Cells and Surveys Should Biological Measures Be Included in Social Science Research? (2001) / Chapter Skim
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Informed Consent for the Collection of Biological Samples in Household Surveys
Informed Consent for the Collection of Biological Samples in Household Surveys
Pages 276-302
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From page 276... ...
However, if the analysis of stored tissues poses some risk to the tissue source, and adequate informed consent has not been obtained, then use of the specimens may not be appropriate. Recontacting tissue sources for consent may be prohibitive in terms of time, effort, and expense, thereby rendering the repository useless for research purposes.
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From page 277... ...
This brief sketch of the recent controversies over stored tissue samples illustrates two points. First, the current discussion of the collection of biologic samples in household surveys occurs within a charged atmosphere.
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From page 278... ...
The most egregious examples of abuse in U.S. biomedical research have involved nontherapeutic research projects, including the Tuskegee syphilis experiments, the lewish Chronic Disease Hospital, Willowbrook, and the human radiation experiments (Advisory Committee on Human Radiation Experiments, 1995~.
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From page 279... ...
The other essential pillar on which the ethical justification of research rests is peer review. THE COMMON RULE A household survey with the collection of biologic specimens constitutes nontherapeutic research and, if conducted under the auspices of the federal government, is subject to federal regulations under Title 45, Part 46 of the Code of Federal Regulations (Department of Health and Human Services, 1991~.
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From page 280... ...
Of course, most useful household surveys will involve extensive data collection, including sensitive information such as health status, and collection of specimens for a variety of analyses. Therefore, it is unlikely that household surveys with specimen collection would qualify for waiver of consent under any circumstances.
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From page 281... ...
In addition, genetic testing may reveal family information, including the mutation status of a parent, or revelations like misattributed paternity. Third, the concern over genetic information is heightened by the history of abuse of genetic information during the eugenics era and under German National Socialism, but also more recently with the sickle cell screening program in the United States during the 1970s.
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From page 282... ...
are not generally useful for detecting silent or presymptomatic disease. For example, inclusion of nongenetic tests such as liver or renal function tests on a household survey would confer the ability to detect current liver or kidney dysfunction problems about which the subject may not be aware.
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From page 283... ...
An initial decision with any proposal to conduct a household survey with tissue acquisition will be about the storage and management of the specimens. A repository refers to a tissue bank that is established as a source of samples for future, currently unspecified research.
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From page 284... ...
Coded samples, or linked samples, are labeled with a code that permits identification of the tissue source. In many circumstances, only the repository or a designated third party will have access to the database containing the link between the code and the individual identifiers.
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From page 285... ...
The scientific value of the samples is enhanced with more information about the subjects available, but the threats to subject privacy and confidentiality are increased as well. Depending on the nature of the project, a common balance between these competing interests is struck by maintaining a repository with identified specimens and by establishing procedures for distributing unlinked or coded samples to qualified investigators subject to IRB review.
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From page 286... ...
The following issues will be presented as points to consider in developing a consent process for a household survey involving biological samples. An assumption in developing these points is that specimens will be identifiable in a repository.
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From page 287... ...
It also will be important to explain to potential subjects why they have been asked to participate. Particularly in the context of a household survey (that is, outside a health care environment)
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Communicating Results of the Research When and how to return research results to subjects remains somewhat controversial. In some circumstances, research protocols use validated tests, the results of which may be clinically valuable for the subject (such as cholesterol measurements or renal function tests)
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The NHANES III project returned clinically valid results to subjects directly through letters to the subjects. Subjects who had results that were medically concerning were advised to make an appointment with their physician.
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From page 290... ...
When clinically valid tests are part of the protocol, such as cholesterol or blood pressure measurement, subjects may benefit from individual results provided conveniently without financial cost. However, assuming subjects are not being selected based on disease status and provided therapeutic interventions, survey projects are nontherapeutic research.
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From page 291... ...
. Therefore, unless comprehensive federal legislation is passed, a multistate household survey would approach potential subjects who have a complex mix of baseline risks for discrimination based on the results of testing.
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From page 292... ...
An occasional risk in genetic research projects is the detection of misattributed paternity, that is, the finding that the subject's social father is not his or her genetic father. A history of adoption also might be discovered through genetic testing, although this is a less common problem.
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From page 293... ...
concludes: "It is inappropriate to ask a subject to grant blanket consent for all future unspecified genetic research projects on any disease or in any area if the samples are identifiable in those subsequent studies." The National Bioethics Advisory Commission (1999) in its Recommendation 9 outlined six options that investigators might include in consent forms.
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From page 294... ...
Of course, the investigator may not know the identities of the tissue sources, but the repository does, and it would be left with a dilemma if the investigator reports to the repository that she found subjects who are mutation carriers on clinically valid tests to which the subject did not consent. A potential solution to the problem of recontacting subjects for consent is to unlink samples that are distributed to investigators.
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From page 295... ...
This issue has not been the subject of commentary by the organizations that have developed guidelines on stored tissues. Commercial Use of Specimens Academic medicine and public agencies have an increasingly complex relationship with biotechnology companies that may seek to use resources developed for research or public health activities for the development of commercial products.
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From page 296... ...
Specific federal regulations apply to children (Department of Health and Human Services, 1991~. In brief, research involving no greater than minimal risk (as defined above)
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Children may be especially vulnerable to social stigma and discrimination based on predictive test results. Therefore any household survey research that included testing of linked specimens of children for serious adult onset disorders probably would be considered greater than minimal risk.
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From page 298... ...
However, a number of states have legislated prohibitions on research with mentally impaired subjects that would have to be carefully evaluated in a national survey (NBAC, 1998:note 280~. The National Bioethics Advisory Commission's 1998 recommendations would not change these general guidelines if the research is deemed of minimal risk.
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From page 299... ...
Consent may been seen as a perfunctory exercise in response to a litigious society, and/or as a futile effort to quickly educate laypersons in complex medical concepts. Indeed, subjects often have a poor recollection of basic research facts, and may even forget that they are involved in research (Advisory Committee on Human Radiation Experiments, 1995~.
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From page 300... ...
American Journal of Human Genetics 59:471-474. American Society of Human Genetics, American College of Medical Genetics 1995 Points to consider: Ethical, legal, and psycho-social implications of genetic testing in children and adolescents.
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From page 301... ...
Weiss 1995 Informed consent for genetic research on stored tissue samples. Journal of the American Medical Association 274:1786-1792.
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From page 302... ...
McQuillan, and M.J. Khoury 1998 Use of stored tissue samples for genetic research in epidemiologic studies.
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