Educating researchers: ethics and the protection of human research participants.

Abstract

To improve the protection of human participants in research, the federal government has mandated education and training in bioethics and issues relevant to human research. Despite the large time and financial commitments involved with such education, little is known about whether these efforts will actually improve the protection of human subjects. In this article, I review the history of ethics education in research leading up to the 2000 mandate. I then explore ethics education and its evaluation in the biological sciences and medicine and describe the previous successes and failures of these efforts. Many objectives can be the focus of educational interventions and evaluation. Some interventions in these fields had small, though statistically significant, effects on moral reasoning skills, knowledge, and confidence. Interventions are more likely to have lasting impact on moral reasoning if they were of moderate duration and involved small group discussion of dilemmas. Whether these measurable differences lead to changes in behavior or real-time application of moral reasoning skills remains to be determined. By having a clear understanding of the specific objectives, strengths, and limitations of an educational intervention, educators can design programs that may have an increased likelihood of improving protection of human research participants.