Witness or Legal Guardian’s Signature:
p.000101: (Only when patient cannot read or sign this Informed Consent)
p.000101:
p.000101:
p.000101:
p.000101: Name of Witness/ Signature of Witness/ Date Legal Guardian Legal
p.000101: Guardian
p.000101:
p.000101:
p.000101: Physician’s Signature:
p.000101:
p.000101: I, the undersigned, certify that to the best of my knowledge, the patient signing this consent form has read the above
p.000101: information sheet fully, that this has been carefully explained to him/her, and that he/she clearly understands the
p.000101: nature, risks, and benefits of his/her participation in this study.
p.000101:
p.000101:
p.000101:
p.000101:
...
General/Other / Other Country
Searching for indicator foreign country:
(return to top)
p.000063: To achieve the goals of effective collaborative health researches between North and South, the following
p.000063: guidelines must be given utmost consideration (Swiss Commission for Research Partnership with Developing
p.000063: Countries, 1998):
p.000063:
p.000063: 1. Decide on the objectives together;
p.000063: 2. Build up mutual trust;
p.000063:
p.000064: 64
p.000064:
p.000064:
p.000064:
p.000064: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000064:
p.000064: 3. Share information and develop networks;
p.000064: 4. Share responsibility;
p.000064: 5. Create transparency;
p.000064: 6. Monitor and evaluate the collaboration;
p.000064: 7. Disseminate the results;
p.000064: 8. Apply the results;
p.000064: 9. Share the profits equitably;
p.000064: 10. Increase research capacity; and
p.000064: 11. Build on achievements.
p.000064:
p.000064: Finally, the above considerations should result into a clear agreement on the conduct of collaborative research
p.000064: including data management and research outputs (e.g., storage and utilization of data, publication strategy, dispute
p.000064: settlement, nature of benefits and their distribution) (South African Medical Research Council, 2005).
p.000064:
p.000064: General 1. All research involving human subjects should be
p.000064: guidelines conducted in accordance with the ethical
p.000064: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000064:
p.000064: Special 2. Research approved for implementation by an ethics
p.000064: guidelines review committee (ERC) in a foreign country must
p.000064: also be subjected to ethics review in the country of implementation. When the research is intended for implementation
p.000064: in several communities, the ERC that has jurisdiction over a particular community has the right to conduct its
p.000064: own review before giving approval for the research to be carried out.
p.000064:
p.000064: 3. There shall be clear agreements on all aspects of the research. These include intellectual property
p.000064: sharing, management of the research process, division of responsibilities, finances, spreading of benefits
p.000064: and burdens and other appropriate aspects.
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000065: 65
p.000065:
p.000065: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000065:
p.000065: GUIDELINES ON AUTHORSHIP AND PUBLICATION
p.000065:
p.000065:
p.000065: The publication of research results gives rise to ethical problems and controversies when there are ambiguities
p.000065: regarding credit for authorship and uncertainty on the responsibility for various aspects of the research and the
p.000065: subsequent publication. These ambiguities and uncertainties have made it imperative for the Philippine Health Research
p.000065: Ethics Board to provide guidelines to clarify when researchers may be recognized as authors, and to elucidate the scope
p.000065: of their accountability.
p.000065:
p.000065:
p.000065: Authorship 1. All qualified authors must be given due recognition
p.000065: by being included in the list of authors.
p.000065:
p.000065: 2. Scientists may be listed as authors of a scientific paper only if they have made substantive intellectual
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000010: comment, guidance, and approval.
p.000010:
p.000010: The review must be transparent, timely, and reasonable. Each ethics review committee shall indicate a time frame for
p.000010: completing the review process, and provide the proponent initial feedback within four weeks after receipt of the
p.000010: complete documents.
p.000010:
p.000010: Required 1. The research investigator/proponent shall be documents required to
p.000010: submit the following documents:
p.000010:
p.000010: a. Application for review;
p.000010:
p.000010: b. Research protocol that includes the title of the proposal, background of the study, rationale, objectives,
p.000010: research design, inclusion and exclusion criteria, and safety information. (For general guidelines on the research
p.000010: protocol, refer to the General Ethical Guidelines for Health Research on pp16-29);
p.000010:
p.000010: c. Written information to be provided the participants, which shall include the objectives and significance of
p.000010: the research; the nature of their participation; their rights, privileges, and obligations; the risks involved; and
p.000010: benefits, including payment of trial-related expenses;
p.000010:
p.000010: d. Written informed consent in English, together with the translation in Filipino or any dialect understandable to
p.000010: the participants (see Informed Consent in the General Ethical Guidelines for Health Research. For a template on
p.000010: informed consent see Appendix A);
p.000010:
p.000010: e. Safety information (e.g., safety precautions, contact persons in emergency situations or
p.000010:
p.000011: 11
p.000011:
p.000011: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000011:
p.000011: adverse events, contact telephone numbers);
p.000011:
p.000011: f. Procedure for participant recruitment, including advertisements;
p.000011:
p.000011: g. A section on ethical considerations (e.g., anticipated risks and why they are outweighed by potential
p.000011: benefits, how the risks will be minimized, how confidentiality of data and privacy of participants are
p.000011: going to be protected);
p.000011:
p.000011: h. Investigators’ qualifications (e.g., curriculum vitae). If a conflict of interest exists, the investigator
p.000011: shall formally disclose this; and
p.000011:
p.000011: i. Information regarding funding, sponsors, institutional affiliations, other potential conflict of interest, and
p.000011: compensation for the subjects.
p.000011:
p.000011:
p.000011: Review 2. The ERC should have a standard operating procedure process that
p.000011: should be made available to the
p.000011: researchers and stakeholders. It is advisable for the ethics review committee to have a standard application form
p.000011: (Appendix B).
p.000011:
p.000011: 3. The ERC Chairperson shall schedule a research review meeting reasonably within four weeks after submission of the
p.000011: required documents.
p.000011:
p.000011: 4. ERC members shall be provided with a copy of the documents to be reviewed well ahead of the meeting to give them
p.000011: sufficient time to study the documents and ready their comments.
p.000011:
p.000011: 5. The quorum shall be set and attendance of members recorded. The rule on quorum shall not only specify
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000003:
p.000003: 4. Promote the establishment of functional and effective ethics review committees;
p.000003:
p.000003: 5. Provide advice and make recommenda- tions to the PNHRS Governing Council and other appropriate entities
p.000003: (including the Bureau of Food and Drugs [BFAD]) regarding programs, policies, and regula- tions as they relate to
p.000003: ethical issues in human health research;
p.000003:
p.000003: 6. Initiate and contribute to discourse and discussions of ethical issues in human health research; and
p.000003:
p.000003: 7. Network with relevant local, national, and international organizations.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000004:
p.000004: Regional Research Ethics Boards
p.000004:
p.000004: Composition The regional research ethics boards will be
p.000004: constituted by the PNHRS Governing Council and will have a multidisciplinary, multisectoral, gender- and age-balanced
p.000004: membership that reflects the cultural and social milieu obtaining in the region they are in. They will be under the
p.000004: supervision of PHREB.
p.000004:
p.000004: Functions The regional research ethics boards will be
p.000004: established in key regions to act as a regional research ethics review policy-making authority. Their functions will,
p.000004: therefore, be similar to that of PHREB with the region as their area of responsibility.
p.000004:
p.000004:
p.000004: Ethics Review Committees (ERCs)
p.000004:
p.000004: The Ethics Review Committees include the Cluster Ethics Review Committees, the Institutional Ethics Review
p.000004: Committees and the erstwhile National Ethics Committee. The latter has for several years conducted initial review for
p.000004: researches done in institutions without a functional research ethics review committee.
p.000004:
p.000004:
p.000004: Cluster Ethics Review Committees (CERCs)
p.000004:
p.000004: Several institutions may form a common ethics review committee if it is not feasible to form their own committees.
p.000004:
p.000004: The management of CERCs and its areas of responsibility should be covered by a memorandum of agreement among the
p.000004: involved institutions.
p.000004:
p.000004: The CERC’s functions shall be similar to that of an institutional ethics review committee.
p.000004:
p.000004:
p.000004: The Institutional Ethics Review Committees (IERCs)
p.000004:
p.000004: Philippine institutions that engage in biomedical and behavioral research shall establish an institutional ethics
p.000004: review committee which shall provide
p.000004:
...
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
...
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000029:
p.000029: ETHICAL GUIDELINES FOR CLINICAL TRIALS ON DRUGS, DEVICES, AND DIAGNOSTICS
p.000029:
p.000029: Introduction
p.000029:
p.000029: A clinical trial is a scientifically designed experiment that evaluates the safety and efficacy of a treatment. There
p.000029: are four phases of clinical trials
p.000029:
p.000029: Phase I study refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000029: determine the levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in
p.000029: patients for safety and, in some cases, early evidence of effectiveness.
p.000029:
p.000029: Phase II investigation consists of controlled clinical trials designed to demonstrate efficacy and relative safety.
p.000029: Normally, these are performed on a limited number of closely monitored patients.
p.000029:
p.000029: Phase III trial is performed after a reasonable probability of a drug’s effectiveness has been established. This type
p.000029: of trial is intended to gather additional evidence of effectiveness for specific indications and more precise
p.000029: definition of drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000029:
p.000029: Phase IV trial is conducted after the national drug registration authority (i.e. BFAD) has approved a drug for
p.000029: distribution or marketing. This trial may include research designed to explore a specific pharmacological effect,
p.000029: establish the incidence of adverse reactions, or determine the effects of a long-term drug administration. It may also
p.000029: be designed to evaluate a drug in a population (such as children or the elderly) not studied adequately in the
p.000029: pre-marketing phases, or to establish a new clinical indication for a drug. Such research is to be distinguished from
p.000029: marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug reactions in that
p.000029: these categories ordinarily need not be reviewed by ethics review committees.
p.000029:
p.000029: The four conventional phases in clinical drug development present different ethical issues. Careful
p.000029: consideration should be noted and addressed in each phase as indicated in the International Conference on
p.000029: Harmonization (ICH) Harmonized Tripartite Guidelines for Good
p.000029:
p.000030: 30
p.000030:
p.000030:
p.000030:
p.000030: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000030:
p.000030: Clinical Practice, General Consideration for Clinical Trials (E8).
p.000030:
p.000030: General 1. All research involving human subjects should be guidelines conducted in
...
p.000045: inclinations, among others, may be considered confidential and will require consent prior to collection.
p.000045:
p.000045: 5. Collection of data by questionable means, such as deception, should not be condoned.
p.000045:
p.000045: 6. Data gathered for administrative purposes (as long as the information is not sensitive) do not require consent and
p.000045: may be waived if getting consent is considered impractical or too expensive.
p.000045:
p.000045: 7. Review of medical records may be done without requiring consent if anonymity can be maintained and if
p.000045: information sought is considered non- sensitive (Gordis and Gold, 1980).
p.000045:
p.000045: 8. The appropriate permission for storing biological material for research must be obtained from
p.000045:
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000046:
p.000046: individuals. If the samples are to be used for research not covered by the original consent, an ethics
p.000046: committee should decide whether renewed consent is needed or if the analyses may be done on anonymized samples.
p.000046: Details regarding the collection and storage of biological material are covered in the document on ethical guidelines
p.000046: for genetics research.
p.000046:
p.000046: 9. A person of authority may be allowed to give consent for collection of data among children and other
p.000046: individuals who are temporarily or permanently unable to give informed consent by themselves, provided that the
p.000046: research does not involve more than minimal risks to the participants.
p.000046:
p.000046: 10. If the information is obtained by means of a questionnaire, and adequate information has been given to
p.000046: the research subject, there is no need for a written informed consent, since answering the questionnaire implies
p.000046: consent.
p.000046:
p.000046: 11. There are alternative methods of obtaining informed consent (e.g., verbal consent). These are covered by the
p.000046: document on Ethical Guidelines for Social and Behavioral Research (pp48-49).
p.000046:
p.000046: Privacy and 12. Working with personal data is a privilege that calls confidentiality for a high
p.000046: degree of data protection, especially in
p.000046: situations where data are used without personal consent. A working standard for data protection that secures as little
p.000046: risk of disclosure as possible should be developed.
p.000046:
p.000046: Information 13. Important findings from the research should be shared with made available to
...
p.000059: also ensure that safeguards are in place to avoid accidental disclosure of sensitive information.
p.000059:
p.000060: 60
p.000060:
p.000060:
p.000060:
p.000060: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000060:
p.000060: 16. Disclosure of genetic information is sometimes impossible to avoid. Such information should be dealt with
p.000060: sensitively, and the possibility that such a disclosure may occur should be considered in the initial process of
p.000060: seeking consent.
p.000060:
p.000060: 17. There is potential harm to participants arising from the use of genetic information, including stigmatization
p.000060: or unfair discrimination. Researchers should take special care to protect the privacy and confidentiality of
p.000060: this information.
p.000060:
p.000060: 18. Identifying genetic information must not be released to others, including family members, without the
p.000060: written consent of the individual to whom the information relates, or a person or institution which may
p.000060: legally provide consent for that person.
p.000060:
p.000060: 19. The patient’s right to privacy (researcher’s duty for confidentiality) continues after the patient’s death so
p.000060: that confidential information may be revealed after death only with proper legal authority. The only
p.000060: exception is the right to disclose information to a family member if there is a clear and urgent need to provide
p.000060: information to avoid a serious health risk.
p.000060:
p.000060: Handling of 20. Genetic research often involves the storage of biological DNA or
p.000060: other biological samples in “tissue” or specimens “sample” collections. In some cases, samples
p.000060: can
p.000060: be anonymized so that the donors cannot be identified. This raises problems in cases where the information
p.000060: from research might be of value to the individuals or families. Most genetic research studies will require linking of
p.000060: DNA samples to health records, family pedigrees, and individual results.
p.000060:
p.000060: 21. Handling and preservation of biological samples shall be in accordance with standard scientific procedures.
p.000060:
p.000061: 61
p.000061:
p.000061:
p.000061:
p.000061: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000061:
p.000061: 22. Disposal of stored biological specimens shall be in accordance with standards for handling biohazardous and
p.000061: infectious materials.
p.000061:
p.000061: 23. Transport, transfer, and disposal of all stored biological samples shall be properly documented and filed.
p.000061:
p.000061: 24. Retention time for stored biological samples shall be determined by the respective institution.
p.000061:
p.000061: 25. All specimens in a tissue bank must be accompanied by a copy of the consent agreement signed by the donor.
p.000061:
...
p.000080: blood sample by using a needle and syringe (UNESCO International Declaration on Human Genetic Data)
p.000080:
p.000080: investigator – a person responsible for the conduct of the critical trial at a trial site. If trial is conducted by a
p.000080: team of individuals at a trial site, the investigator is the responsible leader of the team and be called the principal
p.000080: investigator (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6, R1)
p.000080:
p.000080: – a person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The
p.000080: investigator should have qualifications and competence in accordance with local laws and regulations as
p.000080: evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and to provisions of,
p.000080: medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice
p.000080: medicine or dentistry (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000080:
p.000080: – a qualified scientist who undertakes scientific and ethical responsibility, either on his/her behalf or on behalf of
p.000080: an organization, for the ethical and scientific integrity of a research project at a specific site or group of sites
p.000080:
p.000080: legally authorized representative – one that represents another or others, upon their permission in accordance with
p.000080: law, in a special capacity (Merriam- Webster’s Dictionary of Law (c)1996)
p.000080:
p.000081: 81
p.000081:
p.000081: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000081:
p.000081: – A person who has authority, under the law, to stand for, or make decisions in behalf of another
p.000081:
p.000081: legally competent person – qualified or fit to perform an act, in accordance with law, free from addiction or mental
p.000081: defects that renders one incapable of taking care or oneself or one’s property (Merriam-Webster’s Dictionary of Law
p.000081: (c)1996)
p.000081:
p.000081: linkage analysis – gene hunting technique that traces patterns of disease in high risk families for the purpose of
p.000081: locating a disease-causing gene by identifying genetic markers of known chromosomal location that are co-inherited with
p.000081: the trait of interest
p.000081:
p.000081: material transfer agreement – an agreement between the source institution (or community) and the recipient institution
p.000081: (agency or community) that defines responsibilities and ownership of the material under study
p.000081:
p.000081: minimal toxicity data – the lowest dose of the preparation that shall elicit toxicity signs and symptoms in the
p.000081: participants or in animals
p.000081: minors – persons who have not yet reached the age of majority, 18 years old monitor – a person appointed by and
p.000081: responsible to the sponsor or contract
p.000081: research organization for monitoring and reporting progress of the trial
p.000081: and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000081:
p.000081: moral agent – a sentient individual whose acts impact on others and are affected by the act of others
p.000081:
...
