79C3C34C52B45572883A05D425EB0F82
Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of Health Research
http://www.anmat.gov.ar/webanmat/legislacion/medicamentos/Resolucion_1480-2011.pdf
http://leaux.net/URLS/ConvertAPI Text Files/111DB22DA85A4E0B38C0B8DEFECCC623.en.txt
Examining the file media/Synopses/111DB22DA85A4E0B38C0B8DEFECCC623.html:
This file was generated: 2020-12-01 07:59:19
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Refugee Status
Searching for indicator refugee:
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p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
p.(None): Justice. This principle refers to the ethical obligation to treat each person equally, unless
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p.(None): difficult to define, such as unfavorable economic, social, cultural or educational conditions.
p.(None): Individuals unable to grant consent. They are minors and people with disorders
p.(None): transient, fluctuating or permanent mental disorders. Research with these groups is only justified when:
p.(None): (a) the knowledge expected to be obtained from the research is sufficiently relevant in relation to the risks
p.(None): predictable;
p.(None): (b) the risks of an observational study are only slightly higher than those associated with medical examinations and
p.(None): psychological routines of such people in the condition under investigation;
p.(None): (c) the risks of experimental research are similar to those of the interventions usually received by
p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
p.(None): In the case of pregnant women, in addition to the requirement to provide detailed information on the risks for
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Political / displaced
Searching for indicator displaced:
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p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
p.(None): In the case of pregnant women, in addition to the requirement to provide detailed information on the risks for
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Political / political affiliation
Searching for indicator party:
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p.(None): To minimize risks:
p.(None): (a) consent clearly expresses the use of placebo and its risks;
p.(None): (b) the treatment period is the minimum possible to reduce exposure to non-treatment;
p.(None): (c) control of the participants will be frequent and strict, and it is planned to withdraw the patient from the
p.(None): study or transfer to active treatment (rescue) as soon as therapeutic failure is detected;
p.(None): (d) there is an interim analysis plan and an independent data monitoring council, with clear rules for
p.(None): stopping the study for security reasons;
p.(None): (e) crossover design: groups alternately receive active treatment or placebo; Y
p.(None): (f) addition design: when scientifically and medically possible, all participants should
p.(None): receive the standard treatment, adding either the experimental product or placebo.
p.(None): Particular attention should be paid to projects proposing the use of placebo in groups or communities that do not
p.(None): they have access to standard therapy. The use of placebo should not be accepted when this is your only use.
p.(None): basis. Accidental injury compensation. If an investigation causes harm, the entity
p.(None): Sponsor shall compensate the injured party appropriately according to the type of damage. The losses
p.(None): pecuniaries must be repaired promptly. In other cases, it may be difficult to determine compensation
p.(None): appropriate. Violation of confidentiality or indiscriminate publication of
p.(None): conclusions of a study, causing the loss of prestige of an individual or group, can be difficult to remedy, and
p.(None): the IRC shall define what is the appropriate compensation in such cases. The approval of the study by the CEI does not
p.(None): exempts the researcher, the institution or the sponsor from any legal responsibility in case of
p.(None): damage suffered by the participant as a result of their participation in the study.
p.(None): Access to treatment. At the end of the research, all participants should share the benefits
p.(None): obtained from it, for example, by accessing the intervention that has been most beneficial, a
p.(None): alternative intervention or other appropriate benefit.
p.(None): In particular, in clinical trials sponsored by a pharmaceutical company that have shown that a product
p.(None): Experimental is beneficial, the sponsor should continue to provide it to the participants until their access is
p.(None): guarantee by other means. The requirement of this requirement must be determined based on certain considerations
p.(None): relevant, such as the severity of the medical condition in question and the expected effect of withdrawing or modifying the
p.(None): treatment, for example, leaving a sequel or causing the death of the patient. When it is not possible to fulfill it
p.(None): The provision of an alternative intervention or other appropriate benefit, approved by
p.(None): the CEI and for the period that it determines.
p.(None): A10. CLINICAL TRIALS OF CELL AND GENIC THERAPIES
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p.(None): with the investigation without the specific approval of the CEI for the exception of the consent of the
p.(None): participants.
p.(None): 1.1.7. In the case of surveys or interviews that are carried out remotely (by phone or email) or that
p.(None): will be analyzed anonymously, the requirement to sign a document as proof of consent can be omitted
p.(None): but the provision of the information related to the study in written form should not be omitted (personally or by
p.(None): email) or verbal (survey or telephone interview). The researcher must always respect the right to
p.(None): the confidentiality of the person surveyed or interviewed.
p.(None): 1.2. Guidelines for obtaining informed consent
p.(None): 1.2.1. The informed consent document includes at least two sections: the information sheets for the
p.(None): participant and signature sheet. Any document that is intended to be used in the process must be previously approved by
p.(None): the CEI.
p.(None): 1.2.2. Informed consent must be obtained before proceeding with the evaluation of the eligibility criteria
p.(None): or any other specific study procedure.
p.(None): 1.2.3. Oral and written information provided to the potential participant or their representative must be submitted
p.(None): clearly, precisely, completely, truthfully, in practical language and appropriate to their understanding, expressed in
p.(None): primary language of the consenting party and without including any expression that may lead one to believe that the
p.(None): participant lacks or waives any of their rights or that the researcher, institution or sponsor is
p.(None): They release their responsibilities by signing the consent. The written document should guide the explanation
p.(None): verbal.
p.(None): 1.2.4. The researcher or his authorized delegate must ensure that the potential participant or his
p.(None): representative have understood all the information received, for which they must be given the opportunity and time
p.(None): enough to consider all the options, ask all the questions you want and be satisfied
p.(None): with the answers.
p.(None): 1.2.5. After being informed, the potential participant or his legal representative, the researcher or his delegate and the
p.(None): witness, if applicable, must sign and date two originals of the consent signature sheet, such as
p.(None): declaration of having received and understood the study information and of having made the free and voluntary decision
p.(None): to participate in it. After
p.(None): the signatures, the participant or his representative must receive one of the originals of the signature sheet and a copy of
p.(None): the information section for participants.
p.(None): 1.2.6. In clinical trials, the process of obtaining informed consent must be documented in the history
p.(None): participant's clinic, including their start date and time, which was given time to reflect and to make
p.(None): questions, what were those questions, that the understanding of the information was verified, that two were signed
p.(None): originals of the signature sheet and that one of them was given to the participant or his representative. In case of
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p.(None): 2.4.2. The CEI must receive all the documentation required for the review process and make it available to
p.(None): all its members, without prejudice to the fact that the responsibility of the
p.(None): preliminary review of each project and then submit it for discussion by all the members.
p.(None): 2.4.3. The IEC must establish specific quorum requirements for its review meetings, including the number
p.(None): minimum number of members to complete it and the distribution of professions and sex. The quorum must represent both sexes,
p.(None): both sectors - scientific and non-scientific - and at least one independent member of the study's host institution.
p.(None): 2.4.4. The CEI must prepare and keep updated a list of its members, indicating the name, age, sex,
p.(None): profession or occupation, position in the CEI and relationship with the institution.
p.(None): 2.4.5. The IRB must record its meetings, deliberations and decisions, including the members who
p.(None): they participated in them and the result of their voting.
p.(None): 2.4.6. The CEI may consult experts on specific topics, be they scientific, ethical or social, but without
p.(None): give you the right to decide on the project. The participation and opinion of experts must be documented.
p.(None): 2.4.7. A CEI member who is both a researcher or part of a project team should not participate in
p.(None): no evaluation, deliberation or decision about that project.
p.(None): 2.4.8. The RECs must take into consideration a request to challenge one or more of its members, presented by
p.(None): a researcher or other interested party prior to the review of a project, provided the reasons are
p.(None): adequately supported.
p.(None): 2.4.9. In clinical trials, the REC must require the investigator to immediately communicate all information on
p.(None): relevant safety and protocol changes that increase the risk to participants or that have been made
p.(None): to eliminate an immediate danger to them.
p.(None): 2.4.10. In low-risk observational studies, as defined in A4, or in the case of proposed changes
p.(None): administrative or that do not affect the safety of the participants of an already approved investigation, the president of the
p.(None): CEI or a member designated for this purpose can make an expedited evaluation of the proposal, determining if
p.(None): A full committee evaluation is required or not. Expedited evaluations should be documented and
p.(None): inform the rest of the members.
p.(None): 2.5. Application requirements
p.(None): 2.5.1. The request for ethical review of a research project must be submitted by the researcher
p.(None): qualified responsible for the ethical and scientific conduct of research.
p.(None): 2.5.2. The researcher must present, at least, the following documents:
p.(None): (a) application note indicating the title of the study and the financing available;
p.(None): (b) study protocol identified with version number and date;
p.(None): (c) informed consent;
p.(None): (d) material to be used for recruiting participants, for example, notices;
p.(None): (e) in clinical trials of diagnostic or therapeutic products, a summary or monograph describing the
p.(None): preclinical and clinical history;
p.(None): (f) in clinical trials with commercial or industrial sponsorship, a copy of the financial agreement with the sponsor and
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Searching for indicator political:
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p.(None): Researchers or sponsors must use passwords and the best available technology, for
p.(None): For example, encryption, to ensure that only authorized people can read the data. These requirements apply
p.(None): also when data is transmitted from implantable or portable electronic devices, for example,
p.(None): pacemaker or vital sign monitoring systems.
p.(None): A7. CONFLICT OF INTERESTS
p.(None): Q14. The primary duty of every person who plans, sponsors, conducts, or communicates an investigation in
p.(None): human health is respecting dignity, rights, values, interests,
p.(None): the well-being and physical and mental integrity of the individuals who participate in it, above any interest
p.(None): financial, scientific, social or otherwise.
p.(None): Definition: A conflict or competence of interests is considered in the investigation when professional judgment
p.(None): related to a primary interest or duty of the researcher, such as the well-being of the participants or the validity
p.(None): of the research, may be influenced by a secondary interest, for example, raising funds or
p.(None): professional recognition. The interest in protecting participants and obtaining valid knowledge must always
p.(None): prevail over any other interest.
p.(None): In many cases it can be really difficult to determine when there is a real conflict of interest because the
p.(None): Competing interest is not always financial and may be overlapping.
p.(None): The RECs must pay attention to the risk of conflict of interest and not approve proposals where there is evidence of
p.(None): that the professional judgment of the researchers may be affected by an incompatibility of interests.
p.(None): A particular case is the possible financial, academic or political conflicts of interest within the
p.(None): institution to which the researcher belongs. For this reason, an institutional REC must incorporate members
p.(None): impartial and external to the institution to help manage a situation of this nature.
p.(None): Declaration of conflicts of interest. Honesty, transparency and impartiality are essential
p.(None): to formulate, conduct, interpret and communicate the results of the studies. Investigators should disclose to
p.(None): CEI and potential research participants their funding sources and possible conflicts of
p.(None): interests, particularly in the event that a commercial or other sponsor plans to use the results of the
p.(None): research for the registration or promotion of a product or service.
p.(None): Internationally sponsored studios. Internationally sponsored studies are those carried out
p.(None): in a host country but initiated, financed, and sometimes led by a foreign or international entity with
p.(None): collaboration or conformity of the local authority.
p.(None): In these cases, there could be a conflict between the interests of the sponsoring country or entity and those of the community.
p.(None): local, which is why the following ethical requirements must be met:
p.(None): (a) projects must undergo ethical evaluation in both the sponsoring country and the host country;
p.(None): (b) the host country's IRB must ensure that the project meets its ethical requirements; Y
p.(None): (c) researchers must adhere to the ethical rules of the sponsoring country and the host country.
p.(None): The sponsoring country's committee or international organization has a special responsibility to determine if it exists
p.(None): justification for conducting the study in the host country instead of in the sponsoring country and if the
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p.(None): scientific and whose function is to provide a public guarantee of the protection of rights, dignity,
p.(None): safety and well-being of study participants, through, inter alia, protocol review
p.(None): of the study, the informed consent process and the suitability of the researcher.
p.(None): CONFLICT OF INTEREST: a conflict of interest is considered as a primary interest, such as the
p.(None): A patient's well-being or the validity of an investigation may be affected by a secondary interest, such as
p.(None): an economic gain, professional prestige or personal rivalries.
p.(None): INFORMED CONSENT: process by which a person confirms his free and voluntary decision to participate in
p.(None): an investigation, after having been informed about all its relevant aspects. The
p.(None): Informed consent is documented by signing a specific form.
p.(None): SOURCE DATA: information on clinical findings, observations or other activities, necessary for the
p.(None): reconstruction and evaluation of the clinical study and documented in original records or certified copies of them
p.(None): by its manager, called source documents.
p.(None): The source data must be attributable, legible, exact and contemporary.
p.(None): PERSONAL DATA: information of any kind referring to individuals or individuals of ideal existence determined or
p.(None): determinable.
p.(None): SENSITIVE DATA: personal data that reveals racial or ethnic origin, political opinions, convictions
p.(None): religious, philosophical or moral, union affiliation and information regarding health or sexual life.
p.(None): These data can only be processed when there are reasons of general interest authorized by law or for purposes
p.(None): statistical or scientific when their holders cannot be identified.
p.(None): ESSENTIAL DOCUMENTS: documents that individually and collectively allow an evaluation of the conduct of a
p.(None): study and the quality of the data generated.
p.(None): SOURCE DOCUMENTS: original documents and records of the clinical data used in
p.(None): a study, such as medical records, laboratory or pharmacy records, imaging reports, and
p.(None): images themselves, participant diaries, data recorded on automated instruments, magnetic media or
p.(None): microfilm and photographic negatives. Includes copies certified by an authorized or legalized person
p.(None): by notary public.
p.(None): CLINICAL TRIAL: see EXPERIMENTAL INVESTIGATION
p.(None): CLINICAL TRIAL OF CELL THERAPIES: the experimental investigation that is carried out in patients to establish the
p.(None): tolerance, safety and / or efficacy of a product based on human cells or tissues, after having been
p.(None): demonstrated its therapeutic potential and safety in preclinical studies. Obtaining and processing
p.(None): of cells and tissues must ensure, through validated procedures, the absence of conditions of
p.(None): transmissibility of infectious agents, prions, genetic diseases or cancer to the host.
p.(None): CLINICAL TRIAL OF MEDICAL TECHNOLOGY: the experimental research that is carried out to establish the
p.(None): safety and effectiveness of a medical device in humans. The investigation must establish the
p.(None): indications, contraindications and precautions for the use of the device. If the equipment, device, device or
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Political / stateless persons
Searching for indicator nation:
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p.(None): dignity of people, the well-being and physical and mental integrity of those who participate in it.
p.(None): That consequently it is essential to methodically and systematically address both ethical issues,
p.(None): such as the scientific validity and significance that emerge from all research on human beings,
p.(None): formulating the directives that accept the ethical principles to which the activity of the
p.(None): clinical research.
p.(None): That there are numerous international ethical and operational guides related to human health research, among
p.(None): they, the Nüremberg Decalogue (1948), the Declaration of Helsinki (latest version 2008), the Ethical Guidelines
p.(None): Guidelines for Biomedical Research in Humans (latest version 2002), the Guidelines
p.(None): international ethics for epidemiological studies (latest version 2009), the Operational Guides
p.(None): for ethics committees evaluating biomedical research (2000) and the Guidelines for Good Clinical Practice
p.(None): (1996), as well as the International Declarations on Human Genetic Data and on Bioethics and Rights
p.(None): humans (2003 and 2005, respectively) to which the country has adhered.
p.(None): That the research ethics committees formed in a multidisciplinary manner at the official level
p.(None): jurisdictional or in the institutions that carry out health research constitute the central axis of
p.(None): monitoring the protection of participants in such investigations
p.(None): That the MINISTRY OF HEALTH OF THE NATION issued a GUIDE OF GOOD PRACTICES
p.(None): OF CLINICAL RESEARCH IN HUMAN BEINGS approved by Resolution No. 1490 of November 14, 2007, but which is done
p.(None): It is necessary to extend the ethical and operational guidelines to all research in human health.
p.(None): That in fulfillment of the stewardship role of the MINISTRY OF HEALTH OF THE NATION, THE UNDER-SECRETARY OF
p.(None): SANITARY RELATIONS AND INVESTIGATION has elaborated
p.(None): A GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS, which contains ethical and operational guidelines to guide
p.(None): researchers, sponsors, members of research ethics committees and regulatory authorities, and
p.(None): of the different jurisdictions in the proper development and evaluation of the investigations in the
p.(None): involving human beings.
p.(None): That this GUIDE FOR INVESTIGATIONS IN HUMAN HEALTH is complemented by the Good Practice Regime
p.(None): Clinic for Clinical Pharmacology Studies approved by
p.(None): Provision of the NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY -ANMAT N ° 6677/10.
p.(None): That it is the function of the MINISTRY OF HEALTH OF THE NATION to promote research in
p.(None): health and that an important part of the promotion is the systematization and dissemination of
p.(None): information on such investigations in order to socialize their results and promote their application in
p.(None): the formulation of health policies and programs, as well as avoiding duplication of efforts and stimulating
p.(None): transparency of investigations that the Ministry itself finances itself or through its agencies
p.(None): decentralized or regulated through the NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY -
p.(None): ANMAT.
p.(None): That the MINISTRY OF HEALTH OF THE NATION has already created a REGISTRY OF TRIALS
p.(None): CLINICS IN HUMAN BEINGS through Resolution 102/09 that has not yet been implemented but that is
p.(None): it is necessary to extend its coverage to all human health research.
p.(None): That the GENERAL DIRECTORATE OF LEGAL AFFAIRS has taken the intervention of its competence.
p.(None): That it acts in use of the powers granted by the Law of Ministries No. 26,338 (T.O. by Decree No. 438 of 12 of
p.(None): March 1992 and its amendments and supplements).
p.(None): Thus,
p.(None): THE MINISTER OF HEALTH RESOLVES:
p.(None): Article 1 - Approve the GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS, which as ANNEX I forms an integral part of the
p.(None): this Resolution and whose objective is to guide researchers, sponsors, members of ethics committees in
p.(None): research and regulatory and health authorities of the different jurisdictions in the development and evaluation
p.(None): appropriate research involving humans.
p.(None): Art. 2 - Create the NATIONAL REGISTRY OF HEALTH INVESTIGATIONS in order to systematize, consolidate and
p.(None): make information regarding human health research publicly available.
p.(None): Art. 3 ° - Both the GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS and the
p.(None): NATIONAL REGISTRY OF HEALTH INVESTIGATIONS will be mandatory for the Studies of
p.(None): Clinical Pharmacology for registration purposes in the scope of application of the NATIONAL ADMINISTRATION OF MEDICINES,
p.(None): FOOD AND MEDICAL TECHNOLOGY
p.(None): (ANMAT) and for all research financed with funds from the MINISTRY OF HEALTH and / or its organizations
p.(None): Decentralized dependents.
p.(None): Art. 4 - The NATIONAL HEALTH INVESTIGATION COMMISSION that works within the DEPUTY SECRETARIAT OF RELATIONS is empowered
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p.(None): Protection of Human Subjects of Biomedical and Behavioral Research) established the ethical principles for
p.(None): research involving human subjects. In 1982, the Council of International Organizations of the
p.(None): Medical Sciences (CIOMS) formulated the International Ethical Guidelines for Research
p.(None): Biomedical in Human Beings (updated in 1993 and 2002) and, in 1991, the International Guidelines for Ethical Review
p.(None): of Epidemiological Studies (updated in 2009 as International Ethical Guidelines for Epidemiological Studies).
p.(None): The Good Clinical Research Practice (BPIC) is a set of established ethical and scientific requirements
p.(None): for the design, conduct, registration and reporting of clinical trials carried out to support the registration of
p.(None): pharmaceutical products for human use, in order to ensure that the rights and integrity of
p.(None): participants and that the data and results obtained are reliable and accurate. This regulation was developed
p.(None): in 1978 by the United States Food and Drug Administration (FDA), and
p.(None): then validated in 1996 between this country, the European Union and Japan at the International Conference on Harmonization
p.(None): (ICH).
p.(None): In 2002, the World Health Organization issued a Handbook for Good Clinical Researc Practice (BPIC) and
p.(None): In 2005, the Pan American Health Organization published the BPIC guide known as “Document of the Americas”, the
p.(None): which served as the basis for the "Guide to Good Clinical Research Practices in Human Beings" of the Ministry of
p.(None): Health of the Nation (Resolution 1490/07), intended to regulate clinical trials in its field of
p.(None): application. Subsequently, this Guide was revised with the aim of expanding its scope to all research in
p.(None): human health and this document is the result of that review.
p.(None): The following documents were used as reference for the preparation of this Guide:
p.(None): - Declaration of Helsinki (AMM, 2008)
p.(None): - International ethical guidelines for biomedical research in human beings (CIOMS, 2002)
p.(None): - International Ethics Guidelines for Epidemiological Studies (CIOMS, 2009)
p.(None): - Guidelines for the Clinical Translation of Stem Cells (ISSCR, 2008)
p.(None): - Operational guidelines for ethics committees that evaluate biomedical research (WHO, 2000)
p.(None): - Surveying and Evaluating Ethical Review Practices (WHO, 2002)
p.(None): - Guidelines for Good Clinical Practice (ICH, 1996)
p.(None): - Handbook for Good Clinical Research Practice (WHO, 2002)
p.(None): - Good clinical practices: Document of the Americas (PAHO, 2005)
p.(None): - Ethics Committee. Standard working procedures (PAHO, 2009)
p.(None): - Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997)
p.(None): - International Declaration on Human Genetic Data (UNESCO, 2003)
p.(None): - International Declaration on Bioethics and Human Rights (UNESCO, 2005) This Guide has been submitted to
p.(None): evaluation of the following entities:
p.(None): - National Academy of Pharmacy and Biochemistry
p.(None): - National Academy of Medicine
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Political / vulnerable
Searching for indicator vulnerable:
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p.(None): basic ethics: respect for people, charity and justice.
p.(None): Respect for people. This principle implies that people who are autonomous or capable of deliberating about their
p.(None): decisions are respected in their capacity for self-determination, free of undue incentives and influence, and
p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
p.(None): Justice. This principle refers to the ethical obligation to treat each person equally, unless
p.(None): there are relevant differences that justify different treatment.
p.(None): Distributive justice requires that all benefits and burdens of research be distributed
p.(None): equitably between all groups and classes in society, especially if they are dependent or
p.(None): vulnerable. Studies must be planned so that the knowledge sought benefits the group
p.(None): represented by the participants. For example, the risks for vulnerable participants are more
p.(None): justified when they arise from interventions or procedures that offer a specific benefit for your health. In
p.(None): In sum, those who bear the burden of participation should receive an adequate benefit and the group that
p.(None): The beneficiary must assume an equitable proportion of the risks of the study.
p.(None): Respect for the communities. When a researcher plans or conducts research in cultural communities
p.(None): different from yours, you must respect the cultural and ethical values of the host community. An investigation
p.(None): that seeks to stimulate a change in customs or
p.(None): behaviors of a community with the aim of achieving healthier behaviors or a result that is expected to be beneficial for
p.(None): health is considered ethical and not harmful.
p.(None): In general, investigators or study sponsors should not be held responsible for
p.(None): unfair conditions of the place where it takes place, but they must guarantee that they will not carry out
p.(None): practices that could increase injustice or contribute to new inequalities. Investigations in
p.(None): Vulnerable communities must respond to their health needs and priorities, as a way to avoid their
p.(None): exploitation in favor of the most favored communities.
p.(None): Scientific validity. An investigation will be considered valid from the scientific point of view when the
p.(None): Proposed methods are tailored to the research objectives and field of study. Without scientific validity,
p.(None): research cannot generate valid knowledge, produce any benefit or justify the
p.(None): exposure of the participants to the risks of the same. Invalid studies also cause a
p.(None): waste of resources.
p.(None): Qualified researchers. Human health research should be conducted or supervised only by researchers who
p.(None): demonstrate sufficient instruction, training, and experience. Instruction or education refers to the possession of
p.(None): a tertiary professional degree, university or specialization, according to the research object. Training
p.(None): it means participation in focused training programs of relatively short duration. Experience is
p.(None): refers to specific work history or to the stable and prolonged performance of tasks
p.(None): related to professional practice and research.
p.(None): In clinical trials, in particular, a duly qualified and appropriately qualified doctor or dentist
p.(None): enrolled must be responsible for the medical care of the participants and for any medical decision
p.(None): take for them. The vital curriculum of researchers, including proof of degrees, specializations,
p.(None): professional qualification, training and experience, can provide information on your suitability for
p.(None): sponsor, CEI, and regulatory authorities, if applicable. The rest of the team must prove
p.(None): appropriate training in the study protocol, the conduct of clinical trials, and the ethical aspects of
p.(None): human health research.
...
p.(None): research, after being informed according to their ability to understand. People with disorders
p.(None): or permanent mental disorders, such as coma or Alzheimer's disease, and who do not have
p.(None): representative appointed by a judge, pose a particular situation. From an ethical point of view, these people
p.(None): they should not be deprived of the benefit of gaining new knowledge or developing new treatments for
p.(None): condition they suffer from. In accordance with Article 7 of the National Mental Health Law No. 26,657 and with Article 4 of the
p.(None): National Law on Patient Rights No. 26,529, a relative up to the fourth degree of consanguinity, the spouse or the
p.(None): living with the patient are the ones who could best answer for their interests and for the decision he or she would make
p.(None): if they were in full use of their faculties, therefore, it is they who must represent the potential
p.(None): participant to obtain reliable informed consent. As far as possible, or when the
p.(None): Participant recovers the use of his faculties, must be informed about the research and request his
p.(None): consent before continuing with it.
p.(None): The witness of the consent process. The figure of the independent witness of the investigator is a guarantee
p.(None): additional to the evaluation of the CEI that the researcher will respect the values and interests when obtaining the
p.(None): consent of a potential participant vulnerable to possible undue incentive or coercion. This requirement
p.(None): applies exclusively to clinical pharmacology studies for registration or regulatory purposes subject to
p.(None): ANMAT supervision, in the following cases:
p.(None): (a) when the participation of vulnerable populations for cultural, educational reasons is foreseen,
p.(None): social or economic; Y
p.(None): (b) in the case of urgent situations that require the use of an abbreviated consent.
p.(None): The witness must sign the consent form as proof of their participation.
p.(None): Deliberate objection and assent of minors. In general, voluntary cooperation or
p.(None): assent of a minor to participate in an investigation, after providing them with the information appropriate to their degree of
p.(None): maturity. Children who are immature to nod with understanding may be able to voice an ‘objection
p.(None): deliberate ’, that is, an expression of disapproval or denial of the proposed procedure, which should
p.(None): be respected, unless the child needs treatment not available outside the context of the investigation, the
p.(None): study intervention implies a probability of therapeutic benefit and there is no accepted alternative therapy.
p.(None): The CEI must determine the age from which the consent of the minor will be required, based on the
p.(None): characteristics of each study. Community consent. When planning community investigations or
p.(None): groups of people linked by ethnic, geographical, social or common interests reasons, should
...
p.(None): That is, without industrial or commercial purposes, it is acceptable that the treatments or procedures are covered
p.(None): by the participant's regular health funder, as long as these treatments and procedures are
p.(None): fit into the current medical practice for the disease under study and that the cost thereof is not found
p.(None): included in the subsidy or funding received for the research.
p.(None): TO 5. SELECTION OF PARTICIPANTS
p.(None): P12. Participants should be selected based on the objectives and design of the
p.(None): research, and most likely to minimize risks and maximize benefits at the individual level.
p.(None): All individuals and / or groups in a society should have equal access to the possibility of
p.(None): benefit from scientifically valid research, regardless of their cultural or educational situation,
p.(None): social or economic, unless there is a properly justified scientific or security reason. Fair selection.
p.(None): Although the scientific objective of the research is the main criterion for the selection of the participants,
p.(None): the principles that hold that equals should be treated in the same way and that the benefits
p.(None): and the burdens generated by social cooperation, such as research, must be equitably distributed
p.(None): Among the groups involved, they should have similar consideration in the ethical evaluation. This does not
p.(None): means that individuals
p.(None): or selected groups should benefit directly from any research project or that people
p.(None): marginalized, stigmatized or socioeconomically disadvantaged should never be included.
p.(None): Vulnerable population. Group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that due to a social, cultural, educational or economic condition
p.(None): unfavorable is liable to be influenced by the expectation of receiving a benefit for participating in the
p.(None): investigation (undue incentive) or to be the victim of a threat by investigators or others in a
p.(None): situation of power if they refused to participate (coercion).
p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
p.(None): (d) the risks associated with interventions or procedures without direct benefit to the health of the participants not
p.(None): outnumber those associated with routine medical or psychological examinations of such persons, unless CEI authorizes
p.(None): a slight increase in that level of risk;
p.(None): (e) in the case of clinical trials, consent will be obtained in the presence of a witness
p.(None): independent to guarantee the voluntariness and the freedom of the decision to participate.
p.(None): Researchers must identify those individuals or groups in situations of vulnerability in order to implement a
p.(None): special protection for them. However, some vulnerabilities can be relatively easy to identify,
p.(None): such as physical, legal or mental inability to grant voluntary consent, while others are
p.(None): difficult to define, such as unfavorable economic, social, cultural or educational conditions.
p.(None): Individuals unable to grant consent. They are minors and people with disorders
p.(None): transient, fluctuating or permanent mental disorders. Research with these groups is only justified when:
p.(None): (a) the knowledge expected to be obtained from the research is sufficiently relevant in relation to the risks
p.(None): predictable;
p.(None): (b) the risks of an observational study are only slightly higher than those associated with medical examinations and
p.(None): psychological routines of such people in the condition under investigation;
p.(None): (c) the risks of experimental research are similar to those of the interventions usually received by
p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
...
p.(None): the ethical recommendations of Section A were respected.
p.(None): B1. THE INFORMED CONSENT
p.(None): 1.1. Informed consent requirement and exceptions
p.(None): 1.1.1. Informed consent is the process that ensures that a potential participant or their
p.(None): Legal representative voluntarily make the decision to participate, free of undue incentive and coercion
p.(None): in an investigation, provided that it is consistent with their values, interests and preferences. The process of
p.(None): Consent must be conducted by the principal investigator or a member of the professional team of the
p.(None): health or related, for example, nurse, social worker or psychologist, trained for this role. In cases where
p.(None): If a treatment is being investigated, only a doctor or dentist, when appropriate, can provide the information with
p.(None): regarding patient treatment.
p.(None): 1.1.2. In case of legal incompetence or mental incapacity of the potential participant to give consent
p.(None): Voluntary, it must be obtained from the legal representative. To the extent that your understanding allows, you should
p.(None): request the consent of the potential participant, after informing them about the study. Your decision to
p.(None): participate or should not be respected
p.(None): 1.1.3. In clinical trials, when the potential participant is socially vulnerable,
p.(None): cultural, educational or economic, a witness must participate in the informed consent process
p.(None): independent of the researcher or his team, who must sign and date the consent form as
p.(None): proof of your participation.
p.(None): 1.1.4. In medical emergency situations that require immediate intervention, a summary may be used,
p.(None): approved by the CEI, of the written information for the participant. Oral information must be provided in
p.(None): presence of an independent witness, who must sign, together with the investigator, the summary of information and the
p.(None): consent form. The
p.(None): Participant or their representative must sign the consent form and then receive an original thereof and
p.(None): a copy of the summary of information.
p.(None): 1.1.5. In observational studies, it is common to obtain informed consent from potential
p.(None): However, the CEI could approve the following exceptions:
p.(None): (a) when publicly available information is used. In such cases, investigators must demonstrate that they do not
p.(None): there is a risk of disclosure of personal data;
p.(None): (b) when obtaining consent is impracticable, as in the case of biological data or samples
p.(None): irreversibly dissociated, or retrospective cohort studies conducted on medical records. In
...
p.(None): (a) description of research interventions;
p.(None): (b) in drug trials, indicate dose, frequency, route of administration and duration of treatment.
p.(None): and security monitoring;
p.(None): (c) in tests of biological or biotechnological products, the identification and valuation methodology that
p.(None): ensure uniformity of the preparation to be studied;
p.(None): (d) drugs allowed and not allowed;
p.(None): (e) delivery and / or administration mechanisms of the experimental intervention. The protocol should specify the
p.(None): procedures to be followed for its handling, storage and inventory, including its delivery and return of
p.(None): participants and their final disposition.
p.(None): (f) criteria for suspension of treatment;
p.(None): (g) planned rescue treatments and follow-up in the event of failure or adverse events;
p.(None): 4.3.5. Ethical aspects
p.(None): (a) specification that the research will be reviewed by a REC;
p.(None): (b) procedures for obtaining informed consent;
p.(None): (c) procedures to protect the confidentiality of the participants;
p.(None): (d) details of coverage and compensation for damage available to participants;
p.(None): (e) justification of payments or compensation for expenses available to participants;
p.(None): (f) anticipation of access at the end of the trial to the intervention identified as beneficial in the trial, or to a
p.(None): appropriate alternative, or other suitable benefit;
p.(None): (g) justification for the use of placebo, if applicable;
p.(None): (h) justification for conducting the research in a vulnerable group, if applicable;
p.(None): (i) possible conflicts of interest.
p.(None): 4.3.6. Administrative aspects
p.(None): (a) registration and communication of clinical data;
p.(None): (b) procedure for registration and notification to the CEI of adverse events;
p.(None): (c) handling of trial documents;
p.(None): (d) plan and publication rights of the results.
p.(None): 4.3.7. The changes made in the protocol approved by the CEI must be justified based on its
p.(None): potential impact on the participants and the scientific validity of the study; and require the approval of the
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
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p.(None): observed, without posing a hypothesis. Examples: prevalence studies, cross-sectional, demographic,
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
p.(None): a potential participant who is incapable or incompetent to grant the informed consent of a
p.(None): investigation.
p.(None): INDEPENDENT WITNESS: person independent of the researcher and his team who participates in the process of
p.(None): obtaining informed consent as a guarantee that it respects the rights and interests of a potential
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Searching for indicator vulnerability:
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p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
p.(None): (d) the risks associated with interventions or procedures without direct benefit to the health of the participants not
p.(None): outnumber those associated with routine medical or psychological examinations of such persons, unless CEI authorizes
p.(None): a slight increase in that level of risk;
p.(None): (e) in the case of clinical trials, consent will be obtained in the presence of a witness
p.(None): independent to guarantee the voluntariness and the freedom of the decision to participate.
p.(None): Researchers must identify those individuals or groups in situations of vulnerability in order to implement a
p.(None): special protection for them. However, some vulnerabilities can be relatively easy to identify,
p.(None): such as physical, legal or mental inability to grant voluntary consent, while others are
p.(None): difficult to define, such as unfavorable economic, social, cultural or educational conditions.
p.(None): Individuals unable to grant consent. They are minors and people with disorders
p.(None): transient, fluctuating or permanent mental disorders. Research with these groups is only justified when:
p.(None): (a) the knowledge expected to be obtained from the research is sufficiently relevant in relation to the risks
p.(None): predictable;
p.(None): (b) the risks of an observational study are only slightly higher than those associated with medical examinations and
p.(None): psychological routines of such people in the condition under investigation;
p.(None): (c) the risks of experimental research are similar to those of the interventions usually received by
p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
...
p.(None): verbal.
p.(None): 1.2.4. The researcher or his authorized delegate must ensure that the potential participant or his
p.(None): representative have understood all the information received, for which they must be given the opportunity and time
p.(None): enough to consider all the options, ask all the questions you want and be satisfied
p.(None): with the answers.
p.(None): 1.2.5. After being informed, the potential participant or his legal representative, the researcher or his delegate and the
p.(None): witness, if applicable, must sign and date two originals of the consent signature sheet, such as
p.(None): declaration of having received and understood the study information and of having made the free and voluntary decision
p.(None): to participate in it. After
p.(None): the signatures, the participant or his representative must receive one of the originals of the signature sheet and a copy of
p.(None): the information section for participants.
p.(None): 1.2.6. In clinical trials, the process of obtaining informed consent must be documented in the history
p.(None): participant's clinic, including their start date and time, which was given time to reflect and to make
p.(None): questions, what were those questions, that the understanding of the information was verified, that two were signed
p.(None): originals of the signature sheet and that one of them was given to the participant or his representative. In case of
p.(None): participation of the legal representative and / or a witness, the compliance with the requirements that
p.(None): correspond, including the presence or absence of the vulnerability condition.
p.(None): 1.2.7. All new information or changes in the protocol that could affect the safety of the participant or their
p.(None): decision to continue the study must be communicated verbally and in writing to the participant or their
p.(None): legal representative in order to obtain your consent. New participant information sheets must
p.(None): preferably contain only the information that has changed and be approved by the CEI before use, unless
p.(None): that the changes needed to be implemented immediately for the safety of the participant.
p.(None): 1.3. Information for the potential participant or their representative
p.(None): 1.3.1. In observational research that requires consent, the potential participant or their
p.(None): Representative must be informed of the following:
p.(None): (a) the title of the investigation;
p.(None): (b) proof that the individual is invited to participate in the research and the reasons why
p.(None): considers it appropriate to do so; (c) proof that participation in the research is voluntary
p.(None): and that the potential participant may refuse to participate or abandon the research at any
p.(None): moment, without having to express your reasons and without loss of the benefits to which you are entitled, for
p.(None): example, without affecting the relationship with your doctor or with the institution where you are treated;
p.(None): (d) the purpose of the research, the procedures to which the participant will undergo, the visits to which
p.(None): you are expected to attend and the expected duration of your participation;
p.(None): (e) proof that participation in the study will have no costs for the participant;
p.(None): (f) the remuneration available to the participant for the expenses derived from their participation. In cases where
...
p.(None): (g) justification for the use of placebo, if applicable;
p.(None): (h) justification for conducting the research in a vulnerable group, if applicable;
p.(None): (i) possible conflicts of interest.
p.(None): 4.3.6. Administrative aspects
p.(None): (a) registration and communication of clinical data;
p.(None): (b) procedure for registration and notification to the CEI of adverse events;
p.(None): (c) handling of trial documents;
p.(None): (d) plan and publication rights of the results.
p.(None): 4.3.7. The changes made in the protocol approved by the CEI must be justified based on its
p.(None): potential impact on the participants and the scientific validity of the study; and require the approval of the
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
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Health / Cognitive Impairment
Searching for indicator cognitive:
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p.(None): stem, cell proliferation and / or tumor development, exposure to materials of animal origin and
p.(None): possibility of transmission of viral vectors; and in genetics, the possible effects on cells
p.(None): gametics and offspring;
p.(None): (b) the potential therapeutic benefits of the experimental intervention and the existence or not of alternatives
p.(None): therapeutic. Consent should emphasize the experimental aspect of the intervention to avoid expectations
p.(None): erroneous about its therapeutic potential;
p.(None): (c) in the case of cell therapies, the irreversibility of cell transplantation must be clearly explained. The
p.(None): cells, unlike many drug products or implantable medical devices, cannot be removed
p.(None): of the body and could continue to generate its adverse effects throughout the life of the patient;
p.(None): (d) to advance scientific knowledge, potential participants should be asked for consent
p.(None): so that in the event of death it is possible to carry out a partial or complete autopsy to assess the scope of the
p.(None): cell implantation and its morphological and functional consequences. Autopsy request must consider
p.(None): cultural and family sensitivities. The subject is delicate but, without access to post-mortem material, the
p.(None): Trial information would be affected to the detriment of future products or product improvements.
p.(None): Recognizing the potential value of new cell and gene therapies for patients with cognitive impairment and the
p.(None): importance that these are not excluded from such advances, researchers must develop a procedure
p.(None): so that authorized patient representatives can make a decision on their behalf. The
p.(None): Representatives must be duly qualified and with sufficient knowledge to evaluate the
p.(None): test and provide adequate protection.
p.(None): Expert advice. Expert review should ensure that the trial will lead to an improvement in the care of
p.(None): the disease and will generate new and important knowledge. This review should include a comparison of the new
p.(None): therapy with available treatments.
p.(None): The following elements should be evaluated by experts: in vitro and in vivo preclinical studies, studies
p.(None): clinical findings, scientific rationale for the trial, study objectives, statistical analysis, and
p.(None): specific aspects of the disease under study.
p.(None): Regulatory authority oversight. Supervision by a regulatory authority should ensure that the
p.(None): trial with cell or gene therapies has scientific merit, was designed correctly, will be carried out
p.(None): safely and will produce reliable knowledge.
p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): This section describes a series of operational requirements for obtaining informed consent, the evaluation
p.(None): ethics and science of research projects, the supervision of research ethics committees and
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p.(None): possibility of transmission of viral vectors; and in genetics, the possible effects on cells
p.(None): gametics and offspring;
p.(None): (b) the potential therapeutic benefits of the experimental intervention and the existence or not of alternatives
p.(None): therapeutic. Consent should emphasize the experimental aspect of the intervention to avoid expectations
p.(None): erroneous about its therapeutic potential;
p.(None): (c) in the case of cell therapies, the irreversibility of cell transplantation must be clearly explained. The
p.(None): cells, unlike many drug products or implantable medical devices, cannot be removed
p.(None): of the body and could continue to generate its adverse effects throughout the life of the patient;
p.(None): (d) to advance scientific knowledge, potential participants should be asked for consent
p.(None): so that in the event of death it is possible to carry out a partial or complete autopsy to assess the scope of the
p.(None): cell implantation and its morphological and functional consequences. Autopsy request must consider
p.(None): cultural and family sensitivities. The subject is delicate but, without access to post-mortem material, the
p.(None): Trial information would be affected to the detriment of future products or product improvements.
p.(None): Recognizing the potential value of new cell and gene therapies for patients with cognitive impairment and the
p.(None): importance that these are not excluded from such advances, researchers must develop a procedure
p.(None): so that authorized patient representatives can make a decision on their behalf. The
p.(None): Representatives must be duly qualified and with sufficient knowledge to evaluate the
p.(None): test and provide adequate protection.
p.(None): Expert advice. Expert review should ensure that the trial will lead to an improvement in the care of
p.(None): the disease and will generate new and important knowledge. This review should include a comparison of the new
p.(None): therapy with available treatments.
p.(None): The following elements should be evaluated by experts: in vitro and in vivo preclinical studies, studies
p.(None): clinical findings, scientific rationale for the trial, study objectives, statistical analysis, and
p.(None): specific aspects of the disease under study.
p.(None): Regulatory authority oversight. Supervision by a regulatory authority should ensure that the
p.(None): trial with cell or gene therapies has scientific merit, was designed correctly, will be carried out
p.(None): safely and will produce reliable knowledge.
p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): This section describes a series of operational requirements for obtaining informed consent, the evaluation
p.(None): ethics and science of research projects, the supervision of research ethics committees and
p.(None): planning and conducting clinical trials. Compliance with these requirements will demonstrate that
p.(None): the ethical recommendations of Section A were respected.
...
