Researchers at the National Human Genome Research Institute (NHGRI), part of the U.S. National Institutes of Health, asked participants to complete a genetic literacy survey, watch an educational video about genome editing, complete a two-part survey, and take part in focus group discussions about CRISPR somatic genome editing, an experimental treatment option for sickle cell disease.

As genome-editing trials become more common, the process of informed consent is changing. Image courtesy of Ernesto del Aguila III, NHGRI.

"An important goal of informed consent is to facilitate decisions that are consistent with a person's values," said Sara Hull, PhD, director of the Bioethics Core at NHGRI, in a statement. "By talking to sickle cell disease stakeholders ahead of time, we can learn more about their values and hopefully do a better job of pinpointing what kinds of information will be most useful to potential research participants as they make very a difficult decision."

The researchers found that participants wanted to understand treatment side effects and the impact of somatic genome editing on quality of life. The focus groups expressed the need to have flexibility in the types of information they received, since people have differing levels of knowledge in biology and genomes.

Interestingly, while some physicians were concerned about the ability of their patients to understand concepts, sickle cell participants demonstrated higher genetic literacy levels than estimated.

The goal of informed consent for genome editing is ensuring the participant understands the aims of the trial; procedures, risks and benefits; sources of financial conflicts of interest; and researchers' affiliations. The study highlights the need to begin discussing what informed consent for somatic genomic editing looks like, amid lack of information and misconceptions about the risks and benefits of participating in a clinical trial.

"These first-in-human curative genome editing therapies are an opportunity to develop new consent approaches to meet the information needs of potential research study participants and their families," explained senior author Vence Bonham, JD, associate investigator in the Social and Behavioral Research Branch at NHGRI.

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