Shift in philosophy was outgoing director’s goal

Initiatives were a collaborative effort, he says

When the Office for Human Research Protections (OHRP) was created in 2000, Greg Koski, MD, PhD, was appointed its first director. At the time, he outlined plans to strengthen and overhaul existing human research protections programs.

"The time has come for us to take a new approach," he said in the fall of 2000 to the U.S. House of Representatives, Committee on Veterans Affairs (VA), Subcommittee on Oversight and Investigations hearing on VA medical research. The new approach he referred to was an ideology shift, from one of mere compliance with governmental regulations to one where those involved are focused on responsible conduct.

"Compliance in itself doesn’t protect anyone," he said in a May 2001 interview with University of Southern California Health Sciences campus publication. "Every individual has to understand what his or her responsibilities are. The protection of subjects in not just an administrative process, hoops we have to go through. It is the foundation of what we do," he concluded.

In an interview with IRB Advisor, Koski talks about the initiatives launched, the impact the philosophical shift has had, and the success realized during his time as OHRP director.

When he came to OHRP, he was well aware of the challenges that he would face. Criticism of the human subject protections efforts had been detailed over the years in a series of reports released from the Office of the Inspector General dating back to 1982. He points out what he saw as a primary flaw in protection efforts: reliance on IRBs alone to identify research protocols that harmed subjects. "It seemed to me that what we had was a system that was well conceived but not well executed," he says. "The system that was set up that relied on IRBs and informed consent became what many view as barriers to doing research."

Koski says he and others in the community at the regulatory level see protection as a shared responsibility with everyone — IRBs, researchers, even the subjects — playing a vital role. To that end, he launched a program for remodeling the existing system. "In a general way, the overall approach had to be a shift in philosophy from a system of compliance to a system focused on preventing harm," he says.

Quality improvement is a major push

One of the first projects undertaken was the overhaul of the assurance process. According to Koski, it has been simplified dramatically. Additionally, there are plans to make the process electronic, which will allow OHRP to collect data on IRBs that can be used in future evaluations and benchmarking studies. Simplifying that process has allowed the office to redirect resources, Koski says. "We expanded town meetings, sponsored conferences and displays at professional meetings, and expanded education activities."

Additionally, OHRP has increased not-for-cause evaluations. "The government has a responsibility to the public to provide oversight," he says. But, he points out, his aim was not to police IRBs, rather it was to offer technical support to assist them.

OHRP also launched phase I of a quality improvement program. Phase I asks IRBs to complete a self-assessment designed to measure the board’s level of compliance with federal regulations. "The most important part is self-assessment — looking at yourself." Koski points out. The assessment is evaluated by OHRP staff, who then provide feedback in the form of a site visit, videoconference, or letter. The program is voluntary and feedback is designed to help IRBs make improvements. (For more information on the quality improvement initiative, see IRB Advisor, May 2002, p. 54.) According to Koski, the program has been well received. "It has continued to grow," he reports. "It is collaborative rather than confrontational, which is why it has been so well received."

Koski is encouraged by the positive response. "The only option is to go back to no controls or back to policing, which will negatively affect research." His goal is to encourage the community to stay focused on preventing harm and research safety. Most participants are requesting a site visit, he says. To date, OHRP has visited 21 sites and participated in one videoconference. The goal for 2003 is 10 site visits and an occasional 50 letter or videoconference consultations each month.

"We have a regulatory responsibility, then it gets us to a better place," says Koski, referring to phases II, in which best practices will be shared, and III, in which institution-based quality improvement programs will be advanced. "The pilot mode of QI actually provides methodologies for measuring the performance of institutional review boards and their ability to do substantive review of research protocol," he says.

An important element of all of the initiatives launched in the last two years is the ability to collect data. "Many of the new programs — IRB registration, quality improvement — provide an opportunity to collect very useful date on the system and how it works," Koski says. "You can’t improve performance if you can’t measure it. Auditing standards don’t measure performance."

Koski points out that all of the initiatives have been collaborations among all the governmental agencies, from the Food and Drug Administration (FDA) to the VA. Additionally, he noted a concerted effort from the research community to take steps to improve human subjects protections programs without federal prompting. For example, the Association of American Medical Colleges developed conflict-of-interest guidelines, the Association of Clinical Research Professionals pioneered training programs for investigators, and the Association for the Accreditation of Human Research Protection Programs and the National Committee for Quality Assurance have established voluntary accreditation programs for IRBs.

"They are a sign of a willingness of the entire research community to take that charge — taking responsibility rather than have government do it for them. The reason we get regulations is either people won’t do what they’re supposed to or they want to do what they’re not supposed to do."

In the works is a new handbook for investigators and IRB sponsors. A first draft of the electronic handbook should be available during the first quarter of 2003.

Koski is moving back to Boston and will assume his previous position as an associate professor at Harvard Medical School. Additionally, he’ll join the Harvard-based Institutes for Health Policy as a senior scientist. "The past two years have been among the most demanding and most rewarding," he says. "I’ve had an extraordinary opportunity to witness dramatic changes and play a part in them."