IRB, FDA, & Sponsors

Will the IRB Operate on a Normal Schedule?  
The DUHS IRB operations will continue uninterrupted during the COVID-19 outbreak.  Office personnel and Chairs will continue to be available even if working remotely.  Contingency plans are already in place to conduct convened IRB meetings remotely should it become necessary.  Staff and Chairs will still be available via email and regular office telephone numbers during normal business hours, even if working remotely.  

 If you need to consult with the IRB specifically about COVID-19 and its effect on your research, please call the IRB’s main line at 919-668-5111 from 8:30 am to 4:30 pm Monday through Friday and ask for an IRB Chair or the IRB Executive Director.  If calling after hours or on weekends, please call 919-668-5111 and follow the contact instructions for the Chair-on-call.  

I’d like to temporarily suspend my study enrollment; how do I do this?  
If you plan to temporarily suspend or revise any part of your study (enrollment, interventions, data/safety monitoring) due to COVID-19 (multiple bullets may apply) Please see up to date information in the Programmatic Impacts and Project Extensions section of the main Research FAQ page as well as information in recent communications for research administrators. We encourage investigators and study teams to work directly with sponsors for programmatic changes that ensure the continuity of the research. In the event a change materially impacts the scope, budget, ability to meet project aims, or where the sponsor requires an institutional official to sign off, please work through ORA, ORC, or ORS in advance of your communications with the sponsor. Specific contacts are indicated below: 

  • For Federally funded studies and foundation-funded studies, please work through your grants manager and ORA 

  • For Industry-funded studies, please contact ORC 

  • For any studies for which a Duke PI holds the IND/IDE, please contact Duke ORAQ at;  

  • For Duke-funded studies, please inform your CRU Director via email.  

What can I send to my sponsors to communicate necessary changes to our study?
Please use the updated memos and communications linked within this FAQ. An example communication can be downloaded here, and additional guidance can be found in the Sponsor Communications Packet.

Do I need IRB approval to make changes to the protocol to account for response to COVID-19? 
Please refer to the Duke Health IRB policy entitled “COVID-19 and Research at Duke” released on March 11, 2020. As per this policy, the IRB has identified some deviations that do not require IRB notification or approval. For the purposes of this policy, “deviations” shall be considered to be deviations from the IRB-approved protocol that do not affect data integrity or subject safety, rights, or welfare.  Examples of deviations include missed study visits, out-of-window visits, elimination of minor assessments, changing the platform under which data is collected or safety is monitored (such as changing from clinic visit to a phone call), and home-delivery of drugs/devices. The DUHS IRB does not need to be notified of, or approve, deviations from the IRB-approved protocol due to COVID-19 at this time; however, please internally track these deviations in the event that an accounting is required at a later time.  

Any other revisions to the IRB-approved protocol (change in the frequency of safety monitoring, elimination of critical study visits, change in drug/device administration or composition), require submission of an amendment to the IRB.  Please put “COVID” in the amendment title.  These amendments will be given priority for IRB review/approval.