Conducting Biosocial Surveys Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata (2010) / Chapter Skim
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5 Findings, Conclusions, and Recommendations
5 Findings, Conclusions, and Recommendations
Pages 73-86
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From page 73... ...
Researchers who wish to collect biological specimens with social science data will need to develop new skills in a variety of areas, such as the logistics of specimen storage and management, the development of more diverse informed consent forms, and ways of dealing with the disclosure risks associated with sharing biogenetic data. At the same time, NIA and other funding agencies must provide researchers the tools they need to succeed.
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From page 74... ...
The most useful best-practice documents are updated frequently to reflect growing knowledge and changing opinions about the best ways to collect, store, use, and distribute biological specimens. At the same time, however, many issues arising from the inclusion of biospecimens in social science surveys are not fully addressed in the bestpractice documents intended for biomedical researchers.
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From page 75... ...
In addition to staff review, Scientific Review Panels should read and comment on all proposed data sharing plans. In much the same way as an unacceptable human subjects plan, an inadequate data sharing plan should hold up an otherwise acceptable proposal.
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From page 76... ...
Recommendation 4: NIA and other relevant funding agencies should support at least one central facility for the storage and distribution of biospecimens collected as part of the research they support. PROTECTINg PRIvACy AND CONFIDENTIALITy: SHARINg DIgITAL REPRESENTATIONS OF BIOLOgICAL AND SOCIAL DATA Several different types of data must be kept confidential: survey data, data derived from biospecimens, and all administrative and operational data.
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From page 77... ...
Recommendation 5: No individual-level data containing uniquely identify ing variables, such as genomic data, should be publicly released without explicit informed consent. Recommendation 6: genomic data and other individual-level data con taining uniquely identifying variables that are stored or in active use by investigators on their institutional or personal computers should be encrypted at all times.
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From page 78... ...
Standard disclosure limitation methods could be used to generate public-use data sets that would enable low-dimensional analyses involving genes, for example, one gene at a time. However, with several such public releases, it may be possible for a key match to be used to construct a data set with higher-dimensional genomic data.
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From page 79... ...
Beyond enforce ment, the purpose of such audits would be to identify challenges and solutions. Evaluating risks and applying protection methods, whether they involve restricted access or restricted data, is a complex process requiring expertise in disclosure protection methods that exceeds what individual principal investi gators and their institutions usually possess.
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From page 80... ...
This report takes the latter position -- that investigators should do their best to communicate adequately and accurately with participants, to provide procedural safeguards to the extent possible, and not to promise what is not possible.2 Social science researchers need to know that adding the collection of biospecimens to social science surveys changes the nature of informed consent. Informed consent for a traditional social science survey may entail little more than reading a short script over the phone and asking whether the participant is willing to continue; obtaining informed consent for the collection and use of biospecimens and biodata is generally a much more involved process.
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From page 81... ...
In particular, they should be given detail on the storage and use of the specimens that relates to those risks and can assist them in determining whether to take part in the study. Recommendation 11: In designing a consent form for the collection of biospecimens, in addition to those elements that are common to social science and biomedical research, investigators should ensure that certain other information is provided to participants: • ow long researchers intend to retain their biospecimens and the h genomic and other biodata that may be derived from them; • oth the risks associated with genomic data and the limits of what b they can reveal; • hich other researchers will have access to their specimens, to the w data derived therefrom, and to information collected in a survey questionnaire; • the limits on researchers' ability to maintain confidentiality; • ny potential limits on participants' ability to withdraw their speci a mens or data from the research; he penalties3 that may be imposed on researchers for various types • t of breaches of confidentiality; and • hat plans have been put in place to return to them any medically w relevant findings.
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From page 82... ...
One effective way to deal with these different comfort levels is to offer a tiered approach to consent that allows participants to determine just how their specimens and data will be used. Tiers might include participating in the survey, providing specimens for genetic and/or nongenetic analysis in a particular study, and allowing the specimens and data to be stored for future uses (genetic and/or nongenetic)
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From page 83... ...
Recommendation 14: NIA, OHRP, and other appropriate organizations should sponsor training programs, create training modules, and hold informational workshops on informed consent for investigators, staff of survey organizations, including field staff, administrators, and mem bers of IRBs who oversee surveys that collect social science data and biospecimens. The Return of Medically Relevant Information An issue related to informed consent is how much information to provide to survey participants once their biological specimens have been analyzed and in particular, how to deal with medically relevant information that may arise from the analysis.
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From page 84... ...
. Recommendation 16: In institutions that have separate biomedical and social science IRBs, mechanisms should be created for sharing expertise during the review of biosocial protocols.5 What Individual Researchers Need to Do Regarding IRBs Because the collection of biospecimens as part of social science surveys is still relatively unfamiliar to many IRBs, researchers planning such a study can expect their interactions with the IRB overseeing the research to involve a certain learning curve.
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From page 85... ...
. CONCLuSION It is the panel's hope that its recommendations will support the incorpo ration of social science and biological data into empirical models, allowing researchers to better document the linkages among social, behavioral, and biological processes that affect health and other measures of well-being while avoiding or minimizing many of the challenges that may arise.
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