p.000095: Confidentiality,18,19,45,48, 61, 72 Conflict of interest,50,51,72 Consent,46, 61
p.000095: Consent agreement, 62 Contraceptive methods,25
p.000095:
p.000096: 96
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096:
p.000096: Contraceptive implant,36 Control, 72
p.000096: Controlled trials, 17, 72
p.000096: Conventional medicine,42, 73
p.000096: Counseling,49,54,73
p.000096: Gender-sensitive, 56, 77
p.000096: Genetic, 60, 77 Criminal violence,50,73 Cultural beliefs,51 Cultural sensitivity,50,53 Culture bias,54,73
p.000096: Data, administrative, 46
p.000096: Debriefing,49, 73
p.000096: Deception,21,46,49, 73
p.000096: devices, 73
p.000096: biomedical, 59
p.000096: medical, 35
p.000096: Diagnostic/s, 59 ,73 procedures,35,36
p.000096: Dietary supplements,42 Disapproval, 13,14, 73 Discontinuation,33 Disclosure,22,45, 60, 61,
p.000096: of data, 74
p.000096: Discrimination, 61
p.000096: Disease allele, 57, 74
p.000096: Disease susceptibility,57, 74 Disposal of specimens, 62 DNA, 57, 58, 61
p.000096: Deoxyribonucleic acid, 74
p.000096: sequencing,57 Domestic violence,50, 74
p.000096: Donor protection, 63
p.000096: Double blinding, 17, 33, 74
p.000096: Drugs, 59, 74
p.000096: Drug registration authority,30
p.000096: See also Bureau of Food and Drug
p.000096: Egg, fertilized, 55
p.000096: Efficacy, 74
p.000096: Efficacy parameters,34, 39,43 Elements of research ethics, 16-26 Embryo, 55, 56, 74
p.000096: Preimplantation, 63
p.000096: Endpoints, primary and secondary,33 Energy therapies,43
p.000096: Qi gong Reiki
p.000096: Therapeutic touch Pranic healing
p.000096: Electromagnetic field methods Environment, 28 Epidemiology,45,74
p.000096: Epidemiologic research,45, 74
p.000096: Ethical clearance, 27, 75
p.000096: Ethical considerations, 12 Ethical Guidelines in AIDS
p.000096: Investigations in the Philippines,53 Ethical Guidelines –
p.000096: Assisted Reproductive Technology,55-56
p.000096: Authorship and Publication, 66-67 Clinical Trials, 30-37 Complementary and alternative
p.000096: Medicine research,42-44 Epidemiologic research, 45-47
p.000096: Genetic research, 57-62, 77 Herbal Research,38-41 HIV/AIDS research, 53-54 International Collaborative
p.000096: Researches, 64-65 Research on populations
p.000096: traumatized in emergencies and disasters, 50-52
p.000096: Social and Behavioral Research, 48-49
p.000096: Stem cell research, 62-63 Ethical principles, 27, 75
p.000096: Ethics review. 76
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
...
p.000097: International Conference on Harmonization (ICH), 30, 39
p.000097: Interventional study, 54, 81
p.000097: Intervention programs, 51
p.000097: Intimidation, 21
p.000097: In vitro fertilization, 56 Investigator, principal/chief, 69, 70
p.000097: Animals, care and use of laboratory, 28 Legal representative, 24,25
p.000097: Linkage analysis, 57, 82
p.000097: Linking DNA samples to health records, 61
p.000097: Markers, 39
p.000097: Massage, 43
p.000097: Material transfer agreement, 41 Mind-body interventions, 43
p.000097: Meditation, 43
p.000097: Prayer, 43
p.000097: Mental healing, 43
p.000097: Art, 43
p.000097: Music therapy, 43 minutes of meeting,13 medical rationale, 26
p.000097: medical records, 46 medical services,19
p.000097: memorandum of agreement, 41 monitoring mechanism, 51
p.000097: moral agent, 55
p.000097: multifactorial inheritance, 57, 82
p.000097: mutagenicity, 26, 82
p.000097: National Ethics Committee, 3, 5, 87
p.000097: National Unified Health Agenda, 29, 83
p.000097: Natural calamities, 50
p.000097: Naturopathy, 43
p.000097: North-south research collaboration, 64, 83
p.000097: Non-disclosure, 52, 83
p.000097:
p.000098: 98
p.000098:
p.000098: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000098:
p.000098:
p.000098: Nuremberg Code, 3
p.000098: Observational studies, 45, 48 Oriental traditional medicine, 43
p.000098: Ayurveda Unani
p.000098: Traditional Chinese medicine Osteopathic manipulation Ovulatory rates
p.000098: Ovum/ ova, 55, 56
p.000098: Photographs, 67
p.000098: Pain, 17
p.000098: Parallel design, 33 Participant
p.000098: Observation, 48
p.000098: Selection, 33
p.000098: Withdrawal, 33
p.000098: Participatory research, 52, 83
p.000098: Patenting, 41
p.000098: Personal data, 47 Person of authority, 47 pharmacogenetics, 83
p.000098: Philippine Health Research Ethics Board (PHREB), 3-4
p.000098: Functions, 4
p.000098: Philippine National Health Research System, 3
p.000098: Philippine Obstetrical and Gynecological Society (POGS), 55
p.000098: Philippine Society of Reproductive Endocrinology and Infertility, 55
p.000098: Placebo, 31, 33, 34, 84
p.000098: Placebo-controlled, 33, 40, 85
p.000098: Political repression, 50
p.000098: Post-marketing surveillance, 30
p.000098: Practitioner, qualified, 55
p.000098: Preclinical studies, 32, 85
p.000098: Predictive testing, 57, 59, 85
p.000098: Predisposition, 57, 85
p.000098: Pregnancy test, 25
p.000098: Pre-marketing phase, 30
p.000098: Prenatal testing, 57, 85
p.000098: Privacy,18,22,45,48, 61, 85
p.000098: Procedures, invasive, 28
p.000098: Product toxicities, 31
p.000098: Protein, 57, 58
p.000098: Protocol, 32, (see also research protocol), 85
p.000098: Psychocultural aspects, 53, 55
p.000098: Psychosocial needs, 51, 86
p.000098: Publication, 36, 54, 67
p.000098: Impediments to, 67 Qualifications of investigators, 28 Quality of life, 43, 86
p.000098: Quasi-experimental design, 49, 86
p.000098: Questionnaire, 47
p.000098: Quorum, 12
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
p.000090: Philippines, providing for a Traditional and Alternative Health Care Development Fund and for other purposes
p.000090:
p.000090: traditional healer – the relatively old, highly placed respected person in the community, with a profound knowledge of
p.000090: traditional remedies
p.000090:
p.000090: traditional medicine – the sum total of knowledge, skills, and practices in health care, not necessarily explicable in
p.000090: the context of modern, scientific, philosophical framework, but recognized by the people to help maintain and improve
p.000090: their health towards the wholeness of their being, the community and society, and their interrelations based on
p.000090: culture, history, heritage, and consciousness
p.000090:
p.000090: traditional medicine expert – a health care provider employing traditional medicine modalities to give a cure
p.000090: traumatized populations – are individuals who live in communities that have experienced extreme forms of life-
p.000090: threatening stress due to natural calamities or human atrocities such as armed conflict, political repression as well
p.000090: as criminal and domestic violence.
p.000090:
p.000090: trial-related expenses – costs incurred in the course of litigation
p.000090:
p.000090: – Expenses incurred by study participants related to their participation in a research study such as transportation,
p.000090: meals, loss of income.
p.000090:
p.000090: undue influence – improper influence that deprives a person of freedom of choice or substitutes another’s choice or
p.000090: desire for the person’s own. Note: It is a doctrine of equity that a contract, deed, donation. Or
p.000090: testamentary disposition can be set aside if the court finds that someone has exercised undue influence over the
p.000090: maker at the time that the contrast, conveyance, or will was made. To establish a prima facie case it is usually
p.000090: necessary to show a susceptibility to undue influence (as from mental impairment), the opportunity and
p.000090: disposition on someone’s part to exercise such influence, and that the transaction
p.000090:
p.000091: 91
p.000091:
p.000091: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000091:
p.000091: would not have been made except for the undue influence. (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: vulnerable groups – classes of individuals who have characteristics that lessen their capacity to protect their own
p.000091: interests or promote their own welfare
p.000091:
p.000091: waiver of informed consent – the act of intentionally or knowingly relinquishing or abandoning the right to consent to
p.000091: medical treatment by a patient or to participation in a medical experiment by a subject after achieving an
p.000091: understanding of what is involved and especially for the risks (Merriam- Webster’s Dictionary of Law (c)1996)
p.000091:
p.000091: – Permission given by an Ethics Review Committee for research to be conducted without the informed consent of subjects,
p.000091: under exceptional circumstances, such as when research has to be undertaken in an emergencyXsituation
p.000091:
p.000091: Western medicine – or biomedicine, allopathy, regular medicine, conventional medicine, mainstream medicine, orthodox
p.000091: medicine or cosmopolitan medicine, refers to medical care that advocates therapy that produces effects differing from
p.000091: those of the diseases treated (TAMA 1997)
p.000091:
p.000091: zygote – the product of the biological union of the human sperm and egg (process of fertilization) until the
p.000091: blastocyst (32-cell) stage prior to implantation in the endometrium (0 to 4-5 days)
p.000091:
p.000091:
p.000091:
...
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
p.000098: Review procedure, 12-13 Right of access, 18 Risks, 17, 88
p.000098: RNA, 57, 58, 88
p.000098: Safety information, 11-12
p.000098: Safety parameters, 34
p.000098: Scientific rationale, 26
p.000098: Screening, 59
p.000098: Serious adverse events (SAEs), 13, 68
p.000098: Side effects,39
p.000098:
p.000099: 99
p.000099:
p.000099: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000099:
p.000099:
p.000099: Single gene disease/s, 57
p.000099: Social and behavioral research, 48, 88
p.000099: Social risks, 45
p.000099: Solid tissues, 58
p.000099: Sperm, 55, 56
p.000099: Sponsors,19, 89
p.000099: Standard application form, 12, App B Standard of care, 23, 54, 90 Standard operating process, 12 Standard for test
p.000099: preparation, 40 Stem cell research, 57, 62, 90
p.000099: Stigmatization, 50, 54, 61 Stress
p.000099: Emotional, 49
p.000099: Psychological, 49
p.000099: Sustainability, 64
p.000099: Technologies, medical, 59
p.000099: Teratogenicity, 26, 90
p.000099: Termination, early, 17, 22
p.000099: Therapeutic protocols, 53
p.000099: Tissue bank, 62
p.000099: Tolerance profile, 39
p.000099: Traditional and alternative health care Systems, 38, 90
p.000099: Traditional and Alternative Medicine Act, 38, 42, 91
p.000099: Traditional healers, 40, 91
p.000099: Traditional medicine, 42, 91 Transport of materials, 41 Traumatized populations, 50, 91
p.000099: Traumatization, repeat, 50
p.000099: Trial design, 33
p.000099: Trial treatments, 33
p.000099: UndueXinfluence, 21, 91 Uterine hospitability Vaccines, 35, 36, 53
p.000099: Verbal consent, see informed consent
p.000099: Vulnerability, 50
p.000099: Vulnerable groups, 23, 50, 92
p.000099: Welfare of participants, 28 Of animals, 28
p.000099: Withdrawal of approval, 14 Withholding of information, 49, 52 Women of reproductive age, 25
p.000099: Pregnant, 25
p.000099: Zygote/s, 55, 56, 92
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000100: 100
p.000100:
p.000100: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000100:
p.000100: APPENDIX A
p.000100: TEMPLATE FOR PATIENT INFORMATION AND INFORMED CONSENT FORM
p.000100:
p.000100: Project Title:
p.000100:
p.000100: Sponsor:
p.000100:
p.000100: Investigator/s:
p.000100:
p.000100:
p.000100:
p.000100: Purpose and conduct of study:
p.000100: • Why is the study being done?
p.000100: • What has been done previously?
p.000100: • How will the present study be conducted?
p.000100: • What is the nature and extent of involvement of research participants?
p.000100:
p.000100: Risks and inconveniences
p.000100: • Will there be discomforts? Are these described clearly?
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000096: specific types of research, say, genetic studies, are discussed in great detail in the guidelines for that
p.000096: particular type of research. These specific provisions complement those in the General Ethical Guidelines. They should
p.000096: not be considered as separate from the general guidelines. The subject index (pp96-100) should be able to direct
p.000096: the reader to all the sections where a particular item appears.
p.000096:
p.000096: Much effort was exerted to make this guidebook easy to use by researchers, by members of the ERCs and
p.000096: funding agencies, by research policy makers and even by young students in health research.
p.000096:
p.000096: For questions, please call/ email –
p.000096:
p.000096: The Secretariat, Philippine Health Research Ethics Board (PHREB) Philippine Council for Health Research and Development
p.000096: Department of Science and Technology
p.000096: General Santos Avenue, Bicutan, Taguig City Telephone Number(s): 837-7535/36
p.000096: Fax Number: 837-2924
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096: ix
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: ABBREVIATIONS
p.000096: AO - administrative order
p.000096: BFAD - Bureau of Food and Drugs
p.000096: CAM - complementary and alternative medicine CERC - Cluster Ethics Review Committee
p.000096: CIOMS - Council of International Organizations of Medical Sciences DA - Department of
p.000096: Agriculture
p.000096: DNA - deoxyribonucleic acid DOH - Department of Health
p.000096: DOST - Department of Science and Technology ERC - Ethics Review Committee
p.000096: HIV/AIDS - human immunodeficiency virus / acquired immune deficiency syndrome
p.000096: ICH - International Conference on Harmonization IERC - institutional ethics review committee
p.000096: NCCAM - National Center for Complementary and Alternative Medicine
p.000096: NEC - National Ethics Committee
p.000096: PALAS - Philippine Association for Laboratory Animal Science PCHRD - Philippine Council for Health
p.000096: Research and Development PHREB - Philippine Health Research Ethics Board
p.000096: PNHRS - Philippine National Health Research System POGS - Philippine Obstetrical and Gynecological
p.000096: Society RNA - ribonucleic acid
p.000096: SAE - serious adverse event TM - traditional medicine TWG - Technical Working
p.000096: Group
p.000096: WHO - World Health Organization
p.000096:
p.000096: x
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: INTRODUCTION
p.000096:
p.000096: “Research investigators should be aware of the ethical, legal, and regulatory requirements for research on human
p.000096: subjects in their own countries as well as applicable international requirements. No national ethical, legal or
p.000096: regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in
p.000096: the Declaration of Helsinki” (Helsinki, 2004, 9).
p.000096:
p.000096: Various international guidelines have been developed for the protection of human participants in research. These
p.000096: include the World Medical Association’s Helsinki Declaration of 1964 (revised and amended in 1975, 1983, 1989, 1996,
p.000096: and 2000), the WHO Council of International Organ- izations of Medical Sciences (CIOMS) 2002, and the
p.000096: International Conference on Harmonization Good Clinical Practice Guidelines (1996). Nevertheless, national and local
p.000096: guidelines still need to be developed so that research ethics can be embedded in the local practices as well as
p.000096: national laws and regulations while taking into consideration the country’s culture and traditions, and
p.000096: existing research infrastructures.
p.000096:
p.000096: In 1984, the National Ethics Committee (NEC) was organized by the Philippine Council for Health Research and
p.000096: Development (PCHRD) under Special Order No. 84-053 of then Executive Director, Dr. Alberto G. Romualdez, Jr.
p.000096: The following year, the NEC put together the first set of guidelines for the conduct of biomedical research in the
p.000096: country. These guidelines subsequently underwent revisions in 1996 and 2000 to address various developments in
p.000096: health research including multicenter clinical trials, genetic research, and organ transplantation research.
p.000096:
p.000096: In 2003, the Department of Science and Technology (DOST) and the Department of Health (DOH) signed a Memorandum of
p.000096: Understanding to establish the Philippine National Health Research System (PNHRS) that envisions “a vibrant,
p.000096: dynamic, and responsible health research community working for the attainment of national and global health goals.”
p.000096: The PNHRS endeavors “to create and sustain an enabling environment for health research through evidence-informed health
p.000096: and health-related policies and actions.” A Technical Working Group (TWG) on Ethics was one of six groups
...
p.000015: (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: Considerations related to the well-being of the human subject should take precedence over the interests of science and
p.000015: society (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: It is the duty of the researcher to protect the life, health, privacy, and dignity of the human subjects, and to
p.000015: safeguard scientific integrity.
p.000015:
p.000015:
p.000015: I. Elements of Research Ethics
p.000015:
p.000015: Informed consent 1. For all biomedical research involving humans, the
p.000015: investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who
p.000015: is incapable of giving informed consent, the permission of a legally authorized representative in accordance with
p.000015: applicable laws.
p.000015:
p.000016: 16
p.000016:
p.000016: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000016:
p.000016: Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an
p.000016: ethics review committee (Guideline 4 – Council for International Organi- zations of Medical Sciences [CIOMS], 2002).
p.000016:
p.000016: 2. The investigator shall provide the following information to the potential subject, using language that
p.000016: can be understood:
p.000016:
p.000016: a. That the individual is invited to participate in the research, the reasons for considering the individual
p.000016: suitable for the study, and that participation is voluntary;
p.000016:
p.000016: b. That the individual is free to refuse to participate and is free to withdraw from the research at any time
p.000016: without penalty or loss of benefits to which he/she is entitled;
p.000016:
p.000016: c. The purpose of the research, the procedures to be carried out by the investigator and the subject, and an
p.000016: explanation of how the research differs from routine medical care;
p.000016:
p.000016: d. For controlled trials, an explanation of features of the research design (e.g., randomization, double blinding),
p.000016: and that the subject will not be told of the assigned treatment until the study has been completed and the blind
p.000016: has been broken;
p.000016:
p.000016: e. The expected duration of the individual’s participation (including number and duration of visits to the
p.000016: research center and the total time involved) and the possibility of early termination of the trial or of the
p.000016: individual’s participation in it;
p.000016:
p.000016: f. Any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others)
p.000016:
p.000017: 17
p.000017:
p.000017: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000017:
p.000017: associated with participation in the research, (in both the control and experimental group), including risks to the
...
