A nine-year IRB chair veteran and a medical school’s associate dean identified gaps in their institution’s human research protection education. They noticed that online training was fine for general information, but came up short when investigators were struggling with specific protocol issues.
Their solution was the Clinical Research Training and Mentoring Program (CRTMP), a peer-to-peer, hands-on, protocol-specific mentoring and training program.
Often, investigators cannot relate what they learn online to their specific needs, says Robert Edelman, MD, clinical professor of medicine and pediatrics at the University of Maryland School of Medicine in Baltimore. Edelman also is the director of the CRTMP at UMB and an associate director for regulatory affairs and bioethics at the Center for Vaccine Development in Baltimore.
“You can go to a half-dozen classes and not solve the problem of a particular protocol,” Edelman says. “Each protocol is unique in its own right, and there has never been a protocol we have looked at that’s exactly like another — there’s always some wrinkle to it that makes it different.”
Time Savings, Increased Satisfaction
The CRTMP has proven successful. A study of its implementation showed that 179 of 2,340 protocols were assisted by CRTMP. The program reduced the number of protocols that were returned for revisions by the IRB. For non-assisted protocols, the mean number of returns were 1.6 per protocol. For protocols assisted through CRTMP, the mean for returns was 0.7. For protocols that received the program’s assistance while they still were in draft form, the mean protocol returns was only 0.4.1
This saved the IRB an estimated 1,291 hours of work, which equates to 161 person days saved over 4.5 years, or 36 person days per year.1
Also, an anonymous CRTMP survey showed 100% satisfaction for IRB chairs, vice chairs, and staff.1
About 95% of the protocols seen in the program were successfully approved. The remaining 5% were withdrawn by the investigator after they were told their research was not going to be scientifically valid or ethical because of a lack of volunteers, nursing staff, or other issues, Edelman says.
“That’s an enormous time savings for everybody,” he notes. “Those few protocols can take an enormous amount of time of the IRB and panel reviewers, going back and forth until they realize the study cannot be done.”
Research requests for help through the CRTMP come primarily from the school of medicine, though there also are requests from the schools of dentistry, social work, pharmacy, nursing, law, and regular graduate school. “Sometimes faculty in the school of law do healthcare research that requires questionnaires and interviewing people,” Edelman says.
Here’s how the program works:
1. Advertise through presentations. The program was described in presentations at 27 departmental meetings at six UMB professional schools. Other referrals came from the IRB and UMB faculty networking.1
Edelman tells faculty and staff at presentations that the university feels the protocol mentoring program is so important that they are willing to invest his time and other staff’s time to support it.
“The knowledge that this is available to investigators does good things to investigators at the highest level,” Edelman says.
2. Identify principal investigators (PIs) who will benefit. The CRTMP works with principal investigators, department/division chairs, and the IRB and human research protection staff to identify PIs and their protocols that would benefit from the mentoring.1
“You should have a feeling for the needs of the investigator,” Edelman suggests. “You have to empathize with their needs.”
Many investigators are busy, distracted, and involved in research to the point that if they receive an IRB deferral or modification, they feel rejected, he notes.
“So I go in there and reassure them that I really like the research, and it has to be done properly,” Edelman says.
He tells PIs that he’s giving them his time at no cost to the study and that the mentoring program is supported by the president of the university.
3. Customize one-on-one instruction. Edelman spends an average of six hours with each investigator in the mentoring program. The other mentor is a professor of pediatrics, who also is very experienced in human research protection.
“We read over the protocol and go into the science of it, if necessary, and we review the regulatory requirements,” he says.
“We have a slideshow we bring with us and answer the questions their protocol demands from reading off the slide principles,” Edelman adds. “I tell investigators, ‘I am not the IRB. I’m just a representative.’”
Edelman also explains that he cannot guarantee that everything he tells them will be approved by the IRB.
“They understand that, but they also realize that we have an enormous amount of experience,” he says.
“I tell them I’ve spent years doing IRB work and decades of work in clinical research — both international and domestic,” Edelman says. “So they respect my background.”
The goal is to work for the research participant’s welfare, addressing study volunteers’ rights, confidentiality, and the ethical quality of the study, he notes.
“The investigators need to have a certain mindset of caring for the patient,” Edelman says. “Fortunately, most of the time, they’re very much in tune with their volunteers.”
4. Help the PI strengthen the study’s design. The goal is to rescue protocols that need help so they can contribute to science and the world of medicine, Edelman says.
An example of a protocol’s issue is one about kidney failure. The study needed to answer questions about obtaining informed consent, collecting blood, and use of a research blood bank.
Edelman meets with the investigator and staff for an hour or two to focus on the protocol. He answers their questions and reviews their changes.
“Sometimes I give them suggestions on how to improve it, but I always provide constructive criticism, saying, ‘I’m now on your team — I’m not the IRB. You can take my advice or leave it as you wish,’” he says.
Although the CRTMP program mentors researchers from a variety of scientific areas, Edelman is able to help them answer scientific questions after doing a little research.
He says it’s his job to make them answer the hypothesis. “The regulatory requirements are the same, wherever they come from,” Edelman notes.
If an investigator has a question Edelman cannot answer, then Edelman will call an administrator to help him solve the issue.
5. Stay with the PI until protocol is approved or withdrawn. “When a PI gets the protocol approved, it is a major sign that we’re on the right track,” Edelman says. “I think the program not only improves the morale of investigators, but it improves the morale of our HRPP staff.”
From the staff’s perspective, the mentoring program saves them time and helps fill in gaps in their own expertise.
REFERENCE
- Edelman R, Campbell J, Doherty J, et al. Clinical Research Training and Mentoring Program (CRTMP) – A peer to peer approach – 2012-2016. Poster presented at PRIM&R’s 2016 Advancing Ethical Research Conference, held Nov. 13-16, 2016, in Anaheim, CA. Poster: 5.
