The Controversy Surrounding Central Institutional Review Boards

Kristi L. Kirschner; John Whyte; R. Norman Harden; Teresa A. Savage; Debjani Mukherjee

doi:10.1016/j.pmrj.2009.12.013

The Controversy Surrounding Central Institutional Review Boards

Kristi L. Kirschner^*, John Whyte, R. Norman Harden, Teresa A. Savage, Debjani Mukherjee

^*Corresponding author for this work

Research output: Contribution to journal › Editorial › peer-review

2 Scopus citations

Original language	English (US)
Pages (from-to)	57-63
Number of pages	7
Journal	PM and R
Volume	2
Issue number	1
DOIs	https://doi.org/10.1016/j.pmrj.2009.12.013
State	Published - Jan 2010

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Physical Therapy, Sports Therapy and Rehabilitation
Rehabilitation
Neurology
Clinical Neurology

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@article{a61e0b00cc7a46748045357315c95232,

title = "The Controversy Surrounding Central Institutional Review Boards",

author = "Kirschner, {Kristi L.} and John Whyte and Harden, {R. Norman} and Savage, {Teresa A.} and Debjani Mukherjee",

note = "Funding Information: In 2005, The National Institutes of Health, the Office for Human Research Protections, the Association of American Medical Colleges, the American Society of Clinical Oncology, and Department of Veterans Affairs held a workshop on alternative models of IRB review. Their summary report presents issues to consider when deciding to use an alternative model, such as a central IRB: “access to expertise, the number of participating sites, the need for consistency among participating study sites, the level of risk, the sponsorship and type of study, the size of the institution's research program, how quickly approval is needed, the type of disease involved in a medical study, the potential for conflicts of interest, liability issues, and available resources” [ 19 ]. In addition, it identifies challenges and suggested strategies for addressing the ethical concerns ( Table 2 ). A subsequent national conference was held a year later with the purpose to “enhance the protection of human subjects of research by encouraging the use of alternative Institutional Review Boards (IRB) models under appropriate circumstances” [ [ 20 ]. The participants, regulators, funders, medical educators and researchers, and stakeholder groups explored in depth the issues identified in the 2005 workshop. One presenter listed the various alternative models of IRB ( Table 3 ) 21 ]. Ideally, both the local IRB and CIRB will negotiate a shared responsibility that improves the protections of human subjects without adversely affecting the efficiency of the review process. The 2006 workshop executive summary concludes with some general points to consider: • There should be a detailed agreement regarding the sharing of regulatory liability between the CIRB and institution; • Outsourcing disengages the principal investigator and research team in the protection of human subjects and may drain resources from the local IRB; and • There should be clear guidance on the use of alternative models of IRBs and harmonization among federal laws and requirements. ",

year = "2010",

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T1 - The Controversy Surrounding Central Institutional Review Boards

AU - Kirschner, Kristi L.

AU - Whyte, John

AU - Harden, R. Norman

AU - Savage, Teresa A.

AU - Mukherjee, Debjani

N1 - Funding Information: In 2005, The National Institutes of Health, the Office for Human Research Protections, the Association of American Medical Colleges, the American Society of Clinical Oncology, and Department of Veterans Affairs held a workshop on alternative models of IRB review. Their summary report presents issues to consider when deciding to use an alternative model, such as a central IRB: “access to expertise, the number of participating sites, the need for consistency among participating study sites, the level of risk, the sponsorship and type of study, the size of the institution's research program, how quickly approval is needed, the type of disease involved in a medical study, the potential for conflicts of interest, liability issues, and available resources” [ 19 ]. In addition, it identifies challenges and suggested strategies for addressing the ethical concerns ( Table 2 ). A subsequent national conference was held a year later with the purpose to “enhance the protection of human subjects of research by encouraging the use of alternative Institutional Review Boards (IRB) models under appropriate circumstances” [ [ 20 ]. The participants, regulators, funders, medical educators and researchers, and stakeholder groups explored in depth the issues identified in the 2005 workshop. One presenter listed the various alternative models of IRB ( Table 3 ) 21 ]. Ideally, both the local IRB and CIRB will negotiate a shared responsibility that improves the protections of human subjects without adversely affecting the efficiency of the review process. The 2006 workshop executive summary concludes with some general points to consider: • There should be a detailed agreement regarding the sharing of regulatory liability between the CIRB and institution; • Outsourcing disengages the principal investigator and research team in the protection of human subjects and may drain resources from the local IRB; and • There should be clear guidance on the use of alternative models of IRBs and harmonization among federal laws and requirements.

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The Controversy Surrounding Central Institutional Review Boards

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