Obtaining informed consent is a cornerstone in protecting human subjects in research. Because the Institutional Review Board (IRB) has received several recent inquiries about requirements for consenting participants, we would encourage you to review the information and resources listed below.
Informed consent requirements for studies involving human subjects:
- Legally effective informed consent must be obtained before a subject undergoes any research interventions
- Legally effective informed consent requires that the basic elements of informed consent, and additional elements when appropriate, are included in the consent form
- The consent document must be signed by the subject (or Legally Authorized Representative) unless the IRB has approved a waiver of documentation of informed consent
Informed consent is not required when:
- The study is determined to be exempt by the IRB
- The IRB approves a waiver of consent
Please review the following resources and IRB policies for more information:
- The Department of Health and Human Service’s Office on Human Research Protections has an informed consent page.
- OHSU IRB policies: Elements of Consent and Waiver of Consent
As always, the Research Integrity Office is happy to answer any questions you may have. You can call them at 503-494-7887 or email the IRB office.