• As genome-editing trials become more com

    From ScienceDaily@1337:3/111 to All on Mon Oct 12 21:30:32 2020
    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

    --- up 7 weeks, 6 hours, 50 minutes
    * Origin: -=> Castle Rock BBS <=- Now Husky HPT Powered! (1337:3/111)