Informed Consent
- Emergency Research Informed Consent Requirements (OPRR Letter, 1996)
- Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
- Informed Consent Checklist (1998)
- Informed Consent FAQ (PDF - 135 KB)
- Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
- Informed Consent: Obtaining and Documenting Informed Consent of Non-English Speakers (OPRR Memo, 1995)
- Informed Consent Requirements (Video)
- Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006)
- Informed Consent Tips (1993)
- IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)
- Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (OHRP Letter, 2010)