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Clinical Research Times

December 18, 2024

Dear Colleague:

As part of our Human Research Protection Program (HRPP) policies, investigators are permitted to request that the Boston Medical Center / Boston University Medical Campus Institutional Review Board (BMC/BUMC IRB) cede IRB review to an external IRB for the review of a new study, such as commercial IRBs for industry-sponsored studies.  The BMC/BUMC IRB also commonly cedes review to non-commercial IRBs; for example, to the IRB of another academic institution that is leading a multi-site study. In order to help you avoid the most common stipulations from the IRB, and thus facilitate an efficient review process, this month’s Feature Article provides insider tips for submitting your initial non-commercial cede application.

Also check out:

  • “Things to Know” on a new HRPP policy regarding when you need to submit translated materials to the BMC/BUMC IRB in international research; changes to the Change Request and Amendment form for ceded studies that are intended to prevent unnecessary submissions; changes to the Continuing Review Submission Form for expedited research that shorten the form; and updated Exempt Information Sheet templates that include Abbreviated HIPAA authorization language
  • “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 beginning of 2025
  • “Getting to Know ClinicalTrials.gov” on completing the “Study/Recruitment Status” section of a CTgov record
  • “Spotlight on SOPs” on the Standard Operating Procedure (SOP) entitled “Participant Recruitment”, which informs the research community about their obligations, responsibilities, and available resources related to participant recruitment
  • “Dear IRB” on IRB guidance for re-opening a study to add collection and analysis of new data variables

Learn more at www.bu.edu/crtimes.

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