Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals

Abstract

The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional societies, and others are proposing remedies based on the assumption that the main problems are researchers' conflict of interest, lack of institutional review board (IRB) resources, and the volume and complexity of clinical research. Developing appropriate reform proposals requires carefully delineating the problems of the current system to know what reforms are needed. To stimulate a more informed and meaningful debate, we delineate 15 current problems into 3 broad categories. First, structural problems encompass 8 specific problems related to the way the research oversight system is organized. Second, procedural problems constitute 5 specific problems related to the operations of IRB review. Finally, performance assessment problems include 2 problems related to absence of systematic assessment of the outcomes of the oversight system. We critically assess proposed reforms, such as accreditation and central IRBs, according to how well they address these 15 problems. None of the reforms addresses all 15 problems. Indeed, most focus on the procedural problems, failing to address either the structure or the performance assessment problems. Finally, on the basis of the delineation of problems, we outline components of a more effective reform proposal, including bringing all research under federal oversight, a permanent advisory committee to address recurrent ethical issues in clinical research, mandatory single-time review for multicenter research protocols, additional financial support for IRB functions, and a standardized system for collecting and disseminating data on both adverse events and the performance assessment of IRBs.

Ethical Review and Children's Research in Ireland

“…Different models of centralisation have been proposed in the debate, including the implementation of national RECs, regional RECs, subject area or research-type specific RECs, or other types of centralised structures (Christian et al, 2002;Downie, 2006;Emanuel et al, 2004;Gandhi, 2005;McWilliams et al, 2006). alternatively, governance systems might focus primarily on the implementation of a central governing body without necessarily having drastic effects on the number of committees that are in operation .…”

“…a central REC governance body), others highlight the importance of self-monitoring of institutions (NhMRC, 2007). In this context, it has been pointed out that care should be taken to develop appropriate criteria that accurately measure the quality of ethics review (Burris and Moss, 2006;Emanuel et al, 2004;Fleischman, 2005) and that might need to include criteria for research ethics quality over and above mere compliance standards (Taylor, 2007b …”

“…Researchers have pointed out the costs involved in REC review in terms of a number of variables: time spent in preparing research ethics application; Costs have been identified as particularly high for multi-centre studies, especially in those systems where several RECs review the same proposals and where researchers are required to meet a range of different and frequently inconsistent demands for amendments and different timelines (Burman et al, 2001;Emanuel et al, 2004;Estlin and ablett, 2001;Larson et al, 2004;McWilliams et al, 2003;Roberts et al, 2004;Seiler et al, 2007). One of the most frequently highlighted issues, and one that has been addressed by many governance systems in recent years, is the need for a more streamlined process of review of such studies, both nationally and -more problematicinternationally (Christian et al, 2002;hearnshaw, 2004;hirtle et al, 2000;Pentz and Khayat, 2004;Pinkerton et al, 2002 (Roberts et al, 2004).…”

Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations

“…7,9 A survey by Green et al shows how significant the variations in IRB decisions for the same study can be. In this study of the 43 IRBs, ten decided expedited review, 31 gave full board review, and one IRB objected to the study because of the risks it involves.…”

“…Moreover, the lack of knowledge on existing national and international laws and regulations, and the medical interventions in the relevant field of research result in inaccurate decisions being made. [4][5][6][7][8][9] On the other hand, there are no standardized decision-making sheets available for IRB members. Some IRBs have developed abstract documents to guide members but none of these contains a detailed list of ethical and legal requirements to be considered before making a decision.…”