Health / Comatose
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p.(None): of an abridged version containing essential information about the study for the potential participant or their
p.(None): representative. In such case, the information must be provided in the presence of an independent witness, who
p.(None): You must sign the consent form together with the researcher and the participant or their representative.
p.(None): An investigator who proposes an exception to obtaining consent or to any of the process requirements
p.(None): You must justify to the IRB the reason for the request and explain how the rights of the
p.(None): participants. The researcher should not proceed with the investigation without the specific approval of the CEI
p.(None): for such exception.
p.(None): Inability to grant consent. In the case of people who cannot grant consent
p.(None): voluntary for physical, mental or legal reasons, it must be obtained from a representative authorized by law
p.(None): applicable, for example, the father or mother in the case of minors. The representative retains the power
p.(None): to withdraw the research from the participant if necessary for their safety or if that were the best decision
p.(None): represents your values and preferences. Respect for people who cannot grant for themselves
p.(None): consent requires that they are also given the opportunity to decide whether or not to participate in the
p.(None): research, after being informed according to their ability to understand. People with disorders
p.(None): or permanent mental disorders, such as coma or Alzheimer's disease, and who do not have
p.(None): representative appointed by a judge, pose a particular situation. From an ethical point of view, these people
p.(None): they should not be deprived of the benefit of gaining new knowledge or developing new treatments for
p.(None): condition they suffer from. In accordance with Article 7 of the National Mental Health Law No. 26,657 and with Article 4 of the
p.(None): National Law on Patient Rights No. 26,529, a relative up to the fourth degree of consanguinity, the spouse or the
p.(None): living with the patient are the ones who could best answer for their interests and for the decision he or she would make
p.(None): if they were in full use of their faculties, therefore, it is they who must represent the potential
p.(None): participant to obtain reliable informed consent. As far as possible, or when the
p.(None): Participant recovers the use of his faculties, must be informed about the research and request his
p.(None): consent before continuing with it.
p.(None): The witness of the consent process. The figure of the independent witness of the investigator is a guarantee
p.(None): additional to the evaluation of the CEI that the researcher will respect the values and interests when obtaining the
p.(None): consent of a potential participant vulnerable to possible undue incentive or coercion. This requirement
p.(None): applies exclusively to clinical pharmacology studies for registration or regulatory purposes subject to
p.(None): ANMAT supervision, in the following cases:
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Health / Drug Usage
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p.(None): justifies the development of guidelines of conduct by consensus, with the aim of guaranteeing the highest level of
p.(None): achievable protection for individuals.
p.(None): The first international ethical guidelines for research were the Nuremberg Code (1947) and the Declaration
p.(None): of Helsinki (World Medical Association, 1964, last update 2008), setting the ethical model still in force
p.(None): for conducting studies with human beings. In 1979, the Belmont Report (National Commission for the
p.(None): Protection of Human Subjects of Biomedical and Behavioral Research) established the ethical principles for
p.(None): research involving human subjects. In 1982, the Council of International Organizations of the
p.(None): Medical Sciences (CIOMS) formulated the International Ethical Guidelines for Research
p.(None): Biomedical in Human Beings (updated in 1993 and 2002) and, in 1991, the International Guidelines for Ethical Review
p.(None): of Epidemiological Studies (updated in 2009 as International Ethical Guidelines for Epidemiological Studies).
p.(None): The Good Clinical Research Practice (BPIC) is a set of established ethical and scientific requirements
p.(None): for the design, conduct, registration and reporting of clinical trials carried out to support the registration of
p.(None): pharmaceutical products for human use, in order to ensure that the rights and integrity of
p.(None): participants and that the data and results obtained are reliable and accurate. This regulation was developed
p.(None): in 1978 by the United States Food and Drug Administration (FDA), and
p.(None): then validated in 1996 between this country, the European Union and Japan at the International Conference on Harmonization
p.(None): (ICH).
p.(None): In 2002, the World Health Organization issued a Handbook for Good Clinical Researc Practice (BPIC) and
p.(None): In 2005, the Pan American Health Organization published the BPIC guide known as “Document of the Americas”, the
p.(None): which served as the basis for the "Guide to Good Clinical Research Practices in Human Beings" of the Ministry of
p.(None): Health of the Nation (Resolution 1490/07), intended to regulate clinical trials in its field of
p.(None): application. Subsequently, this Guide was revised with the aim of expanding its scope to all research in
p.(None): human health and this document is the result of that review.
p.(None): The following documents were used as reference for the preparation of this Guide:
p.(None): - Declaration of Helsinki (AMM, 2008)
p.(None): - International ethical guidelines for biomedical research in human beings (CIOMS, 2002)
p.(None): - International Ethics Guidelines for Epidemiological Studies (CIOMS, 2009)
p.(None): - Guidelines for the Clinical Translation of Stem Cells (ISSCR, 2008)
p.(None): - Operational guidelines for ethics committees that evaluate biomedical research (WHO, 2000)
p.(None): - Surveying and Evaluating Ethical Review Practices (WHO, 2002)
p.(None): - Guidelines for Good Clinical Practice (ICH, 1996)
...
p.(None): this Guide. In cases of dissent, the position presented in the international reference guides was prioritized.
p.(None): SCOPE
p.(None): For the purposes of this Guide, “human health research” refers to any activity in the sciences of the
p.(None): health that involves the systematic collection or analysis of data with the intention of generating
p.(None): new knowledge, in which human beings are exposed to observation, intervention or other
p.(None): of interaction with researchers, either directly or through the alteration of their environment or by
p.(None): means of collecting or using biological material or personal data or other types of records.
p.(None): In order to prevent the rules and regulations from being imposed on the usual practice of medicine or epidemiology
p.(None): procedures created in recent decades to protect research participants, it is important
p.(None): define that, conventionally, "research" refers to those activities designed to develop or
p.(None): contribute to generalizable knowledge.
p.(None): Such knowledge consists of theories, principles or relationships, or the accumulation of information in which these
p.(None): base, which can be corroborated by scientific methods of observation and inference. In the case of practice
p.(None): medical, a professional could modify a conventional treatment to produce a better result for a patient;
p.(None): however, this individual variation does not produce generalizable knowledge; therefore, such activity is related
p.(None): with practice and not with research. In the same way, observational studies carried out by or in
p.(None): compliance with health authorities, such as outbreak or infection surveillance
p.(None): in-hospital, records of disease or adverse drug effects or impact assessment
p.(None): of a health program, they should be seen as an epidemiological or health practice and not as research.
p.(None): The need to establish mechanisms of guidance, regulation and control over a given activity arises from the risk
p.(None): specific to cause harm to the individuals targeted by the activity. For the same reason, those mechanisms
p.(None): they must correspond to the level of risk derived. First, the ethics guidelines for biomedical research
p.(None): They were designed to guide researchers to plan studies in such a way that the
p.(None): consideration for the welfare and rights of the participants is the primary value, above the interest
p.(None): for science or any other interest. From these ethical guidelines emerged, first, the requirement of
p.(None): informed consent of the person prior to their participation, as proof of respect for their autonomy and,
p.(None): second, the requirement of ethical evaluation of projects by a research ethics committee (CEI), such as
p.(None): instance of guarantee of the adherence of the researchers to such guidelines. The multidisciplinary nature and
p.(None): multi-sectoral ERC highlights that the interpretation and application of ethical principles cannot be
p.(None): neither rigid nor dogmatic, if not they must be the result of a consensus between the different actors of the
p.(None): research with their respective approaches.
p.(None): Subsequently, the drug regulatory authorities established regulations for the testing of products
p.(None): Pharmaceuticals under development, prior to commercial registration. This set of ethical requirements and
p.(None): administrative, known as “Good Clinical Practice”, is used as the basis for inspections that
p.(None): regulatory agencies conduct to verify the protection of the rights and welfare of participants, and the
p.(None): quality and veracity of the data generated to support the registration request. In addition to these requirements, more
p.(None): late, the recommendation of the World Health Organization to implement a registration system for
p.(None): health research and accreditation and supervision of the RECs.
p.(None): Considering the risk probabilities of health research, it is possible to establish, first of all, that the
p.(None): research that is not done on humans, or that uses
p.(None): data already available and in the public domain, or that is made with data or biological samples stored in services
p.(None): of health in such a way that the identity of the holders cannot be determined, they do not represent any risk and
p.(None): require no control mechanism.
p.(None): Second, observational investigations that include surveys or interviews or procedures
p.(None): routine diagnoses or are limited to analysis of biological samples or data linked to people and
p.(None): epidemiological or clinical experimental investigations carried out with products or procedures already registered
...
p.(None): human health research.
p.(None): A2. ETHICAL AND SCIENTIFIC EVALUATION
p.(None): P4. The background, objectives, design, size and selection of the sample, selection mechanisms of
p.(None): participants, measurement methods of the variables, statistical analysis, detail of the proposed intervention,
p.(None): if applicable, and the ethical, financial and administrative aspects of health research
p.(None): Humans must be clearly and comprehensively detailed in a study protocol.
p.(None): P5. The study protocol and information intended for potential participants should be submitted to
p.(None): evaluation and approval of a research ethics committee (CEI) before starting the study. The CEI
p.(None): It must be independent of sponsors and researchers. The researcher must inform the CEI
p.(None): periodically about the progress of the study and, immediately, the findings or events
p.(None): relevant that imply unforeseen risks for the research participants. The proposed changes
p.(None): in the study and that may affect the safety of the participants or their decision to continue participating must be
p.(None): evaluated and approved by the CEI before its implementation.
p.(None): Scope. The requirement that human health research projects undergo an ethical review applies
p.(None): independently of the origin of the project: academic-scientific, government, health care, commercial or
p.(None): others. Researchers must recognize the need for this evaluation.
p.(None): Exceptions. The following cases do not require review by a CEI:
p.(None): (a) when human beings do not participate in the investigation or when public information is used, provided that
p.(None): individuals are not identified in any way. For example, the studies of Drug-economy;
p.(None): (b) when the intervention is limited to the study of health systems, official public health programs or the
p.(None): public health surveillance, provided that there is no possibility of identifying individuals. The
p.(None): Public health surveillance includes official records or records conducted in accordance with authority
p.(None): health of diseases and adverse effects of medicines already registered by the competent regulatory authority.
p.(None): It can sometimes be difficult to distinguish whether a specific project is for research or for evaluation of a
p.(None): health program or a health service. The defining characteristic of research is that its purpose
p.(None): is to produce new and generalizable knowledge, on the other hand, an evaluation only seeks to know and describe
p.(None): a characteristic or diagnosis relevant only to a person, group of them or a specific program.
p.(None): The evaluation of an official health program or health service, carried out by the operators themselves
p.(None): program or institution staff should be considered a necessary action to ensure effectiveness
p.(None): and security of a facility or procedure, always under the perspective of benefiting people. The same
p.(None): justification applies to the surveillance of epidemiological events or side effects of drugs or other
p.(None): products for human use. But if the exam was done for research purposes or if it was not clear
p.(None): the scope, the project must be submitted to the CEI for evaluation and definition.
p.(None): Institutional or central committees. By virtue of the responsibility to monitor the protection of the participants, it is
...
p.(None): In particular, in clinical trials sponsored by a pharmaceutical company that have shown that a product
p.(None): Experimental is beneficial, the sponsor should continue to provide it to the participants until their access is
p.(None): guarantee by other means. The requirement of this requirement must be determined based on certain considerations
p.(None): relevant, such as the severity of the medical condition in question and the expected effect of withdrawing or modifying the
p.(None): treatment, for example, leaving a sequel or causing the death of the patient. When it is not possible to fulfill it
p.(None): The provision of an alternative intervention or other appropriate benefit, approved by
p.(None): the CEI and for the period that it determines.
p.(None): A10. CLINICAL TRIALS OF CELL AND GENIC THERAPIES
p.(None): P20. Clinical trials of gene and cellular therapies must follow the principles that protect
p.(None): research participants, including: proper trial planning, fair selection,
p.(None): informed consent, strict medical control of the participants, review by a REC and a
p.(None): expert advice and supervision by a competent regulatory authority.
p.(None): Ethical justification for trials with cell and gene therapies. A therapeutic approach with cell therapies and
p.(None): Gene assays should aim to be clinically similar or superior to existing therapies. If there is already a therapy
p.(None): effective, the risks associated with cell or gene therapy
p.(None): they must be low and offer a potential advantage, for example a better functional result or be a
p.(None): single procedure versus prolonged drug treatment with associated adverse effects. If it doesn't exist yet
p.(None): a therapy, the severity of the disease could justify the risks of an experimental cell or gene therapy.
p.(None): In any case, every effort should be made to minimize the risks of possible associated adverse effects
p.(None): with the use of cells or genes and not taking advantage of the hopes of patients with a poor prognosis. In the
p.(None): gene therapies in particular, given their complexity, the risks could transcend the individual himself and affect the
p.(None): geneticXheritage of the human being. For all this, the suitability and moral integrity of the researchers and the
p.(None): Scientific validity of research must be carefully evaluated.
p.(None): Proper trial planning. The following guidelines should be considered when planning a clinical trial with
p.(None): cellular or gene therapies:
p.(None): (a) preclinical studies in animals and / or other models and previous clinical studies of the therapeutic proposal
p.(None): experimental should show convincing evidence of safety and potential therapeutic benefits for
p.(None): justify its use in humans;
p.(None): (b) the biological characteristics of the intervention and the production procedures must be clearly
p.(None): established. Whenever applicable, production must conform to Good Laboratory Practice, and be carried out
p.(None): under appropriate biosecurity conditions;
p.(None): (c) the proposed clinical trial should provide for a short, medium and, if applicable, long-term safety assessment
p.(None): deadline, with a timely and effective notification plan for adverse events;
p.(None): (d) experimental therapy should be compared with the best available treatment, if any;
p.(None): (e) the risks of experimental therapy should be identified and minimized, and the benefits
...
p.(None): manufacturing and laboratory and toxicology information; Y
p.(None): (g) experimental therapy, if approved, should be accessible to the local population through
p.(None): health services available.
p.(None): Participants' medical care. Participants have the right to receive any medical attention they require in
p.(None): case of toxicity, including the treatment of tumors that may appear, and compensation for derived injuries
p.(None): Of the investigation. Given the long-term persistence of implanted cell products and according to the type of
p.(None): Experimental intervention, participants must undergo long-term health checks.
p.(None): Informed consent. In addition to the usual requirements for the consent of potential participants
p.(None): In research, the information must clearly express:
p.(None): (a) the foreseeable risks of the proposed experimental therapy. For example, in the case of cell therapies
p.(None): stem, cell proliferation and / or tumor development, exposure to materials of animal origin and
p.(None): possibility of transmission of viral vectors; and in genetics, the possible effects on cells
p.(None): gametics and offspring;
p.(None): (b) the potential therapeutic benefits of the experimental intervention and the existence or not of alternatives
p.(None): therapeutic. Consent should emphasize the experimental aspect of the intervention to avoid expectations
p.(None): erroneous about its therapeutic potential;
p.(None): (c) in the case of cell therapies, the irreversibility of cell transplantation must be clearly explained. The
p.(None): cells, unlike many drug products or implantable medical devices, cannot be removed
p.(None): of the body and could continue to generate its adverse effects throughout the life of the patient;
p.(None): (d) to advance scientific knowledge, potential participants should be asked for consent
p.(None): so that in the event of death it is possible to carry out a partial or complete autopsy to assess the scope of the
p.(None): cell implantation and its morphological and functional consequences. Autopsy request must consider
p.(None): cultural and family sensitivities. The subject is delicate but, without access to post-mortem material, the
p.(None): Trial information would be affected to the detriment of future products or product improvements.
p.(None): Recognizing the potential value of new cell and gene therapies for patients with cognitive impairment and the
p.(None): importance that these are not excluded from such advances, researchers must develop a procedure
p.(None): so that authorized patient representatives can make a decision on their behalf. The
p.(None): Representatives must be duly qualified and with sufficient knowledge to evaluate the
p.(None): test and provide adequate protection.
p.(None): Expert advice. Expert review should ensure that the trial will lead to an improvement in the care of
p.(None): the disease and will generate new and important knowledge. This review should include a comparison of the new
p.(None): therapy with available treatments.
...
p.(None): This Guide describes the minimum structure and information that a clinical trial protocol should contain.
p.(None): 4.3.2. General information, background and justification.
p.(None): (a) full study title and protocol version;
p.(None): (b) identification of researchers and research centers;
p.(None): (c) sources of financing;
p.(None): (d) summary of the protocol;
p.(None): (e) description of the problem to be investigated and current state of knowledge;
p.(None): (f) purpose and relevance of the proposed investigation.
p.(None): 4.3.3. Methodological aspects
p.(None): (a) description of the general and specific objectives of the trial, the hypotheses or research questions, their
p.(None): assumptions and their variables;
p.(None): (b) study design and justification for their choice;
p.(None): (c) randomization and masking mechanisms, including procedures for opening the masking
p.(None): in case of emergency, if applicable;
p.(None): (d) expected number of participants, including calculations on the power of the test;
p.(None): (e) inclusion and exclusion criteria of participants, including diagnostic criteria;
p.(None): (f) withdrawal criteria of the participants;
p.(None): (g) description of the statistical tests and computer tools to be used;
p.(None): (h) efficacy parameters to be measured, including instruments and measurement methods;
p.(None): (i) efficacy criteria;
p.(None): (j) criteria for the analysis of security information;
p.(None): (k) criteria for handling missing, excluded and spurious data;
p.(None): (l) criteria for inclusion or exclusion of participants in the analysis;
p.(None): (m) criteria for cancellation of the trial.
p.(None): 4.3.4. Study interventions
p.(None): (a) description of research interventions;
p.(None): (b) in drug trials, indicate dose, frequency, route of administration and duration of treatment.
p.(None): and security monitoring;
p.(None): (c) in tests of biological or biotechnological products, the identification and valuation methodology that
p.(None): ensure uniformity of the preparation to be studied;
p.(None): (d) drugs allowed and not allowed;
p.(None): (e) delivery and / or administration mechanisms of the experimental intervention. The protocol should specify the
p.(None): procedures to be followed for its handling, storage and inventory, including its delivery and return of
p.(None): participants and their final disposition.
p.(None): (f) criteria for suspension of treatment;
p.(None): (g) planned rescue treatments and follow-up in the event of failure or adverse events;
p.(None): 4.3.5. Ethical aspects
p.(None): (a) specification that the research will be reviewed by a REC;
p.(None): (b) procedures for obtaining informed consent;
p.(None): (c) procedures to protect the confidentiality of the participants;
p.(None): (d) details of coverage and compensation for damage available to participants;
p.(None): (e) justification of payments or compensation for expenses available to participants;
p.(None): (f) anticipation of access at the end of the trial to the intervention identified as beneficial in the trial, or to a
p.(None): appropriate alternative, or other suitable benefit;
p.(None): (g) justification for the use of placebo, if applicable;
p.(None): (h) justification for conducting the research in a vulnerable group, if applicable;
p.(None): (i) possible conflicts of interest.
p.(None): 4.3.6. Administrative aspects
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p.(None): based on unethical research.
p.(None): SECTION A: ETHICAL ASPECTS
p.(None): This section presents ethical guidelines for human health research aimed at guiding
p.(None): researchers during study planning and execution and members of research ethics committees
p.(None): for the evaluation of projects.
p.(None): A1. ETHICAL JUSTIFICATION AND SCIENTIFIC VALIDITY
p.(None): P1. For human health research to be ethically justified, it must
p.(None): provide new and scientifically valid knowledge that is not feasible to obtain without participation
p.(None): from them.
p.(None): P2. All research in human health must be based on current scientific knowledge and be based on
p.(None): a comprehensive review of the specialized literature. Investigating a new intervention
p.(None): on human health must be based on appropriate prior laboratory, preclinical and
p.(None): clinical and justified by its preventive, diagnostic or therapeutic value.
p.(None): P3. Human health research must be conducted by researchers who have the appropriate training and
p.(None): homework training.
p.(None): Basic ethical principles: Health research on human beings must comply with the three principles
p.(None): basic ethics: respect for people, charity and justice.
p.(None): Respect for people. This principle implies that people who are autonomous or capable of deliberating about their
p.(None): decisions are respected in their capacity for self-determination, free of undue incentives and influence, and
p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
...
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
p.(None): volunteer through the presence of an independent witness in the process of obtaining the same.
p.(None): In research without potential benefits for the health of the participants, for example, when it comes to
p.(None): healthyXvolunteers, they may receive a payment, the type or amount of which must
p.(None): be approved by the CEI. On the other hand, when the research presents a potential benefit for the health of
p.(None): Participants, only compensation for expenses or lost profits is acceptable.
p.(None): Coercion. The intentional use of force or threats to modify the will of other people, for example, a
p.(None): threat of physical harm or punishment such as loss of job or medical care for refusing to participate in
p.(None): an investigation is unacceptable.
p.(None): Undue influence. Potential participants may not feel free to refuse requests from those with power
p.(None): therefore, investigations should not be proposed with individuals whose decision may be affected by
p.(None): a related authority, if they could be carried out with independent participants. Otherwise, the
p.(None): investigators must justify that choice to the IRB and outline how they plan to neutralize that possible
p.(None): influence.
p.(None): Use of medical data and biological samples. Patients have the right to know if their data or samples
p.(None): They will be used for an investigation, so researchers must obtain their prior consent. A
p.(None): CEI may approve the use for research of data or samples from medical care, without
p.(None): prior consent of patients, only when the project is scientifically proven
p.(None): valid, minimal risk is expected, obtaining consent will be difficult or impractical and will be guaranteed
p.(None): the protection of the privacy and confidentiality of individuals through an irreversible dissociation of the
p.(None): biological data or samples. A probable refusal to participate by individuals should not be considered
p.(None): impracticability criterion to approve the omission of consent.
p.(None): If biological samples are obtained as part of the investigation, informed consent must include the
p.(None): Next information:
p.(None): (a) the possible uses, direct or secondary, of biological samples obtained in the study;
p.(None): (b) the fate of the biological samples at the end of the study, for example, their destruction or storage
p.(None): for future use. In the latter case, the possible future uses should be specified and where,
p.(None): how and for how long the samples will be stored, and that the participant has the right to decide on those uses
p.(None): futures;
p.(None): (c) a statement that the samples or derived data will not be marketed; Y
...
p.(None): Methodological points out that the comparison between two or more active substances only shows the relative efficacy between
p.(None): they, while the comparison with placebo allows to establish the real efficacy and, in addition, distinguish
p.(None): the specific adverse effects of the active substance. This is especially relevant when the condition is
p.(None): characterized by fluctuating symptoms and / or spontaneous remission, has high response rates
p.(None): to placebo and existing therapies are only partially effective or have not shown superiority to placebo
p.(None): consistently in previous studies.
p.(None): The placebo effect refers to the health, physiological or psychological benefits produced by a treatment
p.(None): inert from the pharmacological point of view. A placebo can modify the patient's perception of their symptoms
p.(None): and therefore cause a bias in the results of a trial, particularly when diagnostic and diagnostic techniques are used.
p.(None): Measurement is based on the subjectivity of the perception of the patient or the observer. Examples of these situations
p.(None): are: depression (symptoms are confused with other mental health problems or are usually influenced by
p.(None): external factors), idiopathic hypertension (blood pressure changes spontaneously or by
p.(None): influence of diet, mood, etc.) and pain (pain perception varies between people).
p.(None): All this subject to the condition of minor risk.
p.(None): On the other hand, when the pharmacological response can be measured with objective techniques, the
p.(None): need to use placebo control, except in addition to standard therapy. Examples of these cases are:
p.(None): infections (the progression of pneumonia is measured by x-rays and laboratory tests) or cancer (the
p.(None): Tumor reduction can be verified with imaging or leukemia recoil with cell counts
p.(None): blood).
p.(None): When a project proposes the use of placebo, the CEI should assess whether the protocol includes the following mechanisms
p.(None): To minimize risks:
p.(None): (a) consent clearly expresses the use of placebo and its risks;
p.(None): (b) the treatment period is the minimum possible to reduce exposure to non-treatment;
p.(None): (c) control of the participants will be frequent and strict, and it is planned to withdraw the patient from the
p.(None): study or transfer to active treatment (rescue) as soon as therapeutic failure is detected;
p.(None): (d) there is an interim analysis plan and an independent data monitoring council, with clear rules for
p.(None): stopping the study for security reasons;
p.(None): (e) crossover design: groups alternately receive active treatment or placebo; Y
p.(None): (f) addition design: when scientifically and medically possible, all participants should
...
p.(None): amendments, other information for participants, updated vital curriculum of the researcher, mechanisms of
p.(None): enrollment, details of the payments and compensations expected for participants and the agreement with the sponsor, if
p.(None): apply.
p.(None): 2.2.6. The IRC must assess whether researchers are suitable for professional training and training in
p.(None): ethical and regulatory aspects for the conduct of the study; and if the host institution is suitable for the execution of
p.(None): the investigation.
p.(None): 2.2.7. The IRB must ensure that potential participants will give their consent free of coercion and incentive
p.(None): improper and after receiving all the information appropriately.
p.(None): 2.2.8. The IRB must verify that the information for the participants on compensation and expected payments is
p.(None): accurate, understandable and does not constitute an undue incentive mode.
p.(None): 2.2.9. An IRB has authority to monitor the conduct of an investigation, including the process of obtaining
p.(None): consent.
p.(None): 2.2.10. The CEI must keep all relevant documents of the investigations, such as documents submitted
p.(None): to review, minutes of meetings, opinions and communications in general, for a period of ten years after completion
p.(None): the study, and make them available to the health authorities if they request it.
p.(None): 2.3. Composition
p.(None): 2.3.1. The CEI must be constituted according to the regulations and / or laws of the jurisdiction under which it was created, and
p.(None): in such a way as to guarantee a competent evaluation free of bias and influence of ethical aspects,
p.(None): scientific, social and operational study.
p.(None): 2.3.2. The composition of the CEI must be multidisciplinary, multisectoral and balanced in age, sex and
p.(None): scientific and non-scientific training. The number of members must be adequate to fulfill their role, preferably
p.(None): odd and with a minimum of five regular members and at least two alternate or alternate members in cases of absence
p.(None): of the holders.
p.(None): 2.3.3. Members will need to renew themselves on a regular basis to combine the advantages of the experience with those of
p.(None): new insights. The mechanisms for the selection and replacement of members must guarantee the suitability,
p.(None): plurality and impartiality in the election.
p.(None): 2.3.4. The renewal requirements must include: name or description of the person responsible for making the appointments and
p.(None): selection or decision procedure, for example, by consensus, voting or direct appointment. Selection of
p.(None): New members must include analysis of potential conflicts of interest and require transparency when
p.(None): that risk existed.
p.(None): 2.3.5. The CEI must establish in its regulations the terms of the appointment, including the duration, the
p.(None): renewal of membership and disqualification, resignation and replacement procedures.
p.(None): 2.3.6. Members must be willing to share their full name, profession and institutional affiliation, and
p.(None): to sign a confidentiality agreement on information from investigations and discussions about
p.(None): from the same.
p.(None): 2.3.7. The CEI must establish clearly defined positions to optimize its operation, for example, president,
p.(None): secretary and members. A chair must be chosen to conduct the meetings. The member chosen as
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p.(None): Random distribution. In the same way as for the use of control groups, trials in which the allocation of
p.(None): an experimental treatment is determined by chance can only be performed when there is true uncertainty
p.(None): about which is the best of them.
p.(None): In such a case, participants should be informed about this uncertainty among the alternatives in
p.(None): study and that the purpose of the trial is to know which is the most beneficial.
p.(None): People, whether chosen or excluded for the experimental treatment or procedure, may feel restless
p.(None): or concerned about the reasons why they have been chosen or excluded. Investigators should communicate to
p.(None): potential participants the reason for using randomization (prevention of bias), and
p.(None): reassure them that the randomization process is neither discriminatory nor based on their status
p.(None): of health.
p.(None): Considerations about the scientific need to use placebo. In cases where there is a standard therapy, the
p.(None): Use of placebo control instead of that active control should be restricted to situations where the risks of
p.(None): damage or condition are minor and their scientific need has been adequately justified. A beginning
p.(None): Methodological points out that the comparison between two or more active substances only shows the relative efficacy between
p.(None): they, while the comparison with placebo allows to establish the real efficacy and, in addition, distinguish
p.(None): the specific adverse effects of the active substance. This is especially relevant when the condition is
p.(None): characterized by fluctuating symptoms and / or spontaneous remission, has high response rates
p.(None): to placebo and existing therapies are only partially effective or have not shown superiority to placebo
p.(None): consistently in previous studies.
p.(None): The placebo effect refers to the health, physiological or psychological benefits produced by a treatment
p.(None): inert from the pharmacological point of view. A placebo can modify the patient's perception of their symptoms
p.(None): and therefore cause a bias in the results of a trial, particularly when diagnostic and diagnostic techniques are used.
p.(None): Measurement is based on the subjectivity of the perception of the patient or the observer. Examples of these situations
p.(None): are: depression (symptoms are confused with other mental health problems or are usually influenced by
p.(None): external factors), idiopathic hypertension (blood pressure changes spontaneously or by
p.(None): influence of diet, mood, etc.) and pain (pain perception varies between people).
p.(None): All this subject to the condition of minor risk.
p.(None): On the other hand, when the pharmacological response can be measured with objective techniques, the
p.(None): need to use placebo control, except in addition to standard therapy. Examples of these cases are:
...
p.(None): user of a service or health program, etc. Two subtypes of observational research are recognized:
p.(None): Descriptive or exploratory research: quantitative or qualitative description of facts or phenomena
p.(None): observed, without posing a hypothesis. Examples: prevalence studies, cross-sectional, demographic,
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
p.(None): a potential participant who is incapable or incompetent to grant the informed consent of a
p.(None): investigation.
p.(None): INDEPENDENT WITNESS: person independent of the researcher and his team who participates in the process of
p.(None): obtaining informed consent as a guarantee that it respects the rights and interests of a potential
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Health / Healthy People
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p.(None): images themselves, participant diaries, data recorded on automated instruments, magnetic media or
p.(None): microfilm and photographic negatives. Includes copies certified by an authorized or legalized person
p.(None): by notary public.
p.(None): CLINICAL TRIAL: see EXPERIMENTAL INVESTIGATION
p.(None): CLINICAL TRIAL OF CELL THERAPIES: the experimental investigation that is carried out in patients to establish the
p.(None): tolerance, safety and / or efficacy of a product based on human cells or tissues, after having been
p.(None): demonstrated its therapeutic potential and safety in preclinical studies. Obtaining and processing
p.(None): of cells and tissues must ensure, through validated procedures, the absence of conditions of
p.(None): transmissibility of infectious agents, prions, genetic diseases or cancer to the host.
p.(None): CLINICAL TRIAL OF MEDICAL TECHNOLOGY: the experimental research that is carried out to establish the
p.(None): safety and effectiveness of a medical device in humans. The investigation must establish the
p.(None): indications, contraindications and precautions for the use of the device. If the equipment, device, device or
p.(None): Medical instrument implies the use of an innovative technique, it must be validated against a comparator.
p.(None): CLINICAL TRIAL OF VACCINES: experimental research that allows establishing tolerance, safety,
p.(None): immunogenicity and / or efficacy of a vaccine in voluntary, healthy or sick individuals. May correspond to
p.(None): one of the following phases: (a) Phase I: first human study to assess tolerance, safety and effects
p.(None): biological; (b) Phase II: studies that determine the antibody response (immunogenicity) elicited by the vaccine;
p.(None): and (c) Phase III: controlled studies, with a large number of volunteers, in order to evaluate the effectiveness of
p.(None): the vaccine in disease prevention and safety on a larger scale.
p.(None): EPIDEMIOLOGICAL STUDY: study of the distribution and determinants of related events or situations
p.(None): with health in specific populations. An epidemiological study is mainly based on observation and not
p.(None): requires invasive procedures beyond routine medical questions and exams, such as blood tests
p.(None): laboratory or x-rays, so this type of study poses minimal risks for the participants.
p.(None): Epidemiological studies can be observational or experimental. Observationals, in turn, can be
p.(None): of three subtypes: cross-section, case-control and cohort.
p.(None): A cross-sectional study is generally performed on a random sample of a population with the objective of
p.(None): evaluate aspects of the health of a population, or test hypotheses about possible causes of disease or suspected
p.(None): risk factor's.
p.(None): Case-control study compares history of risk exposure among patients with a condition
p.(None): determined (cases) with the same history of exposure to that risk among the people who share with the cases
p.(None): characteristics such as age and sex, but they do not present said affection (controls). The difference between cases and
p.(None): Controls regarding the frequency of past risk exposure can be statistically analyzed
p.(None): to test hypotheses about causes or about risk factors.
p.(None): A cohort or longitudinal or prospective study identifies and observes during a given period a
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Health / Mentally Disabled
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p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
p.(None): Justice. This principle refers to the ethical obligation to treat each person equally, unless
p.(None): there are relevant differences that justify different treatment.
p.(None): Distributive justice requires that all benefits and burdens of research be distributed
p.(None): equitably between all groups and classes in society, especially if they are dependent or
p.(None): vulnerable. Studies must be planned so that the knowledge sought benefits the group
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p.(None): exposing participants to risks or discomfort without achieving any benefit. RECs may require advice
p.(None): scientist from a qualified expert or board, but they must make their own decision about the scientific validity of the
p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
p.(None): Functioning. An IRB should establish its standard operating procedures for, for example, the frequency of
p.(None): meetings, quorum of members and mechanisms for analysis and decision-making, and must communicate said
p.(None): rules to researchers. When evaluating a project, the different sectors of the committee, scientific and not
p.(None): Scientists must be represented to ensure a comprehensive evaluation.
p.(None): Member responsibilities. The members of a CEI must take special care to avoid all conduct not
p.(None): ethics, including conflicts of interest that may arise in evaluations. The members of the CEI must
...
p.(None): (o) the circumstances and / or anticipated reasons why the investigation or
p.(None): participation of the person, specifying that in such case the necessary measures will be taken to protect their
p.(None): security;
p.(None): (p) a description of the person's rights as a participant in an investigation, including the
p.(None): right to have, modify or delete your data at any time of the investigation when you require it;
p.(None): (q) the contact details of the CEI that has approved the investigation;
p.(None): (r) what are the research sponsors or funding sources, the institutional affiliation of the
p.(None): researcher and other potential conflicts of interest; Y
p.(None): (s) the contact details of the researcher and the REC that approved the study.
p.(None): 1.3.2. In clinical trials, the following specific information should be added:
p.(None): (a) the approximate number of participants that are planned to be incorporated;
p.(None): (b) a detail of the actual or potential benefits and risks of research interventions and
p.(None): alternatives available in case of not participating in it;
p.(None): (c) an explanation about the characteristics of the design and its implications, for example, that randomness and
p.(None): masking are applied to avoid influences on the result and that, as a result of masking, not
p.(None): you will be informed of the assigned treatment until the study is completed;
p.(None): (d) proof that trial interventions and procedures will be free to participants;
p.(None): (e) proof that medical care will be provided at no cost to the participant in the event of related damage
p.(None): with the trial and the nature and duration of this care;
p.(None): (f) if the participant or their relatives will have compensation in case of disability or death as a result of
p.(None): these damages and through what mechanism will be effective;
p.(None): (g) if at the end of the research the participant will have access to the intervention that is most beneficial to
p.(None): from the trial or other appropriate intervention or appropriate benefit, and when and how they will be available; Y
p.(None): (h) the contact details of the investigator and the emergency service where they will be attended in the event of an adverse event
p.(None): related to research.
p.(None): 1.3.3. In the event that the study includes obtaining biological samples, the potential participant or their
p.(None): Representative must receive the following additional information:
p.(None): (a) the possible uses, direct or secondary, of biological samples obtained in the study;
p.(None): (b) the fate of the biological samples at the end of the study, for example, their destruction or storage for
p.(None): future uses. In the latter case, the possible future uses should be specified and where, how and why
p.(None): how long the samples will be stored, and that the participant has the right to decide on those future uses, to
p.(None): destroy the material and refuse storage;
p.(None): (c) a statement that the samples or derived data will not be marketed;
p.(None): (d) if commercial products could be developed from the biological samples and if it is planned to offer the
p.(None): participant monetary or other benefits for that development; Y
p.(None): (e) in the case of genetic research, that the participant has the right to decide whether or not to be informed of the
p.(None): results of their studies, as long as they have clinical relevance and there is a course of action to modify
...
p.(None): expensive.
p.(None): An experimental epidemiological study is one in which the researcher selects the groups of
p.(None): individuals or populations with eligibility criteria, actively intervenes on the variable
p.(None): independent or predictive, and observes and analyzes the changes that occur in the dependent or outcome variable to
p.(None): consequence of the intervention. If two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis.
p.(None): CLINICAL PHARMACOLOGY STUDY: systematic scientific study carried out with drugs or products
p.(None): tests on voluntary individuals, healthy or sick, in order to discover or verify its effects
p.(None): therapeutic (efficacy) and / or identify adverse reactions (safety) and / or study the absorption, distribution,
p.(None): metabolism (biotransformation) and excretion of the active ingredients. Synonym: Clinical Pharmacology Trial.
p.(None): MULTICENTRIC STUDY: research conducted in more than one research institution or center but following a
p.(None): same protocol.
p.(None): ADVERSE EVENT (AE): any unfavorable medical occurrence in a participant of a clinical trial, associated
p.(None): temporarily with the experimental intervention even when a necessary causal relationship is not established. It includes
p.(None): any signs, abnormal laboratory findings, symptoms, or disease.
p.(None): SERIOUS ADVERSE EVENT (EAS): any unfavorable occurrence in the course and context of a
p.(None): research on a diagnostic or therapeutic product or procedure that results in death threatens the
p.(None): life, requires hospitalization or prolongation of existing hospitalization, results in disability or invalidity
p.(None): persistent or significant, is a congenital abnormality or birth defect or is medically significant according to a
p.(None): medical judgment. The foregoing applies without the presumable existence of a causal link between the
p.(None): application of the product or treatment and the adverse event.
p.(None): CONTROL GROUP: group that is used as a comparator and indicates what happens when the variable or the
p.(None): intervention to be studied.
p.(None): INSTITUTION OR RESEARCH CENTER: any public or private entity, agency or medical or dental facility
p.(None): where clinical studies are conducted.
p.(None): EXPERIMENTAL INVESTIGATION: investigation in which the investigator selects individuals with
p.(None): inclusion and exclusion criteria, actively intervenes on the independent or predictor variable, and observes
p.(None): and analyzes the changes that occur in the dependent or outcome variable as a result of the
p.(None): intervention. When two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis. Health interventions can be: synthetic medicines, products
p.(None): biological or biotechnological, medical devices, surgical techniques, etc. Synonym: Clinical trial.
p.(None): OBSERVATIONAL INVESTIGATION: investigation in which the independent or predictive variable is not intervened
p.(None): and only the possible relationships with the dependent or outcome variable are observed. The selection of
p.(None): Participants are not made by the researcher, but by nature: healthy or sick, with or without a risk factor; user or not
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p.(None): This section presents ethical guidelines for human health research aimed at guiding
p.(None): researchers during study planning and execution and members of research ethics committees
p.(None): for the evaluation of projects.
p.(None): A1. ETHICAL JUSTIFICATION AND SCIENTIFIC VALIDITY
p.(None): P1. For human health research to be ethically justified, it must
p.(None): provide new and scientifically valid knowledge that is not feasible to obtain without participation
p.(None): from them.
p.(None): P2. All research in human health must be based on current scientific knowledge and be based on
p.(None): a comprehensive review of the specialized literature. Investigating a new intervention
p.(None): on human health must be based on appropriate prior laboratory, preclinical and
p.(None): clinical and justified by its preventive, diagnostic or therapeutic value.
p.(None): P3. Human health research must be conducted by researchers who have the appropriate training and
p.(None): homework training.
p.(None): Basic ethical principles: Health research on human beings must comply with the three principles
p.(None): basic ethics: respect for people, charity and justice.
p.(None): Respect for people. This principle implies that people who are autonomous or capable of deliberating about their
p.(None): decisions are respected in their capacity for self-determination, free of undue incentives and influence, and
p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
...
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
p.(None): a potential participant who is incapable or incompetent to grant the informed consent of a
p.(None): investigation.
p.(None): INDEPENDENT WITNESS: person independent of the researcher and his team who participates in the process of
p.(None): obtaining informed consent as a guarantee that it respects the rights and interests of a potential
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Health / Motherhood/Family
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p.(None): personal identification and is known by the person and the researcher; or
p.(None): (c) nominal, when the information is linked to the person by personal identification, usually the name.
p.(None): The first two cases (anonymous and non-nominal) are also known as "encoded or reversibly decoupled" data
p.(None): and they are those data not associated with an identified or identifiable person because the
p.(None): information that identifies that person through a code that allows the reverse operation.
p.(None): Confidentiality in genetic research. Whenever genetic testing of known clinical value is planned
p.(None): or predictable on samples linked to an identifiable individual, your consent must be obtained in advance.
p.(None): Conversely, in order to perform a genetic test of known clinical value or that provides
p.(None): information about a known hereditary condition without obtaining prior consent, the investigator should
p.(None): ensure that biological samples have been irreversibly disassociated from their holders and that it could not be derived from
p.(None): research any information about specific individuals.
p.(None): The genetic or proteomic data of a person must not be disclosed or made available to third parties, in
p.(None): private of employers, insurance companies, educational establishments or relatives of the person in question.
p.(None): Investigators must strive to protect the privacy of individuals and the confidentiality of data
p.(None): human genetics associated with an identifiable person, family, or group.
p.(None): As a general rule, human genetic or proteomic data obtained for research purposes
p.(None): Scientists should not remain associated with an identifiable person for longer than necessary to
p.(None): carry out the investigation. Even when they are dissociated from the identity of a person, they
p.(None): they must take all necessary precautions to ensure the security of such data.
p.(None): Confidentiality when using the Internet for research. There are several ways in which researchers could
p.(None): use the Internet for your research:
p.(None): (a) to obtain data: researchers could enroll people to answer surveys or questionnaires placed
p.(None): on a website or use publicly accessible sites to observe, as a data source, what its users say or do
p.(None): without necessarily interacting with them.
p.(None): (b) to transmit data: investigators may send electronic files with research data to others
p.(None): collaborative researchers, or sponsors set up a database for data entry on a website
p.(None): in multicenter studies.
p.(None): (c) to communicate results: some researchers disseminate the results of their studies through a website.
p.(None): In any case, the privacy, confidentiality and security of the participants must be guaranteed by the
p.(None): researchers during data collection, transmission to other centers and the construction of a database
p.(None): shared, particularly when personally identifiable data is transmitted.
p.(None): Researchers or sponsors must use passwords and the best available technology, for
p.(None): For example, encryption, to ensure that only authorized people can read the data. These requirements apply
p.(None): also when data is transmitted from implantable or portable electronic devices, for example,
p.(None): pacemaker or vital sign monitoring systems.
p.(None): A7. CONFLICT OF INTERESTS
...
p.(None): Informed consent. In addition to the usual requirements for the consent of potential participants
p.(None): In research, the information must clearly express:
p.(None): (a) the foreseeable risks of the proposed experimental therapy. For example, in the case of cell therapies
p.(None): stem, cell proliferation and / or tumor development, exposure to materials of animal origin and
p.(None): possibility of transmission of viral vectors; and in genetics, the possible effects on cells
p.(None): gametics and offspring;
p.(None): (b) the potential therapeutic benefits of the experimental intervention and the existence or not of alternatives
p.(None): therapeutic. Consent should emphasize the experimental aspect of the intervention to avoid expectations
p.(None): erroneous about its therapeutic potential;
p.(None): (c) in the case of cell therapies, the irreversibility of cell transplantation must be clearly explained. The
p.(None): cells, unlike many drug products or implantable medical devices, cannot be removed
p.(None): of the body and could continue to generate its adverse effects throughout the life of the patient;
p.(None): (d) to advance scientific knowledge, potential participants should be asked for consent
p.(None): so that in the event of death it is possible to carry out a partial or complete autopsy to assess the scope of the
p.(None): cell implantation and its morphological and functional consequences. Autopsy request must consider
p.(None): cultural and family sensitivities. The subject is delicate but, without access to post-mortem material, the
p.(None): Trial information would be affected to the detriment of future products or product improvements.
p.(None): Recognizing the potential value of new cell and gene therapies for patients with cognitive impairment and the
p.(None): importance that these are not excluded from such advances, researchers must develop a procedure
p.(None): so that authorized patient representatives can make a decision on their behalf. The
p.(None): Representatives must be duly qualified and with sufficient knowledge to evaluate the
p.(None): test and provide adequate protection.
p.(None): Expert advice. Expert review should ensure that the trial will lead to an improvement in the care of
p.(None): the disease and will generate new and important knowledge. This review should include a comparison of the new
p.(None): therapy with available treatments.
p.(None): The following elements should be evaluated by experts: in vitro and in vivo preclinical studies, studies
p.(None): clinical findings, scientific rationale for the trial, study objectives, statistical analysis, and
p.(None): specific aspects of the disease under study.
p.(None): Regulatory authority oversight. Supervision by a regulatory authority should ensure that the
p.(None): trial with cell or gene therapies has scientific merit, was designed correctly, will be carried out
p.(None): safely and will produce reliable knowledge.
p.(None): SECTION B: OPERATIONAL ASPECTS
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Health / Physically Disabled
Searching for indicator illness:
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p.(None): exposing participants to risks or discomfort without achieving any benefit. RECs may require advice
p.(None): scientist from a qualified expert or board, but they must make their own decision about the scientific validity of the
p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
...
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
p.(None): risk.
p.(None): 4.4.7. The use of placebo in a control group must be adequately justified in its methodological and ethical aspects. The
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
p.(None): research-related adverse events, which must be available at any time
p.(None): require. If an intercurrent disease is diagnosed by a procedure of the
p.(None): research, the researcher should guide the participant to get the care they need.
p.(None): 4.4.9. When a modification to the protocol is foreseen or information has been obtained that could affect the
p.(None): safety of participants or their decision to remain in the trial, consent must be requested before
p.(None): implement the change or continue the study.
p.(None): 4.4.10. The interventions or experimental procedures should not have any cost for the participants,
p.(None): regardless of the existence or not of specific funding for the trial. This does not prevent, for
p.(None): be non-commercial scientific research, treatments or procedures that the participant
p.(None): require for your illness to be covered by your usual health coverage.
p.(None): 4.5. Trial supervision
p.(None): 4.5.1. Before starting the investigation, the investigator must have the written approval of a REC. For such
p.(None): Finally, the researcher must send you all the documentation that he requests, including the protocol and its
p.(None): amendments, consent documents and their amendments, and all available information regarding the
p.(None): study interventions.
p.(None): 4.5.2. To carry out the investigation, the investigator must obtain the authorization of the highest authority of the
p.(None): host institution or the authority designated by it.
p.(None): 4.5.3. The investigator should inform the CEI of serious and unexpected adverse reactions to the intervention of the
p.(None): study and any other events that significantly affect the trial and / or the risk for the participants.
p.(None): 4.5.4. The investigator must inform the CEI about the progress of the trial with a minimum annual frequency. The report
p.(None): newspaper must contain, as a minimum, the number of participants incorporated, in follow-up and retired, list
p.(None): code of participants, serious adverse events and their assumed relationship with the study intervention
p.(None): and the deviations to the protocol relevant to the safety of the participants observed during the period.
p.(None): 4.6. Study interventions
p.(None): 4.6.1. In tests with products not defined or governed by Good Laboratory Practice or Good Practice of
p.(None): Manufacturing, for example, products of biological origin, the guidelines for
p.(None): development and control and the procedures for its use.
...
p.(None): inclusion and exclusion criteria, actively intervenes on the independent or predictor variable, and observes
p.(None): and analyzes the changes that occur in the dependent or outcome variable as a result of the
p.(None): intervention. When two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis. Health interventions can be: synthetic medicines, products
p.(None): biological or biotechnological, medical devices, surgical techniques, etc. Synonym: Clinical trial.
p.(None): OBSERVATIONAL INVESTIGATION: investigation in which the independent or predictive variable is not intervened
p.(None): and only the possible relationships with the dependent or outcome variable are observed. The selection of
p.(None): Participants are not made by the researcher, but by nature: healthy or sick, with or without a risk factor; user or not
p.(None): user of a service or health program, etc. Two subtypes of observational research are recognized:
p.(None): Descriptive or exploratory research: quantitative or qualitative description of facts or phenomena
p.(None): observed, without posing a hypothesis. Examples: prevalence studies, cross-sectional, demographic,
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
...
Health / Physically Ill
Searching for indicator sick:
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p.(None): ESSENTIAL DOCUMENTS: documents that individually and collectively allow an evaluation of the conduct of a
p.(None): study and the quality of the data generated.
p.(None): SOURCE DOCUMENTS: original documents and records of the clinical data used in
p.(None): a study, such as medical records, laboratory or pharmacy records, imaging reports, and
p.(None): images themselves, participant diaries, data recorded on automated instruments, magnetic media or
p.(None): microfilm and photographic negatives. Includes copies certified by an authorized or legalized person
p.(None): by notary public.
p.(None): CLINICAL TRIAL: see EXPERIMENTAL INVESTIGATION
p.(None): CLINICAL TRIAL OF CELL THERAPIES: the experimental investigation that is carried out in patients to establish the
p.(None): tolerance, safety and / or efficacy of a product based on human cells or tissues, after having been
p.(None): demonstrated its therapeutic potential and safety in preclinical studies. Obtaining and processing
p.(None): of cells and tissues must ensure, through validated procedures, the absence of conditions of
p.(None): transmissibility of infectious agents, prions, genetic diseases or cancer to the host.
p.(None): CLINICAL TRIAL OF MEDICAL TECHNOLOGY: the experimental research that is carried out to establish the
p.(None): safety and effectiveness of a medical device in humans. The investigation must establish the
p.(None): indications, contraindications and precautions for the use of the device. If the equipment, device, device or
p.(None): Medical instrument implies the use of an innovative technique, it must be validated against a comparator.
p.(None): CLINICAL TRIAL OF VACCINES: experimental research that allows establishing tolerance, safety,
p.(None): immunogenicity and / or efficacy of a vaccine in voluntary, healthy or sick individuals. May correspond to
p.(None): one of the following phases: (a) Phase I: first human study to assess tolerance, safety and effects
p.(None): biological; (b) Phase II: studies that determine the antibody response (immunogenicity) elicited by the vaccine;
p.(None): and (c) Phase III: controlled studies, with a large number of volunteers, in order to evaluate the effectiveness of
p.(None): the vaccine in disease prevention and safety on a larger scale.
p.(None): EPIDEMIOLOGICAL STUDY: study of the distribution and determinants of related events or situations
p.(None): with health in specific populations. An epidemiological study is mainly based on observation and not
p.(None): requires invasive procedures beyond routine medical questions and exams, such as blood tests
p.(None): laboratory or x-rays, so this type of study poses minimal risks for the participants.
p.(None): Epidemiological studies can be observational or experimental. Observationals, in turn, can be
p.(None): of three subtypes: cross-section, case-control and cohort.
p.(None): A cross-sectional study is generally performed on a random sample of a population with the objective of
p.(None): evaluate aspects of the health of a population, or test hypotheses about possible causes of disease or suspected
p.(None): risk factor's.
p.(None): Case-control study compares history of risk exposure among patients with a condition
p.(None): determined (cases) with the same history of exposure to that risk among the people who share with the cases
p.(None): characteristics such as age and sex, but they do not present said affection (controls). The difference between cases and
p.(None): Controls regarding the frequency of past risk exposure can be statistically analyzed
p.(None): to test hypotheses about causes or about risk factors.
p.(None): A cohort or longitudinal or prospective study identifies and observes during a given period a
p.(None): people with different levels of exposure to one or more risk factors, and the rates of occurrence of the
p.(None): condition or disease are compared in relation to exposure levels. This is one more research method
p.(None): solid than the other two cases but requires the analysis of a large number of people for a long time and is also
p.(None): expensive.
p.(None): An experimental epidemiological study is one in which the researcher selects the groups of
p.(None): individuals or populations with eligibility criteria, actively intervenes on the variable
p.(None): independent or predictive, and observes and analyzes the changes that occur in the dependent or outcome variable to
p.(None): consequence of the intervention. If two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis.
p.(None): CLINICAL PHARMACOLOGY STUDY: systematic scientific study carried out with drugs or products
p.(None): tests on voluntary individuals, healthy or sick, in order to discover or verify its effects
p.(None): therapeutic (efficacy) and / or identify adverse reactions (safety) and / or study the absorption, distribution,
p.(None): metabolism (biotransformation) and excretion of the active ingredients. Synonym: Clinical Pharmacology Trial.
p.(None): MULTICENTRIC STUDY: research conducted in more than one research institution or center but following a
p.(None): same protocol.
p.(None): ADVERSE EVENT (AE): any unfavorable medical occurrence in a participant of a clinical trial, associated
p.(None): temporarily with the experimental intervention even when a necessary causal relationship is not established. It includes
p.(None): any signs, abnormal laboratory findings, symptoms, or disease.
p.(None): SERIOUS ADVERSE EVENT (EAS): any unfavorable occurrence in the course and context of a
p.(None): research on a diagnostic or therapeutic product or procedure that results in death threatens the
p.(None): life, requires hospitalization or prolongation of existing hospitalization, results in disability or invalidity
p.(None): persistent or significant, is a congenital abnormality or birth defect or is medically significant according to a
p.(None): medical judgment. The foregoing applies without the presumable existence of a causal link between the
p.(None): application of the product or treatment and the adverse event.
p.(None): CONTROL GROUP: group that is used as a comparator and indicates what happens when the variable or the
p.(None): intervention to be studied.
p.(None): INSTITUTION OR RESEARCH CENTER: any public or private entity, agency or medical or dental facility
p.(None): where clinical studies are conducted.
p.(None): EXPERIMENTAL INVESTIGATION: investigation in which the investigator selects individuals with
p.(None): inclusion and exclusion criteria, actively intervenes on the independent or predictor variable, and observes
p.(None): and analyzes the changes that occur in the dependent or outcome variable as a result of the
p.(None): intervention. When two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis. Health interventions can be: synthetic medicines, products
p.(None): biological or biotechnological, medical devices, surgical techniques, etc. Synonym: Clinical trial.
p.(None): OBSERVATIONAL INVESTIGATION: investigation in which the independent or predictive variable is not intervened
p.(None): and only the possible relationships with the dependent or outcome variable are observed. The selection of
p.(None): Participants are not made by the researcher, but by nature: healthy or sick, with or without a risk factor; user or not
p.(None): user of a service or health program, etc. Two subtypes of observational research are recognized:
p.(None): Descriptive or exploratory research: quantitative or qualitative description of facts or phenomena
p.(None): observed, without posing a hypothesis. Examples: prevalence studies, cross-sectional, demographic,
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): against risks of damage or prejudice and facilitate the performance of studies beneficial to society. The aspects
p.(None): Scientific and ethical are closely related: it is unethical to carry out a study that does not have scientific solidity
p.(None): exposing participants to risks or discomfort without achieving any benefit. RECs may require advice
p.(None): scientist from a qualified expert or board, but they must make their own decision about the scientific validity of the
p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
...
