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Clinical Research Times

April 30, 2024

Dear Colleague:

Screening is the process of collecting information to determine whether a potential subject meets a study’s eligibility criteria. This process can take many forms, including reviewing the medical record, asking questions of a potentially eligible individual, and conducting clinical procedures like a blood draw. This month’s Feature Article discusses screening processes, and provides guidance on the consent and HIPAA requirements that are associated with different types of screening activities.

Also check out:

  • “Things to Know” on recent revisions to the posted IRB consent form templates; new and revised HRPP Policies and Procedures that took effect this month; and a reminder about the new process for closing exempt studies without the need for submission of a Final/Closure Report form
  • “The CRRO Corner” on the updated eConsent Tools and Guidance that are now available for use by the research community
  • “Getting to Know ClinicalTrials.gov” on “Good Cause Extension” requests for extending the results reporting deadline for Applicable Clinical Trials (ACTs) and NIH-funded clinical trials
  • “Spotlight on SOPs” on the current training requirements for the institutional Standard Operating Procedures (SOPs), which took effect on January 1, 2024
  • “Dear IRB” on the relationship between waivers of consent and waivers of HIPAA authorization, and information about the applicability of the HIPAA regulations in international research

Learn more at www.bu.edu/crtimes.

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