Institutional Review Board
Important Announcement as of March 13, 2020
See FAQs for more information
Drs. Karen Antman and Ravin Davidoff, the Institutional Officials at Boston University Medical Campus and Boston Medical Center, have determined that most research activities involving in-person interactions with subjects MUST STOP until further notice. The only exceptions are if canceling or postponing the activities would either (A) increase the risk to the subject’s safety or wellbeing or (B) deprive the subject of a potential direct benefit. This is being done to protect research subject.
The following expands on the implementation of this:
For Ongoing Research with Enrolled Subjects:
Most research activities that involve face-to-face interaction with subjects must stop.
The exceptions are:
1) The research holds the potential for direct benefit to the subject (e.g., investigational drug, devices or surgical procedure) and the interaction is required to deliver that potential direct benefit
2) Collection of safety data (based on clinical judgment of the importance of the visit to detect potential adverse events)
Research activities that involve no face-to-face interactions with subjects may continue.
New Enrollment into Existing Studies:
Most studies must stop enrolling new subjects.
The exception is studies with the potential for direct benefit, that is, benefits that are not available through standard of care.
Pending IRB applications for human subjects research:
The IRB will continue to review and approve submissions. For studies that are approvable, but do not meet the above New Enrollment exception, the IRB will approve the study but explicitly note that enrollment cannot start until the pause in clinical research activities is lifted.
If you have any questions, please contact email@example.com or 617-358-5372
John F. Ennever MD, PhD
Director, Office of Human Research Affairs
The Boston Medical Center and Boston University Medical Campus Institutional Review Board (IRB) provides ethical review of human subjects research to protect the rights and welfare of human subjects of research and to assure that human research is conducted according to applicable federal, state, and local laws and regulations and the relevant policies of the Human Research Protection Program, Boston Medical Center, and Boston University.
Investigators must submit planned human subjects research for IRB review using INSPIR II and no human subjects research activities may be carried out until the IRB has provided approval or an exemption determination. Principal Investigators have the ultimate responsibility for the conduct of the study and protection of human subjects.
Additional information about IRB requirements may be found by contacting us or at the following links: