Evidence map›Paper›PMID 28661730›Full record

ArticleThe American journal of bioethics : AJOB2017

A Proposed Process for Reliably Updating the Common Rule.

Benjamin E Berkman, David Wendler, Haley K Sullivan, Christine Grady

Abstract read
In one paragraph

Article in The American journal of bioethics : AJOB, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Genomics, Big Data, and Broad Consent: a New Ethics Frontier for Prevention Science.Prevention science : the official journal of the Society for Prevention Research · 2018
    Article
  3. The Indefinite "Stay" on Regulatory Reforms for Research With Prisoners.The American journal of bioethics : AJOB · 2017
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Benjamin E Berkmana National Institutes of Health Clinical Center and National Human Genome Research Institute.
David Wendlerb National Institutes of Health Clinical Center.
Haley K Sullivanb National Institutes of Health Clinical Center.ORCID http://orcid.org/0000-0002-0622-1846
Christine Gradyb National Institutes of Health Clinical Center.

Funding

Intramural NIH HHS Z99 CL999999
6 · The paper itself

Abstract

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking (ANPRM) and notice of proposed rulemaking (NPRM). Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations (i.e., pregnant women and fetuses, prisoners, children) where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive (and expeditious) changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes.

Indexed as

Ethics Committees, ResearchResearch PersonnelBiomedical ResearchEthics, ResearchHuman ExperimentationHumansInformed ConsentQuality Assurance, Health CareResearch SubjectsSocial ResponsibilityUnited StatesVulnerable PopulationsCommon Ruleframework legislationpublic consultation

Identifiers

PMID28661730
PMCPMC6010315

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.