Teaching medical students to discern ethical problems in human clinical research studies.
OBJECTIVE
Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill.


METHODS
The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated.


RESULTS
Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p < .02). Students in the criteria-focused group were better able than students in the control group (p < .03) to discern specific ethical problems, more closely resembling expert assessments. Unexpectedly, the group focused on clinical research participants identified fewer problems than did the control group (p < .05).


CONCLUSIONS
The criteria-focused intervention produced enhanced ethical evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.
Roberts
Laura Weiss
LW
Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, Wisconsin 53226, USA. robertsl@mcw.edu
Warner
Teddy D
TD
Green Hammond
Katherine A
KA
Brody
Janet L
JL
Kaminsky
Alexis
A
Roberts
Brian B
BB
D000328:Adult; D035843:Biomedical Research / Q000193:education / Q000941:ethics*; D004504:Education, Medical, Undergraduate / Q000941:ethics; D004992:Ethics, Medical / Q000193:education*; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008297:Male; D009516:New Mexico; D018794:Problem-Based Learning / Q000941:ethics; D012680:Sensitivity and Specificity; D013337:Students, Medical; D013663:Teaching / Q000941:ethics*