One of the more obscure requirements for AAHRPP accreditation is related to Element I.5.B. “The Organization conducts audits or surveys or uses other methods to assess the quality, efficiency, and effectiveness of the Human Research Protection Program. The Organization identifies strengths and weaknesses of the Human Research Protection Program and makes improvements, when necessary, to increase the quality, efficiency, and effectiveness of the program.” To adequately address this element, AAHRPP requires organizations to have a quality improvement plan for the HRPP which defines at least one objective for and one measure of quality, efficiency, or effectiveness.
In order to effectively demonstrate that this element is being satisfied, we recommend that organizations, as part of their regular review of the HRPP, set an objective for the coming year along with a method for measurement. This method for measurement should assess whether or not the objective has been met, in addition to evaluating whether the previous year’s objective has been met. Typical objectives could include reducing IRB turnaround time, increasing investigator satisfaction with the IRB administration, or increasing participation in education programs.