Important DF/HCC Policy Exception, Clarifications, and Guidance Related to COVID-19

Important DF/HCC Policy Exception, Clarifications, and Guidance Related to COVID-19

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DF/HCC Research Community,

We recognize that the recent surge in COVID-19 cases may be impacting our clinic staffing, as well as patients’ ability to come on site for visits.  In an effort to facilitate continuity of research, DF/HCC leadership has reinstated the previous policy exception relaxing delegation of authority requirements. For additional information on this, as well as other important guidance and reminders related to conducting research during this most recent case surge, please read below.

Topics included:

• Relaxed DOA Requirements
• Guidance on Protocol Deviations/Violations Related to COVID-19 Disruptions
• Contingency Planning
• Sponsor-Issued COVID-19 Letters
• Eligibility Checklist Requirements
• FAQs – Research suspension, Consent Forms, Amendments and IRB reporting related to COVID-19

Relaxed Delegation of Authority Requirements

Individuals providing coverage for standard of care procedures or administrative tasks do not generally need to be listed on the delegation of authority. However, any individual performing significant trial-related duties or performing safety related tasks must be appropriately qualified and delegated these responsibilities by the PI. 

Due to staffing shortages, there is an increased need for a limited number of staff to cover a broader range of research activities conducted by staff (MDs, NPs, PAs, Research Nurses, Coordinators, etc.) that are not listed on the study. We would expect this will typically be in situations where the participant is being seen due to an adverse event but may include other visits or tasks when necessary in order to fulfill clinical oversight during periods of reduced staffing. 

DF/HCC leadership has approved a blanket and temporary policy exception starting immediately and continuing through March 1, 2022. Since these are covering situations, these individuals do not need to be added to the delegation of authority log if the appropriate study staff remain accessible remotely and will be able to fulfill research oversight. Communication between the covering staff and study team will be appropriately documented and maintained in the research subject file.

A note-to-file documenting the policy exception is posted to the DF/HCC website 

OHRS Guidance on Potential Protocol Deviations and Violations Related to COVID-19 Disruptions

This information is intended to clarify which protocol deviations or changes require prospective review and approval by the DFCI IRB, and where we may be flexible. A reminder that the PI is ultimately responsible for making the assessment that there is 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 as promptly as feasible and no longer than 30 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 or rescheduling 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. If minor deviations are specific to COVID related circumstances, indicate COVID related in the minor deviation log. Multiple COVID related deviations of the same nature do not have to be reported as major during the period of contingency plan as long as the deviations are not impacting safety or integrity of the data. 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. 

Contingency Planning for Potential Disruptions in Research Activities

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. 
• Research Participant Enrollment: If staff reductions due to Covid infections are occurring, the principal investigator may suspend enrollment temporarily and notify the IRB promptly or within 30 days.

Sponsor-issued COVID-19 Letters

Most of these letters do not change the protocol, but rather provide information and clarifications to research staff. These can be distributed internally in the research group as needed. The DFCI IRB won't be approving or posting these types of letters.

If there is a change the protocol requirements or procedures, the revised study documents must be submitted as an amendment along with any relevant sponsor correspondence. However, the sponsor correspondence alone will not be approved and posted.

Reminder: Eligibility Checklist Requirements

Per recent policy updates codified in policy REGIST-100, if an appropriately qualified member of the study team is not available to complete and sign the eligibility checklist, it can be acknowledged and approved via email. This email documentation must be filed with the eligibility checklist in the research chart. 

Please note that this should only occur in limited circumstances where it is not feasible to obtain a physical or electronic signature prior to registration, and a delay may impact subject safety or patient care.

FAQs

Q: Should we suspend recruitment activities for some research protocols?

A: 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. Additionally, please refer to any information released by your specific institution or contact your institutional officials first.

Q: Do I have to submit an amendment to change an in-person visit to one conducted virtually or by remote means? 
A: It depends. If the approved procedures to be conducted at that visit can be delayed or 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.

Q:The sponsor, PI, or home institution has decided to suspend a portion of research conduct (e.g., new recruitment, halting treatment) temporarily due to COVID-19, do I need to notify the IRB?

A: It depends. 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.

Q: What if my study is under a central/single IRB (e.g., WIRB, CIRB)? Where should I go for guidance?

A: Please communicate directly with the IRB of record and follow their guidance.

Please contact ODQEducation@dfci.harvard.edu and OHRS@dfci.harvard.edu with any questions regarding this announcement.