TY  - BOOK
ED  - Council for International Organizations of Medical Sciences.
ED  - World Health Organization.
TI  - International ethical guidelines for biomedical research involving human subjects
SN  - 9290360569
PY  - 1993///
CY  - Geneva
PB  - CIOMS
KW  - Bioethics
KW  - Human experimentation
N1  - DC.CIOMS
N2  - Presents a series of fifteen guidelines formulated to provide an international tool for the protection of human rights in biomedical research involving human subjects, particularly in developing countries. The guidelines, which were first issued in 1982 largely as guidance on the application of the Declaration of Helsinki to developing countries have been revised and refined in line with several recent developments. Addressed to biomedical researchers, ethical review committees, and sponsors, the guidelines are centred on three main themes: informed consent of prospective subjects, the ethical review process, and the obligations of sponsors, particularly in the case of externally sponsored research. There has been extensive rewording of guidelines concerned with informed consent, research involving subjects in underdeveloped communities, exclusion of pregnant and nursing women, confidentiality, externally sponsored research, and compensation for injury. Each of the fifteen guidelines is accompanied by a commentary on how the guideline should be applied in practice. Where appropriate, the commentaries also indicate which judgements on the part of the investigator must be reviewed and approved by the ethical review committee. Nine of the guidelines address the issue of informed consent, moving from individual informed consent to the special cases of research involving children, persons incapable of giving adequately informed consent by reason of mental or behavioural disorders, prisoners, and persons in underdeveloped communities of both developed and developing countries. The selection of research subjects is addressed by two guidelines, which cover the equitable distribution of burdens and benefits, and the use of pregnant or nursing women as research subjects. The remaining guidelines set out ethical principles governing the confidentiality of data, compensation of research subjects for accidental injury, the constitution and responsibilities of ethical review committees, and the obligations of sponsoring and host countries in regard to externally sponsored research. The guidelines are preceded by a statement of general ethical principles and a preamble. Annexed to the guidelines are the text of the Declaration of Helsinki and an explanation of certain ethical issues raised by clinical trials of vaccines and drugs, which constitute a substantial part of all research involving human subjects
ER  -