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
p.(None): In the case of pregnant women, in addition to the requirement to provide detailed information on the risks for
p.(None): for them and for the fetus, it is recommended that the consent of the partner of the pregnant woman be obtained, if
p.(None): corresponds. An investigation in this population can only be carried out if it is relevant to health problems
p.(None): related to pregnancy and the product of conception, and if adequately supported by experiments
p.(None): in animals, particularly to establish the risks of teratogenesis and mutagenesis.
p.(None): A6. CONFIDENTIALITY OF INFORMATION
p.(None): P13. Investigators must take all necessary precautions to protect privacy and
p.(None): confidentiality of the information of the study participants.
p.(None): Confidentiality Human health research frequently involves manipulating sensitive data from
p.(None): individuals or groups; therefore there is a risk that the disclosure of such data to third parties may cause
p.(None): harm or anguish to the participants. Investigators should take all possible precautions to
p.(None): protect the privacy and confidentiality of the information of the participants, in accordance with National Law 25,326
p.(None): Habeas Data, for example, omitting data that could identify individuals or limiting their
p.(None): access only to authorized persons.
p.(None): Identifiable personal data should not be used when a study can be done without it. When necessary
p.(None): register personal identification data, investigators must justify this need to the REC, and
p.(None): explain how your confidentiality will be protected and what the limitations of such protection will be, for example, that
...
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
p.(None): risk.
p.(None): 4.4.7. The use of placebo in a control group must be adequately justified in its methodological and ethical aspects. The
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.(None): Scientific and ethical are closely related: it is unethical to carry out a study that does not have scientific solidity
p.(None): exposing participants to risks or discomfort without achieving any benefit. RECs may require advice
p.(None): scientist from a qualified expert or board, but they must make their own decision about the scientific validity of the
p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
...
Health / injured
Searching for indicator injured:
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p.(None): When a project proposes the use of placebo, the CEI should assess whether the protocol includes the following mechanisms
p.(None): To minimize risks:
p.(None): (a) consent clearly expresses the use of placebo and its risks;
p.(None): (b) the treatment period is the minimum possible to reduce exposure to non-treatment;
p.(None): (c) control of the participants will be frequent and strict, and it is planned to withdraw the patient from the
p.(None): study or transfer to active treatment (rescue) as soon as therapeutic failure is detected;
p.(None): (d) there is an interim analysis plan and an independent data monitoring council, with clear rules for
p.(None): stopping the study for security reasons;
p.(None): (e) crossover design: groups alternately receive active treatment or placebo; Y
p.(None): (f) addition design: when scientifically and medically possible, all participants should
p.(None): receive the standard treatment, adding either the experimental product or placebo.
p.(None): Particular attention should be paid to projects proposing the use of placebo in groups or communities that do not
p.(None): they have access to standard therapy. The use of placebo should not be accepted when this is your only use.
p.(None): basis. Accidental injury compensation. If an investigation causes harm, the entity
p.(None): Sponsor shall compensate the injured party appropriately according to the type of damage. The losses
p.(None): pecuniaries must be repaired promptly. In other cases, it may be difficult to determine compensation
p.(None): appropriate. Violation of confidentiality or indiscriminate publication of
p.(None): conclusions of a study, causing the loss of prestige of an individual or group, can be difficult to remedy, and
p.(None): the IRC shall define what is the appropriate compensation in such cases. The approval of the study by the CEI does not
p.(None): exempts the researcher, the institution or the sponsor from any legal responsibility in case of
p.(None): damage suffered by the participant as a result of their participation in the study.
p.(None): Access to treatment. At the end of the research, all participants should share the benefits
p.(None): obtained from it, for example, by accessing the intervention that has been most beneficial, a
p.(None): alternative intervention or other appropriate benefit.
p.(None): In particular, in clinical trials sponsored by a pharmaceutical company that have shown that a product
p.(None): Experimental is beneficial, the sponsor should continue to provide it to the participants until their access is
p.(None): guarantee by other means. The requirement of this requirement must be determined based on certain considerations
p.(None): relevant, such as the severity of the medical condition in question and the expected effect of withdrawing or modifying the
p.(None): treatment, for example, leaving a sequel or causing the death of the patient. When it is not possible to fulfill it
p.(None): The provision of an alternative intervention or other appropriate benefit, approved by
p.(None): the CEI and for the period that it determines.
...
Health / of childbearing age/fertile
Searching for indicator childbearing age:
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p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
p.(None): risk.
p.(None): 4.4.7. The use of placebo in a control group must be adequately justified in its methodological and ethical aspects. The
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
p.(None): research-related adverse events, which must be available at any time
p.(None): require. If an intercurrent disease is diagnosed by a procedure of the
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Health / stem cells
Searching for indicator stemXcells:
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p.(None): pharmaceutical products for human use, in order to ensure that the rights and integrity of
p.(None): participants and that the data and results obtained are reliable and accurate. This regulation was developed
p.(None): in 1978 by the United States Food and Drug Administration (FDA), and
p.(None): then validated in 1996 between this country, the European Union and Japan at the International Conference on Harmonization
p.(None): (ICH).
p.(None): In 2002, the World Health Organization issued a Handbook for Good Clinical Researc Practice (BPIC) and
p.(None): In 2005, the Pan American Health Organization published the BPIC guide known as “Document of the Americas”, the
p.(None): which served as the basis for the "Guide to Good Clinical Research Practices in Human Beings" of the Ministry of
p.(None): Health of the Nation (Resolution 1490/07), intended to regulate clinical trials in its field of
p.(None): application. Subsequently, this Guide was revised with the aim of expanding its scope to all research in
p.(None): human health and this document is the result of that review.
p.(None): The following documents were used as reference for the preparation of this Guide:
p.(None): - Declaration of Helsinki (AMM, 2008)
p.(None): - International ethical guidelines for biomedical research in human beings (CIOMS, 2002)
p.(None): - International Ethics Guidelines for Epidemiological Studies (CIOMS, 2009)
p.(None): - Guidelines for the Clinical Translation of Stem Cells (ISSCR, 2008)
p.(None): - Operational guidelines for ethics committees that evaluate biomedical research (WHO, 2000)
p.(None): - Surveying and Evaluating Ethical Review Practices (WHO, 2002)
p.(None): - Guidelines for Good Clinical Practice (ICH, 1996)
p.(None): - Handbook for Good Clinical Research Practice (WHO, 2002)
p.(None): - Good clinical practices: Document of the Americas (PAHO, 2005)
p.(None): - Ethics Committee. Standard working procedures (PAHO, 2009)
p.(None): - Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997)
p.(None): - International Declaration on Human Genetic Data (UNESCO, 2003)
p.(None): - International Declaration on Bioethics and Human Rights (UNESCO, 2005) This Guide has been submitted to
p.(None): evaluation of the following entities:
p.(None): - National Academy of Pharmacy and Biochemistry
p.(None): - National Academy of Medicine
p.(None): - National Academy of Dentistry
p.(None): - National Administration of Laboratories and Health Institutes (ANLIS)
p.(None): - National Administration of Medicines, Food and Medical Technology (ANMAT)
p.(None): - Argentine Association of Respiratory Medicine
p.(None): - Association of Medicine Faculties of the Argentine Republic (AFACIMERA)
p.(None): - Association of Dentistry Faculties of the Argentine Republic (AFORA)
p.(None): - Joint Commission for Health Research and Central Ethics Committee - Undersecretariat for Health Planning
p.(None): - Ministry of Health of the Province of Buenos Aires
p.(None): - Central Committee of Research Ethics - Ministry of Health of the Government of the City of Buenos Aires (GCBA)
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Social / Access to Social Goods
Searching for indicator access:
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p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
p.(None): Functioning. An IRB should establish its standard operating procedures for, for example, the frequency of
p.(None): meetings, quorum of members and mechanisms for analysis and decision-making, and must communicate said
p.(None): rules to researchers. When evaluating a project, the different sectors of the committee, scientific and not
p.(None): Scientists must be represented to ensure a comprehensive evaluation.
p.(None): Member responsibilities. The members of a CEI must take special care to avoid all conduct not
p.(None): ethics, including conflicts of interest that may arise in evaluations. The members of the CEI must
p.(None): respect the confidentiality of the documents received for evaluation and the deliberations of the committee.
p.(None): A3. INFORMED CONSENT
p.(None): P6. The decision of an individual or his representative to participate in an investigation must be voluntary and free of
p.(None): undueXinfluence, undue incentive or coercion. To make a free decision, each potential participant or
p.(None): Your legal representative must receive the information clearly and precisely about the purpose,
p.(None): procedures, benefits and foreseeable risks and sources of research funding, and your rights to
p.(None): access and rectify your data and refuse to participate or leave the study at any time, without
p.(None): need to justify themselves and without exposing themselves to any retaliation. After verifying that the individual or their
p.(None): representative have understood all the information, the investigator must request the
p.(None): consent.
p.(None): Q7. In all experimental research, each potential participant must also be informed of the
p.(None): expected risks and benefits of both the experimental intervention and the available alternatives; of payment
p.(None): for participation and remuneration for expenses, if applicable; and care coverage and
p.(None): compensation provided in case of damage directly related to the investigation.
p.(None): Q8. In the course of the research, participants should be informed of any findings or
p.(None): event that could affect your security or your decision to continue participating. At the end of
p.(None): research, the results of the same should be made available to the participants.
p.(None): Definition. Informed consent is voluntary and free when granted by an autonomous person and
p.(None): competent who can understand the purpose and nature of the research, the risks to be faced and the
p.(None): benefits you may receive, and you know your rights as a research participant. An autonomous person and
p.(None): competent is the one capable of making a decision voluntarily, solely based on their own values,
p.(None): interests and preferences, and as long as you have the information you need to evaluate your options. As a principle
p.(None): In general, consent must be obtained for all research involving human beings or carried out
...
p.(None): researcher or between researchers or others must be free, without prejudice to the participant being able to receive a
p.(None): financial compensation for expenses or inconvenience suffered or that the recipient must cover shipping and storage costs
p.(None): of samples or materials.
p.(None): Secondary use of biological samples. Researchers may request to use biological samples that have been
p.(None): obtained as part of another investigation, or samples that at the time of collection had not been defined
p.(None): purpose. Secondary uses are subject to the conditions defined in the original consent, however,
p.(None): a REC could approve a secondary use as long as the original consent specified the following:
p.(None): (a) whether or not there will be a secondary use for those samples and, if so, what type of studies could
p.(None): be made with those materials;
p.(None): (b) the conditions under which researchers will have to contact participants to request
p.(None): additional authorization for secondary or as yet undefined use;
p.(None): (c) the plan, if any, to destroy the unused samples or irreversibly dissociate them; Y
p.(None): (d) the right of the participants to request the destruction or dissociation of the samples.
p.(None): Consent in genetic or proteomic research. Before samples are obtained for genetic research or
p.(None): proteomics, potential participants should be informed about the purpose of the research, its risks and
p.(None): consequences, that they have the right to decide whether or not to know their genetic data and that, if they wish, they will have access
p.(None): to them, unless they have been irreversibly dissociated from your identification or the information obtained
p.(None): have no relevant consequences for your health.
p.(None): As a general rule, human genetic or proteomic data obtained for scientific research should not
p.(None): Remain associated with an identifiable person for longer than necessary to carry out the
p.(None): investigation.
p.(None): Human genetic or proteomic data collected for scientific research purposes should not be used with
p.(None): purposes incompatible with the original consent, unless a new consent is obtained from the participant
p.(None): or your representative. Investigators must further ensure that the use of data will not expose
p.(None): individuals, families, groups or communities at risk of discrimination or stigmatization.
p.(None): When genetic tests are carried out that may have relevant consequences for the health of a
p.(None): person, appropriate genetic counseling should be made available to them. This advice should be
p.(None): non-coercive, adapt to the culture in question and serve the best interest of the person involved.
p.(None): Consent by mail or by electronic means. When a survey is projected to large numbers of people,
p.(None): researchers usually propose to carry it out by post, email or the Internet, which
p.(None): It includes obtaining the consent of potential respondents through the same means. The problem in this case is the
p.(None): difficulty in ensuring that participants understand the relevant aspects of their participation in the study.
...
p.(None): individual or a community. The benefits of an investigation can be maximized with the following strategies:
p.(None): (a) training of health personnel: an investigation is an opportunity to train the health team in
p.(None): techniques and procedures that can optimize routine care;
p.(None): (b) improvement in health services: the incorporation into health services of the inputs or instruments that are
p.(None): have obtained or acquired for the study is an additional benefit for the community where the
p.(None): investigation; Y
p.(None): (c) dissemination of research results: dissemination of study results in the studied community
p.(None): or in the scientific field it is a benefit in itself, since this tends to improve the health of the population.
p.(None): Research funding. In any type of research, all treatments and procedures
p.(None): defined in the protocol must be provided to all participants at no cost to them. In the case of
p.(None): studies that do not have financial sponsorship or that it was only of a philanthropic or scientific type, is
p.(None): That is, without industrial or commercial purposes, it is acceptable that the treatments or procedures are covered
p.(None): by the participant's regular health funder, as long as these treatments and procedures are
p.(None): fit into the current medical practice for the disease under study and that the cost thereof is not found
p.(None): included in the subsidy or funding received for the research.
p.(None): TO 5. SELECTION OF PARTICIPANTS
p.(None): P12. Participants should be selected based on the objectives and design of the
p.(None): research, and most likely to minimize risks and maximize benefits at the individual level.
p.(None): All individuals and / or groups in a society should have equal access to the possibility of
p.(None): benefit from scientifically valid research, regardless of their cultural or educational situation,
p.(None): social or economic, unless there is a properly justified scientific or security reason. Fair selection.
p.(None): Although the scientific objective of the research is the main criterion for the selection of the participants,
p.(None): the principles that hold that equals should be treated in the same way and that the benefits
p.(None): and the burdens generated by social cooperation, such as research, must be equitably distributed
p.(None): Among the groups involved, they should have similar consideration in the ethical evaluation. This does not
p.(None): means that individuals
p.(None): or selected groups should benefit directly from any research project or that people
p.(None): marginalized, stigmatized or socioeconomically disadvantaged should never be included.
p.(None): Vulnerable population. Group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that due to a social, cultural, educational or economic condition
p.(None): unfavorable is liable to be influenced by the expectation of receiving a benefit for participating in the
p.(None): investigation (undue incentive) or to be the victim of a threat by investigators or others in a
p.(None): situation of power if they refused to participate (coercion).
p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
p.(None): (d) the risks associated with interventions or procedures without direct benefit to the health of the participants not
p.(None): outnumber those associated with routine medical or psychological examinations of such persons, unless CEI authorizes
p.(None): a slight increase in that level of risk;
p.(None): (e) in the case of clinical trials, consent will be obtained in the presence of a witness
p.(None): independent to guarantee the voluntariness and the freedom of the decision to participate.
p.(None): Researchers must identify those individuals or groups in situations of vulnerability in order to implement a
p.(None): special protection for them. However, some vulnerabilities can be relatively easy to identify,
p.(None): such as physical, legal or mental inability to grant voluntary consent, while others are
p.(None): difficult to define, such as unfavorable economic, social, cultural or educational conditions.
p.(None): Individuals unable to grant consent. They are minors and people with disorders
p.(None): transient, fluctuating or permanent mental disorders. Research with these groups is only justified when:
p.(None): (a) the knowledge expected to be obtained from the research is sufficiently relevant in relation to the risks
p.(None): predictable;
p.(None): (b) the risks of an observational study are only slightly higher than those associated with medical examinations and
...
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
p.(None): In the case of pregnant women, in addition to the requirement to provide detailed information on the risks for
p.(None): for them and for the fetus, it is recommended that the consent of the partner of the pregnant woman be obtained, if
p.(None): corresponds. An investigation in this population can only be carried out if it is relevant to health problems
p.(None): related to pregnancy and the product of conception, and if adequately supported by experiments
p.(None): in animals, particularly to establish the risks of teratogenesis and mutagenesis.
p.(None): A6. CONFIDENTIALITY OF INFORMATION
p.(None): P13. Investigators must take all necessary precautions to protect privacy and
p.(None): confidentiality of the information of the study participants.
p.(None): Confidentiality Human health research frequently involves manipulating sensitive data from
p.(None): individuals or groups; therefore there is a risk that the disclosure of such data to third parties may cause
p.(None): harm or anguish to the participants. Investigators should take all possible precautions to
p.(None): protect the privacy and confidentiality of the information of the participants, in accordance with National Law 25,326
p.(None): Habeas Data, for example, omitting data that could identify individuals or limiting their
p.(None): access only to authorized persons.
p.(None): Identifiable personal data should not be used when a study can be done without it. When necessary
p.(None): register personal identification data, investigators must justify this need to the REC, and
p.(None): explain how your confidentiality will be protected and what the limitations of such protection will be, for example, that
p.(None): Research records will be reviewed by sponsor or regulatory authority personnel. A mechanism
p.(None): usual protection is the elimination of the identification data when the results are consolidated for the
p.(None): statistic analysis. Investigators must obtain the prior consent of potential participants to
p.(None): use your data and express your commitment to preserve their confidentiality.
p.(None): The CEI must approve both the information provided to potential participants and the mechanisms provided
p.(None): to protect your privacy and confidentiality.
p.(None): Unrelated information. It is the information that cannot be related to the individual to whom it refers and, given that
p.(None): the investigator does not know the person, confidentiality is not at risk and there is no need to obtain a
p.(None): consent. The data or samples may have been originally linked and then the
p.(None): link with the information that identifies the individual ("anonymization" or "irreversible dissociation"), which leaves
p.(None): If possible, connect a data or sample with the person to whom it refers. In order to proceed with anonymization
...
p.(None): such that it allows its adequate interpretation and verification.
p.(None): P16. When the result of an investigation is published, the accuracy of the data and its
p.(None): interpretation. Publications must declare the sources of financing, labor relations and
p.(None): other possible conflicts of interest. Items that do not meet ethical standards should not be
p.(None): accepted for publication.
p.(None): Data register. All the information obtained from the investigation must be registered, preserved, analyzed,
p.(None): interpreted and communicated in a way that demonstrates the quality and integrity of the data. Quality
p.(None): of the data means that they must be exact, legible, complete, contemporary (recorded at the time that
p.(None): are measured or obtained) and attributable to the person who generated them.
p.(None): The integrity of the data is an attribution of all of them and refers to the fact that the data is credible,
p.(None): consistent and verifiable.
p.(None): The data record can be handwritten or electronic. In any case, its preservation must be ensured and the
p.(None): confidentiality of personal data. Documents "source" are those documents in which
p.(None): which data is recorded for the first time, for example, the medical records of the participants. In
p.(None): Therefore, the "essential" documents are those that demonstrate that during the investigation
p.(None): fulfilled all ethical and scientific requirements, for example the protocol, the documents of the
p.(None): informed consent and the CEI approval note. Essential documents must be kept in one place
p.(None): secure to protect the confidentiality of information and allow its preservation and direct access to
p.(None): verification, if required by the CEI or the competent authority. When it comes to people's health data,
p.(None): the essential documents of a study must meet the legal requirements for the preservation of information
p.(None): medical.
p.(None): Communication of study results. Part of the benefits that communities and individuals can expect
p.(None): Their participation in research is to be informed of the conclusions or results concerning their health.
p.(None): If public health recommendations arise, they must be made available to the authorities
p.(None): sanitary.
p.(None): Impossibility of communicating the results of the study. In some cases, for example, when the data is not
p.(None): linked to people, it will not be feasible to extract from the general results the information concerning them or
p.(None): their families, therefore, participants in these studies should be warned that they will not be
p.(None): informed about the conclusions concerning their health and that they should not infer that
p.(None): do not have the disease or condition under study.
p.(None): Publication of the study results. Investigators have an obligation to disclose information that is
p.(None): in the public interest, by any appropriate means available and provided that the confidentiality of
p.(None): the participants and that the interpretations or inferences are not presented as if they were proven truths or in a
p.(None): that promote or appear to promote special interests, for example, that a product has been shown to be effective.
p.(None): The publication of the results, both positive and negative, of the research is strongly recommended.
p.(None): to facilitate its transparency and to avoid repeating studies already carried out and submitting it to new participants
p.(None): yet
p.(None): unnecessary risk.
p.(None): To guarantee the integrity of scientific information and promote the highest standards of professional conduct,
p.(None): researchers should present their results in peer-reviewed publications or scientific conferences
p.(None): before communicating them to the public media
p.(None): or patient advocacy associations.
p.(None): A9. SPECIAL CONSIDERATIONS FOR CLINICAL TRIALS
p.(None): Q17. The benefits and risks of a new intervention should be compared with the one that has been shown to be the best
p.(None): Until now. The use of placebo is only acceptable when there is no proven alternative intervention
p.(None): or when this technique is necessary
p.(None): for valid methodological or scientific reasons and the risks of harm or suffering are less.
p.(None): Q18. In the event of harm arising from trial participation, participants should have access to care
p.(None): necessary medical care and appropriate compensation through insurance or other form of guarantee
p.(None): demonstrable.
p.(None): P19. At the end of the research, all participants should share the benefits they have
p.(None): arising from it, for example, continue receiving the intervention that has been identified as the most
p.(None): beneficial to them. If it is not possible to ensure this intervention, for a justified reason, the
p.(None): access to an appropriate alternative intervention or other appropriate benefit, approved by the CEI and for the period that it
p.(None): determine or until your access is guaranteed by another means.
p.(None): Control groups. The design of control groups is justified only when there is a true uncertainty in the
p.(None): scientific community about which of the study treatments is the best, since it is unethical to subject
p.(None): participants at risk of receiving less effective treatment. For this reason, the protocols of these trials
p.(None): They should include procedures to monitor the occurrence of therapeutic failures or adverse events and the measures of
p.(None): case, for example, cancel the investigation if an interim analysis showed that a treatment is clearly
p.(None): superior to others. In this case, and as a general principle, the other participants should be offered the
p.(None): treatment that has been superior, always depending on the clinical situation and the response of each
p.(None): competitor. In clinical trials measuring frequency of mortality or serious health events, evaluate
p.(None): high-risk interventions or involving large numbers of individuals, it is advisable to have a
p.(None): Data monitoring and independent security to evaluate interim data.
p.(None): Random distribution. In the same way as for the use of control groups, trials in which the allocation of
p.(None): an experimental treatment is determined by chance can only be performed when there is true uncertainty
p.(None): about which is the best of them.
p.(None): In such a case, participants should be informed about this uncertainty among the alternatives in
p.(None): study and that the purpose of the trial is to know which is the most beneficial.
p.(None): People, whether chosen or excluded for the experimental treatment or procedure, may feel restless
p.(None): or concerned about the reasons why they have been chosen or excluded. Investigators should communicate to
...
p.(None): need to use placebo control, except in addition to standard therapy. Examples of these cases are:
p.(None): infections (the progression of pneumonia is measured by x-rays and laboratory tests) or cancer (the
p.(None): Tumor reduction can be verified with imaging or leukemia recoil with cell counts
p.(None): blood).
p.(None): When a project proposes the use of placebo, the CEI should assess whether the protocol includes the following mechanisms
p.(None): To minimize risks:
p.(None): (a) consent clearly expresses the use of placebo and its risks;
p.(None): (b) the treatment period is the minimum possible to reduce exposure to non-treatment;
p.(None): (c) control of the participants will be frequent and strict, and it is planned to withdraw the patient from the
p.(None): study or transfer to active treatment (rescue) as soon as therapeutic failure is detected;
p.(None): (d) there is an interim analysis plan and an independent data monitoring council, with clear rules for
p.(None): stopping the study for security reasons;
p.(None): (e) crossover design: groups alternately receive active treatment or placebo; Y
p.(None): (f) addition design: when scientifically and medically possible, all participants should
p.(None): receive the standard treatment, adding either the experimental product or placebo.
p.(None): Particular attention should be paid to projects proposing the use of placebo in groups or communities that do not
p.(None): they have access to standard therapy. The use of placebo should not be accepted when this is your only use.
p.(None): basis. Accidental injury compensation. If an investigation causes harm, the entity
p.(None): Sponsor shall compensate the injured party appropriately according to the type of damage. The losses
p.(None): pecuniaries must be repaired promptly. In other cases, it may be difficult to determine compensation
p.(None): appropriate. Violation of confidentiality or indiscriminate publication of
p.(None): conclusions of a study, causing the loss of prestige of an individual or group, can be difficult to remedy, and
p.(None): the IRC shall define what is the appropriate compensation in such cases. The approval of the study by the CEI does not
p.(None): exempts the researcher, the institution or the sponsor from any legal responsibility in case of
p.(None): damage suffered by the participant as a result of their participation in the study.
p.(None): Access to treatment. At the end of the research, all participants should share the benefits
p.(None): obtained from it, for example, by accessing the intervention that has been most beneficial, a
p.(None): alternative intervention or other appropriate benefit.
p.(None): In particular, in clinical trials sponsored by a pharmaceutical company that have shown that a product
p.(None): Experimental is beneficial, the sponsor should continue to provide it to the participants until their access is
p.(None): guarantee by other means. The requirement of this requirement must be determined based on certain considerations
p.(None): relevant, such as the severity of the medical condition in question and the expected effect of withdrawing or modifying the
p.(None): treatment, for example, leaving a sequel or causing the death of the patient. When it is not possible to fulfill it
p.(None): The provision of an alternative intervention or other appropriate benefit, approved by
p.(None): the CEI and for the period that it determines.
p.(None): A10. CLINICAL TRIALS OF CELL AND GENIC THERAPIES
p.(None): P20. Clinical trials of gene and cellular therapies must follow the principles that protect
p.(None): research participants, including: proper trial planning, fair selection,
p.(None): informed consent, strict medical control of the participants, review by a REC and a
p.(None): expert advice and supervision by a competent regulatory authority.
p.(None): Ethical justification for trials with cell and gene therapies. A therapeutic approach with cell therapies and
p.(None): Gene assays should aim to be clinically similar or superior to existing therapies. If there is already a therapy
p.(None): effective, the risks associated with cell or gene therapy
p.(None): they must be low and offer a potential advantage, for example a better functional result or be a
p.(None): single procedure versus prolonged drug treatment with associated adverse effects. If it doesn't exist yet
p.(None): a therapy, the severity of the disease could justify the risks of an experimental cell or gene therapy.
p.(None): In any case, every effort should be made to minimize the risks of possible associated adverse effects
...
p.(None): In research, the information must clearly express:
p.(None): (a) the foreseeable risks of the proposed experimental therapy. For example, in the case of cell therapies
p.(None): stem, cell proliferation and / or tumor development, exposure to materials of animal origin and
p.(None): possibility of transmission of viral vectors; and in genetics, the possible effects on cells
p.(None): gametics and offspring;
p.(None): (b) the potential therapeutic benefits of the experimental intervention and the existence or not of alternatives
p.(None): therapeutic. Consent should emphasize the experimental aspect of the intervention to avoid expectations
p.(None): erroneous about its therapeutic potential;
p.(None): (c) in the case of cell therapies, the irreversibility of cell transplantation must be clearly explained. The
p.(None): cells, unlike many drug products or implantable medical devices, cannot be removed
p.(None): of the body and could continue to generate its adverse effects throughout the life of the patient;
p.(None): (d) to advance scientific knowledge, potential participants should be asked for consent
p.(None): so that in the event of death it is possible to carry out a partial or complete autopsy to assess the scope of the
p.(None): cell implantation and its morphological and functional consequences. Autopsy request must consider
p.(None): cultural and family sensitivities. The subject is delicate but, without access to post-mortem material, the
p.(None): Trial information would be affected to the detriment of future products or product improvements.
p.(None): Recognizing the potential value of new cell and gene therapies for patients with cognitive impairment and the
p.(None): importance that these are not excluded from such advances, researchers must develop a procedure
p.(None): so that authorized patient representatives can make a decision on their behalf. The
p.(None): Representatives must be duly qualified and with sufficient knowledge to evaluate the
p.(None): test and provide adequate protection.
p.(None): Expert advice. Expert review should ensure that the trial will lead to an improvement in the care of
p.(None): the disease and will generate new and important knowledge. This review should include a comparison of the new
p.(None): therapy with available treatments.
p.(None): The following elements should be evaluated by experts: in vitro and in vivo preclinical studies, studies
p.(None): clinical findings, scientific rationale for the trial, study objectives, statistical analysis, and
p.(None): specific aspects of the disease under study.
p.(None): Regulatory authority oversight. Supervision by a regulatory authority should ensure that the
p.(None): trial with cell or gene therapies has scientific merit, was designed correctly, will be carried out
p.(None): safely and will produce reliable knowledge.
p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): This section describes a series of operational requirements for obtaining informed consent, the evaluation
...
p.(None): security;
p.(None): (p) a description of the person's rights as a participant in an investigation, including the
p.(None): right to have, modify or delete your data at any time of the investigation when you require it;
p.(None): (q) the contact details of the CEI that has approved the investigation;
p.(None): (r) what are the research sponsors or funding sources, the institutional affiliation of the
p.(None): researcher and other potential conflicts of interest; Y
p.(None): (s) the contact details of the researcher and the REC that approved the study.
p.(None): 1.3.2. In clinical trials, the following specific information should be added:
p.(None): (a) the approximate number of participants that are planned to be incorporated;
p.(None): (b) a detail of the actual or potential benefits and risks of research interventions and
p.(None): alternatives available in case of not participating in it;
p.(None): (c) an explanation about the characteristics of the design and its implications, for example, that randomness and
p.(None): masking are applied to avoid influences on the result and that, as a result of masking, not
p.(None): you will be informed of the assigned treatment until the study is completed;
p.(None): (d) proof that trial interventions and procedures will be free to participants;
p.(None): (e) proof that medical care will be provided at no cost to the participant in the event of related damage
p.(None): with the trial and the nature and duration of this care;
p.(None): (f) if the participant or their relatives will have compensation in case of disability or death as a result of
p.(None): these damages and through what mechanism will be effective;
p.(None): (g) if at the end of the research the participant will have access to the intervention that is most beneficial to
p.(None): from the trial or other appropriate intervention or appropriate benefit, and when and how they will be available; Y
p.(None): (h) the contact details of the investigator and the emergency service where they will be attended in the event of an adverse event
p.(None): related to research.
p.(None): 1.3.3. In the event that the study includes obtaining biological samples, the potential participant or their
p.(None): Representative must receive the following additional information:
p.(None): (a) the possible uses, direct or secondary, of biological samples obtained in the study;
p.(None): (b) the fate of the biological samples at the end of the study, for example, their destruction or storage for
p.(None): future uses. In the latter case, the possible future uses should be specified and where, how and why
p.(None): how long the samples will be stored, and that the participant has the right to decide on those future uses, to
p.(None): destroy the material and refuse storage;
p.(None): (c) a statement that the samples or derived data will not be marketed;
p.(None): (d) if commercial products could be developed from the biological samples and if it is planned to offer the
p.(None): participant monetary or other benefits for that development; Y
p.(None): (e) in the case of genetic research, that the participant has the right to decide whether or not to be informed of the
p.(None): results of their studies, as long as they have clinical relevance and there is a course of action to modify
p.(None): the evolution. If you were informed of the results, where and how will you have specialized counseling.
p.(None): B2. THE ETHICS COMMITTEE IN INVESTIGATION
p.(None): 2.1. Assessment requirement and exceptions
...
p.(None): by research.
p.(None): 2.6. The review process
p.(None): 2.6.1. The CEI's main task is the review of research projects and supporting documents. For the
p.(None): review, RECs must take into account applicable laws and regulations, and
p.(None): take into account the scientific aspects, the proposed recruitment mechanism, the consent process
p.(None): informed and protecting the participants and the communities involved, during and after the research.
p.(None): 2.6.2. The scientific evaluation of the study must consider, at least, the following:
p.(None): (a) the adequacy of the chosen design to the objectives, the statistical methodology and the potential to achieve
p.(None): solid conclusions from the study and to provide a benefit to society;
p.(None): (b) the adequacy of the proposed control or comparator, if any;
p.(None): (c) the balance between the risks and drawbacks and the potential and actual benefits for participants and
p.(None): communities involved in the study;
p.(None): (d) justification for the inclusion or exclusion of concomitant treatments;
p.(None): (e) characteristics of the population to study, including sex, age, ethnicity, education and socio-economic level, among
p.(None): others;
p.(None): (f) specific inclusion and exclusion criteria of the participants;
p.(None): (g) the criteria for the premature withdrawal of research participants;
p.(None): (h) the criteria for suspending or prematurely ending the investigation;
p.(None): (i) the adequacy of the research center; including equipment, facilities and, in the case of tests
p.(None): clinicians, access to emergency care;
p.(None): (j) the way in which they will communicate and publish the results of the investigation.
p.(None): 2.6.3. Regarding the informed consent process, the CEI must consider the following:
p.(None): (a) the process envisaged for obtaining informed consent;
p.(None): (b) relevance, clarity and precision of the study information to be provided to potential participants or,
p.(None): when appropriate, their representatives;
p.(None): (c) guarantee that the participants or their representatives will receive information on the progress of the study and its
p.(None): results, and that they may ask or make complaints during it.
p.(None): 2.6.4. The CEI must review and approve the following precautions for the care and protection of the participants of the
p.(None): investigation:
p.(None): (a) the qualification, suitability and experience of the investigator to conduct the investigation;
p.(None): (b) the medical care to be provided to participants;
p.(None): (c) measures to minimize the risks of the investigation;
p.(None): (d) the procedures for participants who decide to withdraw from the research;
p.(None): (e) the guarantee of access to study treatment when the investigation is concluded;
p.(None): (f) free participation in research;
p.(None): (g) the expected remuneration for per diem or loss of earnings for the participants;
p.(None): (h) the measures for treatment and guarantee of compensation in case of damage attributable to participation in the
p.(None): investigation;
p.(None): (i) roles of the people who will have access to the data of the participants and the measures that will be taken to
p.(None): ensure the confidentiality of personal information.
p.(None): 2.6.5. The CEI must take into account the following aspects related to the community:
p.(None): (a) the impact and relevance of the research to the community where it will be carried out;
p.(None): (b) the measures to consult the community or its representatives before and during the study;
p.(None): (c) the future availability of any successful research product;
p.(None): (d) the availability of the research results for the communities involved;
p.(None): (e) the contribution of research to health services, for example, the training of human resources and
p.(None): provision of materials or equipment.
p.(None): 2.6.6. In clinical trials sponsored by a pharmaceutical or other commercial company, the REC must verify that
p.(None): the agreement or contract between researcher, institution and sponsor:
p.(None): (a) does not include clauses that limit or appear to limit the rights of the participants;
p.(None): (b) does not present inconsistencies with the information that will be provided to the participants nor does it require actions that oppose
p.(None): to the ethical requirements of the CEI;
p.(None): (c) states that the costs of the trial, including study procedures and treatments, and full coverage in
p.(None): In case of damage derived from these, they will be covered by the sponsor;
p.(None): (d) makes explicit that the institution and the investigators will remain unscathed in any case of claim for damages
p.(None): caused by participation in the trial, in the responsibilities that correspond to the sponsor and that, in case of
p.(None): conflict between the parties, these will be settled in local courts regarding the research centers;
p.(None): (e) the sponsor has an insurance or guarantee subject to Argentine law;
...
p.(None): established to appeal the decision;
p.(None): (k) date and signature of the president or other authorized person of the CEI;
p.(None): (l) updated list of CEI members, including name, age, sex, profession or occupation, position
p.(None): in the CEI and relationship with the institution that houses the committee.
p.(None): 2.9. Continuous review
p.(None): 2.9.1. The CEI must establish procedures for monitoring approved studies until their completion,
p.(None): including:
p.(None): (a) quorum requirements and review and follow-up procedures, which may differ from that established for the
p.(None): initial review;
p.(None): (b) interval of follow-up reviews not exceeding once per year, although the period may be shortened by
p.(None): depending on the nature of the investigation and the anticipated risks;
p.(None): (c) the instances or events that require revision of the CEI and the corresponding deadlines for their communication, for
p.(None): example, modifications to protocol or consent, serious and unexpected adverse events, and
p.(None): any other safety information that affects the risk / benefit ratio of the study;
p.(None): (d) in case of suspension or premature termination of the study by the sponsor or researcher, the
p.(None): requirement to notify the CEI of the reasons for such action;
p.(None): (e) the requirement to present to the CEI a final report with the results of the study.
p.(None): 2.10. Documentation and file
p.(None): 2.10.1. All documentation and communications of a REC must be dated, numbered and filed in accordance with
p.(None): written procedures. Access to documents should be restricted to authorized personnel.
p.(None): 2.10.2. The archive of documents related to an investigation must be kept for a period of not less than ten
p.(None): years after its termination or suspension.
p.(None): 2.10.3. The CEI document file must include at least the following:
p.(None): (a) constitution document, regulation, POE, guides for the presentation of projects and, if any, the reports of
p.(None): management;
p.(None): (b) CV of all the members of the CEI;
p.(None): (c) registration of all income and expenses of the CEI;
p.(None): (d) scheduling of meetings;
p.(None): (e) minutes of the CEI meetings;
p.(None): (f) copy of all documents received for initial and continuous review of the studies;
p.(None): (g) communications of the results of the reviews;
p.(None): (h) correspondence issued and received by the CEI.
p.(None): B3. REGISTRATION AND SUPERVISION OF ETHICS COMMITTEES IN INVESTIGATION
p.(None): 3.1. Purposes and scope
p.(None): 3.1.1. The purposes of registering and auditing RECs are: a) to provide public assurance that the ethical review and
p.(None): Scientific research in human health is carried out according to an established standard; and b)
p.(None): assist the RECs to review their procedures and practices.
p.(None): 3.1.2. Taking into account the country's federal organization, responsibility for the registration and supervision of
p.(None): CEI falls to the provincial health authorities, which must create an agency for this purpose, or assign the
p.(None): enforcement authority to an existing body, for example in areas of health research, epidemiology,
p.(None): general inspection, management of health services or human resources.
...
p.(None): (i) efficacy criteria;
p.(None): (j) criteria for the analysis of security information;
p.(None): (k) criteria for handling missing, excluded and spurious data;
p.(None): (l) criteria for inclusion or exclusion of participants in the analysis;
p.(None): (m) criteria for cancellation of the trial.
p.(None): 4.3.4. Study interventions
p.(None): (a) description of research interventions;
p.(None): (b) in drug trials, indicate dose, frequency, route of administration and duration of treatment.
p.(None): and security monitoring;
p.(None): (c) in tests of biological or biotechnological products, the identification and valuation methodology that
p.(None): ensure uniformity of the preparation to be studied;
p.(None): (d) drugs allowed and not allowed;
p.(None): (e) delivery and / or administration mechanisms of the experimental intervention. The protocol should specify the
p.(None): procedures to be followed for its handling, storage and inventory, including its delivery and return of
p.(None): participants and their final disposition.
p.(None): (f) criteria for suspension of treatment;
p.(None): (g) planned rescue treatments and follow-up in the event of failure or adverse events;
p.(None): 4.3.5. Ethical aspects
p.(None): (a) specification that the research will be reviewed by a REC;
p.(None): (b) procedures for obtaining informed consent;
p.(None): (c) procedures to protect the confidentiality of the participants;
p.(None): (d) details of coverage and compensation for damage available to participants;
p.(None): (e) justification of payments or compensation for expenses available to participants;
p.(None): (f) anticipation of access at the end of the trial to the intervention identified as beneficial in the trial, or to a
p.(None): appropriate alternative, or other suitable benefit;
p.(None): (g) justification for the use of placebo, if applicable;
p.(None): (h) justification for conducting the research in a vulnerable group, if applicable;
p.(None): (i) possible conflicts of interest.
p.(None): 4.3.6. Administrative aspects
p.(None): (a) registration and communication of clinical data;
p.(None): (b) procedure for registration and notification to the CEI of adverse events;
p.(None): (c) handling of trial documents;
p.(None): (d) plan and publication rights of the results.
p.(None): 4.3.7. The changes made in the protocol approved by the CEI must be justified based on its
p.(None): potential impact on the participants and the scientific validity of the study; and require the approval of the
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
p.(None): risk.
p.(None): 4.4.7. The use of placebo in a control group must be adequately justified in its methodological and ethical aspects. The
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
p.(None): research-related adverse events, which must be available at any time
p.(None): require. If an intercurrent disease is diagnosed by a procedure of the
p.(None): research, the researcher should guide the participant to get the care they need.
p.(None): 4.4.9. When a modification to the protocol is foreseen or information has been obtained that could affect the
p.(None): safety of participants or their decision to remain in the trial, consent must be requested before
p.(None): implement the change or continue the study.
p.(None): 4.4.10. The interventions or experimental procedures should not have any cost for the participants,
...
p.(None): 4.6.2. The investigator must manage, indicate and / or administer the experimental intervention in the established manner
p.(None): in the protocol. The researcher or his delegate must instruct each participant on the correct use
p.(None): of the product / s under investigation, make sure that you have understood it and then verify at each clinical visit that
p.(None): you have followed the instructions.
p.(None): 4.6.3. If the study uses a masking method, the protocol should specify a procedure for
p.(None): decoding for emergency situations.
p.(None): 4.6.4. In the event that the researcher supplies and / or administers the experimental intervention, he must take
p.(None): a record of their delivery and / or administration to the participants, in order to
p.(None): demonstrate compliance with the protocol.
p.(None): 4.7. Registration of clinical data
p.(None): 4.7.1. The protocol should describe the procedures designed for obtaining and recording clinical data on
p.(None): the participants, as well as the method of encoding the data to preserve its confidentiality.
p.(None): 4.7.2. The researcher must respect the veracity, legibility, consistency and timeliness of the data records.
p.(None): of the study both in the medical records and in the clinical data registration forms that
p.(None): The confidentiality of the information of the participants is used, as well.
p.(None): 4.7.3. If automated devices are used to carry out study measurements, such as
p.(None): electrocardiograms and spirometry, a printed source document must be obtained and filed in the medical history
p.(None): identifiable of the procedure performed.
p.(None): 4.8. Essential essay documents
p.(None): 4.8.1. The investigator should keep the trial documents in a safe place, locked and with access
p.(None): restricted to authorized personnel.
p.(None): 4.8.2. The essential documents of the trial should be kept for ten years from its completion, taking
p.(None): the necessary measures to prevent the loss or accidental destruction of the same.
p.(None): 4.8.3. The documents considered essential to the trial are the following:
p.(None): (a) protocol approved by the CEI;
p.(None): (b) informed consent approved by the CEI;
p.(None): (c) recruitment mechanism approved by the CEI, if any;
p.(None): (d) approval note of the study by the CEI, indicating the approved documents: protocol and version, consent
p.(None): informed and version, recruitment mechanism, etc .;
p.(None): (e) authorization note from the highest authority of the institution hosting the study;
p.(None): (f) dated list of members and positions of the CEI;
p.(None): (g) the delegation of functions of the researcher to his team;
p.(None): (h) vital resumes of the researcher and his team;
p.(None): (i) amendments to the protocol approved by the CEI, if any;
p.(None): (j) amendments to informed consent approved by the CEI, if any;
p.(None): (k) CEI approval notes for protocol amendments and consent, if any;
p.(None): (l) notifications to the CEI of serious and unexpected reactions to the study interventions or other information from
p.(None): security;
p.(None): (m) periodic and final reports presented to the CEI;
p.(None): (n) participant identification list;
p.(None): (o) research product accounting forms, if applicable;
p.(None): (p) signed informed consents;
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Social / Age
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p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
p.(None): Functioning. An IRB should establish its standard operating procedures for, for example, the frequency of
p.(None): meetings, quorum of members and mechanisms for analysis and decision-making, and must communicate said
p.(None): rules to researchers. When evaluating a project, the different sectors of the committee, scientific and not
p.(None): Scientists must be represented to ensure a comprehensive evaluation.
p.(None): Member responsibilities. The members of a CEI must take special care to avoid all conduct not
p.(None): ethics, including conflicts of interest that may arise in evaluations. The members of the CEI must
p.(None): respect the confidentiality of the documents received for evaluation and the deliberations of the committee.
p.(None): A3. INFORMED CONSENT
...
p.(None): applies exclusively to clinical pharmacology studies for registration or regulatory purposes subject to
p.(None): ANMAT supervision, in the following cases:
p.(None): (a) when the participation of vulnerable populations for cultural, educational reasons is foreseen,
p.(None): social or economic; Y
p.(None): (b) in the case of urgent situations that require the use of an abbreviated consent.
p.(None): The witness must sign the consent form as proof of their participation.
p.(None): Deliberate objection and assent of minors. In general, voluntary cooperation or
p.(None): assent of a minor to participate in an investigation, after providing them with the information appropriate to their degree of
p.(None): maturity. Children who are immature to nod with understanding may be able to voice an ‘objection
p.(None): deliberate ’, that is, an expression of disapproval or denial of the proposed procedure, which should
p.(None): be respected, unless the child needs treatment not available outside the context of the investigation, the
p.(None): study intervention implies a probability of therapeutic benefit and there is no accepted alternative therapy.
p.(None): The CEI must determine the age from which the consent of the minor will be required, based on the
p.(None): characteristics of each study. Community consent. When planning community investigations or
p.(None): groups of people linked by ethnic, geographical, social or common interests reasons, should
p.(None): seek the agreement of a community representative, for example by including him in the assessment
p.(None): of the CEI. The representative should be chosen according to the nature and traditions of the community, and the
p.(None): CEI researchers and members should ensure that these individuals unequivocally represent the interests of
p.(None): that. In communities where collective decisions are often made, researchers should
p.(None): consider the advisability of obtaining the approval of community leaders, prior to decisions
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
...
