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MRC 03-233 – HSR&D Study

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MRC 03-233
Best Precedents in Human Subjects Protection for Health Services Research
Julie C. Lowery PhD MHSA
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, MI
Funding Period: October 2003 - September 2004

BACKGROUND/RATIONALE:
Despite a number of studies examining local variability in the IRB decision-making process, none has taken the next step to review the quality of these decisions in an effort to identify those that meet the criteria of providing protection to human subjects while ensuring the conduct of rigorous, generalizable research.

OBJECTIVE(S):
The objective of the proposed study is to identify the "best precedents" for a number of human studies issues in health services research.

METHODS:
The study consists of a cross-sectional, observational design with primarily qualitative analyses. Study protocols, IRB applications, and IRB responses will be reviewed to develop a list of key IRB issues/decisions for which considerable variability in responses exists across VA sites. Following identification of key issues/decisions, case studies will be written to illustrate each issue, along with a description of the actual responses taken by IRBs. An expert panel will be established, to include IRB experts, ethicists, health services researchers, and a patient representative to review the case studies and select the best precedent among the actual responses. The resultant best precedents will be assembled in a document and Web site, for dissemination to IRBs and investigators.

FINDINGS/RESULTS:
None yet.

IMPACT:
The dissemination of precedents would improve the protection of human subjects and minimize the current variability in the means by which protection is implemented. Improving the consistency in decisions across sites would facilitate the process of ensuring human subjects’ protection, and the research process as a whole, by providing researchers with a clearer set of standards for designing and implementing their studies.

PUBLICATIONS:
None at this time.


DRA: Health Systems
DRE: none
Keywords: none
MeSH Terms: none

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