Best Practices Report: Improve orientation, training

Improve your IRB's orientation & continuing education for members

Columbia University's IRB offers tips

It might take an individual IRB member from six months to a year to become fully acclimated to participating on an ethics board. So research institutions should do what they can to improve both new IRB member orientation and continuing education and training.

"We focused on orientation early on, and now we realize it's a continuing process," says Brenda L. Ruotolo, CIP, associate director of the Columbia University IRB office in New York, NY.

IRB members need to receive continuing education for several reasons:

IRB members need to handle diverse protocols: IRB members often are asked to review a wide variety of research, which means that it takes time to build competence and experience.

"Most of our IRB members are on the board for at least three years, and many are on the board for longer than that," Ruotolo notes. "We are a large institution and have large volumes of protocols, and our boards on the medical center campus are not specific, which means IRB members on any board will see any type of research."

Columbia University's IRBs include one that reviews primarily social science and behavioral research and three on the medical center campus that review the full range of biomedical research.

IRB reviews are becoming more complex: The work that IRBs are doing is more complex with a wider range of protocols and the addition of genetic research into the mix.

"We have a school of public health on the medical center campus, and the IRB will see social science, behavioral epidemiology, and many biomedical projects that have a behavioral component, including questionnaires," Ruotolo explains. "All of the IRBs are seeing more genetic research because there's a genetic testing component in many of our protocols."

For example, some clinical trials might involve a look at markers for genes that predispose people to a condition or to a response to a condition, she adds.

"All of the IRBs are seeing crossover research," Ruotolo says. "Starting with behavioral interventions, investigators are asking subjects questions or showing them stimuli and looking at their brain responses through a magnetic resonance imaging [MRI] device."

As this trend continues, increasing numbers of IRBs will no longer specialize exclusively in reviewing only social-behavioral research, Ruotolo predicts.

Learning the basic ethical guidelines, regulations, and history takes time: "So even though we have reviewers who come to the IRB because of their expertise, it takes a while to understand how the regulations are applied to research," Ruotolo says.

Plus with the emphasis on crossover research, IRB members need to understand a greater range of ethical issues.

Almost all IRB members are potential primary reviewers: All of the members of Columbia's Morningside IRB, which consists primarily of social scientists, behavioral scientists, and nonscientists, could be a primary reviewer for a protocol, Ruotolo says.

"On the Columbia medical center campus IRBs, it would be unusual for us to assign a nonscientist to be a primary reviewer for a biomedical protocol," she notes.

Even so, nonscientists could be secondary reviewers, so it's important that the training be adequate for either role.

To begin training for new IRB members, the institution provides a two-hour orientation session that may be a one-on-one session or a workshop with several attendees.

"We talk about the history of IRBs and the mission of IRBs," Ruotolo says. "It's important that we focus on how IRBs protect human subjects."

This mission is emphasized particularly for the benefit of clinician members who are accustomed to focusing on their medical responsibilities with regard to protecting patients, themselves, and their institution against medical risks.

"But for the IRB they need to focus solely on the research subject because that's who we're protecting," Ruotolo says. "It's not our responsibility to worry about risk to the institution or investigator.

"When we move over to the IRB, the focus is absolutely and singly on protecting the subject," Ruotolo says. "It's important for us to have them understand that, and in most cases, they are able to do so."

The orientation program also covers regulations that apply to human subjects research and IRBs, and there's an introduction to the Belmont Report, Ruotolo says.

IRB members learn the difference between human subjects protection regulations postulated by the federal Department of Health and Human Services and the FDA regulations that apply to research.

"A two-hour discussion is not enough to go into details about these, so we give new IRB members some materials, including a book that lists the regulations and has an overview of the IRB process," Ruotolo says. "We think it's a good reference."

The orientation also touches on the institution's own policies and procedures, including what the IRB staff does to assist the IRB and what IRB members need to do to prepare for each meeting.

For instance, the IRBs at Columbia meet twice a month for several hours at a time, and members are expected to do some homework before each meeting, Ruotolo says.

"We screen potential IRB members to see if they can handle the commitment as well as their other duties," Ruotolo notes. "We'll assign some people as alternates who can fill in on the IRB for regular members."

Part of any education and training includes marketing. So new IRB members are taught that their role isn't all work.

"There's an opportunity for them to interact with their colleagues on a different level than they do clinically," Ruotolo says. "They can discuss new technologies and procedures that are coming through, and they are able to see the new research and provide valuable service to the community."

Many IRB members find it to be very rewarding work, Ruotolo says.

The orientation session also discusses the IRB office's electronic submission process, but there is a separate training program for learning to use that system.

"Then we talk a lot about the processes, how IRB meetings are run, how we need a quorum, and we try to impress upon new members that the IRB is not a scientific review board," Ruotolo says. "It's an ethical review board."

Occasionally the IRB will receive protocols where the study is not well put together, but it's not the IRB's job to evaluate the science unless the science is so poor that it puts people at risk, Ruotolo says.

"Then it becomes an ethical decision that there couldn't be valid data that comes out of it," she adds.

"The other thing we impress upon them is they shouldn't spend a lot of time word-smithing," she adds. "We need certain elements and information in the informed consent document, but it may not be worded exactly the way an IRB member would like to have it worded."

As long as the main concept is there and the informed consent form is comprehensible to subjects then it needs to go forward, Ruotolo says.

For continuing education, there are relevant topics discussed at each IRB meeting.

"We discuss with IRB members a topic that's relevant to the research we're seeing," Ruotolo says.

These short educational pieces take about 5-10 minutes of the meeting time, and they're summarized on a one-page handout.

"We've tried half-hour educational sessions at the beginning of the IRB meeting, but the boards don't have time to devote to that," Ruotolo says. "It's not a commitment they can make."

The topics selected have included information about informed consent, criteria for waiver of consent, and other issues that have ongoing importance or might be especially relevant to a particular IRB review, Ruotolo says.

"A staff member for that IRB will present the topic and restrict the time to 10 minutes or less," she explains. "The staff member will give the board a handout, and there's an opportunity for discussion."

Basically, the educational session is an introduction. IRB staff members send follow-up information to the board electronically, Ruotolo says.

"We've had good response to this and often introduce new policies this way, as well as new interpretations of the regulations," she says. "If we see some kind of research being reviewed that's different from what we've seen before we'll feature that as a topic."

Other educational opportunities include monthly investigator meetings which some IRB members attend, and there's an annual IRB conference, held in April, that's open to outside institutions, Ruotolo says.

"We decide which topics will be presented based on feedback from IRB members and chairs," she says. "We try to address challenging issues like genetic research and testing and informed consent issues."

The conference typically features nationally recognized speakers and is well attended by IRB members, she notes.

Although the orientation and continuing education are basically the same for IRB members, regardless of their scientific background, the individualized attention gives everyone the attention they need, Ruotolo says.

"The role of the nonscientist is very important on the board, and we want to emphasize what that role is," she explains. "So our orientation for them would be a little different and address more of those kinds of issues important to their unique presence on the board."