Funding Source and Project Period: NLM, 2009-2102

 

Key HIV Center Key Personnel:

Robert Klitzman, M.D. (HIV Center)

 

Project Overview:

(from abstract)

Established in 1974, following the Tuskegee scandal, to protect human subjects, Institutional Review Boards (IRBs) have been shown to be inconsistent and discrepant, applying standards differently, and are facing mounting challenges (e.g., concerning clinical trials). Ideally, IRB review can abet research, protecting subjects, and avoiding unnecessary harms, fostering trust of communities and the public. Yet critics argue that IRBs can delay or impede recruitment & some kinds of research, hampering attainment of important knowledge, thus antagonizing Principal Investigators (PIs) who may then try to "bend the rules". Unethical practices can cause harms (e.g., death of subjects), & distrust, especially in vulnerable communities. These issues are particularly important with HIV, and other rapidly evolving areas (e.g., genetics), and in the developing world, where US-funded research is increasing. Recently, IRBs have been receiving more scholarly attention, but most of this work has been theoretical.

IRBs are deeply embedded in intricate social, regulatory, political, institutional, historical & scientific contexts. A few quantitative studies have examined logistical issues about IRBs (e.g., composition), but almost no qualitative data have explored these complex issues. No book has systematically examined how IRBs themselves grapple with the complex demands, conflicts, and social and institutional pressures they confront. This grant will result in a book that examines several crucial and related issues concerning Institutional Review Boards (IRBs), which were established through Congress in 1974 to review research to ensure that human subjects are adequately protected. But increasingly, IRBs have been facing multiple problems and dilemmas, with critics arguing that IRBs at times delay or impede recruitment and some kinds of research, hampering attainment of important knowledge that could benefit public health, and antagonizing researchers, who may then try to "bend the rules", and engage in unethical practices that can in turn harm subjects and generate distrust, especially in vulnerable communities. This project will examine possible approaches for improving education of IRBs, researchers, staff, and patients, IRB practice and policies, and future research in this area.