Effective Dates & Applicability:
The revised policy manual applies as follows:
- To ALL research initially approved on or after January 21, 2019
To some research approved prior to January 21, 2019:
- For federally funded research, the IRB may decide (on a case-by-case basis) to apply the Three Burden-Reducing Provisions as well as some or any of those revisions in the revised policy manual that do not conflict with the pre-2018 Common Rule. Projects approved utilizing the three burden-reducing provisions will comply with the revised Common Rule as required on January 21, 2019.
- For projects not otherwise subject to the Common Rule, the SBS IRB Office or SBS IRB may apply some or all of the revisions in the revised manual on a case-by-case basis.
When the research invokes multiple regulatory frameworks (e.g., Common Rule, DOJ, HIPAA, Illinois laws, etc.), all will be considered and applied as required. For those projects not transitioned (or only partially transitioned) to the new policy, the previous version of this policy manual will continue to apply as applicable.
The manual will continue to be updated as OHRP provides additional guidance related to the revised Common Rule.
New: Revised SBS IRB Policies & Procedures Manual (02/24/2019)