The MICHR Genomic DNA BioLibrary: An Empirical Study of the Ethics of Biorepository Development.
In this article, we report on an effort to study the development and usefulness of a large, broad-use, opt-in biorepository for genomic research, focusing on three ethical issues: providing appropriate understanding, recruiting in ways that do not comprise autonomous decisions, and assessing costs versus benefits. We conclude the following: (a) Understanding can be improved by separating the task of informing subjects from documenting informed consent (Common Rule) and permission to use personal health information and samples for research (Health Insurance Portability and Accountability Act [HIPAA]); however, regulations might have to be changed to accommodate this approach. (b) Changing recruiting methods increases efficiency but can interfere with subject autonomy. (c) Finally, we propose a framework for the objective evaluation of the utility of biorepositories and suggest that more attention needs to be paid to use and sustainability.
Michigan Institute for Clinical and Health Research (MICHR), University of Michigan Medical School, Ann Arbor, Michigan, USA Division of Rheumatology, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Blake J
BJ
Roessler
Michigan Institute for Clinical and Health Research (MICHR), University of Michigan Medical School, Ann Arbor, Michigan, USA Department of History, College of Literature, Science and the Arts, University of Michigan, Ann Arbor, Michigan, USA nsteneck@umich.edu.
Nicholas H
NH
Steneck
Michigan Institute for Clinical and Health Research (MICHR), University of Michigan Medical School, Ann Arbor, Michigan, USA.
Lisa
L
Connally
D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics*; D032882:Comprehension; D032962:Consent Forms; D003362:Cost-Benefit Analysis; D004247:DNA; D016678:Genome; D023281:Genomics / Q000941:ethics*; D020408:Health Insurance Portability and Accountability Act; D055991:Health Records, Personal / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D018579:Patient Selection; D026684:Personal Autonomy; D035842:Research Subjects; D014481:United States
D004247:DNA
autonomy; biobank; biorepository; cost–benefit analysis; ethics; genomic research; informed consent; understanding