(Editor’s note: IRB Advisor asked IRB and human subjects protection experts from across the nation to discuss the state of human subjects protection regulations and how IRBs are interpreting federal requirements. This article, which is the last in the three-part series, will discuss investigator certification and training.)

Is investigator certification the wave of the future?

Arizona health system already is on board 

The NIH may have set the bar, requiring all NIH-funded research to show evidence of human subjects training, but it’s the lack of details that raise concerns among some IRB members and experts.

"Everyone who applies for an NIH grant must be able to check the box that says, I have evidence of human subjects training,’ but it doesn’t say how often, how much, or what happens to co-investigators and other members of the research staff," says Robert Reed, PhD, IRB administrator for Maricopa Integrated Health System in Phoenix.

"That’s pretty much left up to the local institutions, and many default and leave it to the principal investigator to do," he says.

IRB reviews are intended to be in partnership with investigators, sharing in decision making, says Ernest Prentice, PhD, associate vice chancellor for academic affairs at the University of Nebraska Medical Center in Omaha. He also is the chair of the Secretary’s Advisory Committee on Human Research Protection for the U.S. Department of Health and Human Services.

"But ultimately, you have to rely on the integrity and competence of your investigators, and we’ve had a tendency to move away from the position of trust — or maybe we trust our investigators, but we should verify," Prentice says.

One concern is that there have been very little educational requirements for clinical investigators in private practice, he notes.

"They go through the pharmaceutical companies’ protocol orientation session, and that’s about it," Prentice says. "Even at institutions that have NIH funds and an education program, the program in some cases is scanty and limited."

While other programs may have a much more comprehensive education component, the fact is that there is no requirement for what should be in such a program, he points.

"It seems to me that we should have a certification program in place to allow physicians to engage in human subjects research period, and they have to go through a program to become certified," Prentice says. "Pharmaceutical companies should say, We won’t recruit physicians who are not certified investigators and there should be a nationally recognized program to educate."

It would be a good idea to have national standards and to ensure that all people involved in research are aware of the important human subjects protection issues, Reed says.

However, one possible drawback to a national certification program would be that it might be a one-size-fits-all model when that won’t really work for some who work in the research field, he notes.

"My worry with a national certification test is if there was a single standard, it may not apply well to people who are doing public health research or behavioral research, or it may be difficult to certify for people who have lower level responsibilities on the research protocols," Reed explains.

Still, a national certification program may be preferable to the piecemeal and haphazard approach to how investigators and staff currently are educated and trained in human subjects protection, Prentice explains.

"If you’re going to be an oncologist you have to be board-certified," he says. "So you should have to be certified to be a clinical investigator by some appropriate mechanism and by an appropriate process."

When you think about it, human subjects protection has lagged behind the rules and regulations in place for animals that are used in research studies, Prentice notes.

There has been certification of lab use of animals since the 1960s, while even voluntary accreditation of IRBs has only recently occurred, he explains.

A few already requiring certification 

Meantime, there are some good examples of research certification programs, and there are web-based and other educational materials that institutions could use in their education and certification programs.

The University of California-Los Angeles (UCLA) requires investigators to be certified, and this must be updated every two years, says Steven Peckman, associate director for human subjects research at the Office for Protection of Research Subjects at UCLA.

"One, we want to educate and help investigators to stay informed and, two, by educating them to local responsibilities, hopefully this will improve applications to the IRB," he says. "I think education is a very important thing — you can’t tell someone they’ve done something wrong if you haven’t told them how to do it right."

Maricopa Integrated Health System also has an extensive certification program for IRB members and all members of research teams, Reed reports.

"We also have a special requirement for people who are being principal investigators for the first time," Reed says. "We have a policy in place that says everybody involved in research has to have some sort of human subjects ethics training initially and then renew it every two years."

IRB members, investigators, and research staff have a variety of options for how to obtain and renew their certificates. For one, they could attend a one-day session about the IRB process and human subjects protection, Reed says.

Or they could read a 200-page book titled Protecting Study Volunteers in Research, published by Thomson CenterWatch. The book has 14 chapters that cover a variety of subjects, including ethical issues, conflicts of interest, general ethics, and roles of institutions and investigators. There is a written test at the end of the book, he says.

Another option permits investigators and others to take a subscription-paid, web-based program at www.citiprogram.org. The Collaborative IRB Training Initiative (CITI) course option has the added advantage of an educational track designed specifically for behavioral and public health types of research, Reed notes.

"Very recently, we put in place two other modules available through Citi course combination, and these are aimed to people who are limited to the medical record review," he says. "These have a high emphasis on confidentiality and the Health Insurance Portability and Accountability Act."

Investigators who are renewing their certification also may attend human subjects protection conferences, except for the ones that are pharmaceutical company-sponsored training courses for clinical trials, Reed says.

If the course is offered by a professional society and if it includes continuing education credit, then it likely will be acceptable for recertification, Reed says.

"We’re a little more flexible in how people choose to renew," Reed explains. "The spirit of continuing education is that you keep up with things that you learn."