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Educate investigators about waivers, research activities
IRB applications often show lack of understanding
Investigators, particularly when they are new to human subjects research, often fail to include all necessary information in their IRB applications because they are unaware of what's required.
IRBs can prevent these types of errors by educating new investigators about two of the more common types of omissions that are made, suggests Donna B. Konradi, PhD, RN, CNE, chair of the IRB at the University of Indianapolis and an associate professor in the School of Nursing at the University of Indianapolis in Indianapolis, IN.
Konradi offers advice for how IRBs can handle problems with missing waivers and inadequate descriptions of research activities:
Incomplete or missing waivers: New investigators might not understand what a waiver is, or they might ask for the wrong kind of waiver, Konradi says.
"They might want a waiver of documentation but ask for a waiver of informed consent instead," she adds. "Or they might have an incomplete request for a waiver, failing to provide justification for why this study is appropriate for a waiver."
REMEDY: "We gave investigators resources about waivers, information from CFR 46.117c, where they talk about the waiver of informed consent," she says.
The IRB provide resources in electronic format with links to its presentation on the topic of protocol submissions and common mistakes.
"So if they're thinking about submitting a protocol, they can download the presentation and use it with their students who are doing research," Konradi says.
Another solution was putting electronic prompts on the submission form.
"The prompt asks if they are requesting a waiver of informed consent, and another prompt asks them to provide justification," she says.
Insufficient description of research activities: IRB applications often fail to describe exactly what the investigator and the research staff is going to do and how they're going to do it.
For instance, the application might include an attached data collection form, but the investigator doesn't say whether this collection form will be read to participants or left for them to fill out themselves, Konradi explains.
"If it has sensitive personal information, will they be filling it out in a group or individually?" she says. "If a person will be walking on a treadmill, then tell us specifically what speed or safety procedures you'll use."
Konradi recalls chairing one IRB review meeting in which the research submission said subjects would receive a modest shock for a nerve conduction study.
"I couldn't evaluate to what extent that would cause pain or put people at risk, so I went over there and had them give me the shock," she says. "I couldn't say the procedure would cause a little bit of discomfort unless I had something I could relate it to, and this was out of my comfort zone."
For instance, the IRB application could have said that the shock would be comparable to an electrostatic shock in wintertime.
"We have to know exactly what it is that participants will experience," Konradi explains. "Until we understand that, we're not in a position to appraise the risk."
REMEDY: Konradi suggests IRBs tell investigators to paint a picture and use language that will help IRB members understand the procedures and risk from the perspective of a participant. They should describe the activities fully, say how long each one will take, and use descriptive language to show how the participant will experience the study's procedures.