In a national survey of institutions with federally assured human research protection programs, we obtained workload and other relevant data on their Institutional Review Boards (IRBs) and management organizations. The number of IRBs increased substantially from 1995 to 2005/06 (491 to 2,728 IRBs) with a further increase in 2008 to 3,853 IRBs. Nationally, IRBs reviewed over a quarter million research applications in the year prior to our survey, of which 35% were new applications requiring full committee review. Compared to estimates from 1995, current IRBs review more new and full committee review applications, but the relative percentage of new and full committee applications remained about the same. High volume research institutions have IRBs with a substantially larger per person workload, relative to smaller volume IRBs (i.e., members spent nearly seven times more hours reviewing new applications outside formal committee meetings). Virtually all IRBs included community representatives as members (92%); however, a small number may not be compliant with federal regulations. The present findings suggest the need for research to (a) examine workload and its effects on review quality, research costs, and faculty morale, (b) develop methods for determining optimal fit between IRB workload demands and institutional labor and Address correspondence to: Prof. Joseph A. Catania, College of Health and Human Sciences, Oregon State University, 705 NW Elizabeth Drive, Corvallis,; E-MAIL: catania1951@comcast.net.. Author Contributions. Drs. Catania, Lo, Wolf, Dolcini, Barker, and Pollack were involved in the design and execution of the project, as well as in the evaluation of the data and writing of the manuscript. Ms. Wertlieb co-directed field work, helped to analyze the data, and helped to conceptualize and develop the manuscript. Mr. Henne was responsible for the data collection; he also participated in the design and execution of the project, and reviewed the final manuscript. 1 Tier One has 120 Institutional Review Board Organizations (IORGs) among 100 institutions, i.e., 29 IORGs are "extras." Tier Two has 1,950 IORGs (2,070 total IORGs: 120 Tier One IORGs and 1,950 Tier Two IORGs), of which 99% are in single IORG institutions, or . 99 × 1,950 = 1,930 single IORG institutions. Of the remaining 20 IORGs in Tier Two, these are all represented by institutions with only 2 IORGs, so 20/2 = 10 institutions. Thus, Tier One (100) + Tier Two (1,930 + 10) institutions = 2,040 total institutions. 2 The following data were used in computing hours worked in reviewing new applications.Bell Report: 14.9 hrs/review high-volume IRBs, 7.1 hrs/review low-volume IRBs on "initial" reviews; overall mean hours = 11.0 hrs/ review for new applications. Present Study data: M new applications = 87.8, M committee size = 13.4 members. New applications = (11.0 hrs/review × 87.8 new applications per IRB)/13.9 members = Number of hours spent on review over all IRBs= 69.5 hours per person/year on new applications. Tier One new applications...

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We obtained data on Institutional Review Boards (IRBs) that review mental health–related applications (MHRAs) in a national survey of institutions with federally assured human research protection programs. Approximately 57% of IRBs review MHRAs, and among these a small percentage may not have mental health experts on their committees (5%). Moreover, mental health experts on IRB committees at high research volume institutions are carrying substantially greater workloads than their lower volume counterparts. In terms of committee demographics, more women (36%) are serving as IRB Chairs on committees that review MHRAs than expected from their representation on medical or university faculties; ethnic minority faculty have lower representation among Chairs than might be expected from their overall faculty representation. Our findings suggest the need for additional studies to (a) examine if the number of mental health experts on IRBs should be increased particularly among IRBs reviewing a high volume of MHRAs, (b) determine if the breadth of expertise among IRB mental health experts corresponds to the range of substantive and methodological approaches represented by the mental health protocols under review, and (c) examine if recruiting IRB scientific expertise from outside an institution, a more common practice among smaller research entities, impacts review quality.

The United Network for Organ Sharing (UNOS) waiting list was designed as a just and equitable system through which the limited number of organs is allocated to the millions of Americans in need of a transplant. People have trusted the system because of the belief that everyone on the list has an equal opportunity to receive an organ and also that allocation is blind to matters of financial standing, celebrity or political power. Recent events have revealed that certain practices and policies have the potential to be exploited. The policies addressed in this paper enable those on the list with the proper resources to gain an advantage over other less fortunate members, creating a system that benefits not the individual most in medical need, but the one with the best resources. These policies are not only unethical but threaten the balance and success of the entire UNOS system. This paper proposes one possible solution, which seeks to balance the concepts of justice and utility.

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It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

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