CIOMS Guidelines - Global Health Trials

ecause they can be more easily induced to participate in exchange for small payments. In mostcases, these people would be called upon to bear the burdens of research so that others who arebetter off could enjoy the benefits. However, although the burdens of research should not falldisproportionately on socio-economically disadvantaged groups, neither should such groups becategorically excluded from research protocols. It would not be unjust to selectively recruit poorpeople to serve as subjects in research designed to address problems that are prevalent in theirgroup – malnutrition, for example. Similar considerations apply to institutionalized groups or thosewhose availability to the investigators is for other reasons administratively convenient.Not only may certain groups within a society be inappropriately overused as research subjects, butalso entire communities or societies may be overused. This has been particularly likely to occur incountries or communities with insufficiently well-developed systems for the protection of the rightsand welfare of human research subjects. Such overuse is especially questionable when thepopulations or communities concerned bear the burdens of participation in research but areextremely unlikely ever to enjoy the benefits of new knowledge and products developed as a resultof the research. (See Guideline 10: Research in populations and communities with limited resources.)Guideline 13: Research involving vulnerable personsSpecial justification is required for inviting vulnerable individuals to serve as research subjectsand, if they are selected, the means of protecting their rights and welfare must be strictly applied.Commentary on Guideline 13Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their owninterests. More formally, they may have insufficient power, intelligence, education, resources,strength, or other needed attributes to protect their own interests.General considerations. The central problem presented by plans to involve vulnerable persons asresearch subjects is that such plans may entail an inequitable distribution of the burdens andbenefits of research participation. Classes of individuals conventionally considered vulnerable arethose with limited capacity or freedom to consent or to decline to consent. They are the subject ofspecific guidelines in this document (Guidelines 14,15) and include children, and persons whobecause of mental or behavioural disorders are incapable of giving informed consent. Ethicaljustification of their involvement usually requires that investigators satisfy ethical reviewcommittees that:• the research could not be carried out equally well with less vulnerable subjects;• the research is intended to obtain knowledge that will lead to improved diagnosis,prevention or treatment of diseases or other health problems characteristic of, or unique to,the vulnerable class– either the actual subjects or other similarly situated members of thevulnerable class;• research subjects and other members of the vulnerable class from which subjects arerecruited will ordinarily be assured reasonable access to any diagnostic, preventive ortherapeutic products that will become available as a consequence of the research;