Ethical, legal and social implications associated with rapidly advancing human genome editing capability grow in importance due in part to the advent of technology breakthroughs such as CRISPR. Patients with serious diseases, however, in their hope of finding a cure, may overestimate the benefits of early-stage clinical trials while underestimating the risks. This kind of situation makes the informed consent process incredibly important. Patients and their families or medical providers must be truly informed as to the full range of risks faced in addition to the possible benefits. A recent study led by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH), delved into this serious question by studying the sickle cell disease community. In a quest to identify what patients, parents and physicians needed to know about gene editing to make informed decisions about participation in genome-editing clinical trials, the results of this important work were most recently published in the journal AJOB Empirical Bioethics.
Recently tracked by Science, TrialSite summarizes this important topic.
Overall, the sickle cell disease community has a generally positive outlook about the future of somatic genome editing.
Sponsors & PIs: Informed Consent Considerations
First, researchers were surprised by the study participants’ higher than expected genetic literacy levels. The study team uncovered that all participants seek an open and candid discussion about potential side effects of CRISPR somatic genome editing.
Moreover, sponsors should certainly describe how gene editing works in informed consent as well as how such technology advancement could impact the patient’s quality of life—good or bad. The details are important!
Flexibility is really important. Why? Well, because there are many different kinds of participating patients with various education levels for example. Hence, the way the sponsor/investigator describes the treatment may need to change depending on the individual reading the informed consent.
Sara Hull, PhD, director of Bioethics Core, NHGRI
Vence Bonham, JD, associate investigator in the Social and Behavioral Research Branch, NHGRI
This study has certainly helped Dr. Hull and Vence Bonham, JD, associate investigator, accumulate valuable knowledge about considerations for genome-based clinical trial informed consent. Dr. Hull tells the reader, “An important goal of informed consent is to facilitate decisions that are consistent with a person’s values.” Emphasizing the evolving learning here: “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 difficult decisions.”
Call to Action: For those involved with creation of informed consents for genome-based clinical trials, consider reading the underlying study.