What Organizations Say about Accreditation
Community Hospitals
Newton-Wellesley Hospital
Leslie G. Selbovitz, M.D.
Chief Medical Officer and Senior Vice President for Medical Affairs
“As a community teaching hospital, Newton-Wellesley considers research to be a key component of physician training and patient care. Our accreditation demonstrates that community hospitals can adhere to the same high standards—and conduct research of the same caliber—as the major medical centers. We can bring the advantages of research and the highest principles of protection directly to our community.
“We recognized early on that everyone involved, from investigators to patients, would benefit if our HRPP were accredited. We decided to be among the first to seek accreditation and we made that decision at a time when our program was expanding. We knew AAHRPP’s requirements would force us to develop and maintain the necessary protections.”
Contract Research Organizations
ethica Clinical Research, Inc.
Janice E. Parente, Ph.D.
President
“Our joint venture with Matrix Group in India would not have been possible if we weren’t accredited. Both Matrix Group and the Indian government wanted a partner they could count on to hold itself to high standards and minimize the risks to research volunteers. As the only contract research organization (CRO) in the world to have earned AAHRPP accreditation to date, ethica was in a unique position to provide what Matrix Group and the Indian government were seeking.
“Having that seal of excellence from AAHRPP serves almost as our letter of recommendation. It offers assurances that no other CRO can provide.”
Independent IRBs
New England Institutional Review Board
James Saunders
Vice President
“In the current climate of increased scrutiny on institutional review boards (IRBs), it's welcome news that FDA has sent written notification that the results of their recent audit indicate no significant findings. No further action is required.
“With six plus years of AAHRPP accreditation under our belts, however, this is not unexpected news.”
Chesapeake Research Review, Inc.
Felix A. Khin-Maung-Gyi, Pharm.D., M.B.A., C.I.P., R.A.C.
Founder, CEO
“We are starting to see some of the longer-term benefits of accreditation, such as the opportunity to partner with ethica Clinical Research, another accredited organization, for mutually beneficial outcomes. We believe that accreditation and this partnership make us more competitive because we can demonstrate—to our institutional and industry colleagues—that we’ve made a concerted commitment to excellence.
“Everyone in our organization has embraced accreditation and its standards. Whenever we consider a change, we evaluate it with respect to accreditation standards. We are constantly cognizant of where the bar ought to be because accreditation has given us a visible, tangible target.”
IntegReview Ethical Review Board
Lynn A. Meyer, C.I.P., C.I.M., C.C.R.P.
President
“AAHRPP’s emphasis on continuous process improvement is a significant benefit for our clients and for us. Accreditation provides an assurance of an ongoing commitment to ethics, standards, and quality. It requires us to stay on top of changes and additions to guidelines and regulations, and to incorporate them effectively into our policies and practices.
“Already we’re seeing the impact of having the AAHRRP seal of excellence on our Web site and printed materials. We are being contacted by new clients who are interested in us because they know we’re accredited.”
Teaching Hospitals
Cedars-Sinai Medical Center
Shlomo Melmed, M.D.
Senior Vice President, Academic Affairs
“Accreditation attests to the public, sponsors, and investigators that we are totally committed to the safety, integrity, and quality of our research programs.”
Department of Veterans Affairs Salt Lake City Health Care System
Laurence J. Meyer, Ph.D., M.D.
Associate Chief of Staff for Research and Development
“The accreditation process required us to work closely with our sister institution. We’ve always been fortunate to have a very cooperative, robust human research program with our academic affiliate, the University of Utah, but now our programs are better and are more closely aligned than before. The self-assessment made us aware of areas that needed improvement, and we improved them. It made us consider scenarios that we hadn’t experienced and required us to develop procedures to cover those scenarios.
“Within our community of researchers, accreditation is highly respected. When they see the AAHRPP seal on our applications and our program description, it’s evidence that we have a good program—and that we’ve documented it.”
The MetroHealth System
Ben H. Brouhard, M.D.
Executive Vice President for Medical Affairs & Chief Medical Officer
“For hospitals and health care systems, AAHRPP accreditation is the official designation of excellence—the HRPP equivalent of Magnet status. Like Magnet, accreditation requires a long-term commitment and is something that all organizations should be striving to achieve.
“Many of the advantages of accreditation are actually realized during the self-assessment process because of the increased focus on policies and procedures. At MetroHealth, we’ve seen a heightened awareness and understanding of what our policies and procedures require and what constitutes a deviation. That, in turn, results in improved compliance.”
