Navigators: Liaisons guide families through informed consent

But must overcome perception they are IRB 'spies'

When a family is adrift on the unfamiliar waters of pediatric research, it helps to have a guide and translator. That's the forward thinking behind a program at Seattle Children's Hospital, which assigns two staff members to help bridge the informed consent process between investigators and parents fretfully considering research for their children.

The research and family liaison (RFL) program was introduced because of concerns that families needed support as they tried to get through the informed consent documents and conferences. RFLs work to meet this need, both by assisting families directly and by educating investigators about how to better communicate the fundamentals of informed consent to parents.

"We thought, was there a role that could help make the informed consent process do what it's intended to do, which is to inform the families about what research participation looks like?" says Halle Showalter Salas, MPhil, one of the RFLs currently serving at Seattle Children's Hospital. "There really was no role that sort of looks at the process. With IRB review, there's a lot of focus on the front end, but not a lot that happens after studies are approved in terms of looking at the informed consent process."

The RFLs attend all IRB meetings and have occasionally been asked by the IRB to help an investigator with informed consent issues. However, decision was made from the outset not to have the RFLs report directly to the IRB, emphasizes Douglas S. Diekema, MD, MPG, chairman of the hospital's IRB.

"I like the fact that the RFLs have a relationship with the IRB, but it's not necessarily a reporting relationship," he says. "The problem is that people do really see the IRB as serving a regulatory and police function, so anything directly associated with the IRB will unfortunately be perceived as, 'They're spying on us, they're watching us.' We didn't want [investigators] thinking the RFL was there to check up on them. They are there to assist them."

A touch of humanity

While the RFLs have spent time studying the research process and human subjects protection principles, they do not actually have clinical experience. A problem or benefit? As Diekema sees it, the latter.

"I think it's much more valuable to have somebody with a social science background than a science background," he says. "The problem with people with science backgrounds is that they already understand and speak a language that's a little above most people. Somebody with a background in the humanities or the social sciences is going to more readily pick up when science jargon is being used, helping [identify] when people might not understand what's being said."

The RFLs began by sitting in on dozens of informed consent conferences, not to assist families at first, but to get an understanding of how conferences worked and where they could be improved. Salas says they now attend some conferences to assist families. Because workload constraints make it impossible to attend all the conferences, they try to focus on higher-risk, more complex studies that may be more challenging for families to understand. One RFL is fluent in Spanish, making her an invaluable resource for Spanish-speaking families and for investigators who want to recruit them, Diekema says.

Lost in translation

In that regard, the RFL involvement with the Spanish-speaking parents has revealed that there were unreported difficulties in this area. In short, some things may have literally been lost in translation.

The families never shared that with anybody, because in order to share it they'd have to share it through the interpreter," he says, adding that the RFL has taken on the project of strengthening the hospital's overall interpreter services.

In addition to one-on-one meetings with families, the RFLs also work directly with investigators, sometimes at the urging of the IRB, if a protocol has been sent back because of informed consent issues. They conduct training for investigators to help them improve their informed consent documents and presentations. And they attend all IRB meetings to provide their perspective there, as well.

"We really try to bring up issues with assent and consent and parental permission, and to let them know what we have been seeing and what we're concerned about in this area," Salas says.

Both Salas and Diekema believe the presence of the RFLs has been helpful for IRB members. "They've helped the IRB be more sensitive to issues around recruitment and consent and how something might be perceived by a family," Diekema says.

An important factor in the success of the program has been institutional support, particularly because RFLs don't generate any additional income that would offset the costs of the program.

"I'm convinced to make this kind of thing work you need a very powerful champion," he says. "In our case, it was the president for research, who really felt passionate about the need for a role like this. Without that kind of person to block opposition, it's really difficult to get a program like this off the ground. Investigators inevitably will perceive it as one more barrier, one more hassle and they simply won't call — they won't use it. You do really need a champion who will say, 'You don't have a choice here. This is a program we're going to implement.' Once you do that, everybody sees there's some value added."