Leaders: National Cancer Centre Japan (NCC), National Institutes of Health (NIH), Council on Health Research for Development (COHRED)
To promote quality, consistency and training for Research Ethics Committees (RECs).
Description of the work:
In spite of common guidelines (e.g. the WMA Declaration of Helsinki), the ethical review of clinical trials remains divergent across countries. Differences in national definitions, organisation and roles of ethics committees, and language/culture, as well as the existence of specific regulatory or legal requirements prevent the harmonisation of the ethical review of multinational studies.
Moreover, there are no standard recommendations for the training and education of ethics committee members, nor are there standard requirements for patient representatives in ethics committees.
Against this backdrop, this activity will strive to develop quality indicators that can be used by countries to accredit their research ethics systems. Furthermore, recommendations for the education and training of ethics committee members will be developed. Finally, in support of a current worldwide initiative to develop a common informed consent template, the use of such a template will be promoted to encourage greater patient involvement in clinical research.