Ramp-up of Human Subjects Research

Recommencement of in-person contact with already enrolled research study participants in IRB protocols that fall under the Priority I or Priority II Tier may begin June 22, 2020 with the subsequent approval of the respective department or schoolThis communication from the Human Research Protection Office/IRBs to CUIMC IRB PIs and Study Coordinators dated June 8, 2020 described the Priority Tiers.

If a study does not fall into Priority Tier I or II, in-person procedures may not resume at this time. Please note that if a department or school has received approval from the IRB for a specific plan to recommence studies, that plan prevails.

When in-person procedures resume, all efforts should still be made to limit in-person procedures and interactions to the extent possible. If study goals are able to be met by using study procedures without in-person contact with participants, such procedures should continue to be used. It is the PI’s responsibility to comply with all University, school, and departmental requirements that have been implemented to reduce the risk of exposure to the SARS-CoV-2 virus.

The PI of each IRB-approved protocol for which in-person study procedures have been paused or modified will receive an email that states either (a) the study has been determined to fall into Priority Tier I or II, or (b) the study does not fall into Priority II but may fall into Priority I.  In the latter, the criteria will be provided so the PI and department/school can make the determination.  Notification that a study definitely or may fall into Priority Tier I or II is being provided to departments/schools.

Enrollment of new subjects must remain on hold unless the research falls under one of the following categories:

  1. COVID-19 clinical research and trials;
  2. Clinical trials that offer the prospect of direct benefit;
  3. Enrollment is conducted remotely, and study procedures do not require in-person contact;
  4. On-site (i.e. at CUIMC) clinical research in which the research activity occurs during a clinical encounter (e.g., inpatient stay, outpatient visit, or emergency department visit);
  5. Clinical trials and research funded by federal or foundation sponsors; or
  6. Exception granted by the IRB.

If in-person research procedures are being conducted outside of CUIMC (e.g., in community clinics, at other domestic or international sites, etc.), compliance with local requirements is required. If the University’s IRB is not the reviewing IRB for a study, compliance with any more stringent restrictions or requirements established by the reviewing IRB is required.


Editor's note:

Refer to  COVID-19 (Novel Coronavirus): FAQs Relating to Research for human subjects research ramp-up FAQs. See COVID-19 Research Ramp-up: FAQs and Resources for general information.

Questions about ramp-up of human subjects research studies should be directed to: [email protected].

June 21, 2020