Is the Human Research Office operating as usual?
Yes. The UMMC HRO office is fully functional and operating at our normal capacity. Usual operations are expected to continue even if the University guidelines change for contagion control purposes. Semi-monthly Convened IRB meetings will be held remotely for the foreseeable future as well.
Can I still interact with my research participants?
Yes, however, Principal Investigators and their study teams should carefully consider their research protocols in light of the rapidly evolving environment, while being mindful of UMMC guidelines.
Do I need IRB approval if I decide to modify my study procedures/add study procedures?
If the Principal Investigator decides to modify study procedures in order to protect participants and/or study staff, e.g., to replace in person visits with remote options for questionnaires, surveys, focus groups, check-ins, screening, consenting, etc., s/he should submit a modification prior to implementation. Note: It may not be necessary to modify your IRB-approved protocol if it does not specify whether interaction will occur in person or remotely.
What if I need to modify the study procedures immediately in order to protect researchers and/or study participants?
If it is in the best interest of researchers and participants to eliminate immediate apparent hazards, the Principal Investigator may implement changes without prior IRB approval, but must report such action as Reportable New Information in ESTR within 5 business days of the modification.
What should I do if I decide to temporarily suspend study activities, e.g., enrollment, study procedures, etc.?
If the Principal Investigator decides to voluntarily suspend study activities, s/he should submit as Protocol Deviation form within 5 business days of the suspension. If submitting a COVID-19 related deviation, please include “COVID-19” somewhere in the title of the protocol deviation submission.
May I submit an addendum to address coronavirus-related procedures instead of updating all of my study materials?
Yes. You may submit study-related materials that address procedures related to mitigating COVID-19. For example, if you’re conducting your questionnaires over the phone instead of in-person, a simple document stating that will suffice.
If a student or researcher needs to access and/or analyze a data set from home in order to keep working on a project, how do we address privacy requirements, if the data set contains sensitive or private information?
As the University prepares to support remote operations, we anticipate that research teams may need to rethink how they access and analyze research data sets. Successful remote research operations during implementation of coronavirus precautions requires maintaining compliance with required controls. If your research data use is covered by a data use agreement (DUA) or other contractual obligations or if an IRB has determined the data contain elements that are high risk (DSL4), please submit a protocol modification and ensure the modification is approved before moving data sets to a new technology platform. We will expedite reviews to the extent possible to support continuity.
Can I request Priority IRB review for new coronavirus research or modifications to existing protocols due to COVID-19?
Yes. In order for the IRB to prioritize the review of COVID-19 research or changes to existing research because of the virus, include a comment that explains that this is a novel/urgent COVID-19 related.
What if the above information did not answer my question?
We understand that each study is unique. For study specific questions, please contact Chris Moore.
What additional resources exist?
We recommend closely monitoring advice from the WHO, CDC, and/or any clinical site you may be working with to assess how disruptions in research could impact the safety and welfare of research participants.