Evidence map›Paper›PMID 30744311›Full record

ArticleEthics & human research2019

Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions.

Robert Klitzman, Ekaterina Pivovarova, Alexandra Murray, Paul S Appelbaum, Deborah F Stiles, Charles W Lidz

Abstract read
In one paragraph

Article in Ethics & human research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

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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

6 authors.

Robert KlitzmanProfessor of psychiatry and the director of the Master of Science in Bioethics Program at Columbia University.
Ekaterina PivovarovaAssistant professor of psychiatry at the University of Massachusetts Medical School in Worcester.
Alexandra MurrayResearch coordinator II at the University of Massachusetts Medical School in Worcester.
Paul S AppelbaumDollard professor of psychiatry, medicine, & law and the director of the Center for Law, Ethics, and Psychiatry at Columbia University.
Deborah F StilesVice president for research operations and policy and the chief operating officer in the Office of the Executive Vice President for Research at Columbia University.
Charles W LidzProfessor emeritus of psychiatry at the University of Massachusetts Medical School in Worcester.

Funding

Linking Opioid Dependent Patients from Inpatient Detoxification to Primary CareR01DA034261 · NIDA · BUTLER HOSPITAL (PROVIDENCE, RI) · PI BAILEY, GENIE, STEIN, MICHAEL D · 2012 to 2016
$2.4M
Central IRBs: Enhanced Protections for Human Research Participants?R01GM113640 · NIGMS · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI LIDZ, CHARLES W · 2014 to 2016
$1.7M
NIDA NIH HHS R01 DA034261NIGMS NIH HHS R01 GM113640
6 · The paper itself

Abstract

New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.

Indexed as

Ethics Committees, ResearchKnowledgeEfficiency, OrganizationalHumansResearch PersonnelCommon Rulehuman subjects researchlocal IRBsmultisite studiesresearch ethicssingle IRBs

Identifiers

PMID30744311
PMCPMC9205159

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.