A one-size-fits-all model for informed consent fails to meet the needs of patients and clinicians, according to the authors a new report.1
“Indeed, we believe that the current approach is primarily concerned with legal coverage,” says Philip G. Day, PhD, the paper’s lead author and an assistant professor in the department of family and community medicine at UT Southwestern Medical Center in Dallas.
Day and colleagues presented a novel idea — involving community members in the process of drafting consent forms. “We argue that the idea of a ‘community standard’ that holds in consenting for clinical care could be extended to research contexts,” Day reports.
The result would be consent forms, and a consenting process, that is primarily suited to meeting the needs of potential participants. “It was surprising to find a lack of research in this area or much data on a community-oriented consent process,” Day says.
Informed consent “has lost a lot of its meaning,” says Robert P. Lennon, MD, JD, FAAFP, another paper co-author. Clinicians have gotten used to simply asking patients to sign consent waivers, and forms have evolved into complex legal documents.
“As our culture become less homogenous, we’re finding that our traditional concept of informed consent does not always match a given patient’s concept of consent,” says Lennon, director of resident scholarly activity in the department of family and community medicine at Penn State Milton S. Hershey Medical Center.
The goal is to have a consent process that is less cumbersome and more culturally competent. “We need to get back to the intent of informed consent, an effort to achieve mutual understanding for risks, benefits, and alternatives to any given intervention,” Lennon says.
- Day PG, Satin D, Lennon RP, Tunzi M. Utilizing community research committees to improve the informed consent process. Am J Bioeth 2021;21:73-75.