I plan to write a book exploring several crucial &related issues concerning Institutional Review Boards (IRBs), which have increasingly been facing critical challenges, problems &dilemmas. Established in 1974, following the Tuskegee scandal, to protect human subjects, IRBs have been shown to be inconsistent &discrepant, applying standards differently, &are facing mounting challenges (e.g., concerning clinical trials). Ideally, IRB review can abet research, protecting subjects, &avoiding unnecessary harms, fostering trust of communities &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, &other rapidly evolving areas (e.g., genetics), &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. Interviews I have conducted suggest that 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, &social &institutional pressures they confront.
The specific aims of this book are to provide a framework for examining several issues, e.g., 1) conflicts IRBs face with PIs, 2) variations between IRBs, &3) suggestions for reform. To understand these phenomena, it is essential to grasp how IRBs function today: the contents &contexts of decisions. I will explore several key questions: 1) What problems do IRBs see themselves as facing regarding the contents of decisions? (e.g., what &how they weigh individual &social risks &benefits, competing ethical principles, &varying interpretations &applications of principles ®ulations)? 2) What challenges do IRBs face regarding the contexts of decisions (i.e., shifting social, economic, institutional &scientific contexts of research, e.g., more multi-site studies, industry-funded trials, university-industry collaborations, managed care, &research """"""""scandals"""""""")? 3) How do IRBs view &address these problems &criticisms (e.g., costs to PIs of IRB review, &inconsistencies), &possible changes (e.g., centralized IRBs, or appeals processes)? 4) What are the implications of the above for improving education (e.g., of IRBs, PIs, &policy-makers), IRB practices &policies, &future research in this area? I have interviewed in-depth chairs &members from over 60 IRBs, &other key stakeholders (e.g., PIs &research staff, &study subjects), mostly in the US, &to a lesser extent in the developing world. The book, which my editor at Oxford University Press is extremely interesting in publishing, will focus on IRBs in the US, though exploring these issues, though to a lesser degree, in the developing world as well.
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.
|Klitzman, Robert (2014) How US institutional review boards decide when researchers need to translate studies. J Med Ethics 40:193-7|
|Klitzman, Robert (2013) Views of IRBs Concerning their Local Ecologies: Perceptions of Relationships, Systems, and Tensions between IRBs and their Institutions. AJOB Prim Res 4:31-43|
|Klitzman, Robert L (2013) How IRBs view and make decisions about consent forms. J Empir Res Hum Res Ethics 8:8-19|
|Klitzman, Robert L (2013) How IRBs view and make decisions about social risks. J Empir Res Hum Res Ethics 8:58-65|
|Klitzman, Robert (2013) How IRBs view and make decisions about coercion and undue influence. J Med Ethics 39:224-9|
|Klitzman, Robert (2013) How good does the science have to be in proposals submitted to Institutional Review Boards? An interview study of Institutional Review Board personnel. Clin Trials 10:761-6|
|Klitzman, Robert (2013) How IRB leaders view and approach challenges raised by industry-funded research. IRB 35:9-17|
|Klitzman, Robert (2012) From anonymity to ""open doors"": IRB responses to tensions with researchers. BMC Res Notes 5:347|
|Klitzman, Robert L (2012) Local IRBs vs. federal agencies: shifting dynamics, systems, and relationships. J Empir Res Hum Res Ethics 7:50-62|
|Klitzman, Robert; Appelbaum, Paul S (2012) Research ethics. To protect human subjects, review what was done, not proposed. Science 335:1576-7|
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