Experts on IRB education offer ideas and tips for improving member training
Washington University program wins award
Most IRBs long have provided education and training to IRB members; but in recent years, IRB members’ education has become a top priority for some boards.
Education of IRB members is such a priority at Kaiser Foundation Research Institute (KFRI) of Oakland, CA, that KFRI recently published a 150-page book about human subjects protection and informed consent for IRB members, says Jeffrey Braff, DrPH, director of KFRI.
IRB education also is an integral part of the human subjects protection program at Washington University School of Medicine in St. Louis, where the human studies committee received a 2002 Award for Excellence in Human Research Protection for its comprehensive education program geared toward IRB members and researchers.
For the past two years, the Washington University program has had a full-time education specialist. "They really wanted to beef up their education program, and that happens to be my background," says Sarah Frankel, PhD, education specialist.
Washington University has 14 IRBs, more than 300 IRB members, six new protocol committees, four continuing review committees, four subcommittees, and staff to assist with minimum-risk protocols, Frankel says.
"We have had IRB members here for years, and some others will go through the orientation and realize it’s not for them," she says. "We also have a mock IRB that has been held twice and is open to the Washington University community and to people who could become committee members."
Even smaller institutions can stress education among IRB members, especially as federal agencies increasingly see this as an important way to enhance human subjects protection, says Carole Ehleben, EDD, senior partner with Consultants for Evaluation and Applied Research in Norcross, GA.
"I do think this is a topic that’s going to become more important," Ehleben says. "I work with community hospitals, and we have set up a resource of listings that are passed down to IRB members as an introduction packet."
The packet lists web sites for on-line training, web sites for the Office of Human Research Protection, information sheets from the Food and Drug Administration, federal regulations regarding human subjects protection in research, and periodicals about IRBs and human subjects protection, Ehleben says.
The Goodwyn IRB in Cincinnati has IRB members who are geographically spread apart, so education is handled via the Internet, as well as through an annual 2½-day retreat, says Ellen Holt, CIP, managing member and administrative vice chair.
"We give ourselves enough time to do it right, and there’s a big educational opportunity there," she adds.
Here are some tips on improving an IRB’s educational system:
1. Thoroughly train new members and train as you recruit. All IRB members receive a thick book about the process of informed consent at Kaiser Foundation Research Institute, Braff says.
The book, created with funding from the National Institutes of Health (NIH), is provided to the various IRBs as one component of IRB member training and education. Each IRB also may supplement the education in various other ways, Braff says.
At Washington University School of Medicine, new IRB member orientations are held once a month. "Members are introduced to some of the major areas they will have to discuss, and they’ll discuss these as if they are at a committee meeting," Frankel explains. "There are three types of committees, including new protocols and subcommittees, and the information new members receive pertains to their own committee."
This gives new members an opportunity to gain insight into the process of sending protocols through a committee review, she says.
The institution also has started an orientation for people who are new to research or new to submitting a protocol, Frankel says. "It’s a basic workshop that lets them know how to check on a protocol, which ones to renew, and what happens during the year. Researchers may also attend a workshop for IRB members because they want to see the other perspective."
Washington University holds a mock IRB meeting for potential IRB committee members. "It’s like a new-member orientation for people who are not committee members, and they can be taken through the process for submitting a protocol," Frankel says.
The mock protocols are based on real protocols that have been changed and reprinted with the permission of the researchers.
Ehleben has a template for IRB member education, and it includes an IRB submission booklet that includes references to regulations.
Along with IRB chairpersons, Ehleben will sit down with each new IRB member to answer questions and explain the packet’s information.
2. Educate in a variety of ways. Washington University varies educational sessions, using some special half-day sessions, conferences, web site education, and other ways to give IRB members information. The basic topics covered include the following:
- expedited and exempt protocols and whether studies are minimal risk;
- all informed consent issues;
- data monitoring;
- regulations and guidelines;
- vulnerable populations, including prisoners and minors;
- use of autopsy materials;
- participant screening;
- literature summaries;
- ethical discussions;
- third parties’ interest in research.
"We do a monthly inservice for staff, and it could be on professional development, providing them with information so they can help people submitting protocols," Frankel says. "Once the staff become more knowledgeable, then we have them do education as well."
Each KFRI IRB may devote up to 30 minutes to education at each meeting, Braff says.
"We have a portion of the IRB meeting that is devoted to the education on salient topics and is left to discussion by the IRB chair and the administration at each of the IRBs," Braff reports. "There are nine IRB meetings in eight regions, and each has a biomedical and health services panel."
Small hospital-based IRBs can provide educational information through the Internet, as well as at meetings through the introduction of 15-minute topics for discussion, Ehleben says.
Members of Goodwyn IRB will receive updates and reminders about federal regulations as part of their materials distributed with protocols, Holt says.
"We put together pieces of information that address various items, such as what are the considerations of these regulations or of these populations," she explains.
Whenever there is a change or new event on the human subjects protection horizon, Goodwyn IRB members will receive up-to-date information about it, Holt adds.
3. Use educational conferences or forums. KFRI holds an annual IRB leadership conference where IRB administrators and chairs come together to discuss issues of interest and importance, changes in rules, regulations, and specific events that have impacted the IRB community within the previous year, Braff says.
For an IRB that has members who live in various parts of the country, an annual, weekend educational retreat is the most efficient and easiest way to update members on human subjects protection, Holt says.
Washington University holds a conference each year, sometimes hosting national conferences that include information on regulatory agencies or regional conferences that are cosponsored by research organizations. Topics may include research and privacy regulations and compliance topics, Frankel says.
The institution also makes good use of forums. "Forums are very instructional and help the reviewer know what to look for in protocols," she says.
IRB chairs are sent to human subjects protection conferences sponsored by other organizations, and they are expected to bring the information back for the benefit of fellow IRB members, Frankel adds.
4. Provide opportunities for questions and answers. Making time for questions and answers also is an important part of educating IRB members. When someone asks Frankel or an IRB chairperson a question, they will provide answers to both the individual and the entire IRB, when this is appropriate.
"I attend the committee meeting and talk about specific issues," Frankel says. "What I might do is talk about how to assess risk, and we go through some examples of what would be greater than minimal risk."
The IRB members would discuss a particular protocol and use examples from it to discuss and identify greater than minimal risk.
It will encourage IRB members to ask questions when educational sessions are kept small — with fewer than 30 attendees, Frankel adds.
The goal is to make the educational session conducive to question-asking, and this means paying attention to the time of day that the session is held and making sure it’s a convenient time for members, Frankel says.
"We found that if we have a longer session, people like it to be on Friday afternoon," Frankel says. "Also, early mornings are very good if they’re held before people go into their office."
The worst time is in the middle of the day, and don’t worry about providing a meal or snacks because food does not attract attendees, Frankel notes.
Most IRBs long have provided education and training to IRB members; but in recent years, IRB members education has become a top priority for some boards.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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