How you can fix common problems

Simple strategies improve process

The relationship between IRBs and principal investigators often seems strained and adversarial, but IRB and research experts say the problems mostly can be solved with a few creative changes.

Here are some suggestions for reducing protocol submission problems and improving communication between IRBs and PIs:

1. Turn an obstacle into an IRB member or speaker.

"The person who complains the most is a really good candidate for being on the IRB for a couple of reasons," says E. Helen Berry, PhD, professor of sociology at Utah State University in Logan. Berry is a former chair of the USU IRB.

"The first reason is that the person who complains can tell the IRB what the IRB is doing that makes them crazy," she says. "The PI can tell the IRB where they’re being inconsiderate or acting rude when there should be a door opening rather than a wall."

The other reason to invite a PI with complaints to join the board is because he or she will gain a greater understanding of the regulations and IRB process and be able to pass on some of this knowledge and change of mindset to other investigators.

"We’re all on the same team," Berry notes. "The PI, IRB, participants, and the university are on the same side — we want research to be done."

2. Change your own behavior first.

"One of the realities in life that is tedious, but important to accept, is you cannot force the other person to change," says C. Kristina Gunsalus, JD, special counsel and adjunct professor in the College of Law at the University of Illinois in Champaign.

"But you can control your own conduct, and you can change your conduct so that you improve the way the interaction proceeds," she says. "As much as it’s gratifying to sit around and talk about what’s wrong with the other guy, what you can change is yourself."

By improving one’s own professional skills and approach to problem solving, a person can change the outcome for the better, Gunsalus points out. For example, if the problem is that PIs are not completing documentation effectively, the question is this: "What can I do differently that would help?" she says.

"It’s easy to say, We put out educational materials and did this, but they didn’t take advantage of it,’" Gunsalus says. "But the reality is that all of us in our lives are in information overload."

So the road to a solution is to find a way to provide educational information and support to PIs at the moment that they need it, such as when they are filling out the protocol submission form, she says.

"Make it accessible, understandable, and recognize that people are deadline-driven, so you should schedule some time into the process," Gunsalus adds.

"If our goal is to assist the public and to improve the state of knowledge and be an asset to the university, rather than struggle against human nature all the time, one way to do things is to say, There will be people who are frantic at the last minute, so what can I do to keep me from being behind in my work because of them,’" she says.

3. Put the chair in charge of building bridges.

IRB chairs are responsible for airing and reconciling various IRB members’ opinions before the board’s findings and concerns are reported to investigators, says Jonathan Woodson, MD, associate professor of surgery at the Boston University Medical Center.

"If there’s any sort of expertise assigned to the IRB chair it’s that they have to work the interface between controversies within the committee and between the IRB and PIs," he explains. "The chair needs to be well versed with the protocol and should do his or her own examination of the protocol before walking into the meeting."

While reviewing the protocol, the chair should anticipate friction points and facilitate the discussion of these issues, Woodson adds.

"Where there’s a breakdown in understanding between one perspective and another, the chair needs to build bridges and links so various constituents can understand what’s being said," he explains.

For instance, if the PI has written the protocol in a way that may lead to misunderstandings among some IRB members, it’s the chair’s responsibility to provide the background and intent of the protocol in an effort to clarify the proposal and build consensus at the committee, Woodson says.

Then when the IRB’s decision and comments are sent to the PI, the IRB chair could help the PI understand what the IRB wants done in the interest of further protecting human subjects, Woodson says.

4. Provide natural consequences.

IRBs sometimes establish deadlines and rules for submission, but then let investigators get away with being late or breaking a few rules. This sends the message to the investigator that it’s not important to be efficient and timely and soon, the investigator becomes a chronic noncomplier, Gunsalus notes.

"You need to say, Here are the rules and here are some natural consequences for not following them,’" she says.

The chief goal is to make the IRB’s own system efficient and professional and to have IRB staff and members hone their own professional skills at communication and negotiation, Gunsalus says.

Once the IRB has become as professional as possible, then it’s important to enforce deadlines and rules, she says.

However, if an IRB has allowed an investigator to be late with applications continually, then when the IRB suddenly clamps down, the PI will feel as though the decision is arbitrary, irrational, and unfair, Gunsalus explains.

But PIs will respect an IRB and its deadlines if the IRB is clear from the beginning about what is expected and what will be done if the PI doesn’t adhere to the rules, she says.

5. Try different educational approaches.

Web-based education is popular now, and training lectures remain a common way of teaching IRB members, investigators, and research professionals. However, these may not be the most effective ways to teach people, Gunsalus says.

If an IRB continuously finds that its education has not produced the desired results of having better informed and more cooperative PIs, then it’s likely the way the education is conducted needs to be changed, she adds.

For example, most people learn more readily by doing rather than listening, so perhaps the best way to teach investigators about the IRB process is by setting up a mock IRB meeting for PIs and others to attend, Gunsalus suggests.

6. Use a language dictionary and templates for informed consent.

"We adapted a language dictionary from the University of Texas in San Antonio," reports Robert Larsen, MD, associate professor and vice chair of the Health Science Campus IRB at the University of Southern California, Keck School of Medicine in Los Angeles.

The language dictionary gives PIs a quick reference for using substitute words and phrases in informed consent documents with the goal of making them easier to understand by subjects, he says.

Since the IRB is familiar with the dictionary and its terms, this also helps to make the protocol review process more efficient. Now when an investigator is struggling to come up with a substitute word for medical term, he or she can use a term that the committee agrees to rather than guess incorrectly and have to change it per IRB orders, Larsen says.

Likewise, IRB staff could develop a template for an informed consent document and make this readily available to PIs who are writing informed consent documents for their own protocols, Woodson suggests.

"After so many years of doing this, we know what kinds of language work best in terms of creating reading levels that are best for subjects," he says. "We know exactly what will pass the board, and we know what the federal regulations require, so it helps PIs understand what is required by providing the templated language."