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Quality Assessment Program

OHRP's Quality Assessment Program is intended to help institutions evaluate and improve the quality of their human research protections program. Institutions may do a self-assessment utilizing the QA Self-Assessment Tool. In addition, institutions may contact OHRP to request an in-depth QA consultation or workshop. 

How can your institution participate in OHRP's Quality Assessment Program?

OHRP offers a variety of resources to help institutions evaluate and strengthen the quality of their human research protection program. OHRP can:

  • Provide tools to help your institution identify strengths and areas for improvement, such as the OHRP QA Self-Assessment tool.
  • Through direct consultation, in-person of via a video or phone conference:
    • Clarify regulatory requirements.
    • Provide detailed review of IRB written procedures and meeting minutes.
    • Explore ways to improve the quality, efficiency, and effectiveness of IRB administration.
    • Identify "best practices."
    • Foster partnerships and collaborations among institutions.
  • Conduct a training session addressing human subject protections issues on-site at your institution, or via video teleconference.

These are described below. For more information and to discuss how your program might benefit from one of these services, please contact Michelle Feige

 


A Guided Self-Assessment for Human Research Protection Programs

Utilizing the OHRP QA Self-Assessment Tool, institutions can conduct a guided self-assessment of human research protections programs. 


Direct OHRP Consultation

To Contact OHRP to request an OHRP QA consultation of your human research protections program, please:

  • Send a written request to the Division of Education and Development (DED)
  • Provide DED with your institution's written IRB procedures and minutes from three (3) recent IRB meetings
  • The Quality Assessment team will contact you to arrange one of the following:
    • An onsite consultation
    • A video conference
    • A teleconference

Quality Assessment Workshops

OHRP's Division of Education and Development  conducts free workshops on “Developing Your Human Research Protections Program: Regulatory Compliance and Additional Considerations.” They are only offered to institutions that review and conduct U.S. Department of Health and Human Services (HHS)–supported research, and are designed for an institution’s key personnel involved with the development and implementation of human research protections policies and procedures. 
 

At the conclusion of this program, the participant should be able to:

  • Understand the basic history and requirements of the HHS human subjects protections regulations at 45 CFR part 46
  • Identify the elements of a Human Subjects Protections Program
  • Identify and develop required Institutional Review Board (IRB) procedures
  • Develop recommended IRB policies
  • Describe the membership requirements of a duly constituted IRB
  • Identify essential elements of meeting minutes
  • Understand the requirements for IRB record retention

A full-day workshop is offered to FWA holding institutions. The workshop includes didactic and interactive sessions, as well as “hands-on” learning exercises.  Institutions which hold an OHRP-approved Federal Wide Assurance (FWA) receive invitations based on the region in which the workshops are held throughout the United States. Registration is limited. 

For more information regarding the OHRP Quality Assessment Program, please contact Michelle Feige