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.
For more information and to discuss how your program might benefit from one of these services, please send your request to OHRP-EDU@hhs.gov
Quality Assessment Workshops
OHRP's Division of Education and Development conducts full day workshops entitled “Quality Assessment Workshop 2.0: Focus on Informed Consent”. They are only offered to institutions that review and conduct U.S. Department of Health and Human Services (HHS)–supported research. The workshop includes didactic and interactive sessions, as well as “hands-on” learning exercises, and are designed for an institution’s key personnel involved with the development and implementation of human research protections policies and procedures. The current workshop has been designed specifically to enrich people’s knowledge of the regulations, and more specifically, of complex issues involving informed consent. The course provides over 6 hours of human subject protections education and has been granted approval by the Council of Certified IRB Professionals (CCIP) for 4.00 hours of CIP continuing education units.
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
- Describe the membership requirements of a duly constituted IRB
- Identify essential elements of meeting minutes
- Understand the requirements for IRB record retention
- Describe the requirements for informed consent
- Understand how to use waivers for informed consent
Institutions which hold an OHRP-approved Federal Wide Assurance (FWA) receive invitations based on the region in which the workshops are held. For more information regarding the OHRP Quality Assessment Program, please send your request to OHRP-EDU@hhs.gov.
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.
- Visit the QA Self-Assessment Tool Page.
- Please note that the completed QA Self-Assessment Tool is not sent to OHRP
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 at OHRP-EDU@hhs.gov
- Provide DED with your institution's written IRB procedures and minutes from three (3) recent IRB meetings
- DED staff will contact you to arrange an initial teleconference