Best Practices Spotlight
Research institution revamps HRPP training
NIH updates education FAQs
Human research protection programs (HRPPs) receive only general guidance on how they might fulfil their educational requirements, so programs range from simply requiring research staff to complete online courses to institutions that offer a broad smorgasbord of educational options.
The National Institutes of Health recently updated its educational information for human subjects research (HSR), highlighting the importance of providing HSR education to all key personnel involved in human subjects research.
NIH's frequently asked questions (FAQs) emphasize the need for all individuals involved in NIH-funded HSR to fulfil the education requirement. This applies even to subcontractors, consultants, and staff who do not receive compensation from the NIH award, according to the FAQs updated Dec. 12, 2013.
The NIH leaves the curriculum and any continuing education requirements up to each research institution's discretion.
So where can IRBs and research programs find the optimal training program?
One model is from the Indiana University School of Medicine in Indianapolis. The institution recently revamped its research education program, providing comprehensive training and education opportunities to all research coordinators, from first hired to experienced personnel, says Jody Harland, MS, CIP, program manager, regulatory knowledge and support, Indiana Clinical and Translational Sciences Institute (CTSI), pediatric clinical and translational research, Indiana University School of Medicine.
The institution's new program has four levels of education with ongoing program evaluation efforts. Average evaluation scores for Level One training were 4.78 on a 5-point scale.1
"The first thing we did was make sure whatever programming we developed would be something people would be interested in and want to attend," Harland says. "Part of our goal was to enhance a couple of existing programs for coordinators."
Here are the steps they took in revamping their education and training program:
Create a task force. In 2012, when the university's HRPP decided to create a more centralized education and training program, they created a multidisciplinary task force, Harland says.
"We thought it had to be a team approach to be the most effective, and we have a lot of stakeholders inside the human research protection program," Harland says.
The task force included a number of interested parties, including representatives from the CTSI, the university's office of research compliance, and the local Veterans Affairs Medical Center.
Task force members serve as consultants, providing expertise as needed.
"We still go to them when we have a question or consideration involving their areas [of expertise]," Harland says.
The task force reviews and conducts annual evaluations of the program. Also, the task force collaborates with the HRPP.1
Start with Level 1 training. The task force created a new program for entry-level coordinators. Offered monthly, it is mandatory for some research staff.
"That was the first program we focused on developing," Harland says. "We used survey data we had collected from staff in the school of medicine to develop what we wanted to cover in some of these areas."
They also worked with the university's human resources office and arranged to have the HR office send them a monthly list of new research coordinators, she adds.
The new hire training program is held monthly in a two-hour session. The program is capped at 12 participants and is intended to be informal and to facilitate conversations, Harland says.
Trainers include Harland, a representative from the HRPP office, and two experienced coordinators.
- Add Level 2 training. This stage of training is geared toward beginning research coordinators and is meant to enhance their existing training. It's offered semi-annually and covers the basics of clinical research.1
Offer Level 3 training for mid-level staff. The third level provides training for mid-level research coordinators, and it's also offered semi-annually. Its purpose is to provide more in-depth information of clinical research topics.1
The Level 3 program was created to enhance existing educational programs, Harland notes.
"But we revamped it pretty heavily," she says.
Attendees include staff with three or more years of experience. It's a two-day course. While the course isn't mandatory, continuing medical education credits are offered, she adds.
"We talk about the IRB and some hot topics in research budgeting and billing," Harland says. "We talk about quality assurance and improvement activities that you can implement in your own shop."
Other topics include time management and project management.
"We have a journal club hour where we distribute a journal article about the role of the research coordinator, and we have people read that and then come back the next day to say how they fit into this picture," Harland explains.
At the first Level 3 session, 17 staff members attended, she adds.
Expand to Level 4 for experienced staff. The final level of training is offered to experienced coordinators, research administrators, and research managers. It's a high-level, annual program.1
The Level 4 education is continuing to be developed, Harland says.
"We hope to launch it in 2015," she adds. "The concept is that once we get folks trained and they're in research for at least five years, then we want a session that is for much higher-level folks."
The annual, one-day program would have speakers from within and outside the academic medical college, and it would be a voluntary educational choice, she says.
CME would be offered, and attendees would need to have a professional certification in clinical research coordination, such as a CIP, or a research coordinator certification, Harland says.
"We recognize that there are a lot of people who have knowledge and expertise and are out in departments where we don't have a lot of ways of sharing best practices and information," she explains. "These sessions could have best practice sharing and promote that kind of interaction."
Incorporate informed consent and other hot topics. The research coordinator topics include the IRB and informed consent and HIPAA privacy, as well as other topics that often draw questions from research coordinators, Harland says.
"One topic everyone says they want to hear about is HIPAA and privacy," she adds. "That's important, but there were other topics that resonated more with coordinators."
For instance, coordinators wanted to learn more about quality and data management and what resources were available on campus, she says.
They were interested in the IRB and regulatory issues, but less interested in the finance and contract side, Harland says.
- Harland, J, Miller L, Sears M, et al. A new program to enhance research coordinator education at a large academic medical center. Poster presented at the 2013 Advancing Ethical Research Conference, held by the Public Responsibility in Medicine and Research (PRIM&R), Nov. 7-9, 2013, in Boston.