Medical librarians can be a bridge between IRBs and researchers

Non-scientist perspective, attention to detail

An IRB looking to recruit a good non-scientist to the board may have to look no further than its own institution's medical library. Medical or health services librarians can bring a unique perspective and useful expertise in searching medical literature to the process of IRB review, say librarians who have served for years on their own institutions' boards.

"I think librarians, not only by training, but by some more inherent characteristics, make very good IRB members," says Deborah Klein, MSLS, AHIP, medical librarian at Pomona Valley Hospital Medical Center, who serves on IRBs at two institutions. "We have a service mentality, so we tend to be willing to volunteer for this kind of thing."

While some librarians approach volunteer service with the idea of primarily conducting literature searches, their IRB roles have increased to include assessing informed consent documents, voting on protocols and in some cases even conducting primary reviews. They say they enjoy their service on the IRB, despite the extra workload it can require.

"I think this is one of the few times that you actually have a chance of having an impact on the lives of people," says Carlos Rodriguez, BA, MS, medical school liaison at the University of Pennsylvania Biomedical Library in Philadelphia. "The fact that you may be looking at a study that 10 years down the road may affect somebody's life for the better, makes all the angst and anxiety that I have when I'm trying to finish all the work worthwhile."

Interest triggered by tragedy

The push by medical librarians across the country to become a more integral part of the research process was triggered in part by the 2001 death of Ellen Roche, a healthy volunteer in a study conducted at Johns Hopkins University. Roche died after inhaling the chemical hexamethonium during a study designed to help researchers better understand the underlying causes of asthma attacks.

Reports on the incident noted that initial literature searches conducted about hexamethonium failed to turn up articles from the 1950s that contained information about its potential toxicity. In its own effort to improve research oversight in the wake of Roche's death, Johns Hopkins committed to requiring investigators to collaborate with a librarian and a pharmacist to strengthen literature searches.

While expertise in combing medical literature is a big part of the appeal of recruiting a medical or health services librarian to an IRB, librarians bring other advantages to the board table. "I think librarians are knowledgeable about a wide range of subjects," Klein says. "I don't have a degree in biochemistry, but I know more than a layperson does about it and other subjects.

"We are analytical thinkers; we are very detail-orientated. On an IRB, you need to pay attention to details and structure, primarily because of the federal regulations. You have to pay a lot of attention to form, to making sure that a whole bunch of elements are included in the consent form. We're used to double-checking that kind of thing."

Klein and other librarians note that they can fulfill the requirements for a non-scientist member, who often can be hard to recruit to the IRB. And in some cases, they can serve as community members.

Klein is a non-scientist member of the IRB at the Pomona Valley Hospital Medical Center, where she works. A few years ago, she was approached by nearby California State Polytechnic University (Cal Poly) in Pomona to join their board as a community member.

"Cal Poly is a big university that does very different kinds of research (from the medical center)," she says. "They have a lot of social science programs, educational programs, food and nutrition, exercise science. It's a whole different thing than cancer trials. But their IRB was looking for a community member and because I'm not affiliated with the university, I could (fulfill that role)."

As she had already been serving on an IRB, Klein did not have to undergo as much training to begin work with the Cal Poly committee.

Many medical librarians felt they could also help improve human subjects protection by volunteering to work with IRBs. Nancy Harger, RN, MS LIS, librarian at the University of Massachusetts Medical School in Worcester, was one of two library staff members who began serving on the university's Committee for the Protection of Human Subjects in 2002 shortly after the Johns Hopkins case.

"Initially, we just took our laptops into the meetings and we'd be available to answer questions that came up in the course of the meetings," Harger says. "And the two of us sat there for the whole year and hardly anyone asked us any questions."

So they began looking at other ways they could contribute, and realized that some protocols were being submitted with few references to medical literature on the subject being studied. In other cases, they knew from their own work that some of the citations were not the most current. So they began doing their own literature searches on each protocol.

"We would submit the results of those searches to the two reviewers," Harger says. "At first, we'd just send them the citations and then we decided it would be more useful if we sent them the full text. We'd send a few articles that would give them background to help the reviewer. It's actually come about that they like that a lot. I think our biggest contribution is really to the reviewers, to provide them with information on the topic when they're reviewing the protocol."

Harger and Judy Nordberg, BA, MLIS, another University of Massachusetts medical librarian who joined one of the IRB committees more recently, are both voting members of their committees. They've been called upon to read through informed consent documents for clarity and readability.

"We're in a good position to read a consent form and from our own perspective say that we understand it or we don't understand it," Nordberg says. "If we can't understand it, it's a pretty good indication that (it could be improved)."

Knowing the researchers

Ellen Schellhause, MSLS, currently serves as a community member on the IRB at the University of Illinois College of Medicine at Rockford. She used to serve on the board as a non-scientist member, before she left her job as director at the university's Crawford Library.

She describes the library as a "bridge" between researchers and the IRB at an institution, and believes librarians can bring that same quality to review.

"You can make things flow more smoothly for everybody, because you've already worked with the researchers as clients," Schellhause says. "When you're on the committee, you separate yourself from the personal, but you also know enough about research that when it's discussed, you have some input and understanding of what the research is about. You can help with clarity and explanation."

In addition, her work with a campus health literacy group led her to look at the readability of informed consent documents.

"We noticed that the consent forms were just horrible for people to read," she says. "They'd be written at a 12th-grade level. Our group passed a rule that said consents and assents written on our campus for local studies had to be written at a fifth- to eighth-grade reading level."

Schellhause says she believes the focus on literacy in consent documents was her most valuable contribution to the IRB. Librarians also can be useful to an IRB that uses electronic submissions, she says.

"Librarians are very into databases and have a good understanding of this kind of a system. They have technical expertise in electronics and in forms posted online. They understand how the Internet works. I think that can also be a very valuable contribution."

Despite their technical expertise, librarians also bring something of an outside perspective, Rodriguez says. While other IRB members have much more technical and medical knowledge, he can provide a point of view that they may overlook.

"It has to do with being immersed in a certain environment, so that (other perspective) doesn't even occur to you, or it becomes invisible," Rodriguez says. "That is really, in many respects, the value of having a non-scientist on the board."

Seeking a meaningful role

At the University of Pennsylvania, Rodriguez says the associate director of his library spoke with the Office of Regulatory Affairs, offering the services of the librarians. Rodriguez says he and other librarians who joined the IRB committees originally viewed their role as offering a literature search service — "sort of like a private librarian to the IRB." In the meantime, he completed the necessary IRB training, observed meetings and began reviewing informed consent documents.

Now, Rodriguez conducts continuing reviews, reviews amendments, and sometimes acts as a secondary reviewer for new protocols. Though he'd love to be a primary reviewer, Rodriguez knows that he doesn't have the necessary expertise.

"If I had a science background, maybe, but I don't," he says. "When you're a secondary reviewer, the real hard work has been done, everything in the protocol, all the science has been worked out."

Rodriguez's library background enabled him to create a list of resources that other non-scientist IRB members could use for looking up things they didn't understand. "There were people on the board as well as people in the Office of Regulatory Affairs who had never seen some of these resources," Rodriguez says. "So it was a win-win situation for everybody all around."

The librarians say that their service on the IRB adds to their existing workloads, and much of that work must be done on their own time.

"My family will tell you, 'Oh, Dad's doing the IRB — we won't see him until Wednesday night after the IRB meeting,'" Rodriguez says. "I dedicate myself to looking at the protocols and there's a lot of stuff that I don't know, so I have to look up a lot of things."