MUSC Awarded AHRP Accreditation
Guest: Dr. Robert Malcolm - Psychiatry & Behavioral Sciences, MUSC
Host: Dr. Linda Austin – Psychiatrist, MUSC
Dr. Linda Austin: Dr. Robert Malcolm is Professor of Psychiatry and Director of the Office of Research Integrity. Dr. Malcolm, I know you have some, really, very big and important news to tell us about, and news that, also, really, is important for the many people that participate in clinical trials here at MUSC. We have recently won the accreditation from AHRP. What does AHRP stand for?
Dr. Robert Malcolm: That’s the Association for the Accreditation of Human Research Protection Programs. It’s a nonprofit organization, based in Washington DC, that accredits human research safety to medical schools, institutions of higher learning, and universities all over the world, really.
Dr. Linda Austin: And, why is it so important that we receive that accreditation?
Dr. Robert Malcolm: Well, it’s a mark of excellence. As our president, Ray Greenberg, has said, it’s the gold standard that an institution’s research, in any area of human research, is accredited and safe. It’s a major undertaking. And we’re very proud of that accreditation.
Dr. Linda Austin: Tell us about the undertaking. What went into that process?
Dr. Robert Malcolm: Well, it was two years of work spearheaded by Dr. Stephen Lanier, Associate Provost for Research here MUSC. And, really, his energy and vision led to our applying and working on our policies and procedures, and self study, for many months; almost two years, leading up to almost a week-long site visit by numerous site visitors from AHRP, in which they interviewed over 150 research staff, research faculty, the staff of the IRBs; the senior administrators of the institutions, many groups of people. Plus, they audited, literally, hundreds of our research files in the IRB.
Dr. Linda Austin: Now, in order to prepare for this, were there any particular processes or procedures that had to be changed or brought up to an even higher level of standard than we had before?
Dr. Robert Malcolm: Both, Linda. We had to write new policies and procedures that we didn’t have, and we had to update policies and procedures that we did have. It was a big undertaking. And, again, Dr. Lanier’s staff was just tremendous in helping our internal IRB staff do this. It was an iterative process that went back and forth between us and the AHRP staff for about 18 months.
Dr. Linda Austin: Dr. Malcolm, for somebody listening to this podcast, who may be considering becoming a subject in a clinical trial, tell us about some of the behind the scenes safeguards for human protections that people may not be aware of.
Dr. Robert Malcolm: Well, first of all, I would say that human safeguards are not just a responsibility of what we call the IRB; the institutional review boards. And, institutional review board, just to give you a word on those, Linda, are groups of people made up of lay people from citizens in our community, scientists, physicians, nurses, social workers, and pharmacists within the MUSC family. They get together and review the scientific merit, and particularly the safety and ethics, of any human research project going on.
But, not only is the IRB doing that, it’s the commitment of the senior administration of MUSC; its department chairs, and the directors of institutes within MUSC. And, it’s the education of research assistants, project coordinators, principal investigators that all go into this program for the safety of our human subjects. And, you know, without human subject research, we cannot advance medical science. We really must have that. And so, we really try to get people in the community involved in our programs too. And, as part of our AHRP accreditation, we had to demonstrate our good faith in community outreach.
Dr. Linda Austin: Dr. Malcolm, you mentioned that this is a huge honor for us at MUSC. How many other institutions like ours are accredited across the country?
Dr. Robert Malcolm: Well, throughout the world, AHRP has now accredited about 175 institutions. We join a very select group of medical centers; medical universities, in the United States that include Emory, Duke University, University of Alabama at Birmingham, University of California in San Francisco, Vanderbilt University, many fine institutions. And I might add that our accreditation was jointly with the Ralph H. Johnson VA Medical Center. We serve as the body of review; the institutional review board, for VA Medical Center studies. And, as you know, we share joint faculty with the VA. So, it’s very important to us in the VA for this accreditation.
Dr. Linda Austin: And, when is the next review? There must be a periodic review in order to maintain accreditation. Is that right?
Dr. Robert Malcolm: They’re, all, every three years. We’re, interestingly enough, starting to work, now, on the reaccreditation process for three years hence.
Dr. Linda Austin: Are there any new procedures or processes that you’re working on now that you think will take us to even one notch higher?
Dr. Robert Malcolm: Well, you know, with the funding of the South Carolina Translational Research Center, yes. I think that we’re providing better education for potential research subjects. We’re putting into place a research advocate procedure that Melissa Henshaw is heading up. We now have new tools available in Regulatory
Affairs through the SCTR program, South Carolina Clinical and Translational Research Institute, that Stephanie Gentilin is heading up. So, a young person, a young scientist or physician, at MUSC, who wants to do human research, now, will get a great deal of support, particularly in the area of human safety.
Dr. Linda Austin: Very exciting. Thank you so much for your leadership in this effort.
Dr. Robert Malcolm: Thank you, Linda.