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
p.(None): In the case of pregnant women, in addition to the requirement to provide detailed information on the risks for
p.(None): for them and for the fetus, it is recommended that the consent of the partner of the pregnant woman be obtained, if
p.(None): corresponds. An investigation in this population can only be carried out if it is relevant to health problems
p.(None): related to pregnancy and the product of conception, and if adequately supported by experiments
p.(None): in animals, particularly to establish the risks of teratogenesis and mutagenesis.
p.(None): A6. CONFIDENTIALITY OF INFORMATION
p.(None): P13. Investigators must take all necessary precautions to protect privacy and
p.(None): confidentiality of the information of the study participants.
p.(None): Confidentiality Human health research frequently involves manipulating sensitive data from
p.(None): individuals or groups; therefore there is a risk that the disclosure of such data to third parties may cause
...
p.(None): apply.
p.(None): 2.2.6. The IRC must assess whether researchers are suitable for professional training and training in
p.(None): ethical and regulatory aspects for the conduct of the study; and if the host institution is suitable for the execution of
p.(None): the investigation.
p.(None): 2.2.7. The IRB must ensure that potential participants will give their consent free of coercion and incentive
p.(None): improper and after receiving all the information appropriately.
p.(None): 2.2.8. The IRB must verify that the information for the participants on compensation and expected payments is
p.(None): accurate, understandable and does not constitute an undue incentive mode.
p.(None): 2.2.9. An IRB has authority to monitor the conduct of an investigation, including the process of obtaining
p.(None): consent.
p.(None): 2.2.10. The CEI must keep all relevant documents of the investigations, such as documents submitted
p.(None): to review, minutes of meetings, opinions and communications in general, for a period of ten years after completion
p.(None): the study, and make them available to the health authorities if they request it.
p.(None): 2.3. Composition
p.(None): 2.3.1. The CEI must be constituted according to the regulations and / or laws of the jurisdiction under which it was created, and
p.(None): in such a way as to guarantee a competent evaluation free of bias and influence of ethical aspects,
p.(None): scientific, social and operational study.
p.(None): 2.3.2. The composition of the CEI must be multidisciplinary, multisectoral and balanced in age, sex and
p.(None): scientific and non-scientific training. The number of members must be adequate to fulfill their role, preferably
p.(None): odd and with a minimum of five regular members and at least two alternate or alternate members in cases of absence
p.(None): of the holders.
p.(None): 2.3.3. Members will need to renew themselves on a regular basis to combine the advantages of the experience with those of
p.(None): new insights. The mechanisms for the selection and replacement of members must guarantee the suitability,
p.(None): plurality and impartiality in the election.
p.(None): 2.3.4. The renewal requirements must include: name or description of the person responsible for making the appointments and
p.(None): selection or decision procedure, for example, by consensus, voting or direct appointment. Selection of
p.(None): New members must include analysis of potential conflicts of interest and require transparency when
p.(None): that risk existed.
p.(None): 2.3.5. The CEI must establish in its regulations the terms of the appointment, including the duration, the
p.(None): renewal of membership and disqualification, resignation and replacement procedures.
p.(None): 2.3.6. Members must be willing to share their full name, profession and institutional affiliation, and
p.(None): to sign a confidentiality agreement on information from investigations and discussions about
p.(None): from the same.
p.(None): 2.3.7. The CEI must establish clearly defined positions to optimize its operation, for example, president,
p.(None): secretary and members. A chair must be chosen to conduct the meetings. The member chosen as
p.(None): The president must have experience in evaluating investigations and be competent and suitable to deal with and
p.(None): ponder all its aspects.
p.(None): 2.3.8. Institutional RECs must include an external member who has no ties to the institution and who can
p.(None): account for the interests of the assisted community.
p.(None): 2.4. Functioning
p.(None): 2.4.1. The CEI must prepare and update standard operating procedures (SOPs) to regulate their composition
p.(None): and operation, including the following: method of selection of members, duration of membership and criteria of
p.(None): renewal, plan of sessions, means of convening, quorum to meet, type specifications, format
p.(None): and opportunity of the documents required for the evaluation of a project, evaluation procedures,
p.(None): notification and appeal of opinions, monitoring of studies and declaration of conflicts of
p.(None): interests of its members. The CEI must make its POEs public and operate in accordance with them.
p.(None): 2.4.2. The CEI must receive all the documentation required for the review process and make it available to
p.(None): all its members, without prejudice to the fact that the responsibility of the
p.(None): preliminary review of each project and then submit it for discussion by all the members.
p.(None): 2.4.3. The IEC must establish specific quorum requirements for its review meetings, including the number
p.(None): minimum number of members to complete it and the distribution of professions and sex. The quorum must represent both sexes,
p.(None): both sectors - scientific and non-scientific - and at least one independent member of the study's host institution.
p.(None): 2.4.4. The CEI must prepare and keep updated a list of its members, indicating the name, age, sex,
p.(None): profession or occupation, position in the CEI and relationship with the institution.
p.(None): 2.4.5. The IRB must record its meetings, deliberations and decisions, including the members who
p.(None): they participated in them and the result of their voting.
p.(None): 2.4.6. The CEI may consult experts on specific topics, be they scientific, ethical or social, but without
p.(None): give you the right to decide on the project. The participation and opinion of experts must be documented.
p.(None): 2.4.7. A CEI member who is both a researcher or part of a project team should not participate in
p.(None): no evaluation, deliberation or decision about that project.
p.(None): 2.4.8. The RECs must take into consideration a request to challenge one or more of its members, presented by
p.(None): a researcher or other interested party prior to the review of a project, provided the reasons are
p.(None): adequately supported.
p.(None): 2.4.9. In clinical trials, the REC must require the investigator to immediately communicate all information on
p.(None): relevant safety and protocol changes that increase the risk to participants or that have been made
p.(None): to eliminate an immediate danger to them.
p.(None): 2.4.10. In low-risk observational studies, as defined in A4, or in the case of proposed changes
p.(None): administrative or that do not affect the safety of the participants of an already approved investigation, the president of the
p.(None): CEI or a member designated for this purpose can make an expedited evaluation of the proposal, determining if
...
p.(None): (b) study protocol identified with version number and date;
p.(None): (c) informed consent;
p.(None): (d) material to be used for recruiting participants, for example, notices;
p.(None): (e) in clinical trials of diagnostic or therapeutic products, a summary or monograph describing the
p.(None): preclinical and clinical history;
p.(None): (f) in clinical trials with commercial or industrial sponsorship, a copy of the financial agreement with the sponsor and
p.(None): of the insurance or medical coverage guarantee and of the compensation provided in the event of damage caused to the participants
p.(None): by research.
p.(None): 2.6. The review process
p.(None): 2.6.1. The CEI's main task is the review of research projects and supporting documents. For the
p.(None): review, RECs must take into account applicable laws and regulations, and
p.(None): take into account the scientific aspects, the proposed recruitment mechanism, the consent process
p.(None): informed and protecting the participants and the communities involved, during and after the research.
p.(None): 2.6.2. The scientific evaluation of the study must consider, at least, the following:
p.(None): (a) the adequacy of the chosen design to the objectives, the statistical methodology and the potential to achieve
p.(None): solid conclusions from the study and to provide a benefit to society;
p.(None): (b) the adequacy of the proposed control or comparator, if any;
p.(None): (c) the balance between the risks and drawbacks and the potential and actual benefits for participants and
p.(None): communities involved in the study;
p.(None): (d) justification for the inclusion or exclusion of concomitant treatments;
p.(None): (e) characteristics of the population to study, including sex, age, ethnicity, education and socio-economic level, among
p.(None): others;
p.(None): (f) specific inclusion and exclusion criteria of the participants;
p.(None): (g) the criteria for the premature withdrawal of research participants;
p.(None): (h) the criteria for suspending or prematurely ending the investigation;
p.(None): (i) the adequacy of the research center; including equipment, facilities and, in the case of tests
p.(None): clinicians, access to emergency care;
p.(None): (j) the way in which they will communicate and publish the results of the investigation.
p.(None): 2.6.3. Regarding the informed consent process, the CEI must consider the following:
p.(None): (a) the process envisaged for obtaining informed consent;
p.(None): (b) relevance, clarity and precision of the study information to be provided to potential participants or,
p.(None): when appropriate, their representatives;
p.(None): (c) guarantee that the participants or their representatives will receive information on the progress of the study and its
p.(None): results, and that they may ask or make complaints during it.
p.(None): 2.6.4. The CEI must review and approve the following precautions for the care and protection of the participants of the
p.(None): investigation:
p.(None): (a) the qualification, suitability and experience of the investigator to conduct the investigation;
p.(None): (b) the medical care to be provided to participants;
p.(None): (c) measures to minimize the risks of the investigation;
...
p.(None): (f) in cases of conditional decisions, the REC must provide clear recommendations
p.(None): for the required changes or clarifications and specify the procedure for its new revision;
p.(None): (g) negative decisions must be clearly supported by their reasons.
p.(None): 2.8. Communication of decisions
p.(None): 2.8.1. The decision about a research project should preferably be communicated within two
p.(None): weeks after taking, including the following:
p.(None): (a) name of the CEI;
p.(None): (b) the exact title of the proposed investigation;
p.(None): (c) detail of all the documents reviewed, including identification with their version number and date of the
p.(None): same;
p.(None): (d) the name and title of the applicant;
p.(None): (e) the name of the institution hosting the investigation;
p.(None): (f) the result of the review clearly and precisely;
p.(None): (g) CEI suggestions regarding the project;
p.(None): (h) in the event of a positive decision, a list of the applicant's responsibilities in relation to the suggestions
p.(None): of the CEI and the continuous review of the study, for example, confirmation of acceptance of the requirements imposed,
p.(None): timely submission of periodic and final reports of the investigation, of future amendments to the
p.(None): protocol and informed consent and, where appropriate, serious and unexpected adverse events;
p.(None): (i) the CEI plan for the continuous review of the project during its development;
p.(None): (j) in case of negative decision, a clear explanation of the reasons for it and what is the procedure
p.(None): established to appeal the decision;
p.(None): (k) date and signature of the president or other authorized person of the CEI;
p.(None): (l) updated list of CEI members, including name, age, sex, profession or occupation, position
p.(None): in the CEI and relationship with the institution that houses the committee.
p.(None): 2.9. Continuous review
p.(None): 2.9.1. The CEI must establish procedures for monitoring approved studies until their completion,
p.(None): including:
p.(None): (a) quorum requirements and review and follow-up procedures, which may differ from that established for the
p.(None): initial review;
p.(None): (b) interval of follow-up reviews not exceeding once per year, although the period may be shortened by
p.(None): depending on the nature of the investigation and the anticipated risks;
p.(None): (c) the instances or events that require revision of the CEI and the corresponding deadlines for their communication, for
p.(None): example, modifications to protocol or consent, serious and unexpected adverse events, and
p.(None): any other safety information that affects the risk / benefit ratio of the study;
p.(None): (d) in case of suspension or premature termination of the study by the sponsor or researcher, the
p.(None): requirement to notify the CEI of the reasons for such action;
p.(None): (e) the requirement to present to the CEI a final report with the results of the study.
p.(None): 2.10. Documentation and file
p.(None): 2.10.1. All documentation and communications of a REC must be dated, numbered and filed in accordance with
p.(None): written procedures. Access to documents should be restricted to authorized personnel.
p.(None): 2.10.2. The archive of documents related to an investigation must be kept for a period of not less than ten
p.(None): years after its termination or suspension.
...
p.(None): one of the following phases: (a) Phase I: first human study to assess tolerance, safety and effects
p.(None): biological; (b) Phase II: studies that determine the antibody response (immunogenicity) elicited by the vaccine;
p.(None): and (c) Phase III: controlled studies, with a large number of volunteers, in order to evaluate the effectiveness of
p.(None): the vaccine in disease prevention and safety on a larger scale.
p.(None): EPIDEMIOLOGICAL STUDY: study of the distribution and determinants of related events or situations
p.(None): with health in specific populations. An epidemiological study is mainly based on observation and not
p.(None): requires invasive procedures beyond routine medical questions and exams, such as blood tests
p.(None): laboratory or x-rays, so this type of study poses minimal risks for the participants.
p.(None): Epidemiological studies can be observational or experimental. Observationals, in turn, can be
p.(None): of three subtypes: cross-section, case-control and cohort.
p.(None): A cross-sectional study is generally performed on a random sample of a population with the objective of
p.(None): evaluate aspects of the health of a population, or test hypotheses about possible causes of disease or suspected
p.(None): risk factor's.
p.(None): Case-control study compares history of risk exposure among patients with a condition
p.(None): determined (cases) with the same history of exposure to that risk among the people who share with the cases
p.(None): characteristics such as age and sex, but they do not present said affection (controls). The difference between cases and
p.(None): Controls regarding the frequency of past risk exposure can be statistically analyzed
p.(None): to test hypotheses about causes or about risk factors.
p.(None): A cohort or longitudinal or prospective study identifies and observes during a given period a
p.(None): people with different levels of exposure to one or more risk factors, and the rates of occurrence of the
p.(None): condition or disease are compared in relation to exposure levels. This is one more research method
p.(None): solid than the other two cases but requires the analysis of a large number of people for a long time and is also
p.(None): expensive.
p.(None): An experimental epidemiological study is one in which the researcher selects the groups of
p.(None): individuals or populations with eligibility criteria, actively intervenes on the variable
p.(None): independent or predictive, and observes and analyzes the changes that occur in the dependent or outcome variable to
p.(None): consequence of the intervention. If two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis.
p.(None): CLINICAL PHARMACOLOGY STUDY: systematic scientific study carried out with drugs or products
p.(None): tests on voluntary individuals, healthy or sick, in order to discover or verify its effects
p.(None): therapeutic (efficacy) and / or identify adverse reactions (safety) and / or study the absorption, distribution,
p.(None): metabolism (biotransformation) and excretion of the active ingredients. Synonym: Clinical Pharmacology Trial.
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Social / Child
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p.(None): additional to the evaluation of the CEI that the researcher will respect the values and interests when obtaining the
p.(None): consent of a potential participant vulnerable to possible undue incentive or coercion. This requirement
p.(None): applies exclusively to clinical pharmacology studies for registration or regulatory purposes subject to
p.(None): ANMAT supervision, in the following cases:
p.(None): (a) when the participation of vulnerable populations for cultural, educational reasons is foreseen,
p.(None): social or economic; Y
p.(None): (b) in the case of urgent situations that require the use of an abbreviated consent.
p.(None): The witness must sign the consent form as proof of their participation.
p.(None): Deliberate objection and assent of minors. In general, voluntary cooperation or
p.(None): assent of a minor to participate in an investigation, after providing them with the information appropriate to their degree of
p.(None): maturity. Children who are immature to nod with understanding may be able to voice an ‘objection
p.(None): deliberate ’, that is, an expression of disapproval or denial of the proposed procedure, which should
p.(None): be respected, unless the child needs treatment not available outside the context of the investigation, the
p.(None): study intervention implies a probability of therapeutic benefit and there is no accepted alternative therapy.
p.(None): The CEI must determine the age from which the consent of the minor will be required, based on the
p.(None): characteristics of each study. Community consent. When planning community investigations or
p.(None): groups of people linked by ethnic, geographical, social or common interests reasons, should
p.(None): seek the agreement of a community representative, for example by including him in the assessment
p.(None): of the CEI. The representative should be chosen according to the nature and traditions of the community, and the
p.(None): CEI researchers and members should ensure that these individuals unequivocally represent the interests of
p.(None): that. In communities where collective decisions are often made, researchers should
p.(None): consider the advisability of obtaining the approval of community leaders, prior to decisions
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
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Searching for indicator children:
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p.(None): against risks of damage or prejudice and facilitate the performance of studies beneficial to society. The aspects
p.(None): Scientific and ethical are closely related: it is unethical to carry out a study that does not have scientific solidity
p.(None): exposing participants to risks or discomfort without achieving any benefit. RECs may require advice
p.(None): scientist from a qualified expert or board, but they must make their own decision about the scientific validity of the
p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
...
p.(None): Participant recovers the use of his faculties, must be informed about the research and request his
p.(None): consent before continuing with it.
p.(None): The witness of the consent process. The figure of the independent witness of the investigator is a guarantee
p.(None): additional to the evaluation of the CEI that the researcher will respect the values and interests when obtaining the
p.(None): consent of a potential participant vulnerable to possible undue incentive or coercion. This requirement
p.(None): applies exclusively to clinical pharmacology studies for registration or regulatory purposes subject to
p.(None): ANMAT supervision, in the following cases:
p.(None): (a) when the participation of vulnerable populations for cultural, educational reasons is foreseen,
p.(None): social or economic; Y
p.(None): (b) in the case of urgent situations that require the use of an abbreviated consent.
p.(None): The witness must sign the consent form as proof of their participation.
p.(None): Deliberate objection and assent of minors. In general, voluntary cooperation or
p.(None): assent of a minor to participate in an investigation, after providing them with the information appropriate to their degree of
p.(None): maturity. Children who are immature to nod with understanding may be able to voice an ‘objection
p.(None): deliberate ’, that is, an expression of disapproval or denial of the proposed procedure, which should
p.(None): be respected, unless the child needs treatment not available outside the context of the investigation, the
p.(None): study intervention implies a probability of therapeutic benefit and there is no accepted alternative therapy.
p.(None): The CEI must determine the age from which the consent of the minor will be required, based on the
p.(None): characteristics of each study. Community consent. When planning community investigations or
p.(None): groups of people linked by ethnic, geographical, social or common interests reasons, should
p.(None): seek the agreement of a community representative, for example by including him in the assessment
p.(None): of the CEI. The representative should be chosen according to the nature and traditions of the community, and the
p.(None): CEI researchers and members should ensure that these individuals unequivocally represent the interests of
p.(None): that. In communities where collective decisions are often made, researchers should
p.(None): consider the advisability of obtaining the approval of community leaders, prior to decisions
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
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Social / Ethnicity
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p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
...
p.(None): social or economic; Y
p.(None): (b) in the case of urgent situations that require the use of an abbreviated consent.
p.(None): The witness must sign the consent form as proof of their participation.
p.(None): Deliberate objection and assent of minors. In general, voluntary cooperation or
p.(None): assent of a minor to participate in an investigation, after providing them with the information appropriate to their degree of
p.(None): maturity. Children who are immature to nod with understanding may be able to voice an ‘objection
p.(None): deliberate ’, that is, an expression of disapproval or denial of the proposed procedure, which should
p.(None): be respected, unless the child needs treatment not available outside the context of the investigation, the
p.(None): study intervention implies a probability of therapeutic benefit and there is no accepted alternative therapy.
p.(None): The CEI must determine the age from which the consent of the minor will be required, based on the
p.(None): characteristics of each study. Community consent. When planning community investigations or
p.(None): groups of people linked by ethnic, geographical, social or common interests reasons, should
p.(None): seek the agreement of a community representative, for example by including him in the assessment
p.(None): of the CEI. The representative should be chosen according to the nature and traditions of the community, and the
p.(None): CEI researchers and members should ensure that these individuals unequivocally represent the interests of
p.(None): that. In communities where collective decisions are often made, researchers should
p.(None): consider the advisability of obtaining the approval of community leaders, prior to decisions
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
p.(None): volunteer through the presence of an independent witness in the process of obtaining the same.
p.(None): In research without potential benefits for the health of the participants, for example, when it comes to
p.(None): healthyXvolunteers, they may receive a payment, the type or amount of which must
p.(None): be approved by the CEI. On the other hand, when the research presents a potential benefit for the health of
p.(None): Participants, only compensation for expenses or lost profits is acceptable.
...
p.(None): such as physical, legal or mental inability to grant voluntary consent, while others are
p.(None): difficult to define, such as unfavorable economic, social, cultural or educational conditions.
p.(None): Individuals unable to grant consent. They are minors and people with disorders
p.(None): transient, fluctuating or permanent mental disorders. Research with these groups is only justified when:
p.(None): (a) the knowledge expected to be obtained from the research is sufficiently relevant in relation to the risks
p.(None): predictable;
p.(None): (b) the risks of an observational study are only slightly higher than those associated with medical examinations and
p.(None): psychological routines of such people in the condition under investigation;
p.(None): (c) the risks of experimental research are similar to those of the interventions usually received by
p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
...
p.(None): scientific and whose function is to provide a public guarantee of the protection of rights, dignity,
p.(None): safety and well-being of study participants, through, inter alia, protocol review
p.(None): of the study, the informed consent process and the suitability of the researcher.
p.(None): CONFLICT OF INTEREST: a conflict of interest is considered as a primary interest, such as the
p.(None): A patient's well-being or the validity of an investigation may be affected by a secondary interest, such as
p.(None): an economic gain, professional prestige or personal rivalries.
p.(None): INFORMED CONSENT: process by which a person confirms his free and voluntary decision to participate in
p.(None): an investigation, after having been informed about all its relevant aspects. The
p.(None): Informed consent is documented by signing a specific form.
p.(None): SOURCE DATA: information on clinical findings, observations or other activities, necessary for the
p.(None): reconstruction and evaluation of the clinical study and documented in original records or certified copies of them
p.(None): by its manager, called source documents.
p.(None): The source data must be attributable, legible, exact and contemporary.
p.(None): PERSONAL DATA: information of any kind referring to individuals or individuals of ideal existence determined or
p.(None): determinable.
p.(None): SENSITIVE DATA: personal data that reveals racial or ethnic origin, political opinions, convictions
p.(None): religious, philosophical or moral, union affiliation and information regarding health or sexual life.
p.(None): These data can only be processed when there are reasons of general interest authorized by law or for purposes
p.(None): statistical or scientific when their holders cannot be identified.
p.(None): ESSENTIAL DOCUMENTS: documents that individually and collectively allow an evaluation of the conduct of a
p.(None): study and the quality of the data generated.
p.(None): SOURCE DOCUMENTS: original documents and records of the clinical data used in
p.(None): a study, such as medical records, laboratory or pharmacy records, imaging reports, and
p.(None): images themselves, participant diaries, data recorded on automated instruments, magnetic media or
p.(None): microfilm and photographic negatives. Includes copies certified by an authorized or legalized person
p.(None): by notary public.
p.(None): CLINICAL TRIAL: see EXPERIMENTAL INVESTIGATION
p.(None): CLINICAL TRIAL OF CELL THERAPIES: the experimental investigation that is carried out in patients to establish the
p.(None): tolerance, safety and / or efficacy of a product based on human cells or tissues, after having been
p.(None): demonstrated its therapeutic potential and safety in preclinical studies. Obtaining and processing
p.(None): of cells and tissues must ensure, through validated procedures, the absence of conditions of
p.(None): transmissibility of infectious agents, prions, genetic diseases or cancer to the host.
p.(None): CLINICAL TRIAL OF MEDICAL TECHNOLOGY: the experimental research that is carried out to establish the
p.(None): safety and effectiveness of a medical device in humans. The investigation must establish the
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Searching for indicator ethnicity:
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p.(None): (c) informed consent;
p.(None): (d) material to be used for recruiting participants, for example, notices;
p.(None): (e) in clinical trials of diagnostic or therapeutic products, a summary or monograph describing the
p.(None): preclinical and clinical history;
p.(None): (f) in clinical trials with commercial or industrial sponsorship, a copy of the financial agreement with the sponsor and
p.(None): of the insurance or medical coverage guarantee and of the compensation provided in the event of damage caused to the participants
p.(None): by research.
p.(None): 2.6. The review process
p.(None): 2.6.1. The CEI's main task is the review of research projects and supporting documents. For the
p.(None): review, RECs must take into account applicable laws and regulations, and
p.(None): take into account the scientific aspects, the proposed recruitment mechanism, the consent process
p.(None): informed and protecting the participants and the communities involved, during and after the research.
p.(None): 2.6.2. The scientific evaluation of the study must consider, at least, the following:
p.(None): (a) the adequacy of the chosen design to the objectives, the statistical methodology and the potential to achieve
p.(None): solid conclusions from the study and to provide a benefit to society;
p.(None): (b) the adequacy of the proposed control or comparator, if any;
p.(None): (c) the balance between the risks and drawbacks and the potential and actual benefits for participants and
p.(None): communities involved in the study;
p.(None): (d) justification for the inclusion or exclusion of concomitant treatments;
p.(None): (e) characteristics of the population to study, including sex, age, ethnicity, education and socio-economic level, among
p.(None): others;
p.(None): (f) specific inclusion and exclusion criteria of the participants;
p.(None): (g) the criteria for the premature withdrawal of research participants;
p.(None): (h) the criteria for suspending or prematurely ending the investigation;
p.(None): (i) the adequacy of the research center; including equipment, facilities and, in the case of tests
p.(None): clinicians, access to emergency care;
p.(None): (j) the way in which they will communicate and publish the results of the investigation.
p.(None): 2.6.3. Regarding the informed consent process, the CEI must consider the following:
p.(None): (a) the process envisaged for obtaining informed consent;
p.(None): (b) relevance, clarity and precision of the study information to be provided to potential participants or,
p.(None): when appropriate, their representatives;
p.(None): (c) guarantee that the participants or their representatives will receive information on the progress of the study and its
p.(None): results, and that they may ask or make complaints during it.
p.(None): 2.6.4. The CEI must review and approve the following precautions for the care and protection of the participants of the
p.(None): investigation:
p.(None): (a) the qualification, suitability and experience of the investigator to conduct the investigation;
p.(None): (b) the medical care to be provided to participants;
p.(None): (c) measures to minimize the risks of the investigation;
p.(None): (d) the procedures for participants who decide to withdraw from the research;
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Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
p.(None): In the case of pregnant women, in addition to the requirement to provide detailed information on the risks for
p.(None): for them and for the fetus, it is recommended that the consent of the partner of the pregnant woman be obtained, if
p.(None): corresponds. An investigation in this population can only be carried out if it is relevant to health problems
p.(None): related to pregnancy and the product of conception, and if adequately supported by experiments
p.(None): in animals, particularly to establish the risks of teratogenesis and mutagenesis.
p.(None): A6. CONFIDENTIALITY OF INFORMATION
p.(None): P13. Investigators must take all necessary precautions to protect privacy and
p.(None): confidentiality of the information of the study participants.
p.(None): Confidentiality Human health research frequently involves manipulating sensitive data from
p.(None): individuals or groups; therefore there is a risk that the disclosure of such data to third parties may cause
p.(None): harm or anguish to the participants. Investigators should take all possible precautions to
p.(None): protect the privacy and confidentiality of the information of the participants, in accordance with National Law 25,326
p.(None): Habeas Data, for example, omitting data that could identify individuals or limiting their
p.(None): access only to authorized persons.
p.(None): Identifiable personal data should not be used when a study can be done without it. When necessary
p.(None): register personal identification data, investigators must justify this need to the REC, and
...
p.(None): Representative must be informed of the following:
p.(None): (a) the title of the investigation;
p.(None): (b) proof that the individual is invited to participate in the research and the reasons why
p.(None): considers it appropriate to do so; (c) proof that participation in the research is voluntary
p.(None): and that the potential participant may refuse to participate or abandon the research at any
p.(None): moment, without having to express your reasons and without loss of the benefits to which you are entitled, for
p.(None): example, without affecting the relationship with your doctor or with the institution where you are treated;
p.(None): (d) the purpose of the research, the procedures to which the participant will undergo, the visits to which
p.(None): you are expected to attend and the expected duration of your participation;
p.(None): (e) proof that participation in the study will have no costs for the participant;
p.(None): (f) the remuneration available to the participant for the expenses derived from their participation. In cases where
p.(None): a payment for participating, its amount and the payment scheme would be acceptable;
p.(None): (g) a description of the potential benefits of the research to the participant. If no benefit is anticipated
p.(None): direct to the participant, this must be specifically stated;
p.(None): (h) a description of the benefits expected from the research for the community or society in general, or its
p.(None): contribution to scientific knowledge;
p.(None): (i) a description of the foreseeable risks or inconveniences for the participant or his environment and, in case of pregnancy or
p.(None): lactation, for the embryo, fetus or infant;
p.(None): (j) all the commitments it assumes if it agrees to participate;
p.(None): (k) the measures that will be taken to protect the confidentiality of personal data;
p.(None): (l) limitations, legal or otherwise, on the ability of investigators to protect confidentiality and
p.(None): the possible consequences of its breakdown;
p.(None): (m) the commitment to provide a timely response to questions, clarifications or doubts about the procedures, risks or
p.(None): research related benefits;
p.(None): (n) the commitment to timely communication to the participant or his representative of all related information
p.(None): with your health status, or information about the study that could affect your safety or your decision to continue
p.(None): participating in the study and research results as they become available;
p.(None): (o) the circumstances and / or anticipated reasons why the investigation or
p.(None): participation of the person, specifying that in such case the necessary measures will be taken to protect their
p.(None): security;
p.(None): (p) a description of the person's rights as a participant in an investigation, including the
p.(None): right to have, modify or delete your data at any time of the investigation when you require it;
p.(None): (q) the contact details of the CEI that has approved the investigation;
p.(None): (r) what are the research sponsors or funding sources, the institutional affiliation of the
p.(None): researcher and other potential conflicts of interest; Y
p.(None): (s) the contact details of the researcher and the REC that approved the study.
p.(None): 1.3.2. In clinical trials, the following specific information should be added:
...
p.(None): potential impact on the participants and the scientific validity of the study; and require the approval of the
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
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Social / Incarcerated
Searching for indicator liberty:
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p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
p.(None): Functioning. An IRB should establish its standard operating procedures for, for example, the frequency of
p.(None): meetings, quorum of members and mechanisms for analysis and decision-making, and must communicate said
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Searching for indicator restricted:
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p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
...
p.(None): superior to others. In this case, and as a general principle, the other participants should be offered the
p.(None): treatment that has been superior, always depending on the clinical situation and the response of each
p.(None): competitor. In clinical trials measuring frequency of mortality or serious health events, evaluate
p.(None): high-risk interventions or involving large numbers of individuals, it is advisable to have a
p.(None): Data monitoring and independent security to evaluate interim data.
p.(None): Random distribution. In the same way as for the use of control groups, trials in which the allocation of
p.(None): an experimental treatment is determined by chance can only be performed when there is true uncertainty
p.(None): about which is the best of them.
p.(None): In such a case, participants should be informed about this uncertainty among the alternatives in
p.(None): study and that the purpose of the trial is to know which is the most beneficial.
p.(None): People, whether chosen or excluded for the experimental treatment or procedure, may feel restless
p.(None): or concerned about the reasons why they have been chosen or excluded. Investigators should communicate to
p.(None): potential participants the reason for using randomization (prevention of bias), and
p.(None): reassure them that the randomization process is neither discriminatory nor based on their status
p.(None): of health.
p.(None): Considerations about the scientific need to use placebo. In cases where there is a standard therapy, the
p.(None): Use of placebo control instead of that active control should be restricted to situations where the risks of
p.(None): damage or condition are minor and their scientific need has been adequately justified. A beginning
p.(None): Methodological points out that the comparison between two or more active substances only shows the relative efficacy between
p.(None): they, while the comparison with placebo allows to establish the real efficacy and, in addition, distinguish
p.(None): the specific adverse effects of the active substance. This is especially relevant when the condition is
p.(None): characterized by fluctuating symptoms and / or spontaneous remission, has high response rates
p.(None): to placebo and existing therapies are only partially effective or have not shown superiority to placebo
p.(None): consistently in previous studies.
p.(None): The placebo effect refers to the health, physiological or psychological benefits produced by a treatment
p.(None): inert from the pharmacological point of view. A placebo can modify the patient's perception of their symptoms
p.(None): and therefore cause a bias in the results of a trial, particularly when diagnostic and diagnostic techniques are used.
p.(None): Measurement is based on the subjectivity of the perception of the patient or the observer. Examples of these situations
p.(None): are: depression (symptoms are confused with other mental health problems or are usually influenced by
p.(None): external factors), idiopathic hypertension (blood pressure changes spontaneously or by
...
p.(None): (k) date and signature of the president or other authorized person of the CEI;
p.(None): (l) updated list of CEI members, including name, age, sex, profession or occupation, position
p.(None): in the CEI and relationship with the institution that houses the committee.
p.(None): 2.9. Continuous review
p.(None): 2.9.1. The CEI must establish procedures for monitoring approved studies until their completion,
p.(None): including:
p.(None): (a) quorum requirements and review and follow-up procedures, which may differ from that established for the
p.(None): initial review;
p.(None): (b) interval of follow-up reviews not exceeding once per year, although the period may be shortened by
p.(None): depending on the nature of the investigation and the anticipated risks;
p.(None): (c) the instances or events that require revision of the CEI and the corresponding deadlines for their communication, for
p.(None): example, modifications to protocol or consent, serious and unexpected adverse events, and
p.(None): any other safety information that affects the risk / benefit ratio of the study;
p.(None): (d) in case of suspension or premature termination of the study by the sponsor or researcher, the
p.(None): requirement to notify the CEI of the reasons for such action;
p.(None): (e) the requirement to present to the CEI a final report with the results of the study.
p.(None): 2.10. Documentation and file
p.(None): 2.10.1. All documentation and communications of a REC must be dated, numbered and filed in accordance with
p.(None): written procedures. Access to documents should be restricted to authorized personnel.
p.(None): 2.10.2. The archive of documents related to an investigation must be kept for a period of not less than ten
p.(None): years after its termination or suspension.
p.(None): 2.10.3. The CEI document file must include at least the following:
p.(None): (a) constitution document, regulation, POE, guides for the presentation of projects and, if any, the reports of
p.(None): management;
p.(None): (b) CV of all the members of the CEI;
p.(None): (c) registration of all income and expenses of the CEI;
p.(None): (d) scheduling of meetings;
p.(None): (e) minutes of the CEI meetings;
p.(None): (f) copy of all documents received for initial and continuous review of the studies;
p.(None): (g) communications of the results of the reviews;
p.(None): (h) correspondence issued and received by the CEI.
p.(None): B3. REGISTRATION AND SUPERVISION OF ETHICS COMMITTEES IN INVESTIGATION
p.(None): 3.1. Purposes and scope
p.(None): 3.1.1. The purposes of registering and auditing RECs are: a) to provide public assurance that the ethical review and
p.(None): Scientific research in human health is carried out according to an established standard; and b)
p.(None): assist the RECs to review their procedures and practices.
p.(None): 3.1.2. Taking into account the country's federal organization, responsibility for the registration and supervision of
p.(None): CEI falls to the provincial health authorities, which must create an agency for this purpose, or assign the
p.(None): enforcement authority to an existing body, for example in areas of health research, epidemiology,
p.(None): general inspection, management of health services or human resources.
p.(None): 3.1.3. The RECs can be formed at the central jurisdictional level or at the level of assistance institutions and
...
p.(None): in the protocol. The researcher or his delegate must instruct each participant on the correct use
p.(None): of the product / s under investigation, make sure that you have understood it and then verify at each clinical visit that
p.(None): you have followed the instructions.
p.(None): 4.6.3. If the study uses a masking method, the protocol should specify a procedure for
p.(None): decoding for emergency situations.
p.(None): 4.6.4. In the event that the researcher supplies and / or administers the experimental intervention, he must take
p.(None): a record of their delivery and / or administration to the participants, in order to
p.(None): demonstrate compliance with the protocol.
p.(None): 4.7. Registration of clinical data
p.(None): 4.7.1. The protocol should describe the procedures designed for obtaining and recording clinical data on
p.(None): the participants, as well as the method of encoding the data to preserve its confidentiality.
p.(None): 4.7.2. The researcher must respect the veracity, legibility, consistency and timeliness of the data records.
p.(None): of the study both in the medical records and in the clinical data registration forms that
p.(None): The confidentiality of the information of the participants is used, as well.
p.(None): 4.7.3. If automated devices are used to carry out study measurements, such as
p.(None): electrocardiograms and spirometry, a printed source document must be obtained and filed in the medical history
p.(None): identifiable of the procedure performed.
p.(None): 4.8. Essential essay documents
p.(None): 4.8.1. The investigator should keep the trial documents in a safe place, locked and with access
p.(None): restricted to authorized personnel.
p.(None): 4.8.2. The essential documents of the trial should be kept for ten years from its completion, taking
p.(None): the necessary measures to prevent the loss or accidental destruction of the same.
p.(None): 4.8.3. The documents considered essential to the trial are the following:
p.(None): (a) protocol approved by the CEI;
p.(None): (b) informed consent approved by the CEI;
p.(None): (c) recruitment mechanism approved by the CEI, if any;
p.(None): (d) approval note of the study by the CEI, indicating the approved documents: protocol and version, consent
p.(None): informed and version, recruitment mechanism, etc .;
p.(None): (e) authorization note from the highest authority of the institution hosting the study;
p.(None): (f) dated list of members and positions of the CEI;
p.(None): (g) the delegation of functions of the researcher to his team;
p.(None): (h) vital resumes of the researcher and his team;
p.(None): (i) amendments to the protocol approved by the CEI, if any;
p.(None): (j) amendments to informed consent approved by the CEI, if any;
p.(None): (k) CEI approval notes for protocol amendments and consent, if any;
p.(None): (l) notifications to the CEI of serious and unexpected reactions to the study interventions or other information from
p.(None): security;
p.(None): (m) periodic and final reports presented to the CEI;
p.(None): (n) participant identification list;
p.(None): (o) research product accounting forms, if applicable;
p.(None): (p) signed informed consents;
p.(None): (q) primary data documents, such as medical records, laboratory and pharmacy records, journals of
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Social / Infant
Searching for indicator infant:
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p.(None): Representative must be informed of the following:
p.(None): (a) the title of the investigation;
p.(None): (b) proof that the individual is invited to participate in the research and the reasons why
p.(None): considers it appropriate to do so; (c) proof that participation in the research is voluntary
p.(None): and that the potential participant may refuse to participate or abandon the research at any
p.(None): moment, without having to express your reasons and without loss of the benefits to which you are entitled, for
p.(None): example, without affecting the relationship with your doctor or with the institution where you are treated;
p.(None): (d) the purpose of the research, the procedures to which the participant will undergo, the visits to which
p.(None): you are expected to attend and the expected duration of your participation;
p.(None): (e) proof that participation in the study will have no costs for the participant;
p.(None): (f) the remuneration available to the participant for the expenses derived from their participation. In cases where
p.(None): a payment for participating, its amount and the payment scheme would be acceptable;
p.(None): (g) a description of the potential benefits of the research to the participant. If no benefit is anticipated
p.(None): direct to the participant, this must be specifically stated;
p.(None): (h) a description of the benefits expected from the research for the community or society in general, or its
p.(None): contribution to scientific knowledge;
p.(None): (i) a description of the foreseeable risks or inconveniences for the participant or his environment and, in case of pregnancy or
p.(None): lactation, for the embryo, fetus or infant;
p.(None): (j) all the commitments it assumes if it agrees to participate;
p.(None): (k) the measures that will be taken to protect the confidentiality of personal data;
p.(None): (l) limitations, legal or otherwise, on the ability of investigators to protect confidentiality and
p.(None): the possible consequences of its breakdown;
p.(None): (m) the commitment to provide a timely response to questions, clarifications or doubts about the procedures, risks or
p.(None): research related benefits;
p.(None): (n) the commitment to timely communication to the participant or his representative of all related information
p.(None): with your health status, or information about the study that could affect your safety or your decision to continue
p.(None): participating in the study and research results as they become available;
p.(None): (o) the circumstances and / or anticipated reasons why the investigation or
p.(None): participation of the person, specifying that in such case the necessary measures will be taken to protect their
p.(None): security;
p.(None): (p) a description of the person's rights as a participant in an investigation, including the
p.(None): right to have, modify or delete your data at any time of the investigation when you require it;
p.(None): (q) the contact details of the CEI that has approved the investigation;
p.(None): (r) what are the research sponsors or funding sources, the institutional affiliation of the
p.(None): researcher and other potential conflicts of interest; Y
p.(None): (s) the contact details of the researcher and the REC that approved the study.
p.(None): 1.3.2. In clinical trials, the following specific information should be added:
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Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): have no relevant consequences for your health.
p.(None): As a general rule, human genetic or proteomic data obtained for scientific research should not
p.(None): Remain associated with an identifiable person for longer than necessary to carry out the
p.(None): investigation.
p.(None): Human genetic or proteomic data collected for scientific research purposes should not be used with
p.(None): purposes incompatible with the original consent, unless a new consent is obtained from the participant
p.(None): or your representative. Investigators must further ensure that the use of data will not expose
p.(None): individuals, families, groups or communities at risk of discrimination or stigmatization.
p.(None): When genetic tests are carried out that may have relevant consequences for the health of a
p.(None): person, appropriate genetic counseling should be made available to them. This advice should be
p.(None): non-coercive, adapt to the culture in question and serve the best interest of the person involved.
p.(None): Consent by mail or by electronic means. When a survey is projected to large numbers of people,
p.(None): researchers usually propose to carry it out by post, email or the Internet, which
p.(None): It includes obtaining the consent of potential respondents through the same means. The problem in this case is the
p.(None): difficulty in ensuring that participants understand the relevant aspects of their participation in the study.
p.(None): For this reason, it is important that the language used in the consent text is clear and precise, and that the
p.(None): researchers make a phone number or email available to answer questions
p.(None): of the recipients of the survey. Considering, in addition, the risk of violation of correspondence by third parties,
p.(None): investigators should avoid the inclusion of potentially sensitive information about individuals throughout the
p.(None): process.
p.(None): Partial retention of information. In some studies of observation of human behavior, a
p.(None): Selective communication of study information to participants to avoid influencing behavior
p.(None): investigates and elicits responses intended to please the investigator, which seems to contradict the requirements
p.(None): of informed consent. The CEI could approve the use of this technique as long as selective retention does not induce
p.(None): people to do what they would not otherwise consent to do and the researcher agrees to communicate to the
p.(None): participants that information and obtain their consent before using the data that has been generated.
p.(None): Responsibilities for information for participants. Primary responsibility for
p.(None): Information, both oral and written, for the research participants falls on the researcher. Without
p.(None): However, in cases involving health interventions with products, the veracity of the information on the
p.(None): Their effectiveness and safety will be the responsibility of the producer and / or sponsor of the research. In
p.(None): In all cases, the REC must verify that the written information is presented appropriately.
...
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
...
p.(None): CEI how the study will conform to ethical principles in such a case. The investigator should not proceed
p.(None): with the investigation without the specific approval of the CEI for the exception of the consent of the
p.(None): participants.
p.(None): 1.1.7. In the case of surveys or interviews that are carried out remotely (by phone or email) or that
p.(None): will be analyzed anonymously, the requirement to sign a document as proof of consent can be omitted
p.(None): but the provision of the information related to the study in written form should not be omitted (personally or by
p.(None): email) or verbal (survey or telephone interview). The researcher must always respect the right to
p.(None): the confidentiality of the person surveyed or interviewed.
p.(None): 1.2. Guidelines for obtaining informed consent
p.(None): 1.2.1. The informed consent document includes at least two sections: the information sheets for the
p.(None): participant and signature sheet. Any document that is intended to be used in the process must be previously approved by
p.(None): the CEI.
p.(None): 1.2.2. Informed consent must be obtained before proceeding with the evaluation of the eligibility criteria
p.(None): or any other specific study procedure.
p.(None): 1.2.3. Oral and written information provided to the potential participant or their representative must be submitted
p.(None): clearly, precisely, completely, truthfully, in practical language and appropriate to their understanding, expressed in
p.(None): primary language of the consenting party and without including any expression that may lead one to believe that the
p.(None): participant lacks or waives any of their rights or that the researcher, institution or sponsor is
p.(None): They release their responsibilities by signing the consent. The written document should guide the explanation
p.(None): verbal.
p.(None): 1.2.4. The researcher or his authorized delegate must ensure that the potential participant or his
p.(None): representative have understood all the information received, for which they must be given the opportunity and time
p.(None): enough to consider all the options, ask all the questions you want and be satisfied
p.(None): with the answers.
p.(None): 1.2.5. After being informed, the potential participant or his legal representative, the researcher or his delegate and the
p.(None): witness, if applicable, must sign and date two originals of the consent signature sheet, such as
p.(None): declaration of having received and understood the study information and of having made the free and voluntary decision
p.(None): to participate in it. After
p.(None): the signatures, the participant or his representative must receive one of the originals of the signature sheet and a copy of
p.(None): the information section for participants.
p.(None): 1.2.6. In clinical trials, the process of obtaining informed consent must be documented in the history
p.(None): participant's clinic, including their start date and time, which was given time to reflect and to make
p.(None): questions, what were those questions, that the understanding of the information was verified, that two were signed
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Social / Literacy
Searching for indicator illiterate:
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p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
...
p.(None): such as physical, legal or mental inability to grant voluntary consent, while others are
p.(None): difficult to define, such as unfavorable economic, social, cultural or educational conditions.
p.(None): Individuals unable to grant consent. They are minors and people with disorders
p.(None): transient, fluctuating or permanent mental disorders. Research with these groups is only justified when:
p.(None): (a) the knowledge expected to be obtained from the research is sufficiently relevant in relation to the risks
p.(None): predictable;
p.(None): (b) the risks of an observational study are only slightly higher than those associated with medical examinations and
p.(None): psychological routines of such people in the condition under investigation;
p.(None): (c) the risks of experimental research are similar to those of the interventions usually received by
p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
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Social / Occupation
Searching for indicator job:
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p.(None): that. In communities where collective decisions are often made, researchers should
p.(None): consider the advisability of obtaining the approval of community leaders, prior to decisions
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
p.(None): volunteer through the presence of an independent witness in the process of obtaining the same.
p.(None): In research without potential benefits for the health of the participants, for example, when it comes to
p.(None): healthyXvolunteers, they may receive a payment, the type or amount of which must
p.(None): be approved by the CEI. On the other hand, when the research presents a potential benefit for the health of
p.(None): Participants, only compensation for expenses or lost profits is acceptable.
p.(None): Coercion. The intentional use of force or threats to modify the will of other people, for example, a
p.(None): threat of physical harm or punishment such as loss of job or medical care for refusing to participate in
p.(None): an investigation is unacceptable.
p.(None): Undue influence. Potential participants may not feel free to refuse requests from those with power
p.(None): therefore, investigations should not be proposed with individuals whose decision may be affected by
p.(None): a related authority, if they could be carried out with independent participants. Otherwise, the
p.(None): investigators must justify that choice to the IRB and outline how they plan to neutralize that possible
p.(None): influence.
p.(None): Use of medical data and biological samples. Patients have the right to know if their data or samples
p.(None): They will be used for an investigation, so researchers must obtain their prior consent. A
p.(None): CEI may approve the use for research of data or samples from medical care, without
p.(None): prior consent of patients, only when the project is scientifically proven
p.(None): valid, minimal risk is expected, obtaining consent will be difficult or impractical and will be guaranteed
p.(None): the protection of the privacy and confidentiality of individuals through an irreversible dissociation of the
p.(None): biological data or samples. A probable refusal to participate by individuals should not be considered
p.(None): impracticability criterion to approve the omission of consent.
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Searching for indicator occupation:
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p.(None): The president must have experience in evaluating investigations and be competent and suitable to deal with and
p.(None): ponder all its aspects.
p.(None): 2.3.8. Institutional RECs must include an external member who has no ties to the institution and who can
p.(None): account for the interests of the assisted community.
p.(None): 2.4. Functioning
p.(None): 2.4.1. The CEI must prepare and update standard operating procedures (SOPs) to regulate their composition
p.(None): and operation, including the following: method of selection of members, duration of membership and criteria of
p.(None): renewal, plan of sessions, means of convening, quorum to meet, type specifications, format
p.(None): and opportunity of the documents required for the evaluation of a project, evaluation procedures,
p.(None): notification and appeal of opinions, monitoring of studies and declaration of conflicts of
p.(None): interests of its members. The CEI must make its POEs public and operate in accordance with them.
p.(None): 2.4.2. The CEI must receive all the documentation required for the review process and make it available to
p.(None): all its members, without prejudice to the fact that the responsibility of the
p.(None): preliminary review of each project and then submit it for discussion by all the members.
p.(None): 2.4.3. The IEC must establish specific quorum requirements for its review meetings, including the number
p.(None): minimum number of members to complete it and the distribution of professions and sex. The quorum must represent both sexes,
p.(None): both sectors - scientific and non-scientific - and at least one independent member of the study's host institution.
p.(None): 2.4.4. The CEI must prepare and keep updated a list of its members, indicating the name, age, sex,
p.(None): profession or occupation, position in the CEI and relationship with the institution.
p.(None): 2.4.5. The IRB must record its meetings, deliberations and decisions, including the members who
p.(None): they participated in them and the result of their voting.
p.(None): 2.4.6. The CEI may consult experts on specific topics, be they scientific, ethical or social, but without
p.(None): give you the right to decide on the project. The participation and opinion of experts must be documented.
p.(None): 2.4.7. A CEI member who is both a researcher or part of a project team should not participate in
p.(None): no evaluation, deliberation or decision about that project.
p.(None): 2.4.8. The RECs must take into consideration a request to challenge one or more of its members, presented by
p.(None): a researcher or other interested party prior to the review of a project, provided the reasons are
p.(None): adequately supported.
p.(None): 2.4.9. In clinical trials, the REC must require the investigator to immediately communicate all information on
p.(None): relevant safety and protocol changes that increase the risk to participants or that have been made
p.(None): to eliminate an immediate danger to them.
p.(None): 2.4.10. In low-risk observational studies, as defined in A4, or in the case of proposed changes
p.(None): administrative or that do not affect the safety of the participants of an already approved investigation, the president of the
p.(None): CEI or a member designated for this purpose can make an expedited evaluation of the proposal, determining if
p.(None): A full committee evaluation is required or not. Expedited evaluations should be documented and
p.(None): inform the rest of the members.
