Institutional review board and regulatory solutions in the dental PBRN

TY - JOUR

T1 - Institutional review board and regulatory solutions in the dental PBRN

AU - Gilbert, Gregg H

AU - Qvist, Vibeke

AU - Moore, Sheila D

AU - Rindal, D Brad

AU - Fellows, Jeffrey L

AU - Gordan, Valeria V

AU - Williams, O Dale

AU - DPBRN Collaborative Group

PY - 2010/12

Y1 - 2010/12

N2 - Objectives: Effectively 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. Methods: Following 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. Results: IRBs 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. Conclusions: Instead 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.

AB - Objectives: Effectively 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. Methods: Following 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. Results: IRBs 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. Conclusions: Instead 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.

KW - Clinical Trials as Topic

KW - Computer Communication Networks

KW - Dental Research

KW - Ethics Committees, Research

KW - Financing, Government

KW - Government Regulation

KW - Humans

KW - Informed Consent

KW - Research Subjects

KW - Scandinavia

KW - United States

U2 - 10.1111/j.1752-7325.2009.00139.x

DO - 10.1111/j.1752-7325.2009.00139.x

M3 - Journal article

C2 - 19694937

SN - 0022-4006

VL - 70

SP - 19

EP - 27

JO - Journal of Public Health Dentistry

JF - Journal of Public Health Dentistry

IS - 1

ER -