Evidence map›Paper›PMID 30058382›Full record

ArticleAccountability in research2018

How U.S. research institutions are responding to the single Institutional Review Board mandate.

David B Resnik, Elise M Smith, Min Shi

Abstract read
In one paragraph

Article in Accountability in research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

David B Resnika National Institute of Environmental Health Sciences, National Institutes of Health , Research Triangle Park , North Carolina , USA.
Elise M Smitha National Institute of Environmental Health Sciences, National Institutes of Health , Research Triangle Park , North Carolina , USA.
Min Shia National Institute of Environmental Health Sciences, National Institutes of Health , Research Triangle Park , North Carolina , USA.

Funding

Ethical, social, and legal issues in environmental health researchZIAES102646 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI RESNIK, DAVID · 2009 to 2025
$1.8M
Intramural NIH HHS ZIA ES102646
6 · The paper itself

Abstract

One of the most significant changes to the Common Rule is the requirement that institutions use a single Institutional Review Board (IRB) for cooperative research in the United States, unless more than one IRB is required by state, local, or tribal law, or a signatory federal agency decides an exception is warranted. We surveyed Human Research Protection Program (HRPP) officials at the top U.S. research institutions to understand their knowledge and opinion of the mandate, what steps their institutions are taking, and difficulties their institutions are facing. One-hundred seven institutions (56.9%) responded to the survey. While support for the single-IRB mandate was positive overall, most respondents acknowledged that their institution is likely to face some difficulties complying with it. Regulatory agencies can help institutions to comply with the mandate by providing guidance concerning such issues as exceptions to the mandate, local context review, oversight, and implementation of reliance agreements, and development of policies, procedures, and best practices.

Indexed as

Research SubjectsAcademies and InstitutesEthics Committees, ResearchHumansKnowledgeUnited StatesCommon rulehuman research regulationinstitutional review boardslegal liabilityreliance agreements

Identifiers

PMID30058382
PMCPMC6336442

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.