Perspectives of non-specialists on the potential to serve as ethics committee members.

OBJECTIVE

In Japan, under the new Clinical Trials Act pertaining to investigator-initiated clinical trials that came into effect on 1 April 2018, review boards should review proposed clinical trials while considering written opinions from specialists. Additionally, involvement of non-specialists is mandatory, and attention is being placed on their effective contributions. This study was performed to determine representative key issues with which to promote these contributions.

METHODS

This qualitative study was conducted in 2018 using a focus group interview of six non-specialists regarding perspectives on clinical research itself and research ethics committees.

RESULTS

For perspectives on clinical research itself, 33 codes were established and sorted into 2 categories and 6 subcategories relating to ambivalence toward clinical research. For perspectives on research ethics committees, 54 codes were established and sorted into 3 categories and 10 subcategories relating to the theme "knowledge and an environment that promotes non-specialist members' participation." One notable result was the willingness of participants to obtain details about a study should they be selected.

CONCLUSIONS

The results suggest that detailed explanation of a particular study would encourage non-specialist members to participate in a clinical research review committee. Education aimed at non-specialist participation should therefore be considered in future studies.