Evidence map›Paper›PMID 26304976›Full record

ArticleAnnals of family medicine2015

Challenges in the Ethical Review of Peer Support Interventions.

David Simmons, Christopher Bunn, Fred Nakwagala, Monika M Safford, Guadalupe X Ayala, Michaela Riddell, Jonathan Graffy, Edwin B Fisher

Registry-linked trialOpen access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of family medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02193984 (Alliance to Control Diabetes), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 31% of its field
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.

NCT02193984 naunknown statusnot on this map

Alliance to Control Diabetes

TypeinterventionalSponsorSan Diego State UniversityRan2009 to 2017Enrolled336ConditionsDiabetes MellitusArmsPeer support
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  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

8 authors at 8 institutions in 4 countries.

David SimmonsSchool of Medicine, University of Western Sydney, Sydney, Australia Institute of Metabolic Science, Cambridge University Hospitals, NHS Foundation Trust, Cambridge, England dsworkster@gmail.com.
Christopher BunnInstitute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland.
Fred NakwagalaDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Monika M SaffordDepartment of Medicine, School of Medicine, University of Alabama, Birmingham, Alabama.
Guadalupe X AyalaSan Diego State University College of Health and Human Services and the Institute for Behavioral and Community Health, San Diego State University Research Foundation, San Diego, California.
Michaela RiddellGlobal Health and Society Unit, SPHPM, Monash University, Melbourne, Australia.
Jonathan GraffyDepartment of Public Health and Primary Care, University of Cambridge, Cambridge, England.
Edwin B FisherPeers for Progress, American Academy of Family Physicians Foundation, Leawood, Kansas Department of Health Behavior and Health Education, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.
Makerere University · UGMonash University · AUSan Diego State University · USUniversity of Alabama at Birmingham · USUniversity of Cambridge · GBUniversity of Glasgow · GBUniversity of North Carolina at Chapel Hill · USWestern Sydney University · AU

Funding

University of Alabama at Birmingham's Diabetes Research CenterP30DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Kirk Michael Habegger · 2013 to 2026
$19.5M
Department of Health PB-PG-0610-22311NIDDK NIH HHS P30 DK079626
6 · The paper itself

Abstract

purposeEthical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees.

methodsThe ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the "4+1 ethical framework" (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application).

resultsEthics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees' reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support.

conclusionEthics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of "light touch" consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support.

Indexed as

Clinical Trials as TopicDiabetes MellitusEthical ReviewEthics CommitteesHumansdiabetesethicsethics review committeesglobal researchpeer support

Identifiers

PMID26304976
PMCPMC4648134
OpenAlexW1938403643

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.