Research Participants and the COVID-19 Vaccine

To all staff participating in human subject research at DF/HCC:

Below is some important information regarding research participants and vaccination against COVID-19.

Whenever possible, we want to allow research participants to be vaccinated against COVID-19, if they choose to do so, and minimize any impact on their research participation. To that end, if the research protocol is silent on COVID-19 vaccination, DF/HCC places no general restrictions on research subjects who are vaccinated against COVID-19. 

There may be limited situations where administration of a COVID-19 vaccine is directly addressed within the research protocol. In such a situation, the current, IRB-approved protocol must be followed. In the absence of specific protocol language, research participants may be vaccinated against COVID-19 without restriction.

Some sponsors may issue optional guidance advising changes to treatment or research participation following COVID-19 vaccination. If such guidance is unclear, research teams should confirm with sponsors whether following the guidance is a protocol requirement and inquire whether the research protocol will be amended accordingly. Optional guidance does not require submission to OHRS or review by the DFCI IRB; however, a formal amendment that changes the protocol requirements will require IRB approval and activation prior to implementation.

Feel free to email OHRS@dfci.harvard.edu if you have questions about this notification.