Does It Go Far Enough?

As the first director of the HHS Office of Human Research Protection (OHRP), Greg Koski has seen the evolution and impact of the Common Rule since its inception. “It began the year the regulations were adopted. Recommendations for changes have been coming out over and over again from different groups,” Koski told a roomful of researchers recently on the campuses of NIH. “The [problems with the system already were] there. And the number of reports and concerns reflect that this is a complicated set of issues.”

However, none of those reports resulted in any major changes to the current system, and Koski said he does not have much confidence that this new initiative will achieve anything different.

“It seems that the proposal focuses mostly [on] inefficiencies and redundancies in the system, and that a spin-off of fixing that would be improving human subject protection,” Koski said.

Those proposed system changes are mainly good ones, he noted, but are not thought out far enough. “Obviously we ought to be streamlining multisite studies. It’s a silly waste of time and resources. But if there’s only going to be one IRB review, we have to make certain it’s a very good one, because everyone else will be depending on it. And we don’t have a really good mechanism for determining if an IRB is any good in the first place.”

Koski also questioned whether there was any way to prevent researchers from shopping around for the most lenient IRB.

“ ‘Harmonizing,’ in my mind, is a euphemism for ‘failure to standardize.’ If we want to avoid ambiguity, we just need to standardize across the board,” Koski said. “I’ve examined this process for 30 years from virtually every side of it — IRB chair, university administrator, OHRP investigator. I think it’s time to simply say, ‘What we have is not working the way we want it to. Let’s scrap it.’ I think we should have a single federal office for the oversight of human research. Not in any one agency, but somewhere else, where it is not subordinate to any one agency.”

Koski argued that the way to protect subjects is not to focus on improving the research regulations but on improving the researchers. “The way we protect human subjects is having people doing the research that understand it, that are committed to it and are going to act responsibility,” he said. “If the behavior we’re looking for is centered around regulations, then we missed the boat. The behavior we want is for investigators to understand their responsibilities, and make a commitment to fulfilling those responsibilities.”

“We have bred a new generation of investigators that are not coming from the same place as in 1978. Tuskegee was a long time ago. So was Guatemala. How many people really believe that, in today’s climate, we would actually have a recurrence of the kinds of unethical research that led to the creation of this system,” Koski said, referring to notorious research projects in the past. “The system that we have was imposed on a generation of scientists, and many of them resented it. I think that scientists today are more responsible. They’re certainly better educated and more sensitized to the issues around human research.”

Office for Human Research Protections (OHRP)

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