Throughout the world, research ethics committees are relied on to prevent unethical research and protect research subjects. Given that reliance, the composition of committees and the manner in which decisions are arrived at by committee members is of critical importance. There have been Instances in which an inadequate review process has resulted in serious harm to research subjects. Deficient committee review was identified as one of the factors In a study in New Zealand which resulted in the suffering and death (...) of many women diagnosed with carcinoma in situ. (shrink)

The mission of the Indian Health Service affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards developed seven research Model Volunteer Consent Forms.