QA self-assessment tool now on-line

Questionnaire asks for detailed info

In last month’s issue of IRB Advisor, we discussed the Office for Human Research Protections’ (OHRP) new quality initiative. A major part of that program is the Quality Assurance Self-Assessment Tool. That tool, developed by OHRP, is now on-line and can be accessed at

The tool is a 19-page questionnaire covering all aspects of IRB management and responsibilities, including workload and staffing resources, IRB record keeping, the committee-review process, and written operating procedures and forms. (To see the list of forms that should be in the project packet submitted for initial IRB review, click here.)

Participants will be asked questions, such as:

  • Who oversees the day-to-day operations of the human subjects protection program?
  • Who selects and appoints IRB members?
  • Does your institution/IRB have a separate committee for review of noncompliance incidents?
  • Does your institution/IRB have established policies and procedures for disclosure and management of potential conflicts of interest?

Other areas covered by the questionnaire are workload and staffing resources; educational training; and IRB chair, member, and staff functions.

"The OHRP QA/QI Self-Assessment Tool is a good starting point for self-assessment of a human research protection program" says Erica Heath, MBA, CIP, president of IRC, an independent IRB in San Anselmo, CA. "Its target is a far more achievable goal than the incredible documentation required for the two accreditation programs — the Association for Accreditation of Human Research Protection Programs and the Joint Commission on Accreditation of Healthcare Organizations. This tool seems quite rational and provides a good starting point for program assessment."

Though generally complimentary, Heath does point out what she perceives to be a shortcoming — the reliance on IRB minutes. "It’s too bad that OHRP continues to put so much reliance on documentation in the minutes while effectively ignoring study file documentation," she explains.

Heath also references the Food and Drug Administration tool, "A Self-Evaluation Checklist for IRBs," which has been available since the mid-1970’s. "In my opinion," Heath says, "the two tools target different aspects of a program and compliment each other nicely."

Institutions wanting to participate in Phase I of the quality assurance program should contact the Office for Human Research Protections, Division of Assurances and Quality Improvement, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, attn: George Gasparis.