Institutional review board and regulatory solutions in The Dental PBRN

Abstract

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 timeintensive and complex, these solutions improve acceptability of practice-based research to patients, practitioners, and university researchers.

Rubber Dam Use During Routine Operative Dentistry Procedures: Findings FromThe Dental PBRN

“…This training session discussed in detail the study protocol, data collection forms, and related details. Additional requirements varied by DPBRN region and are described elsewhere 23. These questionnaires are publicly available at the DPBRN Supplement page 29…”

“…DPBRN is a consortium of dental practices that have affiliated to investigate research questions, to share experiences and expertise, and that are committed to improving clinical practice through research and collegiality 22,23. Many details about DPBRN are publicly available at its web site,24 but briefly, it comprises practitioner-investigators and staff in outpatient dental practices from five regions: AL/MS: Alabama/Mississippi, FL/GA: Florida/Georgia, MN: dentists employed by HealthPartners Dental Group25 and private practitioners in Minnesota, PDA: Permanente Dental Associates26 in Oregon and Washington, and SK: the Scandinavian countries of Denmark, Norway, and Sweden.…”

Reasons for Placement of Restorations on Previously Unrestored Tooth Surfaces by Dentists in The Dental Practice-Based Research Network

“…As part of the eligibility criteria, all dentists completed (1) an enrollment questionnaire describing their demographic and practice characteristics and certain personal characteristics, (2) an assessment of caries diagnosis and caries treatment questionnaire, (3) training in human subjects protection, and (4) attended a DPBRN orientation session with the regional coordinator in their practice 14. Additional requirements varied by DPBRN region and are described elsewhere 15. These questionnaires and further details about the training sessions are available at http://www.DentalPBRN.org.…”

The decision to repair or replace a defective restoration is affected by who placed the original restoration: Findings from the National Dental PBRN

“…Additional requirements varied by network region and are described elsewhere. 21 Copies of the questionnaires and summary data for dentists’ demographic and practice characteristics are also available at http://www.dpbrn.org/users/publications/Default.aspx and elsewhere. 22 and 23 …”