The DOI matches its Crossref record.
Reform of Clinical Research Regulations, Finally
Abstract
Interview with Prof. Alexander Capron on proposed changes to regulations governing human-subjects research. (16:55)Download The proposed changes to the Common Rule for human subjects research, though imperfect, are a significant step forward. They would enhance protections of research participants and improve the efficiency of the review process.
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The proposed changes have been the subject of intense debate, with some supporting the NPRM's clarification and specification of procedures for biospecimen research and others saying the consequences will be missed opportunities and lost lives caused by delays in important research.
“The proposed changes have been the subject of intense debate.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [34]
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Lessons from HeLa Cells: The Ethics and Policy of Biospecimens
Beskow, L. M. (2016) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-083115-022536 · Cited by 146
“Although some support the NPRM’s clarification and specification of procedures for biospecimen research (34), others say the consequences will be missed opportunities and lost lives caused by delays in important research (50).”
Background
Metadata
- Authors
- Emanuel, E. J.
- Affiliations
- University of Pennsylvania (US)
- Corresponding author
- Emanuel, Ezekiel J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-12-10
- Volume
- 373
- Issue
- 24
- Pages
- 2296-2299
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2315059419
- Cited by
- 34
- References
- 0
- Citations by year
- 2024: 1 · 2021: 1 · 2020: 1 · 2019: 3 · 2018: 3 · 2017: 10 · 2016: 15
- FWCI
- 10.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- Common Rule, human subjects research, research participant protection, informed consent, research ethics oversight
- MeSH terms
- Humans, Human Experimentation, Informed Consent, Specimen Handling, United States, Databases as Topic, Ethics Committees, Research, Codes of Ethics, Government Regulation, Research Subjects, History, 20th Century
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