Clinical Research Times

May 28, 2026

Dear Colleague:

This month’s Feature Article presents a practical wish list from the BMC/BUMC IRB staff: the foundational knowledge, habits, and resources that, if understood at the outset, would meaningfully improve the quality and efficiency of IRB submissions from Principal Investigators new to research or new to the institution. Topics include identifying the correct level of review, harmonizing application materials, operationalizing recruitment and consent, and making the most of key institutional resources.

Also check out:

• “Things to Know” on recent updates to the HRPP Policies and Procedures, including a sneak peek at upcoming changes to the short form consent process
• “The CRRO Corner” on the importance of internal consistency in your IRB submissions, including real-world examples drawn from CRRO consultations and concrete strategies for avoiding the most common pitfalls
• “Getting to Know ClinicalTrials.gov” on NIH’s updated definition of “intervention”, and what that means for how clinical trials are classified and reported going forward
• “Dear IRB” on IRB oversight for research involving deceased individuals, as well as institutional contact information for setting up Data Use Agreements

Learn more at www.bu.edu/crtimes.

Matthew Ogrodnik, MS, CIP, Editor, CR TIMES
Director, Office of Human Research Affairs