Abstract

Background:Since 1993, government agencies in Japan have introduced a series of guidelines for gene therapy clinical trials. Appraisals of these guidelines were obtained from academic societies, institutional review boards (IRBs) of hospitals, and ethics committees (ECs) at medical schools nationwide.
Material/Methods: Using data from a large-scale national opinion survey, this study evaluates the experts’ appraisals of the contents of these official guidelines in Japan and the process of their development.
Results: 26.3% of the respondents from academic societies and 39.3% of those from university ECs gave positive appraisals of the speediness of the decision process for the 1994 guidelines. Appraisals of speediness improved for the 2002 guidelines. Concerning the clarity of the 1994 guidelines, the proportion of positive appraisals was slightly smaller than negative appraisals among academic societies and hospital IRBs, though the majority of university ECs gave positive ratings. The 2002 guidelines were appraised significantly more positively than the 1994 guidelines. Information received after the decision was consistently rated better than the information before the decision. All groups reported that the opinions of patients and those of citizens were less adequately considered than were the opinions of experts. A majority of respondents rated information disclosure as important for future agendas.
Conclusions:Clarity of the guidelines could be improved by revision. More information disclosure was considered desirable, especially information available before decisions are made. Incorporation of patients and citizens in policymaking is an important future goal

Keywords: Genetic Therapy - standards, Data Collection, Clinical Trials as Topic - standards, Hospitals, Japan, Policy Making, Practice Guidelines as Topic, Schools, Medical, Societies, Scientific