Abstract

This survey has been designed as a multinationalcollaboration to collect data from several countries focusing ondeveloping countries. The main purpose was to elaborate thefunctions of ethics committees regarding externally-sponsoredresearch . In March 2004 a total of 89 open-endedquestionnaires were sent to ethics review committees inmedical schools, medical research institutes and hospitalsaffiliated to the public and private medical universities inJapan.Twenty two ECs replied , and among them five ECshad reviewed eleven ESR proposals in 2002-3. Five of thoseESR proposals have been approved and four proposals havebeen approved after some revisions. Two proposals weredeferred but not resumed. In their review, respondents weremore concerned about “individual consent” than “communityconsent”. Post-trial access to effective interventions was not areal concern. As for “Standard of care”, seven ECs replied thatthey review the ESR proposal based on the internationalstandards and four based on the local standards. WhetherESR proposal is matched with the national health prioritieswas not a great concern. Respondents expressed theirconcern about socio-cultural issues.Ethics in research especially dealing with externallysponsoredresearch is a relatively new subject and underdevelopment in Japan. Although Japan is not a developingcountry, in order to protect individual human subjects and localcommunity, capacity building in ethics review especially inresearch collaboration with other developed and developingcountries is crucial and it has to be included in ethics inresearch programs through out the country