IRB Review and Public Health Biobanking: A Case Study of the Michigan Bio Trust for Health

The regulatory exception to consent is based on the assumption that when researchers obtain deidentified biospecimens, there is little risk that the individuals from whom the materials were obtained would be harmed by the research. Because of the deidentification process, the possibility of identify...

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Bibliographic Details
Published inIRB Vol. 34; no. 3; p. 11
Main Authors Mongoven, Ann, McGee, Harry
Format Journal Article
LanguageEnglish
Published Garrison The Hastings Center 01.05.2012
Subjects
Blood
Children & youth
Consent
Decision making
Ethics
Fiduciary responsibility
Medical screening
Nonprofit organizations
Parental rights
R&D
Research & development
United States > US
Michigan
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Summary:The regulatory exception to consent is based on the assumption that when researchers obtain deidentified biospecimens, there is little risk that the individuals from whom the materials were obtained would be harmed by the research. Because of the deidentification process, the possibility of identifying individuals whose biospecimens were stored was deemed negligible. Up to this point, blood had been collected and stored for purposes related to newborn screening and for possible personal use.\n Within Michigan, some participants in the citizen engagement sessions had expressed concerns that various social groups might be differentially benefited or burdened by BioTrust research. [...]the IRB felt that the spirit of respect for persons demands going beyond the "letter" of regulatory requirements that focus on individual risk to consider potential group harms.
ISSN:2578-2355
2578-2363