Chenneville Tiffany, Menezes Lynette, Bylsma Lauren M, Mann Angela, Kosambiya Jayendrakumar, Baxi Rajendra
University of South Florida, St. Petersburg, FL, USA
University of South Florida, Tampa, FL, USA.
J Empir Res Hum Res Ethics. 2014 Oct;9(4):50-9. doi: 10.1177/1556264614544101. Epub 2014 Aug 5.
Institutional ethics committees (IECs) are currently still in their infancy in low- to middle-income countries (LMICs), which may have important implications with regard to the oversight of the protection of human participants. Understanding how these IECs currently function is a critical first step in helping LMICs build infrastructures that support the protection of research participants and improve the scientific quality of health research worldwide. We assessed the functioning of the IECs at two medical colleges in Gujarat, India, by administering the Institutional Review Board Researcher's Assessment Tool (IRB-RAT) to 42 IEC and faculty members. The IRB-RAT includes eight scales assessing various domains related to how investigators and members perceive their ethics committees. Results from t tests revealed significant differences between ideal ratings and descriptive ratings on each of the IRB-RAT scales with ideal ratings being higher than current descriptive ratings on all of the scales (<.001). These findings suggest areas that can be targeted for improvement and also provide important information about the values of Indian IECs.
在低收入和中等收入国家（LMICs），机构伦理委员会（IECs）目前仍处于起步阶段，这可能对人类受试者保护的监督产生重要影响。了解这些IECs目前的运作方式是帮助低收入和中等收入国家建立支持研究受试者保护并提高全球卫生研究科学质量的基础设施的关键第一步。我们通过向42名IEC成员和教员发放机构审查委员会研究人员评估工具（IRB-RAT），评估了印度古吉拉特邦两所医学院的IECs的运作情况。IRB-RAT包括八个量表，用于评估与研究者和成员如何看待其伦理委员会相关的各个领域。t检验结果显示，IRB-RAT各量表的理想评分与描述性评分之间存在显著差异，所有量表的理想评分均高于当前描述性评分（<.001）。这些发现指出了可以改进的领域，也提供了有关印度IECs价值观的重要信息。
