The DOI matches its Crossref record.
Waving Goodbye to Waivers of Consent
Abstract
The Common Rule governs research on human subjects and attempts to balance respect for individual decision-making with efficiency when research risks are low. The regulations allow research to be conducted without consent if the data or biospecimens collected in a study are deidentified, and consent can be waived for identifiable data and biospecimens if the risks of the research are minimal and consent is deemed impracticable. These approaches have been widely used for research using clinical databases and residual clinical and research biospecimens, and they have proven remarkably successful over the past twenty-five years, if success is measured by a lack of adverse events.But the landscape is changing.
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“Finally, too much weight on consent elevates autonomy—a word referenced 43 times in the NPRM—as the guiding ethical principle at a high cost to other principles and values (17).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [17]
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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
“Finally, too much weight on consent elevates autonomy—a word referenced 43 times in the NPRM—as the guiding ethical principle at a high cost to other principles and values (17).”
Background
Metadata
- Authors
- Botkin, J. R.
- Corresponding author
- Botkin, Jeffrey R.
- ORCID
- Botkin, Jeffrey R.
- Venue
- Hastings Center Report
- Publisher
- Wiley
- Published
- 2015-11
- Volume
- 45
- Issue
- 6
- Pages
- insidebackcover-insidebackcover
- ISSN
- 0093-0334 (ISSN-L)
- 1552-146X
- OpenAlex
- W2228638706
- Cited by
- 2
- References
- 0
- Citations by year
- 2020: 1 · 2016: 1
- FWCI
- 0.36
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Hastings Center Report (publishedVersion)
- PubMed (publishedVersion)
- 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 › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Keywords
- Common Rule, waiver of consent, informed consent, de-identified data, biological specimen, medical databases, minimal risk research, research regulation, adverse events
- MeSH terms
- Decision Making, Humans, Informed Consent, Personal Autonomy, Parental Consent, Patient Safety
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