CoChat
Sign Up
Cited by 2Ethics in Clinical ResearchEthics and bioethics in healthcareBiomedical Ethics and Regulation

The DOI matches its Crossref record.

Waving Goodbye to Waivers of Consent

Botkin, Jeffrey R.·2015·Hastings Center Report
DOI 10.1002/hast.520
Open this paper in CoChat — free account

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.

Overview

Integrity signals

Registry

Crossref · 10.1002/hast.520

Cites

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cited by

Sorted by citations

See all 2

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
DOI
10.1002/hast.520
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
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor, 9 d)
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

How to cite

Cite CoChat for the checks on this page, and the paper for its own findings.

This page
CoChat. (2026). Citation check: Waving Goodbye to Waivers of Consent. https://app.cochat.ai/papers/10.1002/hast.520
The paper
Botkin, J. R. (2015). Waving Goodbye to Waivers of Consent. Hastings Center Report. https://doi.org/10.1002/hast.520