Broad Consent for Research With Biological Samples: Workshop Conclusions
Open accessAbstract
Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.
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As illustrated by current US regulations, the result of non-specific and non-harmonized regulations has sometimes been ambiguity, inadvertent constraints on research access, and research proceeding without consent.
“As illustrated by current US regulations, the result has sometimes been ambiguity, inadvertent constraints on research access, and research proceeding without consent (40, 47, 69).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [47]
The Abstract states that variation in consent practices has caused confusion, inadvertent constraints on future research, and research without consent. The Introduction likewise describes uncertainty limiting specimen use, and 'The Argument for Consent for Research with Biospecimens' explains that current U.S. guidance permits some research without consent. The paper does not specifically attribute all three outcomes to non-specific or non-harmonized regulations; it attributes them to variation in consent practices. (LLM, conf=0.84)
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- Authors
- Grady, C., Eckstein, L., Berkman, B., Brock, D., Cook-Deegan, R., Fullerton, S. M., Greely, H., Hansson, M. G., Hull, S., Kim, S., Lo, B., Pentz, R., Rodriguez, L., Weil, C., Wilfond, B. S., & Wendler, D.
- Affiliations
- National Institutes of Health Clinical Center (US)
- University of Tasmania (AU)
- Harvard University (US)
- Duke University (US)
- University of Washington (US)
- Stanford University (US)
- Uppsala University (SE)
- National Institutes of Health (US)
- Greenwall Foundation (US)
- Emory University (US)
- National Human Genome Research Institute (US)
- National Cancer Institute (US)
- Seattle Children's Hospital (US)
- Corresponding author
- Grady, Christine
- ORCID
- Venue
- The American Journal of Bioethics
- Publisher
- Informa UK Limited
- Published
- 2015-08-25
- Volume
- 15
- Issue
- 9
- Pages
- 34-42
- ISSN
- 1526-5161 (ISSN-L)
- 1536-0075
- PMC
- PMC4791589
- OpenAlex
- W2154438221
- Cited by
- 332
- References
- 41
- Citations by year
- 2026: 22 · 2025: 24 · 2024: 33 · 2023: 20 · 2022: 38 · 2021: 43 · 2020: 31 · 2019: 26 · 2018: 30 · 2017: 20 · 2016: 26 · 2015: 19
- FWCI
- 33.96
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The American Journal of Bioethics (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eCite Digital Repository (University of Tasmania) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Funders
- University of Utah
- National Institutes of Health (Z99CL999999)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- broad consent, human biospecimens, informed consent, research ethics, Common Rule, research oversight
- MeSH terms
- Communication, Congresses as Topic, Humans, Informed Consent, National Institutes of Health (U.S.), Tissue Donors, United States, Biological Specimen Banks, Personal Autonomy, Ethical Analysis, Ethics, Research, Biomedical Research
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