BU CRC IRB Guidance on Restarting In-person Research Activities

Updated May 22, 2020

Boston University, the State of Massachusetts and the City of Boston are planning for small-scale resumption of services. These services include in-person research activities and in-person interactions/interventions with research participants on-campus and at external facilities. Below, please find guidance and recommendations on initiating, or reinitiating, human subjects research.

1. Remote Research Activities

Overall and overwhelmingly, public health authorities strongly advise that any activities that can be conducted remotely continue to be conducted remotely. Therefore, this is the recommendation of the CRC IRB. If you can change study procedures to remote procedures or continue with remote activities (if you have already made changes), please do so.

What to submit to the CRC IRB:

  • If you have already submitted an Amendment or Change Request Form to conduct research remotely and intend to continue doing so for the duration of the research project, nothing further needs to be submitted to the IRB office at this time.
  • If you have not yet submitted changes to conduct research remotely, but wish to do so, please submit an amendment request at your earliest convenience.
  • Any changes to current research projects that are made without prior IRB approval must be reported to the IRB via the Event Form.
  • NOTE: if a Change Request or Amendment Form was submitted to notify the IRB of remote activities but relevant IRB applications and research materials were not updated to reflect the changes and need to be, please submit those documents for review and approval. You may note on your email to the IRB office that the material accompanies the Change Request/Amendment Form and the date of the submission.

2. Resumption of On-campus Research Activities

a. First, obtain approval of the Research Recovery Workgroup: For projects or phases of projects that can only be conducted on-campus, please refer to the BU Research Recovery Toolkit. At this time, the Office of Research will approve which studies may resume on campus, when, and under what conditions.

b. What to submit to the CRC IRB:

  • If you have already submitted an Amendment or Change Request Form to conduct research remotely and would like to resume in-person on-campus research using the existing IRB-approved protocol and approved materials (e.g. the only difference is returning to in-person activities), send to the IRB an email that includes: PI name, protocol number, confirmation that activities will resume without material changes, and attach the approved Research Recovery Plan with the approval letter of the Office of Research.
  • If you must make changes to your protocol or research materials to resume in-person research activities, please submit an amendment with all material changes prior to implementation. With the amendment, submit the approved Research Recovery Plan with the approval letter of the Office of Research.
  • Any changes to current research projects that are made without prior IRB approval must be reported to the IRB via the Event Form.

3. Resumption of In-person, Off-campus Research Activities

a. For projects or phases of projects that can only be conducted in-person, but will take place off-campus (including in locations that may have different rules and guidance than that of BU), a plan must be developed that includes similar information to that required in the BU Research Recovery Plan. The plan should follow the requirements of the location in which the research will be conducted, and include:

  • COVID-19 screening procedures for research personnel and research participants. The screening procedures should be consistent with those being used on campus, recommended by the CDC, and/or the personal protection requirements of the location in which you are conducting research.
  • While some locations may have more relaxed rules than those at BU/in Massachusetts, the plan should include protections for research participants and personnel such as:
    • The use of personal protective equipment (PPE).
    • The implementation of physical distancing measures.
    • Proper cleaning/sterilization of common use equipment/devices after and before each use.
    • Phasing of research procedures to protect those who may be at higher risk of severe illness from COVID-19 and extra protections that will be provided for these individuals.
  • The plan to provide or send PPE or other supplies needed in the location of the research.
  • The plan for ramp-down, should procedures need to stop due to increased risk of COVID-19.

b. What to submit to the CRC IRB:

  • If you would like to resume in-person off-campus research using the existing IRB approved protocol and approved materials (e.g. the only difference is returning to in-person activities), send to the IRB an email that includes: PI name, protocol number, confirmation that activities will resume without material changes, and attach your off-campus COVID-19 research plan inclusive of the information requested in items 3a (i-iv), above.
  • If you must make changes to your protocol or research materials to resume in-person research activities, please submit an amendment with all material changes prior to implementation. With the amendment, attach your off-campus COVID-19 research plan inclusive of the information requested in items 3a (i-iv), above.
  • Any changes to current research projects that are made without prior IRB approval must be reported to the IRB via the Event Form.
  • NOTE: If your off-campus research is approved by another IRB (domestic or international) you must submit revised research plans to that IRB for review and approval, prior to implementation

Recommendations for Research Protocols Related to COVID-19

Pre-visit screening procedures:

  • Notification to participants that, similar to the risk of exposure to COVID-19 in other public locations, there is a risk to exposure of COVID-19 by coming to campus to participate in research.
  • The precautions the research team is taking to help keep participants safe while attending (and, if applicable, in transit to) the study visit.
  • What to expect upon arrival at campus or the study visit (e.g. any additional screening procedures, staff in PPE, personal use of PPE, etc.)
  • Participants should be advised to wear a mask in public, not to touch their face, and to wash their hands/use hand sanitizer after contact with public surfaces.
  • If participants do not have masks or hand sanitizer at home, consider sending a mask to the participant to wear in-transit to the research facility.
  • Discuss how participants will travel to the study visit and the safest method to do so (e.g. personal car, taxi, uber, etc.). If possible, provide transportation or arrange transportation and payment of transportation for the participant.
  • If the participant will be driven to and from the study visit by someone who will wait for them, be sure to have a discussion with the participant of whether this person will be allowed to wait in the building, required to wait in their car, or someplace else that is safe.
  • Collect contact information in the event that contact tracing is needed.

Enrollment:

  • Consider whether it is necessary to enroll persons at higher risk of severe illness from COVID-19 or whether these individuals should be excluded from the research at this time.

Study Visits: 

  • If safer for participants, consider whether clinical research procedures (e.g. MRI, blood draws, etc.) could/should take place in clinics or laboratories closer to the participant’s homes, rather than coming to the BU campus or a major hospital for these procedures.
  • Restructure or stage participant visits so that those at higher risk of severe illness from COVID-19 are seen at a later date.
  • Restructure visits to combine/consolidate procedures or series of procedures to minimize participant travel and exposure.

Continued Vigilance:

  • Create a plan for what will happen if a staff member or research participant develops COVID-19 (e.g., rescheduling visits, study withdrawal, consult with Occupational Health, etc.).
  • Create a notification plan in the event that a staff member or research participant develops COVID-19 and research participants or others may have been exposed as a result of their participation in the research. In this circumstance, an Event Form must be submitted to the IRB Office.

Questions & Resources

Please do not hesitate to contact the CRC IRB office if you have any questions at 617-358-6115 or irb@bu.edu.

Resources: