Clinical Research Times

February 27, 2026

Dear Colleague:

“Should I submit this as an amendment or a new study?” Study teams frequently need to determine whether proposed changes belong in an existing protocol or warrant a completely new study as research evolves, new funding arrives, collaborations develop, and scientific directions shift. This month’s Feature Article provides detailed guidance for making this determination with the use of a practical tool:  The 3 Ps Framework.  A detailed walkthrough of each component, categorical rules, special situations, and scenarios for applying this framework are discussed.

Also check out:

• “Things to Know” on changes to the IRS reporting threshold for research participant payments, including required actions for currently affected studies; on recent updates to the HRPP Policies and Procedures; on recent updates to the consent form templates; and on improvements to the Templates page on the IRB website
• “The CRRO Corner” on upcoming trainings (Fundamentals in the Conduct of Clinical Research and Principal Investigator Role training), as well as the Clinical Research Seminar and RPN calendars for the winter/spring 2026
• “Getting to Know ClinicalTrials.gov” on important changes to regulatory requirements for Basic Experimental Studies in Humans (BESH)
• “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 personnel change requirements for “not human subjects research” (NHSR) studies

Learn more at www.bu.edu/crtimes.

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