Making Research Consent Forms Informative and Understandable: The Experience of the Indian Health Service

The mission of the Indian Health Service (IHS) 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 (AI/AN) potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards (IRBs) developed seven research Model Volunteer Consent Forms (available from the author).