...
p.(None): for the required changes or clarifications and specify the procedure for its new revision;
p.(None): (g) negative decisions must be clearly supported by their reasons.
p.(None): 2.8. Communication of decisions
p.(None): 2.8.1. The decision about a research project should preferably be communicated within two
p.(None): weeks after taking, including the following:
p.(None): (a) name of the CEI;
p.(None): (b) the exact title of the proposed investigation;
p.(None): (c) detail of all the documents reviewed, including identification with their version number and date of the
p.(None): same;
p.(None): (d) the name and title of the applicant;
p.(None): (e) the name of the institution hosting the investigation;
p.(None): (f) the result of the review clearly and precisely;
p.(None): (g) CEI suggestions regarding the project;
p.(None): (h) in the event of a positive decision, a list of the applicant's responsibilities in relation to the suggestions
p.(None): of the CEI and the continuous review of the study, for example, confirmation of acceptance of the requirements imposed,
p.(None): timely submission of periodic and final reports of the investigation, of future amendments to the
p.(None): protocol and informed consent and, where appropriate, serious and unexpected adverse events;
p.(None): (i) the CEI plan for the continuous review of the project during its development;
p.(None): (j) in case of negative decision, a clear explanation of the reasons for it and what is the procedure
p.(None): established to appeal the decision;
p.(None): (k) date and signature of the president or other authorized person of the CEI;
p.(None): (l) updated list of CEI members, including name, age, sex, profession or occupation, position
p.(None): in the CEI and relationship with the institution that houses the committee.
p.(None): 2.9. Continuous review
p.(None): 2.9.1. The CEI must establish procedures for monitoring approved studies until their completion,
p.(None): including:
p.(None): (a) quorum requirements and review and follow-up procedures, which may differ from that established for the
p.(None): initial review;
p.(None): (b) interval of follow-up reviews not exceeding once per year, although the period may be shortened by
p.(None): depending on the nature of the investigation and the anticipated risks;
p.(None): (c) the instances or events that require revision of the CEI and the corresponding deadlines for their communication, for
p.(None): example, modifications to protocol or consent, serious and unexpected adverse events, and
p.(None): any other safety information that affects the risk / benefit ratio of the study;
p.(None): (d) in case of suspension or premature termination of the study by the sponsor or researcher, the
p.(None): requirement to notify the CEI of the reasons for such action;
p.(None): (e) the requirement to present to the CEI a final report with the results of the study.
p.(None): 2.10. Documentation and file
p.(None): 2.10.1. All documentation and communications of a REC must be dated, numbered and filed in accordance with
p.(None): written procedures. Access to documents should be restricted to authorized personnel.
p.(None): 2.10.2. The archive of documents related to an investigation must be kept for a period of not less than ten
p.(None): years after its termination or suspension.
p.(None): 2.10.3. The CEI document file must include at least the following:
...
p.(None): (h) correspondence issued and received by the CEI.
p.(None): B3. REGISTRATION AND SUPERVISION OF ETHICS COMMITTEES IN INVESTIGATION
p.(None): 3.1. Purposes and scope
p.(None): 3.1.1. The purposes of registering and auditing RECs are: a) to provide public assurance that the ethical review and
p.(None): Scientific research in human health is carried out according to an established standard; and b)
p.(None): assist the RECs to review their procedures and practices.
p.(None): 3.1.2. Taking into account the country's federal organization, responsibility for the registration and supervision of
p.(None): CEI falls to the provincial health authorities, which must create an agency for this purpose, or assign the
p.(None): enforcement authority to an existing body, for example in areas of health research, epidemiology,
p.(None): general inspection, management of health services or human resources.
p.(None): 3.1.3. The RECs can be formed at the central jurisdictional level or at the level of assistance institutions and
p.(None): investigation, according to the decision of the health authority of the jurisdiction. For such a decision, the
p.(None): local complexity of the healthcare and research network and the local presence of university institutions in
p.(None): Health Sciences.
p.(None): 3.2. CEI registration
p.(None): 3.2.1. To register a CEI, the enforcement authority must request at least the following:
p.(None): (a) request note from the president or coordinator of the CEI;
p.(None): (b) document creating the CEI;
p.(None): (c) updated list of CEI members, including name, date of birth, sex, profession or
p.(None): occupation, position on the committee and relationship with the institution;
p.(None): (d) SOP of the CEI, which must comply with the provisions of section B2 of this Guide.
p.(None): 3.3. CEI supervision
p.(None): 3.3.1. In order to supervise the RECs of the jurisdiction, the enforcement authority must prepare the POE necessary to
p.(None): such activity, including the appointment of independent supervisors, design of the supervision plan, documents
p.(None): to review, the interviews to be carried out, the supervision report model and the distribution of such report.
p.(None): 3.3.2. The choice of the supervisor should guarantee the following:
p.(None): (a) knowledge and training in research ethics review practices;
p.(None): (b) independence of the CEI. The supervisor must declare any real or potential conflict of interest with a CEI and,
p.(None): if the existence of a substantial conflict of interest is determined, the enforcement authority must assign the
p.(None): assign another supervisor;
p.(None): (c) complete confidentiality of the groups or individuals participating in the research and the design and / or data of
p.(None): the investigations.
p.(None): The supervisor must sign a confidentiality agreement and no document arising from the supervision should
p.(None): record data or information considered confidential.
p.(None): 3.3.3. The designated supervisor must prepare a plan for each assigned supervision, which must be communicated to the CEI
p.(None): prior to the supervisory visit. The plan should include:
p.(None): (a) supervisor identification;
p.(None): (b) identification of the CEI and its representatives to be interviewed;
p.(None): (c) reason (routine or for specific cause), objectives and scope of supervision;
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Social / Racial Minority
Searching for indicator race:
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p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
p.(None): Functioning. An IRB should establish its standard operating procedures for, for example, the frequency of
p.(None): meetings, quorum of members and mechanisms for analysis and decision-making, and must communicate said
p.(None): rules to researchers. When evaluating a project, the different sectors of the committee, scientific and not
p.(None): Scientists must be represented to ensure a comprehensive evaluation.
p.(None): Member responsibilities. The members of a CEI must take special care to avoid all conduct not
p.(None): ethics, including conflicts of interest that may arise in evaluations. The members of the CEI must
p.(None): respect the confidentiality of the documents received for evaluation and the deliberations of the committee.
p.(None): A3. INFORMED CONSENT
p.(None): P6. The decision of an individual or his representative to participate in an investigation must be voluntary and free of
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Searching for indicator racial:
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p.(None): of the sponsor and the researcher, made up of medical or scientific professionals and non-medical or non-medical members
p.(None): scientific and whose function is to provide a public guarantee of the protection of rights, dignity,
p.(None): safety and well-being of study participants, through, inter alia, protocol review
p.(None): of the study, the informed consent process and the suitability of the researcher.
p.(None): CONFLICT OF INTEREST: a conflict of interest is considered as a primary interest, such as the
p.(None): A patient's well-being or the validity of an investigation may be affected by a secondary interest, such as
p.(None): an economic gain, professional prestige or personal rivalries.
p.(None): INFORMED CONSENT: process by which a person confirms his free and voluntary decision to participate in
p.(None): an investigation, after having been informed about all its relevant aspects. The
p.(None): Informed consent is documented by signing a specific form.
p.(None): SOURCE DATA: information on clinical findings, observations or other activities, necessary for the
p.(None): reconstruction and evaluation of the clinical study and documented in original records or certified copies of them
p.(None): by its manager, called source documents.
p.(None): The source data must be attributable, legible, exact and contemporary.
p.(None): PERSONAL DATA: information of any kind referring to individuals or individuals of ideal existence determined or
p.(None): determinable.
p.(None): SENSITIVE DATA: personal data that reveals racial or ethnic origin, political opinions, convictions
p.(None): religious, philosophical or moral, union affiliation and information regarding health or sexual life.
p.(None): These data can only be processed when there are reasons of general interest authorized by law or for purposes
p.(None): statistical or scientific when their holders cannot be identified.
p.(None): ESSENTIAL DOCUMENTS: documents that individually and collectively allow an evaluation of the conduct of a
p.(None): study and the quality of the data generated.
p.(None): SOURCE DOCUMENTS: original documents and records of the clinical data used in
p.(None): a study, such as medical records, laboratory or pharmacy records, imaging reports, and
p.(None): images themselves, participant diaries, data recorded on automated instruments, magnetic media or
p.(None): microfilm and photographic negatives. Includes copies certified by an authorized or legalized person
p.(None): by notary public.
p.(None): CLINICAL TRIAL: see EXPERIMENTAL INVESTIGATION
p.(None): CLINICAL TRIAL OF CELL THERAPIES: the experimental investigation that is carried out in patients to establish the
p.(None): tolerance, safety and / or efficacy of a product based on human cells or tissues, after having been
p.(None): demonstrated its therapeutic potential and safety in preclinical studies. Obtaining and processing
p.(None): of cells and tissues must ensure, through validated procedures, the absence of conditions of
p.(None): transmissibility of infectious agents, prions, genetic diseases or cancer to the host.
p.(None): CLINICAL TRIAL OF MEDICAL TECHNOLOGY: the experimental research that is carried out to establish the
p.(None): safety and effectiveness of a medical device in humans. The investigation must establish the
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Social / Threat of Stigma
Searching for indicator threat:
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p.(None): CEI researchers and members should ensure that these individuals unequivocally represent the interests of
p.(None): that. In communities where collective decisions are often made, researchers should
p.(None): consider the advisability of obtaining the approval of community leaders, prior to decisions
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
p.(None): volunteer through the presence of an independent witness in the process of obtaining the same.
p.(None): In research without potential benefits for the health of the participants, for example, when it comes to
p.(None): healthyXvolunteers, they may receive a payment, the type or amount of which must
p.(None): be approved by the CEI. On the other hand, when the research presents a potential benefit for the health of
p.(None): Participants, only compensation for expenses or lost profits is acceptable.
p.(None): Coercion. The intentional use of force or threats to modify the will of other people, for example, a
p.(None): threat of physical harm or punishment such as loss of job or medical care for refusing to participate in
p.(None): an investigation is unacceptable.
p.(None): Undue influence. Potential participants may not feel free to refuse requests from those with power
p.(None): therefore, investigations should not be proposed with individuals whose decision may be affected by
p.(None): a related authority, if they could be carried out with independent participants. Otherwise, the
p.(None): investigators must justify that choice to the IRB and outline how they plan to neutralize that possible
p.(None): influence.
p.(None): Use of medical data and biological samples. Patients have the right to know if their data or samples
p.(None): They will be used for an investigation, so researchers must obtain their prior consent. A
p.(None): CEI may approve the use for research of data or samples from medical care, without
p.(None): prior consent of patients, only when the project is scientifically proven
p.(None): valid, minimal risk is expected, obtaining consent will be difficult or impractical and will be guaranteed
p.(None): the protection of the privacy and confidentiality of individuals through an irreversible dissociation of the
p.(None): biological data or samples. A probable refusal to participate by individuals should not be considered
...
p.(None): benefit from scientifically valid research, regardless of their cultural or educational situation,
p.(None): social or economic, unless there is a properly justified scientific or security reason. Fair selection.
p.(None): Although the scientific objective of the research is the main criterion for the selection of the participants,
p.(None): the principles that hold that equals should be treated in the same way and that the benefits
p.(None): and the burdens generated by social cooperation, such as research, must be equitably distributed
p.(None): Among the groups involved, they should have similar consideration in the ethical evaluation. This does not
p.(None): means that individuals
p.(None): or selected groups should benefit directly from any research project or that people
p.(None): marginalized, stigmatized or socioeconomically disadvantaged should never be included.
p.(None): Vulnerable population. Group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that due to a social, cultural, educational or economic condition
p.(None): unfavorable is liable to be influenced by the expectation of receiving a benefit for participating in the
p.(None): investigation (undue incentive) or to be the victim of a threat by investigators or others in a
p.(None): situation of power if they refused to participate (coercion).
p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
p.(None): (d) the risks associated with interventions or procedures without direct benefit to the health of the participants not
p.(None): outnumber those associated with routine medical or psychological examinations of such persons, unless CEI authorizes
p.(None): a slight increase in that level of risk;
p.(None): (e) in the case of clinical trials, consent will be obtained in the presence of a witness
p.(None): independent to guarantee the voluntariness and the freedom of the decision to participate.
p.(None): Researchers must identify those individuals or groups in situations of vulnerability in order to implement a
...
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
p.(None): a potential participant who is incapable or incompetent to grant the informed consent of a
p.(None): investigation.
p.(None): INDEPENDENT WITNESS: person independent of the researcher and his team who participates in the process of
p.(None): obtaining informed consent as a guarantee that it respects the rights and interests of a potential
...
Searching for indicator stigmatization:
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p.(None): be made with those materials;
p.(None): (b) the conditions under which researchers will have to contact participants to request
p.(None): additional authorization for secondary or as yet undefined use;
p.(None): (c) the plan, if any, to destroy the unused samples or irreversibly dissociate them; Y
p.(None): (d) the right of the participants to request the destruction or dissociation of the samples.
p.(None): Consent in genetic or proteomic research. Before samples are obtained for genetic research or
p.(None): proteomics, potential participants should be informed about the purpose of the research, its risks and
p.(None): consequences, that they have the right to decide whether or not to know their genetic data and that, if they wish, they will have access
p.(None): to them, unless they have been irreversibly dissociated from your identification or the information obtained
p.(None): have no relevant consequences for your health.
p.(None): As a general rule, human genetic or proteomic data obtained for scientific research should not
p.(None): Remain associated with an identifiable person for longer than necessary to carry out the
p.(None): investigation.
p.(None): Human genetic or proteomic data collected for scientific research purposes should not be used with
p.(None): purposes incompatible with the original consent, unless a new consent is obtained from the participant
p.(None): or your representative. Investigators must further ensure that the use of data will not expose
p.(None): individuals, families, groups or communities at risk of discrimination or stigmatization.
p.(None): When genetic tests are carried out that may have relevant consequences for the health of a
p.(None): person, appropriate genetic counseling should be made available to them. This advice should be
p.(None): non-coercive, adapt to the culture in question and serve the best interest of the person involved.
p.(None): Consent by mail or by electronic means. When a survey is projected to large numbers of people,
p.(None): researchers usually propose to carry it out by post, email or the Internet, which
p.(None): It includes obtaining the consent of potential respondents through the same means. The problem in this case is the
p.(None): difficulty in ensuring that participants understand the relevant aspects of their participation in the study.
p.(None): For this reason, it is important that the language used in the consent text is clear and precise, and that the
p.(None): researchers make a phone number or email available to answer questions
p.(None): of the recipients of the survey. Considering, in addition, the risk of violation of correspondence by third parties,
p.(None): investigators should avoid the inclusion of potentially sensitive information about individuals throughout the
p.(None): process.
p.(None): Partial retention of information. In some studies of observation of human behavior, a
p.(None): Selective communication of study information to participants to avoid influencing behavior
p.(None): investigates and elicits responses intended to please the investigator, which seems to contradict the requirements
...
Searching for indicator stigmatized:
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p.(None): studies that do not have financial sponsorship or that it was only of a philanthropic or scientific type, is
p.(None): That is, without industrial or commercial purposes, it is acceptable that the treatments or procedures are covered
p.(None): by the participant's regular health funder, as long as these treatments and procedures are
p.(None): fit into the current medical practice for the disease under study and that the cost thereof is not found
p.(None): included in the subsidy or funding received for the research.
p.(None): TO 5. SELECTION OF PARTICIPANTS
p.(None): P12. Participants should be selected based on the objectives and design of the
p.(None): research, and most likely to minimize risks and maximize benefits at the individual level.
p.(None): All individuals and / or groups in a society should have equal access to the possibility of
p.(None): benefit from scientifically valid research, regardless of their cultural or educational situation,
p.(None): social or economic, unless there is a properly justified scientific or security reason. Fair selection.
p.(None): Although the scientific objective of the research is the main criterion for the selection of the participants,
p.(None): the principles that hold that equals should be treated in the same way and that the benefits
p.(None): and the burdens generated by social cooperation, such as research, must be equitably distributed
p.(None): Among the groups involved, they should have similar consideration in the ethical evaluation. This does not
p.(None): means that individuals
p.(None): or selected groups should benefit directly from any research project or that people
p.(None): marginalized, stigmatized or socioeconomically disadvantaged should never be included.
p.(None): Vulnerable population. Group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that due to a social, cultural, educational or economic condition
p.(None): unfavorable is liable to be influenced by the expectation of receiving a benefit for participating in the
p.(None): investigation (undue incentive) or to be the victim of a threat by investigators or others in a
p.(None): situation of power if they refused to participate (coercion).
p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.(None): The first international ethical guidelines for research were the Nuremberg Code (1947) and the Declaration
p.(None): of Helsinki (World Medical Association, 1964, last update 2008), setting the ethical model still in force
p.(None): for conducting studies with human beings. In 1979, the Belmont Report (National Commission for the
p.(None): Protection of Human Subjects of Biomedical and Behavioral Research) established the ethical principles for
p.(None): research involving human subjects. In 1982, the Council of International Organizations of the
p.(None): Medical Sciences (CIOMS) formulated the International Ethical Guidelines for Research
p.(None): Biomedical in Human Beings (updated in 1993 and 2002) and, in 1991, the International Guidelines for Ethical Review
p.(None): of Epidemiological Studies (updated in 2009 as International Ethical Guidelines for Epidemiological Studies).
p.(None): The Good Clinical Research Practice (BPIC) is a set of established ethical and scientific requirements
p.(None): for the design, conduct, registration and reporting of clinical trials carried out to support the registration of
p.(None): pharmaceutical products for human use, in order to ensure that the rights and integrity of
p.(None): participants and that the data and results obtained are reliable and accurate. This regulation was developed
p.(None): in 1978 by the United States Food and Drug Administration (FDA), and
p.(None): then validated in 1996 between this country, the European Union and Japan at the International Conference on Harmonization
p.(None): (ICH).
p.(None): In 2002, the World Health Organization issued a Handbook for Good Clinical Researc Practice (BPIC) and
p.(None): In 2005, the Pan American Health Organization published the BPIC guide known as “Document of the Americas”, the
p.(None): which served as the basis for the "Guide to Good Clinical Research Practices in Human Beings" of the Ministry of
p.(None): Health of the Nation (Resolution 1490/07), intended to regulate clinical trials in its field of
p.(None): application. Subsequently, this Guide was revised with the aim of expanding its scope to all research in
p.(None): human health and this document is the result of that review.
p.(None): The following documents were used as reference for the preparation of this Guide:
p.(None): - Declaration of Helsinki (AMM, 2008)
p.(None): - International ethical guidelines for biomedical research in human beings (CIOMS, 2002)
p.(None): - International Ethics Guidelines for Epidemiological Studies (CIOMS, 2009)
p.(None): - Guidelines for the Clinical Translation of Stem Cells (ISSCR, 2008)
p.(None): - Operational guidelines for ethics committees that evaluate biomedical research (WHO, 2000)
p.(None): - Surveying and Evaluating Ethical Review Practices (WHO, 2002)
p.(None): - Guidelines for Good Clinical Practice (ICH, 1996)
p.(None): - Handbook for Good Clinical Research Practice (WHO, 2002)
p.(None): - Good clinical practices: Document of the Americas (PAHO, 2005)
...
p.(None): safety and well-being of study participants, through, inter alia, protocol review
p.(None): of the study, the informed consent process and the suitability of the researcher.
p.(None): CONFLICT OF INTEREST: a conflict of interest is considered as a primary interest, such as the
p.(None): A patient's well-being or the validity of an investigation may be affected by a secondary interest, such as
p.(None): an economic gain, professional prestige or personal rivalries.
p.(None): INFORMED CONSENT: process by which a person confirms his free and voluntary decision to participate in
p.(None): an investigation, after having been informed about all its relevant aspects. The
p.(None): Informed consent is documented by signing a specific form.
p.(None): SOURCE DATA: information on clinical findings, observations or other activities, necessary for the
p.(None): reconstruction and evaluation of the clinical study and documented in original records or certified copies of them
p.(None): by its manager, called source documents.
p.(None): The source data must be attributable, legible, exact and contemporary.
p.(None): PERSONAL DATA: information of any kind referring to individuals or individuals of ideal existence determined or
p.(None): determinable.
p.(None): SENSITIVE DATA: personal data that reveals racial or ethnic origin, political opinions, convictions
p.(None): religious, philosophical or moral, union affiliation and information regarding health or sexual life.
p.(None): These data can only be processed when there are reasons of general interest authorized by law or for purposes
p.(None): statistical or scientific when their holders cannot be identified.
p.(None): ESSENTIAL DOCUMENTS: documents that individually and collectively allow an evaluation of the conduct of a
p.(None): study and the quality of the data generated.
p.(None): SOURCE DOCUMENTS: original documents and records of the clinical data used in
p.(None): a study, such as medical records, laboratory or pharmacy records, imaging reports, and
p.(None): images themselves, participant diaries, data recorded on automated instruments, magnetic media or
p.(None): microfilm and photographic negatives. Includes copies certified by an authorized or legalized person
p.(None): by notary public.
p.(None): CLINICAL TRIAL: see EXPERIMENTAL INVESTIGATION
p.(None): CLINICAL TRIAL OF CELL THERAPIES: the experimental investigation that is carried out in patients to establish the
p.(None): tolerance, safety and / or efficacy of a product based on human cells or tissues, after having been
p.(None): demonstrated its therapeutic potential and safety in preclinical studies. Obtaining and processing
p.(None): of cells and tissues must ensure, through validated procedures, the absence of conditions of
p.(None): transmissibility of infectious agents, prions, genetic diseases or cancer to the host.
p.(None): CLINICAL TRIAL OF MEDICAL TECHNOLOGY: the experimental research that is carried out to establish the
p.(None): safety and effectiveness of a medical device in humans. The investigation must establish the
p.(None): indications, contraindications and precautions for the use of the device. If the equipment, device, device or
p.(None): Medical instrument implies the use of an innovative technique, it must be validated against a comparator.
...
Social / Unemployment
Searching for indicator unemployment:
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p.(None): psychological routines of such people in the condition under investigation;
p.(None): (c) the risks of experimental research are similar to those of the interventions usually received by
p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
...
Social / Victim of Abuse
Searching for indicator victim:
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p.(None): All individuals and / or groups in a society should have equal access to the possibility of
p.(None): benefit from scientifically valid research, regardless of their cultural or educational situation,
p.(None): social or economic, unless there is a properly justified scientific or security reason. Fair selection.
p.(None): Although the scientific objective of the research is the main criterion for the selection of the participants,
p.(None): the principles that hold that equals should be treated in the same way and that the benefits
p.(None): and the burdens generated by social cooperation, such as research, must be equitably distributed
p.(None): Among the groups involved, they should have similar consideration in the ethical evaluation. This does not
p.(None): means that individuals
p.(None): or selected groups should benefit directly from any research project or that people
p.(None): marginalized, stigmatized or socioeconomically disadvantaged should never be included.
p.(None): Vulnerable population. Group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that due to a social, cultural, educational or economic condition
p.(None): unfavorable is liable to be influenced by the expectation of receiving a benefit for participating in the
p.(None): investigation (undue incentive) or to be the victim of a threat by investigators or others in a
p.(None): situation of power if they refused to participate (coercion).
p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
p.(None): (d) the risks associated with interventions or procedures without direct benefit to the health of the participants not
p.(None): outnumber those associated with routine medical or psychological examinations of such persons, unless CEI authorizes
p.(None): a slight increase in that level of risk;
p.(None): (e) in the case of clinical trials, consent will be obtained in the presence of a witness
p.(None): independent to guarantee the voluntariness and the freedom of the decision to participate.
p.(None): Researchers must identify those individuals or groups in situations of vulnerability in order to implement a
...
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
p.(None): a potential participant who is incapable or incompetent to grant the informed consent of a
p.(None): investigation.
p.(None): INDEPENDENT WITNESS: person independent of the researcher and his team who participates in the process of
p.(None): obtaining informed consent as a guarantee that it respects the rights and interests of a potential
...
Social / Women
Searching for indicator women:
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p.(None): Scientific and ethical are closely related: it is unethical to carry out a study that does not have scientific solidity
p.(None): exposing participants to risks or discomfort without achieving any benefit. RECs may require advice
p.(None): scientist from a qualified expert or board, but they must make their own decision about the scientific validity of the
p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
...
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
p.(None): The requirements to minimize risks are: inform potential participants in detail about the risks
p.(None): for pregnancy and fetus and guarantee them access to pregnancy tests and effective contraceptive methods before
p.(None): and throughout the investigation.
p.(None): In the case of pregnant women, in addition to the requirement to provide detailed information on the risks for
p.(None): for them and for the fetus, it is recommended that the consent of the partner of the pregnant woman be obtained, if
p.(None): corresponds. An investigation in this population can only be carried out if it is relevant to health problems
p.(None): related to pregnancy and the product of conception, and if adequately supported by experiments
p.(None): in animals, particularly to establish the risks of teratogenesis and mutagenesis.
p.(None): A6. CONFIDENTIALITY OF INFORMATION
p.(None): P13. Investigators must take all necessary precautions to protect privacy and
p.(None): confidentiality of the information of the study participants.
p.(None): Confidentiality Human health research frequently involves manipulating sensitive data from
p.(None): individuals or groups; therefore there is a risk that the disclosure of such data to third parties may cause
p.(None): harm or anguish to the participants. Investigators should take all possible precautions to
p.(None): protect the privacy and confidentiality of the information of the participants, in accordance with National Law 25,326
p.(None): Habeas Data, for example, omitting data that could identify individuals or limiting their
p.(None): access only to authorized persons.
p.(None): Identifiable personal data should not be used when a study can be done without it. When necessary
...
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
p.(None): risk.
p.(None): 4.4.7. The use of placebo in a control group must be adequately justified in its methodological and ethical aspects. The
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
p.(None): research-related adverse events, which must be available at any time
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): participant to obtain reliable informed consent. As far as possible, or when the
p.(None): Participant recovers the use of his faculties, must be informed about the research and request his
p.(None): consent before continuing with it.
p.(None): The witness of the consent process. The figure of the independent witness of the investigator is a guarantee
p.(None): additional to the evaluation of the CEI that the researcher will respect the values and interests when obtaining the
p.(None): consent of a potential participant vulnerable to possible undue incentive or coercion. This requirement
p.(None): applies exclusively to clinical pharmacology studies for registration or regulatory purposes subject to
p.(None): ANMAT supervision, in the following cases:
p.(None): (a) when the participation of vulnerable populations for cultural, educational reasons is foreseen,
p.(None): social or economic; Y
p.(None): (b) in the case of urgent situations that require the use of an abbreviated consent.
p.(None): The witness must sign the consent form as proof of their participation.
p.(None): Deliberate objection and assent of minors. In general, voluntary cooperation or
p.(None): assent of a minor to participate in an investigation, after providing them with the information appropriate to their degree of
p.(None): maturity. Children who are immature to nod with understanding may be able to voice an ‘objection
p.(None): deliberate ’, that is, an expression of disapproval or denial of the proposed procedure, which should
p.(None): be respected, unless the child needs treatment not available outside the context of the investigation, the
p.(None): study intervention implies a probability of therapeutic benefit and there is no accepted alternative therapy.
p.(None): The CEI must determine the age from which the consent of the minor will be required, based on the
p.(None): characteristics of each study. Community consent. When planning community investigations or
p.(None): groups of people linked by ethnic, geographical, social or common interests reasons, should
p.(None): seek the agreement of a community representative, for example by including him in the assessment
p.(None): of the CEI. The representative should be chosen according to the nature and traditions of the community, and the
p.(None): CEI researchers and members should ensure that these individuals unequivocally represent the interests of
p.(None): that. In communities where collective decisions are often made, researchers should
p.(None): consider the advisability of obtaining the approval of community leaders, prior to decisions
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
p.(None): volunteer through the presence of an independent witness in the process of obtaining the same.
p.(None): In research without potential benefits for the health of the participants, for example, when it comes to
...
p.(None): treatment that has been superior, always depending on the clinical situation and the response of each
p.(None): competitor. In clinical trials measuring frequency of mortality or serious health events, evaluate
p.(None): high-risk interventions or involving large numbers of individuals, it is advisable to have a
p.(None): Data monitoring and independent security to evaluate interim data.
p.(None): Random distribution. In the same way as for the use of control groups, trials in which the allocation of
p.(None): an experimental treatment is determined by chance can only be performed when there is true uncertainty
p.(None): about which is the best of them.
p.(None): In such a case, participants should be informed about this uncertainty among the alternatives in
p.(None): study and that the purpose of the trial is to know which is the most beneficial.
p.(None): People, whether chosen or excluded for the experimental treatment or procedure, may feel restless
p.(None): or concerned about the reasons why they have been chosen or excluded. Investigators should communicate to
p.(None): potential participants the reason for using randomization (prevention of bias), and
p.(None): reassure them that the randomization process is neither discriminatory nor based on their status
p.(None): of health.
p.(None): Considerations about the scientific need to use placebo. In cases where there is a standard therapy, the
p.(None): Use of placebo control instead of that active control should be restricted to situations where the risks of
p.(None): damage or condition are minor and their scientific need has been adequately justified. A beginning
p.(None): Methodological points out that the comparison between two or more active substances only shows the relative efficacy between
p.(None): they, while the comparison with placebo allows to establish the real efficacy and, in addition, distinguish
p.(None): the specific adverse effects of the active substance. This is especially relevant when the condition is
p.(None): characterized by fluctuating symptoms and / or spontaneous remission, has high response rates
p.(None): to placebo and existing therapies are only partially effective or have not shown superiority to placebo
p.(None): consistently in previous studies.
p.(None): The placebo effect refers to the health, physiological or psychological benefits produced by a treatment
p.(None): inert from the pharmacological point of view. A placebo can modify the patient's perception of their symptoms
p.(None): and therefore cause a bias in the results of a trial, particularly when diagnostic and diagnostic techniques are used.
p.(None): Measurement is based on the subjectivity of the perception of the patient or the observer. Examples of these situations
p.(None): are: depression (symptoms are confused with other mental health problems or are usually influenced by
p.(None): external factors), idiopathic hypertension (blood pressure changes spontaneously or by
p.(None): influence of diet, mood, etc.) and pain (pain perception varies between people).
p.(None): All this subject to the condition of minor risk.
p.(None): On the other hand, when the pharmacological response can be measured with objective techniques, the
p.(None): need to use placebo control, except in addition to standard therapy. Examples of these cases are:
p.(None): infections (the progression of pneumonia is measured by x-rays and laboratory tests) or cancer (the
p.(None): Tumor reduction can be verified with imaging or leukemia recoil with cell counts
p.(None): blood).
p.(None): When a project proposes the use of placebo, the CEI should assess whether the protocol includes the following mechanisms
p.(None): To minimize risks:
p.(None): (a) consent clearly expresses the use of placebo and its risks;
p.(None): (b) the treatment period is the minimum possible to reduce exposure to non-treatment;
p.(None): (c) control of the participants will be frequent and strict, and it is planned to withdraw the patient from the
p.(None): study or transfer to active treatment (rescue) as soon as therapeutic failure is detected;
p.(None): (d) there is an interim analysis plan and an independent data monitoring council, with clear rules for
p.(None): stopping the study for security reasons;
p.(None): (e) crossover design: groups alternately receive active treatment or placebo; Y
p.(None): (f) addition design: when scientifically and medically possible, all participants should
p.(None): receive the standard treatment, adding either the experimental product or placebo.
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p.(None): The beneficiary must assume an equitable proportion of the risks of the study.
p.(None): Respect for the communities. When a researcher plans or conducts research in cultural communities
p.(None): different from yours, you must respect the cultural and ethical values of the host community. An investigation
p.(None): that seeks to stimulate a change in customs or
p.(None): behaviors of a community with the aim of achieving healthier behaviors or a result that is expected to be beneficial for
p.(None): health is considered ethical and not harmful.
p.(None): In general, investigators or study sponsors should not be held responsible for
p.(None): unfair conditions of the place where it takes place, but they must guarantee that they will not carry out
p.(None): practices that could increase injustice or contribute to new inequalities. Investigations in
p.(None): Vulnerable communities must respond to their health needs and priorities, as a way to avoid their
p.(None): exploitation in favor of the most favored communities.
p.(None): Scientific validity. An investigation will be considered valid from the scientific point of view when the
p.(None): Proposed methods are tailored to the research objectives and field of study. Without scientific validity,
p.(None): research cannot generate valid knowledge, produce any benefit or justify the
p.(None): exposure of the participants to the risks of the same. Invalid studies also cause a
p.(None): waste of resources.
p.(None): Qualified researchers. Human health research should be conducted or supervised only by researchers who
p.(None): demonstrate sufficient instruction, training, and experience. Instruction or education refers to the possession of
p.(None): a tertiary professional degree, university or specialization, according to the research object. Training
p.(None): it means participation in focused training programs of relatively short duration. Experience is
p.(None): refers to specific work history or to the stable and prolonged performance of tasks
p.(None): related to professional practice and research.
p.(None): In clinical trials, in particular, a duly qualified and appropriately qualified doctor or dentist
p.(None): enrolled must be responsible for the medical care of the participants and for any medical decision
p.(None): take for them. The vital curriculum of researchers, including proof of degrees, specializations,
p.(None): professional qualification, training and experience, can provide information on your suitability for
p.(None): sponsor, CEI, and regulatory authorities, if applicable. The rest of the team must prove
p.(None): appropriate training in the study protocol, the conduct of clinical trials, and the ethical aspects of
p.(None): human health research.
p.(None): A2. ETHICAL AND SCIENTIFIC EVALUATION
p.(None): P4. The background, objectives, design, size and selection of the sample, selection mechanisms of
p.(None): participants, measurement methods of the variables, statistical analysis, detail of the proposed intervention,
p.(None): if applicable, and the ethical, financial and administrative aspects of health research
p.(None): Humans must be clearly and comprehensively detailed in a study protocol.
p.(None): P5. The study protocol and information intended for potential participants should be submitted to
p.(None): evaluation and approval of a research ethics committee (CEI) before starting the study. The CEI
p.(None): It must be independent of sponsors and researchers. The researcher must inform the CEI
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p.(None): for participation and remuneration for expenses, if applicable; and care coverage and
p.(None): compensation provided in case of damage directly related to the investigation.
p.(None): Q8. In the course of the research, participants should be informed of any findings or
p.(None): event that could affect your security or your decision to continue participating. At the end of
p.(None): research, the results of the same should be made available to the participants.
p.(None): Definition. Informed consent is voluntary and free when granted by an autonomous person and
p.(None): competent who can understand the purpose and nature of the research, the risks to be faced and the
p.(None): benefits you may receive, and you know your rights as a research participant. An autonomous person and
p.(None): competent is the one capable of making a decision voluntarily, solely based on their own values,
p.(None): interests and preferences, and as long as you have the information you need to evaluate your options. As a principle
p.(None): In general, consent must be obtained for all research involving human beings or carried out
p.(None): with biological samples or personal data. The informed consent process should include the following
p.(None): elements: competence to make decisions of the potential participant or his legal representative, clear information and
p.(None): complete before and during the investigation, understanding of the information, voluntary and free decision, and documentation
p.(None): of the whole process. The understanding of the information depends on the maturity, intelligence and education of the individuals,
p.(None): but also of the capacity and will
p.(None): of the researcher to transmit it. Exceptions to obtaining consent. In the following
p.(None): situations, applicable only to observational investigations, a REC could exempt the obtaining of the
p.(None): consent:
p.(None): (a) when only non-binding data or samples, or publicly available information are used in the investigation.
p.(None): That is, it is not possible to establish the identity of people and, therefore, researchers cannot
p.(None): Contact them to request their consent.
p.(None): (b) when linkable data is used but obtaining consent is impractical or very difficult, and the
p.(None): Proposed research represents only minimal risks. For example, a study using only medical records.
p.(None): In such cases, the investigator must guarantee that it will protect the confidentiality of the data, for example,
p.(None): deleting all personally identifiable information from study records after compiling the
p.(None): health data. However, the use of medical data or biological samples for a purpose for which it has not been
p.(None): consent is an ethical problem, even if it does not imply any risk for the owner; therefore, the
p.(None): Health institutions that carry out studies on medical records or sample banks must obtain a
p.(None): advance consent of their patients for such practices, informing them about the measures that will be taken to
p.(None): protect your confidentiality.
p.(None): (c) when the study uses health records established or officially recognized by the authorities
p.(None): health, for example, records of diseases or therapeutic or adverse effects or genetic data,
p.(None): as long as the registered data is not linked to people. These records are an important source
p.(None): Information for public health activities such as disease prevention and resource allocation.
p.(None): Exceptions to specific requirements of the consent process. The IEC could exempt a requirement from the
p.(None): Obtaining consent in the following situations:
p.(None): (a) when the advance of consent could invalidate the results of the investigation, for example, when
p.(None): study the behavior of a human group. Upon being warned, the subjects could modify their habitual behaviors
p.(None): Or it could cause unnecessary concern. Investigators must justify to the CEI the exception and
p.(None): commit to obtaining the consent of the participants before disseminating the results of the study;
p.(None): (b) in experimental epidemiological investigations in which the intervention is directed at a group of people or
p.(None): to a community, such as students in a school or all residents of a defined area, for example, when
p.(None): study an immunization or education strategy or the fluoridation of water to avoid cavities, consent
p.(None): It can be obtained from a representative of the community or the corresponding authority, who must assess whether the
p.(None): Expected benefits of the study intervention for the group or community outweigh its risks. Additionally,
p.(None): individuals should be informed about the research and have the opportunity, to the extent possible, to
p.(None): reject your participation;
p.(None): (c) in clinical trials on situations requiring immediate medical intervention, the CEI may approve the use
p.(None): of an abridged version containing essential information about the study for the potential participant or their
p.(None): representative. In such case, the information must be provided in the presence of an independent witness, who
p.(None): You must sign the consent form together with the researcher and the participant or their representative.
p.(None): An investigator who proposes an exception to obtaining consent or to any of the process requirements
p.(None): You must justify to the IRB the reason for the request and explain how the rights of the
p.(None): participants. The researcher should not proceed with the investigation without the specific approval of the CEI
p.(None): for such exception.
p.(None): Inability to grant consent. In the case of people who cannot grant consent
p.(None): voluntary for physical, mental or legal reasons, it must be obtained from a representative authorized by law
p.(None): applicable, for example, the father or mother in the case of minors. The representative retains the power
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p.(None): (d) material to be used for recruiting participants, for example, notices;
p.(None): (e) in clinical trials of diagnostic or therapeutic products, a summary or monograph describing the
p.(None): preclinical and clinical history;
p.(None): (f) in clinical trials with commercial or industrial sponsorship, a copy of the financial agreement with the sponsor and
p.(None): of the insurance or medical coverage guarantee and of the compensation provided in the event of damage caused to the participants
p.(None): by research.
p.(None): 2.6. The review process
p.(None): 2.6.1. The CEI's main task is the review of research projects and supporting documents. For the
p.(None): review, RECs must take into account applicable laws and regulations, and
p.(None): take into account the scientific aspects, the proposed recruitment mechanism, the consent process
p.(None): informed and protecting the participants and the communities involved, during and after the research.
p.(None): 2.6.2. The scientific evaluation of the study must consider, at least, the following:
p.(None): (a) the adequacy of the chosen design to the objectives, the statistical methodology and the potential to achieve
p.(None): solid conclusions from the study and to provide a benefit to society;
p.(None): (b) the adequacy of the proposed control or comparator, if any;
p.(None): (c) the balance between the risks and drawbacks and the potential and actual benefits for participants and
p.(None): communities involved in the study;
p.(None): (d) justification for the inclusion or exclusion of concomitant treatments;
p.(None): (e) characteristics of the population to study, including sex, age, ethnicity, education and socio-economic level, among
p.(None): others;
p.(None): (f) specific inclusion and exclusion criteria of the participants;
p.(None): (g) the criteria for the premature withdrawal of research participants;
p.(None): (h) the criteria for suspending or prematurely ending the investigation;
p.(None): (i) the adequacy of the research center; including equipment, facilities and, in the case of tests
p.(None): clinicians, access to emergency care;
p.(None): (j) the way in which they will communicate and publish the results of the investigation.
p.(None): 2.6.3. Regarding the informed consent process, the CEI must consider the following:
p.(None): (a) the process envisaged for obtaining informed consent;
p.(None): (b) relevance, clarity and precision of the study information to be provided to potential participants or,
p.(None): when appropriate, their representatives;
p.(None): (c) guarantee that the participants or their representatives will receive information on the progress of the study and its
p.(None): results, and that they may ask or make complaints during it.
p.(None): 2.6.4. The CEI must review and approve the following precautions for the care and protection of the participants of the
p.(None): investigation:
p.(None): (a) the qualification, suitability and experience of the investigator to conduct the investigation;
p.(None): (b) the medical care to be provided to participants;
p.(None): (c) measures to minimize the risks of the investigation;
p.(None): (d) the procedures for participants who decide to withdraw from the research;
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p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
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p.(None): condition they suffer from. In accordance with Article 7 of the National Mental Health Law No. 26,657 and with Article 4 of the
p.(None): National Law on Patient Rights No. 26,529, a relative up to the fourth degree of consanguinity, the spouse or the
p.(None): living with the patient are the ones who could best answer for their interests and for the decision he or she would make
p.(None): if they were in full use of their faculties, therefore, it is they who must represent the potential
p.(None): participant to obtain reliable informed consent. As far as possible, or when the
p.(None): Participant recovers the use of his faculties, must be informed about the research and request his
p.(None): consent before continuing with it.
p.(None): The witness of the consent process. The figure of the independent witness of the investigator is a guarantee
p.(None): additional to the evaluation of the CEI that the researcher will respect the values and interests when obtaining the
p.(None): consent of a potential participant vulnerable to possible undue incentive or coercion. This requirement
p.(None): applies exclusively to clinical pharmacology studies for registration or regulatory purposes subject to
p.(None): ANMAT supervision, in the following cases:
p.(None): (a) when the participation of vulnerable populations for cultural, educational reasons is foreseen,
p.(None): social or economic; Y
p.(None): (b) in the case of urgent situations that require the use of an abbreviated consent.
p.(None): The witness must sign the consent form as proof of their participation.
p.(None): Deliberate objection and assent of minors. In general, voluntary cooperation or
p.(None): assent of a minor to participate in an investigation, after providing them with the information appropriate to their degree of
p.(None): maturity. Children who are immature to nod with understanding may be able to voice an ‘objection
p.(None): deliberate ’, that is, an expression of disapproval or denial of the proposed procedure, which should
p.(None): be respected, unless the child needs treatment not available outside the context of the investigation, the
p.(None): study intervention implies a probability of therapeutic benefit and there is no accepted alternative therapy.
p.(None): The CEI must determine the age from which the consent of the minor will be required, based on the
p.(None): characteristics of each study. Community consent. When planning community investigations or
p.(None): groups of people linked by ethnic, geographical, social or common interests reasons, should
p.(None): seek the agreement of a community representative, for example by including him in the assessment
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p.(None): techniques and procedures that can optimize routine care;
p.(None): (b) improvement in health services: the incorporation into health services of the inputs or instruments that are
p.(None): have obtained or acquired for the study is an additional benefit for the community where the
p.(None): investigation; Y
p.(None): (c) dissemination of research results: dissemination of study results in the studied community
p.(None): or in the scientific field it is a benefit in itself, since this tends to improve the health of the population.
p.(None): Research funding. In any type of research, all treatments and procedures
p.(None): defined in the protocol must be provided to all participants at no cost to them. In the case of
p.(None): studies that do not have financial sponsorship or that it was only of a philanthropic or scientific type, is
p.(None): That is, without industrial or commercial purposes, it is acceptable that the treatments or procedures are covered
p.(None): by the participant's regular health funder, as long as these treatments and procedures are
p.(None): fit into the current medical practice for the disease under study and that the cost thereof is not found
p.(None): included in the subsidy or funding received for the research.
p.(None): TO 5. SELECTION OF PARTICIPANTS
p.(None): P12. Participants should be selected based on the objectives and design of the
p.(None): research, and most likely to minimize risks and maximize benefits at the individual level.
p.(None): All individuals and / or groups in a society should have equal access to the possibility of
p.(None): benefit from scientifically valid research, regardless of their cultural or educational situation,
p.(None): social or economic, unless there is a properly justified scientific or security reason. Fair selection.
p.(None): Although the scientific objective of the research is the main criterion for the selection of the participants,
p.(None): the principles that hold that equals should be treated in the same way and that the benefits
p.(None): and the burdens generated by social cooperation, such as research, must be equitably distributed
p.(None): Among the groups involved, they should have similar consideration in the ethical evaluation. This does not
p.(None): means that individuals
p.(None): or selected groups should benefit directly from any research project or that people
p.(None): marginalized, stigmatized or socioeconomically disadvantaged should never be included.
p.(None): Vulnerable population. Group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that due to a social, cultural, educational or economic condition
p.(None): unfavorable is liable to be influenced by the expectation of receiving a benefit for participating in the
p.(None): investigation (undue incentive) or to be the victim of a threat by investigators or others in a
p.(None): situation of power if they refused to participate (coercion).
p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
p.(None): (d) the risks associated with interventions or procedures without direct benefit to the health of the participants not
p.(None): outnumber those associated with routine medical or psychological examinations of such persons, unless CEI authorizes
p.(None): a slight increase in that level of risk;
p.(None): (e) in the case of clinical trials, consent will be obtained in the presence of a witness
p.(None): independent to guarantee the voluntariness and the freedom of the decision to participate.
p.(None): Researchers must identify those individuals or groups in situations of vulnerability in order to implement a
p.(None): special protection for them. However, some vulnerabilities can be relatively easy to identify,
p.(None): such as physical, legal or mental inability to grant voluntary consent, while others are
p.(None): difficult to define, such as unfavorable economic, social, cultural or educational conditions.
p.(None): Individuals unable to grant consent. They are minors and people with disorders
p.(None): transient, fluctuating or permanent mental disorders. Research with these groups is only justified when:
p.(None): (a) the knowledge expected to be obtained from the research is sufficiently relevant in relation to the risks
p.(None): predictable;
p.(None): (b) the risks of an observational study are only slightly higher than those associated with medical examinations and
p.(None): psychological routines of such people in the condition under investigation;
p.(None): (c) the risks of experimental research are similar to those of the interventions usually received by
p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
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p.(None): Linked information. It is the information that can be related or connected with the person to whom it refers. The
p.(None): Linked information, meanwhile, can be:
p.(None): (a) anonymous, when it cannot be linked to the person to whom it refers except through a code or other means
p.(None): known only to the owner of the information;
p.(None): (b) non-nominal, when the information can be linked to the person through a code, which does not include the
p.(None): personal identification and is known by the person and the researcher; or
p.(None): (c) nominal, when the information is linked to the person by personal identification, usually the name.
p.(None): The first two cases (anonymous and non-nominal) are also known as "encoded or reversibly decoupled" data
p.(None): and they are those data not associated with an identified or identifiable person because the
p.(None): information that identifies that person through a code that allows the reverse operation.
p.(None): Confidentiality in genetic research. Whenever genetic testing of known clinical value is planned
p.(None): or predictable on samples linked to an identifiable individual, your consent must be obtained in advance.
p.(None): Conversely, in order to perform a genetic test of known clinical value or that provides
p.(None): information about a known hereditary condition without obtaining prior consent, the investigator should
p.(None): ensure that biological samples have been irreversibly disassociated from their holders and that it could not be derived from
p.(None): research any information about specific individuals.
p.(None): The genetic or proteomic data of a person must not be disclosed or made available to third parties, in
p.(None): private of employers, insurance companies, educational establishments or relatives of the person in question.
p.(None): Investigators must strive to protect the privacy of individuals and the confidentiality of data
p.(None): human genetics associated with an identifiable person, family, or group.
p.(None): As a general rule, human genetic or proteomic data obtained for research purposes
p.(None): Scientists should not remain associated with an identifiable person for longer than necessary to
p.(None): carry out the investigation. Even when they are dissociated from the identity of a person, they
p.(None): they must take all necessary precautions to ensure the security of such data.
p.(None): Confidentiality when using the Internet for research. There are several ways in which researchers could
p.(None): use the Internet for your research:
p.(None): (a) to obtain data: researchers could enroll people to answer surveys or questionnaires placed
p.(None): on a website or use publicly accessible sites to observe, as a data source, what its users say or do
p.(None): without necessarily interacting with them.
p.(None): (b) to transmit data: investigators may send electronic files with research data to others
p.(None): collaborative researchers, or sponsors set up a database for data entry on a website
p.(None): in multicenter studies.
p.(None): (c) to communicate results: some researchers disseminate the results of their studies through a website.
p.(None): In any case, the privacy, confidentiality and security of the participants must be guaranteed by the
p.(None): researchers during data collection, transmission to other centers and the construction of a database
p.(None): shared, particularly when personally identifiable data is transmitted.
p.(None): Researchers or sponsors must use passwords and the best available technology, for
...
p.(None): 1.1. Informed consent requirement and exceptions
p.(None): 1.1.1. Informed consent is the process that ensures that a potential participant or their
p.(None): Legal representative voluntarily make the decision to participate, free of undue incentive and coercion
p.(None): in an investigation, provided that it is consistent with their values, interests and preferences. The process of
p.(None): Consent must be conducted by the principal investigator or a member of the professional team of the
p.(None): health or related, for example, nurse, social worker or psychologist, trained for this role. In cases where
p.(None): If a treatment is being investigated, only a doctor or dentist, when appropriate, can provide the information with
p.(None): regarding patient treatment.
p.(None): 1.1.2. In case of legal incompetence or mental incapacity of the potential participant to give consent
p.(None): Voluntary, it must be obtained from the legal representative. To the extent that your understanding allows, you should
p.(None): request the consent of the potential participant, after informing them about the study. Your decision to
p.(None): participate or should not be respected
p.(None): 1.1.3. In clinical trials, when the potential participant is socially vulnerable,
p.(None): cultural, educational or economic, a witness must participate in the informed consent process
p.(None): independent of the researcher or his team, who must sign and date the consent form as
p.(None): proof of your participation.
p.(None): 1.1.4. In medical emergency situations that require immediate intervention, a summary may be used,
p.(None): approved by the CEI, of the written information for the participant. Oral information must be provided in
p.(None): presence of an independent witness, who must sign, together with the investigator, the summary of information and the
p.(None): consent form. The
p.(None): Participant or their representative must sign the consent form and then receive an original thereof and
p.(None): a copy of the summary of information.
p.(None): 1.1.5. In observational studies, it is common to obtain informed consent from potential
p.(None): However, the CEI could approve the following exceptions:
p.(None): (a) when publicly available information is used. In such cases, investigators must demonstrate that they do not
p.(None): there is a risk of disclosure of personal data;
p.(None): (b) when obtaining consent is impracticable, as in the case of biological data or samples
p.(None): irreversibly dissociated, or retrospective cohort studies conducted on medical records. In
p.(None): In the latter case, investigators must guarantee strict measures to protect the confidentiality of
...
p.(None): appropriate alternative, or other suitable benefit;
p.(None): (g) justification for the use of placebo, if applicable;
p.(None): (h) justification for conducting the research in a vulnerable group, if applicable;
p.(None): (i) possible conflicts of interest.
p.(None): 4.3.6. Administrative aspects
p.(None): (a) registration and communication of clinical data;
p.(None): (b) procedure for registration and notification to the CEI of adverse events;
p.(None): (c) handling of trial documents;
p.(None): (d) plan and publication rights of the results.
p.(None): 4.3.7. The changes made in the protocol approved by the CEI must be justified based on its
p.(None): potential impact on the participants and the scientific validity of the study; and require the approval of the
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
...
