Ethics guidelines for care after drug trials revised
Researchers conducting clinical trials should make clear their commitments to post-trial patient care before trials begin, according to a clarification of the Declaration of Helsinki, a set of ethical guidelines for scientists engaged in biomedical research.
Since the declaration was last revised in 2000, there have been calls the scientific community for further clarification of paragraph 30.
The paragraph, which reads: "at the conclusion of the study every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study", has been called unrealistic.
The full text of the footnote reads: The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.