Our primary concern is the safety of our research participants and the research team members. We understand that the COVID-19 outbreak will affect the continuity and integrity of many research studies. We hope the following guidance is helpful in protecting
our participants and staff and minimizing adverse impacts for research.
Federal regulations and COMIRB policies allow researchers to make changes to eliminate apparent immediate hazards to subjects without IRB approval.
Protocol deviations: If researchers deviate from their approved protocol to eliminate apparent immediate hazards to subjects, that does not require COMIRB approval and does not fall under COMIRB 5-day reporting requirements. Deviations are considered temporary and relatively minor. Researchers should document these deviations and submit a summary report to COMIRB at time of Continuing Review or, for research that does not require Continuing Review, within a reasonable amount of time.
If researchers change their protocol to eliminate apparent immediate hazards to subjects, they can do so without prior IRB approval but should report the protocol change to COMIRB and submit an amendment for review and approval. COMIRB will review and approve those amendments quickly but since prior approval is not required, researchers are not out of compliance in the interim.
Examples of changes to eliminate immediate hazards to subjects in response to COVID-19 include, but are not limited to, cancelling non-essential study visits, conducting phone visits in lieu of in-person visits, conducting additional screening of current and potential research subjects prior to in-person visits, and suspending enrollment. Also, any new screening procedures or other policies implemented by the campus or any of our affiliate health care systems are not “IRB approved procedures” and do not necessarily require an amendment to the protocol.
The conduct of research must otherwise remain in compliance with human subjects regulations and COMIRB policies. For example, if signed consent is required for research participation, changing to verbal consent would not be an acceptable deviation or protocol change without IORB approval. If circumstances make obtaining signed consent impractical, researchers should consider slowing or suspending enrollment.
Researchers should also be careful that changes to eliminate one potential hazard do not create new potential hazards. For example, moving study visits from a clinic to the subject’s home in the current environment would need to involve new screening procedures for the subjects, household members, and research staff. Such a change may also require additional training and protective clothing for research staff. Investigators seeking to move the location of study visits should seek prior approval from COMIRB and include sufficient detail to ensure that risks are minimized.
If researchers wish to collect additional data for their studies or add research objectives to approved research in response to COVID-19, this does require prior IRB approval.
If sponsors issue updated protocols, or require evidence of IRB approval of changes, researchers should submit an amendment to COMIRB as usual.
Given public announcements and awareness regarding the spread of COVID-19, if a research subject or research staff member tests positive for COVID-19, this is not considered unanticipated and does not in and of itself require reporting to COMIRB.
If deviations from the protocol are necessary which might result in potential new risks to subjects, these must be reported to COMIRB within 5 days. Examples include interruption of study drug prescriptions, or cancellations of study visits required for subject safety.
The COMIRB Office is currently open but we are prepared for the case that we have to conduct operations remotely. In that case COMIRB will remain fully operational. COMIRB will remain available to consult with and assist our researchers. Contact us and we will respond promptly. We are happy to set up conference calls and/or virtual meetings.