Under no circumstances should anyone who is not listed as key personnel on the IRB application and not current with IRB training requirements, obtain consent, interact, or intervene with, or access identifiable data of a potential study participant. Key personnel who will obtain consent must also be designated as “Authorized to Obtain Consent” on the application.
For some studies, the board may require consent only be obtained by a licensed provider. In these studies, only they may have the consent role as authorized to obtain consent. Some of these studies may include treatment studies, greater than minimal risk studies, and studies involving research-only procedures. This requirement will be communicated as part of the review process in ensuring the appropriate roles are being utilized.
Studies Involving MU Health:
In certain studies, involving MU Health, the IRB may follow their policy to determine which research personnel can be authorized to obtain consent. MU Health policy entitled “Patient Rights & Responsibilities – Consent for Medical and Surgical Treatment” outlines their requirements for who is responsible for ensuring informed consent is properly obtained for medical and surgical treatment in the clinical setting. See our Informed Consent Requirements SOP under “Authorization to Obtain Consent” for an outline of MU Health policy.
Key personnel are defined as all persons obtaining:
- Data about the subjects of the research through intervention or interaction with them;
- Identifiable private information about the subjects of the research; or
- The informed consent of human subjects for the research.
All key personnel must be listed on the IRB application and have up-to-date IRB training. If restrictions are in place on who may be authorized to obtain consent, the study team must adhere to the requirements as future personnel changes are made.