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
p.(None): a potential participant who is incapable or incompetent to grant the informed consent of a
p.(None): investigation.
p.(None): INDEPENDENT WITNESS: person independent of the researcher and his team who participates in the process of
p.(None): obtaining informed consent as a guarantee that it respects the rights and interests of a potential
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): 1.3.1. In observational research that requires consent, the potential participant or their
p.(None): Representative must be informed of the following:
p.(None): (a) the title of the investigation;
p.(None): (b) proof that the individual is invited to participate in the research and the reasons why
p.(None): considers it appropriate to do so; (c) proof that participation in the research is voluntary
p.(None): and that the potential participant may refuse to participate or abandon the research at any
p.(None): moment, without having to express your reasons and without loss of the benefits to which you are entitled, for
p.(None): example, without affecting the relationship with your doctor or with the institution where you are treated;
p.(None): (d) the purpose of the research, the procedures to which the participant will undergo, the visits to which
p.(None): you are expected to attend and the expected duration of your participation;
p.(None): (e) proof that participation in the study will have no costs for the participant;
p.(None): (f) the remuneration available to the participant for the expenses derived from their participation. In cases where
p.(None): a payment for participating, its amount and the payment scheme would be acceptable;
p.(None): (g) a description of the potential benefits of the research to the participant. If no benefit is anticipated
p.(None): direct to the participant, this must be specifically stated;
p.(None): (h) a description of the benefits expected from the research for the community or society in general, or its
p.(None): contribution to scientific knowledge;
p.(None): (i) a description of the foreseeable risks or inconveniences for the participant or his environment and, in case of pregnancy or
p.(None): lactation, for the embryo, fetus or infant;
p.(None): (j) all the commitments it assumes if it agrees to participate;
p.(None): (k) the measures that will be taken to protect the confidentiality of personal data;
p.(None): (l) limitations, legal or otherwise, on the ability of investigators to protect confidentiality and
p.(None): the possible consequences of its breakdown;
p.(None): (m) the commitment to provide a timely response to questions, clarifications or doubts about the procedures, risks or
p.(None): research related benefits;
p.(None): (n) the commitment to timely communication to the participant or his representative of all related information
p.(None): with your health status, or information about the study that could affect your safety or your decision to continue
p.(None): participating in the study and research results as they become available;
p.(None): (o) the circumstances and / or anticipated reasons why the investigation or
p.(None): participation of the person, specifying that in such case the necessary measures will be taken to protect their
p.(None): security;
p.(None): (p) a description of the person's rights as a participant in an investigation, including the
p.(None): right to have, modify or delete your data at any time of the investigation when you require it;
p.(None): (q) the contact details of the CEI that has approved the investigation;
p.(None): (r) what are the research sponsors or funding sources, the institutional affiliation of the
p.(None): researcher and other potential conflicts of interest; Y
p.(None): (s) the contact details of the researcher and the REC that approved the study.
...
p.(None): (d) plan and publication rights of the results.
p.(None): 4.3.7. The changes made in the protocol approved by the CEI must be justified based on its
p.(None): potential impact on the participants and the scientific validity of the study; and require the approval of the
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
p.(None): 4.4.3. The researcher must guarantee that each participant will have access to their health information and
p.(None): results of the study when they are available, and that your right to confidentiality will be protected in
p.(None): every moment.
p.(None): 4.4.4. In case of health interventions that imply risks for the pregnancy, embryo or fetus, they should be considered
p.(None): the following precautions:
p.(None): (a) women of childbearing age should be warned of this risk before giving their
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
...
Social / employees
Searching for indicator employees:
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p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
p.(None): it is not fair to waste funds or resources that could be dedicated to other social benefits.
p.(None): Additionally, institutional RECs must consider the impact that research activities
p.(None): they will have on the habitual operation of the institution.
p.(None): Assessment of risks, benefits and selection mechanisms. The RECs must pay special attention to the projects of
p.(None): research involving children, pregnant or breastfeeding women, people with mental illness or any
p.(None): type of disability, members of communities not familiar with medical concepts and people with freedom
p.(None): restricted to make decisions, such as: people deprived of their liberty, health science students in
p.(None): investigations carried out by their teachers and employees of the entities that carry out the research.
p.(None): They should also pay attention to selection mechanisms to avoid inequities based on age,
p.(None): socioeconomic status, degree of disability or other variables, unless they are inclusion criteria. The
p.(None): Possible benefits or harms of research should be equitably distributed among groups that
p.(None): differ
p.(None): from the point of view of age, sex, race, culture or other variables, as well as within them.
p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
p.(None): Functioning. An IRB should establish its standard operating procedures for, for example, the frequency of
p.(None): meetings, quorum of members and mechanisms for analysis and decision-making, and must communicate said
p.(None): rules to researchers. When evaluating a project, the different sectors of the committee, scientific and not
p.(None): Scientists must be represented to ensure a comprehensive evaluation.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): of health in such a way that the identity of the holders cannot be determined, they do not represent any risk and
p.(None): require no control mechanism.
p.(None): Second, observational investigations that include surveys or interviews or procedures
p.(None): routine diagnoses or are limited to analysis of biological samples or data linked to people and
p.(None): epidemiological or clinical experimental investigations carried out with products or procedures already registered
p.(None): by the regulatory authority, require obtaining the informed consent of the participants and the
p.(None): initial and periodic evaluation by a CEI. Within this group, observational studies considered low
p.(None): risk, that is, those who present the same risk as routine medical practice, may receive
p.(None): an expedited initial evaluation and do not require periodic review.
p.(None): Third, clinical pharmacology studies for the purpose of registering or regulating a product require,
p.(None): in addition to the mechanisms described above, the authorization of the National Administration of Medicines,
p.(None): Food and Medical Technology (ANMAT) nationwide. For their part, each health jurisdiction has
p.(None): competence to establish a local regulatory and oversight body for this type of investigation.
p.(None): Finally, it must be recognized that the content of this Guide will not solve all the ethical problems that may arise.
p.(None): of health research. Some situations will require a thorough analysis and informed opinion from
p.(None): researchers, members of ethics committees, health professionals, authorities and representatives of the
p.(None): community.
p.(None): Sanctions. The Research Ethics Committees have the authority not to approve, suspend or definitively cancel
p.(None): an investigation that does not meet ethical standards, and must inform the authorities of the institution
p.(None): or health on any serious or persistent ethical breach in the development of investigations
p.(None): previously approved. Failure to submit a research protocol to the evaluation of a REC is considered serious
p.(None): violation of ethical standards.
p.(None): Health authorities, the institution or professional associations must sanction researchers who
p.(None): do not adhere to ethical requirements, through fines or suspension of research grants.
p.(None): ANMAT, in case of breach of ethical precepts and in its scope, can:
p.(None): (a) object to or reject a clinical pharmacology study project or an investigator or research center
p.(None): proposed;
p.(None): (b) suspend or cancel a clinical pharmacology study during its execution, and apply sanctions
p.(None): administrative or financial that correspond;
p.(None): (c) reject data submitted in support of a marketing registration application.
p.(None): The sanctions of the health authorities of the jurisdictions and of ANMAT can apply both to the researcher and
p.(None): to the research host institution and, if applicable, also to the sponsor in the case of
p.(None): clinical pharmacology for registration purposes.
p.(None): Editors of scientific journals should not publish results of studies carried out without respecting the rules
...
p.(None): renewal, plan of sessions, means of convening, quorum to meet, type specifications, format
p.(None): and opportunity of the documents required for the evaluation of a project, evaluation procedures,
p.(None): notification and appeal of opinions, monitoring of studies and declaration of conflicts of
p.(None): interests of its members. The CEI must make its POEs public and operate in accordance with them.
p.(None): 2.4.2. The CEI must receive all the documentation required for the review process and make it available to
p.(None): all its members, without prejudice to the fact that the responsibility of the
p.(None): preliminary review of each project and then submit it for discussion by all the members.
p.(None): 2.4.3. The IEC must establish specific quorum requirements for its review meetings, including the number
p.(None): minimum number of members to complete it and the distribution of professions and sex. The quorum must represent both sexes,
p.(None): both sectors - scientific and non-scientific - and at least one independent member of the study's host institution.
p.(None): 2.4.4. The CEI must prepare and keep updated a list of its members, indicating the name, age, sex,
p.(None): profession or occupation, position in the CEI and relationship with the institution.
p.(None): 2.4.5. The IRB must record its meetings, deliberations and decisions, including the members who
p.(None): they participated in them and the result of their voting.
p.(None): 2.4.6. The CEI may consult experts on specific topics, be they scientific, ethical or social, but without
p.(None): give you the right to decide on the project. The participation and opinion of experts must be documented.
p.(None): 2.4.7. A CEI member who is both a researcher or part of a project team should not participate in
p.(None): no evaluation, deliberation or decision about that project.
p.(None): 2.4.8. The RECs must take into consideration a request to challenge one or more of its members, presented by
p.(None): a researcher or other interested party prior to the review of a project, provided the reasons are
p.(None): adequately supported.
p.(None): 2.4.9. In clinical trials, the REC must require the investigator to immediately communicate all information on
p.(None): relevant safety and protocol changes that increase the risk to participants or that have been made
p.(None): to eliminate an immediate danger to them.
p.(None): 2.4.10. In low-risk observational studies, as defined in A4, or in the case of proposed changes
p.(None): administrative or that do not affect the safety of the participants of an already approved investigation, the president of the
p.(None): CEI or a member designated for this purpose can make an expedited evaluation of the proposal, determining if
p.(None): A full committee evaluation is required or not. Expedited evaluations should be documented and
p.(None): inform the rest of the members.
p.(None): 2.5. Application requirements
p.(None): 2.5.1. The request for ethical review of a research project must be submitted by the researcher
p.(None): qualified responsible for the ethical and scientific conduct of research.
p.(None): 2.5.2. The researcher must present, at least, the following documents:
p.(None): (a) application note indicating the title of the study and the financing available;
p.(None): (b) study protocol identified with version number and date;
...
Social / precarious housing
Searching for indicator precarious housing:
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p.(None): individuals for the condition being investigated; Y
p.(None): (d) the CEI has specialists or consults experts in those particular groups.
p.(None): Cultural, educational, social or economic vulnerability: participation in clinical trials of vulnerable populations
p.(None): for cultural, educational, social or economic reasons, such as ethnic minorities or people
p.(None): illiterate, subordinate, refugee, destitute or with unsatisfied basic needs, requires protection
p.(None): additional. As a guarantee that the potential values and interests of the potential participant were respected
p.(None): Vulnerable, consent must be obtained in the presence of a witness independent of the investigator and his
p.(None): equipment. As a guideline, observing one or more of the following indicators can be used to
p.(None): establish the need for this additional protection:
p.(None): (a) unemployment or informal or unstable work in the main breadwinner;
p.(None): (b) without housing or precarious housing (hotel or pension, tenancy, house taken or construction not intended for housing)
p.(None): or located in unfavorable areas (village or informal settlement);
p.(None): (c) without social security coverage (social work or prepaid);
p.(None): (d) illiteracy or incomplete primary study;
p.(None): (e) people originating from or belonging to an ethnic group whose primary language is not Spanish;
p.(None): (f) refugee or displaced status.
p.(None): When research is proposed in populations or communities with limited resources,
p.(None): researchers must ensure that research meets the health needs and priorities of the
p.(None): population or community and that any benefit generated from the research, be it a knowledge or a
p.(None): product will be reasonably available for the benefit of that population or community. If knowledge
p.(None): obtained from the research will be used primarily for the benefit of other groups that can assume the cost of
p.(None): Once the product is marketed, the research can be characterized as exploitative and unethical.
p.(None): Participation of women of reproductive age or pregnant. The possibility of becoming pregnant during the study does not
p.(None): by itself, should be used as a reason to exclude or limit the participation of women of age
p.(None): reproductive.
...
Economic / Economic/Poverty
Searching for indicator poor:
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p.(None): treatment, for example, leaving a sequel or causing the death of the patient. When it is not possible to fulfill it
p.(None): The provision of an alternative intervention or other appropriate benefit, approved by
p.(None): the CEI and for the period that it determines.
p.(None): A10. CLINICAL TRIALS OF CELL AND GENIC THERAPIES
p.(None): P20. Clinical trials of gene and cellular therapies must follow the principles that protect
p.(None): research participants, including: proper trial planning, fair selection,
p.(None): informed consent, strict medical control of the participants, review by a REC and a
p.(None): expert advice and supervision by a competent regulatory authority.
p.(None): Ethical justification for trials with cell and gene therapies. A therapeutic approach with cell therapies and
p.(None): Gene assays should aim to be clinically similar or superior to existing therapies. If there is already a therapy
p.(None): effective, the risks associated with cell or gene therapy
p.(None): they must be low and offer a potential advantage, for example a better functional result or be a
p.(None): single procedure versus prolonged drug treatment with associated adverse effects. If it doesn't exist yet
p.(None): a therapy, the severity of the disease could justify the risks of an experimental cell or gene therapy.
p.(None): In any case, every effort should be made to minimize the risks of possible associated adverse effects
p.(None): with the use of cells or genes and not taking advantage of the hopes of patients with a poor prognosis. In the
p.(None): gene therapies in particular, given their complexity, the risks could transcend the individual himself and affect the
p.(None): geneticXheritage of the human being. For all this, the suitability and moral integrity of the researchers and the
p.(None): Scientific validity of research must be carefully evaluated.
p.(None): Proper trial planning. The following guidelines should be considered when planning a clinical trial with
p.(None): cellular or gene therapies:
p.(None): (a) preclinical studies in animals and / or other models and previous clinical studies of the therapeutic proposal
p.(None): experimental should show convincing evidence of safety and potential therapeutic benefits for
p.(None): justify its use in humans;
p.(None): (b) the biological characteristics of the intervention and the production procedures must be clearly
p.(None): established. Whenever applicable, production must conform to Good Laboratory Practice, and be carried out
p.(None): under appropriate biosecurity conditions;
p.(None): (c) the proposed clinical trial should provide for a short, medium and, if applicable, long-term safety assessment
p.(None): deadline, with a timely and effective notification plan for adverse events;
p.(None): (d) experimental therapy should be compared with the best available treatment, if any;
p.(None): (e) the risks of experimental therapy should be identified and minimized, and the benefits
p.(None): potential therapeutics defined realistically;
p.(None): (f) evaluation and supervision of the trial requires a detailed protocol, with well defined objectives, standards
p.(None): manufacturing and laboratory and toxicology information; Y
p.(None): (g) experimental therapy, if approved, should be accessible to the local population through
p.(None): health services available.
...
General/Other / Dependent
Searching for indicator dependent:
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p.(None): CLINICS IN HUMAN BEINGS through Resolution 102/09 that has not yet been implemented but that is
p.(None): it is necessary to extend its coverage to all human health research.
p.(None): That the GENERAL DIRECTORATE OF LEGAL AFFAIRS has taken the intervention of its competence.
p.(None): That it acts in use of the powers granted by the Law of Ministries No. 26,338 (T.O. by Decree No. 438 of 12 of
p.(None): March 1992 and its amendments and supplements).
p.(None): Thus,
p.(None): THE MINISTER OF HEALTH RESOLVES:
p.(None): Article 1 - Approve the GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS, which as ANNEX I forms an integral part of the
p.(None): this Resolution and whose objective is to guide researchers, sponsors, members of ethics committees in
p.(None): research and regulatory and health authorities of the different jurisdictions in the development and evaluation
p.(None): appropriate research involving humans.
p.(None): Art. 2 - Create the NATIONAL REGISTRY OF HEALTH INVESTIGATIONS in order to systematize, consolidate and
p.(None): make information regarding human health research publicly available.
p.(None): Art. 3 ° - Both the GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS and the
p.(None): NATIONAL REGISTRY OF HEALTH INVESTIGATIONS will be mandatory for the Studies of
p.(None): Clinical Pharmacology for registration purposes in the scope of application of the NATIONAL ADMINISTRATION OF MEDICINES,
p.(None): FOOD AND MEDICAL TECHNOLOGY
p.(None): (ANMAT) and for all research financed with funds from the MINISTRY OF HEALTH and / or its organizations
p.(None): Decentralized dependents.
p.(None): Art. 4 - The NATIONAL HEALTH INVESTIGATION COMMISSION that works within the DEPUTY SECRETARIAT OF RELATIONS is empowered
p.(None): SANITARY AND INVESTIGATION dependent on the SECRETARY OF DETERMINANTS OF HEALTH AND SANITARY RELATIONS
p.(None): for
p.(None): update or modify the GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS when deemed necessary.
p.(None): Art. 5 - Appoint to the NATIONAL INVESTIGATION HEALTH COMMISSION of the UNDERSECRETARY OF SANITARY RELATIONS
p.(None): INVESTIGATION under the SECRETARY OF
p.(None): DETERMINANTS OF HEALTH AND SANITARY RELATIONS administrative body of the NATIONAL REGISTRY OF INVESTIGATIONS
p.(None): IN HEALTH, being empowered to design and implement it.
p.(None): Art. 6 - The Resolution of the MINISTRY OF HEALTH No. 1490 of November 14, 2007, which approved the GUIDE OF
p.(None): THE GOOD PRACTICES OF CLINICAL INVESTIGATION
p.(None): IN HUMAN BEINGS, which is replaced by the GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS approved by the
p.(None): Article 1 of this Resolution.
p.(None): Art. 7 - The Resolution of the MINISTRY OF HEALTH No. 102 of February 2, 2009, which created the REGISTRY OF
p.(None): CLINICAL TRIALS IN HUMAN BEINGS, which is replaced by the NATIONAL REGISTRY OF INVESTIGATIONS IN
p.(None): HEALTH created by Article 2 of this Resolution.
p.(None): Art. 8 ° - This resolution will come into effect on the NINETY (90) days of its publication in the
p.(None): Official bulletin.
p.(None): Art. 9 - Register, communicate, publish, give yourself to the National Directorate of the Official Registry and
p.(None): file away. - Juan L. Manzur.
p.(None): ANNEX I
p.(None): GUIDE FOR INVESTIGATIONS IN HUMAN HEALTH INDEX
p.(None): INTRODUCTION SCOPE
p.(None): SECTION A: ETHICAL ASPECTS
p.(None): A1. Ethical justification and scientific validity A2. Ethical and scientific evaluation
p.(None): A3. Informed consent
p.(None): A4. Benefits and risks of research A5. Selection of participants
p.(None): A6. Confidentiality of information A7. Conflict of interests
...
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
p.(None): Justice. This principle refers to the ethical obligation to treat each person equally, unless
p.(None): there are relevant differences that justify different treatment.
p.(None): Distributive justice requires that all benefits and burdens of research be distributed
p.(None): equitably between all groups and classes in society, especially if they are dependent or
p.(None): vulnerable. Studies must be planned so that the knowledge sought benefits the group
p.(None): represented by the participants. For example, the risks for vulnerable participants are more
p.(None): justified when they arise from interventions or procedures that offer a specific benefit for your health. In
p.(None): In sum, those who bear the burden of participation should receive an adequate benefit and the group that
p.(None): The beneficiary must assume an equitable proportion of the risks of the study.
p.(None): Respect for the communities. When a researcher plans or conducts research in cultural communities
p.(None): different from yours, you must respect the cultural and ethical values of the host community. An investigation
p.(None): that seeks to stimulate a change in customs or
p.(None): behaviors of a community with the aim of achieving healthier behaviors or a result that is expected to be beneficial for
p.(None): health is considered ethical and not harmful.
p.(None): In general, investigators or study sponsors should not be held responsible for
p.(None): unfair conditions of the place where it takes place, but they must guarantee that they will not carry out
p.(None): practices that could increase injustice or contribute to new inequalities. Investigations in
p.(None): Vulnerable communities must respond to their health needs and priorities, as a way to avoid their
p.(None): exploitation in favor of the most favored communities.
p.(None): Scientific validity. An investigation will be considered valid from the scientific point of view when the
...
p.(None): evaluate aspects of the health of a population, or test hypotheses about possible causes of disease or suspected
p.(None): risk factor's.
p.(None): Case-control study compares history of risk exposure among patients with a condition
p.(None): determined (cases) with the same history of exposure to that risk among the people who share with the cases
p.(None): characteristics such as age and sex, but they do not present said affection (controls). The difference between cases and
p.(None): Controls regarding the frequency of past risk exposure can be statistically analyzed
p.(None): to test hypotheses about causes or about risk factors.
p.(None): A cohort or longitudinal or prospective study identifies and observes during a given period a
p.(None): people with different levels of exposure to one or more risk factors, and the rates of occurrence of the
p.(None): condition or disease are compared in relation to exposure levels. This is one more research method
p.(None): solid than the other two cases but requires the analysis of a large number of people for a long time and is also
p.(None): expensive.
p.(None): An experimental epidemiological study is one in which the researcher selects the groups of
p.(None): individuals or populations with eligibility criteria, actively intervenes on the variable
p.(None): independent or predictive, and observes and analyzes the changes that occur in the dependent or outcome variable to
p.(None): consequence of the intervention. If two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis.
p.(None): CLINICAL PHARMACOLOGY STUDY: systematic scientific study carried out with drugs or products
p.(None): tests on voluntary individuals, healthy or sick, in order to discover or verify its effects
p.(None): therapeutic (efficacy) and / or identify adverse reactions (safety) and / or study the absorption, distribution,
p.(None): metabolism (biotransformation) and excretion of the active ingredients. Synonym: Clinical Pharmacology Trial.
p.(None): MULTICENTRIC STUDY: research conducted in more than one research institution or center but following a
p.(None): same protocol.
p.(None): ADVERSE EVENT (AE): any unfavorable medical occurrence in a participant of a clinical trial, associated
p.(None): temporarily with the experimental intervention even when a necessary causal relationship is not established. It includes
p.(None): any signs, abnormal laboratory findings, symptoms, or disease.
p.(None): SERIOUS ADVERSE EVENT (EAS): any unfavorable occurrence in the course and context of a
p.(None): research on a diagnostic or therapeutic product or procedure that results in death threatens the
p.(None): life, requires hospitalization or prolongation of existing hospitalization, results in disability or invalidity
p.(None): persistent or significant, is a congenital abnormality or birth defect or is medically significant according to a
p.(None): medical judgment. The foregoing applies without the presumable existence of a causal link between the
p.(None): application of the product or treatment and the adverse event.
p.(None): CONTROL GROUP: group that is used as a comparator and indicates what happens when the variable or the
p.(None): intervention to be studied.
p.(None): INSTITUTION OR RESEARCH CENTER: any public or private entity, agency or medical or dental facility
p.(None): where clinical studies are conducted.
p.(None): EXPERIMENTAL INVESTIGATION: investigation in which the investigator selects individuals with
p.(None): inclusion and exclusion criteria, actively intervenes on the independent or predictor variable, and observes
p.(None): and analyzes the changes that occur in the dependent or outcome variable as a result of the
p.(None): intervention. When two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis. Health interventions can be: synthetic medicines, products
p.(None): biological or biotechnological, medical devices, surgical techniques, etc. Synonym: Clinical trial.
p.(None): OBSERVATIONAL INVESTIGATION: investigation in which the independent or predictive variable is not intervened
p.(None): and only the possible relationships with the dependent or outcome variable are observed. The selection of
p.(None): Participants are not made by the researcher, but by nature: healthy or sick, with or without a risk factor; user or not
p.(None): user of a service or health program, etc. Two subtypes of observational research are recognized:
p.(None): Descriptive or exploratory research: quantitative or qualitative description of facts or phenomena
p.(None): observed, without posing a hypothesis. Examples: prevalence studies, cross-sectional, demographic,
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
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General/Other / Diminished Autonomy
Searching for indicator diminished:
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p.(None): homework training.
p.(None): Basic ethical principles: Health research on human beings must comply with the three principles
p.(None): basic ethics: respect for people, charity and justice.
p.(None): Respect for people. This principle implies that people who are autonomous or capable of deliberating about their
p.(None): decisions are respected in their capacity for self-determination, free of undue incentives and influence, and
p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
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General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): medical, a professional could modify a conventional treatment to produce a better result for a patient;
p.(None): however, this individual variation does not produce generalizable knowledge; therefore, such activity is related
p.(None): with practice and not with research. In the same way, observational studies carried out by or in
p.(None): compliance with health authorities, such as outbreak or infection surveillance
p.(None): in-hospital, records of disease or adverse drug effects or impact assessment
p.(None): of a health program, they should be seen as an epidemiological or health practice and not as research.
p.(None): The need to establish mechanisms of guidance, regulation and control over a given activity arises from the risk
p.(None): specific to cause harm to the individuals targeted by the activity. For the same reason, those mechanisms
p.(None): they must correspond to the level of risk derived. First, the ethics guidelines for biomedical research
p.(None): They were designed to guide researchers to plan studies in such a way that the
p.(None): consideration for the welfare and rights of the participants is the primary value, above the interest
p.(None): for science or any other interest. From these ethical guidelines emerged, first, the requirement of
p.(None): informed consent of the person prior to their participation, as proof of respect for their autonomy and,
p.(None): second, the requirement of ethical evaluation of projects by a research ethics committee (CEI), such as
p.(None): instance of guarantee of the adherence of the researchers to such guidelines. The multidisciplinary nature and
p.(None): multi-sectoral ERC highlights that the interpretation and application of ethical principles cannot be
p.(None): neither rigid nor dogmatic, if not they must be the result of a consensus between the different actors of the
p.(None): research with their respective approaches.
p.(None): Subsequently, the drug regulatory authorities established regulations for the testing of products
p.(None): Pharmaceuticals under development, prior to commercial registration. This set of ethical requirements and
p.(None): administrative, known as “Good Clinical Practice”, is used as the basis for inspections that
p.(None): regulatory agencies conduct to verify the protection of the rights and welfare of participants, and the
p.(None): quality and veracity of the data generated to support the registration request. In addition to these requirements, more
p.(None): late, the recommendation of the World Health Organization to implement a registration system for
p.(None): health research and accreditation and supervision of the RECs.
p.(None): Considering the risk probabilities of health research, it is possible to establish, first of all, that the
p.(None): research that is not done on humans, or that uses
p.(None): data already available and in the public domain, or that is made with data or biological samples stored in services
...
p.(None): for the evaluation of projects.
p.(None): A1. ETHICAL JUSTIFICATION AND SCIENTIFIC VALIDITY
p.(None): P1. For human health research to be ethically justified, it must
p.(None): provide new and scientifically valid knowledge that is not feasible to obtain without participation
p.(None): from them.
p.(None): P2. All research in human health must be based on current scientific knowledge and be based on
p.(None): a comprehensive review of the specialized literature. Investigating a new intervention
p.(None): on human health must be based on appropriate prior laboratory, preclinical and
p.(None): clinical and justified by its preventive, diagnostic or therapeutic value.
p.(None): P3. Human health research must be conducted by researchers who have the appropriate training and
p.(None): homework training.
p.(None): Basic ethical principles: Health research on human beings must comply with the three principles
p.(None): basic ethics: respect for people, charity and justice.
p.(None): Respect for people. This principle implies that people who are autonomous or capable of deliberating about their
p.(None): decisions are respected in their capacity for self-determination, free of undue incentives and influence, and
p.(None): coercion, and that persons absolutely or relatively incapable of giving consent receive protections
p.(None): additional specials.
p.(None): Autonomy is the capacity for self-determination of a person to make a decision voluntarily, in
p.(None): based solely on your own values, interests and preferences, and provided you have the information
p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
p.(None): Justice. This principle refers to the ethical obligation to treat each person equally, unless
p.(None): there are relevant differences that justify different treatment.
p.(None): Distributive justice requires that all benefits and burdens of research be distributed
p.(None): equitably between all groups and classes in society, especially if they are dependent or
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p.(None): 4.8.3. The documents considered essential to the trial are the following:
p.(None): (a) protocol approved by the CEI;
p.(None): (b) informed consent approved by the CEI;
p.(None): (c) recruitment mechanism approved by the CEI, if any;
p.(None): (d) approval note of the study by the CEI, indicating the approved documents: protocol and version, consent
p.(None): informed and version, recruitment mechanism, etc .;
p.(None): (e) authorization note from the highest authority of the institution hosting the study;
p.(None): (f) dated list of members and positions of the CEI;
p.(None): (g) the delegation of functions of the researcher to his team;
p.(None): (h) vital resumes of the researcher and his team;
p.(None): (i) amendments to the protocol approved by the CEI, if any;
p.(None): (j) amendments to informed consent approved by the CEI, if any;
p.(None): (k) CEI approval notes for protocol amendments and consent, if any;
p.(None): (l) notifications to the CEI of serious and unexpected reactions to the study interventions or other information from
p.(None): security;
p.(None): (m) periodic and final reports presented to the CEI;
p.(None): (n) participant identification list;
p.(None): (o) research product accounting forms, if applicable;
p.(None): (p) signed informed consents;
p.(None): (q) primary data documents, such as medical records, laboratory and pharmacy records, journals of
p.(None): participants, reports of images and the images themselves, etc .;
p.(None): (r) documentation of the processing of the data obtained.
p.(None): GLOSSARY
p.(None): AUTONOMY: capacity of self-determination of a person to make a decision freely and
p.(None): voluntary, according to their own values, interests and preferences, and provided they have the necessary information to
p.(None): evaluate all options.
p.(None): GOOD PRACTICE OF CLINICAL INVESTIGATION (BPIC): set of procedural requirements for the
p.(None): design, conduct, record, analyze, monitor, audit, and report clinical trials conducted to
p.(None): support the registration of pharmaceutical products for human use, in order to ensure that the
p.(None): rights and integrity of the participants and that the data and results obtained are reliable and accurate.
p.(None): GOOD MANUFACTURING PRACTICE (GMP): standard to guarantee a uniform production that satisfies requirements
p.(None): of identity, activity and purity of the products.
p.(None): GOOD LABORATORY PRACTICE (GLP): organization and laboratory tasks standard under which the
p.(None): Studies are planned, carried out, recorded, controlled and presented.
p.(None): COMMITTEE ON ETHICS IN INVESTIGATION (CEI): organization acting within its sphere of competence, independent
p.(None): of the sponsor and the researcher, made up of medical or scientific professionals and non-medical or non-medical members
p.(None): scientific and whose function is to provide a public guarantee of the protection of rights, dignity,
p.(None): safety and well-being of study participants, through, inter alia, protocol review
p.(None): of the study, the informed consent process and the suitability of the researcher.
p.(None): CONFLICT OF INTEREST: a conflict of interest is considered as a primary interest, such as the
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General/Other / Incapacitated
Searching for indicator incapacitated:
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p.(None): necessary to evaluate options. An autonomous person, by definition, can give consent
p.(None): informed without the need for any protection other than receiving the information they need to deliberate
p.(None): freely. On the other hand, those individuals who have diminished or non-existent autonomy are in
p.(None): a vulnerable situation to defend their own interests and therefore require special protections. A
p.(None): autonomy is considered diminished in cases of cultural, educational, social or economic disadvantage, for example,
p.(None): Ethnic minorities or illiterate, subordinate, refugee, destitute or people with unsatisfied basic needs.
p.(None): In clinical trials, an additional protection for them is the participation of a witness
p.(None): independent during the consent process to guarantee respect for your rights and interests. The absence
p.(None): of autonomy occurs when an individual is legally or mentally incapacitated to give voluntary consent,
p.(None): just as it happens in minors and in those who have a transitory or permanent mental disorder. In such
p.(None): cases, consent must be obtained from a legally recognized representative of the potential participant, provided
p.(None): respecting the will of the latter, to the extent that his ability allows.
p.(None): Charity. This principle refers to the ethical requirement to achieve the maximum possible benefits and to reduce
p.(None): the probability of damage to a minimum. This implies that the risks of an investigation must be reasonable compared to the
p.(None): expected benefits, that the research is well designed and that the researchers are competent to carry it out
p.(None): out, guaranteeing the well-being of those who participate in it. Another principle follows from this principle: that of "no
p.(None): maleficence ”, which protects study participants from preventable harm.
p.(None): Justice. This principle refers to the ethical obligation to treat each person equally, unless
p.(None): there are relevant differences that justify different treatment.
p.(None): Distributive justice requires that all benefits and burdens of research be distributed
p.(None): equitably between all groups and classes in society, especially if they are dependent or
p.(None): vulnerable. Studies must be planned so that the knowledge sought benefits the group
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Searching for indicator incapacity:
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p.(None): by the participant's regular health funder, as long as these treatments and procedures are
p.(None): fit into the current medical practice for the disease under study and that the cost thereof is not found
p.(None): included in the subsidy or funding received for the research.
p.(None): TO 5. SELECTION OF PARTICIPANTS
p.(None): P12. Participants should be selected based on the objectives and design of the
p.(None): research, and most likely to minimize risks and maximize benefits at the individual level.
p.(None): All individuals and / or groups in a society should have equal access to the possibility of
p.(None): benefit from scientifically valid research, regardless of their cultural or educational situation,
p.(None): social or economic, unless there is a properly justified scientific or security reason. Fair selection.
p.(None): Although the scientific objective of the research is the main criterion for the selection of the participants,
p.(None): the principles that hold that equals should be treated in the same way and that the benefits
p.(None): and the burdens generated by social cooperation, such as research, must be equitably distributed
p.(None): Among the groups involved, they should have similar consideration in the ethical evaluation. This does not
p.(None): means that individuals
p.(None): or selected groups should benefit directly from any research project or that people
p.(None): marginalized, stigmatized or socioeconomically disadvantaged should never be included.
p.(None): Vulnerable population. Group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that due to a social, cultural, educational or economic condition
p.(None): unfavorable is liable to be influenced by the expectation of receiving a benefit for participating in the
p.(None): investigation (undue incentive) or to be the victim of a threat by investigators or others in a
p.(None): situation of power if they refused to participate (coercion).
p.(None): An investigation of a vulnerable population could involve an unequal distribution of its burdens and benefits,
p.(None): therefore, researchers must guarantee the CEI that:
p.(None): (a) the research could not be equally well conducted with less vulnerable people;
p.(None): (b) the research tries to obtain knowledge that will lead to better disease care or
p.(None): other characteristic or own health problems of the vulnerable group;
p.(None): (c) Study participants and other members of the vulnerable group will have reasonable access to products that
p.(None): become available as a result of the investigation;
p.(None): (d) the risks associated with interventions or procedures without direct benefit to the health of the participants not
p.(None): outnumber those associated with routine medical or psychological examinations of such persons, unless CEI authorizes
...
p.(None): safely and will produce reliable knowledge.
p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): This section describes a series of operational requirements for obtaining informed consent, the evaluation
p.(None): ethics and science of research projects, the supervision of research ethics committees and
p.(None): planning and conducting clinical trials. Compliance with these requirements will demonstrate that
p.(None): the ethical recommendations of Section A were respected.
p.(None): B1. THE INFORMED CONSENT
p.(None): 1.1. Informed consent requirement and exceptions
p.(None): 1.1.1. Informed consent is the process that ensures that a potential participant or their
p.(None): Legal representative voluntarily make the decision to participate, free of undue incentive and coercion
p.(None): in an investigation, provided that it is consistent with their values, interests and preferences. The process of
p.(None): Consent must be conducted by the principal investigator or a member of the professional team of the
p.(None): health or related, for example, nurse, social worker or psychologist, trained for this role. In cases where
p.(None): If a treatment is being investigated, only a doctor or dentist, when appropriate, can provide the information with
p.(None): regarding patient treatment.
p.(None): 1.1.2. In case of legal incompetence or mental incapacity of the potential participant to give consent
p.(None): Voluntary, it must be obtained from the legal representative. To the extent that your understanding allows, you should
p.(None): request the consent of the potential participant, after informing them about the study. Your decision to
p.(None): participate or should not be respected
p.(None): 1.1.3. In clinical trials, when the potential participant is socially vulnerable,
p.(None): cultural, educational or economic, a witness must participate in the informed consent process
p.(None): independent of the researcher or his team, who must sign and date the consent form as
p.(None): proof of your participation.
p.(None): 1.1.4. In medical emergency situations that require immediate intervention, a summary may be used,
p.(None): approved by the CEI, of the written information for the participant. Oral information must be provided in
p.(None): presence of an independent witness, who must sign, together with the investigator, the summary of information and the
p.(None): consent form. The
p.(None): Participant or their representative must sign the consent form and then receive an original thereof and
p.(None): a copy of the summary of information.
p.(None): 1.1.5. In observational studies, it is common to obtain informed consent from potential
...
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
p.(None): a potential participant who is incapable or incompetent to grant the informed consent of a
p.(None): investigation.
p.(None): INDEPENDENT WITNESS: person independent of the researcher and his team who participates in the process of
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General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): in an investigation, provided that it is consistent with their values, interests and preferences. The process of
p.(None): Consent must be conducted by the principal investigator or a member of the professional team of the
p.(None): health or related, for example, nurse, social worker or psychologist, trained for this role. In cases where
p.(None): If a treatment is being investigated, only a doctor or dentist, when appropriate, can provide the information with
p.(None): regarding patient treatment.
p.(None): 1.1.2. In case of legal incompetence or mental incapacity of the potential participant to give consent
p.(None): Voluntary, it must be obtained from the legal representative. To the extent that your understanding allows, you should
p.(None): request the consent of the potential participant, after informing them about the study. Your decision to
p.(None): participate or should not be respected
p.(None): 1.1.3. In clinical trials, when the potential participant is socially vulnerable,
p.(None): cultural, educational or economic, a witness must participate in the informed consent process
p.(None): independent of the researcher or his team, who must sign and date the consent form as
p.(None): proof of your participation.
p.(None): 1.1.4. In medical emergency situations that require immediate intervention, a summary may be used,
p.(None): approved by the CEI, of the written information for the participant. Oral information must be provided in
p.(None): presence of an independent witness, who must sign, together with the investigator, the summary of information and the
p.(None): consent form. The
p.(None): Participant or their representative must sign the consent form and then receive an original thereof and
p.(None): a copy of the summary of information.
p.(None): 1.1.5. In observational studies, it is common to obtain informed consent from potential
p.(None): However, the CEI could approve the following exceptions:
p.(None): (a) when publicly available information is used. In such cases, investigators must demonstrate that they do not
p.(None): there is a risk of disclosure of personal data;
p.(None): (b) when obtaining consent is impracticable, as in the case of biological data or samples
p.(None): irreversibly dissociated, or retrospective cohort studies conducted on medical records. In
p.(None): In the latter case, investigators must guarantee strict measures to protect the confidentiality of
p.(None): information owners, for example, irreversible decoupling of health data in health records
p.(None): research regarding personal identification data; Y
p.(None): (c) when obtaining consent frustrates the objective of a study of habits or behavior with
p.(None): regarding the health of communities or groups. By being informed, participants would modify the
...
p.(None): (q) the contact details of the CEI that has approved the investigation;
p.(None): (r) what are the research sponsors or funding sources, the institutional affiliation of the
p.(None): researcher and other potential conflicts of interest; Y
p.(None): (s) the contact details of the researcher and the REC that approved the study.
p.(None): 1.3.2. In clinical trials, the following specific information should be added:
p.(None): (a) the approximate number of participants that are planned to be incorporated;
p.(None): (b) a detail of the actual or potential benefits and risks of research interventions and
p.(None): alternatives available in case of not participating in it;
p.(None): (c) an explanation about the characteristics of the design and its implications, for example, that randomness and
p.(None): masking are applied to avoid influences on the result and that, as a result of masking, not
p.(None): you will be informed of the assigned treatment until the study is completed;
p.(None): (d) proof that trial interventions and procedures will be free to participants;
p.(None): (e) proof that medical care will be provided at no cost to the participant in the event of related damage
p.(None): with the trial and the nature and duration of this care;
p.(None): (f) if the participant or their relatives will have compensation in case of disability or death as a result of
p.(None): these damages and through what mechanism will be effective;
p.(None): (g) if at the end of the research the participant will have access to the intervention that is most beneficial to
p.(None): from the trial or other appropriate intervention or appropriate benefit, and when and how they will be available; Y
p.(None): (h) the contact details of the investigator and the emergency service where they will be attended in the event of an adverse event
p.(None): related to research.
p.(None): 1.3.3. In the event that the study includes obtaining biological samples, the potential participant or their
p.(None): Representative must receive the following additional information:
p.(None): (a) the possible uses, direct or secondary, of biological samples obtained in the study;
p.(None): (b) the fate of the biological samples at the end of the study, for example, their destruction or storage for
p.(None): future uses. In the latter case, the possible future uses should be specified and where, how and why
p.(None): how long the samples will be stored, and that the participant has the right to decide on those future uses, to
p.(None): destroy the material and refuse storage;
p.(None): (c) a statement that the samples or derived data will not be marketed;
p.(None): (d) if commercial products could be developed from the biological samples and if it is planned to offer the
p.(None): participant monetary or other benefits for that development; Y
p.(None): (e) in the case of genetic research, that the participant has the right to decide whether or not to be informed of the
p.(None): results of their studies, as long as they have clinical relevance and there is a course of action to modify
p.(None): the evolution. If you were informed of the results, where and how will you have specialized counseling.
p.(None): B2. THE ETHICS COMMITTEE IN INVESTIGATION
p.(None): 2.1. Assessment requirement and exceptions
p.(None): 2.1.1. A human health research project must be submitted to the evaluation, guidance and approval of a Committee of
p.(None): Research Ethics (CEI) independent of the researcher and the sponsor, before its start and during its
p.(None): development.
