Clinical Research Times

October 10, 2025

Dear Colleague:

The BMC/BUMC IRB has released translated Spanish versions of the Adult Consent Form template and the Exempt Information Sheet template. As an accompaniment to the release of these translated consent form templates, this month’s Feature Article discusses the inclusion of individuals with limited English proficiency (LEP); and how to ensure that these individuals are given the opportunity to make a fully informed and autonomous decision about whether participating in a research study is right for them.

Also check out:

• “Things to Know” on the newly available Spanish translations of the Adult Consent Form template and the Exempt Information Sheet template; on a quick guide to BMC’s Export Control Policies; and for an announcement about the new Boston Medical Center Health System (BMCHS) virtual Innovation Community
• “The CRRO Corner” on upcoming trainings, in-person Back to School sessions, and the Clinical Research Seminar and RPN calendars for the rest of 2025
• “Getting to Know ClinicalTrials.gov” on the role of the Responsible Party (RP) 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 when Marketing/Communications review is required for recruitment materials developed and approved by external sites

Learn more at www.bu.edu/crtimes.

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