Evidence map›Paper›PMID 27366845›Full record

ArticleThe American journal of bioethics : AJOB2016

IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom?

Michael C Freed, Laura A Novak, William D S Killgore, Sheila A M Rauch, Tracey P Koehlmoos, J P Ginsberg, Janice L Krupnick, Albert Skip Rizzo, Anne Andrews, Charles C Engel

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Article in The American journal of bioethics : AJOB, 2016. 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. Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Michael C Freeda Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury and Uniformed Services University of the Health Sciences.
Laura A Novakb Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury.
William D S Killgorec University of Arizona, McLean Hospital, and Harvard Medical School.
Sheila A M Rauchd Emory University School of Medicine and Atlanta VA Medical Center.
Tracey P Koehlmoose Headquarters, U.S. Marine Corps and Uniformed Services University of the Health Sciences.
J P Ginsbergf William Jennings Bryan Dorn VA Medical Center and University of South Carolina School of Medicine.
Janice L Krupnickg Georgetown University School of Medicine.
Albert Skip Rizzoh University of Southern California Institute for Creative Technologies.
Anne Andrewsi Headquarters, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury and National Institute of Standards and Technology.
Charles C Engelj Uniformed Services University of the Health Sciences and RAND Corporation.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.

Indexed as

Ethics Committees, ResearchMilitary MedicineMilitary PersonnelEthics, ResearchHumansResearch PersonnelRiskhuman subjects researchIRB (institutional review board)Keywordsregulatory issuesresearch ethics

Identifiers

PMID27366845

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.