...
p.(None): 2.6. The review process
p.(None): 2.6.1. The CEI's main task is the review of research projects and supporting documents. For the
p.(None): review, RECs must take into account applicable laws and regulations, and
p.(None): take into account the scientific aspects, the proposed recruitment mechanism, the consent process
p.(None): informed and protecting the participants and the communities involved, during and after the research.
p.(None): 2.6.2. The scientific evaluation of the study must consider, at least, the following:
p.(None): (a) the adequacy of the chosen design to the objectives, the statistical methodology and the potential to achieve
p.(None): solid conclusions from the study and to provide a benefit to society;
p.(None): (b) the adequacy of the proposed control or comparator, if any;
p.(None): (c) the balance between the risks and drawbacks and the potential and actual benefits for participants and
p.(None): communities involved in the study;
p.(None): (d) justification for the inclusion or exclusion of concomitant treatments;
p.(None): (e) characteristics of the population to study, including sex, age, ethnicity, education and socio-economic level, among
p.(None): others;
p.(None): (f) specific inclusion and exclusion criteria of the participants;
p.(None): (g) the criteria for the premature withdrawal of research participants;
p.(None): (h) the criteria for suspending or prematurely ending the investigation;
p.(None): (i) the adequacy of the research center; including equipment, facilities and, in the case of tests
p.(None): clinicians, access to emergency care;
p.(None): (j) the way in which they will communicate and publish the results of the investigation.
p.(None): 2.6.3. Regarding the informed consent process, the CEI must consider the following:
p.(None): (a) the process envisaged for obtaining informed consent;
p.(None): (b) relevance, clarity and precision of the study information to be provided to potential participants or,
p.(None): when appropriate, their representatives;
p.(None): (c) guarantee that the participants or their representatives will receive information on the progress of the study and its
p.(None): results, and that they may ask or make complaints during it.
p.(None): 2.6.4. The CEI must review and approve the following precautions for the care and protection of the participants of the
p.(None): investigation:
p.(None): (a) the qualification, suitability and experience of the investigator to conduct the investigation;
p.(None): (b) the medical care to be provided to participants;
p.(None): (c) measures to minimize the risks of the investigation;
p.(None): (d) the procedures for participants who decide to withdraw from the research;
p.(None): (e) the guarantee of access to study treatment when the investigation is concluded;
p.(None): (f) free participation in research;
p.(None): (g) the expected remuneration for per diem or loss of earnings for the participants;
p.(None): (h) the measures for treatment and guarantee of compensation in case of damage attributable to participation in the
p.(None): investigation;
p.(None): (i) roles of the people who will have access to the data of the participants and the measures that will be taken to
...
p.(None): and supplies to use for the clinical trial.
p.(None): 4.2.7. The planned recruitment mechanism must be approved by the CEI, including notices in any means of
p.(None): communication. Notices should not implicitly or explicitly state that the investigational product is effective or
p.(None): safe or equivalent or better than other existing products.
p.(None): 4.2.8. It is recommended that the researcher implement a quality control process during obtaining and registering
p.(None): data in order to ensure that it is conducted and documented according to the protocol and that the data is processed
p.(None): correctly and are reliable.
p.(None): 4.3. The trial protocol
p.(None): 4.3.1. The protocol is the document that describes the background, justification, objectives, design, analysis
p.(None): statistics, measurement procedures, interventions, and ethical and administrative considerations of a study.
p.(None): This Guide describes the minimum structure and information that a clinical trial protocol should contain.
p.(None): 4.3.2. General information, background and justification.
p.(None): (a) full study title and protocol version;
p.(None): (b) identification of researchers and research centers;
p.(None): (c) sources of financing;
p.(None): (d) summary of the protocol;
p.(None): (e) description of the problem to be investigated and current state of knowledge;
p.(None): (f) purpose and relevance of the proposed investigation.
p.(None): 4.3.3. Methodological aspects
p.(None): (a) description of the general and specific objectives of the trial, the hypotheses or research questions, their
p.(None): assumptions and their variables;
p.(None): (b) study design and justification for their choice;
p.(None): (c) randomization and masking mechanisms, including procedures for opening the masking
p.(None): in case of emergency, if applicable;
p.(None): (d) expected number of participants, including calculations on the power of the test;
p.(None): (e) inclusion and exclusion criteria of participants, including diagnostic criteria;
p.(None): (f) withdrawal criteria of the participants;
p.(None): (g) description of the statistical tests and computer tools to be used;
p.(None): (h) efficacy parameters to be measured, including instruments and measurement methods;
p.(None): (i) efficacy criteria;
p.(None): (j) criteria for the analysis of security information;
p.(None): (k) criteria for handling missing, excluded and spurious data;
p.(None): (l) criteria for inclusion or exclusion of participants in the analysis;
p.(None): (m) criteria for cancellation of the trial.
p.(None): 4.3.4. Study interventions
p.(None): (a) description of research interventions;
p.(None): (b) in drug trials, indicate dose, frequency, route of administration and duration of treatment.
p.(None): and security monitoring;
p.(None): (c) in tests of biological or biotechnological products, the identification and valuation methodology that
p.(None): ensure uniformity of the preparation to be studied;
p.(None): (d) drugs allowed and not allowed;
p.(None): (e) delivery and / or administration mechanisms of the experimental intervention. The protocol should specify the
p.(None): procedures to be followed for its handling, storage and inventory, including its delivery and return of
p.(None): participants and their final disposition.
p.(None): (f) criteria for suspension of treatment;
p.(None): (g) planned rescue treatments and follow-up in the event of failure or adverse events;
p.(None): 4.3.5. Ethical aspects
p.(None): (a) specification that the research will be reviewed by a REC;
p.(None): (b) procedures for obtaining informed consent;
...
p.(None): host institution or the authority designated by it.
p.(None): 4.5.3. The investigator should inform the CEI of serious and unexpected adverse reactions to the intervention of the
p.(None): study and any other events that significantly affect the trial and / or the risk for the participants.
p.(None): 4.5.4. The investigator must inform the CEI about the progress of the trial with a minimum annual frequency. The report
p.(None): newspaper must contain, as a minimum, the number of participants incorporated, in follow-up and retired, list
p.(None): code of participants, serious adverse events and their assumed relationship with the study intervention
p.(None): and the deviations to the protocol relevant to the safety of the participants observed during the period.
p.(None): 4.6. Study interventions
p.(None): 4.6.1. In tests with products not defined or governed by Good Laboratory Practice or Good Practice of
p.(None): Manufacturing, for example, products of biological origin, the guidelines for
p.(None): development and control and the procedures for its use.
p.(None): 4.6.2. The investigator must manage, indicate and / or administer the experimental intervention in the established manner
p.(None): in the protocol. The researcher or his delegate must instruct each participant on the correct use
p.(None): of the product / s under investigation, make sure that you have understood it and then verify at each clinical visit that
p.(None): you have followed the instructions.
p.(None): 4.6.3. If the study uses a masking method, the protocol should specify a procedure for
p.(None): decoding for emergency situations.
p.(None): 4.6.4. In the event that the researcher supplies and / or administers the experimental intervention, he must take
p.(None): a record of their delivery and / or administration to the participants, in order to
p.(None): demonstrate compliance with the protocol.
p.(None): 4.7. Registration of clinical data
p.(None): 4.7.1. The protocol should describe the procedures designed for obtaining and recording clinical data on
p.(None): the participants, as well as the method of encoding the data to preserve its confidentiality.
p.(None): 4.7.2. The researcher must respect the veracity, legibility, consistency and timeliness of the data records.
p.(None): of the study both in the medical records and in the clinical data registration forms that
p.(None): The confidentiality of the information of the participants is used, as well.
p.(None): 4.7.3. If automated devices are used to carry out study measurements, such as
p.(None): electrocardiograms and spirometry, a printed source document must be obtained and filed in the medical history
p.(None): identifiable of the procedure performed.
p.(None): 4.8. Essential essay documents
p.(None): 4.8.1. The investigator should keep the trial documents in a safe place, locked and with access
p.(None): restricted to authorized personnel.
p.(None): 4.8.2. The essential documents of the trial should be kept for ten years from its completion, taking
p.(None): the necessary measures to prevent the loss or accidental destruction of the same.
p.(None): 4.8.3. The documents considered essential to the trial are the following:
p.(None): (a) protocol approved by the CEI;
p.(None): (b) informed consent approved by the CEI;
p.(None): (c) recruitment mechanism approved by the CEI, if any;
...
General/Other / Relationship to Authority
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p.(None): Subsequently, the drug regulatory authorities established regulations for the testing of products
p.(None): Pharmaceuticals under development, prior to commercial registration. This set of ethical requirements and
p.(None): administrative, known as “Good Clinical Practice”, is used as the basis for inspections that
p.(None): regulatory agencies conduct to verify the protection of the rights and welfare of participants, and the
p.(None): quality and veracity of the data generated to support the registration request. In addition to these requirements, more
p.(None): late, the recommendation of the World Health Organization to implement a registration system for
p.(None): health research and accreditation and supervision of the RECs.
p.(None): Considering the risk probabilities of health research, it is possible to establish, first of all, that the
p.(None): research that is not done on humans, or that uses
p.(None): data already available and in the public domain, or that is made with data or biological samples stored in services
p.(None): of health in such a way that the identity of the holders cannot be determined, they do not represent any risk and
p.(None): require no control mechanism.
p.(None): Second, observational investigations that include surveys or interviews or procedures
p.(None): routine diagnoses or are limited to analysis of biological samples or data linked to people and
p.(None): epidemiological or clinical experimental investigations carried out with products or procedures already registered
p.(None): by the regulatory authority, require obtaining the informed consent of the participants and the
p.(None): initial and periodic evaluation by a CEI. Within this group, observational studies considered low
p.(None): risk, that is, those who present the same risk as routine medical practice, may receive
p.(None): an expedited initial evaluation and do not require periodic review.
p.(None): Third, clinical pharmacology studies for the purpose of registering or regulating a product require,
p.(None): in addition to the mechanisms described above, the authorization of the National Administration of Medicines,
p.(None): Food and Medical Technology (ANMAT) nationwide. For their part, each health jurisdiction has
p.(None): competence to establish a local regulatory and oversight body for this type of investigation.
p.(None): Finally, it must be recognized that the content of this Guide will not solve all the ethical problems that may arise.
p.(None): of health research. Some situations will require a thorough analysis and informed opinion from
p.(None): researchers, members of ethics committees, health professionals, authorities and representatives of the
p.(None): community.
p.(None): Sanctions. The Research Ethics Committees have the authority not to approve, suspend or definitively cancel
p.(None): an investigation that does not meet ethical standards, and must inform the authorities of the institution
p.(None): or health on any serious or persistent ethical breach in the development of investigations
p.(None): previously approved. Failure to submit a research protocol to the evaluation of a REC is considered serious
p.(None): violation of ethical standards.
p.(None): Health authorities, the institution or professional associations must sanction researchers who
p.(None): do not adhere to ethical requirements, through fines or suspension of research grants.
p.(None): ANMAT, in case of breach of ethical precepts and in its scope, can:
p.(None): (a) object to or reject a clinical pharmacology study project or an investigator or research center
p.(None): proposed;
p.(None): (b) suspend or cancel a clinical pharmacology study during its execution, and apply sanctions
p.(None): administrative or financial that correspond;
p.(None): (c) reject data submitted in support of a marketing registration application.
p.(None): The sanctions of the health authorities of the jurisdictions and of ANMAT can apply both to the researcher and
p.(None): to the research host institution and, if applicable, also to the sponsor in the case of
p.(None): clinical pharmacology for registration purposes.
p.(None): Editors of scientific journals should not publish results of studies carried out without respecting the rules
p.(None): ethics and subsequently disavow those articles in which falsified data has been verified or that have been
p.(None): based on unethical research.
p.(None): SECTION A: ETHICAL ASPECTS
p.(None): This section presents ethical guidelines for human health research aimed at guiding
...
p.(None): Humans must be clearly and comprehensively detailed in a study protocol.
p.(None): P5. The study protocol and information intended for potential participants should be submitted to
p.(None): evaluation and approval of a research ethics committee (CEI) before starting the study. The CEI
p.(None): It must be independent of sponsors and researchers. The researcher must inform the CEI
p.(None): periodically about the progress of the study and, immediately, the findings or events
p.(None): relevant that imply unforeseen risks for the research participants. The proposed changes
p.(None): in the study and that may affect the safety of the participants or their decision to continue participating must be
p.(None): evaluated and approved by the CEI before its implementation.
p.(None): Scope. The requirement that human health research projects undergo an ethical review applies
p.(None): independently of the origin of the project: academic-scientific, government, health care, commercial or
p.(None): others. Researchers must recognize the need for this evaluation.
p.(None): Exceptions. The following cases do not require review by a CEI:
p.(None): (a) when human beings do not participate in the investigation or when public information is used, provided that
p.(None): individuals are not identified in any way. For example, the studies of Drug-economy;
p.(None): (b) when the intervention is limited to the study of health systems, official public health programs or the
p.(None): public health surveillance, provided that there is no possibility of identifying individuals. The
p.(None): Public health surveillance includes official records or records conducted in accordance with authority
p.(None): health of diseases and adverse effects of medicines already registered by the competent regulatory authority.
p.(None): It can sometimes be difficult to distinguish whether a specific project is for research or for evaluation of a
p.(None): health program or a health service. The defining characteristic of research is that its purpose
p.(None): is to produce new and generalizable knowledge, on the other hand, an evaluation only seeks to know and describe
p.(None): a characteristic or diagnosis relevant only to a person, group of them or a specific program.
p.(None): The evaluation of an official health program or health service, carried out by the operators themselves
p.(None): program or institution staff should be considered a necessary action to ensure effectiveness
p.(None): and security of a facility or procedure, always under the perspective of benefiting people. The same
p.(None): justification applies to the surveillance of epidemiological events or side effects of drugs or other
p.(None): products for human use. But if the exam was done for research purposes or if it was not clear
p.(None): the scope, the project must be submitted to the CEI for evaluation and definition.
p.(None): Institutional or central committees. By virtue of the responsibility to monitor the protection of the participants, it is
p.(None): It is advisable that the RECs work in the institutions where the investigations are carried out or at the level of
p.(None): jurisdictional authority. This does not prevent other entities such as medical colleges or associations
p.(None): professionals can form a CEI in their respective fields.
p.(None): In the event that an institution does not have a CEI or that it does not meet the requirements established in this Guide,
p.(None): Your research projects should be evaluated by a CEI that belongs to another institution or to the central level
p.(None): of the jurisdiction.
p.(None): Scientific and ethical evaluation. The main purposes of the evaluation are: to protect people
p.(None): against risks of damage or prejudice and facilitate the performance of studies beneficial to society. The aspects
p.(None): Scientific and ethical are closely related: it is unethical to carry out a study that does not have scientific solidity
p.(None): exposing participants to risks or discomfort without achieving any benefit. RECs may require advice
p.(None): scientist from a qualified expert or board, but they must make their own decision about the scientific validity of the
p.(None): study based on those queries. After establishing the scientific validity, it should be evaluated whether the benefits
p.(None): Anticipated risks justify the known risks to participants, if the risks have been minimized and the benefits
p.(None): have maximized whether the selection procedures will be equitable and whether the procedure for obtaining
p.(None): consent is appropriate.
p.(None): Scientific evaluation also involves considering the social value of research, that is, ensuring that its
p.(None): results will lead to an improvement in the health or well-being of society, even when knowledge is not
p.(None): immediate application. It is unethical to subject people to the risk of an investigation if it will not offer any
...
p.(None): protect your confidentiality.
p.(None): (c) when the study uses health records established or officially recognized by the authorities
p.(None): health, for example, records of diseases or therapeutic or adverse effects or genetic data,
p.(None): as long as the registered data is not linked to people. These records are an important source
p.(None): Information for public health activities such as disease prevention and resource allocation.
p.(None): Exceptions to specific requirements of the consent process. The IEC could exempt a requirement from the
p.(None): Obtaining consent in the following situations:
p.(None): (a) when the advance of consent could invalidate the results of the investigation, for example, when
p.(None): study the behavior of a human group. Upon being warned, the subjects could modify their habitual behaviors
p.(None): Or it could cause unnecessary concern. Investigators must justify to the CEI the exception and
p.(None): commit to obtaining the consent of the participants before disseminating the results of the study;
p.(None): (b) in experimental epidemiological investigations in which the intervention is directed at a group of people or
p.(None): to a community, such as students in a school or all residents of a defined area, for example, when
p.(None): study an immunization or education strategy or the fluoridation of water to avoid cavities, consent
p.(None): It can be obtained from a representative of the community or the corresponding authority, who must assess whether the
p.(None): Expected benefits of the study intervention for the group or community outweigh its risks. Additionally,
p.(None): individuals should be informed about the research and have the opportunity, to the extent possible, to
p.(None): reject your participation;
p.(None): (c) in clinical trials on situations requiring immediate medical intervention, the CEI may approve the use
p.(None): of an abridged version containing essential information about the study for the potential participant or their
p.(None): representative. In such case, the information must be provided in the presence of an independent witness, who
p.(None): You must sign the consent form together with the researcher and the participant or their representative.
p.(None): An investigator who proposes an exception to obtaining consent or to any of the process requirements
p.(None): You must justify to the IRB the reason for the request and explain how the rights of the
p.(None): participants. The researcher should not proceed with the investigation without the specific approval of the CEI
p.(None): for such exception.
p.(None): Inability to grant consent. In the case of people who cannot grant consent
p.(None): voluntary for physical, mental or legal reasons, it must be obtained from a representative authorized by law
p.(None): applicable, for example, the father or mother in the case of minors. The representative retains the power
p.(None): to withdraw the research from the participant if necessary for their safety or if that were the best decision
p.(None): represents your values and preferences. Respect for people who cannot grant for themselves
...
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
p.(None): volunteer through the presence of an independent witness in the process of obtaining the same.
p.(None): In research without potential benefits for the health of the participants, for example, when it comes to
p.(None): healthyXvolunteers, they may receive a payment, the type or amount of which must
p.(None): be approved by the CEI. On the other hand, when the research presents a potential benefit for the health of
p.(None): Participants, only compensation for expenses or lost profits is acceptable.
p.(None): Coercion. The intentional use of force or threats to modify the will of other people, for example, a
p.(None): threat of physical harm or punishment such as loss of job or medical care for refusing to participate in
p.(None): an investigation is unacceptable.
p.(None): Undue influence. Potential participants may not feel free to refuse requests from those with power
p.(None): therefore, investigations should not be proposed with individuals whose decision may be affected by
p.(None): a related authority, if they could be carried out with independent participants. Otherwise, the
p.(None): investigators must justify that choice to the IRB and outline how they plan to neutralize that possible
p.(None): influence.
p.(None): Use of medical data and biological samples. Patients have the right to know if their data or samples
p.(None): They will be used for an investigation, so researchers must obtain their prior consent. A
p.(None): CEI may approve the use for research of data or samples from medical care, without
p.(None): prior consent of patients, only when the project is scientifically proven
p.(None): valid, minimal risk is expected, obtaining consent will be difficult or impractical and will be guaranteed
p.(None): the protection of the privacy and confidentiality of individuals through an irreversible dissociation of the
p.(None): biological data or samples. A probable refusal to participate by individuals should not be considered
p.(None): impracticability criterion to approve the omission of consent.
p.(None): If biological samples are obtained as part of the investigation, informed consent must include the
p.(None): Next information:
p.(None): (a) the possible uses, direct or secondary, of biological samples obtained in the study;
p.(None): (b) the fate of the biological samples at the end of the study, for example, their destruction or storage
p.(None): for future use. In the latter case, the possible future uses should be specified and where,
...
p.(None): relevance of the new knowledge expected to be obtained.
p.(None): Identification of risks. The term "risk" refers to the possibility of damage occurring.
p.(None): For their part, the expressions "low risk" and "high risk" describe the magnitude of the probability of
p.(None): damage occurrence in terms of frequency and severity. A risk is considered low when it is similar or
p.(None): equivalent to the risks of routine medical practice. When planning an investigation, investigators
p.(None): They should try to identify all possible risks for the participants. The risks can be:
p.(None): a) physical: risks of adverse effects of the study interventions or procedures;
p.(None): (b) mental or emotional: when the sensitivity, values or rights of the participants can be affected, for
p.(None): example, if personal information is disclosed to third parties; Y
p.(None): (c) economic: when the participation can cause pecuniary losses. Risk minimization: After the
p.(None): Identifying the risks, researchers should develop a plan to minimize their effects.
p.(None): The usual strategies to minimize are:
p.(None): (a) surveillance of the safety of participants with adequate and frequent controls to prevent, detect and
p.(None): quickly treat the occurrence of adverse events;
p.(None): (b) periodically report adverse events to the CEI and, if applicable, to the sponsor;
p.(None): (c) immediately report serious and unexpected adverse events to the CEI and, where appropriate, to the
p.(None): sponsor and regulatory authority;
p.(None): (d) perform interim analyzes to detect changes in the frequency or magnitude of expected adverse events in
p.(None): relationship to expected benefits and / or premature resolution of the research question. In rehearsals
p.(None): clinicians who measure the frequency of mortality or serious health events, such as cardiovascular events, or who
p.(None): evaluating high-risk interventions or involving a large number of individuals, it is advisable to have
p.(None): with an independent data monitoring council to evaluate interim data; Y
p.(None): (e) Provisionally or definitively suspend the study intervention in a participant, or their participation in the
p.(None): study or, if necessary, all research to protect the health and well-being of the participants.
p.(None): Risks for groups or communities. A study can cause harm to a group or community, for example, when it deviates
p.(None): of their routine obligations to health personnel to attend to research activities, the
p.(None): priorities of health care or creates a situation of inequity among users.
p.(None): Investigations of preventive interventions, for example of a vaccine, deserve special consideration,
p.(None): because these interventions imply that all participants are exposed to their potential risks while
p.(None): that only those who would have contracted the disease would benefit if the research had not been carried out.
p.(None): This is actually an inherent problem of all preventive programs, and requires special attention from
p.(None): researchers and the CEI to assess the risks and inconveniences for those who may not receive
p.(None): no direct benefit from your participation.
...
p.(None): related to pregnancy and the product of conception, and if adequately supported by experiments
p.(None): in animals, particularly to establish the risks of teratogenesis and mutagenesis.
p.(None): A6. CONFIDENTIALITY OF INFORMATION
p.(None): P13. Investigators must take all necessary precautions to protect privacy and
p.(None): confidentiality of the information of the study participants.
p.(None): Confidentiality Human health research frequently involves manipulating sensitive data from
p.(None): individuals or groups; therefore there is a risk that the disclosure of such data to third parties may cause
p.(None): harm or anguish to the participants. Investigators should take all possible precautions to
p.(None): protect the privacy and confidentiality of the information of the participants, in accordance with National Law 25,326
p.(None): Habeas Data, for example, omitting data that could identify individuals or limiting their
p.(None): access only to authorized persons.
p.(None): Identifiable personal data should not be used when a study can be done without it. When necessary
p.(None): register personal identification data, investigators must justify this need to the REC, and
p.(None): explain how your confidentiality will be protected and what the limitations of such protection will be, for example, that
p.(None): Research records will be reviewed by sponsor or regulatory authority personnel. A mechanism
p.(None): usual protection is the elimination of the identification data when the results are consolidated for the
p.(None): statistic analysis. Investigators must obtain the prior consent of potential participants to
p.(None): use your data and express your commitment to preserve their confidentiality.
p.(None): The CEI must approve both the information provided to potential participants and the mechanisms provided
p.(None): to protect your privacy and confidentiality.
p.(None): Unrelated information. It is the information that cannot be related to the individual to whom it refers and, given that
p.(None): the investigator does not know the person, confidentiality is not at risk and there is no need to obtain a
p.(None): consent. The data or samples may have been originally linked and then the
p.(None): link with the information that identifies the individual ("anonymization" or "irreversible dissociation"), which leaves
p.(None): If possible, connect a data or sample with the person to whom it refers. In order to proceed with anonymization
p.(None): data or samples, the owner must have previously consented.
p.(None): Linked information. It is the information that can be related or connected with the person to whom it refers. The
p.(None): Linked information, meanwhile, can be:
p.(None): (a) anonymous, when it cannot be linked to the person to whom it refers except through a code or other means
p.(None): known only to the owner of the information;
p.(None): (b) non-nominal, when the information can be linked to the person through a code, which does not include the
...
p.(None): professional recognition. The interest in protecting participants and obtaining valid knowledge must always
p.(None): prevail over any other interest.
p.(None): In many cases it can be really difficult to determine when there is a real conflict of interest because the
p.(None): Competing interest is not always financial and may be overlapping.
p.(None): The RECs must pay attention to the risk of conflict of interest and not approve proposals where there is evidence of
p.(None): that the professional judgment of the researchers may be affected by an incompatibility of interests.
p.(None): A particular case is the possible financial, academic or political conflicts of interest within the
p.(None): institution to which the researcher belongs. For this reason, an institutional REC must incorporate members
p.(None): impartial and external to the institution to help manage a situation of this nature.
p.(None): Declaration of conflicts of interest. Honesty, transparency and impartiality are essential
p.(None): to formulate, conduct, interpret and communicate the results of the studies. Investigators should disclose to
p.(None): CEI and potential research participants their funding sources and possible conflicts of
p.(None): interests, particularly in the event that a commercial or other sponsor plans to use the results of the
p.(None): research for the registration or promotion of a product or service.
p.(None): Internationally sponsored studios. Internationally sponsored studies are those carried out
p.(None): in a host country but initiated, financed, and sometimes led by a foreign or international entity with
p.(None): collaboration or conformity of the local authority.
p.(None): In these cases, there could be a conflict between the interests of the sponsoring country or entity and those of the community.
p.(None): local, which is why the following ethical requirements must be met:
p.(None): (a) projects must undergo ethical evaluation in both the sponsoring country and the host country;
p.(None): (b) the host country's IRB must ensure that the project meets its ethical requirements; Y
p.(None): (c) researchers must adhere to the ethical rules of the sponsoring country and the host country.
p.(None): The sponsoring country's committee or international organization has a special responsibility to determine if it exists
p.(None): justification for conducting the study in the host country instead of in the sponsoring country and if the
p.(None): project is in accordance with the ethical standards of the sponsoring country or international organization.
p.(None): The host country committee has a special responsibility to determine whether the research objectives
p.(None): respond to your own ethical requirements and local health needs and priorities. Must also
p.(None): make sure that the proposal to carry out the research in the host country instead of the sponsoring country does not comply
p.(None): to an ethical impediment in the latter and, if that were the case, the proposal should not be accepted.
p.(None): A8. DATA MANAGEMENT AND RESULTS
p.(None): Q15. The information obtained in a human health investigation must be recorded and filed in a
p.(None): such that it allows its adequate interpretation and verification.
p.(None): P16. When the result of an investigation is published, the accuracy of the data and its
p.(None): interpretation. Publications must declare the sources of financing, labor relations and
p.(None): other possible conflicts of interest. Items that do not meet ethical standards should not be
p.(None): accepted for publication.
p.(None): Data register. All the information obtained from the investigation must be registered, preserved, analyzed,
p.(None): interpreted and communicated in a way that demonstrates the quality and integrity of the data. Quality
p.(None): of the data means that they must be exact, legible, complete, contemporary (recorded at the time that
p.(None): are measured or obtained) and attributable to the person who generated them.
p.(None): The integrity of the data is an attribution of all of them and refers to the fact that the data is credible,
p.(None): consistent and verifiable.
p.(None): The data record can be handwritten or electronic. In any case, its preservation must be ensured and the
p.(None): confidentiality of personal data. Documents "source" are those documents in which
p.(None): which data is recorded for the first time, for example, the medical records of the participants. In
p.(None): Therefore, the "essential" documents are those that demonstrate that during the investigation
p.(None): fulfilled all ethical and scientific requirements, for example the protocol, the documents of the
p.(None): informed consent and the CEI approval note. Essential documents must be kept in one place
p.(None): secure to protect the confidentiality of information and allow its preservation and direct access to
p.(None): verification, if required by the CEI or the competent authority. When it comes to people's health data,
p.(None): the essential documents of a study must meet the legal requirements for the preservation of information
p.(None): medical.
p.(None): Communication of study results. Part of the benefits that communities and individuals can expect
p.(None): Their participation in research is to be informed of the conclusions or results concerning their health.
p.(None): If public health recommendations arise, they must be made available to the authorities
p.(None): sanitary.
p.(None): Impossibility of communicating the results of the study. In some cases, for example, when the data is not
p.(None): linked to people, it will not be feasible to extract from the general results the information concerning them or
p.(None): their families, therefore, participants in these studies should be warned that they will not be
p.(None): informed about the conclusions concerning their health and that they should not infer that
p.(None): do not have the disease or condition under study.
p.(None): Publication of the study results. Investigators have an obligation to disclose information that is
p.(None): in the public interest, by any appropriate means available and provided that the confidentiality of
p.(None): the participants and that the interpretations or inferences are not presented as if they were proven truths or in a
p.(None): that promote or appear to promote special interests, for example, that a product has been shown to be effective.
p.(None): The publication of the results, both positive and negative, of the research is strongly recommended.
p.(None): to facilitate its transparency and to avoid repeating studies already carried out and submitting it to new participants
p.(None): yet
p.(None): unnecessary risk.
p.(None): To guarantee the integrity of scientific information and promote the highest standards of professional conduct,
...
p.(None): exempts the researcher, the institution or the sponsor from any legal responsibility in case of
p.(None): damage suffered by the participant as a result of their participation in the study.
p.(None): Access to treatment. At the end of the research, all participants should share the benefits
p.(None): obtained from it, for example, by accessing the intervention that has been most beneficial, a
p.(None): alternative intervention or other appropriate benefit.
p.(None): In particular, in clinical trials sponsored by a pharmaceutical company that have shown that a product
p.(None): Experimental is beneficial, the sponsor should continue to provide it to the participants until their access is
p.(None): guarantee by other means. The requirement of this requirement must be determined based on certain considerations
p.(None): relevant, such as the severity of the medical condition in question and the expected effect of withdrawing or modifying the
p.(None): treatment, for example, leaving a sequel or causing the death of the patient. When it is not possible to fulfill it
p.(None): The provision of an alternative intervention or other appropriate benefit, approved by
p.(None): the CEI and for the period that it determines.
p.(None): A10. CLINICAL TRIALS OF CELL AND GENIC THERAPIES
p.(None): P20. Clinical trials of gene and cellular therapies must follow the principles that protect
p.(None): research participants, including: proper trial planning, fair selection,
p.(None): informed consent, strict medical control of the participants, review by a REC and a
p.(None): expert advice and supervision by a competent regulatory authority.
p.(None): Ethical justification for trials with cell and gene therapies. A therapeutic approach with cell therapies and
p.(None): Gene assays should aim to be clinically similar or superior to existing therapies. If there is already a therapy
p.(None): effective, the risks associated with cell or gene therapy
p.(None): they must be low and offer a potential advantage, for example a better functional result or be a
p.(None): single procedure versus prolonged drug treatment with associated adverse effects. If it doesn't exist yet
p.(None): a therapy, the severity of the disease could justify the risks of an experimental cell or gene therapy.
p.(None): In any case, every effort should be made to minimize the risks of possible associated adverse effects
p.(None): with the use of cells or genes and not taking advantage of the hopes of patients with a poor prognosis. In the
p.(None): gene therapies in particular, given their complexity, the risks could transcend the individual himself and affect the
p.(None): geneticXheritage of the human being. For all this, the suitability and moral integrity of the researchers and the
p.(None): Scientific validity of research must be carefully evaluated.
p.(None): Proper trial planning. The following guidelines should be considered when planning a clinical trial with
p.(None): cellular or gene therapies:
p.(None): (a) preclinical studies in animals and / or other models and previous clinical studies of the therapeutic proposal
p.(None): experimental should show convincing evidence of safety and potential therapeutic benefits for
p.(None): justify its use in humans;
p.(None): (b) the biological characteristics of the intervention and the production procedures must be clearly
...
p.(None): so that in the event of death it is possible to carry out a partial or complete autopsy to assess the scope of the
p.(None): cell implantation and its morphological and functional consequences. Autopsy request must consider
p.(None): cultural and family sensitivities. The subject is delicate but, without access to post-mortem material, the
p.(None): Trial information would be affected to the detriment of future products or product improvements.
p.(None): Recognizing the potential value of new cell and gene therapies for patients with cognitive impairment and the
p.(None): importance that these are not excluded from such advances, researchers must develop a procedure
p.(None): so that authorized patient representatives can make a decision on their behalf. The
p.(None): Representatives must be duly qualified and with sufficient knowledge to evaluate the
p.(None): test and provide adequate protection.
p.(None): Expert advice. Expert review should ensure that the trial will lead to an improvement in the care of
p.(None): the disease and will generate new and important knowledge. This review should include a comparison of the new
p.(None): therapy with available treatments.
p.(None): The following elements should be evaluated by experts: in vitro and in vivo preclinical studies, studies
p.(None): clinical findings, scientific rationale for the trial, study objectives, statistical analysis, and
p.(None): specific aspects of the disease under study.
p.(None): Regulatory authority oversight. Supervision by a regulatory authority should ensure that the
p.(None): trial with cell or gene therapies has scientific merit, was designed correctly, will be carried out
p.(None): safely and will produce reliable knowledge.
p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): This section describes a series of operational requirements for obtaining informed consent, the evaluation
p.(None): ethics and science of research projects, the supervision of research ethics committees and
p.(None): planning and conducting clinical trials. Compliance with these requirements will demonstrate that
p.(None): the ethical recommendations of Section A were respected.
p.(None): B1. THE INFORMED CONSENT
p.(None): 1.1. Informed consent requirement and exceptions
p.(None): 1.1.1. Informed consent is the process that ensures that a potential participant or their
p.(None): Legal representative voluntarily make the decision to participate, free of undue incentive and coercion
p.(None): in an investigation, provided that it is consistent with their values, interests and preferences. The process of
p.(None): Consent must be conducted by the principal investigator or a member of the professional team of the
p.(None): health or related, for example, nurse, social worker or psychologist, trained for this role. In cases where
p.(None): If a treatment is being investigated, only a doctor or dentist, when appropriate, can provide the information with
p.(None): regarding patient treatment.
...
p.(None): how long the samples will be stored, and that the participant has the right to decide on those future uses, to
p.(None): destroy the material and refuse storage;
p.(None): (c) a statement that the samples or derived data will not be marketed;
p.(None): (d) if commercial products could be developed from the biological samples and if it is planned to offer the
p.(None): participant monetary or other benefits for that development; Y
p.(None): (e) in the case of genetic research, that the participant has the right to decide whether or not to be informed of the
p.(None): results of their studies, as long as they have clinical relevance and there is a course of action to modify
p.(None): the evolution. If you were informed of the results, where and how will you have specialized counseling.
p.(None): B2. THE ETHICS COMMITTEE IN INVESTIGATION
p.(None): 2.1. Assessment requirement and exceptions
p.(None): 2.1.1. A human health research project must be submitted to the evaluation, guidance and approval of a Committee of
p.(None): Research Ethics (CEI) independent of the researcher and the sponsor, before its start and during its
p.(None): development.
p.(None): 2.1.2. Research that is not carried out on human beings, which does not require evaluation by a CEI,
p.(None): use data that is publicly available or limited to the study of health systems, health programs
p.(None): officials or public health surveillance, provided that there is no possibility of identifying individuals in the
p.(None): study records.
p.(None): Examples of public health surveillance are records of diseases or adverse effects of
p.(None): Medicines already registered by the competent regulatory authority.
p.(None): 2.2. Objectives and scope of the CEI evaluation
p.(None): 2.2.1. The primary objective of the evaluation of a research in human health by a CEI is to protect dignity,
p.(None): the rights, safety and well-being of the participants.
p.(None): 2.2.2. The IRB must provide an independent, competent and timely evaluation of ethical aspects,
p.(None): scientific, social and operational aspects of the proposed studies, based on the current state of knowledge
p.(None): scientific and applicable ethical standards.
p.(None): 2.2.3. Human health research must be evaluated by a CEI before it starts and then at least once
p.(None): per year until completion. Depending on the degree of risk of the same, the CEI can determine shorter intervals.
p.(None): Likewise, the CEI can exempt low-risk observational studies from the annual review requirement, according to
p.(None): defined in A4.
p.(None): 2.2.4. The CEI has the authority to approve, request modifications, disapprove, interrupt or cancel a
p.(None): research, before and during its development. The CEI must report its opinions in writing to the
p.(None): investigator, including the reasons for the decision.
p.(None): 2.2.5. The REC must request and make available to its members all the documents of the investigation that
p.(None): require for a comprehensive evaluation, including: protocol and its amendments, informed consent and its
p.(None): amendments, other information for participants, updated vital curriculum of the researcher, mechanisms of
p.(None): enrollment, details of the payments and compensations expected for participants and the agreement with the sponsor, if
p.(None): apply.
p.(None): 2.2.6. The IRC must assess whether researchers are suitable for professional training and training in
p.(None): ethical and regulatory aspects for the conduct of the study; and if the host institution is suitable for the execution of
p.(None): the investigation.
p.(None): 2.2.7. The IRB must ensure that potential participants will give their consent free of coercion and incentive
p.(None): improper and after receiving all the information appropriately.
p.(None): 2.2.8. The IRB must verify that the information for the participants on compensation and expected payments is
p.(None): accurate, understandable and does not constitute an undue incentive mode.
p.(None): 2.2.9. An IRB has authority to monitor the conduct of an investigation, including the process of obtaining
p.(None): consent.
p.(None): 2.2.10. The CEI must keep all relevant documents of the investigations, such as documents submitted
p.(None): to review, minutes of meetings, opinions and communications in general, for a period of ten years after completion
p.(None): the study, and make them available to the health authorities if they request it.
p.(None): 2.3. Composition
p.(None): 2.3.1. The CEI must be constituted according to the regulations and / or laws of the jurisdiction under which it was created, and
p.(None): in such a way as to guarantee a competent evaluation free of bias and influence of ethical aspects,
p.(None): scientific, social and operational study.
p.(None): 2.3.2. The composition of the CEI must be multidisciplinary, multisectoral and balanced in age, sex and
p.(None): scientific and non-scientific training. The number of members must be adequate to fulfill their role, preferably
p.(None): odd and with a minimum of five regular members and at least two alternate or alternate members in cases of absence
p.(None): of the holders.
p.(None): 2.3.3. Members will need to renew themselves on a regular basis to combine the advantages of the experience with those of
p.(None): new insights. The mechanisms for the selection and replacement of members must guarantee the suitability,
p.(None): plurality and impartiality in the election.
p.(None): 2.3.4. The renewal requirements must include: name or description of the person responsible for making the appointments and
p.(None): selection or decision procedure, for example, by consensus, voting or direct appointment. Selection of
...
p.(None): 2.10.1. All documentation and communications of a REC must be dated, numbered and filed in accordance with
p.(None): written procedures. Access to documents should be restricted to authorized personnel.
p.(None): 2.10.2. The archive of documents related to an investigation must be kept for a period of not less than ten
p.(None): years after its termination or suspension.
p.(None): 2.10.3. The CEI document file must include at least the following:
p.(None): (a) constitution document, regulation, POE, guides for the presentation of projects and, if any, the reports of
p.(None): management;
p.(None): (b) CV of all the members of the CEI;
p.(None): (c) registration of all income and expenses of the CEI;
p.(None): (d) scheduling of meetings;
p.(None): (e) minutes of the CEI meetings;
p.(None): (f) copy of all documents received for initial and continuous review of the studies;
p.(None): (g) communications of the results of the reviews;
p.(None): (h) correspondence issued and received by the CEI.
p.(None): B3. REGISTRATION AND SUPERVISION OF ETHICS COMMITTEES IN INVESTIGATION
p.(None): 3.1. Purposes and scope
p.(None): 3.1.1. The purposes of registering and auditing RECs are: a) to provide public assurance that the ethical review and
p.(None): Scientific research in human health is carried out according to an established standard; and b)
p.(None): assist the RECs to review their procedures and practices.
p.(None): 3.1.2. Taking into account the country's federal organization, responsibility for the registration and supervision of
p.(None): CEI falls to the provincial health authorities, which must create an agency for this purpose, or assign the
p.(None): enforcement authority to an existing body, for example in areas of health research, epidemiology,
p.(None): general inspection, management of health services or human resources.
p.(None): 3.1.3. The RECs can be formed at the central jurisdictional level or at the level of assistance institutions and
p.(None): investigation, according to the decision of the health authority of the jurisdiction. For such a decision, the
p.(None): local complexity of the healthcare and research network and the local presence of university institutions in
p.(None): Health Sciences.
p.(None): 3.2. CEI registration
p.(None): 3.2.1. To register a CEI, the enforcement authority must request at least the following:
p.(None): (a) request note from the president or coordinator of the CEI;
p.(None): (b) document creating the CEI;
p.(None): (c) updated list of CEI members, including name, date of birth, sex, profession or
p.(None): occupation, position on the committee and relationship with the institution;
p.(None): (d) SOP of the CEI, which must comply with the provisions of section B2 of this Guide.
p.(None): 3.3. CEI supervision
p.(None): 3.3.1. In order to supervise the RECs of the jurisdiction, the enforcement authority must prepare the POE necessary to
p.(None): such activity, including the appointment of independent supervisors, design of the supervision plan, documents
p.(None): to review, the interviews to be carried out, the supervision report model and the distribution of such report.
p.(None): 3.3.2. The choice of the supervisor should guarantee the following:
p.(None): (a) knowledge and training in research ethics review practices;
p.(None): (b) independence of the CEI. The supervisor must declare any real or potential conflict of interest with a CEI and,
p.(None): if the existence of a substantial conflict of interest is determined, the enforcement authority must assign the
p.(None): assign another supervisor;
p.(None): (c) complete confidentiality of the groups or individuals participating in the research and the design and / or data of
p.(None): the investigations.
p.(None): The supervisor must sign a confidentiality agreement and no document arising from the supervision should
p.(None): record data or information considered confidential.
p.(None): 3.3.3. The designated supervisor must prepare a plan for each assigned supervision, which must be communicated to the CEI
p.(None): prior to the supervisory visit. The plan should include:
p.(None): (a) supervisor identification;
p.(None): (b) identification of the CEI and its representatives to be interviewed;
p.(None): (c) reason (routine or for specific cause), objectives and scope of supervision;
p.(None): (d) expected date / s and estimated duration of supervisory activities;
p.(None): (e) schedule of interviews or meetings during supervision;
p.(None): (f) base documents for supervision, for example, this Guide and the SOPs of the CEI;
p.(None): (g) CEI documents to be reviewed during supervision;
p.(None): (h) distribution of the supervision report.
p.(None): 3.4. Supervision driving
p.(None): 3.4.1. The supervision of the CEI begins with a meeting between the supervisor and the authorities or representatives of the CEI,
p.(None): with the following objectives:
p.(None): (a) review of the purpose and scope of supervision;
p.(None): (b) review of the supervision plan;
p.(None): (c) discussion about the CEI's ethical review practices;
p.(None): (d) discussion about the documents to be reviewed;
p.(None): (e) discussion about the legal or regulatory requirements applicable to the ethical review;
p.(None): (f) confirmation of the date and time of the supervisory closing meeting.
p.(None): 3.4.2. During supervision, the supervisor should review the facilities of the archive and, at least, the
...
p.(None): their representatives, and prepare a final supervision report with the initial report plus an evaluation of the
p.(None): actions effectively implemented.
p.(None): B4. CLINICAL TRIALS
p.(None): 4.1. objective
p.(None): 4.1.1. This section establishes procedures for conducting clinical trials of products or
p.(None): preventive, diagnostic or therapeutic procedures carried out solely with the aim of obtaining new
p.(None): knowledge for the best health care. In the case of clinical pharmacology studies for the purpose of
p.(None): registration and regulation, these have been subject to the Good Clinical Practice Regime for Pharmacology Studies
p.(None): Clinic — Provision 6677/10 of the National Administration of Medicines, Food and Medical Technology.
p.(None): 4.2. Investigator responsibilities
p.(None): 4.2.1. The researcher is the person who conducts a clinical trial in a health center and who participates in the design,
p.(None): analysis and communication of the same.
p.(None): 4.2.2. The investigator must be qualified by training and experience to conduct a clinical trial, according to
p.(None): Be on your resume.
p.(None): 4.2.3. The researcher can constitute a team of qualified and trained collaborators in all the requirements
p.(None): applicable to carry out the investigation and delegate some of its functions but keeping the
p.(None): responsibility to monitor their performance. The aptitude of the collaborators must be documented in their CVs
p.(None): updated vitals.
p.(None): 4.2.4. The researcher must keep an updated list of his collaborators, indicating the name, function
p.(None): delegate, start date of activities and registration of signatures.
p.(None): 4.2.5. The researcher and his collaborators must know and respect the guidelines established in this guide, the
p.(None): research regulations of the jurisdictional health authority and the trial protocol.
p.(None): 4.2.6. The researcher must guarantee the adequacy of the center's infrastructure and instruments, equipment
p.(None): and supplies to use for the clinical trial.
p.(None): 4.2.7. The planned recruitment mechanism must be approved by the CEI, including notices in any means of
p.(None): communication. Notices should not implicitly or explicitly state that the investigational product is effective or
p.(None): safe or equivalent or better than other existing products.
p.(None): 4.2.8. It is recommended that the researcher implement a quality control process during obtaining and registering
p.(None): data in order to ensure that it is conducted and documented according to the protocol and that the data is processed
p.(None): correctly and are reliable.
p.(None): 4.3. The trial protocol
p.(None): 4.3.1. The protocol is the document that describes the background, justification, objectives, design, analysis
p.(None): statistics, measurement procedures, interventions, and ethical and administrative considerations of a study.
p.(None): This Guide describes the minimum structure and information that a clinical trial protocol should contain.
p.(None): 4.3.2. General information, background and justification.
p.(None): (a) full study title and protocol version;
p.(None): (b) identification of researchers and research centers;
p.(None): (c) sources of financing;
p.(None): (d) summary of the protocol;
p.(None): (e) description of the problem to be investigated and current state of knowledge;
p.(None): (f) purpose and relevance of the proposed investigation.
p.(None): 4.3.3. Methodological aspects
p.(None): (a) description of the general and specific objectives of the trial, the hypotheses or research questions, their
p.(None): assumptions and their variables;
p.(None): (b) study design and justification for their choice;
...