p.000018:
p.000018: s. That the subjects have the right to decide about such future use, continued storage, or destruction of
p.000018: collected specimens;
p.000018:
p.000018: t. Whether commercial products may be developed from biological specimens, and whether the participant will
p.000018: receive monetary or other benefits from the development of such products;
p.000018:
p.000018: u. Whether the investigator is serving only as an investigator or as both investigator and the subject’s
p.000018: physician;
p.000018:
p.000018: v. The extent of the investigator’s responsibility to provide medical services to the participant;
p.000018:
p.000018: w. That treatment will be provided free of charge for specified types of research-related injury or for
p.000018: complications associated with the
p.000018:
p.000019: 19
p.000019:
p.000019: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000019:
p.000019: research, the nature and duration of such care, the name of the organization or individual that will provide the
p.000019: treatment, and whether there is any uncertainty regarding funding of such treatment;
p.000019:
p.000019: x. In what way, and by what organization the subject or the subject’s family or dependents will be
p.000019: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to
p.000019: provide such compensation);
p.000019:
p.000019: y. That an ethics review committee has approved or cleared the research protocol (Guideline 5
p.000019: – CIOMS, 2002).
p.000019:
p.000019: 3. After ensuring that the subject has understood the information, the physician should then obtain the
p.000019: subject’s freely given informed consent, preferably in writing. If the consent cannot be obtained in
p.000019: writing, the non-written consent must be formally documented and witnessed (Principle 22 – Declaration of Helsinki,
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
p.000019: 5. The participation of children in research requires extra protection, as children cannot volunteer to participate
...
p.000020: parent’s or guardian’s permission should be obtained prior to enrolling a child in a research study.
p.000020:
p.000020: 6. In obtaining informed consent, sponsors and investigators have a duty to:
p.000020:
p.000020: a. avoid deception, undue influence, or intimidation;
p.000020:
p.000020: b. seek consent only after ascertaining that the prospective subject has adequate understanding of the
p.000020: relevant facts and the consequences of participation, and has had sufficient opportunity to consider whether to
p.000020: participate;
p.000020:
p.000020: c. as a general rule, obtain from each prospective subject a signed form as evidence of informed consent;
p.000020: investigators shall justify any exceptions to this general rule and obtain the approval of the ethics review committee;
p.000020:
p.000020: d. renew the informed consent of each subject if there are any significant changes in the conditions or
p.000020: procedures of the research, or if new information becomes available that could affect the willingness of
p.000020: subjects to continue to participate;
p.000020:
p.000020: e. renew the informed consent of each subject in long-term studies at pre-determined intervals even if there are
p.000020: no changes in the design or objectives of the research (Guideline 6 - CIOMS, 2002).
p.000020:
p.000020: Risks, benefits, 7. Health research is only justified if there is a and safety
p.000020: reasonable likelihood that the populations in which
p.000020: the research is carried out stand to benefit from
p.000020:
p.000021: 21
p.000021:
p.000021: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000021:
p.000021: the research results (Principle 19 – Declaration of Helsinki, 2004).
p.000021:
p.000021: 8. Every health research project involving human subjects should be preceded by a careful assessment of
p.000021: predictable risks and burdens in comparison with foreseeable benefits to the subject or to others (Principle 16 –
p.000021: Declaration of Helsinki, 2004).
p.000021:
p.000021: 9. Every precaution should be taken to minimize the negative impact of the study on the subject’s physical
p.000021: and mental integrity (Principle 21 – Declaration of Helsinki, 2004).
p.000021:
p.000021: 10. There must be an assurance of reasonable availability of a research product within the local market.
p.000021:
p.000021: Community 11. The conclusion or termination of the research care activity
p.000021: should not preclude the possibility of administering extended community care. This
p.000021: should be especially considered in researches involving depressed communities, ethnic groups or in international
p.000021: collaborative protocols (Bhutta, 2000).
p.000021:
p.000021: Privacy and 12. Every precaution should be taken to respect the confidentiality privacy of the
p.000021: participant and the confidentiality
...
p.000021:
p.000021: b. the findings have significant implications for the subject’s health concerns; and
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000022:
p.000022: c. the course of action to ameliorate or treat these concerns is readily available when research results
p.000022: are disclosed to its subjects. Appropriate medical advice or referral should be provided.
p.000022:
p.000022: Standard of care 14. The particular needs of the economically and
p.000022: medically disadvantaged must be recognized in determining the standard of care that must be provided them as
p.000022: research subjects.
p.000022:
p.000022: 15. The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best
p.000022: current prophylactic, diagnostic, or therapeutic methods. Placebo, or no treatment, may be used in studies
p.000022: where no proven prophylactic, diagnostic, or therapeutic method exists (Principle 29 – Declaration of Helsinki,
p.000022: 2004).
p.000022:
p.000022: Compensation 16. Compensation given to subjects for lost earnings, for research travel costs, and
p.000022: other expenses incurred in taking subjects part in a study; free medical services; and
p.000022: compensation for the inconvenience and time spent by those who do not have direct benefit from the research should
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000023:
p.000023: c. a parent or legal representative of each child (0-18 years old) has given permission The following order of
p.000023: authority is suggested:
p.000023:
p.000023: Parents Surviving Parent Grandparents
p.000023: Surviving Grandparents
p.000023: Oldest sibling over 21 years old Actual custodian
p.000023:
p.000023: d. the assent of each child has been obtained to the extent of the child’s capabilities; and
p.000023:
p.000023: e. a child’s refusal to participate or continue in the research is respected (Guideline 14 – CIOMS, 2002).
p.000023:
p.000023: 19. Before undertaking any research involving individuals who, by reason of mental or behavioral disorders, are not
p.000023: capable of adequately giving an informed consent, the investigator shall ensure that:
p.000023:
p.000023: a. the research cannot be carried out equally well on persons whose capacity to give informed consent is not
p.000023: impaired;
p.000023:
p.000023: b. the purpose of the research is to obtain knowledge relevant to the particular health needs of persons
p.000023: with mental or behavioral disorders;
p.000023:
p.000023: c. the consent of each subject has been obtained to the extent of that person’s capabilities; and
p.000023:
p.000024: 24
p.000024:
p.000024: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000024:
p.000024: d. in cases where prospective subjects lack the capacity to consent, permission is obtained from a responsible family
p.000024: member or a legally authorized representative in accordance with applicable laws (Guideline 15 – CIOMS, 2002).
p.000024:
p.000024: 20. Investigators, sponsors, or ethics review committees shall not arbitrarily exclude women of reproductive age
p.000024: from biomedical research. The potential for becoming pregnant during a study shall not, in itself, be used as a
p.000024: reason for precluding or limiting women’s participation in research.
p.000024:
p.000024: 21. The following should be considered in enrolling women who may become pregnant during research:
p.000024:
p.000024: a. A thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman’s ability to
p.000024: make rational decision to enroll in a clinical study.
p.000024:
p.000024: b. A pregnancy test shall be done and access to effective contraceptive methods ensured before the research
p.000024: commences if participation in the research might be hazardous to a fetus or a woman if she becomes pregnant. Where such
p.000024: access is not possible for legal or religious reasons, investigators shall not recruit for such possibly hazardous
p.000024: research women who might become pregnant (Guideline 16 – CIOMS, 2002).
p.000024:
p.000024: c. Investigators and ethics review committees shall ensure that prospective subjects who are pregnant are
p.000024: adequately informed about the risks and benefits to themselves, their pregnancy, the fetus and their
p.000024: subsequent offspring, and their fertility.
p.000024:
p.000025: 25
p.000025:
p.000025: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000025:
p.000025: d. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000025: pregnant woman or her fetus, or of pregnant women in general and, when appropriate, if it is supported by
p.000025: reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity (Guideline 17
p.000025: –CIOMS, 2002).
p.000025:
p.000025: 22. Competent advice and assistance shall be provided to subjects who, by virtue of social, economic,
p.000025: political or medical disadvantages, are liable to give consent under duress or without the benefit of adequate
p.000025: information.
p.000025:
p.000025: Absence of 23. When there is ethical and scientific justification direct benefit to conduct
p.000025: research with individuals capable of
p.000025: giving informed consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000025: the individual subject should be no more likely and no greater than the risk attached to routine medical or
p.000025: psychological examination of such persons. Slight or minor increases above such risk may be permitted when there is an
p.000025: overriding scientific or medical rationale for such increases and when an ethics review committee has approved
p.000025: them (Guideline 9 – CIOMS, 2002).
p.000025:
p.000025:
p.000025: II. Ensuring Quality Research
p.000025:
p.000025: Role of the 24. The ERC shall:
p.000025: ethics review
p.000025: committee (ERC) a. Review the scientific merit and ethical
p.000025: acceptability of any research involving human participants;
p.000025:
p.000025: b. Conduct further reviews as necessary in the course of the research as well as monitor the study’s progress
p.000025: (Guideline 2 – CIOMS, 2002);
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000026:
p.000026: c. Research approved by a foreign ERC for implementation in the Philippines shall also be subjected to ethics
p.000026: review.
p.000026:
p.000026: Ensure that the ethical standards applied are no less stringent than they would be if the research were to be
p.000026: carried out in the country of the sponsoring agency;
p.000026:
p.000026: d. Ensure that the proposed research is responsive to the health needs and priorities of the Philippines and
p.000026: meets the requisite ethical standards (Guideline 3 - CIOMS, 2002);
p.000026:
p.000026: e. Issue the ethical clearance required for the implementation of any research it has reviewed and approved; and
p.000026:
p.000026: f. Review amendments/changes in the protocol of researches that have been previously approved.
p.000026:
p.000026: Research 25. The research protocol should adequately address protocol the four
p.000026: ethical principles: respect for persons, beneficence, non-maleficence, and justice. And
p.000026: should be sufficiently detailed to serve as documentation of the study. It should -
p.000026:
p.000026: a. justify the need for the study, i.e., why the study should be conducted given the current state of
p.000026: knowledge;
p.000026:
p.000026: b. demonstrate the appropriateness of the proposed methods for testing the stated hypothesis;
p.000026:
p.000026: c. demonstrate the feasibility of doing the study as proposed, i.e., that the study can be completed
p.000026: successfully in the specified time and with the available resources;
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000027:
p.000027: 26. The purpose of the study, the design, the population, the methods of data collection, and the planned
p.000027: analyses shall be described in the protocol.
p.000027:
p.000027: 27. All procedures, whether invasive or not, should be satisfactorily described in detail.
p.000027:
p.000027: 28. The protocol should provide information on how the welfare of the participants shall be protected.
p.000027:
p.000027: 29. It is also advisable to include in the protocol the agreements on the time schedule, publication of research
...
p.000028: setting (Margetts, Arab, Nelson, & Kok, 1999).
p.000028:
p.000028: 34. Government-sponsored health researches should conform with the National Unified Health Research Agenda.
p.000028:
p.000028: Community 35. A larger and more difficult challenge is to involve participation the
p.000028: communities themselves in the research
p.000028: questions and to link the research to their own development. Such a participatory process with the community is a
p.000028: continuum that includes community consultation in protocol development, appropriate information disclosure and
p.000028: informed consent, protection of condidentiality and right of dissent, and community involvement in the conduct of
p.000028: research (Wejer & Emmanuel, 2000).
p.000028:
p.000028:
p.000028: Externally- 36. In externally sponsored collaborative research, sponsored sponsors
p.000028: and investigators have an ethical collaborative obligation to ensure that biomedical research
p.000028: research projects for which they are responsible shall
p.000028: contribute effectively to capacity building which may include, but is not limited to the following activities:
p.000028:
p.000028: a. Designing and conducting biomedical research
p.000028:
p.000028: b. Strengthening research capacity to develop technologies appropriate to healthcare and biomedical research
p.000028: training of research and healthcare staff
p.000028:
p.000028: c. Educating the community from which research subjects will be drawn (Guideline 20 – CIOMS, 2002)
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029:
p.000029: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000029:
p.000029: ETHICAL GUIDELINES FOR CLINICAL TRIALS ON DRUGS, DEVICES, AND DIAGNOSTICS
p.000029:
p.000029: Introduction
p.000029:
p.000029: A clinical trial is a scientifically designed experiment that evaluates the safety and efficacy of a treatment. There
p.000029: are four phases of clinical trials
p.000029:
p.000029: Phase I study refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000029: determine the levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in
p.000029: patients for safety and, in some cases, early evidence of effectiveness.
p.000029:
p.000029: Phase II investigation consists of controlled clinical trials designed to demonstrate efficacy and relative safety.
p.000029: Normally, these are performed on a limited number of closely monitored patients.
p.000029:
p.000029: Phase III trial is performed after a reasonable probability of a drug’s effectiveness has been established. This type
p.000029: of trial is intended to gather additional evidence of effectiveness for specific indications and more precise
p.000029: definition of drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000029:
p.000029: Phase IV trial is conducted after the national drug registration authority (i.e. BFAD) has approved a drug for
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.002006: composition of the Philippine Health Research Ethics Board (PHREB) as a national body, as well as that of institutional
p.002006: ethics review committees.
p.002006:
p.002006: The 2006 National Ethical Guidelines for Health Research likewise seeks to address the role of research and the various
p.002006: issues and gaps relating to research in the context of developing countries. These include ethical issues pertaining to
p.002006: international collaborative research funded by industrialized countries and carried out in developing countries. Such
p.002006: issues include difficulties in creating ethical guidelines and review processes in developing countries, the standard
p.002006: of care to be provided during and after clinical trials, traditional medicines, genomics and global health, benefit
p.002006: sharing and intellectual property, and culture and informed/misinformed consent.
p.002006:
p.002006: Given the increasing universality of what were once region-specific health concerns, these Guidelines have also
p.002006: identified issues/topics that are commonly addressed by the four international ethics guidelines, namely the
p.002006: International Declaration on Human Genetic Data, the Council for International Organizations of Medical Sciences,
p.002006: UNAIDS, and the Declaration of Helsinki.
p.002006:
p.002006: Written in simple, concise, and reader-friendly style, the 2006 National Ethical Guidelines for Health Research will
p.002006: hopefully encourage more studies conducted by Filipinos on local health concerns, thereby addressing the problem of
p.002006: under-representation of the Philippines in high-impact general medical journals, which is another key ethical issue in
p.002006: health research.
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: Estrella F. Alabastro, Ph. D.
p.002006: Secretary
p.002006: Department of Science and Technology 23 June, 2006
p.002006:
p.002006:
p.002006:
p.002006:
p.002006: iii
p.002006:
p.002006:
p.002006: Republic of the Philippines Department of Health
p.002006: OFFICE OF THE SECRETARY
p.002006: MANILA, PHILIPPINES
p.002006: Tel Nos. (632) 743-83-01 local 1107,1111
p.002006: MESSAGE
p.002006:
p.002006: The landscape of health research has immensely changed with the explosion of new information, the ease of exchange of
p.002006: scientific knowledge, and information technology (IT) that allows for the quick and downloadable access of the outputs
p.002006: of research. There are also challenges being posed by new ethical considerations such as in balancing the need to shed
p.002006: light to emerging public health threats, which especially hit low-income populations against human rights not to be
p.002006: misused when these poor people are chosen as research subjects We must therefore adapt with the times and revolutionize
p.002006: ways in which we conduct local research by becoming more responsive to these scientific, technological, and
p.002006: social advances.
p.002006:
...
p.000096: HIV/AIDS - human immunodeficiency virus / acquired immune deficiency syndrome
p.000096: ICH - International Conference on Harmonization IERC - institutional ethics review committee
p.000096: NCCAM - National Center for Complementary and Alternative Medicine
p.000096: NEC - National Ethics Committee
p.000096: PALAS - Philippine Association for Laboratory Animal Science PCHRD - Philippine Council for Health
p.000096: Research and Development PHREB - Philippine Health Research Ethics Board
p.000096: PNHRS - Philippine National Health Research System POGS - Philippine Obstetrical and Gynecological
p.000096: Society RNA - ribonucleic acid
p.000096: SAE - serious adverse event TM - traditional medicine TWG - Technical Working
p.000096: Group
p.000096: WHO - World Health Organization
p.000096:
p.000096: x
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: INTRODUCTION
p.000096:
p.000096: “Research investigators should be aware of the ethical, legal, and regulatory requirements for research on human
p.000096: subjects in their own countries as well as applicable international requirements. No national ethical, legal or
p.000096: regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in
p.000096: the Declaration of Helsinki” (Helsinki, 2004, 9).
p.000096:
p.000096: Various international guidelines have been developed for the protection of human participants in research. These
p.000096: include the World Medical Association’s Helsinki Declaration of 1964 (revised and amended in 1975, 1983, 1989, 1996,
p.000096: and 2000), the WHO Council of International Organ- izations of Medical Sciences (CIOMS) 2002, and the
p.000096: International Conference on Harmonization Good Clinical Practice Guidelines (1996). Nevertheless, national and local
p.000096: guidelines still need to be developed so that research ethics can be embedded in the local practices as well as
p.000096: national laws and regulations while taking into consideration the country’s culture and traditions, and
p.000096: existing research infrastructures.
p.000096:
p.000096: In 1984, the National Ethics Committee (NEC) was organized by the Philippine Council for Health Research and
p.000096: Development (PCHRD) under Special Order No. 84-053 of then Executive Director, Dr. Alberto G. Romualdez, Jr.
p.000096: The following year, the NEC put together the first set of guidelines for the conduct of biomedical research in the
p.000096: country. These guidelines subsequently underwent revisions in 1996 and 2000 to address various developments in
p.000096: health research including multicenter clinical trials, genetic research, and organ transplantation research.
p.000096:
p.000096: In 2003, the Department of Science and Technology (DOST) and the Department of Health (DOH) signed a Memorandum of
p.000096: Understanding to establish the Philippine National Health Research System (PNHRS) that envisions “a vibrant,
p.000096: dynamic, and responsible health research community working for the attainment of national and global health goals.”
p.000096: The PNHRS endeavors “to create and sustain an enabling environment for health research through evidence-informed health
...
p.000001: context of Philippine values and realities. It embodies the adherence of Philippine health researchers to
p.000001: ethical principles to protect human life and the dignity of the human person.
p.000001:
p.000001: Just like the earlier editions, these guidelines are meant to promote, and not to stifle, good and ethical
p.000001: scientific research. After all, advancement of the frontiers of knowledge brings hope for the good life, even for
p.000001: survival. But rules, codified as they are, are only rules on paper. In the final analysis, all individuals concerned
p.000001: with health research must resolve for themselves the omnipresent conflict between present peril or risk and future
p.000001: benefits of the study at hand.
p.000001:
p.000001:
p.000001: Philippine Health Research Ethics Board 2006
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000002:
p.000002: ETHICS REVIEW AUTHORITIES
p.000002:
p.000002:
p.000002: Introduction
p.000002:
p.000002: Advancement in science and technology in the ‘70s has made biomedical research involving human participants a necessity
p.000002: in order to determine the efficacy and safety of such new discoveries. Ethical issues involving the rights, safety, and
p.000002: protection of research participants emerged and these brought about the formulation of international guidelines in
p.000002: addition to the Nuremberg Code of 1949 and the Helsinki Declaration of 1964. As a national response, the Philippines
p.000002: established the National Ethics Committee (NEC) in 1984 through Special Order No. 84-053 issued by Dr. Alberto G.
p.000002: Romualdez, Jr., then Executive Director of the Philippine Council for Health Research and Development (PCHRD).
p.000002:
p.000002: The NEC was created to ensure that all health research and development proposals conformed with ethical standards.
p.000002: It also promoted the establishment of ethics review committees in various localities and institutions.
p.000002:
p.000002: In 2003, the Philippine National Health Research System (PNHRS) led to the creation of the Philippine Health Research
p.000002: Ethics Board (PHREB), a national policymaking body on health research ethics. In the different regions, policymaking
p.000002: boards shall also be established as Regional Health Research Ethics Boards.
p.000002:
p.000002:
p.000002: The Philippine Health Research Ethics Board (PHREB)
p.000002:
p.000002: Composition The Philippine Health Research Ethics Board has
p.000002: 13 members, including two ex-officio members: the Department of Science and Technology (DOST)-PCHRD Executive
p.000002: Director, and the Department of Health (DOH) Research Ethics Committee Chair. Except for the ex-officio
p.000002: members, appointments shall be for a term of three years (initially, however, five were appointed for three
...
