Exploration and Reflection on Informatization Construction in Optimizing the Ethical Review Process / 中国医学伦理学

ABSTRACT

Currently, the number of clinical research projects continues to grow. Both sponsors and researchers hope to accelerate medical ethical review efficiency, and the regulatory agencies strengthen the control over the ethical review quality. The ethics committee (EC) offices of medical institutions are relatively insufficient in terms of human resource allocation and archiving space. Combined with the development goals of the EC and the requirements of the homogeneity construction of ethical review, it was urgent to optimize the ethics review process and accelerate the efficiency of ethics review through informatization construction. Through informatization construction, the process management of ethical review could be strengthened, the work steps could be simplified, the ethical review level could be improved, and the supervision ability and efficacy of EC on clinical research could be strengthened, which may provide continuous quality improvement strategies and specific optimization measures for the operation and management of the EC, so as to effectively protect the safety, the rights and interests of subjects.