COVID-19 Research FAQs: Animals / Human Subjects

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Q: How should research labs focused on human subjects research prepare for the impact of COVID-19?

Given Boston University and State of Massachusetts public health directives, Charles River Campus researchers must make alternative plans for projects that involve in-person interactions with research participants. In-person interactions with participants should only occur at this time if it would adversely impact the safety and welfare of the participant if that interaction did not take place. Learn more in this statement from the CRC IRB. Medical Campus researchers can find the latest guidance in these FAQs.

Q: How does the IRB need to be notified of visit changes?

Visit changes must be made in a way that protects the safety and well-being of subjects, and therefore such changes would be considered minor deviations, which must be summarized at the time of continuing review or status check-in. The IRB considers that changes made in response to COVID-19 disruptions are NOT major deviations, even though there could potentially be significant damage to the overall completeness, accuracy and/or reliability of the data collected for the study.

The IRB has posted a customizable template for recording minor deviations resulting from the pause in research due to COVID-19. To download the template, click here:

http://www.bumc.bu.edu/irb/files/2020/03/COVID-19-Minor-Deviation-Log-Template.docx

If a circumstance does arise with the potential to harm a subject (for example, a crucial in-person treatment or safety visit is impossible), the study team’s focus should be on ways to mitigate the potential harm. After this occurs, the IRB should be notified by a Reportable Events and New Information (RENI) submission.

Q: How does the IRB need to be notified of other protocol changes?

Other modifications to the approved protocol, such as adding testing for COVID-19 for research purposes, must be submitted on a Change Request and Amendment form and must receive IRB approval prior to implementation, unless the testing is done to prevent apparent immediate harm to the subject, in which case the IRB should be notified by a Reportable Events and New Information (RENI) submission. Please note that modifications to research given an exempt determination by the IRB do not need to be reported to the IRB unless they change the exempt determination.

Q: My IRB/IACUC is not able to process my protocol or protocol continuation. May I proceed anyway?

BU Committees are continuing operations remotely. PIs can continue to send protocols, amendments, continuations, etc.

Q: Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUCs) Due to COVID-19

The NIH Office of Laboratory Animal Welfare (OLAW) is deeply concerned about the impact of the expanding outbreak of the respiratory illness, COVID-19, on the ability of Assured institutions to support the well-being of animals and personnel during this public health emergency.

See NOT-OD-20-088 for flexibilities provided in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) that are applicable to implementing a pandemic plan for animal care and use programs

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