Clinical Research Times

April 30, 2025

Dear Colleague:

This month’s Feature Article focuses on exempt category 13, which covers most types of minimal risk research that involves adults who are able to provide abbreviated consent. This category encompasses a wide variety of research methods.  Understanding whether your study qualifies for exempt category 13 will enable you to adequately plan for considerations such as selecting the correct IRB application review path, using the appropriate “abbreviated consent” template, and determining when verbal consent is sufficient.

Also check out:

• “Things to Know” on new fields in the electronic IRB application that collect drug schedule information and drug storage location; on BMC’s new Clinical Research Unit (CRU); and a reminder about the requirement to use a detailed protocol if the study funder requires results posting on ClinicalTrials.gov
• “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 spring and summer 2025
• “Getting to Know ClinicalTrials.gov” on the 25th anniversary of ClinicalTrials.gov, and the critical events and milestones that have occurred during this period
• “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 Certificate of Confidentiality (CoC) language needs to be included in consent forms that will be used to enroll international participants

Learn more at www.bu.edu/crtimes.

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