U. S. Department of Health and Human Services (DHHS)
Office for Human Research Protections (OHRP)


Quality Assurance Self-Assessment Tool
Instructions

Version Date 05/06/2002


Introduction

The purpose of this QA Self-Assessment Tool is to assist your institution or independent Institutional Review Board (IRB) in assessing your human subjects protection program. The questions presented are primarily designed to assess compliance with the federal regulations for the protection of human subjects in research. Additional information is requested to gain an understanding of your institution's or independent IRB's program, including: i) elements of the program that may go beyond the requirements of the federal regulations, ii) volume of work conducted by your IRB, and iii) available resources for your human subjects protection program. Therefore, not all questions require a positive (i.e., "yes") response. Please do not assume that a "yes" response means that your program is in compliance with a given federal regulation.

Instructions
This self-assessment tool should be completed by one or more individuals who are knowledgeable about your institution's or independent IRB's human subjects protection program, such as the IRB Chair(s), IRB Administrator(s), or Signatory Official.

While the intent of this tool is to be as comprehensive as possible, it was also designed with consideration for the amount of effort required to complete it. Some questions may involve discussion with your colleagues. In an effort to decrease the amount of time required for completion of this instrument, we offer the following suggestions. If a question requires review of information or appears difficult to answer, we recommend flagging it and moving on to the next question. You may also write draft responses in pencil and then erase them and write the final answer in pen. Once the tool is completed, you should review it and respond to any flagged, unanswered questions. In this manner the first pass through of the questions may be completed in less than two hours.

Most questions can be answered with a simple response, such as "yes," "no," or "not applicable." If you are unable to respond to a question, you may respond with answers such as "not known" or "not sure." Some questions may apply only to biomedical research and others only to behavioral research. If such questions are not applicable to your program, you may simply respond with "not applicable."

Once this tool is completed, your institution or independent IRB and OHRP should be able to begin assessment of your institution's or independent IRB's human subjects protection program, including its strengths and weaknesses. The tool may identify areas where clarification of regulatory requirements is needed or where to focus necessary education. Information regarding IRB workload and time allocation may increase an IRB's awareness of its resources, delegation of responsibility, and time management. This awareness may facilitate changes that in turn can increase efficiency. OHRP can assist your institution in this process and provide consultation toward increasing the performance, efficiency, and quality of your human subjects protection program.

If additional space is needed to answer any question, please copy the relevant page and attach it as an appendix.

If you have questions about human subject research, click   ohrp@osophs.dhhs.gov
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Updated May 8, 2002