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Cited by 258Ethics in Clinical ResearchEthics and bioethics in healthcareResearch Data Management Practices

A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States

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Garrison, Nanibaa'A., Sathe, Nila A., Antommaria, Armand H. Matheny, Holm, Ingrid A., Sanderson, Saskia C., Smith, Maureen E., McPheeters, Melissa L., Clayton, Ellen W.·2016·Genetics in Medicine
DOI 10.1038/gim.2015.138PMC PMC4873460
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Abstract

Vast amounts of genomic and phenotypic data are needed for many types of research.Frequently, data must be aggregated from several sites to achieve the necessary sample size.These data are often placed in biobanks or biorepositories, which may exist at both the site(s) of collection and in aggregated or centralized sites, such as the database of Genotypes and Phenotypes.These data, which often were collected for one purpose-whether for clinical use or a specific research project-frequently can be studied for other research.These facts raise two distinct, but related, questions.The first is under what conditions data can and should be repurposed for other research in order to increase what can be learned from them.The second is whether data can and should be shared with other investigators in academic institutions, the government, and the commercial sector.Currently, regulations for the protection of research participants and the Health Information Technology for Economic and Clinical Health Act amendments to the Health Insurance Portability and Accessibility Act Privacy Rule 1 permit the sharing and repurposing of data under certain conditions without the consent of the individual from whom the data were obtained.However, the regulatory landscape is rapidly changing.The Advanced Notice of Proposed Rule Making (ANPRM) issued in 2011 by the Office of Human Research Protections deemed all biospecimens "identifiable per se" and so would require that individuals sign a "standard, brief general consent form" that would provide to participants an opportunity to say no to all future research.2 In 2014 the National Institutes of Health (NIH) required that investigators obtain broad consent for research and data sharing as a condition of funding for genomics research, with very few exceptions.3 Nonetheless, questions remain about the ethical and practical desirability and acceptability of broad consent for research and data sharing.Approaches to obtain permission for use of genomic samples and data include no consent, opt-out, opt-in, case-by-case, tiered or categorical, 4 and broad or blanket consent.Many have argued that blanket consent for unanticipated future research uses is unethical 5 or unworkable, 6 whereas others argue that such consent is acceptable as long as additional protections are in place, 7 especially since broad data sharing

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  • Some of the reviews rated the quality of the evidence, but their synthesized findings are limited by nontrivial limitations in the underlying studies.

    “Some of the reviews rated the quality of the evidence (24, 43), but their synthesized findings are limited by nontrivial limitations in the underlying studies.”

    From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [43]

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Cited by

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Authors
Garrison, N., Sathe, N. A., Antommaria, A. H. M., Holm, I. A., Sanderson, S. C., Smith, M. E., McPheeters, M. L., & Clayton, E. W.
Affiliations
  • Vanderbilt University Medical Center (US)
  • Cincinnati Children's Hospital Medical Center (US)
  • Boston Children's Hospital (US)
  • Icahn School of Medicine at Mount Sinai (US)
  • Northwestern University (US)
  • Vanderbilt University (US)
Corresponding author
Garrison, Nanibaa'A.
ORCID
Venue
Genetics in Medicine
Publisher
Elsevier BV
Published
2016-07
Volume
18
Issue
7
Pages
663-671
ISSN
1098-3600 (ISSN-L)
DOI
10.1038/gim.2015.138
PMC
PMC4873460
OpenAlex
W2263165437
Cited by
258
References
1
Citations by year
2026: 20 · 2025: 21 · 2024: 18 · 2023: 30 · 2022: 35 · 2021: 27 · 2020: 26 · 2019: 21 · 2018: 30 · 2017: 12 · 2016: 17
FWCI
2.85
Type
journal article
Language
en
Open access
Licence
Locations
  • Genetics in Medicine (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
Funders
  • Children's Hospital of Philadelphia (U01HG006389, U01-HG006830)
  • Cincinnati Children's Hospital Medical Center (U01HG006828)
  • National Human Genome Research Institute (U01HG006385, U01HG006379, U01HG006830, U01HG008666, K01HG008818, U01HG006375, U01HG008673, U01HG008672, U01HG006380, U01HG006382, U01HG006828, U01HG006378, U01HG008684, U01HG006388, U01HG006389)
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
  • Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
Keywords
broad consent, data sharing, genomic data, biobanks, biorepository, participant perceptions, research ethics, data reuse, presumed consent, opt-in consent, HIPAA
MeSH terms
Humans, National Institutes of Health (U.S.), United States, Biological Specimen Banks, Genomics, Information Dissemination, Genetic Research

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