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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIllegal Activityunlawful1
PoliticalIndigenousindigenous7
Politicalcriminalcriminal4
Politicalpolitical affiliationpolitical10
Politicalvulnerablevulnerable7
Politicalvulnerablevulnerability2
HealthCognitive Impairmentimpaired1
HealthCognitive Impairmentimpairment2
HealthDrug Usagedrug28
HealthDrug Usageinfluence4
HealthDrug Usagesubstance5
HealthHIV/AIDSHIV18
HealthHIV/AIDShiv/aids0
HealthHealthy Peoplehealthy people1
HealthHealthy Peoplehealthy volunteers1
HealthHealthy Peoplevolunteers9
HealthMentally Disabledmentally1
HealthMentally Disableddisability3
HealthMentally Incapacitatedincapable2
HealthMotherhood/Familyfamily22
HealthPhysically Disabledillness8
HealthPhysically Disabledphysically1
HealthPregnantpregnant9
Healthillill1
Healthpatients in emergency situationsemergencies3
Healthstem cellsstem cells4
Healthvisual impairmentblind3
SocialAccess to Social Goodsaccess10
SocialAgeage8
SocialChildchild8
SocialChildchildren13
SocialElderlyelderly1
SocialEthnicityethnic2
SocialFetus/Neonatefetus8
SocialFetus/Neonatefetuses3
SocialLaboratory Staffresearch staff1
SocialLinguistic Proficiencylanguage1
SocialMarital Statussingle7
SocialOccupationoccupation1
SocialProperty Ownershipproperty11
SocialRacial Minorityrace1
SocialRacial Minorityracial1
SocialReligionbelief1
SocialReligionreligious5
SocialThreat of Stigmastigmatization3
SocialThreat of Stigmastigmatized1
SocialThreat of Violenceviolence9
SocialTrade Union Membershipunion1
SocialVictim of Abuseabuse1
SocialWomenwomen7
SocialYouth/Minorsminor6
SocialYouth/Minorsyouth2
Socialeducationeducation3
Socialeducationeducational3
Socialembryoembryo11
Socialgendergender21
Socialparentsparent6
Socialparentsparents1
Socialphilosophical differences/differences of opinionphilosophy8
EconomicEconomic/Povertypoor2
EconomicEconomic/Povertypoverty2
EconomicEconomic/Povertylow-income1
General/OtherDependentdependent1
General/OtherDiminished Autonomydiminished1
General/OtherImpaired Autonomyautonomy3
General/OtherIncapacitatedincapacitated1
General/OtherOther Countryforeign country1
General/OtherPublic Emergencyemergency1
General/OtherRelationship to Authorityauthority8
General/OtherUndue Influenceundue influence4
General/Othercioms guidelinescioms14
General/Otherdeclaration of helsinkihelsinki16
General/Otherparticipants in a control groupcontrol group8
General/Otherparticipants in a control groupplacebo22

Political / Illegal Activity

Searching for indicator unlawful:

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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 violenceviolence 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:

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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.
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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.
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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:
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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
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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:

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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:
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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
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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:
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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:
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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
...

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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:
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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:
...

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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
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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
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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 violenceviolence 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:
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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

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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:
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p.000096:
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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:
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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
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...

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:
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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
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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
...

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p.000067: 67
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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:
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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:

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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 riskharm 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 violenceviolence 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:

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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:
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p.000036:
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p.000036:
p.000036:
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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:

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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:

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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:

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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 riskharm 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 violenceviolence 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:

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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:

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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 violenceviolence 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:
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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:
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p.000103:
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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
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p.000106:
p.000106:
p.000106:
p.000106:
...

Economic / Economic/Poverty

Searching for indicator poor:

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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:

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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:
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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:
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