C Foster1, S Holley. 1. Centre of Medical Law and Ethics, King's College London.
Abstract
OBJECTIVE: To generate baseline data about the experiences of researchers applying to five or more local research ethics committees (LRECs) for ethical review. The new multi-centre review system will be compared with these data. DESIGN: Ninety-seven researchers, whose status as multicentre researchers was unclear, were identified from various sources in the South Thames Region. They were each sent a questionnaire asking for their views on the substance of ethical review and their experiences of the process of ethical review. RESULTS: Of the completed questionnaires, 24 fitted the multicentre criteria of applying to five or more LRECs. Responses showed dissatisfaction with LRECs' treatment of the scientific aspects of research, but satisfaction with aspects relating to consent and protection of patients' welfare. Respondents experienced great difficulty in the administration of the process of ethical review. CONCLUSIONS: The need for a new system of ethical review for multi-centre research is beyond doubt. It remains to be seen whether it will be an improvement.
OBJECTIVE: To generate baseline data about the experiences of researchers applying to five or more local research ethics committees (LRECs) for ethical review. The new multi-centre review system will be compared with these data. DESIGN: Ninety-seven researchers, whose status as multicentre researchers was unclear, were identified from various sources in the South Thames Region. They were each sent a questionnaire asking for their views on the substance of ethical review and their experiences of the process of ethical review. RESULTS: Of the completed questionnaires, 24 fitted the multicentre criteria of applying to five or more LRECs. Responses showed dissatisfaction with LRECs' treatment of the scientific aspects of research, but satisfaction with aspects relating to consent and protection of patients' welfare. Respondents experienced great difficulty in the administration of the process of ethical review. CONCLUSIONS: The need for a new system of ethical review for multi-centre research is beyond doubt. It remains to be seen whether it will be an improvement.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach