Informed Consent in the Women's Health Initiative Clinical Trial and Observational Study

The Women's Health Initiative (WHI) is one of the largest and most complex disease prevention studies ever conducted. Educating prospective participants about the study and obtaining informed consent is a sequential, multicomponent process, consisting of verbal and written information, a video, and the reading and witnessed signing of the informed consent forms. All informed consent materials were reviewed by study investigators, local Institutional Review Boards; the WHI Data and Safety Monitoring Board; the Women's Health Initiative Policy Advisory Committee; the National Institutes of Health; the Institute of Medicine in Washington, D.C.; focus groups of postmenopausal women; and the media. The consent process continues to be dynamic; as more is known about potential risks and benefits associated with participating in the WHI, the consent process has and will be revised accordingly.