Moral reasoning in biomedical research protocols.

An analysis was performed of the ethics section in 134 biomedical research protocols submitted for review to a Danish Research Ethical Committee (REC) in 1990. The statements made in the ethics sections were identified and classified. It was found that 20% of the protocols lack an ethics section despite a specific requirement for such a section in the Helsinki-II declaration and the guidelines issued by the REC. The ethics sections have a median length of 6 lines of text and contain a median of 3 ethically relevant statements, thereby comprising 1.13% of the total research protocol. An analysis of the statements made show that 32% are purely formal and 30% are concerned with the area of information, consent and voluntariness. The remaining 38% are spread over a wide range of considerations. It is hypothesized that this relatively meager result reflects the researchers perception of the research review procedure as a mostly formal procedure.