Guidance for COVID-19 Research
To manage the large number of proposed studies, we have developed a streamlined process for reviewing COVID-19 protocols that our investigators are developing as Investigator-initiated trials (IITs) or through collaborations with sponsors or other institutions. A centralized review by the COVID-19 Protocol Review Committee will serve as a mechanism for ensuring that the protocol’s scientific aims align with our overall institutional goals, there are adequate resources to support the trial and that there will be internal oversight of the conduct of the trial.
The Review Committee is tasked with the review and approval of fully developed or finalized protocols. Please follow the steps outlined below for submission for review.
- Complete the Protocol Review form and send the final protocol along with the completed form to email@example.com.
- The protocol and COVID-19 Protocol Review form will be sent to an assigned reviewer.
- A Committee decision is generally expected to be within 3 to 5 business days with exceptions for some types of studies, e.g. IND requirements.
- Committee decisions will be made based on clinical impact, scientific design and funding.
- If the protocol is approved to proceed, then the PI will work with his/her respective research leader to move forward to obtain additional approvals such as the Research Medical Director Dyad for the department.
- Approval by the COVID-19 Protocol Review Committee is required prior to:
- IRB review & approval
- OSP (Office of Sponsored Programs) budget review & contract negotiations
- Grant review & application submission