Simplifying Consent for Pharmacogenomics: A Defense of Verbal Consent for Pharmacogenomics Testing in Primary Care
Friday, October 13, 2023
8:00 AM – 9:15 AM ET
Location: Chasseur (Third Floor)
Pharmacogenomic testing (PGx), a genetic test that helps determine the efficacy and safety of certain medications, may be the first type of genetic testing to be widely implemented in primary care and general medicine. In this paper, we argue that pharmacogenomic testing does not require a robust consent process similar to that carried out before other sorts of genetic testing, such as genetic counseling before prenatal testing for recessive diseases, or before whole genome sequencing. Verbal disclosure of the main benefits and the potential risks, followed by verbal consent by the patient, is ethically acceptable, we argue, much like the process before a Complete Blood Count or Comprehensive Metabolic Panel. We acknowledge, of course, that as a form of genetic testing, PGx carries risks similar to those of genetic tests, and has longer implications than a standard blood test. But we argue that the risks are small enough, and the potential benefit is large enough and easily enough explained, that simple consent is appropriate. However, given the relative novelty of PGx, we also argue that in order for patients to receive the full benefit of PGx testing as outlined in a simple consent process, physicians and healthcare systems must emphasize patient education of PGx results and the importance of PGx results on their future healthcare. We make these arguments by considering the ethical issues in deciding on simple vs. complex consent, consent before other forms of genetic testing and other situations, and the risks and benefits of PGx testing.
Peter Schwartz, PHD, MD – Professor, IU Center for Bioethics, Indiana University School of Medicine