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000015:
p.000015: GENERAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000015:
p.000015: Introduction
p.000015:
p.000015: For the purposes of these guidelines, an activity is deemed to be “research” if it aims to develop or
p.000015: contribute to generalizable knowledge (including theories, principles, relationships, or any accumulation of
p.000015: information using scientific methods, observation, and inference).
p.000015:
p.000015: These general guidelines shall govern all health researches involving human subjects. Additionally, special guidelines
p.000015: on clinical trials (pp30- 37), herbal medicine research (pp38-41), complementary and alternative medicine research
p.000015: (pp42-44), epidemiological research (pp45-47), social and behavioral research (pp48-49), research involving
p.000015: traumatized populations (pp50-52), HIV/AIDS research (pp53-54), research on assisted reproductive technology
p.000015: (pp55-56), and genetic research (pp57- 63), international/collaborative research (pp64-65), have been formulated
p.000015: because of special concerns that have been identified by practitioners.
p.000015:
p.000015: Health research involving human subjects includes research on identifiable human material or identifiable data
p.000015: (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: Considerations related to the well-being of the human subject should take precedence over the interests of science and
p.000015: society (Principle 1 – Declaration of Helsinki, 2004).
p.000015:
p.000015: It is the duty of the researcher to protect the life, health, privacy, and dignity of the human subjects, and to
p.000015: safeguard scientific integrity.
p.000015:
p.000015:
p.000015: I. Elements of Research Ethics
p.000015:
p.000015: Informed consent 1. For all biomedical research involving humans, the
p.000015: investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who
p.000015: is incapable of giving informed consent, the permission of a legally authorized representative in accordance with
p.000015: applicable laws.
p.000015:
p.000016: 16
p.000016:
p.000016: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000016:
p.000016: Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an
p.000016: ethics review committee (Guideline 4 – Council for International Organi- zations of Medical Sciences [CIOMS], 2002).
p.000016:
p.000016: 2. The investigator shall provide the following information to the potential subject, using language that
p.000016: can be understood:
p.000016:
p.000016: a. That the individual is invited to participate in the research, the reasons for considering the individual
p.000016: suitable for the study, and that participation is voluntary;
p.000016:
...
p.000018: physician;
p.000018:
p.000018: v. The extent of the investigator’s responsibility to provide medical services to the participant;
p.000018:
p.000018: w. That treatment will be provided free of charge for specified types of research-related injury or for
p.000018: complications associated with the
p.000018:
p.000019: 19
p.000019:
p.000019: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000019:
p.000019: research, the nature and duration of such care, the name of the organization or individual that will provide the
p.000019: treatment, and whether there is any uncertainty regarding funding of such treatment;
p.000019:
p.000019: x. In what way, and by what organization the subject or the subject’s family or dependents will be
p.000019: compensated for disability or death resulting from such injury (or, when indicated, that there are no plans to
p.000019: provide such compensation);
p.000019:
p.000019: y. That an ethics review committee has approved or cleared the research protocol (Guideline 5
p.000019: – CIOMS, 2002).
p.000019:
p.000019: 3. After ensuring that the subject has understood the information, the physician should then obtain the
p.000019: subject’s freely given informed consent, preferably in writing. If the consent cannot be obtained in
p.000019: writing, the non-written consent must be formally documented and witnessed (Principle 22 – Declaration of Helsinki,
p.000019: 2004).
p.000019:
p.000019: 4. Caution must be exercised in obtaining informed consent for a research project if the subject is in a dependent
p.000019: relationship with the investigator (e.g., as a patient) to ensure that the consent is not given under duress.
p.000019: The ethics review committee may stipulate that the informed consent should be obtained by a well-informed physician
p.000019: who is not engaged in the investigation and who is completely independent of the relationship (Principle 23
p.000019: –Declaration of Helsinki, 2004).
p.000019:
p.000019: 5. The participation of children in research requires extra protection, as children cannot volunteer to participate
p.000019: in a research study in the same way as an adult can. While they cannot give informed consent, they can participate in
p.000019: the process of
p.000019:
p.000020: 20
p.000020:
p.000020: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000020:
p.000020: obtaining consent by being asked for their assent to participate. When appropriate, both a child’s assent and the
p.000020: parent’s or guardian’s permission should be obtained prior to enrolling a child in a research study.
p.000020:
p.000020: 6. In obtaining informed consent, sponsors and investigators have a duty to:
p.000020:
p.000020: a. avoid deception, undue influence, or intimidation;
p.000020:
p.000020: b. seek consent only after ascertaining that the prospective subject has adequate understanding of the
p.000020: relevant facts and the consequences of participation, and has had sufficient opportunity to consider whether to
p.000020: participate;
p.000020:
p.000020: c. as a general rule, obtain from each prospective subject a signed form as evidence of informed consent;
p.000020: investigators shall justify any exceptions to this general rule and obtain the approval of the ethics review committee;
p.000020:
p.000020: d. renew the informed consent of each subject if there are any significant changes in the conditions or
p.000020: procedures of the research, or if new information becomes available that could affect the willingness of
p.000020: subjects to continue to participate;
p.000020:
p.000020: e. renew the informed consent of each subject in long-term studies at pre-determined intervals even if there are
p.000020: no changes in the design or objectives of the research (Guideline 6 - CIOMS, 2002).
p.000020:
p.000020: Risks, benefits, 7. Health research is only justified if there is a and safety
p.000020: reasonable likelihood that the populations in which
p.000020: the research is carried out stand to benefit from
p.000020:
p.000021: 21
p.000021:
p.000021: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000021:
p.000021: the research results (Principle 19 – Declaration of Helsinki, 2004).
p.000021:
p.000021: 8. Every health research project involving human subjects should be preceded by a careful assessment of
p.000021: predictable risks and burdens in comparison with foreseeable benefits to the subject or to others (Principle 16 –
p.000021: Declaration of Helsinki, 2004).
p.000021:
p.000021: 9. Every precaution should be taken to minimize the negative impact of the study on the subject’s physical
p.000021: and mental integrity (Principle 21 – Declaration of Helsinki, 2004).
p.000021:
p.000021: 10. There must be an assurance of reasonable availability of a research product within the local market.
p.000021:
p.000021: Community 11. The conclusion or termination of the research care activity
p.000021: should not preclude the possibility of administering extended community care. This
p.000021: should be especially considered in researches involving depressed communities, ethnic groups or in international
p.000021: collaborative protocols (Bhutta, 2000).
p.000021:
p.000021: Privacy and 12. Every precaution should be taken to respect the confidentiality privacy of the
p.000021: participant and the confidentiality
p.000021: of the participant’s information.
p.000021:
p.000021:
p.000021: Disclosure of 13. Disclosure of research results to subjects should research results occur only when
p.000021: all of the following apply:
p.000021:
p.000021: a. the findings are scientifically valid and confirmed;
p.000021:
p.000021: b. the findings have significant implications for the subject’s health concerns; and
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000022:
p.000022: c. the course of action to ameliorate or treat these concerns is readily available when research results
p.000022: are disclosed to its subjects. Appropriate medical advice or referral should be provided.
p.000022:
p.000022: Standard of care 14. The particular needs of the economically and
p.000022: medically disadvantaged must be recognized in determining the standard of care that must be provided them as
p.000022: research subjects.
p.000022:
p.000022: 15. The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best
p.000022: current prophylactic, diagnostic, or therapeutic methods. Placebo, or no treatment, may be used in studies
p.000022: where no proven prophylactic, diagnostic, or therapeutic method exists (Principle 29 – Declaration of Helsinki,
p.000022: 2004).
p.000022:
p.000022: Compensation 16. Compensation given to subjects for lost earnings, for research travel costs, and
p.000022: other expenses incurred in taking subjects part in a study; free medical services; and
p.000022: compensation for the inconvenience and time spent by those who do not have direct benefit from the research should
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
p.000023: a. the research cannot be carried out equally well in adults;
p.000023:
...
p.000026:
p.000026: c. demonstrate the feasibility of doing the study as proposed, i.e., that the study can be completed
p.000026: successfully in the specified time and with the available resources;
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000027:
p.000027: 26. The purpose of the study, the design, the population, the methods of data collection, and the planned
p.000027: analyses shall be described in the protocol.
p.000027:
p.000027: 27. All procedures, whether invasive or not, should be satisfactorily described in detail.
p.000027:
p.000027: 28. The protocol should provide information on how the welfare of the participants shall be protected.
p.000027:
p.000027: 29. It is also advisable to include in the protocol the agreements on the time schedule, publication of research
p.000027: findings, and authorship (see Guidelines on Authorship and Publication, pp66-67).
p.000027:
p.000027: Qualifications 30. Persons engaged in health research involving of investigators human subjects
p.000027: should be scientifically qualified.
p.000027: The investigator must have the ability and skills to conduct the proposed study and the knowledge of the literature on
p.000027: the subject of interest.
p.000027:
p.000027: Protection of 31. In the conduct of biomedical or behavioral the environment research,
p.000027: appropriate caution shall be exercised and biosafety to avoid harm or damage to the environment
p.000027: (Principle 12 – Declaration of Helsinki, 2004).
p.000027:
p.000027: In the use of biological and hazardous materials including those that involved genetic modification and manipulation
p.000027: of microorganisms and of animal and plant tissue cells.
p.000027:
p.000027: Welfare of 32. In regard to the use of animals for research, animals
p.000027: investigators shall abide by RA No. 8485 - Animal Welfare Act of 1998 and its Implementing Rules
p.000027: and Regulations [DA Administrative Order No. 40 series of 1998 and the Code of Practice for the Care and Use of
p.000027: Laboratory Animals in the Philippines, 2nd edition, 2002 developed by the Philippine Association for Laboratory
p.000027: Animal Science (PALAS)].
p.000027:
p.000028: 28
p.000028:
p.000028: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000028:
p.000028:
p.000028: III. Other Considerations
p.000028:
p.000028: The National 33. In general, researches should adhere to the Unified Health national unified
p.000028: health research agenda that must Research be firmly grounded through a process of priority Agenda
p.000028: setting (Margetts, Arab, Nelson, & Kok, 1999).
p.000028:
p.000028: 34. Government-sponsored health researches should conform with the National Unified Health Research Agenda.
p.000028:
p.000028: Community 35. A larger and more difficult challenge is to involve participation the
p.000028: communities themselves in the research
p.000028: questions and to link the research to their own development. Such a participatory process with the community is a
p.000028: continuum that includes community consultation in protocol development, appropriate information disclosure and
...
p.000076: disorder that may be genetic, concerning the consequences of the disorder, the probability or developing or
p.000076: transmitting it, and the ways in which it may be prevented or ameliorated
p.000076:
p.000076: genetic research – the study of the structure and functions of individual genes, genetic variation in human
p.000076: populations, and the applications of genetics in diagnosis and patient care
p.000076:
p.000076: genetic screening – a population-based method for identifying a subset of individuals at risk of developing
p.000076: or of transmitting a specific genetic disease or disorder
p.000076:
p.000076: gene testing – analysis done on affected persons or carriers within family already identified because of a history of
p.000076: high risk for having or transmitting a specific genetic disorder
p.000076:
p.000076: Good Clinical Practice Guidelines (GCP) – an international ethical and scientific quality standard for designing,
p.000076: conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this
p.000076:
p.000077: 77
p.000077:
p.000077: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000077:
p.000077: standard provides public assurance that the rights, safety, and well- being of trial subjects are protected,
p.000077: consistent with the principles that have their origin in the International Declaration of Helsinki, and that the
p.000077: clinical trial data are credible (CPMP/ICH/135/95)
p.000077:
p.000077: – standards and procedures for clinical trials that encompass the design, protocol approval, monitoring,
p.000077: termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and
p.000077: activities of the sponsor, principal investigators and monitor involved in the clinical trials. The code GCP
p.000077: ensures that the studies are scientifically and ethically sound, and all the clinical properties of the product under
p.000077: investigation are properly documented. For compete information, reference is made to the published WHO and
p.000077: International Conference on Harmonization Code of Good Clinical Practice (Department of Health Administrative
p.000077: Order No. 47-A series of 2001 [August 30, 2001])
p.000077:
p.000077: – a standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses,
p.000077: reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound
p.000077: and that the clinical properties of the pharmaceutical products (diagnostic, therapeutic or prophylactic) under
p.000077: investigation are properly documented (World Health Organization, Guidelines for Good Clinical Practice (GCP) for
p.000077: trials of pharmaceutical products)
p.000077:
p.000077: – set of principles and rules that define the responsibilities of the sponsor, the researcher and participants in a
p.000077: clinical drug trial that ensures ethical conduct of research and integrity of research data
p.000077:
p.000077: good laboratory practices – are standards and procedures whereby a laboratory achieves a defined, consistent, and
...
p.000096: Ethics Review Authorities, 3-10 Ethics Review Committees, 5-10
p.000096: Foreign ERC, 26-27
p.000096: Role of, 26-27
p.000096: Experimental design,49, 76
p.000096: Exploitation of subjects, 50, 60 Family medical history, 57 Family studies, 57, 76
p.000096: Feasibility, 27, 76
p.000096: Feedback session, 49
p.000096: Fertilization success, 55
p.000096: Fetus, 76
p.000096:
p.000097: 97
p.000097:
p.000097: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000097:
p.000097:
p.000097: aborted, 63
p.000097: Forensic medicine, 59
p.000097: Gender, 77
p.000097: Gender bias,54, 77
p.000097: Gender issues, 55
p.000097: Gender sensitivity, 77
p.000097: General Ethical Guidelines, 16-29 Gene/s, 57, 77
p.000097: Cloning, 57, 71
p.000097: Activity, 77
p.000097: Gene expression, variability, 57 Genetics,
p.000097: behavioral, 57
p.000097: population-based, 57 genetic information, stored, 60 Genetic material, 45
p.000097: Genetic research, 57, 77
p.000097: Genetic testing, 57, 77
p.000097: Genetic traits, 59
p.000097: Good clinical practice, 38, 77
p.000097: Good laboratory practices, 32, 78 Good manufacturing practice, 32 Good Manufacturing Practice
p.000097: Guidelines, 39, 78
p.000097: Health equity, 64, 79
p.000097: Health research involving human Subjects, 16, 22
p.000097: Helsinki Declaration, 3,16
p.000097: Herbal products, 42
p.000097: Herbal remedies, 38
p.000097: Homeopathy, 43
p.000097: Human atrocities, 50
p.000097: Identifiable information, 67
p.000097: Inconvenience, 17 Indicators of success, 64 Inducement, 59
p.000097: Information in the public domain,46 Informed Consent, 11, 20, 21, 33, 40, 48,
p.000097: 52, 59, 67, 80
p.000097: Alternative methods, 47
p.000097: Verbal consent, 47, 48 Injury, research related, 19
p.000097: Institutional Ethics Review Committees (IERCs), 5-10, 87
p.000097: Appointment of members, 7
p.000097: Composition, 6-7
p.000097: Continuing education, 10
p.000097: External consultants, 7-8
p.000097: Functions and Responsibilities, 8-10 Meetings and Deliberations, 10 Training, 10
p.000097: Intellectual property sharing, 65, 81
p.000097: International collaborative research/es, 64, 81
p.000097: International Conference on Harmonization (ICH), 30, 39
p.000097: Interventional study, 54, 81
p.000097: Intervention programs, 51
p.000097: Intimidation, 21
p.000097: In vitro fertilization, 56 Investigator, principal/chief, 69, 70
p.000097: Animals, care and use of laboratory, 28 Legal representative, 24,25
p.000097: Linkage analysis, 57, 82
p.000097: Linking DNA samples to health records, 61
p.000097: Markers, 39
p.000097: Massage, 43
p.000097: Material transfer agreement, 41 Mind-body interventions, 43
p.000097: Meditation, 43
p.000097: Prayer, 43
p.000097: Mental healing, 43
p.000097: Art, 43
p.000097: Music therapy, 43 minutes of meeting,13 medical rationale, 26
p.000097: medical records, 46 medical services,19
p.000097: memorandum of agreement, 41 monitoring mechanism, 51
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.000047: guardian must be obtained. Assent of the minor must also be obtained, properly documented, and attested to by an
p.000047: impartial witness of legal age.
p.000047:
p.000047: Privacy and 3. The researcher shall respect the respondent’s confidentiality right to
p.000047: privacy and preserve the confidentiality of of information information. He/She shall make provisions
p.000047: to
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048:
p.000048: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000048:
p.000048: render the participants anonymous to those not directly involved in the research.
p.000048:
p.000048: 4. The researcher shall not release information that permits linking specific individuals to specific
p.000048: information. In cases where information pertaining to groups or specific communities exposes them to possible harm or
p.000048: abuse, the researcher shall refrain from identifying such groups or communities unless required by law.
p.000048:
p.000048: Access to 5. In carrying out experimental or quasi-experimental services or designs in
p.000048: field research, access to services or benefits benefits provided to the experimental group shall
p.000048: also be provided to the control group.
p.000048:
p.000048: 6. In the case of field research, the participants may be given information about the study through feedback
p.000048: sessions or other means, with the possible exception of the intervention being the benefit itself.
p.000048:
p.000048: 7. Where the research may cause emotional and psychological stress to the study participants, there shall be
p.000048: provisions for care and counseling.
p.000048:
p.000048: Withholding 8. The researcher should avoid deception. In information exceptional cases
p.000048: where the withholding of
p.000048: information may be justified by the integrity of the research design and the importance of the objectives,
p.000048: debriefing must be performed. However, in no instance should the withholding of information result into irreversible
p.000048: harm.
