The seas were rough for the Medical Center when the Office for Protection from Research Risks shut down most clinical research studies for four days, but there is now a sense of calm after the storm.
Still afloat, Duke is in the process of administrative and procedural improvement. Meanwhile, ripple effects from the University's embarrassing censure have been felt nationwide; many other medical institutions are now reviewing their own research protocols. Dr. Adil Shamoo, a bioethicist at the University of Maryland's medical school, said lenient research protocols are more common, and less apparent, than one might think.
"Duke is not unique...," he said. "All medical centers have a similar unconcerned attitude nationwide, and a lot of these people are caring, loving, wonderful people." Shamoo is editor-in-chief of the journal Accountability in Research and has chaired seven international conferences on ethics and research with regard to the use of human subjects.
He added that, despite their best intentions, medical schools find it difficult to perform thoroughly objective self-reviews. "You cannot see how the ferris wheel is rotating when you are a part of it," he said.
Dr. Glen Gaulton, the vice dean for research and research training at the University of Pennsylvania's School of Medicine, noted that many institutions are in need of self-review. "It's always good to require people to take a step back and take a fresh perspective," he said.
Although Gaulton is confident that Penn appropriately ensures proper patient protection, the evaluative process became more intense when officials learned of the situation at Duke. At Penn, he said, "it forced everyone to take a look at the way we are doing things."
Researchers and administrators note that more intense awareness of research protocols did not entirely result from the Duke shutdown.
"As the clinical trials become more successful, they are generally of more interest," said Kathy McClelland, research compliance director at Stanford University Medical Center. In response to the events at Duke, McClelland, who is responsible for managing Stanford's Institutional Review Board staff and for enforcing research regulations, said Stanford reviewed its record-keeping procedures.
Duke, meanwhile, is working diligently to improve its program. As per a June 1 report to the OPRR, the Medical Center will set up effective educational programs, add a second, fully-functioning IRB and re-review 274 protocols. "I think it's going to be the benchmark program in the country,"said Edward Holmes, dean of the School of Medicine.
Officials at OPRR have also watched as their initial decision sent shockwaves across the nation. "I think clearly our action has raised awareness about the need to have programs to adequately protect human subjects," said Michael Carome, chief compliance officer at OPRR.
Given the highly-publicized Duke incident and the growing public interest in clinical research, OPRR's role is gaining more attention at the national level.
A June 3 report from an OPRR review panel suggested the organization be moved from the auspices of the National Institutes of Health into the Department of Health and Human Services. Because NIH is involved in funding medical research, the report considers the current affiliation a possible conflict of interest. The report also suggested that OPRR be expanded to become a more effective monitoring mechanism.
Satisfied with the report, Carome said, "It doesn't change our role at all-it just places us at a higher level which should improve our stature and apparent authority."
The report, which was the result of seven months of discussion, has prompted discussion about OPRR's role.
"I think that there needs to be very strong monitoring of the IRB process and the way researchers conduct human studies," Gaulton said. "OPRR should establish clear guidelines and give guidance to people for following those guidelines."
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