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MRR 02-114 – HSR&D Study

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MRR 02-114
Pilot Just-In-Time IRB Review Evaluation
Peter Adam Kelly PhD MBA BS
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, TX
Funding Period: April 2002 - March 2003

BACKGROUND/RATIONALE:
In April, 2002, VA HSR&D adopted a Just-in-Time (JIT) IRB review policy similar to that of the National Institutes of Health. In order to proactively respond to issues arising from implementation of the policy, HSR&D commissioned a simultaneous policy evaluation for the period of April 1, 2002 through March 31, 2003.

OBJECTIVE(S):
To assess the efficacy of HSR&D’s JIT IRB review policy and identify actual or potential pitfalls that may arise as unintended consequences of JIT IRB review.

METHODS:
Observation of the June, 2002 and January, 2003 HSR&D scientific merit review board (SMRB) meetings; telephone interviews of selected (1) Principal investigators and academic affiliate IRB members at HSR&D’s largest and smallest research program sites and (2) 2002-2003 SMRB grant application reviewers; and site visit to HSR&D central office to observe the grant funds disbursement process.

FINDINGS/RESULTS:
SMRB reviewers spent on average 3% of discussion time per grant application on human subjects issues; reviewers were confident that attentiveness to these issues was adequate and would continue. Principal investigators reported that the JIT IRB review policy made submitting grant applications easier, while IRB members noted no major change in review workload. However, new delays in grant funds disbursement were noted at HSR&D central office, and monitoring IRB approvals in multi-site grants was seen as a growing challenge.

IMPACT:
HSR&D’s JIT IRB review policy may reduce IRBs’ review workload (1) absolutely, because IRBs see fewer grant applications than before, and (2) conditionally, to the extent that IRB reviewers recognize prior HSR&D funding approval as a positive signal of human subjects compliance. However, HSR&D should carefully attend to the grant funds disbursement process, and prepare to accommodate a likely increase in processing and monitoring workloads.

PUBLICATIONS:

Journal Articles

  1. Kelly PA, Johnson ML. Just-in-time IRB review: capitalizing on scientific merit review to improve human subjects research compliance. IRB. 2005 May 1; 27(2):6-10.
Reports

  1. Kelly PA, Johnson MJ, Alsarraj AA. Pilot Just-In-Time IRB Review Evaluation. 2003 Jul 1.


DRA: Health Systems
DRE: Epidemiology
Keywords: Ethics, Management
MeSH Terms: none

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