Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?
Article first published online: 26 JUN 2013
© 2013 American Society of Law, Medicine & Ethics, Inc.
The Journal of Law, Medicine & Ethics
Special Issue: SYMPOSIUM: Revising the Common Rule: Prospects and Challenges
Volume 41, Issue 2, pages 440–453, Summer 2013
How to Cite
Williams, B. A. and Wolf, L. E. (2013), Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?. The Journal of Law, Medicine & Ethics, 41: 440–453. doi: 10.1111/jlme.12054
- Issue published online: 26 JUN 2013
- Article first published online: 26 JUN 2013
In its Advanced Notice of Proposed Rule Making (ANPRM), the U.S. Department of Health and Human Services proposed substantial changes to how biospecimen research is treated under the regulations governing human subjects research. Currently, much of this research can be conducted without consent because it may not be considered “human subjects” research, is considered exempt, or consent may be waived. Responding to criticisms that scientific changes have made biospecimen research riskier than contemplated when the Common Rule was last amended, the ANPRM proposes to require written consent for biospecimen research, even if they have been stripped of identifiers or initially collected for a non-research purpose.
The ANPRM's recognition of these risks is consistent with relatively recent NIH recommendations that research projects involving genetics, genomics, or biospecimen repositories should consider getting a Certificate of Confidentiality to provide additional protections to participants where breach of confidentiality is typically the primary risk. Ironically, the ANPRM proposals may make it more difficult to provide these protections. Our paper explores the implications of the conflicting requirements of the Certificate and the ANPRM proposals and makes recommendations for achieving the dual goals of appropriate consent and adequate confidentiality protections.