Important Updates Regarding Expansion of Research Activities

June 8, 2020

DF/HCC Research Community,

The DF/HCC member institutions are each developing plans to resume clinical research activities. Human subject research activities, regardless of where and how they occur, must be consistent with the currently allowed services at each institution and must be consistent with each hospital’s guidelines for infection control. Principal investigators should prepare a plan for resuming research activities following the process designated at each institution.

What changes to my IRB approved research DO NOT require prior IRB review and approval?

There is no change at this time to previous guidance released by OHRS. As a reminder, prospective IRB approval is not required to:

• Implement mandatory COVID-19 symptom and exposure screening required by your institution.
• Conduct the same IRB-approved procedures remotely instead of in-person. This should be noted on the minor deviation log for each occurrence.
• Make changes that do not impact subject safety, compromise the integrity of study data and/or affect a subject’s willingness to participate in the study. This should be noted on the minor deviation log for each occurrence.
• Eliminate an immediate hazard for participants already enrolled in the study. The PI is responsible for making the assessment that there is a need for immediate action to protect the safety and well-being of a participant. If this occurs, the event must be submitted to the IRB within 5 business days.

For deviations and violations related to COVID-19 restrictions, please clearly document that each event is related to COVID-19. For these COVID-19 events, three or more minor violations of the same type will not require automatic reporting of a major violation to the DFCI IRB.

What changes to my research DO require prior IRB review and approval?

There is no change at this time to previous guidance released by OHRS. As a reminder, prospective IRB approval must be obtained prior to:

• Any changes to the approved protocol that may impact participant safety or the integrity of the study data.
• Dispensing study drug without performing a key safety lab or procedure.
• Not capturing key endpoint assessment data.
• Modifying study procedures, study drug dispensing, study assessments, and/or addition or removal of study visits.
• Eliminating a procedure or assessment at regularly scheduled visits (e.g. study visit now conducted remotely but the physical exam or vital check will no longer be performed).
• Changing from written informed consent (wet signature) to a waiver of consent documentation (no signature).

When requesting a change for one participant, please submit a protocol deviation for IRB review. Otherwise, for changes involving more than one participant, please submit an amendment.

How do I go about conducting remote research visits?

1. Please follow any guidance/policy per your institution for telehealth/video visits
2. Notify the study participant (or potential participant) when in-person visits cannot occur due to institutional contingency plans, and that research visits may be performed remotely.
3. Ensure that participants are comfortable with the use of remote visits, have a quiet and private space in which to attend the visit, and the appropriate technology to make the connection.
4. Only use approved technology solutions that meet institutional requirements. Provide clear and detailed instructions to participants on how to connect for the visit.

Minimal Risk Research: How do I request a Waiver of Documentation of Consent?

Federal regulations allow the IRB to approve a waiver of documentation of consent when the research is no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context. For any minimal risk research which does not currently have a waiver of documentation of consent, the IRB will normally approve revising the consent procedures so that no signature is required on the consent document. To obtain approval of this change, investigators should submit an amendment to the IRB to request a waiver of documentation and revise recruitment procedures to conduct a verbal consent process (no signature).

The consent discussion may occur over the phone or through telehealth/video conference, provided institutional requirements are followed. The IRB normally requires that the researcher provide the participant with a written statement regarding the research. This can be submitted as part of the amendment.

Greater than Minimal Risk Research: How do I obtain informed consent without an in person visit?

Whenever feasible, researchers may conduct consent discussions over the phone or through telehealth/video conference, provided institutional requirements are followed. The person obtaining consent will provide the consent form to the participant via email, fax or mail. The participant (or legally authorized representative, when applicable) signs the consent form and emails, faxes or mails the consent form back to the research team. The investigator signs the consent form, documents the consent process as required by DF/HCC policy CON-100, and provides a copy of the fully executed consent form to the participant for their records.

In all circumstances the research team member obtaining informed consent must obtain the signed consent form from the participant and sign the consent form themselves before any study procedures may begin.

Who do I contact if I have additional questions?

For questions regarding institutional restrictions and contingency plans, please contact the appropriate institutional official at your organization. If you have any questions about this announcement, please email OHRS@dfci.harvard.edu.