IRB's core training gives new staff autonomy
Goal is broader program
IRB staff professionals need a greater breadth of knowledge and training now than they might have a decade ago, which is why one HRPP recently created a more comprehensive educational program that also offers greater autonomy to staff.
"We really wanted a broader education program," says Judith Birk, JD, director of the IRBs at the University of Michigan Medical School (IRBMED) in Ann Arbor.
The new program provides self-directed study, timelines, and checkpoints, says S. Joseph Austin, JD, LLM, senior education and regulatory coordinator at IRBMED.
The result is a new core training curriculum for staff with focus on three general areas: orientation, self-directed education, and continuing education.1
"Our previous program relied heavily on peer-to-peer education and training," Austin says. "We took this as an opportunity to expand the program and make it more autonomous for new employees."
The curriculum incorporates a multiplatform approach with a reading and self-directed portion, face-to-face classes, an online module, and peer-to-peer mentorship, he adds.
The new program has been well-received by new IRB staff, and it has continued to improve and evolve based on continuous feedback.1
Austin and Birk describe how each of the three general areas works:
-
Orientation:The first part of the educational program provides an introduction and overview of human subjects research regulations and institutional policies, Birk says.
New staff training includes a meeting with the education coordinator, who goes over human subjects research, Austin says.
New employees will learn more about HIPAA, research ethics, conflicts of interest, and IRB oversight and responsibilities in online modules, which have to be completed within the first week. Occasionally, the new employee will be given two weeks to meet the deadline, he adds.
The last part of the orientation involves a one-on-one meeting with the eResearch coordinator, who provides basic information about the IRB's electronic application process, Austin says.
"We try to give new employees dedicated time to complete these educational components," Birk says. "We want them to have peer-to-peer training and not just have them do videos and self-directed reading."
New staff also can meet with other IRB professionals and attend IRB meetings, she adds.
-
Self-directed education:Presented as a peer-to-peer education module, this part of new staff education and training includes a core education handbook and online modules, Austin says.
"There are multiple IRBs at the University of Michigan, and our University of Michigan IRB collaborative brings them all to the table to create standardized online materials," he explains. "This sends a consistent message to the UM community and to all IRB members and staff."
New employees will view IRB materials online during this second education segment, and they'll cover broad topics. This part can last several months, Birk says.
"There are close to 30 sessions," she says.
New employees review a core education handbook of 52 pages. It provides a high-level review of all applicable regulations and information related to institutional practices, as well as information on collaborative units. This includes information about conflicts of interest and compliance, Austin says.
"It's an interactive program that is best utilized in an electronic format," Birk notes. "It has links to additional information, so it's a more interactive approach than just reading 52 pages."
There also is a regulatory component where the new employee can watch an OHRP video, she adds.
"The program has action items, usually one or more at the end of the session, and these might direct them to a video, Web guidance, or a University of Michigan resource," Austin says.
The goal is for this multi-platform program to move education away from paper and have it more adapted to the way people are learning today, Birk says.
-
Continuing education:All IRB employees — new and experienced — participate in the continuing education component of the core training program.
"Some components are practice and guidance documents, and the practice and guidance committee meets here," Austin says. "The members represent different roles of the IRB, including management and five IRB regulatory teams."
The five regulatory teams support the IRB's activities, Birk says.
The teams document how the most effective and experienced employees do their jobs so new and other staff can learn from their best practices, Birk explains.
Best practices committee
"If you talk to one team, they do a job correctly one way, and another team does it correctly another way, so we created a committee to collect the best practices and document that," Birk says. "We select the best among them and document them, working toward consolidating our practices."
The committee's primary purpose is to provide standardized internal documents about how the board acts as a unit. The group meets every two weeks, Austin says.
"We expect our new staff to review pre-existing documents, such as internal practices and procedures that we've developed within the group and that are finalized," Austin explains. "Everyone in the office has access to them, but our new staff should look at what those practice documents say and how they impact their staff position," he adds. "As the practice documents are completed, we teach them at all staff meetings."
Other aspects of continuing education include conferences, seminars, webinars, in-house classes, and special programs on topics such as informed consent. These subjects are designed for the research community, but IRB staff also must attend, Austin says.
The core training program was designed to rely heavily on autonomous education partly to help conserve the IRB's resources, Birk notes.
"In light of the fact that academic budgets are tight and only getting tighter, we can't just hire three or four people to have education coordinator roles and manage all of it," she says. "So the program is moving toward being more self-sustaining, and we have one full-time education coordinator with small amounts of people to do more planning."
Education sessions are taught by existing staff experts, as well as university experts, she adds.
Reference
- Austin SJ, Miller D, Birk J. Development of core training for IRB staff: reimagining the education and training program for new members of IRB staff. 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, MA.
