Cells and Surveys Should Biological Measures Be Included in Social Science Research? (2001) / Chapter Skim
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Ethical and Social Issues in Incorporating Genetic Research into Survey Studies
Ethical and Social Issues in Incorporating Genetic Research into Survey Studies
Pages 303-328
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From page 303... ...
have described existing population survey studies, enumerated the potential applications of population surveys for genetic study, and suggested means by which existing population surveys could be modified to render them more applicable for use in genetic studies. The purpose of this chapter is to provide an overview of the ethical and social issues associated with broadening existing household surveys to include biological sampling and associated 303
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From page 304... ...
Four general categories of ethical and social issues in genetic research studies are considered, including privacy, access and ownership of genetic information and materials, psychosocial risks of participating in genetic research studies, and potential grouprelated harms. In each of these sections, an overview of the relevant concerns associated with genetic research is provided and any special issues particular to survey studies are discussed.
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From page 305... ...
Genome Projects: How Big, How Fast? 1993 Human Genetic Research 1994 Assessing Genetic Risks: Implications for Health and Social Policy 1997 Promoting Safe and Effective Genetic Testing in the United States: Principles and Recommendations 1997 Evaluating Human Genetic Diversity 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Committee for the Study of Inborn Errors of Metabolism, Division of Medical Sciences, Assembly of Life Sciences, National Academy of Sciences President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Committee on Mapping and Sequencing the Human Genome, Board on Basic Biology, Commission on Life Sciences, National Research Council U.S.
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From page 306... ...
These include its familial nature, coupled with its unique identifying characteristics (Annas, 1993; Institute of Medicine, 1994; Tonsen et al., 1996; American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure, 1998~. With the exception of identical twins, a person's DNA is unique to them, but at the same time, knowledge of genetic information about a person can reveal information about directly identifiable others, including their relatives and even larger groups of individuals.
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The following sections of the chapter provide an overview of the issues to consider in planning and executing genetic research studies in each of these four categories, and directly relate these considerations to incorporating genetic research into survey studies. PRIVACY OF GENETIC INFORMATION IN RESEARCH STUDIES Paramount in the conduct of genetic studies is concern about protecting the privacy of potentially sensitive genetic information generated about research participants.
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From page 308... ...
Most institutions that receive some federal funds require that nonfederally funded projects be reviewed by their IRB as well. The critical importance of the informed consent process in describing the privacy-associated risks of genetic research studies and the mechanisms in place to protect participants is discussed in detail by Botkin in this volume, as well as elsewhere (Institute of Medicine, 1994; Clayton et al., 1995; American Society of Human Genetics, 1996~.
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From page 309... ...
However, most agree that researchers and IRBs should consider how study results will be reported, and should communicate any plans for publication to study participants as part of the informed consent process (OPRR, 1993; Powers, 1993~. When considering adding genetic studies to existing household demographic surveys, privacy-related concerns should be considered in light of the fact that at least some data from a number of current longitudinal U.S.
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From page 310... ...
Finally, existing database protections and operating procedures will need to be reexamined in light of collecting biological samples for genetic studies and sharing genetic information and/or samples. Issues associated with exploiting the accessibility of the Internet, and potential electronic security risks associated with genetic data that retains identifiers, are discussed in more detail elsewhere (National Research Council, 1997~.
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This alert also supports the need for further discussions that the Society hopes will be directed toward developing better regulations that will protect study participants without unduly restricting human genetic and genetic epidemiology research studies. In the context of a household survey, IRBs will have to carefully consider whether the acquisition of data on other family members makes those family members human subjects and whether informed consent must be obtained from them.
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All of these policies must be clearly communicated to study participants as part of the informed consent process.
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Compelling reasons must be presented to waive informed consent in genetic studies, and it does not appear that adding genetic research studies to survey studies would automatically qualify for a waiver, although this will depend very much on the nature of the genetic research under consideration. Specific situations in which waiver of consent for genetic studies might be possible have been discussed elsewhere (NBAC, 1999; American Society of Human Genetics, Executive Committee, 2000~.
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One solution to communicating very complicated genetic information of uncertain value that is generated in the context of a research proposal is to be very clear, in policy and communication with study participants, that interim results will not be provided to research participants. Even if researchers do not plan to provide study participants with interim research results, circumstances may occur to cause them to recon
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PSYCHOLOGICAL RISKS OF PARTICIPATION IN GENETIC RESEARCH STUDIES Many studies have documented psychological effects associated with receipt of genetic information. For genetic studies that plan to provide genetic information to participants as part of the study, these effects must be considered.
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Discussing these possibilities with study participants is an important component of the informed consent process for applicable genetic studies. As much as is possible, investigators must articulate plans to address such possibilities, and IRBs evaluating these research studies must be aware of these potential risks associated with genetic study participation and evaluate the study procedures accordingly (OPRR, 1993~.
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Assessing the impact of genetic information on individuals and their families in terms of the life decisions they make over extended periods of time would greatly enhance the informed consent process both in genetic research studies and in clinical genetic testing. GROUP-RELATED HARMS OF PARTICIPATION IN GENETIC RESEARCH STUDIES Privacy, access, ownership, and psychological risks of genetic information all must be considered within the context of cultural views of genetic and medical information and scientific research.
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, made a number of recommendations for conducting research studies on human genetic variation in a multinational, multicultural setting that can be extrapolated to genetic research within survey studies. The Committee made recommendations relevant to considering genetic research
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Community consultation is an approach of increasing importance in genetic research as well as in research with human subjects in general. NEW DIRECTIONS Coupling ongoing and planned survey studies with biological sampling for genetic studies holds considerable potential to contribute to our understanding of human diseases, conditions, and aging.
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From page 320... ...
This brochure advises potential study participants on the areas they should consider and the questions they should ask prior to agreeing to participate in a research study. In a second example of the involvement of research participants in the research process, the National Institutes of Health (NIH)
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Incorporating genetic research into survey studies may provide an opportunity to engage the general population in this discussion. Rethinking the relationship between the parties in genetic research will also force examination of the researcherparticipant relationship in general, and will require a reexamination of the nature of genetic information and research and how they are similar to or different from other types of medical information and research.
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There are very few data on the impact of genetic testing and research on the family unit. The lack of data poses challenges for the informed consent process in genetic research studies because it makes it difficult to give potential study participants good information about the true nature of the risks and benefits associated with their participation in a given study.
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From page 323... ...
It seems that the time is ripe for a merging of Me many disciplines, approaches, and resources that would be involved if genetic studies were appended to survey studies. If approached in a thoughtful and systematic fashion, expanding survey studies to include a genetic component has the potential to address many questions directly relevant to the introduction of genetic information and genetic services to the population as a whole.
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Or perish the thought? American Journal of Human Genetics 63:678-681.
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Hall, M.A., and S.S. Rich 2000 Laws restricting health insurers' use of genetic information: Impact on genetic discrimination.
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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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1998 Rethinking risks to human subjects in genetic research. American Journal of Human Genetics 63:682-685.
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328 ETHICAL AND SOCIAL ISSUES IN GENETIC RESEARCH Welsh, M.J., L-C.
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