What does the law require about informed consent forms?
The Federal regulations and University policies concerning human subject involvement in research activities exist to ensure, among other items, that each human subject enters into the research voluntarily and with adequate information. Therefore, consent must be obtained from all human subjects and such consent must be informed and voluntary. The requirement and circumstances for obtaining informed consent are specific and must be followed by all students and researchers. Federal regulations require that all informed consent forms contain certain elements. If the research project requires a more comprehensive form for informed consent, an IRB member can assist the researcher in developing such a form. Researchers should read the Basic Elements of Informed Consent to become familiar with the appropriate principles of informed consent.
