Clinical Research Times
June 26, 2025
Dear Colleague:
The decision about whether IRB review is required is not always clear-cut in multi-site research. Often, multi-site research involves both institutions that are conducting human subjects research (are “engaged”), and institutions that are not conducting human subjects research (are “not engaged”). Institutions that are “not engaged” generally do not require IRB oversight. This month’s CR TIMES Feature Article describes the criteria for engagement, and provides examples to help illustrate when IRB review is or is not required.
Also check out:
- “Things to Know” on getting to know Boston University’s Institutional Animal Care and Use Committee (IACUC); and on BMC’s new Clinical Research Unit (CRU)
- “The CRRO Corner” on two upcoming “Back to School” sessions of practical learning accompanied by interactive activities and cases on two important topics, Informed Consent and Recruitment
- “Getting to Know ClinicalTrials.gov” on the Individual Participant Data (IPD) Sharing Statement module in ClinicalTrials.gov
- “Spotlight on SOPs” on the SOP entitled “Research Training”, which provides detail on available training for conducting clinical research. This includes required training, and additional training that may be applicable based on the roles delegated to investigators and research staff
- “Dear IRB” on what is needed in your IRB submission when professional organizations are used to disseminate information about your research study
Learn more at www.bu.edu/crtimes.
Matthew Ogrodnik, MS, CIP, Editor, CR TIMES
Director, Office of Human Research Affairs