National Healthcare Group, Singapore
Professor Chee Yam Cheng, M.B.B.S., F.A.M.S., F.R.C.P. (London), F.R.A.C.P.
Assistant CEO (Clinical)
“The rigorous accreditation process resulted in system-wide improvements that provide greater protection for research participants and ensure the integrity of the research conducted in our institutions. Because AAHRPP accreditation sets the highest standards for clinical studies, the pharmaceutical industry, academic drug developers, and regulatory bodies can have confidence in the quality of data they receive from studies conducted here.
“With accreditation has come increased awareness of the importance of a robust HRPP. Consequently, we are allocating more resources to educate investigators and coordinators and to engage patients on their rights and safety. We are also building a pool of talented clinician scientists to support the growth of Singapore’s biomedical industry.”
Universities
The University of South Dakota
Laura J. Jenski, Ph.D.
Vice President for Research
“A major benefit of accreditation is the respect that our program has gained from faculty. They appreciate the effort and input that went into attaining accreditation and they realize its significance to our program and to the university. As a result, they have a better understanding of what we require of them, and why.
“Accreditation also has provided valuable opportunities for us to network with other accredited organizations—to exchange information and collaborate with institutions that have similar experiences and face the same complex issues.”
The University of Texas at Austin
Juan M. Sanchez, Ph.D.
Vice President for Research
“In my view, the accreditation process was the best thing that could have happened to our program. The process has raised the level of awareness of administrators, faculty, and students. It also has driven a significant increase in our investment in compliance. We now have an Office of Research Support and Compliance that coordinates human subjects research, animal care and use, and biosafety. We have four coordinators for human subjects research, all of whom have a Ph.D. or medical degree.
“The quality of our program has always been good, but now we put an even greater emphasis on training for everyone involved. One result is that our graduate students are more aware of research protections and better prepared as they move on to develop their own research programs.”
University of Cincinnati
Sandra J. Degen, Ph.D.
Vice President for Research
“We’ve only been accredited a short time, so most of the benefits we’ve seen are the result not of accreditation itself but of the self-assessment process. Even so, the benefits have been significant. For example, to meet the accreditation standards, we implemented a formal auditing and monitoring system—something that had not existed before. Subsequently, we were audited by the FDA, which found that the necessary safeguards were in place. I can honestly say that’s because of AAHRPP. We did what AAHRPP required, and that made the difference when the FDA came in.”
University of Louisville
John D. Burke
Director of the Human Subjects Protection Program
"Colleagues have asked why we might welcome FDA audits twice in four months. Here's why: Accreditation doesn't prevent audits, but it certainly prepares us for them, and those audits demonstrate the high quality of our HRPP.
"The first audit did not even generate a letter back, but we were told that there were no findings. The second, on the other hand, generated a multi-page report that stated how efficient we were. We have undergone three FDA audits, all demonstrating the superior quality of our work, since we received AAHRPP accreditation in June 2005.
"I attribute our success to the policies, procedures, and best practices we now follow because of our continued accreditation."
University of Minnesota
R. Timothy Mulcahy, Ph.D.
Vice President for Research
“As a research university, we have an obligation to the public to ensure that our research is of the highest quality: that it is ethical, has scientific merit, and protects participants. Accreditation signals our commitment to excellence and fulfillment of our responsibilities. As such, it fosters the public trust that is critical to the future of research.”
Moira A. Keane, M.A., C.I.P.
Director of Research Subjects Protection Programs IRB/IACUC/IBC
“Our peer experts are more and more likely to be at accredited institutions. When a colleague has successfully completed the accreditation process, you can be sure that they’ve attained a platform of expertise. There’s a built-in confidence that you have a common understanding of the standards of excellence and that your interaction—whether it involves a consultation, participant outreach, or negotiating sponsor contracts—will reflect those standards.”
Utah State University
Brent C. Miller, Ph.D.
Vice President for Research
"AAHRPP accreditation has become one of the most respected, objective indications of a quality human research program."
Russell Price, M.Arch.
Federal Compliance Manager
Office of the Provost
"I think the biggest change we made in our system was to get the university community to recognize that the entire organization had a major stake in strengthening our human research protections program."
Virginia Commonwealth University
Lisa R. Ballance, M.A.
Special Assistant to the Vice President for Research
"The accreditation process is invaluable. AAHRPP provides the cheapest, most expert advice you can get for your human research protection program."
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