As genome-editing trials become more common, informed consent is
changing
NHGRI researchers are working with patients, families and the scientific community to improve the informed consent process

Date:
October 12, 2020
Source:
NIH/National Human Genome Research Institute
Summary:
As public interest and expanded research in human genome editing
grows, many questions remain about ethical, legal and social
implications of the technology. People who are seriously ill
may overestimate the benefits of early clinical trials while
underestimating the risks. This makes properly understanding
informed consent, the full knowledge of risks and benefits of
treatments, especially important.



FULL STORY ==========================================================================
As public interest and expanded research in human genome editing grows,
many questions remain about ethical, legal and social implications of the technology. People who are seriously ill may overestimate the benefits
of early clinical trials while underestimating the risks. This makes
properly understanding informed consent, the full knowledge of risks
and benefits of treatments, especially important.


==========================================================================
In response to this emerging need, researchers at the National Human
Genome Research Institute (NHGRI), part of the National Institutes of
Health, asked patients, parents and physicians in the sickle cell disease community what they wanted and needed to know about genome editing to
make informed decisions about participating in genome-editing clinical
trials. Gene-editing treatments, which appear to provide a potential for
sickle cell, are among the most widely publicized medical advances in
recent years. The results were published this week in the journal AJOB Empirical Bioethics.

"An important goal of informed consent is to facilitate decisions
that are consistent with a person's values," said Sara Hull, Ph.D.,
director of the Bioethics Core at NHGRI. "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." Researchers contacted adults with sickle
cell disease and parents and physicians of adults and children with the disease. These participants completed a genetic literacy survey, watched
an educational video about genome editing, completed a two-part survey,
and took part in focus group discussions about CRISPR somatic genome
editing, an experimental treatment option for sickle cell disease.

The researchers found that all participants wanted informed consent to
include the treatment side effects of CRISPR somatic genome editing. Many people also wanted to know how such editing works and its impact on
their quality of life.

The groups reflected on the need to have flexibility in the kind of
information provided since people have differing levels of knowledge of
biology and genomics.

Interestingly, while some physicians were concerned about how well
patients would understand concepts related to somatic genome editing,
study participants demonstrated higher genetic literacy levels than
estimated.

The NHGRI study suggests that the sickle cell disease community is
optimistic about the promises of somatic genome editing. Responses
highlight the need to begin discussing what informed consent looks like, especially when lack of information and misconceptions about the risks
and benefits can influence a person's decision to participate in a
clinical trial.

"Designing clinical trials for curative genetic therapies requires
addressing the patient communities and their families need for accessible information about the risks and benefits," said Vence Bonham, J.D., an associate investigator in the Social and Behavioral Research Branch at
NHGRI and senior author on the paper. "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." By creating a standard for informed
consent with respect to genome editing clinical trials, such engagement
with patient communities may be replicated across biotechnology companies
and research institutions.

"Participating in any clinical trial is both a matter of faith and good judgment for individuals, and the research community must build models of consent, understanding and trust as crucial pillars that promote safety
and success for the patients," Bonham said.


========================================================================== Story Source: Materials provided by NIH/National_Human_Genome_Research_Institute. Original written by Prabarna Ganguly. Note: Content may be edited for style and length.


========================================================================== Journal Reference:
1. Stacy Desine, Brittany M. Hollister, Khadijah E. Abdallah, Anitra
Persaud, Sara Chandros Hull, Vence L. Bonham. The Meaning
of Informed Consent: Genome Editing Clinical Trials for
Sickle Cell Disease. AJOB Empirical Bioethics, 2020; 1 DOI:
10.1080/23294515.2020.1818876 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/10/201012132021.htm

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