Annex consists of: International guidelines for biomedical research involving human subjects.

Records the main presentations and discussions held at an international conference organized to review an early draft of revised international ethical guidelines for biomedical research involving human subjects. Revisions reflect the need for a fundamental rethinking of several principles embodied in the previous guidelines, which were issued in 1982 by CIOMS largely as guidance on the application to developing countries of the Declaration of Helsinki. The proceedings of the conference reflect the developments in biomedical research and bioethics that had occurred over the previous decade and which pointed to the need to revise the 1982 guidelines. The proceedings consist of fourteen presentations and summaries of discussions. Key questions debated include the circumstances under which proxy consent is justified, mechanisms for the review of externally sponsored research and multi-centre trials, the distinction between vulnerable and exploitable populations, and the question of whether refusal to publish the results of unethically conducted research is a reasonable and sound sanction. There are useful discussions on the unique ethical issues raised by HIV infection and AIDS, by the asserted right of HIV-infected people to have access to incompletely tested new treatments, and by the prospect of field trials of candidate AIDS vaccines and drugs. New problems have been raised by studies designed to detect HIV infection and other diseases in large populations, by externally sponsored research, and by advances in the management of electronically collected and stored data, which call for a rethinking of the principles of confidentiality and informed consent. Chapters also reflect a growing perception that research involving human subjects is beneficial rather than threatening and that vulnerable groups, such as women, children, the elderly, and prisoners, should not be deprived arbitrarily of the opportunity to benefit from investigational drugs, vaccines or devices. Other topics discussed include ethical implications of the distinction between therapeutic, or clinical, and non-therapeutic research, the question of providing financial or other material inducements to research subjects, and the sponsors obligation to ensure that study subjects are compensated for any harm caused by participation as a research subject and are among the first to profit from the outcome of a research project. Participants also discussed criteria for the establishment of national and local ethical committees and the need to involve local researchers in externally sponsored research so that some knowledge or technology is passed on. The guidelines, revised to reflect the consensus of the conference, are also issued as a separate publication .

WHODOC

WHO monograph

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