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000049:
p.000049: ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCH ON POPULATIONS TRAUMATIZED
p.000049: IN EMERGENCIES AND DISASTERS
p.000049:
p.000049: Introduction
p.000049:
p.000049: Traumatized populations live in communities that have experienced extreme forms of life- threatening stress due
p.000049: to natural calamities or human atrocities such as armed conflict, political repression as well as criminal and domestic
...
p.000052: implications of being identified as a potential HIV/AIDS case or of belonging to a high-risk
p.000052: group. Specific mechanisms to protect the privacy of individuals shall be described and put in place.
p.000052:
p.000052: 3. Special attention shall be given to the possible sensitive nature of the information to be extracted from the
p.000052: research participants and, if applicable, the necessity of undergoing an HIV test. It is also important to determine
p.000052: the participant’s willingness to be informed of the test result, the test’s
p.000052:
p.000053: 53
p.000053:
p.000053:
p.000053:
p.000053: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000053:
p.000053: reportability, and the implication on his/her sexual activities if found positive.
p.000053:
p.000053: The participant must also be informed that he/ she is free to withdraw from the study anytime.
p.000053:
p.000053: Pre- and 4. Pre- and post-test counseling by well-trained, post-test
p.000053: culture- and gender-sensitive research personnel counseling shall be put in place as part of
p.000053: the research
p.000053: protocol.
p.000053:
p.000053: Standard 5. In an interventional study, the control group shall of care receive
p.000053: the standard of care accepted by the larger community. It is unethical to subject the
p.000053: control group of affected individuals to placebo treatment or be withdrawn from the current mode of treatment before
p.000053: the start of the study.
p.000053:
p.000053: Research 6. Special effort shall be exerted to make the benefits beneficial
p.000053: findings of the research project accessible and available to participants under
p.000053: reasonable circumstances.
p.000053:
p.000053: Use of 7. Special care shall be taken in the public use of research data research data
p.000053: and the publication of reports so and publication that participant groups are not further stigmatized of
p.000053: reports or become blameworthy targets. Reports shall be
p.000053: carefully examined for gender and culture bias.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054:
p.000054: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000054:
p.000054: ETHICAL GUIDELINES FOR RESEARCH ON ASSISTED REPRODUCTIVE TECHNOLOGY
p.000054:
p.000054: Introduction
p.000054:
p.000054: Research in assisted reproductive technology includes studies to improve ovulatory rates, ejaculatory efficiency,
p.000054: embryo viability, fertilization success, and uterine hospitability. It may also involve studies on the
p.000054: psychosociocultural aspects of reproductive technology. Research in the reproductive health field in general is studded
...
p.000071:
p.000071: complementary medicine – a health treatment modality that is used together in a conventional or mainstream medicine
p.000071:
p.000071: conception – pregnancy beginning from the process of fertilization to form a zygote or its implantation
p.000071:
p.000071: conditional approval – approval of the protocol by the Ethics Committee to proceed after certain conditions or
p.000071: modifications set by the EC are met
p.000071:
p.000071: confidentiality – a duty of health care providers and health researchers toward patients and research participants to
p.000071: protect privacy and to refrain from unauthorized disclosure of information pertaining to them
p.000071:
p.000071: – prevention of disclosure of the IEC/IRB information, deliberations and documents to other than authorized individuals
p.000071:
p.000071: conflict of interest – a conflict of interest arises when a member (or members) of the Ethics Committee holds
p.000071: interests with respect to specific applications for review that may jeopardize his/her ability to provide a
p.000071: free and independent evaluation of the research focused on the protection of the research participants. Conflict of
p.000071: interests may arise when an EC member has financial, material, institutional or social ties to the research.
p.000071:
p.000071: control – the standard by which experimental observation are evaluated. In many clinical trials, one group of patients
p.000071: will be given an experimental drug or treatment, while the control group is either given a standard treatment for the
p.000071: illness or a placebo (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000071:
p.000071: controlled trials – a trial in which one group of participants is given an experimental drug, while another group (the
p.000071: control group) is given either a standard treatment for the disease or a placebo
p.000071:
p.000072: 72
p.000072:
p.000072: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000072:
p.000072: conventional medicine – (see Western medicine) that discipline of medical care advocating therapy with remedies that
p.000072: produce effects differing from those of the disease treated
p.000072:
p.000072: counseling – non-coercive interaction between a health professional and a patient/ client and/or family that is meant
p.000072: to clarify personal values and priorities, health care options, expectations, risks, benefits, and resources in
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
p.000072: cultural bias – prejudice based on community values and traditions
p.000072:
p.000072: culture – the way of life of groups of people that is defined by mores, shared values, traditions and sociopolitical
p.000072: structures and institutions
p.000072:
...
p.000083: indications, new methods of administration or new combinations, etc., are normality considered as trials for new
p.000083: pharmaceutical products. (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000083: products)
p.000083:
p.000083: Philippine Health Research Ethics Board – was created on March 1, 2006 through DOST Special Order No. 091 series of
p.000083: 2006 as a policy-making body for research ethics in the Philippines
p.000083:
p.000083: Philippine National Health Research System – formally organized in 2004, it was conceptualized in support of a
p.000083: vibrant, dynamic, and responsible health research community working on a unified health research agenda with enhanced
p.000083: cooperation between the Department of Health, the Department of Science and Technology, and the Commission on Higher
p.000083: Education. The Philippine Health Research Ethics Board is one of the six groups working under its Governing Council.
p.000083:
p.000083: placebo – a substance that is not biologically active, does not interact with other substances nor is it expected to
p.000083: affect the health status of an individual
p.000083:
p.000083: – an inactive pill, liquid, or powder that has no treatment value. In clinical trial, experimental treatments are
p.000083: often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the
p.000083: participants in the control group will receive a placebo instead of an
p.000083:
p.000084: 84
p.000084:
p.000084: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000084:
p.000084: active drug or experimental treatment (http://www.Clinicaltrials.gov/ct/ info/whatis. Retrieved May 17, 2006)
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
p.000084: pre-clinical trials – investigation of the pharmacologic properties of a drug or preparation done in animals prior to
p.000084: human studies. Pre-clinical studies shall include pharmacodynamics, pharmacokinetics, and toxicity studies (BFAD
p.000084: Guidelines for Registration of Pharmaceutical Products, 1997)
p.000084:
p.000084: predictive testing – determination of the presence of disease-associated genes prior to the onset or manifestation of
p.000084: the disease
p.000084:
p.000084: predisposition or risk testing – determination of genetic parameters in an individual associated with increased risk of
p.000084: disease
p.000084:
p.000084: prenatal testing – determination of whether a fetus has (or probably has) a designated condition for which an increased
p.000084: risk is indicated by later maternal age, family history, or other well-defined risk factors
p.000084:
p.000084: prior dose finding – quantity or dosage of the herbal medicine established in earlier studies or practice to be
p.000084: effective
p.000084:
...
p.000092: research involving human subjects. Guideline 4.
p.000092:
p.000092: Department of Health. (2001). Administrative Order 47-A s 2001. Rules and regulations on the registration including
p.000092: approval and conduct of clinical trials, and lot or batch release certification of vaccines and biologic products.
p.000092:
p.000092: Freedman, R. (1987). Equipose and the ethics of clinical research. New England Journal of Medicine 317(3), 141-145.
p.000092:
p.000092: Gordis, L. & Gold, E. (1980). Privacy, confidentiality, and the use of medical records in research. Science 207, 153-6.
p.000092:
p.000092: International Conference on Harmonization. (1996). Guidance for industry; E6 Good clinical practice: Consolidated
p.000092: guidelines.
p.000092:
p.000092: International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for
p.000092: Human Use. (1995). ICH harmonized tripartite guideline, structure and content of clinical study reports (E3).
p.000092:
p.000092: International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human
p.000092: Use. (1996). ICH harmonized tripartite guideline, guideline for good clinical practice (E6) (R1).
p.000092:
p.000092: International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human
p.000092: Use. (1997). ICH harmonized tripartite guideline, general consideration for clinical trials (E8).
p.000092:
p.000092: International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for
p.000092: Human Use. (2000). ICH harmonized tripartite guideline, choice of control group and related issues in clinical
p.000092: trials (E10).
p.000092:
p.000093: 93
p.000093:
p.000093: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000093:
p.000093: Lansang, M. A. & Crawley, F. P. (2000). The ethics of international biomedical research. British Medical Journal 321,
p.000093: 777-778.
p.000093:
p.000093: Margetts, B., Arab L., Nelson M., & Kok F. (1999). Who and what sets the international agenda for research and public
p.000093: health action? Public Health Nutrition 2, 35-36.
p.000093:
p.000093: National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH), US
p.000093: Department of Health and Human Services. (2006). Understanding CAM. Retrieved (March 10, 2006) from
p.000093: http://nccam.nih.gov/.
p.000093:
p.000093: Reyes, Marita V. T. (2004). Directions in Philippine health research: ethics review. Proceedings of the 1st Philippine
p.000093: National Health Research System Assembly. Manila.
p.000093:
p.000093: Rothman, K. (1991). The ethics of research sponsorship. Journal of Clinical Epidemiology 44, 25S-28S.
p.000093:
p.000093: South African Medical Research Council. (2005). Guide to ethical considerations in medical research.
p.000093:
p.000093: Swiss Commission for Research Partnership with Developing Countries. (1998). Guidelines for research in partnership
p.000093: with developing countries. Berne: Swiss Academy of Sciences.
p.000093:
...
Searching for indicator placebo:
(return to top)
p.000021: Community 11. The conclusion or termination of the research care activity
p.000021: should not preclude the possibility of administering extended community care. This
p.000021: should be especially considered in researches involving depressed communities, ethnic groups or in international
p.000021: collaborative protocols (Bhutta, 2000).
p.000021:
p.000021: Privacy and 12. Every precaution should be taken to respect the confidentiality privacy of the
p.000021: participant and the confidentiality
p.000021: of the participant’s information.
p.000021:
p.000021:
p.000021: Disclosure of 13. Disclosure of research results to subjects should research results occur only when
p.000021: all of the following apply:
p.000021:
p.000021: a. the findings are scientifically valid and confirmed;
p.000021:
p.000021: b. the findings have significant implications for the subject’s health concerns; and
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000022:
p.000022: c. the course of action to ameliorate or treat these concerns is readily available when research results
p.000022: are disclosed to its subjects. Appropriate medical advice or referral should be provided.
p.000022:
p.000022: Standard of care 14. The particular needs of the economically and
p.000022: medically disadvantaged must be recognized in determining the standard of care that must be provided them as
p.000022: research subjects.
p.000022:
p.000022: 15. The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best
p.000022: current prophylactic, diagnostic, or therapeutic methods. Placebo, or no treatment, may be used in studies
p.000022: where no proven prophylactic, diagnostic, or therapeutic method exists (Principle 29 – Declaration of Helsinki,
p.000022: 2004).
p.000022:
p.000022: Compensation 16. Compensation given to subjects for lost earnings, for research travel costs, and
p.000022: other expenses incurred in taking subjects part in a study; free medical services; and
p.000022: compensation for the inconvenience and time spent by those who do not have direct benefit from the research should
p.000022: not be so large, or the medical services so extensive as to induce the prospective subjects to consent to participate
p.000022: in the research against their better judgment (Guideline 7 – CIOMS, 2002).
p.000022:
p.000022: Subject groups 17. Some populations require special protection that require because of
p.000022: characteristics or situations that render special them vulnerable. Vulnerable groups should not
p.000022: consideration be included in research unless a) such research
p.000022: is necessary to promote the health of the population represented, and b) such research cannot be
p.000022: performed on legally competent persons.
p.000022:
p.000022: 18. Before undertaking research involving children, the investigator shall ensure that:
p.000022:
p.000023: 23
p.000023:
p.000023: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000023:
...
p.000029: pre-marketing phases, or to establish a new clinical indication for a drug. Such research is to be distinguished from
p.000029: marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug reactions in that
p.000029: these categories ordinarily need not be reviewed by ethics review committees.
p.000029:
p.000029: The four conventional phases in clinical drug development present different ethical issues. Careful
p.000029: consideration should be noted and addressed in each phase as indicated in the International Conference on
p.000029: Harmonization (ICH) Harmonized Tripartite Guidelines for Good
p.000029:
p.000030: 30
p.000030:
p.000030:
p.000030:
p.000030: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000030:
p.000030: Clinical Practice, General Consideration for Clinical Trials (E8).
p.000030:
p.000030: General 1. All research involving human subjects should be guidelines conducted in
p.000030: accordance with the ethical
p.000030: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000030:
p.000030: 2. All clinical trials must have scientific and social value and, therefore, shall be adequately justified.
p.000030:
p.000030: 3. The various phases of the pharmaceutical trial present different ethical issues that should be keenly looked
p.000030: into by the institutional ethics review committee (IERC). These issues include product toxicities in Phase I, use of
p.000030: placebo in Phases II and III, and professional integrity and conflict of interest in post-marketing activities in Phase
p.000030: IV.
p.000030:
p.000030: Clinical 4. Investigator/s involved in clinical trials shall be equipoise
p.000030: governed by clinical equipoise. A state of clinical
p.000030: equipoise means that on the basis of available data, a condition of genuine uncertainty on the part of the clinical
p.000030: investigator/s and/or a community of medical experts exists regarding the comparative therapeutic merits of each
p.000030: arm in a trial. Thus they would be content to have their patients/clients pursue any of the treatment strategies
p.000030: being tested since none of them has been clearly established as preferable.
p.000030:
p.000030: Enlistment 5. The investigators/ should have adequate time to period enlist the
p.000030: necessary number of participants to, and
p.000030: conduct the trial.
p.000030:
p.000030: Adequacy of 6. The investigator/s should have adequate and fully staff and informed
p.000030: staff, and adequate facilities to facilities accurately and carefully undertake the trial.
p.000030:
p.000030: Compliance 7. A clinical research shall comply with the necessary with regulatory regulatory
p.000030: requirements for the conduct of the requirements clinical trial based on the current rules and
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000031:
p.000031: regulations on the approval and conduct of clinical trials issued by the Department of Health - Bureau of Food and
p.000031: Drugs (DOH-BFAD) in Administrative Order 47-A dated August 30, 2001.
p.000031:
...
p.000031: the product shall be made available for review.
p.000031:
p.000031: 9. Good laboratory practices shall be strictly observed when a clinical trial requires laboratory assay.
p.000031:
p.000031: Agreement 10. The investigator/s shall establish with the sponsor with sponsor an agreement on
p.000031: the protocol, standard operating
p.000031: procedures, monitoring, and auditing of the trial and allocation of trial-related responsibilities including
p.000031: publication and authorship.
p.000031:
p.000031: Protocol 11. The protocol shall at least contain the following:
p.000031:
p.000031: a. General information about the trial such as investigator/s, sponsor/s, monitor/s, other qualified medical
p.000031: expert/s, diagnostic laboratories, and research institutions involved.
p.000031:
p.000031: b. Background information regarding the product under investigation, relevant current research findings and
p.000031: references to such information and data, potential risks and benefits, reasons for the indicated route of
p.000031: administration, dosage, periods of treatment, population to be studied, a declaration regarding
p.000031:
p.000032: 32
p.000032:
p.000032:
p.000032:
p.000032: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000032:
p.000032: compliance with good clinical practice, and regulatory requirements.
p.000032:
p.000032: c. Objectives and purpose.
