Eliminating barriers to effective discussion between PIs and IRBs

(Editor’s note: Attendees to the 2004 Annual IRB Conference, sponsored by the Public Responsibility in Medicine and Research and held Oct. 28-31 in San Diego, will find a great deal of discussion about improving communication between IRBs and principal investigators in both biomedical and social-behavioral research areas. IRB Advisor spoke to several people who are scheduled to be PRIM&R panel members before the conference convened in late October, and this issue features stories that explore how to remove communication barriers and strategies for improving the relationship between PIs and IRBs, as well as strategies for helping the IRB process run more smoothly. )

Here’s what works and what doesn’t

Human subject protection is an evolving system that occasionally encounters obstacles in the form of old attitudes and bureaucratic rules. One way to overcome these barriers is through improving relationships and communication between IRBs and principal investigators (PIs), research experts say.

"If you look at what was required 10-15 years ago, you would see the process has undergone dramatic changes since then," says Jonathan Woodson, MD, an associate professor of surgery at the Boston University Medical Center. He is scheduled to be part of a panel discussing enhancing communication between IRBs and PIs, to be held during the 2004 Annual IRB Conference, sponsored by the Public Responsibility in Medicine and Research (PRIM&R) Oct. 28-31 in San Diego.

"Admittedly, there have been bureaucratic types of changes, but the bottom line is that the whole issue of ethics and human subjects research and human protection is an evolving area," Woodson says. "So what was true 15 years ago may not be true today."

The evolution has contributed to an IRB’s difficulty with PIs, who may not understand why they are being required to do things differently for research they’ve always conducted another way, he notes.

"I think one of the biggest barriers is how researchers think this is one more piece of bureaucracy to get through," says E. Helen Berry, PhD, professor of sociology at Utah State University in Logan. She also is the former chair of the USU IRB, and also is scheduled to speak about improving communication at the PRIM&R conference.

"You’ve written a grant and made sure you dotted all I’s and crossed all T’s for the grant and sent it off to the granting agency, who asks you to change certain things," Berry says. "And then there’s still the IRB — one more barrier to doing research."

The process gives PIs the impression that IRBs are just another group of people from whom the investigator needs to get approval, she says.

"It makes the IRB seem like they have an adversarial relationship with the researcher, and that’s not the goal; but that’s the way it feels," Berry says. "That’s what makes the relationship so negative."

The chief barriers to communication between IRBs and PIs are two-way streets, says Robert Larsen, MD, an associate professor and vice chair of Health Science Campus IRBs at the University of Southern California, Keck School of Medicine, in Los Angeles. Larsen is scheduled to join Woodson in speaking about this topic at the PRIM&R conference.

"IRBs demand certain things of investigators; when they don’t do these or are confused about them, that will delay the process," he explains. "Investigators want IRBs to be prompt in their evaluations because it’s no good submitting protocols and waiting forever."

Taking a look from a broader perspective, this type of communication problem is predictable whenever two groups come to an issue with very different perspectives, says C. Kristina Gunsalus, JD, special counsel and adjunct professor in the College of Law at the University of Illinois in Champaign. She is scheduled to be on the PRIM&R conference panel with Berry.

"I think it has roots in how we’re all busy and deeply rooted in our own perspective, and there’s a lot of social psychology that talks about why it’s hard for us to listen well, hear completely, and understand — much less, empathize with others," Gunsalus says. "This is true particularly if we don’t have good personal connections with them in advance."

Woodson, Berry, and Larsen provide this look at the barriers IRBs experience in the quest for better communication with PIs:

Encountering duplication and delays: "One thing that frustrates investigators is the amount of duplication that is necessary to get something done," Larsen says.

For example, most centers require investigators to summarize the clinical protocol they’re proposing and then have them submit the complete clinical protocol and grant application where the information already is present, he notes.

"So we’re asking investigators to cut and paste because we don’t want to read both documents," Larsen says.

Instead, IRBs should ask PIs for background information references, he suggests.

"You could say where there is background information, saying, Clinical protocol — page seven,’" Larsen says. "That solves a whole lot of problems."

