ETHICS, POLICY AND SOCIETY

Grant Title:Views and Approaches Toward Research Integrity Among IRBs

Funding Source and Project Period:
NHGRI, R01-HG02431, 2002-2007

Key HIV Center Personnel:

Principal Investigator: Robert L. Klitzman, M.D.
Co-Principal Investigator: Ruth Fischbach, Ph.D.
Co-Investigator: Ronald Bayer, Ph.D.

Project Overview
(from abstract submitted to NICHD:

Institutional Review Boards (IRBs) can play vital roles in observing and responding to research integrity (Rl) issues among principal investigators (PIs), yet how these boards view and approach these roles has not been seriously examined. Our pilot data indicate that IRBs commonly are involved in monitoring and responding to Rl problems (e.g., PI non-compliance, conflicts of interest (COI), adverse events, and problems in multi-site collaborations). But IRBs wrestle with uncertainties, and differ in how broadly they define their roles concerning Rl.

In an institution, IRBs are often the only detailed reviewer of protocols, and thus have potentially important roles concerning Rl. But IRBs may be affected by institutional, social, educational and psychological factors as barriers or facilitators. Members range in background, training, values, and group norms. Unfortunately, little empirical research has been conducted on IRBs. and we have found none on how they view and approach these pressing Rl issues (e.g., what Rl problems they confront, and how frequently, how they respond, or feel they should, and what needs they may have for further guidelines, training or resources to maximize Rl).

This study aims to identify and describe the range of views, problems, barriers, facilitators, and approaches concerning Rl among IRBs, in order to improve education of IRBs, PIs and others, refine guidelines, and foster further research.

Research questions for this study include the following: 1) How do IRBs differ in monitoring and responding to lapses in Rl? 2) What Rl issues do they encounter? 3) What factors are involved? 4) What are the implications for education and guidelines?  Specific Aims for this study include the following: 1) Documenting and understanding the types and frequencies of Rl issues IRBs face, focusing on: non-compliance, adverse events, and COI; 2) Documenting and understanding the types and frequencies of IRB responses to Rl problems, focusing on: auditing, sanctions against Pis, and reporting of Rl problems to institutional or external entities; and 3) Documenting and understanding factors involved in IRB responses, focusing on characteristics of the institution (eg., size, past Rl violations), the IRB. (e.g., staff support, logistics, views of IRB roles, responsibilities, and standards, and relationships with compliance offices, COI committees, and institutional leadership), and protocols with Rl problems (e.g., the PI, and funding).

We will conduct in-depth phone interviews with 80 IRB chairs and 40 members for 2-3 hours each, using a semi-structured instrument, sampling and comparing IRBs from larger, research intensive vs. smaller institutions. We anticipate that the data from this study will serve as a significant foundation in assisting future research and the improvement of Rl through guidelines, education and other capacity building.

updated 5/16/07