Evidence map›Paper›PMID 40372559›Full record

ArticleMonash bioethics review2025

The role of HRECs in regulating medical research: from peer review to regulation.

Lisa Eckstein, Jenny C Kaldor, Cameron Stewart

Abstract read
In one paragraph

Article in Monash bioethics review, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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.

Lisa EcksteinCollege of Arts Law and Education, University of Tasmania, Hobart, Australia.ORCID http://orcid.org/0000-0002-7161-7521
Jenny C KaldorDepartment of Health, Hobart, TAS, Australia.
Cameron StewartSydney Law School, University of Sydney, Darlington, Australia. cameron.stewart@sydney.edu.au.

Funding

ARC DP180101262
6 · The paper itself

Abstract

In Australia, Human Research Ethics Committees (HRECs) play a ubiquitous role reviewing human subjects research, as do Institutional Review Boards in the US and elsewhere. While HRECs were established as peer review bodies, we argue they should now be characterised a 'devolved regulator' within the broader context of the regulatory state. We evidence HRECs' regulatory role through three examples of current responsibilities. By categorising HRECs as a regulator, we are able to assess their role through a regulatory lens. Drawing on Reeve and Magnusson's 'regulatory scaffolding' approach, we suggest key ways in which the role provided by HRECs could be improved. These include setting clear roles and responsibilities HREC review; ensuring HREC accountability for the substantive aspects of their decision making; and accountability for trial sponsors who seek review of trials under the Clinical Trials Notification Scheme. Deficits in the above must incur a credible expectation of escalation and review.

Indexed as

Biomedical ResearchEthics Committees, ResearchHuman ExperimentationPeer Review, ResearchAustraliaHumansSocial ResponsibilityClinical trialsDecision makingEthics committeesPeer reviewResearchWaivers of consent

Identifiers

PMID40372559
PMCPMC12202549

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.