It also frees the IRB to concentrate on what’s important, such as these issues, he says:

— How is the PI going to implement the trial at the institution?

— What are the PI’s qualifications?

— Is the research environment supportive enough to get it done?

— Is the budget sufficient to do what the PI intends to do?

— Does the PI have access to patients, and can they make good judgments about whether they should be in research?

— How does the PI implement the trial at this site and make it acceptable?

— What are some risks, benefits, and procedures that will be the same across centers?

• Having different perspectives: "PIs grow up in an environment of academics and investigation, focusing on exploring new concepts and discovery, and they almost take it as a given that in the process good people are trying to do good work that will protect human subjects," Woodson says.

"To a certain extent, it’s laudable and understandable," he says. "On the other hand, it’s the IRB whose job it is, in a very diligent way, to examine protocols for compliance with human protection regulations."

So PIs and IRBs are approaching research from two different perspectives, Woodson adds. "What makes it worse is that the investigator community doesn’t have, by and large, a fundamental knowledge base about what the regulations are and their intent," he says. "That’s not to be overly critical, but that’s just the way they grew up — they don’t know chapter and verse of what’s required."

Another characteristic that leads to communication problems is that IRBs are by design eclectic, Woodson says.

"These are a group of individuals convened from different perspectives to examine those protocols," he says. "So you have scientists on the panel, legal people on the panel, and lay people on the panel, and so there should be no expectation that they will all see the protocol the same way."

This diversity of opinion and approach naturally will lead to disagreement and some misunderstandings, Woodson notes.

Likewise, the common experience and perspective of many investigators could lead to communication problems, such as writing protocols in a language that is well understood by the experts in that field, but confusing to some IRB members, he says.

"The PI can’t communicate the general idea or intent of what they wish to do and what the PI is intending to send if the message is not received," Woodson says.

Attending to documentation details: PIs often fail to write down everything they intend to do in a protocol, Berry notes.

"The IRB has to consider whatever the PIs wrote and not what they didn’t write, but would do anyway," she explains.

For example, researchers might describe a drug trial with three groups of children, including one that would receive the study medication, one that would receive another medication, and a third group that would receive no medication, but would be treated with behavioral therapy, she says.

The children participating in the trial might all have a diagnosis of a behavioral problem. In the protocol, researchers might have neglected to say what would happen if the children who were receiving medication began to experience problems and at which point this would result in a change, Berry says.

However, the IRB catches this omission and asks the researcher if he or she intends to keep children on the study medication even if it is causing problems, she points out.

"The researcher says, Obviously, we’d pull the children from the study and find other ways to treat them,’" Berry says. "But if the PI doesn’t tell us this in the protocol, we don’t know."

Knowing the regs: "One issue that came up recently was the issue of when an IRB could grant a waiver of informed consent," Woodson says. "Again, it related to an industry-sponsored study in which there was promising new therapy for blood replacement, and the federal regulations has specific guidance about when a waiver of consent can be granted."

In this situation, the PIs didn’t quite understand that if another model of investigation could be constructed to obtain the desired information, then they are obligated to investigate the treatment in that way rather than in the model that would require a waiver of consent, Woodson says.

"People have a right to say, I do or do not want to be involved as a subject in this study,’" Woodson says. "And just because a study is hard to do in another model where consent can be obtained does not mean it cannot be done that way."

In the blood replacement study example, there was the possibility of constructing a model in which patients could provide informed consent right before surgery so if they were to begin to hemorrhage during surgery, the surgeon could use the blood substitute, Woodson says.

The model the investigators had proposed would have used subjects involved in emergencies that resulted in blood loss, and since those emergencies could not be anticipated, there would be a waiver of informed consent. However, the study could be conducted based on the surgery model, instead, Woodson says.

Most importantly, IRBs need to find ways to improve communication between PIs and IRB members, so when a PI submits a protocol such as the blood substitute study, he or she will understand that the IRB may require a major change in how the study is conducted and be able to address that issue.

"It seems to me that we can be suspicious of PIs and PIs can argue we’re trying to keep them from getting research done," Berry says. "But if both sides don’t communicate and explain what’s needed, then neither side will be happy."