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Regulatory Core

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Director

Susan Harkema, Ph.D.

 

Managers

Shannon Martin
Blair Cade

Personnel

Andi Willhite
Anthony Gallahar
Christie Ferreira
Debra Williams
Eddie Brown
Manpreet Chopra
Taylor Blades

C.O.R.E.

Comprehensive

Objective

Research-driven

Evidence-based

The Regulatory Core Team is committed to the protection of all human participants involved in research.  The Regulatory Core promotes a culture of compliance and oversees adherence to the ethical principles of The Belmont Report, federal and state regulations, the Human Subjects Protection Program at the University of Louisville, and sponsoring agencies.

The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects.

The Regulatory Core Team:

  • Disseminates information and provides guidance regarding compliance with Federal regulations and University and sponsoring agency policies and procedures.
  • Develops and maintains electronic submissions related to the administration of human participant research.
  • Facilitates changes to protocols for all research involving human participants.
  • Reviews approved research protocols at intervals appropriate to the degree of risk, but no less than once per year.
  • Helps to ensure that all consent documents include the required elements of consent in accordance with federal and state regulations and University and sponsoring agency policies and procedures.
  • Conducts internal monitoring of human subject research records in accordance with established policies.
  • Supports and endorses cooperation with University compliance and monitoring efforts.
  • Maintains records for all IRB actions and all protocols submitted for review.

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