CIOMS Guidelines - Global Health Trials

Research with human subjects should be carried out only by, or strictly supervised by, suitablyqualified and experienced investigators and in accordance with a protocol that clearly states: the aimof the research; the reasons for proposing that it involve human subjects; the nature and degree ofany known risks to the subjects; the sources from which it is proposed to recruit subjects; and themeans proposed for ensuring that subjects' consent will be adequately informed and voluntary. Theprotocol should be scientifically and ethically appraised by one or more suitably constituted reviewbodies, independent of the investigators.New vaccines and medicinal drugs, before being approved for general use, must be tested on humansubjects in clinical trials; such trials constitute a substantial part of all research involving humansubjects.THE GUIDELINESGuideline 1: Ethical justification and scientific validity of biomedical research involving humanbeingsThe ethical justification of biomedical research involving human subjects is the prospect ofdiscovering new ways of benefiting people's health. Such research can be ethically justifiable onlyif it is carried out in ways that respect and protect, and are fair to, the subjects of that researchand are morally acceptable within the communities in which the research is carried out.Moreover, because scientifically invalid research is unethical in that it exposes research subjects torisks without possible benefit, investigators and sponsors must ensure that proposed studiesinvolving human subjects conform to generally accepted scientific principles and are based onadequate knowledge of the pertinent scientific literature.Commentary on Guideline 1Among the essential features of ethically justified research involving human subjects, includingresearch with identifiable human tissue or data, are that the research offers a means of developinginformation not otherwise obtainable, that the design of the research is scientifically sound, and thatthe investigators and other research personnel are competent. The methods to be used should beappropriate to the objectives of the research and the field of study. Investigators and sponsors mustalso ensure that all who participate in the conduct of the research are qualified by virtue of theireducation and experience to perform competently in their roles. These considerations should beadequately reflected in the research protocol submitted for review and clearance to scientific andethical review committees (Appendix I).Scientific review is discussed further in the Commentaries to Guidelines 2 and 3: Ethical reviewcommittees and Ethical review of externally sponsored research. Other ethical aspects of researchare discussed in the remaining guidelines and their commentaries. The protocol designed forsubmission for review and clearance to scientific and ethical review committees should include,when relevant, the items specified in Appendix I, and should be carefully followed in conducting theresearch.Guideline 2: Ethical review committees