To all staff participating in human subject research at DF/HCC:
Below is some additional information to clarify what changes require prospective review and approval by the DFCI IRB in light of the steps we are all taking to reduce transmission of COVID-19. For protocols under a central/single IRB (e.g., WIRB, CIRB), please make sure to follow the policies of the IRB of record.
We want to emphasize the priority must always be the safety and protection of the research participants and our research staff. It's important to remember that changes to research protocols that may be needed to prevent an immediate hazard to research participants do not require prospective IRB approval under the regulations. The PI is responsible for making the assessment that there is a need for immediate action to protect the safety and well-being of the participant.
Changes to the protocol which DO NOT require prior IRB review and approval
- Implementing COVID-19 screening of research participants prior to planned study visits. Please check with your institutional officials to determine if any COVID-19 screening procedures are required by your institution. This does not require a protocol amendment nor a deviation request.
- Changes to protocols to prevent an immediate hazard to research participants. As noted above, the PI is responsible for making the assessment that there is a need for immediate action to protect the safety and well-being of the participant. If there is a need, the PI may make the change without first obtaining IRB approval. Note this option is only available for changes that would impact participants already enrolled in the study. It is not appropriate to make such a change in order to enroll a new participant (for example exceptions to inclusion/exclusion criteria.)
Prospective IRB approval is not required. However, an Other Event should be submitted to the DFCI IRB within 5 business days if this occurs.
- Minor protocol deviations that do not impact subject safety, compromise the integrity of study data and/or affect a subject’s willingness to participate in the study. For example, cancelling visits or procedures that are not safety related, performing adverse event assessments over the phone or having labs drawn at a local facility. Per DFCI IRB policy, minor deviations are documented on the minor deviation log and reported at the time of continuing review. Please see here for more information.
Changes to the protocol which DO require prior IRB review and approval
- Changes to the protocol and requests for protocol exceptions that may impact participant safety or the integrity of the study data. This may include dispensing study drug without performing a key safety lab or procedure, or failure to capture endpoint assessment data. If submitting urgent requests due to COVID-19, please send a high priority email to OHRS@dfci.harvard.edu with COVID-19 in the subject line.
Investigators and study teams should begin planning now for potential disruptions in clinical research activities.
- Investigational Drugs: If research participants are on investigational drugs, work with your research pharmacy and the protocol sponsor (as applicable) to determine what the plan would be if the investigational drug could not be dispensed to research participants.
- Research Procedures: Investigators need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures. For example, specimen collection may not be safe if the study does not have appropriately trained staff available to conduct the specimen collection.
1. Do I have to submit an amendment to change an in-person visit to one conducted virtually or by remote means?
If the approved procedures to be conducted at that visit can be done remotely without compromising the safety of the research participant or the scientific validity of the study, this would be considered minor deviation and would not require prior approval by the IRB. However, if there are procedures that cannot be conducted because an in-person visit cannot occur AND those procedures impact the safety of the participant or the scientific validity of the study, this should be submitted to IRB for approval as described above.
2. Should consent forms be revised to include the risk of contracting coronavirus at the hospital or during a study visit?
Research teams should carefully consider the risks of participants attending study visits in light of the factors discussed above.
3. Do I need to report to the IRB if a subject or member of the research team tests positive for COVID-19?
The PI and research teams should follow applicable hospital policy for reporting all new COVID-19 infections. For research subjects, and adverse event may need to be documented in the research chart. However, the DFCI IRB only requires immediate reporting of adverse events when they meet the criteria listed in the Adverse Event Reporting policy.
4. Should we suspend recruitment activities for some research protocols?
Please refer to any information released by your specific institution or contact your institutional officials first. Each PI should carefully consider whether they can appropriately conduct screening and recruitment activities, as well as meet protocol requirements for the conduct of the research. Teams should assess whether they will have sufficient number of trained staff and supplies, support services, and “treatments” (drug, devices, agents) to continue the research without interruption.
5. The Sponsor, PI or home institution has decided to suspend any portion of research conduct (e.g., new recruitment, halting treatment) temporarily due to COVID-19, do I need to notify the IRB?
If this is a non-therapeutic research study where the temporary suspension would not impact the safety or welfare of research participants, this would be considered a minor deviation and would not require prior approval by the IRB. If the study is therapeutic, please submit a status change amendment and include information on contingency planning related to interruption or changes in investigational product and/or safety monitoring. Status change amendments to suspend research for this purpose, with no other changes, are exempt from the business rule limited protocols to a single amendment at a time.
Feel free to email OHRS@dfci.harvard.edu if you have questions about this notification.