Informed consent is not just about documentation, says Erica Jonlin, a regulatory manager at the University of Washington. Done properly, it can improve the pool of patients and the overall reputation of clinical trials, she adds.
It’s incumbent upon the person doing the informing to understand the study backward and forwards—that means without having to refer to documents throughout the conversation, Jonlin says. “They must understand the scientific and regulatory” aspects of the trial, she notes. “Otherwise, they’re just reading a piece of paper” instead of reading the face of the potential participant.
Eye contact is critical, as is paying attention to verbal and nonverbal cues. For example, if a potential participant seems nervous or is asking an inordinate number of questions, he or she might not be right for the study. “They might be on the fence or might [ultimately] be noncompliant,” Jonlin warns. However, trial practitioners are less likely to catch that kind of critical nuance if they’ve got their noses buried in trial documents as they perfunctorily tick boxes in basic informed consent checklists.
Part of the problem, according to Jonlin, is that “very few practitioners practice informed consent before they do it.” She advocates in-house training, including roleplaying scenarios, to ensure potential participants are treated with respect and are given every opportunity to understand the process.
Learn effective informed consent techniques and strategies at the ACRP 2017 Meeting & Expo, April 28-May 2 in Seattle. Jonlin and Halle Showalter Salas of Premera will present an interactive master series session – Dramatization of the Informed Consent Process: Good Theater or Bad? – designed to help you improve informed consent procedures. View Program and Schedule
“Many [patients] are hearing about research for the first time,” Jonlin says. They may be facing a life-threatening condition, and they deserve high-quality informed consent, she stresses.
Too often, informed consent professionals don’t see the forest for the trees. “There’s too much emphasis on the documentation form,” Jonlin says. Standing alone, the form is only documentation that the conversation occurred, and “not documentation that the potential participant understood” the information presented, she notes.
“We’re all patients, we’re all human beings, and we all deserve to be treated with respect,” Jonlin says.
Author: Michael Causey