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
p.(None): research-related adverse events, which must be available at any time
p.(None): require. If an intercurrent disease is diagnosed by a procedure of the
p.(None): research, the researcher should guide the participant to get the care they need.
p.(None): 4.4.9. When a modification to the protocol is foreseen or information has been obtained that could affect the
p.(None): safety of participants or their decision to remain in the trial, consent must be requested before
p.(None): implement the change or continue the study.
p.(None): 4.4.10. The interventions or experimental procedures should not have any cost for the participants,
p.(None): regardless of the existence or not of specific funding for the trial. This does not prevent, for
p.(None): be non-commercial scientific research, treatments or procedures that the participant
p.(None): require for your illness to be covered by your usual health coverage.
p.(None): 4.5. Trial supervision
p.(None): 4.5.1. Before starting the investigation, the investigator must have the written approval of a REC. For such
p.(None): Finally, the researcher must send you all the documentation that he requests, including the protocol and its
p.(None): amendments, consent documents and their amendments, and all available information regarding the
p.(None): study interventions.
p.(None): 4.5.2. To carry out the investigation, the investigator must obtain the authorization of the highest authority of the
p.(None): host institution or the authority designated by it.
p.(None): 4.5.3. The investigator should inform the CEI of serious and unexpected adverse reactions to the intervention of the
p.(None): study and any other events that significantly affect the trial and / or the risk for the participants.
p.(None): 4.5.4. The investigator must inform the CEI about the progress of the trial with a minimum annual frequency. The report
p.(None): newspaper must contain, as a minimum, the number of participants incorporated, in follow-up and retired, list
p.(None): code of participants, serious adverse events and their assumed relationship with the study intervention
p.(None): and the deviations to the protocol relevant to the safety of the participants observed during the period.
p.(None): 4.6. Study interventions
p.(None): 4.6.1. In tests with products not defined or governed by Good Laboratory Practice or Good Practice of
p.(None): Manufacturing, for example, products of biological origin, the guidelines for
p.(None): development and control and the procedures for its use.
p.(None): 4.6.2. The investigator must manage, indicate and / or administer the experimental intervention in the established manner
p.(None): in the protocol. The researcher or his delegate must instruct each participant on the correct use
p.(None): of the product / s under investigation, make sure that you have understood it and then verify at each clinical visit that
p.(None): you have followed the instructions.
p.(None): 4.6.3. If the study uses a masking method, the protocol should specify a procedure for
p.(None): decoding for emergency situations.
p.(None): 4.6.4. In the event that the researcher supplies and / or administers the experimental intervention, he must take
p.(None): a record of their delivery and / or administration to the participants, in order to
...
p.(None): 4.7.1. The protocol should describe the procedures designed for obtaining and recording clinical data on
p.(None): the participants, as well as the method of encoding the data to preserve its confidentiality.
p.(None): 4.7.2. The researcher must respect the veracity, legibility, consistency and timeliness of the data records.
p.(None): of the study both in the medical records and in the clinical data registration forms that
p.(None): The confidentiality of the information of the participants is used, as well.
p.(None): 4.7.3. If automated devices are used to carry out study measurements, such as
p.(None): electrocardiograms and spirometry, a printed source document must be obtained and filed in the medical history
p.(None): identifiable of the procedure performed.
p.(None): 4.8. Essential essay documents
p.(None): 4.8.1. The investigator should keep the trial documents in a safe place, locked and with access
p.(None): restricted to authorized personnel.
p.(None): 4.8.2. The essential documents of the trial should be kept for ten years from its completion, taking
p.(None): the necessary measures to prevent the loss or accidental destruction of the same.
p.(None): 4.8.3. The documents considered essential to the trial are the following:
p.(None): (a) protocol approved by the CEI;
p.(None): (b) informed consent approved by the CEI;
p.(None): (c) recruitment mechanism approved by the CEI, if any;
p.(None): (d) approval note of the study by the CEI, indicating the approved documents: protocol and version, consent
p.(None): informed and version, recruitment mechanism, etc .;
p.(None): (e) authorization note from the highest authority of the institution hosting the study;
p.(None): (f) dated list of members and positions of the CEI;
p.(None): (g) the delegation of functions of the researcher to his team;
p.(None): (h) vital resumes of the researcher and his team;
p.(None): (i) amendments to the protocol approved by the CEI, if any;
p.(None): (j) amendments to informed consent approved by the CEI, if any;
p.(None): (k) CEI approval notes for protocol amendments and consent, if any;
p.(None): (l) notifications to the CEI of serious and unexpected reactions to the study interventions or other information from
p.(None): security;
p.(None): (m) periodic and final reports presented to the CEI;
p.(None): (n) participant identification list;
p.(None): (o) research product accounting forms, if applicable;
p.(None): (p) signed informed consents;
p.(None): (q) primary data documents, such as medical records, laboratory and pharmacy records, journals of
p.(None): participants, reports of images and the images themselves, etc .;
p.(None): (r) documentation of the processing of the data obtained.
p.(None): GLOSSARY
p.(None): AUTONOMY: capacity of self-determination of a person to make a decision freely and
p.(None): voluntary, according to their own values, interests and preferences, and provided they have the necessary information to
p.(None): evaluate all options.
p.(None): GOOD PRACTICE OF CLINICAL INVESTIGATION (BPIC): set of procedural requirements for the
p.(None): design, conduct, record, analyze, monitor, audit, and report clinical trials conducted to
p.(None): support the registration of pharmaceutical products for human use, in order to ensure that the
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General/Other / Undue Influence
Searching for indicator undueXinfluence:
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p.(None): Composition. The RECs must be composed in such a way that an adequate evaluation of the projects of
p.(None): investigation. Its members should include health professionals and experts in methodology, in ethics of the
p.(None): research and participant rights, as well as legacies in science but trained to consider a
p.(None): range of community, cultural and moral values. Members must be renewed periodically in order to
p.(None): combine the advantages of experience with those of new perspectives. To stay
p.(None): Independent of the investigators, the RECs should prevent any member who has a direct interest in
p.(None): a project participates in the evaluation and decision about it.
p.(None): Functioning. An IRB should establish its standard operating procedures for, for example, the frequency of
p.(None): meetings, quorum of members and mechanisms for analysis and decision-making, and must communicate said
p.(None): rules to researchers. When evaluating a project, the different sectors of the committee, scientific and not
p.(None): Scientists must be represented to ensure a comprehensive evaluation.
p.(None): Member responsibilities. The members of a CEI must take special care to avoid all conduct not
p.(None): ethics, including conflicts of interest that may arise in evaluations. The members of the CEI must
p.(None): respect the confidentiality of the documents received for evaluation and the deliberations of the committee.
p.(None): A3. INFORMED CONSENT
p.(None): P6. The decision of an individual or his representative to participate in an investigation must be voluntary and free of
p.(None): undueXinfluence, undue incentive or coercion. To make a free decision, each potential participant or
p.(None): Your legal representative must receive the information clearly and precisely about the purpose,
p.(None): procedures, benefits and foreseeable risks and sources of research funding, and your rights to
p.(None): access and rectify your data and refuse to participate or leave the study at any time, without
p.(None): need to justify themselves and without exposing themselves to any retaliation. After verifying that the individual or their
p.(None): representative have understood all the information, the investigator must request the
p.(None): consent.
p.(None): Q7. In all experimental research, each potential participant must also be informed of the
p.(None): expected risks and benefits of both the experimental intervention and the available alternatives; of payment
p.(None): for participation and remuneration for expenses, if applicable; and care coverage and
p.(None): compensation provided in case of damage directly related to the investigation.
p.(None): Q8. In the course of the research, participants should be informed of any findings or
p.(None): event that could affect your security or your decision to continue participating. At the end of
p.(None): research, the results of the same should be made available to the participants.
p.(None): Definition. Informed consent is voluntary and free when granted by an autonomous person and
p.(None): competent who can understand the purpose and nature of the research, the risks to be faced and the
p.(None): benefits you may receive, and you know your rights as a research participant. An autonomous person and
...
p.(None): individual.
p.(None): Undue incentive. Sometimes it can be difficult to clearly distinguish between legitimate motivation and the offer of
p.(None): excessive or inappropriate stimulation. The potential and actual benefits of research, for example, obtaining
p.(None): of a knowledge, are appropriate incentives.
p.(None): Similarly, the promise of compensation and medical care for damages, injuries or loss of income does not
p.(None): They must be considered as an induction to participate. On the other hand, those who lack basic goods or
p.(None): proper health care they are especially exposed to an undue incentive when goods are offered to them,
p.(None): services or cash payments for their participation and therefore require a guarantee of free consent and
p.(None): volunteer through the presence of an independent witness in the process of obtaining the same.
p.(None): In research without potential benefits for the health of the participants, for example, when it comes to
p.(None): healthyXvolunteers, they may receive a payment, the type or amount of which must
p.(None): be approved by the CEI. On the other hand, when the research presents a potential benefit for the health of
p.(None): Participants, only compensation for expenses or lost profits is acceptable.
p.(None): Coercion. The intentional use of force or threats to modify the will of other people, for example, a
p.(None): threat of physical harm or punishment such as loss of job or medical care for refusing to participate in
p.(None): an investigation is unacceptable.
p.(None): Undue influence. Potential participants may not feel free to refuse requests from those with power
p.(None): therefore, investigations should not be proposed with individuals whose decision may be affected by
p.(None): a related authority, if they could be carried out with independent participants. Otherwise, the
p.(None): investigators must justify that choice to the IRB and outline how they plan to neutralize that possible
p.(None): influence.
p.(None): Use of medical data and biological samples. Patients have the right to know if their data or samples
p.(None): They will be used for an investigation, so researchers must obtain their prior consent. A
p.(None): CEI may approve the use for research of data or samples from medical care, without
p.(None): prior consent of patients, only when the project is scientifically proven
p.(None): valid, minimal risk is expected, obtaining consent will be difficult or impractical and will be guaranteed
p.(None): the protection of the privacy and confidentiality of individuals through an irreversible dissociation of the
p.(None): biological data or samples. A probable refusal to participate by individuals should not be considered
p.(None): impracticability criterion to approve the omission of consent.
p.(None): If biological samples are obtained as part of the investigation, informed consent must include the
p.(None): Next information:
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.(None): A3. Informed consent
p.(None): A4. Benefits and risks of research A5. Selection of participants
p.(None): A6. Confidentiality of information A7. Conflict of interests
p.(None): A8. Data and results management
p.(None): A9. Special considerations for clinical trials A10. Clinical trials of cell and gene therapies
p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): B1. Informed consent
p.(None): B2. The research ethics committee
p.(None): B3. Registration and supervision of research ethics committees B4. Clinical trials
p.(None): GLOSSARY INTRODUCTION
p.(None): This Guide is an expression of concern to ensure that human health research adheres to guidelines.
p.(None): ethical and acceptable scientific and methodological techniques. Ethical issues are generally the result of
p.(None): conflicts between competing sets of values, for example the conflict between individual rights
p.(None): and the development needs of the community. The diversity of values present in a society
p.(None): justifies the development of guidelines of conduct by consensus, with the aim of guaranteeing the highest level of
p.(None): achievable protection for individuals.
p.(None): The first international ethical guidelines for research were the Nuremberg Code (1947) and the Declaration
p.(None): of Helsinki (World Medical Association, 1964, last update 2008), setting the ethical model still in force
p.(None): for conducting studies with human beings. In 1979, the Belmont Report (National Commission for the
p.(None): Protection of Human Subjects of Biomedical and Behavioral Research) established the ethical principles for
p.(None): research involving human subjects. In 1982, the Council of International Organizations of the
p.(None): Medical Sciences (CIOMS) formulated the International Ethical Guidelines for Research
p.(None): Biomedical in Human Beings (updated in 1993 and 2002) and, in 1991, the International Guidelines for Ethical Review
p.(None): of Epidemiological Studies (updated in 2009 as International Ethical Guidelines for Epidemiological Studies).
p.(None): The Good Clinical Research Practice (BPIC) is a set of established ethical and scientific requirements
p.(None): for the design, conduct, registration and reporting of clinical trials carried out to support the registration of
p.(None): pharmaceutical products for human use, in order to ensure that the rights and integrity of
p.(None): participants and that the data and results obtained are reliable and accurate. This regulation was developed
p.(None): in 1978 by the United States Food and Drug Administration (FDA), and
p.(None): then validated in 1996 between this country, the European Union and Japan at the International Conference on Harmonization
p.(None): (ICH).
p.(None): In 2002, the World Health Organization issued a Handbook for Good Clinical Researc Practice (BPIC) and
p.(None): In 2005, the Pan American Health Organization published the BPIC guide known as “Document of the Americas”, the
p.(None): which served as the basis for the "Guide to Good Clinical Research Practices in Human Beings" of the Ministry of
...
General/Other / cioms guidelines
Searching for indicator cioms:
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p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): B1. Informed consent
p.(None): B2. The research ethics committee
p.(None): B3. Registration and supervision of research ethics committees B4. Clinical trials
p.(None): GLOSSARY INTRODUCTION
p.(None): This Guide is an expression of concern to ensure that human health research adheres to guidelines.
p.(None): ethical and acceptable scientific and methodological techniques. Ethical issues are generally the result of
p.(None): conflicts between competing sets of values, for example the conflict between individual rights
p.(None): and the development needs of the community. The diversity of values present in a society
p.(None): justifies the development of guidelines of conduct by consensus, with the aim of guaranteeing the highest level of
p.(None): achievable protection for individuals.
p.(None): The first international ethical guidelines for research were the Nuremberg Code (1947) and the Declaration
p.(None): of Helsinki (World Medical Association, 1964, last update 2008), setting the ethical model still in force
p.(None): for conducting studies with human beings. In 1979, the Belmont Report (National Commission for the
p.(None): Protection of Human Subjects of Biomedical and Behavioral Research) established the ethical principles for
p.(None): research involving human subjects. In 1982, the Council of International Organizations of the
p.(None): Medical Sciences (CIOMS) formulated the International Ethical Guidelines for Research
p.(None): Biomedical in Human Beings (updated in 1993 and 2002) and, in 1991, the International Guidelines for Ethical Review
p.(None): of Epidemiological Studies (updated in 2009 as International Ethical Guidelines for Epidemiological Studies).
p.(None): The Good Clinical Research Practice (BPIC) is a set of established ethical and scientific requirements
p.(None): for the design, conduct, registration and reporting of clinical trials carried out to support the registration of
p.(None): pharmaceutical products for human use, in order to ensure that the rights and integrity of
p.(None): participants and that the data and results obtained are reliable and accurate. This regulation was developed
p.(None): in 1978 by the United States Food and Drug Administration (FDA), and
p.(None): then validated in 1996 between this country, the European Union and Japan at the International Conference on Harmonization
p.(None): (ICH).
p.(None): In 2002, the World Health Organization issued a Handbook for Good Clinical Researc Practice (BPIC) and
p.(None): In 2005, the Pan American Health Organization published the BPIC guide known as “Document of the Americas”, the
p.(None): which served as the basis for the "Guide to Good Clinical Research Practices in Human Beings" of the Ministry of
p.(None): Health of the Nation (Resolution 1490/07), intended to regulate clinical trials in its field of
p.(None): application. Subsequently, this Guide was revised with the aim of expanding its scope to all research in
p.(None): human health and this document is the result of that review.
p.(None): The following documents were used as reference for the preparation of this Guide:
p.(None): - Declaration of Helsinki (AMM, 2008)
p.(None): - International ethical guidelines for biomedical research in human beings (CIOMS, 2002)
p.(None): - International Ethics Guidelines for Epidemiological Studies (CIOMS, 2009)
p.(None): - Guidelines for the Clinical Translation of Stem Cells (ISSCR, 2008)
p.(None): - Operational guidelines for ethics committees that evaluate biomedical research (WHO, 2000)
p.(None): - Surveying and Evaluating Ethical Review Practices (WHO, 2002)
p.(None): - Guidelines for Good Clinical Practice (ICH, 1996)
p.(None): - Handbook for Good Clinical Research Practice (WHO, 2002)
p.(None): - Good clinical practices: Document of the Americas (PAHO, 2005)
p.(None): - Ethics Committee. Standard working procedures (PAHO, 2009)
p.(None): - Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997)
p.(None): - International Declaration on Human Genetic Data (UNESCO, 2003)
p.(None): - International Declaration on Bioethics and Human Rights (UNESCO, 2005) This Guide has been submitted to
p.(None): evaluation of the following entities:
p.(None): - National Academy of Pharmacy and Biochemistry
p.(None): - National Academy of Medicine
p.(None): - National Academy of Dentistry
p.(None): - National Administration of Laboratories and Health Institutes (ANLIS)
p.(None): - National Administration of Medicines, Food and Medical Technology (ANMAT)
p.(None): - Argentine Association of Respiratory Medicine
p.(None): - Association of Medicine Faculties of the Argentine Republic (AFACIMERA)
p.(None): - Association of Dentistry Faculties of the Argentine Republic (AFORA)
p.(None): - Joint Commission for Health Research and Central Ethics Committee - Undersecretariat for Health Planning
p.(None): - Ministry of Health of the Province of Buenos Aires
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.(None): Ministry of Health PUBLIC HEALTH
p.(None): Resolution 1480/2011
p.(None): Approve the Guide for Investigations with Human Beings. Goals.
p.(None): Bs. As., 9/13/2011
p.(None): HAVING SEEN File No. 1-2002-11.180 / 11-8 of the registry of the MINISTRY OF HEALTH; and WHEREAS:
p.(None): That human health research is important for society because it allows improving the quality of life,
p.(None): protection of the health and care of the disease of the individuals that compose it.
p.(None): That human health research includes both epidemiological studies and biomedical research and
p.(None): clinical trials evaluating a preventive, diagnostic or therapeutic intervention on the disease.
p.(None): That all research involving human beings must be based on ethical values founded on respect for the
p.(None): dignity of people, the well-being and physical and mental integrity of those who participate in it.
p.(None): That consequently it is essential to methodically and systematically address both ethical issues,
p.(None): such as the scientific validity and significance that emerge from all research on human beings,
p.(None): formulating the directives that accept the ethical principles to which the activity of the
p.(None): clinical research.
p.(None): That there are numerous international ethical and operational guides related to human health research, among
p.(None): they, the Nüremberg Decalogue (1948), the Declaration of Helsinki (latest version 2008), the Ethical Guidelines
p.(None): Guidelines for Biomedical Research in Humans (latest version 2002), the Guidelines
p.(None): international ethics for epidemiological studies (latest version 2009), the Operational Guides
p.(None): for ethics committees evaluating biomedical research (2000) and the Guidelines for Good Clinical Practice
p.(None): (1996), as well as the International Declarations on Human Genetic Data and on Bioethics and Rights
p.(None): humans (2003 and 2005, respectively) to which the country has adhered.
p.(None): That the research ethics committees formed in a multidisciplinary manner at the official level
p.(None): jurisdictional or in the institutions that carry out health research constitute the central axis of
p.(None): monitoring the protection of participants in such investigations
p.(None): That the MINISTRY OF HEALTH OF THE NATION issued a GUIDE OF GOOD PRACTICES
p.(None): OF CLINICAL RESEARCH IN HUMAN BEINGS approved by Resolution No. 1490 of November 14, 2007, but which is done
p.(None): It is necessary to extend the ethical and operational guidelines to all research in human health.
p.(None): That in fulfillment of the stewardship role of the MINISTRY OF HEALTH OF THE NATION, THE UNDER-SECRETARY OF
p.(None): SANITARY RELATIONS AND INVESTIGATION has elaborated
p.(None): A GUIDE FOR INVESTIGATIONS WITH HUMAN BEINGS, which contains ethical and operational guidelines to guide
p.(None): researchers, sponsors, members of research ethics committees and regulatory authorities, and
...
p.(None): file away. - Juan L. Manzur.
p.(None): ANNEX I
p.(None): GUIDE FOR INVESTIGATIONS IN HUMAN HEALTH INDEX
p.(None): INTRODUCTION SCOPE
p.(None): SECTION A: ETHICAL ASPECTS
p.(None): A1. Ethical justification and scientific validity A2. Ethical and scientific evaluation
p.(None): A3. Informed consent
p.(None): A4. Benefits and risks of research A5. Selection of participants
p.(None): A6. Confidentiality of information A7. Conflict of interests
p.(None): A8. Data and results management
p.(None): A9. Special considerations for clinical trials A10. Clinical trials of cell and gene therapies
p.(None): SECTION B: OPERATIONAL ASPECTS
p.(None): B1. Informed consent
p.(None): B2. The research ethics committee
p.(None): B3. Registration and supervision of research ethics committees B4. Clinical trials
p.(None): GLOSSARY INTRODUCTION
p.(None): This Guide is an expression of concern to ensure that human health research adheres to guidelines.
p.(None): ethical and acceptable scientific and methodological techniques. Ethical issues are generally the result of
p.(None): conflicts between competing sets of values, for example the conflict between individual rights
p.(None): and the development needs of the community. The diversity of values present in a society
p.(None): justifies the development of guidelines of conduct by consensus, with the aim of guaranteeing the highest level of
p.(None): achievable protection for individuals.
p.(None): The first international ethical guidelines for research were the Nuremberg Code (1947) and the Declaration
p.(None): of Helsinki (World Medical Association, 1964, last update 2008), setting the ethical model still in force
p.(None): for conducting studies with human beings. In 1979, the Belmont Report (National Commission for the
p.(None): Protection of Human Subjects of Biomedical and Behavioral Research) established the ethical principles for
p.(None): research involving human subjects. In 1982, the Council of International Organizations of the
p.(None): Medical Sciences (CIOMS) formulated the International Ethical Guidelines for Research
p.(None): Biomedical in Human Beings (updated in 1993 and 2002) and, in 1991, the International Guidelines for Ethical Review
p.(None): of Epidemiological Studies (updated in 2009 as International Ethical Guidelines for Epidemiological Studies).
p.(None): The Good Clinical Research Practice (BPIC) is a set of established ethical and scientific requirements
p.(None): for the design, conduct, registration and reporting of clinical trials carried out to support the registration of
p.(None): pharmaceutical products for human use, in order to ensure that the rights and integrity of
p.(None): participants and that the data and results obtained are reliable and accurate. This regulation was developed
p.(None): in 1978 by the United States Food and Drug Administration (FDA), and
p.(None): then validated in 1996 between this country, the European Union and Japan at the International Conference on Harmonization
p.(None): (ICH).
p.(None): In 2002, the World Health Organization issued a Handbook for Good Clinical Researc Practice (BPIC) and
p.(None): In 2005, the Pan American Health Organization published the BPIC guide known as “Document of the Americas”, the
p.(None): which served as the basis for the "Guide to Good Clinical Research Practices in Human Beings" of the Ministry of
p.(None): Health of the Nation (Resolution 1490/07), intended to regulate clinical trials in its field of
p.(None): application. Subsequently, this Guide was revised with the aim of expanding its scope to all research in
p.(None): human health and this document is the result of that review.
p.(None): The following documents were used as reference for the preparation of this Guide:
p.(None): - Declaration of Helsinki (AMM, 2008)
p.(None): - International ethical guidelines for biomedical research in human beings (CIOMS, 2002)
p.(None): - International Ethics Guidelines for Epidemiological Studies (CIOMS, 2009)
p.(None): - Guidelines for the Clinical Translation of Stem Cells (ISSCR, 2008)
p.(None): - Operational guidelines for ethics committees that evaluate biomedical research (WHO, 2000)
p.(None): - Surveying and Evaluating Ethical Review Practices (WHO, 2002)
p.(None): - Guidelines for Good Clinical Practice (ICH, 1996)
p.(None): - Handbook for Good Clinical Research Practice (WHO, 2002)
p.(None): - Good clinical practices: Document of the Americas (PAHO, 2005)
p.(None): - Ethics Committee. Standard working procedures (PAHO, 2009)
p.(None): - Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997)
p.(None): - International Declaration on Human Genetic Data (UNESCO, 2003)
p.(None): - International Declaration on Bioethics and Human Rights (UNESCO, 2005) This Guide has been submitted to
p.(None): evaluation of the following entities:
p.(None): - National Academy of Pharmacy and Biochemistry
p.(None): - National Academy of Medicine
p.(None): - National Academy of Dentistry
p.(None): - National Administration of Laboratories and Health Institutes (ANLIS)
p.(None): - National Administration of Medicines, Food and Medical Technology (ANMAT)
p.(None): - Argentine Association of Respiratory Medicine
p.(None): - Association of Medicine Faculties of the Argentine Republic (AFACIMERA)
p.(None): - Association of Dentistry Faculties of the Argentine Republic (AFORA)
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
p.(None): risk.
p.(None): 4.4.7. The use of placebo in a control group must be adequately justified in its methodological and ethical aspects. The
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
p.(None): research-related adverse events, which must be available at any time
p.(None): require. If an intercurrent disease is diagnosed by a procedure of the
p.(None): research, the researcher should guide the participant to get the care they need.
p.(None): 4.4.9. When a modification to the protocol is foreseen or information has been obtained that could affect the
p.(None): safety of participants or their decision to remain in the trial, consent must be requested before
p.(None): implement the change or continue the study.
p.(None): 4.4.10. The interventions or experimental procedures should not have any cost for the participants,
p.(None): regardless of the existence or not of specific funding for the trial. This does not prevent, for
p.(None): be non-commercial scientific research, treatments or procedures that the participant
p.(None): require for your illness to be covered by your usual health coverage.
p.(None): 4.5. Trial supervision
p.(None): 4.5.1. Before starting the investigation, the investigator must have the written approval of a REC. For such
p.(None): Finally, the researcher must send you all the documentation that he requests, including the protocol and its
p.(None): amendments, consent documents and their amendments, and all available information regarding the
p.(None): study interventions.
...
p.(None): consequence of the intervention. If two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis.
p.(None): CLINICAL PHARMACOLOGY STUDY: systematic scientific study carried out with drugs or products
p.(None): tests on voluntary individuals, healthy or sick, in order to discover or verify its effects
p.(None): therapeutic (efficacy) and / or identify adverse reactions (safety) and / or study the absorption, distribution,
p.(None): metabolism (biotransformation) and excretion of the active ingredients. Synonym: Clinical Pharmacology Trial.
p.(None): MULTICENTRIC STUDY: research conducted in more than one research institution or center but following a
p.(None): same protocol.
p.(None): ADVERSE EVENT (AE): any unfavorable medical occurrence in a participant of a clinical trial, associated
p.(None): temporarily with the experimental intervention even when a necessary causal relationship is not established. It includes
p.(None): any signs, abnormal laboratory findings, symptoms, or disease.
p.(None): SERIOUS ADVERSE EVENT (EAS): any unfavorable occurrence in the course and context of a
p.(None): research on a diagnostic or therapeutic product or procedure that results in death threatens the
p.(None): life, requires hospitalization or prolongation of existing hospitalization, results in disability or invalidity
p.(None): persistent or significant, is a congenital abnormality or birth defect or is medically significant according to a
p.(None): medical judgment. The foregoing applies without the presumable existence of a causal link between the
p.(None): application of the product or treatment and the adverse event.
p.(None): CONTROL GROUP: group that is used as a comparator and indicates what happens when the variable or the
p.(None): intervention to be studied.
p.(None): INSTITUTION OR RESEARCH CENTER: any public or private entity, agency or medical or dental facility
p.(None): where clinical studies are conducted.
p.(None): EXPERIMENTAL INVESTIGATION: investigation in which the investigator selects individuals with
p.(None): inclusion and exclusion criteria, actively intervenes on the independent or predictor variable, and observes
p.(None): and analyzes the changes that occur in the dependent or outcome variable as a result of the
p.(None): intervention. When two interventions are compared, the research hypothesis is tested against
p.(None): a null hypothesis. Health interventions can be: synthetic medicines, products
p.(None): biological or biotechnological, medical devices, surgical techniques, etc. Synonym: Clinical trial.
p.(None): OBSERVATIONAL INVESTIGATION: investigation in which the independent or predictive variable is not intervened
p.(None): and only the possible relationships with the dependent or outcome variable are observed. The selection of
p.(None): Participants are not made by the researcher, but by nature: healthy or sick, with or without a risk factor; user or not
p.(None): user of a service or health program, etc. Two subtypes of observational research are recognized:
p.(None): Descriptive or exploratory research: quantitative or qualitative description of facts or phenomena
p.(None): observed, without posing a hypothesis. Examples: prevalence studies, cross-sectional, demographic,
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
p.(None): Statistical, ethical considerations and organization of a study.
p.(None): LEGAL REPRESENTATIVE: individual authorized by Civil Code or by applicable laws who acts as representative of
...
Searching for indicator placebo:
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p.(None): sanitary.
p.(None): Impossibility of communicating the results of the study. In some cases, for example, when the data is not
p.(None): linked to people, it will not be feasible to extract from the general results the information concerning them or
p.(None): their families, therefore, participants in these studies should be warned that they will not be
p.(None): informed about the conclusions concerning their health and that they should not infer that
p.(None): do not have the disease or condition under study.
p.(None): Publication of the study results. Investigators have an obligation to disclose information that is
p.(None): in the public interest, by any appropriate means available and provided that the confidentiality of
p.(None): the participants and that the interpretations or inferences are not presented as if they were proven truths or in a
p.(None): that promote or appear to promote special interests, for example, that a product has been shown to be effective.
p.(None): The publication of the results, both positive and negative, of the research is strongly recommended.
p.(None): to facilitate its transparency and to avoid repeating studies already carried out and submitting it to new participants
p.(None): yet
p.(None): unnecessary risk.
p.(None): To guarantee the integrity of scientific information and promote the highest standards of professional conduct,
p.(None): researchers should present their results in peer-reviewed publications or scientific conferences
p.(None): before communicating them to the public media
p.(None): or patient advocacy associations.
p.(None): A9. SPECIAL CONSIDERATIONS FOR CLINICAL TRIALS
p.(None): Q17. The benefits and risks of a new intervention should be compared with the one that has been shown to be the best
p.(None): Until now. The use of placebo is only acceptable when there is no proven alternative intervention
p.(None): or when this technique is necessary
p.(None): for valid methodological or scientific reasons and the risks of harm or suffering are less.
p.(None): Q18. In the event of harm arising from trial participation, participants should have access to care
p.(None): necessary medical care and appropriate compensation through insurance or other form of guarantee
p.(None): demonstrable.
p.(None): P19. At the end of the research, all participants should share the benefits they have
p.(None): arising from it, for example, continue receiving the intervention that has been identified as the most
p.(None): beneficial to them. If it is not possible to ensure this intervention, for a justified reason, the
p.(None): access to an appropriate alternative intervention or other appropriate benefit, approved by the CEI and for the period that it
p.(None): determine or until your access is guaranteed by another means.
p.(None): Control groups. The design of control groups is justified only when there is a true uncertainty in the
p.(None): scientific community about which of the study treatments is the best, since it is unethical to subject
p.(None): participants at risk of receiving less effective treatment. For this reason, the protocols of these trials
p.(None): They should include procedures to monitor the occurrence of therapeutic failures or adverse events and the measures of
p.(None): case, for example, cancel the investigation if an interim analysis showed that a treatment is clearly
p.(None): superior to others. In this case, and as a general principle, the other participants should be offered the
p.(None): treatment that has been superior, always depending on the clinical situation and the response of each
p.(None): competitor. In clinical trials measuring frequency of mortality or serious health events, evaluate
p.(None): high-risk interventions or involving large numbers of individuals, it is advisable to have a
p.(None): Data monitoring and independent security to evaluate interim data.
p.(None): Random distribution. In the same way as for the use of control groups, trials in which the allocation of
p.(None): an experimental treatment is determined by chance can only be performed when there is true uncertainty
p.(None): about which is the best of them.
p.(None): In such a case, participants should be informed about this uncertainty among the alternatives in
p.(None): study and that the purpose of the trial is to know which is the most beneficial.
p.(None): People, whether chosen or excluded for the experimental treatment or procedure, may feel restless
p.(None): or concerned about the reasons why they have been chosen or excluded. Investigators should communicate to
p.(None): potential participants the reason for using randomization (prevention of bias), and
p.(None): reassure them that the randomization process is neither discriminatory nor based on their status
p.(None): of health.
p.(None): Considerations about the scientific need to use placebo. In cases where there is a standard therapy, the
p.(None): Use of placebo control instead of that active control should be restricted to situations where the risks of
p.(None): damage or condition are minor and their scientific need has been adequately justified. A beginning
p.(None): Methodological points out that the comparison between two or more active substances only shows the relative efficacy between
p.(None): they, while the comparison with placebo allows to establish the real efficacy and, in addition, distinguish
p.(None): the specific adverse effects of the active substance. This is especially relevant when the condition is
p.(None): characterized by fluctuating symptoms and / or spontaneous remission, has high response rates
p.(None): to placebo and existing therapies are only partially effective or have not shown superiority to placebo
p.(None): consistently in previous studies.
p.(None): The placebo effect refers to the health, physiological or psychological benefits produced by a treatment
p.(None): inert from the pharmacological point of view. A placebo can modify the patient's perception of their symptoms
p.(None): and therefore cause a bias in the results of a trial, particularly when diagnostic and diagnostic techniques are used.
p.(None): Measurement is based on the subjectivity of the perception of the patient or the observer. Examples of these situations
p.(None): are: depression (symptoms are confused with other mental health problems or are usually influenced by
p.(None): external factors), idiopathic hypertension (blood pressure changes spontaneously or by
p.(None): influence of diet, mood, etc.) and pain (pain perception varies between people).
p.(None): All this subject to the condition of minor risk.
p.(None): On the other hand, when the pharmacological response can be measured with objective techniques, the
p.(None): need to use placebo control, except in addition to standard therapy. Examples of these cases are:
p.(None): infections (the progression of pneumonia is measured by x-rays and laboratory tests) or cancer (the
p.(None): Tumor reduction can be verified with imaging or leukemia recoil with cell counts
p.(None): blood).
p.(None): When a project proposes the use of placebo, the CEI should assess whether the protocol includes the following mechanisms
p.(None): To minimize risks:
p.(None): (a) consent clearly expresses the use of placebo and its risks;
p.(None): (b) the treatment period is the minimum possible to reduce exposure to non-treatment;
p.(None): (c) control of the participants will be frequent and strict, and it is planned to withdraw the patient from the
p.(None): study or transfer to active treatment (rescue) as soon as therapeutic failure is detected;
p.(None): (d) there is an interim analysis plan and an independent data monitoring council, with clear rules for
p.(None): stopping the study for security reasons;
p.(None): (e) crossover design: groups alternately receive active treatment or placebo; Y
p.(None): (f) addition design: when scientifically and medically possible, all participants should
p.(None): receive the standard treatment, adding either the experimental product or placebo.
p.(None): Particular attention should be paid to projects proposing the use of placebo in groups or communities that do not
p.(None): they have access to standard therapy. The use of placebo should not be accepted when this is your only use.
p.(None): basis. Accidental injury compensation. If an investigation causes harm, the entity
p.(None): Sponsor shall compensate the injured party appropriately according to the type of damage. The losses
p.(None): pecuniaries must be repaired promptly. In other cases, it may be difficult to determine compensation
p.(None): appropriate. Violation of confidentiality or indiscriminate publication of
p.(None): conclusions of a study, causing the loss of prestige of an individual or group, can be difficult to remedy, and
p.(None): the IRC shall define what is the appropriate compensation in such cases. The approval of the study by the CEI does not
p.(None): exempts the researcher, the institution or the sponsor from any legal responsibility in case of
p.(None): damage suffered by the participant as a result of their participation in the study.
p.(None): Access to treatment. At the end of the research, all participants should share the benefits
p.(None): obtained from it, for example, by accessing the intervention that has been most beneficial, a
p.(None): alternative intervention or other appropriate benefit.
p.(None): In particular, in clinical trials sponsored by a pharmaceutical company that have shown that a product
p.(None): Experimental is beneficial, the sponsor should continue to provide it to the participants until their access is
p.(None): guarantee by other means. The requirement of this requirement must be determined based on certain considerations
p.(None): relevant, such as the severity of the medical condition in question and the expected effect of withdrawing or modifying the
...
p.(None): (m) criteria for cancellation of the trial.
p.(None): 4.3.4. Study interventions
p.(None): (a) description of research interventions;
p.(None): (b) in drug trials, indicate dose, frequency, route of administration and duration of treatment.
p.(None): and security monitoring;
p.(None): (c) in tests of biological or biotechnological products, the identification and valuation methodology that
p.(None): ensure uniformity of the preparation to be studied;
p.(None): (d) drugs allowed and not allowed;
p.(None): (e) delivery and / or administration mechanisms of the experimental intervention. The protocol should specify the
p.(None): procedures to be followed for its handling, storage and inventory, including its delivery and return of
p.(None): participants and their final disposition.
p.(None): (f) criteria for suspension of treatment;
p.(None): (g) planned rescue treatments and follow-up in the event of failure or adverse events;
p.(None): 4.3.5. Ethical aspects
p.(None): (a) specification that the research will be reviewed by a REC;
p.(None): (b) procedures for obtaining informed consent;
p.(None): (c) procedures to protect the confidentiality of the participants;
p.(None): (d) details of coverage and compensation for damage available to participants;
p.(None): (e) justification of payments or compensation for expenses available to participants;
p.(None): (f) anticipation of access at the end of the trial to the intervention identified as beneficial in the trial, or to a
p.(None): appropriate alternative, or other suitable benefit;
p.(None): (g) justification for the use of placebo, if applicable;
p.(None): (h) justification for conducting the research in a vulnerable group, if applicable;
p.(None): (i) possible conflicts of interest.
p.(None): 4.3.6. Administrative aspects
p.(None): (a) registration and communication of clinical data;
p.(None): (b) procedure for registration and notification to the CEI of adverse events;
p.(None): (c) handling of trial documents;
p.(None): (d) plan and publication rights of the results.
p.(None): 4.3.7. The changes made in the protocol approved by the CEI must be justified based on its
p.(None): potential impact on the participants and the scientific validity of the study; and require the approval of the
p.(None): CEI before its implementation, except when they have been carried out to preserve the security of the
p.(None): participants.
p.(None): 4.4. Trial participant protection
p.(None): 4.4.1. The researcher is responsible for the process of obtaining the informed consent of all participants,
p.(None): even if you have delegated this function to a member of your team. Staff who obtain informed consent
p.(None): You must be trained for it.
p.(None): 4.4.2. Before requesting informed consent, the researcher must evaluate each potential participant
p.(None): a possible condition of economic, educational, cultural or social vulnerability, in order to determine the need or not
p.(None): of the presence of an independent witness in the consent process.
...
p.(None): consent to participate in the study and the need to immediately inform the investigator if
p.(None): suspect they are pregnant at any time during the study;
p.(None): (b) Performing women of childbearing age with a pregnancy test prior to study entry and then at each
p.(None): control visit provided in the protocol;
p.(None): (c) a positive pregnancy test will imply the exclusion of the potential participant or, if already
p.(None): participating, the preventive suspension of the intervention, if applicable. In case of pregnancy, the investigator must
p.(None): guide the participant to receive appropriate care;
p.(None): (d) the researcher should ensure the participants' access to adequate contraceptive methods, respecting
p.(None): as much as possible their freedom of choice and then controlling their adherence. When non-adherence is verified, the
p.(None): Participant must be excluded from the research.
p.(None): 4.4.5. A medical or dental professional, as appropriate, should be in charge of the health care of
p.(None): participants in the course of the study.
p.(None): 4.4.6. In case the study jeopardizes the integrity or health of the participant, for example, by reaction
p.(None): Adverse or due to therapeutic failure, the investigator must take all precautions to stop exposure to
p.(None): risk.
p.(None): 4.4.7. The use of placebo in a control group must be adequately justified in its methodological and ethical aspects. The
p.(None): Addition strategies to standard therapy, use for short periods and quick rescue are recommended in this type of
p.(None): design.
p.(None): 4.4.8. The investigator must ensure that participants will receive appropriate medical attention in the event of events
p.(None): research-related adverse events, which must be available at any time
p.(None): require. If an intercurrent disease is diagnosed by a procedure of the
p.(None): research, the researcher should guide the participant to get the care they need.
p.(None): 4.4.9. When a modification to the protocol is foreseen or information has been obtained that could affect the
p.(None): safety of participants or their decision to remain in the trial, consent must be requested before
p.(None): implement the change or continue the study.
p.(None): 4.4.10. The interventions or experimental procedures should not have any cost for the participants,
p.(None): regardless of the existence or not of specific funding for the trial. This does not prevent, for
p.(None): be non-commercial scientific research, treatments or procedures that the participant
p.(None): require for your illness to be covered by your usual health coverage.
p.(None): 4.5. Trial supervision
p.(None): 4.5.1. Before starting the investigation, the investigator must have the written approval of a REC. For such
p.(None): Finally, the researcher must send you all the documentation that he requests, including the protocol and its
p.(None): amendments, consent documents and their amendments, and all available information regarding the
...
p.(None): Participants are not made by the researcher, but by nature: healthy or sick, with or without a risk factor; user or not
p.(None): user of a service or health program, etc. Two subtypes of observational research are recognized:
p.(None): Descriptive or exploratory research: quantitative or qualitative description of facts or phenomena
p.(None): observed, without posing a hypothesis. Examples: prevalence studies, cross-sectional, demographic,
p.(None): sociological, etc.
p.(None): Analytical research: a hypothesis that can be association, risk or causality is proposed and tested
p.(None): that hypothesis versus a null hypothesis. The predictor variable is the risk factor and the outcome variable is
p.(None): the illness. The researcher only analyzes the frequency of appearance of the variables but does not intervene on them.
p.(None): INVESTIGATOR: individual responsible for conducting the investigation in the research center. If it's a team
p.(None): the one who conducts the research in a center, the researcher is responsible for the team and is called the researcher
p.(None): principal. The Principal Investigator may delegate tasks to his team but retains his responsibility for
p.(None): supervision.
p.(None): PARTICIPANT: healthy or sick individual who participates in an investigation or contributes to the investigation with their data
p.(None): personal or biological samples.
p.(None): SPONSOR: natural or legal person responsible for the initiation, management and financing of a clinical trial.
p.(None): PLACEBO: inert substance or sham treatment or procedure given to a control group in trials
p.(None): clinicians in order to provide a baseline measurement for the study, reducing bias due to suggestion effect.
p.(None): VULNERABLE POPULATION: group of individuals with mental or legal incapacity to understand the characteristics of a
p.(None): research or to express your will or that
p.(None): due to an unfavorable social, cultural, educational or economic condition, it has greater susceptibility
p.(None): to be influenced by the expectation of receiving a benefit for participating in the research (incentive
p.(None): improper) or to be the victim of a threat from investigators or others in a situation of
p.(None): power in case of refusing to
p.(None): participate (coercion).
p.(None): ACTIVE SUBSTANCE: chemical substance of natural, biological or synthetic origin that has a pharmacological effect
p.(None): specific and is used in human medicine for its therapeutic potential.
p.(None): STANDARDIZED OPERATIONAL PROCEDURES (POE): written set of
p.(None): instructions in order to achieve uniformity in the execution of a specific function.
p.(None): PROTOCOL: document that describes the background, rationale, purpose, objectives, design, methodology, plan
...
Orphaned Trigger Words
p.(None): - International Declaration on Bioethics and Human Rights (UNESCO, 2005) This Guide has been submitted to
p.(None): evaluation of the following entities:
p.(None): - National Academy of Pharmacy and Biochemistry
p.(None): - National Academy of Medicine
p.(None): - National Academy of Dentistry
p.(None): - National Administration of Laboratories and Health Institutes (ANLIS)
p.(None): - National Administration of Medicines, Food and Medical Technology (ANMAT)
p.(None): - Argentine Association of Respiratory Medicine
p.(None): - Association of Medicine Faculties of the Argentine Republic (AFACIMERA)
p.(None): - Association of Dentistry Faculties of the Argentine Republic (AFORA)
p.(None): - Joint Commission for Health Research and Central Ethics Committee - Undersecretariat for Health Planning
p.(None): - Ministry of Health of the Province of Buenos Aires
p.(None): - Central Committee of Research Ethics - Ministry of Health of the Government of the City of Buenos Aires (GCBA)
p.(None): - Research Protocol Ethics Committee - Hospital Italiano de Buenos Aires
p.(None): - Council for Ethical Evaluation of Health Research - Ministry of Health of Córdoba
p.(None): - Directorate for Research, Science and Technology - Undersecretariat for Planning and Control - Ministry of Health of
p.(None): Mendoza
p.(None): - General Directorate for Teaching and Research - Ministry of Health - GCBA
p.(None): - Teaching and Research Directorate - Ministry of Health of Jujuy
p.(None): - Argentine Federation of Cardiology
p.(None): - Argentine Federation of Nursing
p.(None): - Argentine Federation of Clinical Research Societies
p.(None): - Argentine Cardiology Foundation
p.(None): - Foundation for Ethics and Quality of Clinical Research in Latin America
p.(None): - Pan American Health Organization (PAHO)
p.(None): - World Health Organization (WHO)
p.(None): - Ministry of Health Programming - Ministry of Health of Córdoba
p.(None): - Society of Gynecology and Obstetrics of Buenos Aires
p.(None): - Argentine Society of Cardiology
p.(None): - Argentine Diabetes Society
p.(None): - Argentine Society of Gastroenterology
p.(None): - Argentine Society of Arterial Hypertension
p.(None): - Argentine Society of Infectology
p.(None): - Argentine Society of Internal Medicine
p.(None): - Argentine Society of Nephrology
p.(None): - Argentine Nutrition Society
p.(None): - Argentine Society of Clinical Oncology
p.(None): - Argentine Society of Pediatrics
p.(None): - Argentine Society of Rheumatology
p.(None): Note: All comments and suggestions received were considered and most of them were incorporated into the
p.(None): this Guide. In cases of dissent, the position presented in the international reference guides was prioritized.
p.(None): SCOPE
p.(None): For the purposes of this Guide, “human health research” refers to any activity in the sciences of the
p.(None): health that involves the systematic collection or analysis of data with the intention of generating
p.(None): new knowledge, in which human beings are exposed to observation, intervention or other
p.(None): of interaction with researchers, either directly or through the alteration of their environment or by
p.(None): means of collecting or using biological material or personal data or other types of records.
p.(None): In order to prevent the rules and regulations from being imposed on the usual practice of medicine or epidemiology
p.(None): procedures created in recent decades to protect research participants, it is important
...
p.(None): people to do what they would not otherwise consent to do and the researcher agrees to communicate to the
p.(None): participants that information and obtain their consent before using the data that has been generated.
p.(None): Responsibilities for information for participants. Primary responsibility for
p.(None): Information, both oral and written, for the research participants falls on the researcher. Without
p.(None): However, in cases involving health interventions with products, the veracity of the information on the
p.(None): Their effectiveness and safety will be the responsibility of the producer and / or sponsor of the research. In
p.(None): In all cases, the REC must verify that the written information is presented appropriately.
p.(None): A4. BENEFIT AND RISKS OF THE INVESTIGATION
p.(None): Q9. All human health research projects must include a meticulous evaluation of the
p.(None): expected risks and burdens compared to expected benefits. This does not prevent the participation of
p.(None): healthyXvolunteers in medical research.
p.(None): Q10. A human health investigation may be conducted only if the benefits to individuals or
p.(None): for society clearly outweigh the expected risks, and these have been minimized to the extent
p.(None): as possible. The investigation must be stopped if during its course it is observed that the damages
p.(None): are greater than the benefits or an interim analysis will show that the research question has already been
p.(None): answered.
p.(None): Q11. In all observational or experimental research, the products and procedures indicated in the
p.(None): protocol must be free for all participants. Risk justification. Participation in
p.(None): an investigation in which a diagnostic, therapeutic or preventive benefit is anticipated for the individual
p.(None): must be justified by the expectation that the intervention will be, according to the state of knowledge, as
p.(None): advantageous like any other available alternative. Instead, the risks of investigations without
p.(None): possibility of diagnostic, therapeutic or preventive benefit for the participant can be justified by the
p.(None): relevance of the new knowledge expected to be obtained.
p.(None): Identification of risks. The term "risk" refers to the possibility of damage occurring.
p.(None): For their part, the expressions "low risk" and "high risk" describe the magnitude of the probability of
p.(None): damage occurrence in terms of frequency and severity. A risk is considered low when it is similar or
p.(None): equivalent to the risks of routine medical practice. When planning an investigation, investigators
p.(None): They should try to identify all possible risks for the participants. The risks can be:
p.(None): a) physical: risks of adverse effects of the study interventions or procedures;
p.(None): (b) mental or emotional: when the sensitivity, values or rights of the participants can be affected, for
p.(None): example, if personal information is disclosed to third parties; Y
p.(None): (c) economic: when the participation can cause pecuniary losses. Risk minimization: After the
p.(None): Identifying the risks, researchers should develop a plan to minimize their effects.
p.(None): The usual strategies to minimize are:
...
p.(None): presence of an independent witness, who must sign, together with the investigator, the summary of information and the
p.(None): consent form. The
p.(None): Participant or their representative must sign the consent form and then receive an original thereof and
p.(None): a copy of the summary of information.
p.(None): 1.1.5. In observational studies, it is common to obtain informed consent from potential
p.(None): However, the CEI could approve the following exceptions:
p.(None): (a) when publicly available information is used. In such cases, investigators must demonstrate that they do not
p.(None): there is a risk of disclosure of personal data;
p.(None): (b) when obtaining consent is impracticable, as in the case of biological data or samples
p.(None): irreversibly dissociated, or retrospective cohort studies conducted on medical records. In
p.(None): In the latter case, investigators must guarantee strict measures to protect the confidentiality of
p.(None): information owners, for example, irreversible decoupling of health data in health records
p.(None): research regarding personal identification data; Y
p.(None): (c) when obtaining consent frustrates the objective of a study of habits or behavior with
p.(None): regarding the health of communities or groups. By being informed, participants would modify the
p.(None): behavior you are trying to study, or this could cause unnecessary concern. In such cases,
p.(None): Researchers must commit to requesting the consent of the participants when the study has
p.(None): concluded but before disseminating its results.
p.(None): 1.1.6. An investigator proposing not to obtain informed consent must justify the reason and explain to the
p.(None): CEI how the study will conform to ethical principles in such a case. The investigator should not proceed
p.(None): with the investigation without the specific approval of the CEI for the exception of the consent of the
p.(None): participants.
p.(None): 1.1.7. In the case of surveys or interviews that are carried out remotely (by phone or email) or that
p.(None): will be analyzed anonymously, the requirement to sign a document as proof of consent can be omitted
p.(None): but the provision of the information related to the study in written form should not be omitted (personally or by
p.(None): email) or verbal (survey or telephone interview). The researcher must always respect the right to
p.(None): the confidentiality of the person surveyed or interviewed.
p.(None): 1.2. Guidelines for obtaining informed consent
p.(None): 1.2.1. The informed consent document includes at least two sections: the information sheets for the
p.(None): participant and signature sheet. Any document that is intended to be used in the process must be previously approved by
p.(None): the CEI.
p.(None): 1.2.2. Informed consent must be obtained before proceeding with the evaluation of the eligibility criteria
p.(None): or any other specific study procedure.
p.(None): 1.2.3. Oral and written information provided to the potential participant or their representative must be submitted
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| breastfeeding | breastfeeding |
| child | Child |
| childbearing age | of childbearing age/fertile |
| children | Child |
| cioms | cioms guidelines |
| cognitive | Cognitive Impairment |
| coma | Comatose |
| control group | participants in a control group |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| displaced | displaced |
| drug | Drug Usage |
| education | education |
| educational | education |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| ethnicity | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| helsinki | declaration of helsinki |
| illiterate | Literacy |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| infant | Infant |
| influence | Drug Usage |
| injured | injured |
| job | Occupation |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| nation | stateless persons |
| occupation | Occupation |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| political | political affiliation |
| poor | Economic/Poverty |
| precarious housing | precarious housing |
| pregnant | Pregnant |
| race | Racial Minority |
| racial | Racial Minority |
| refugee | Refugee Status |
| restricted | Incarcerated |
| sick | Physically Ill |
| stemXcells | stem cells |
| stigmatization | Threat of Stigma |
| stigmatized | Threat of Stigma |
| substance | Drug Usage |
| threat | Threat of Stigma |
| undueXinfluence | Undue Influence |
| unemployment | Unemployment |
| union | Trade Union Membership |
| victim | Victim of Abuse |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| cognitive | ['impairment'] |
| control group | ['placebo'] |
| disability | ['mentally'] |
| drug | ['influence', 'substance'] |
| education | ['educational'] |
| educational | ['education'] |
| ethnic | ['ethnicity'] |
| ethnicity | ['ethnic'] |
| impairment | ['cognitive'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| influence | ['drug', 'substance'] |
| job | ['occupation'] |
| liberty | ['restricted'] |
| mentally | ['disability'] |
| occupation | ['job'] |
| party | ['political'] |
| placebo | ['controlXgroup'] |
| political | ['party'] |
| race | ['racial'] |
| racial | ['race'] |
| restricted | ['liberty'] |
| stigmatization | ['threat', 'stigmatized'] |
| stigmatized | ['threat', 'stigmatization'] |
| substance | ['drug', 'influence'] |
| threat | ['stigmatization', 'stigmatized'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
self-determination
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input