IRP researchers work with patients, families and the scientific community to improve the informed consent process

Tuesday, October 13, 2020

As genome-editing trials become more common, informed consent is changing

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.”