Evidence map›Paper›PMID 19694937›Full record

ArticleJournal of public health dentistry2010

Institutional review board and regulatory solutions in the dental PBRN.

Gregg H Gilbert, Vibeke Qvist, Sheila D Moore, D Brad Rindal, Jeffrey L Fellows, Valeria V Gordan, O Dale Williams, DPBRN Collaborative Group

Abstract read
In one paragraph

Article in Journal of public health dentistry, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 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

8 authors.

Gregg H GilbertDepartment of Diagnostic Sciences, School of Dentistry, University of Alabama at Birmingham, AL 35294-0007, USA. ghg@uab.edu
Vibeke Qvist
Sheila D Moore
D Brad Rindal
Jeffrey L Fellows
Valeria V Gordan
O Dale Williams
DPBRN Collaborative Group

Funding

Dental PBRN Network ChairU01DE016747 · NIDCR · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GILBERT, GREGG H · 2005 to 2011
$17.3M
Dental Practice-Based Research Network Coordinating CtrU01DE016746 · NIDCR · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI FUNKHOUSER, ELLEN M · 2005 to 2011
$7.0M
NIDCR NIH HHS DE-16746NIDCR NIH HHS DE-16747NIDCR NIH HHS U01 DE016746NIDCR NIH HHS U01 DE016747
6 · The paper itself

Abstract

objectivesEffectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network called "DPBRN" (http://www.DPBRN.org) comprises dentists in two health maintenance organizations, several universities, seven US states, and three Scandinavian countries. Our objectives are to describe: a) the various human participants and regulatory requirements and solutions for each of DPBRN's five regions; b) their impact on study protocols and implementation; and c) lessons learned from this process.

methodsFollowing numerous discussions with IRB and grants administrative personnel for each region, some practitioner-investigators are attached to their respective IRBs and contracting entities via sub-contracts between their organizations and the network's administrative site. Others are attached via Individual Investigator Agreements and contractually obligated via Memoranda of Agreement.

resultsIRBs approve general operations under one approval, but specific research projects via separate approvals. Various formal IRB and grants administrative agreements have been arranged to customize research to the network context. In some instances, this occurred after feedback from patients and practitioners that lengthy written consent forms impeded research and raised suspicion, instead of decreasing it.

conclusionsInstead of viewing IRBs and institutional administrators as potentially adversarial, customized solutions can be identified by engaging them in collegial discussions that identify common ground within regulatory bounds. Although time-intensive and complex, these solutions improve acceptability of practice-based research to patients, practitioners, and university researchers.

Indexed as

Computer Communication NetworksGovernment RegulationClinical Trials as TopicDental ResearchEthics Committees, ResearchFinancing, GovernmentHumansInformed ConsentResearch SubjectsScandinavian and Nordic CountriesUnited States

Identifiers

PMID19694937
PMCPMC2864321

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.