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Informed consent flexibility needs to be taught to PIs
Process begins with the first conversation
IRBs that deal with social-behavioral-educational research might need to give investigators who also conduct biomedical research updated information and education about how to handle informed consent.
"Biomedical and social-behavioral research are different and have different challenges in terms of gaining informed consent," says Tracy Arwood, MS, director of research compliance at Clemson University in Clemson, SC.
"From a biomedical perspective, we're looking at the volume of information that is a challenge in terms of communicating it to patients," Arwood explains. "From the social-behavioral perspective, it's not the volume as often as it is the process we used to inform the subject and gain their informed consent."
From a compliance perspective, it's important to talk with investigators about the flexibility permitted in regulations, Arwood notes.
"We explain that informed consent is a process that begins with the first conversation with the subject, which could be a flier in the mail, and it continues through the end of the study," Arwood says.
"Also, depending on the type of study they're doing, we'd like for them to propose what makes sense for that study population," she adds. "We evaluate the protocol's informed consent in terms of [regulatory] criteria, and we see if it works in terms of documentation waivers and so forth."