Introduction The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics.
Methods A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot-tested and item discrimination was calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessment tools were created. These assessment tools were administered as a pre-test and post-test to a cohort of 58 Indian junior health research investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course online, the other half in person. Item discrimination was calculated for each question and Cronbach's α for each assessment tool. A final version of the assessment tool that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills 3 months after course delivery.
Results The final version of the REKASA includes 41 items and had a Cronbach's α of 0.837.
Conclusion The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment tool in research ethics capable of not only measuring basic knowledge in research ethics and oversight but also assessing learners' ability to apply ethics knowledge to the analytical task of reasoning through research ethics cases, without reliance on essay or discussion-based examination. These promising preliminary findings should be confirmed with additional groups of learners.
- Informed consent
- qualitative methods
- research ethics
- ethics committees/consultation
- legal aspects
- philosophical ethics
- research on special populations
- availability of contraceptives to minors
- capital punishment
- education for healthcare professionals
- international affairs
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Funding Grants have been received from the Office of AIDS Research, National Institutes of Health, by the BJMC Clinical Trials Unit and the Johns Hopkins Fogarty AIDS International Training and Research Program. Grant Number AIU01069497; D43TW000010.
Competing interests None.
Ethics approval The study proposal was reviewed and approved by research ethics committees at the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, and Johns Hopkins Medicine Institutional Review Board, Baltimore, Maryland, USA.
Provenance and peer review Not commissioned; externally peer reviewed.