title: Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.
abstract: Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.
authors.affiliation: Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, United States of America.
authors.forename: Raymond Gene
authors.identifier: http://orcid.org/0000-0003-3087-3040
authors.initials: RG
authors.lastname: De Vries
authors.affiliation: Center for Ethics and Humanities in the Life Sciences, Michigan State University, East Lansing, Michigan, United States of America.
authors.forename: Tom
authors.initials: T
authors.lastname: Tomlinson
authors.affiliation: Center for Statistical Consultation and Research, University of Michigan, Ann Arbor, Michigan, United States of America.
authors.forename: Hyungjin Myra
authors.initials: HM
authors.lastname: Kim
authors.affiliation: Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, United States of America.
authors.forename: Chris
authors.identifier: http://orcid.org/0000-0002-0514-4586
authors.initials: C
authors.lastname: Krenz
authors.affiliation: Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, Michigan, United States of America.
authors.forename: Diana
authors.initials: D
authors.lastname: Haggerty
authors.affiliation: Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, United States of America.
authors.forename: Kerry A
authors.initials: KA
authors.lastname: Ryan
authors.affiliation: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, United States of America.|Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, United States of America.
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D018907:Privacy; D014019:Tissue Donors; D014481:United States