Publication: Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.
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Accepted Date
2014-10-27
Issued Date
2014-11-18
Copyright Date
2014
Resource Type
Language
eng
ISSN
1932-6203 (electronic)
Rights
Mahidol University
Rights Holder(s)
PubMed Central
Bibliographic Citation
Adams P, Kaewkungwal J, Limphattharacharoen C, Prakobtham S, Pengsaa K, Khusmith S. Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand. PLoS One. 2014 Nov 18;9(11):e113356.
Suggested Citation
Pornpimon Adams, พรพิมล อดัมส์, Jaranit Kaewkungwal, จรณิต แก้วกังวาน, Chanthima Limphattharacharoen, Sukanya Prakobtham, สุกัญญา ประกอบธรรม, Krisana Pengsaa, ฤษณา เพ็งสา, Srisin Khusmith, ศรีสิน คูสมิทธิ์ Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.. Adams P, Kaewkungwal J, Limphattharacharoen C, Prakobtham S, Pengsaa K, Khusmith S. Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand. PLoS One. 2014 Nov 18;9(11):e113356.. doi:10.1371/journal.pone.0113356. Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/814
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Title
Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.
Corresponding Author(s)
Other Contributor(s)
Mahidol University. Faculty of Tropical Medicine. Office of Research Services
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Hygiene
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Pediatrics
Mahidol University. Faculty of Tropical Medicine. Department of Microbiology and Immunology
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Hygiene
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Pediatrics
Mahidol University. Faculty of Tropical Medicine. Department of Microbiology and Immunology
Abstract
Tensions between researchers and ethics committees have been reported in several
institutions. Some reports suggest researchers lack confidence in the quality of
institutional review board (IRB) reviews, and that emphasis on strict procedural
compliance and ethical issues raised by the IRB might unintentionally lead to
delays in correspondence between researchers and ethics committees, and/or even
encourage prevarication/equivocation, if researchers perceive committee concerns
and criticisms unjust. This study systematically analyzed the efficiency of
different IRB functions, and the relationship between efficiency and perceived
quality of the decision-making process. The major purposes of this study were
thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine,
Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and
perceived effectiveness of its ethics committees, and (2) to determine ethical
issues that may cause the duration of approval process to be above the target
limit of 60 days. Based on a literature review of definitions and methods used
and proposed for use, in assessing aspects of IRB quality, an "IRB Metrics" was
developed to assess IRB processes using a structure-process-outcome measurement
model. To observe trends in the indicators evaluated, data related to all
protocols submitted to the two panels of the FTM-EC (clinical and non-clinical),
between January 2010-September 2013, were extracted and analyzed. Quantitative
information based on IRB Metrics structure-process-outcome illuminates different
areas for internal-process improvement. Ethical issues raised with researchers by
the IRB, which were associated with the duration of the approval process in
protocol review, could be considered root causes of tensions between the parties.
The assessment of IRB structure-process-outcome thus provides a valuable
opportunity to strengthen relationships and reduce conflicts between IRBs and
researchers, with positive outcomes for all parties involved in the conduct of
human-subject research.