p.000032:
p.000032: d. Trial design, which substantially determines the scientific integrity of the trial and reliability of the data,
p.000032: and which shall include the following:
p.000032:
p.000032: 1) Description of the type of design and trial plan (double-blind, placebo controlled, parallel design) and
p.000032: diagram of procedures and stages
p.000032: 2) Primary and secondary endpoints to be measured
p.000032: 3) Measures to minimize or avoid bias, such as randomization and blinding
p.000032: 4) Trial treatments and investigation product’s dosage, packaging, labeling, and storage
p.000032: 5) Estimated duration of subjects’ participation in the trial
p.000032: 6) Discontinuation rules for the subjects and the trial
p.000032: 7) Treatment randomization codes maintenance and rules on breaking the code
p.000032: 8) Procedures for accountability for product being investigated, placebos, and comparators
p.000032: 9) Other sources of data
p.000032:
p.000032: e. Selection and withdrawal of participants, which include inclusion, exclusion, and withdrawal criteria
p.000032:
p.000032: f. Informed consent
p.000032:
p.000032: g. Subjects’ therapy or treatment, and monitoring procedures
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033:
p.000033: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000033:
p.000033: h. Efficacy parameters, methods, and timing
p.000033:
p.000033: i. Safety parameters, methods, timing, and procedures for recording and reporting as well as monitoring adverse
p.000033: reactions
p.000033:
p.000033: j. Plan for data and statistical analysis
p.000033:
p.000033: k. Statement regarding direct access to trial data and documents for monitoring, audits, institutional ethics
p.000033: committee reviews, and regulatory inspections
p.000033:
p.000033: l. Ethical considerations
p.000033:
p.000033: m. Data management and record keeping
p.000033:
p.000033: n. Financing and insurance
p.000033:
p.000033: o. Publication plans and procedures
p.000033:
p.000033: p. Clinical trial participants’ information sheet/ brochure
p.000033:
p.000033: 12. Any amendment/s to the protocol should be resubmitted to the IERC and BFAD.
p.000033:
p.000033: Use of placebo 13. Use of placebo is generally not acceptable when
p.000033: there are standard treatments available to a patient population. Thus, a placebo control may be used only when –
p.000033:
p.000033: a. Standard therapy is unavailable
p.000033: b. Existing treatment is of unproven efficacy, or possesses unacceptable side-effects
p.000033: c. The placebo itself is an effective therapy
p.000033: d. The disease has little adverse effect on the patient
p.000033: e. Testing an add-on treatment to a standard therapy when all subjects get all treatments that would normally
p.000033: be given
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034:
p.000034: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000034:
p.000034: f. The patient has provided informed rejection or refusal of standard therapy for a minor condition for
p.000034: which the patient refuses treatment, and when such refusal for therapy will not lead to unjustified affliction
p.000034: or irreparable damage or harm
p.000034:
p.000034: Informed 14. Refer to section on Informed Consent in the consent General
p.000034: Ethical Guidelines for Health Research
p.000034: (pp16-29).
p.000034:
p.000034: Therapy versus 15. The difference between therapy and research research shall be upheld
p.000034: throughout a clinical trial. The
p.000034: investigator/s shall ensure that participants comprehend and keep in mind that in a clinical trial, the drug is
p.000034: experimental and that its benefits are currently being proven.
p.000034:
p.000034: Research on 16. Clinical trials of medical devices, diagnostic medical devices, procedures, and
p.000034: preventive measures, including diagnostic vaccines, raise similar ethical concerns especially
...
p.000039: studied and assessed are the same.
p.000039:
p.000039: 7. In the absence of a standard for the test preparation, the geographic area, maturity of collection
p.000039: of the plant, and the method of its preparation must be clearly described.
p.000039:
p.000039: 8. Priority should be given to clinical trials that are responsive to the country’s health/economic needs.
p.000039:
p.000039: Special guidelines
p.000039:
p.000039: Informed 9. Uncertainty regarding product adulteration, consent interactions
p.000039: between herbal remedies and other entities, minimal toxicity data, and incomplete prior
p.000039: dose finding must be clearly disclosed to all concerned, particularly in the informed consent process (WHO
p.000039: Operational Guidance: Information needed to support clinical trials of herbal products, 2005).
p.000039:
p.000039: Recruitment 10. When normal volunteers are recruited, participants of volunteers must preferably
p.000039: come from the community where
p.000039: the herbal preparations are frequently used.
p.000039:
p.000039: Participation 11. Cultural settings and expectations must be of traditional considered in
p.000039: the review of the proposal and this healers may require inviting a traditional healer or a known
p.000039: scholar of herbal medicines in the ethics review
p.000039: board.
p.000039:
p.000039: Research 12. Placebo-controlled trials may be accommodated design in consonance
p.000039: with the guidelines on the use of placebo as indicated in Ethical Guidelines for
p.000039: Clinical Trials on Drugs, Devices, and Diagnostics
p.000039: - 13b, 13d, and 13f.
p.000039:
p.000039: 13. Effectiveness of herbal preparations may not only be measured with improvements in health or disappearance of
p.000039: physical symptoms and other
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040:
p.000040: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000040:
p.000040: disease-related variables. It may also be measured in terms of overall health and well- being.
p.000040:
p.000040: Transport 14. No indigenous materials used in the research may of materials be
p.000040: transported outside the country unless the
p.000040: source (represented by the community leader, government agency or institution) of the material and the recipient
p.000040: sign a material transfer agreement.
p.000040:
p.000040: 15. Researchers must comply with the transfer agreement if plant products or herbal preparations will be tested
p.000040: outside the country.
p.000040:
p.000040: Benefit sharing 16. Where possible, the community from where the
p.000040: medicine originates should be consulted during the course of the research, and the results and benefits of the research
p.000040: should be shared with this community (WHO Operational Guidance: Information needed to support clinical trials
p.000040: of herbal products, 2005).
p.000040:
p.000040: 17. A memorandum of agreement regarding benefit sharing and patenting conditions especially for indigenous plant
p.000040: products must be set as early as the planning stage of the research.
p.000040:
...
p.000052: group. Specific mechanisms to protect the privacy of individuals shall be described and put in place.
p.000052:
p.000052: 3. Special attention shall be given to the possible sensitive nature of the information to be extracted from the
p.000052: research participants and, if applicable, the necessity of undergoing an HIV test. It is also important to determine
p.000052: the participant’s willingness to be informed of the test result, the test’s
p.000052:
p.000053: 53
p.000053:
p.000053:
p.000053:
p.000053: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000053:
p.000053: reportability, and the implication on his/her sexual activities if found positive.
p.000053:
p.000053: The participant must also be informed that he/ she is free to withdraw from the study anytime.
p.000053:
p.000053: Pre- and 4. Pre- and post-test counseling by well-trained, post-test
p.000053: culture- and gender-sensitive research personnel counseling shall be put in place as part of
p.000053: the research
p.000053: protocol.
p.000053:
p.000053: Standard 5. In an interventional study, the control group shall of care receive
p.000053: the standard of care accepted by the larger community. It is unethical to subject the
p.000053: control group of affected individuals to placebo treatment or be withdrawn from the current mode of treatment before
p.000053: the start of the study.
p.000053:
p.000053: Research 6. Special effort shall be exerted to make the benefits beneficial
p.000053: findings of the research project accessible and available to participants under
p.000053: reasonable circumstances.
p.000053:
p.000053: Use of 7. Special care shall be taken in the public use of research data research data
p.000053: and the publication of reports so and publication that participant groups are not further stigmatized of
p.000053: reports or become blameworthy targets. Reports shall be
p.000053: carefully examined for gender and culture bias.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054:
p.000054: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000054:
p.000054: ETHICAL GUIDELINES FOR RESEARCH ON ASSISTED REPRODUCTIVE TECHNOLOGY
p.000054:
p.000054: Introduction
p.000054:
p.000054: Research in assisted reproductive technology includes studies to improve ovulatory rates, ejaculatory efficiency,
p.000054: embryo viability, fertilization success, and uterine hospitability. It may also involve studies on the
p.000054: psychosociocultural aspects of reproductive technology. Research in the reproductive health field in general is studded
p.000054: with gender issues.
p.000054:
...
p.000070: detect certain diseases or health conditions. Quality of life trials or supportive care trials explore ways to improve
p.000070: comfort and the quality of life for individuals with a chronic illness.
p.000070: (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000070:
p.000070: – a systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to
p.000070: discover or verify the effects of and/or identify any adverse reactions to investigational products, and/or to study
p.000070: the absorption, distribution, metabolism, and excretion of the products with the object of ascertaining their efficacy
p.000070: and safety (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000070:
p.000070: – Investigative work to evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly
p.000070: scientifically controlled settings. Clinical trials may be designed to assess the safety and efficacy of an
p.000070: experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the
p.000070: efficacy of two standard or marketed interventions
p.000070:
p.000070: cloning human genes – transfer of human DNA sequences of interest into nonhuman cells with the purpose of
p.000070: expression, genetic manipulation, and amplification
p.000070:
p.000070: cohort study – type of investigation in which exposure is assessed among unaffected persons and subjects are
p.000070: then observed for subsequent development of the disease
p.000070:
p.000070: comparator (product) – an investigational or marketed product (i.e., active control), or placebo, used as
p.000070: reference in a clinical trial (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6,R1)
p.000070:
p.000070: – a pharmaceutical or other product (which may be a placebo) used as a reference in a clinical trials (WHO Guidelines
p.000070: for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000070:
p.000071: 71
p.000071:
p.000071: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000071:
p.000071: compensation – payments received by the research participants as reimbursement for lost earnings, travel costs and
p.000071: other expenses incurred as a study participant, as reparation for inconvenience and time spent
p.000071:
p.000071: complementary and alternative medicine research – study done in human volunteers to determine the effects
p.000071: of and/or identify any adverse reactions to maneuvers word in complementary and alternative medicine
p.000071:
p.000071: – study undertaken on a systematic and rigorous basis to generate new knowledge regarding diverse medical and health
p.000071: care systems, practices and products that are not presently considered to be part of conventional medicine
p.000071:
p.000071: complementary medicine – a health treatment modality that is used together in a conventional or mainstream medicine
p.000071:
p.000071: conception – pregnancy beginning from the process of fertilization to form a zygote or its implantation
p.000071:
p.000071: conditional approval – approval of the protocol by the Ethics Committee to proceed after certain conditions or
p.000071: modifications set by the EC are met
p.000071:
p.000071: confidentiality – a duty of health care providers and health researchers toward patients and research participants to
p.000071: protect privacy and to refrain from unauthorized disclosure of information pertaining to them
p.000071:
p.000071: – prevention of disclosure of the IEC/IRB information, deliberations and documents to other than authorized individuals
p.000071:
p.000071: conflict of interest – a conflict of interest arises when a member (or members) of the Ethics Committee holds
p.000071: interests with respect to specific applications for review that may jeopardize his/her ability to provide a
p.000071: free and independent evaluation of the research focused on the protection of the research participants. Conflict of
p.000071: interests may arise when an EC member has financial, material, institutional or social ties to the research.
p.000071:
p.000071: control – the standard by which experimental observation are evaluated. In many clinical trials, one group of patients
p.000071: will be given an experimental drug or treatment, while the control group is either given a standard treatment for the
p.000071: illness or a placebo (http://www.Clinicaltrials.gov/ct/info/whatis. Retrieved May 17, 2006)
p.000071:
p.000071: controlled trials – a trial in which one group of participants is given an experimental drug, while another group (the
p.000071: control group) is given either a standard treatment for the disease or a placebo
p.000071:
p.000072: 72
p.000072:
p.000072: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000072:
p.000072: conventional medicine – (see Western medicine) that discipline of medical care advocating therapy with remedies that
p.000072: produce effects differing from those of the disease treated
p.000072:
p.000072: counseling – non-coercive interaction between a health professional and a patient/ client and/or family that is meant
p.000072: to clarify personal values and priorities, health care options, expectations, risks, benefits, and resources in
p.000072: order to help in decision-making. It needs to be offered prior to sensitive testing (pre-test counseling) and/or after
p.000072: testing (post-test counseling) for comprehensive care
p.000072:
p.000072: criminal violence – behaviors by individuals that intentionally threaten, attempt, or inflict physical harm on others
p.000072: (National Research Council’s Panel on the Understanding and Control of Violent Behavior, citing Reiss and Roth, 1993,
p.000072: p. 2, emphasis in original)
p.000072:
p.000072: cultural bias – prejudice based on community values and traditions
p.000072:
p.000072: culture – the way of life of groups of people that is defined by mores, shared values, traditions and sociopolitical
p.000072: structures and institutions
p.000072:
p.000072: debriefing – the process of obtaining information about an experience from an individual who has participated in, or
p.000072: observed particular events
p.000072:
...
p.000082: developed and developing countries or rich and poor countries
p.000082:
p.000082: participatory research – research that involves the participation of the investigator in the activities of the research
p.000082: population. It could also involve involves research subjects in the definition of the research agenda, the conduct of
p.000082: research, monitoring and evaluation, and dissemination of results.
p.000082:
p.000082: patent – government instrument that assigns ownership of a product or creative work that is accompanied by certain
p.000082: rights
p.000082: pharmacodynamics – the study of what a drug does to the body pharmacogenetics – the field of biochemical genetics
p.000082: concerned with drug
p.000082: responses due to genetically-controlled variations
p.000082:
p.000082: pharmacokinetics – the study of what the body does to a drug
p.000082:
p.000082: Phase I clinical trial – the first trials of a new active ingredient or new formulations in man, often carried out
p.000082: in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a first outline of
p.000082: the pharmacokinetic and, where possible, a phramacodynamic profile of the active ingredients in humans. (WHO,
p.000082: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000082: Phase II clinical trial –trials performed in a limited number of subjects, often at a later stage of a comparative
p.000082: (e.g., placebo-controlled) design. Their purpose is to demonstrate therapeutic activity and assess short-term safety of
p.000082: the active ingredient in patients suffering from a disease or condition for which the active ingredient is intended.
p.000082: This phase also aims at the determination of appropriate dose ranges or regimens and (if possible) clarification of
p.000082: dose-response relationships in order to provide an optimal background for the design of extensive therapeutic
p.000082: trials (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000082:
p.000083: 83
p.000083:
p.000083: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000083:
p.000083: Phase III clinical trial – trials in larger (and possibly varied) patient groups with the purpose of determining
p.000083: the short- and long-term safety/efficacy balance of formulation/s of the active ingredient, and of assessing its
p.000083: overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated
p.000083: and special features of the product must be explored (e.g., clinically relevant drug interactions, factors leading to
p.000083: differences in effect such as age). These trials should preferably be of a randomized double-blind design, but other
p.000083: designs may be acceptable (e.g., long-term safety studies). Generally, the conditions under which these trials
p.000083: are carried out should be as close as possible to normal conditions of use. (WHO Guidelines for Good Clinical Practice
p.000083: (GCP) for trials of pharmaceutical products)
p.000083:
p.000083: Phase IV clinical trial – studies performed after marketing of the pharmaceutical product. Trials in this phase are
p.000083: carried out on the basis of the product characteristics on which the marketing authorization was granted and are
p.000083: normally in the form of the post-marketing surveillance, or assessment of therapeutic value or treatment
p.000083: strategies. Although methods may differ, these studies should use the same scientific and ethical standards as applied
p.000083: in pre-marketing studies. After a product has been placed on the market, clinical trials designed to explore new
p.000083: indications, new methods of administration or new combinations, etc., are normality considered as trials for new
p.000083: pharmaceutical products. (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical
p.000083: products)
p.000083:
p.000083: Philippine Health Research Ethics Board – was created on March 1, 2006 through DOST Special Order No. 091 series of
p.000083: 2006 as a policy-making body for research ethics in the Philippines
p.000083:
p.000083: Philippine National Health Research System – formally organized in 2004, it was conceptualized in support of a
p.000083: vibrant, dynamic, and responsible health research community working on a unified health research agenda with enhanced
p.000083: cooperation between the Department of Health, the Department of Science and Technology, and the Commission on Higher
p.000083: Education. The Philippine Health Research Ethics Board is one of the six groups working under its Governing Council.
p.000083:
p.000083: placebo – a substance that is not biologically active, does not interact with other substances nor is it expected to
p.000083: affect the health status of an individual
p.000083:
p.000083: – an inactive pill, liquid, or powder that has no treatment value. In clinical trial, experimental treatments are
p.000083: often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the
p.000083: participants in the control group will receive a placebo instead of an
p.000083:
p.000084: 84
p.000084:
p.000084: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000084:
p.000084: active drug or experimental treatment (http://www.Clinicaltrials.gov/ct/ info/whatis. Retrieved May 17, 2006)
p.000084:
p.000084: placebo-controlled trials – clinical trials that assign the administration of a placebo to the control group while the
p.000084: test drug is given to the experimental group
p.000084:
p.000084: population-based genetics – the study of the distribution of genes in populations and of how the frequencies of genes
p.000084: and genotypes are maintained or changed
p.000084:
p.000084: pre-clinical trials – investigation of the pharmacologic properties of a drug or preparation done in animals prior to
p.000084: human studies. Pre-clinical studies shall include pharmacodynamics, pharmacokinetics, and toxicity studies (BFAD
p.000084: Guidelines for Registration of Pharmaceutical Products, 1997)
p.000084:
p.000084: predictive testing – determination of the presence of disease-associated genes prior to the onset or manifestation of
p.000084: the disease
p.000084:
p.000084: predisposition or risk testing – determination of genetic parameters in an individual associated with increased risk of
p.000084: disease
p.000084:
p.000084: prenatal testing – determination of whether a fetus has (or probably has) a designated condition for which an increased
p.000084: risk is indicated by later maternal age, family history, or other well-defined risk factors
p.000084:
p.000084: prior dose finding – quantity or dosage of the herbal medicine established in earlier studies or practice to be
p.000084: effective
...
