In light of the current COVID-19 epidemic, Sterling IRB would like to provide you with information on the requirement for IRB review of changes in research made in response to this situation. Some changes you may be considering include replacing in-person study visits with home visits or telemedicine and shipping study drug directly to research participants.
The FDA regulations require that:
- Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects. 21 CFR 56.108(a)(4).
Sterling IRB encourages sponsors and investigators to make any changes as necessary to eliminate apparent immediate additional risks to participants. In accordance with our policy, Sterling IRB requests that you report these changes to the IRB within 10 business days. You may report these changes using a memo or letter explaining the changes to research or you may submit a full protocol amendment. The submission will undergo IRB review in accordance with Sterling’s process.
In addition, Sterling IRB’s staff is available to assist you with any questions you may have regarding making changes to research protocols to minimize or eliminate potential safety issues to study participants. Please send any questions to info@sterlingirb.com or call 1-888-636-1062.