Fred Hutch IRB Policy 2.11 Informed Consent (Appendix A) presumes that the Principal Investigator, MD sub‑investigators, and attending physicians with the requisite health care provider credentials will obtain informed consent, especially for high-risk interventional trials. For lower risk trials, the policy outlines other roles that are presumptively qualified to conduct consent discussions. Prospective IRB approval is required for any deviations to this policy.
To request a consent process exception, complete this form in its entirety to request permission for individuals who are not presumptively qualified per the IRB policy guidelines to conduct the informed consent process.
Document Details
| Version | Effective Date | Change Notes |
|---|---|---|
| 1.00 | 8/12/2024 | New form. |