Informed consent for secondary research under the new NIH data sharing policy
Open accessAbstract
The new NIH data sharing policy, effective January 2023, requires researchers to submit a data management and data sharing plan in their grant application. Expanded data sharing, encouraged by NIH to facilitate secondary research, will require informed consent documents to explain data sharing plans, limitations, and procedures.
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Informing participants of potential risks has difficulties with complex research studies.
“Difficulties with complex research studies”
From AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications (2023) · cites this paper as [237]
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AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications
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BackgroundData sharing and community-engaged research
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“This could lead, in some cases, to a consent bias, where there is a signi fi cant difference in measurements in a given piece of research between participants who are willing and participants who decline to be part of the research 24 (Rothstein, 2021).”
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- Authors
- Rothstein, M. A.
- Corresponding author
- Rothstein, Mark A.
- Venue
- Journal of Law, Medicine & Ethics
- Publisher
- Cambridge University Press (CUP)
- Published
- 2021
- Volume
- 49
- Issue
- 3
- Pages
- 489-494
- ISSN
- 1073-1105 (ISSN-L)
- 1748-720X
- OpenAlex
- W3205162638
- Cited by
- 27
- References
- 23
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 13 · 2022: 11
- FWCI
- 5.43
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- The Journal of Law Medicine & Ethics (publishedVersion)
- SSRN Electronic Journal (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- informed consent, secondary research, NIH data sharing policy, research data sharing, grant applications, research ethics
- MeSH terms
- Humans, Informed Consent, Research Personnel, Information Dissemination, Policy
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