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Clinical Research Times

May 28, 2021

Dear Colleague:

This issue of the CR TIMES focuses on the ethical and regulatory issues associated with low enrollment and under-powered research, and new information the IRB is collecting on the feasibility of fulfilling your sample size.

Also check out:

  • “Dear IRB” on the requirements for research studies involving children who are in the custody of the Massachusetts Department of Children and Families (DCF).
  • “The CRRO Corner” on tools for remote maintenance of regulatory files for clinical research.
  • “Things to Know” on updates to the INSPIR application regarding use of HIPAA identifiers and billing for cede review applications; a reminder of Conflict of Interest (COI) Requirements for BU & BMC investigators participating in BMC research; and an announcement about BMC and BU’s participation in the Massachusetts Consortium on Pathogen Readiness (MassCPR), and opportunities for obtaining no-cost biospecimens for funded research.

Learn more at

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