Nurture input from community members
Go beyond informed consent duties
The protocol review discussion will benefit greatly from the questions and input of IRB community members. But this resource too often is underdeveloped as the scientific experts on a board dominate discussions.
What's lost is a diversity of opinion and, sometimes, a true understanding of the risks any particular study poses.
"IRB community members tend to get shunted into things they're going to be 'good' at, such as doing the consent form," says Bruce Gordon, MD, FAAP, professor of pediatrics at the University of Nebraska Medical Center in Omaha, NE. Gordon also is chair of the UNMC IRB and chair of the Joint Pediatric IRB, as well as professor of pediatric hematology/oncology and stem cell transplantation.
"But the informed consent form is not the community members' only role," Gordon says. "They're not just responsible for reviewing consent forms; they're responsible that the protocol satisfies each of the 111 criteria [for IRB approval of research]."
Gordon recommends that IRB chairs nurture their community members by encouraging them to ask questions and by giving them time to understand the answers.
"As chair, you have several responsibilities, and one is to be the regulatory guru, making sure things are done right," Gordon says.
Another responsibility is to make certain all voices are heard at IRB meetings by knowing the board's personalities and dynamics and how to best use each person's strengths, he adds.
"What we tend to do as chairs is grease the squeaky wheels so that those who yell the most get the most attention," Gordon explains.
"So the community member sits there quietly and gets ignored by everyone," he says. "So you need to give that person the assistance they need."
Another way to look at the community member's role is to think about how the protocol should be comprehensible to everyone on the board, including the non-scientist members. And if something in the protocol is not clear, then everyone benefits from having community members who speak up with questions.
One strategy for encouraging these questions would be to distribute information about the federal criteria for IRB approval of research and ask IRB members, along with the community member, to ask these questions of every protocol.
Gordon offers these examples:
* How, where, and when should consent be obtained?
* Is the location for informed consent conducive to thoughtful consideration?
"An application should include this information, or no one on the board should approve it," Gordon says. "And if the community member doesn't understand, then it's his or her responsibility to ask."
Often, investigators leave out some of these details, and the investigators on an IRB believe they know what the investigator plans because of their own past experience. So it's up to community members to point out that no one really does know what will happen unless the investigator clearly states it in the application, he adds.
The IRB chair's and board response to this question from a community member should reflect their respect for that person's input, perhaps with someone saying, "I don't know and haven't thought about it that way that's a really good question, so let's get back to the investigator," Gordon says.
Other questions might be these:
* Who has access to the study's data?
* How will data be discarded?
Answers to these questions might be written into a protocol in a way that community members do not see it, so someone else on the board should
offer an explanation, Gordon suggests.
"Or if they don't see the answer in the protocol, then the board should not approve it," he adds.
Another good question might be this:
* Is inclusion of vulnerable subjects necessary?
"The community member, like other IRB members, has to understand why their inclusion is necessary," Gordon says.
Community members also are the ideal people
to ask questions about risk. If a protocol indicates that a particular procedure is minimal risk, and the
community member cannot see why it's only minimal risk, then he or she should ask about this.
Either the protocol itself or someone on the IRB should be able to explain to the community member's satisfaction why a certain procedure poses minimal risk, or else the protocol should not be approved as it is, Gordon says.
The main point is that community members should not be compartmentalized and given their individual tasks. They need to see each of the IRB protocol approval criteria and encouraged to speak up if they don't understand something the investigator has put in the application, he notes .
"If the community members can't say they're satisfied with the answers, then they can't vote for approving a protocol," Gordon says.