by Jennifer Vergara-Jimenez, MD, MS Bioethics, assistant director of research compliance, Jaeb Center for Health Research and Adjunct Faculty, South University Health Programs
While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference happenings.
My institution, the Jaeb Center for Health Research, is currently starting the accreditation process with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), which has generated a certain amount of anxiety for me. When an organization decides to become accredited, many questions arise. Thankfully, however, AAHRPP offers amazing support prior to and during the accreditation process.
Accreditation is a voluntary process through which an organization can measure the quality of its work and its performance against recognized standards. The accreditation process involves a self-assessment by the organization, as well as a detailed evaluation by a team of external experts or site visitors from AAHRPP. According to AAHRPP, “the primary purpose of the accreditation is to strengthen protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research.”
Being accredited by AAHRPP is beneficial for any institution that conducts research activities. It signifies that the institution complies with established human subjects protections standards and has effective mechanisms of self-regulation and quality assurance.
To prepare for my institution’s accreditation, on the first day of the 2013 AER Conference, I participated in a workshop titled Comprehensive Human Research Protection Program (HRPP): An Overview of the Accreditation Process and Standards, led by Wesley Byerly, Sugatha Sridhar, and Elyse Summers.
During the workshop, Wesley Byerly, assistant systemwide compliance office for research for the University of Texas system, walked attendees thru each domain evaluated by AAHRPP:
- Domain I reviews all aspects of the organization
- Domain II is dedicated to analyzing the IRB’s day to day activities
- Domain III assesses the researchers and research staff
Each domain is equally important, and the elements within each domain must be supported by documentation such as standard operating procedures, investigators’ handbooks, manuals, etc. All of documents applicable to one’s organization should be submitted within the first step of the application process, which is pretty straight forward as it is nicely described on the AAHRPP website. It can take up to nine months to become accredited.
To my delight, Sujatha Sridhar, executive director of research compliance, education, and support services at the University of Texas Health Science Center at Houston, described her personal experiences with AAHRPP accreditation and re-accreditation processes. At that point, I realized that my institution is moving in the right direction. Having heard such a phenomenal testimonial helped me to create new ideas for my institution’s accreditation process.