p.000088:
p.000089: 89
p.000089:
p.000089: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000089:
p.000089: responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates
p.000089: and takes full for a trial, the investigator then also assumes the role of the sponsor responsibility (WHO
p.000089: Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)
p.000089:
p.000089: standard of care – health care intervention or regimen that is generally accepted by health practitioners and experts
p.000089: as beneficial to an individual needing such care
p.000089:
p.000089: prophylactic – professionally accepted level and type of preventive management to prevent the occurrence
p.000089: of a particular health condition
p.000089:
p.000089: diagnostic – professionally accepted level and type of examination to determine a patient’s health condition
p.000089:
p.000089: therapeutic – professionally accepted level and type of treatment or assistance for a particular health condition
p.000089:
p.000089: stem cell research – the study of the properties, development, and transformation of primordial progenitor cells prior
p.000089: to establishment of specialized cells
p.000089:
p.000089: stigma – the negative regard (e.g., shame and dishonor) of the community or society to particular groups because of
p.000089: disability, illness, occupation, poverty, etc. as dictated by culture
p.000089:
p.000089: study/investigational product – a pharmaceutical form of an active ingredient or placebo being tested or used as a
p.000089: reference in a clinical trial, including a product with marketing authorization when used or assembled
p.000089: (formulated or packaged) in a way different from the approved form, or when used fro an unapproved indication, or when
p.000089: used to gain further information about an approved use (ICH Harmonized Tripartite Guideline, Guideline for Good
p.000089: Clinical Practice [E6,R1])
p.000089:
p.000089: susceptibility – genetic condition leading to the development of a disease technical review – see scientific review
p.000089: teratogenicity – the degree or measure of the ability to cause malformations of an embryo or fetus
p.000089:
p.000089: termination of the research – the research study may be ended before its scheduled completion when the safety or
p.000089: benefit of the study participants is doubtful or at risk.
p.000089:
p.000090: 90
p.000090:
p.000090: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000090:
p.000090: test preparation – the formulation or preparation of the herbal remedy or product that is going to be used in the study
p.000090:
p.000090: traditional and alternative health care – the sum total of knowledge, skills and practices on health care, other than
p.000090: those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical and mental disorder (TAMA
p.000090: 1997)
p.000090:
p.000090: Traditional and Alternative Medicine Act (TAMA) – the 1997 law creating the Philippine Institute of Traditional and
p.000090: Alternative Health Care (PITAHC) to accelerate the development of traditional and alternative health care in the
...
p.000097: Markers, 39
p.000097: Massage, 43
p.000097: Material transfer agreement, 41 Mind-body interventions, 43
p.000097: Meditation, 43
p.000097: Prayer, 43
p.000097: Mental healing, 43
p.000097: Art, 43
p.000097: Music therapy, 43 minutes of meeting,13 medical rationale, 26
p.000097: medical records, 46 medical services,19
p.000097: memorandum of agreement, 41 monitoring mechanism, 51
p.000097: moral agent, 55
p.000097: multifactorial inheritance, 57, 82
p.000097: mutagenicity, 26, 82
p.000097: National Ethics Committee, 3, 5, 87
p.000097: National Unified Health Agenda, 29, 83
p.000097: Natural calamities, 50
p.000097: Naturopathy, 43
p.000097: North-south research collaboration, 64, 83
p.000097: Non-disclosure, 52, 83
p.000097:
p.000098: 98
p.000098:
p.000098: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000098:
p.000098:
p.000098: Nuremberg Code, 3
p.000098: Observational studies, 45, 48 Oriental traditional medicine, 43
p.000098: Ayurveda Unani
p.000098: Traditional Chinese medicine Osteopathic manipulation Ovulatory rates
p.000098: Ovum/ ova, 55, 56
p.000098: Photographs, 67
p.000098: Pain, 17
p.000098: Parallel design, 33 Participant
p.000098: Observation, 48
p.000098: Selection, 33
p.000098: Withdrawal, 33
p.000098: Participatory research, 52, 83
p.000098: Patenting, 41
p.000098: Personal data, 47 Person of authority, 47 pharmacogenetics, 83
p.000098: Philippine Health Research Ethics Board (PHREB), 3-4
p.000098: Functions, 4
p.000098: Philippine National Health Research System, 3
p.000098: Philippine Obstetrical and Gynecological Society (POGS), 55
p.000098: Philippine Society of Reproductive Endocrinology and Infertility, 55
p.000098: Placebo, 31, 33, 34, 84
p.000098: Placebo-controlled, 33, 40, 85
p.000098: Political repression, 50
p.000098: Post-marketing surveillance, 30
p.000098: Practitioner, qualified, 55
p.000098: Preclinical studies, 32, 85
p.000098: Predictive testing, 57, 59, 85
p.000098: Predisposition, 57, 85
p.000098: Pregnancy test, 25
p.000098: Pre-marketing phase, 30
p.000098: Prenatal testing, 57, 85
p.000098: Privacy,18,22,45,48, 61, 85
p.000098: Procedures, invasive, 28
p.000098: Product toxicities, 31
p.000098: Protein, 57, 58
p.000098: Protocol, 32, (see also research protocol), 85
p.000098: Psychocultural aspects, 53, 55
p.000098: Psychosocial needs, 51, 86
p.000098: Publication, 36, 54, 67
p.000098: Impediments to, 67 Qualifications of investigators, 28 Quality of life, 43, 86
p.000098: Quasi-experimental design, 49, 86
p.000098: Questionnaire, 47
p.000098: Quorum, 12
p.000098: Randomization, 17, 33, 86 Randomized controlled trials, 43 Reconsideration, 14 Recruitment,40,53
p.000098: Referral mechanism,51 Refusal, child, 24
p.000098: Regional Health Research Ethics Boards, 3, 5
p.000098: Composition, 5
p.000098: Functions, 5
p.000098: Religious issues, 55
p.000098: Reportability, 54, 86
p.000098: Reprisals, 50
p.000098: Research agreement, 65
p.000098: Rescue medication, 44, 87
p.000098: Research capacity, Investment, 64
p.000098: Local, 64
p.000098: strengthening, 29
p.000098: Research design, 17
p.000098: Research Ethics Review Process Required documents, 11-12
p.000098: Research Protocol, 11, 27-28, 88
p.000098: Research team, 51
...
Orphaned Trigger Words
p.000096: of ethical guidelines.
p.000096:
p.000096: In the past few years, the use of the term “human subjects” in reference to individuals involved in the research has
p.000096: been criticized especially by social scientist as an objectification of persons. The recommendation is to use the term
p.000096: “human participants”. However, participation in research includes involvement in the different phases of
p.000096: research including identification of objectives and designing the protocol. In practice, many of health researches are
p.000096: conceptualized without the input of the potential “participants” and therefore, the use of the latter term is
p.000096: inaccurate. In this set of guidelines, therefore the terms “human subjects” and “human participants” are used
p.000096: interchangeably.
p.000096:
p.000096: Three appendices are provided in these guidelines. Appendix A is a template for patient information and informed
p.000096: consent forms. The template lists the essential information that should be reflected in the patient information and
p.000096: informed consent forms. By answering each question under each heading, the proponent/s would be able to make the
p.000096: potential study participant understand the nature, risks, and benefits of his/her participation in the study, and
p.000096: thus be able to decide to participate or not. Appendix B is the standard application form for ethical evaluation
p.000096: of proposal that must be submitted to the ethics review committees (ERC’s) together with the proposal.
p.000096: Appendix C lists the documents that the proponent/s should provide the Ethics Review Committee.
p.000096:
p.000096: A glossary of technical terms is available as a quick reference. (pp68-94)
p.000096:
p.000096: It is important for the readers to familiarize themselves with the General Ethical Guidelines for Health Research
p.000096: (pp16-29) which contain the general provisions on the various elements of and considerations in
p.000096:
p.000096: viii
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: research ethics. Some elements of research ethics (e.g., informed consent) as operationally applied in
p.000096: specific types of research, say, genetic studies, are discussed in great detail in the guidelines for that
p.000096: particular type of research. These specific provisions complement those in the General Ethical Guidelines. They should
p.000096: not be considered as separate from the general guidelines. The subject index (pp96-100) should be able to direct
p.000096: the reader to all the sections where a particular item appears.
p.000096:
p.000096: Much effort was exerted to make this guidebook easy to use by researchers, by members of the ERCs and
p.000096: funding agencies, by research policy makers and even by young students in health research.
p.000096:
p.000096: For questions, please call/ email –
p.000096:
p.000096: The Secretariat, Philippine Health Research Ethics Board (PHREB) Philippine Council for Health Research and Development
p.000096: Department of Science and Technology
p.000096: General Santos Avenue, Bicutan, Taguig City Telephone Number(s): 837-7535/36
p.000096: Fax Number: 837-2924
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096: ix
p.000096:
p.000096: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000096:
p.000096: ABBREVIATIONS
p.000096: AO - administrative order
p.000096: BFAD - Bureau of Food and Drugs
p.000096: CAM - complementary and alternative medicine CERC - Cluster Ethics Review Committee
...
p.000096: guidelines still need to be developed so that research ethics can be embedded in the local practices as well as
p.000096: national laws and regulations while taking into consideration the country’s culture and traditions, and
p.000096: existing research infrastructures.
p.000096:
p.000096: In 1984, the National Ethics Committee (NEC) was organized by the Philippine Council for Health Research and
p.000096: Development (PCHRD) under Special Order No. 84-053 of then Executive Director, Dr. Alberto G. Romualdez, Jr.
p.000096: The following year, the NEC put together the first set of guidelines for the conduct of biomedical research in the
p.000096: country. These guidelines subsequently underwent revisions in 1996 and 2000 to address various developments in
p.000096: health research including multicenter clinical trials, genetic research, and organ transplantation research.
p.000096:
p.000096: In 2003, the Department of Science and Technology (DOST) and the Department of Health (DOH) signed a Memorandum of
p.000096: Understanding to establish the Philippine National Health Research System (PNHRS) that envisions “a vibrant,
p.000096: dynamic, and responsible health research community working for the attainment of national and global health goals.”
p.000096: The PNHRS endeavors “to create and sustain an enabling environment for health research through evidence-informed health
p.000096: and health-related policies and actions.” A Technical Working Group (TWG) on Ethics was one of six groups
p.000096: constituted to firm up the PNHRS programs and strategies. The constitution of the TWG on Ethics
p.000096: emphasized the importance of ethics in promoting a robust and responsible health
p.000096:
p.000001: 1
p.000001:
p.000001: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000001:
p.000001: research system. This Ethics Group later proposed the establishment of the Philippine Health Research Ethics Board
p.000001: (PHREB) and the revision of the national guidelines on biomedical/behavioral research, among its several
p.000001: recommendations.
p.000001:
p.000001: The PHREB evolved from the TWG on Ethics and was formally constituted on March 17, 2006. It is mandated “to
p.000001: ensure that all phases of health research shall adhere to universal ethical principles that value the protection and
p.000001: promotion of the dignity of health research participants.” The membership of the board is
p.000001: multidisciplinary, multisectoral, and reflective of the close collaboration between DOH and DOST.
p.000001:
p.000001: A task force composed of representatives from the National Ethics Committee and from the Technical Working
p.000001: Group on Ethics worked on and prepared a draft revision of the National Ethical Guidelines for Health Research. This
p.000001: was critiqued in roundtable discussions with stakeholders before it was formally presented to a wider audience during
p.000001: the 24th Anniversary of the Philippine Council for Health Research and Development on March 17, 2006.
p.000001:
p.000001: The 2006 version of the National Health Research Ethical Guidelines aims to put global health research norms in the
p.000001: context of Philippine values and realities. It embodies the adherence of Philippine health researchers to
p.000001: ethical principles to protect human life and the dignity of the human person.
p.000001:
p.000001: Just like the earlier editions, these guidelines are meant to promote, and not to stifle, good and ethical
p.000001: scientific research. After all, advancement of the frontiers of knowledge brings hope for the good life, even for
p.000001: survival. But rules, codified as they are, are only rules on paper. In the final analysis, all individuals concerned
p.000001: with health research must resolve for themselves the omnipresent conflict between present peril or risk and future
p.000001: benefits of the study at hand.
p.000001:
p.000001:
p.000001: Philippine Health Research Ethics Board 2006
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000002:
p.000002: ETHICS REVIEW AUTHORITIES
p.000002:
p.000002:
p.000002: Introduction
p.000002:
p.000002: Advancement in science and technology in the ‘70s has made biomedical research involving human participants a necessity
...
p.000012: agencies or institutions.
p.000012:
p.000012: 7. The ERC may invite the investigator/proponent to clarify certain issues. The latter shall leave the room
p.000012: immediately after the clarification has been made.
p.000012:
p.000012:
p.000012: Action on 8. The ERC shall inform the investigator/proponent proposals in writing of
p.000012: the committee’s action. The ERC’s
p.000012: action may be one of the following:
p.000012:
p.000012: a. Approval
p.000012: b. Conditional approval with modifications
p.000012: c. Disapproval
p.000012:
p.000012: 9. The ERC shall include in its letter to the investigator the a) title of the proposal reviewed
p.000012: (revision/amendment, date, version number); b) name and title of applicant; c) documents reviewed; d) name of
p.000012: review site; e) date and place of decision; and f) the name of the ERC making the decision.
p.000012:
p.000012: 10. In case of approval, the ERC shall inform the investigator in writing of the ERC’s requirements for approved
p.000012: researches that must be complied with during the conduct of the research. These include the following:
p.000012:
p.000012: a. Report of serious and/or unexpected adverse event/s (SAEs) related to the conduct of the research within a
p.000012: timeframe required by the ERC (e.g., 24 or 48 hours after occurrence).
p.000012:
p.000012: b. Report of SAEs from other study sites or centers,
p.000012:
p.000013: 13
p.000013:
p.000013: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000013:
p.000013: In case of SAEs, a justification for why the research should continue.
p.000013:
p.000013: c. Any major changes, deviations or amendments to the approved protocol. These shall need another
p.000013: approval by the ERC.
p.000013:
p.000013: d. Any revision in the informed consent form.
p.000013:
p.000013: e. Progress report at least once a year or as requested by the ERC.
p.000013:
p.000013: f. Notice of termination of the research before its anticipated completion date, and the reason for it.
p.000013:
p.000013: 11. In case of conditional approval with modifications, the ERC shall clearly describe the required
p.000013: modifications.
p.000013:
p.000013: 12. In case of disapproval, the ERC shall clearly state its objections and the reason/s for disapproval. The ERC may
p.000013: include its recommendations for improvement.
p.000013:
p.000013:
p.000013: Approval for 13. In case of an unfavorable decision, the reconsideration investigator may
p.000013: make oral or written
p.000013: representation to the ERC for reconsideration.
p.000013:
p.000013:
p.000013: Withdrawal 14. Prior approval may be withdrawn for the following of prior reasons:
p.000013: approval
p.000013: a. Serious or adverse events directly or indirectly attributed to the research
p.000013:
p.000013: b. Breach of previously agreed-upon conduct of the research
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000014:
p.000014: Completion of 15. Upon completion of the research, the investigator the research shall inform the
p.000014: ERC in writing that the study has
p.000014: been completed, and shall furnish the committee a copy of the final report.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
...
p.000042:
p.000042: Study design 3. In contrast to conventional medicine, CAM
p.000042: modalities focus on beneficial effects (e.g., quality of life) rather than efficacy. In this context, study designs
p.000042: other than randomized controlled trials may be acceptable.
p.000042:
p.000042: 4. Blinding could be difficult to achieve in the application of certain CAM modalities, in which case the
p.000042: research protocol should provide mechanisms for blinding the clinical outcome evaluator.
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043:
p.000043: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000043:
p.000043: Rescue 5. The protocol must identify and describe the rescue medication medication
p.000043: which should be available to the study
p.000043: participants who may require such an intervention.
