Conducting Biosocial Surveys Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata (2010) / Chapter Skim
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4 Informed Consent
4 Informed Consent
Pages 55-72
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From page 55... ...
The debate has been particularly heated with respect to large-scale repositories of human biological specimens that are linked to clinical or socioeconomic data and are being used to assess interactions between genes and the environment similar to those discussed in this report. Thus, social scientists considering adding the collection of biospecimens to their surveys will find that doing so makes informed consent a much more complex process than is the case for survey research that involves collecting only selfreported psychological, social, or economic data.
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From page 56... ...
The third section reviews a number of unresolved issues surrounding informed consent in social science survey research that includes the collection of biospecimens. The chapter ends with a discussion of the role of Institutional Review Boards (IRBs)
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From page 57... ...
The purpose of informed consent and the reasons behind it have changed little since the Declaration of Helsinki was issued: no one should be subjected to experimentation -- or other research activities -- without giving permission, and that permission is meaningful only if the person understands what he or she is giving permission for. Thus the process of informed consent is designed to provide human subjects with sufficient information about the nature and purpose of the research, the procedures to be employed, and the potential risks and benefits of their participation so they can make an informed decision about whether to participate.
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From page 58... ...
Generally, although informed consent should be obtained before biospeci mens are collected, in some instances postcollection consent is appropriate. This is the case, for instance, for the use of leftover specimens from earlier surgery or cases in which it was not initially possible to obtain consent because of the participant's illness, undue stress, or inability to comprehend the consent procedure.2 DIFFERENCES IN CONSENT PRACTICES BETWEEN SOCIAL SCIENCE SuRvEy AND BIOMEDICAL RESEARCH When social science surveys include the collection of biospecimens, two hitherto separate informed consent processes coincide.
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From page 59... ...
The addition of data derived from biospecimens to survey data may increase the risk of a breach of confidentiality and the amount of potentially damaging information that could be revealed in such a breach. To the extent that social science surveys that include the collection of biospecimens pose risks commensurate with those posed by biomedical research -- including the risk, real or perceived, of disclosure -- the informed consent process should be of parallel rigor.
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From page 60... ...
Researchers who are collecting biological specimens (or establishing collection protocols for such specimens) as part of a social science survey therefore face a difficult issue concerning consent for potential future research uses of the specimens they collect and the data derived therefrom.
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From page 61... ...
biotech company, has developed "dynamic consent procedures in which subjects are contacted by e-mail each time their DNA is used." Study participants offer informed consent for the initial study, and later, if the same or a different group of researchers wishes to use the biospecimens or the data generated therefrom in a new study, the participants can say yes or no to the new research (Shickle, 2006, p.
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From page 62... ...
Approaches to Mitigating Problems Raised by Blanket Consent One major problem with blanket consent is that it is inherently vague, and thus study participants can never know exactly what their biospecimens and other information will be used for in the future. This lack of knowledge presents a serious ethical issue: blanket consent arguably fails to meet the basic requirement for informed consent that it describe the possible risks of a study to potential participants.
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From page 63... ...
For example, Rothstein argues that "as long as the potential research subjects are clearly apprised of the range of possible future uses of their sample, they should be permitted to give one-time blanket consent to such uses" (Rothstein, 2005, pp.
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From page 64... ...
Deidentification or Anonymization and Consent In certain cases when data have been deidentified -- that is, meeting the requirements of the Health Insurance Portability and Accountability Act (HIPAA) 5 but not rendered completely and irreversibly anonymous -- participants are not considered "human subjects" under the Common Rule (45 CFR Part 46, Subpart A)
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From page 65... ...
The original investigators (and anyone who obtains access to the specimens or data through them or their storage facility) must play by the usual rules governing research with human subjects, while those using the deidentified or anonymized data are deemed no longer subject to the Com mon Rule.
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From page 66... ...
One possibility is to use the consent process to inform participants that no diagnostic information will be disclosed, but that they should have regular medical care and consider asking a physician to obtain genetic or other potential diagnostic indicators such as those collected in the study. This may be a tempting option for studies in which the investigators cannot claim competence to deal with diagnostic issues.
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From page 67... ...
515) comments, "It would be unreasonable and impractical for a participant to require that data previously collected be removed from any analyses previously conducted and potentially published." The more difficult question is whether data derived from a participant's biospecimens can be used in studies after consent is withdrawn.
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From page 68... ...
Third-Party Issues Because relatives of the participants in a study share some of the partici pants' DNA, many of the same risks participants face exist for their relatives as well, albeit in attenuated form. Any sensitive information, such as a genetic predisposition to a disease that is obtained from the genetic sample of a study participant may also apply to his or her biological relatives.
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From page 69... ...
OPRR agreed that the father was a subject and faulted the IRB for its failure to consider whether, in this case, family members were or were not research subjects. In the case of genome-wide association studies, it is impossible to avoid accumulating some information about third parties, since sequencing the genome of a study participant inevitably provides genetic information about that individual's biological relatives.
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From page 70... ...
If informed consent is required, an IRB must approve the informed consent document before the beginning of the study and then review it periodically. IRBs are also permitted to waive or alter the informed consent requirement if a study meets the conditions described in the Common Rule, the basic federal rule governing the role of IRBs in overseeing human subjects research.
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From page 71... ...
from a repository or biobank is unclear, and this subject is not considered in the federal regulations. The current IRB structure was designed primarily for direct human research, and it works especially well in such cases as clinical drug trials because the IRB paradigm assumes that researchers will be working with live human subjects to whom they disclose the probability and magnitude of potential harms that may be associated with the research (Meslin and Quaid, 2004)
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From page 72... ...
As biosocial surveys and studies become more common, it is likely that the number of projects requiring multiple IRBs will increase. To be sure, this issue is not limited to biosocial surveys, but it will become increasingly important to find new ways to provide the oversight that IRBs offer without the complica tions entailed in having to answer to independent and uncoordinated entities at multiple institutions.
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