Leveraging Longitudinal Data in Developing Countries Report of a Workshop (2002) / Chapter Skim
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Overview of Ethical Issues in Collecting Data in Developing Countries, with Special Reference to Longitudinal Designs
Overview of Ethical Issues in Collecting Data in Developing Countries, with Special Reference to Longitudinal Designs
Pages 75-96
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From page 75... ...
Raloirl Program or Ethical Issues irz Ir~terrzatiorzal Health Research DepartmeritofPopul~tiorl arldIriterrlatiorlalHealth Harvard School of Public Health This paper identifies major ethical issues in longitudinal health research and demographic and health data collection and analysis, specifically as they are related to research conducted in developing countries. A discussion of general ethical principles for health research and questions of community-based ethics is followed by a description of the benefits and risks of longitudinal health research, with special reference to the issues of informed consent, confidentiality, and researcher responsibilities to the host community.
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The ICMR proposed that 12 general principles be considered in designing research projects involving human subjects: (1) essentiality (of the research)
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The World Medical Association, founded in 1947 as an independent confederation of medical associations worldwide, adopted the Declaration of Helsinki as its organizational policy on ethical principles for medical research involving human subjects in 1964 (World Medical Assembly, 1964 )
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, originally published by CIOMS in 1993 and presently undergoing revisions, replaced a 1982 set of proposed guidelines that were intended to elucidate how to apply effectively the ethical principles set forth in the Declaration of Helsinki, with particular attention to research conducted in developing countries. The International Ethical Guidelines for Biomedical Research Involving Human SulDjects are designed for use in developing national policies on ethical biomedical research and mechanisms for ethical review of research using human subjects.
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The International Guidelines for Ethical Review of EpidLemiological Stud(iespublished by CIOMS acknowledges in Guideline 25 that there are often cultural differences between researchers and research subjects: Investigators must respect the ethical standards of their own countries and the cultural expectations of the societies in which epidemiological studies are undertaken, unless this implies a violation of a transcending moral rule. Investigators risk harming their reputation by pursuing work that host countries find acceptable but their own countries consider offensive.
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The draft revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human SulDjects offers two statements in response to this question. Guideline 6 states that the research should be "responsive to the health needs and the priorities of the population or community in which it is to be carried out" (Council for International Organizations of Medical Sciences, 20011.
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Increased community involvement marks a dramatic shift in the historically paternalistic attitudes of many researchers, serving to improve the relationship between invectis,~orc Inch the host community. ISSUES OF INFORMED CONSENT , O_ Informed consent is the primary ethical concern of many researchers and ethical review boards (ERBs)
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vidLelines for Biomedical Research on Human Subjects address these issues, acknowledging that many communities in India, because of an insufficient level of education, are less able to understand study procedures or implications than communities in more developed countries: When individuals are to be the subject of any epidemiological studies, the purpose and general objectives of the study has to be explained to them keeping in mind their level of understanding.... In the context of developing countries, obtaining informed consent has been considered many times as difficult/impractical/not meeting the purpose on various grounds such as incompetence to comprehend the meaning or relevance of the consent....
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The NBAC report Research Involving Human Biological Materials: Ethical Issues and Policy GuidLance provides an elaborate discussion of guidelines for collecting specimens for storage, testing, and later use (U.S. National Bioethics Advisory Commission, 19991.
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In other cases, the research ethics committee may require individual informed consent. (Council for International Organizations of Medical Sciences, 2001)
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Another problem is how to communicate the necessary information when the population of interest is illiterate. Finally, in light of the recent shift toward an increased emphasis on the informed consent process, how should the investigator determine whether the participant truly understands the potential risks, benefits, and procedures of the study?
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The CIOMS International Guidelines for Ethical Review of EpidLemiological Studies address the issues related to "harmful publicity" in Guideline 22: Conflict may appear between, on the one hand, doing no harm and, on the other, telling the truth and openly disclosing scientific findings. Harm may be mitigated by interpreting data in a way that protects the interests of those at risk, and is at the same time consistent with scientific integrity.
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, however, there may be a role for community representatives at this stage of the research project, because they could provide important insight into how to minimize potential harms. In the interest of full disclosure of potential harms, the commentary on Guideline 19 of the draft revision of the International Ethical GuidLelines for Biomedical Research Involving Human SHIDjects requires that information about the efforts that will be taken to ensure confidentiality be included in the informed consent process and, just as important, that prospective research participants "be informed of limits to the researchers' ability to ensure strict confidentiality and of the foreseeable adverse social consequences of breaches of confidentiality'' (Council for International Organizations of Medical Science, 20011.
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Guideline 6 in the draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects states:
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These requirements are less extreme than the controversial clause in the most recent version of the Declaration of Helsinki, which states: "At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study" (World Medical Assembly, 20001. If upheld, the mandate that investigators provide their participants with access to the best proven intervention which often far exceeds the community standard of care and is likely to be unsustainable over the long termmay limit the types of research that can be conducted in the developing country context beyond the exploitative situations that the mandate is meant to prevent.
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As a related issue, Guideline 22 of the draft revision of the International Ethical GuidLelines for Biomedical Research Involving Human Subjects deals with the approval of externally sponsored research: An external sponsoring agency should submit the research protocol to ethical and scientific review in the country of the sponsoring agency and according to the standards of that country, and the ethical standards applied should be no less exacting than they would be for research carried out in that country. Appropriate authorities of the host country, including a national or local
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The guideline does specify, however, that the host country committees are responsible for determining whether the research objectives are responsive to the needs and priorities of the country, and charges ethical reviewers in the sponsoring countries with the task of ensuring compliance with broad ethical standards. This guideline suggests that it is unethical to conduct research in a particular country if the study in question would not receive the approval of the ethical review board of the sponsoring agency.
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But this inequality is changing with the development of courses, workshops, and fellowships designed to provide short- and long-term training to researchers and ethical review board members from developing countries. Two such training programs are run through the Program on Ethical Issues in International Health Research at the Harvard School of Public Health, and the Bioethics Institute at the Johns Hopkins University.
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Indeed, many scientists, ERB members, and others have noted informally that much of the research in developing countries does not involve collaboration with Western scientists or companies, and that the international guidelines developed to protect the disadvantaged from foreign exploitation may in fact prevent scientists in developing countries from conducting some research that would, by most standards, be considered ethical in their country (personal communications with participants of research ethics workshops in Mexico, South Africa, India, Pakistan, and Nigeria)
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Geneva: CIOMS. 2001 Draft Revision of 1993 International Ethical Guidelines for Biomedical Research Involving Human Sulojects.
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U.S. National Bioethics Advisory Commission 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance- Volume I, Report and Recommendations of the National Bioethics Advisory Commission.
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