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044:
p.000044:
p.000044: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000044:
p.000044: ETHICAL GUIDELINES FOR EPIDEMIOLOGIC RESEARCH
p.000044:
p.000044:
p.000044: Introduction
p.000044:
p.000044: Epidemiology is the study of the determinants of the incidence of diseases in public health. A related study, clinical
p.000044: epidemiology, deals with the prevention, diagnosis, risk factor analysis, causation, and treatment of diseases.
p.000044: Epidemiological research aims at studying determinants of health and disease in human populations in order to improve
p.000044: people’s opportunities for making choices.
p.000044:
p.000044: A major segment of epidemiologic research involves collection of data from individuals which may or may not require
p.000044: procedural interventions. Although researchers may claim that epidemiologic research such as observational studies
p.000044: often do not involve interventions that may cause discomfort to eligible individuals, these studies still require the
p.000044: individual’s time and attention and may encroach on the individual’s right to privacy and confidentiality. There are
p.000044: also social risks that need to be considered. Most people who take part in public health epidemiological research gain
p.000044: no personal benefit and often may not have a disease that needs treatment.
p.000044:
p.000044: Considering the nature of observational epidemiologic studies, the principles that govern consent procedures
p.000044: need not be as strict as those for experimental study designs. However, when the investigator proposes selective
p.000044: disclosure of information, the ethics committee must review the protocol and decide on its adequacy.
p.000044:
p.000044: Ethics committees and other appropriate authorities should set the conditions for the use of genetic and other
p.000044: biological materials collected in epidemiologic researches.
p.000044:
p.000044: These guidelines are for consideration of ethics committees for the protection of participants in
p.000044: epidemiologic research involving humans, focusing primarily on non- experimental studies. Its main difference from
p.000044: other researches is in the nature and extent of the informed consent process.
p.000044:
p.000044: General 1. All research involving human subjects should be
p.000044: guidelines conducted in accordance with the ethical
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000045:
p.000045: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000045:
p.000045: Specific guidelines
p.000045:
p.000045: Informed 2. For case-control and cohort studies, non- consent disclosure of
p.000045: all the study objectives may be permissible if full disclosure of the study
p.000045: hypothesis could bias the investigation.
p.000045:
p.000045: 3. Consent may not be required for collection of information in the public domain. Public domain information
...
p.000049: guidelines conducted in accordance with the ethical
p.000049: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000050:
p.000050: 2. In deliberations on research involving traumatized populations, a community advocate or representative
p.000050: must be present.
p.000050:
p.000050: 3. In the course of research, the psychosocial needs of the community must be taken into account.
p.000050:
p.000050: 4. The different roles of the researchers, caregivers, and volunteer workers must always be clarified and the
p.000050: potential conflicts of interest identified.
p.000050:
p.000050: 5. The ethics review committee must put in place a monitoring mechanism to ensure that the above guidelines are
p.000050: followed.
p.000050:
p.000050: Special guidelines
p.000050:
p.000050: Research 6. The research proposal must explain how its protocol objectives
p.000050: relate to the priorities of the community.
p.000050:
p.000050: 7. The research methodology must ensure that the research process will not impede the healing or recovery of the
p.000050: community. It must contribute to the process of designing intervention programs.
p.000050:
p.000050: 8. The protocol must include provisions for aftercare, including closure activities and a proper referral
p.000050: mechanism to deal with the health needs of participants and members of the research team.
p.000050:
p.000050: 9. Researchers must demonstrate familiarity with the community’s situation and their cultural beliefs and practices.
p.000050:
p.000050: a. The research team must include a local community counterpart.
p.000050: b. The research team must describe a preliminary community mapping/scoping exercise to ensure familiarity
p.000050: with the situation of the community as well as identify local
p.000050:
p.000051: 51
p.000051:
p.000051:
p.000051:
p.000051: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000051:
p.000051: resources which will support the faithful implementation of the project.
p.000051: c. The research team must demonstrate the ability to anticipate adverse reactions and facilitate
p.000051: appropriate interventions.
p.000051:
p.000051: 10. The researchers have the responsibility to identify the specific vulnerabilities of the research population
p.000051: and the mechanisms that are being put in place to address them.
p.000051:
p.000051: Recruitment 11. The researchers must consult the community and and informed secure its
p.000051: permission before approaching consent individuals for their informed consent.
p.000051:
p.000051: 12. The research team must identify factors that serve as a barrier to the freedom of individual members of the
p.000051: subject population to give consent, and provide effective mechanisms to address them.
p.000051:
p.000051: Community 13. The study design must demonstrate the principles participation of participatory
p.000051: research and describe the
p.000051: involvement of the community participants in research planning, design, conduct, analysis,
p.000051: validation/feedback, and utilization.
p.000051:
...
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063:
p.000063:
p.000063: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000063:
p.000063: ETHICAL GUIDELINES FOR INTERNATIONAL COLLABORATIVE RESEARCHES
p.000063:
p.000063: Introduction
p.000063:
p.000063: Health research is a public good whose burdens and benefits should be shared equally by all the concerned populations
p.000063: (Torres-Edejer, 1999). However, North-South research collaboration is currently plagued by differing interpretations of
p.000063: ethical standards of doing research in developing countries. Should new treatments be compared against Western
p.000063: standards of care or against local existing standards? Can communities benefit from research they have taken part in
p.000063: when they may not be able to afford the new interventions they have helped prove efficacious? How can
p.000063: researchers and institutions in developing countries be strengthened through international collaboration (Lansang and
p.000063: Crawley, 2000)?
p.000063:
p.000063: One other major issue is that of inequitable funding, with only 10 percent of global research funding going to diseases
p.000063: which make up 90 percent of the global burden. For this, three guideposts - Think action - Think local - Think long
p.000063: term - can be used (Torres-Edejer, 1999).
p.000063:
p.000063: Scientific advances are not the only yardstick to measure success of North-South research collaboration: the choice of
p.000063: identified priorities as areas of work, the sustainability of the studied interventions outside the research setting,
p.000063: and the investment in local research capacity are becoming equally important as indicators of success
p.000063: (Torres-Edejer, 1999).
p.000063:
p.000063: In order to support health research in developing countries that is both relevant and meaningful, the focus must
p.000063: be on developing health research that promotes health equity and developing local capacity in bioethics (Bhutta,
p.000063: 2000).
p.000063:
p.000063: To achieve the goals of effective collaborative health researches between North and South, the following
p.000063: guidelines must be given utmost consideration (Swiss Commission for Research Partnership with Developing
p.000063: Countries, 1998):
p.000063:
p.000063: 1. Decide on the objectives together;
p.000063: 2. Build up mutual trust;
p.000063:
p.000064: 64
p.000064:
p.000064:
p.000064:
p.000064: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000064:
p.000064: 3. Share information and develop networks;
p.000064: 4. Share responsibility;
p.000064: 5. Create transparency;
p.000064: 6. Monitor and evaluate the collaboration;
p.000064: 7. Disseminate the results;
p.000064: 8. Apply the results;
p.000064: 9. Share the profits equitably;
p.000064: 10. Increase research capacity; and
p.000064: 11. Build on achievements.
p.000064:
p.000064: Finally, the above considerations should result into a clear agreement on the conduct of collaborative research
p.000064: including data management and research outputs (e.g., storage and utilization of data, publication strategy, dispute
p.000064: settlement, nature of benefits and their distribution) (South African Medical Research Council, 2005).
p.000064:
p.000064: General 1. All research involving human subjects should be
p.000064: guidelines conducted in accordance with the ethical
p.000064: principles provided for in the General Ethical Guidelines for Health Research on pp16-29.
p.000064:
p.000064: Special 2. Research approved for implementation by an ethics
...
p.000074: Health and Human Services http://kartero.pchrd.dost.gov.ph
p.000074: /horde/utilgo.php?url=http%3A%2F%2Fwww.hhs.gov%2Fohrp% 2Firb%2Firb_introduction.htm &Horde=85a91621422a63bcc765
p.000074: ef05290c2baf )
p.000074:
p.000074: beneficence – the quality or state of doing or producing good especially performing acts of kindness and charity
p.000074: (Merriam-Webster’s Dictionary of Law (c) 1996)
p.000074:
p.000074: – the requirement to serve the interests and well being of others, including respect for their rights. It
p.000074: is the principle of doing good in the widest sense (http://kartero.pchrd.dost.gov.ph/horde/util/
p.000074: go.php?url=http%3A%2F%2Fwww.arts.ac.2FCode_of_Practice_on_Research_ Ethics.pdf&Horde=85a91621422a63bcc765ef05290c2baf )
p.000074:
p.000074: – is the professional duty to do or produce good. By “good” is meant the performance of acts of kindness and
p.000074: charity (http://kartero. pchrd.dost.gov.ph/horde/util/go.php?url=http%3A%2F%2F health.enotes.com%2Fpublic health
p.000074: encyclopedia&Horde= 85a91621422a63bcc765 ef05290c2baf)
p.000074:
p.000074: – entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing anticipated
p.000074: benefits and minimizing possible risks of harm. (Institutional Review Board Guidebook, US Department of Health
p.000074: and Human Services http://kartero.pchrd.dost.gov.ph
p.000074: /horde/util/go.php?url= http%3A%2F%2Fwww.hhs.gov%2Fohrp%2
p.000074: Firb%2Firb_introduction.htm&Horde=85a91621422a63bcc765ef05290c2 baf )
p.000074:
p.000074: non-maleficence – duty to do no harm and to prevent harm; defined as
p.000074:
p.000075: 75
p.000075:
p.000075: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000075:
p.000075: the principles of doing, or permitting, no foreeable harm including infringement of rights as a consequence of
p.000075: the research. It is the principle of doing no harm in the widest sense (http://kartero.pchrd.dost.gov.ph/
p.000075: horde/util/go.php?url=http%3A%2F%2Fwww.arts.ac.uk%2Fdocs%2F
p.000075: Code_of_Practice_on_Research_Ethics.pdf&Horde=85a91621422a63bcc765 ef05290c2baf)
p.000075:
p.000075: justice – the quality of being just, impartial, or fair; the administration of law; the establishment or determination
p.000075: of rights according to law or equity (Merriam-Webster’s Dictionary of Law (c)1996); requires that the benefits and
p.000075: burdens of research be distributed fairly (Institutional Review Board Guidebook, US Department of Health and Human
p.000075: Services http:/
p.000075: /kartero.pchrd.dost.gov.ph/horde/utilgo.php?url=http%3A%2F%2F www.hhs.gov%2Fohrp%2Firb%2Firb_introduction.htm&
p.000075: Horde=85a91621422a63bcc765ef05290c2baf)
p.000075:
p.000075: ethics review – the evaluation of a research protocol by an ethics review committee that promotes the
p.000075: safety and protection of the dignity of human participants
p.000075:
p.000075: – a systematic process by which an independent committee evaluates a study protocol to determine if it follows ethical
p.000075: and scientific standards for carrying out biomedical research on human participants. Compliance with these guidelines
p.000075: helps ensure that the dignity, rights, safety and well-being of research participants are promoted.
p.000075:
p.000075: ethics review committee – a Committee constituted to review the ethical aspects of a research proposal and its possible
p.000075: implementation
p.000075:
p.000075: Ethics Committee (IEC/IRB) – Independent Ethics Committee / Institutional Review Board is an independent body
...
p.000092: trials (E10).
p.000092:
p.000093: 93
p.000093:
p.000093: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000093:
p.000093: Lansang, M. A. & Crawley, F. P. (2000). The ethics of international biomedical research. British Medical Journal 321,
p.000093: 777-778.
p.000093:
p.000093: Margetts, B., Arab L., Nelson M., & Kok F. (1999). Who and what sets the international agenda for research and public
p.000093: health action? Public Health Nutrition 2, 35-36.
p.000093:
p.000093: National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH), US
p.000093: Department of Health and Human Services. (2006). Understanding CAM. Retrieved (March 10, 2006) from
p.000093: http://nccam.nih.gov/.
p.000093:
p.000093: Reyes, Marita V. T. (2004). Directions in Philippine health research: ethics review. Proceedings of the 1st Philippine
p.000093: National Health Research System Assembly. Manila.
p.000093:
p.000093: Rothman, K. (1991). The ethics of research sponsorship. Journal of Clinical Epidemiology 44, 25S-28S.
p.000093:
p.000093: South African Medical Research Council. (2005). Guide to ethical considerations in medical research.
p.000093:
p.000093: Swiss Commission for Research Partnership with Developing Countries. (1998). Guidelines for research in partnership
p.000093: with developing countries. Berne: Swiss Academy of Sciences.
p.000093:
p.000093: Torres-Edejer, T.T. (1999). North-South research partnerships: the ethics of carrying out research in developing
p.000093: countries. British Medical Journal 319, 438-441.
p.000093:
p.000093: Wejer, C. & Emanuel, E.J. (2000). Protecting communities in biomedical research. Science 289, 1142-1144.
p.000093:
p.000093: World Health Organization. (1995). Guidelines for good clinical practice for trials of pharmaceutical products. (WHO
p.000093: Technical Reports Series No. 850, Annex 3).
p.000093:
p.000093: World Health Organization. (2000). General guidelines for methodologies on research and evaluation of traditional
p.000093: medicine. Retrieved (month day, year) from http://www.paho.org/Spanish/AD/THS/EV/PM-WHO
p.000093: Traditional-medicines-research-evaluation.pdf.
p.000093:
p.000093: World Health Organization. (2000). Operational guidelines for ethics committees that review biomedical research.
p.000093: Geneva.
p.000093:
p.000093:
p.000094: 94
p.000094:
p.000094: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000094:
p.000094: World Health Organization. (2005). Operational guidelines for the establishment and functioning of data and safety
p.000094: monitoring boards. Geneva.
p.000094:
p.000094: World Health Organization. (2005). Special Programme for Research and Training in Tropical Diseases (TDR).
p.000094: Geneva.
p.000094:
p.000094: World Health Organization. (2005). Special Programme for Research and Training in Tropical Diseases (TDR).
p.000094: Operational guidance: Information needed to support clinical trials of herbal products. Geneva.
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
p.000094:
...
p.000101:
p.000101:
p.000101: CONSENT FORM
p.000101:
p.000101: I have read and understood the above information and had been given the opportunity to consider and ask questions on
p.000101: the information regarding the involvement in this study. I have spoken directly to my doctor who has answered to my
p.000101: satisfaction all my questions. I have received a copy of this Patient Information and Informed Consent Form.
p.000101: I voluntarily agree to participate.
p.000101:
p.000101:
p.000101:
p.000101: Patient’s Signature:
p.000101:
p.000101:
p.000101:
p.000101: Name of Patient Signature of Patient Date
p.000101:
p.000101:
p.000101: Witness or Legal Guardian’s Signature:
p.000101: (Only when patient cannot read or sign this Informed Consent)
p.000101:
p.000101:
p.000101:
p.000101: Name of Witness/ Signature of Witness/ Date Legal Guardian Legal
p.000101: Guardian
p.000101:
p.000101:
p.000101: Physician’s Signature:
p.000101:
p.000101: I, the undersigned, certify that to the best of my knowledge, the patient signing this consent form has read the above
p.000101: information sheet fully, that this has been carefully explained to him/her, and that he/she clearly understands the
p.000101: nature, risks, and benefits of his/her participation in this study.
p.000101:
p.000101:
p.000101:
p.000101:
p.000101: Name of Physician Signature of Physician Date
p.000101:
p.000102: 102
p.000102:
p.000102: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000102:
p.000102: APPENDIX B
p.000102: ETHICS REVIEW COMMITTEE (ERC)
p.000102: Standard Application Form
p.000102: FOR ETHICAL EVALUATION OF PROPOSAL
p.000102:
p.000102: General Instructions:
p.000102:
p.000102: Accomplish ten copies of this application form and attach them to copies of the proposal to be submitted to the
p.000102: National Ethics Committee (NEC).
p.000102:
p.000102: Note: The ERC evaluation will normally require eight weeks from receipt of the proposal from the proponent.
p.000102:
p.000102: For further information, contact:
p.000102: The NEC Secretariat
p.000102: Room 306, 3rd Floor, DOST Main Bldg., Bicutan, Taguig City
p.000102: Telephone No. (632) 837-7535; Telefax Nos. (632) 837-2924, 837-2942
p.000102: e-mail: pchrd@ehealth.ph
p.000102: 1. Reference Number:
p.000102: 2. Name of Organization / Institution:
p.000102: 3. Name:
p.000102: 4. Address / Contact Nos.:
p.000102: 5. Project Coordinator or Principal Investigator: Name:
p.000102: Position: Address:
p.000102:
p.000102: Contact Nos.: (Tel / Fax / Mobile Nos. / e-mail address
p.000102: 6. Project Title:
p.000102:
p.000102:
p.000102: 7. Planned Date of Start:
p.000102: 8. Project Abstract / Ethical Concerns: (Attach summary of proposal and ethical concerns)
p.000102: 9. The NEC has assessed and granted ethical clearance to this proposal: Name of NEC Chair
p.000102: Signature
p.000102:
p.000102: 10. Date:
p.000102:
p.000102:
p.000103: 103
p.000103:
p.000103: NATIONAL ETHICAL GUIDELINES FOR HEALTH RESEARCH
p.000103:
p.000103: APPENDIX C
p.000103: List of Documents that the Proponent/s Should Provide the Ethics Review Committee
p.000103:
p.000103: 1) Ten (10) copies of the final protocol and, if applicable, amendments
p.000103:
p.000103: 2) Ten (10) copies of informed consent (written in English and Filipino or dialect spoken and understood by research
p.000103: participants)
p.000103:
p.000103: 3) Ten (10) copies of Information Sheet (written in English and Filipino or dialect spoken and understood by research
p.000103: participants)
p.000103:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belief | Religion |
| blind | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| control group | participants in a control group |
| criminal | criminal |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| foreign country | Other Country |
| gender | gender |
| healthy people | Healthy People |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| hiv/aids | HIV/AIDS |
| ill | ill |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| indigenous | Indigenous |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| low-income | Economic/Poverty |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| occupation | Occupation |
| parent | parents |
| parents | parents |
| philosophy | philosophical differences/differences of opinion |
| physically | Physically Disabled |
| placebo | participants in a control group |
| political | political affiliation |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| pregnant | Pregnant |
| property | Property Ownership |
| race | Racial Minority |
| racial | Racial Minority |
| religious | Religion |
| research staff | Laboratory Staff |
| single | Marital Status |
| stem cells | stem cells |
| stigmatization | Threat of Stigma |
| stigmatized | Threat of Stigma |
| substance | Drug Usage |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| unlawful | Illegal Activity |
| violence | Threat of Violence |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| HIV | ['hiv/aids'] |
| belief | ['religious'] |
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| disability | ['mentally'] |
| drug | ['influence', 'substance'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
| healthy people | ['healthyXvolunteers', 'volunteers'] |
| healthy volunteers | ['healthyXpeople', 'volunteers'] |
| hiv/aids | ['HIV'] |
| illness | ['physically'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| influence | ['drug', 'substance'] |
| low-income | ['poor', 'poverty'] |
| mentally | ['disability'] |
| minor | ['youth'] |
| parent | ['parents'] |
| parents | ['parent'] |
| physically | ['illness'] |
| placebo | ['controlXgroup'] |
| poor | ['poverty', 'low-income'] |
| poverty | ['poor', 'low-income'] |
| race | ['racial'] |
| racial | ['race'] |
| religious | ['belief'] |
| stigmatization | ['stigmatized'] |
| stigmatized | ['stigmatization'] |
| substance | ['drug', 'influence'] |
| volunteers | ['healthyXpeople', 'healthyXvolunteers'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
| youth | ['minor'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input