The Goldilocks Conundrum: Disclosing Discrimination Risks in Informed Consent
39 Pages Posted: 9 Feb 2022
Date Written: November 2021
Informed consent is a foundational ethical and legal principle in human subjects research and clinical care. Yet, there is extensive debate over how much information must be disclosed to meet ethical goals and legal requirements, especially about non-medical risks. In this online, survey-based experiment of a diverse sample of the US general population, we explored one aspect of this debate by testing whether the level of detail included in informed consent regarding genetic anti-discrimination protections alters individuals’ willingness to participate in a hypothetical research study and their concerns regarding genetic discrimination. Participants were randomized to receive sample informed consent language with one of three levels of disclosure regarding the protections and limitations of the Genetic Information Nondiscrimation Act (GINA). Our sample (n=1195) had a mean age of 45.9 (SD=17.9) years and 40% with ≤ high school education. It was 51.3% female and 36.7% non-Hispanic White. On average, those who received consent language with none of GINA’s limitations highlighted were more willing to participate than those who were warned about various gaps in GINA. They also had significantly lower perceived risk of discrimination than those presented with the most information about limitations. Our study found that providing more comprehensive information about GINA notably increased discrimination concerns and lessened willingness to participate in the hypothetical studies, highlighting the need for clinicians and researchers to thoughtfully consider how to disclose anti-discrimination risks in informed consent.
Funding Information: Research reported in this publication was supported by the National Human Genome Research Institute of the National Institutes of Health under Award Number R00HG008819.
Declaration of Interests: AERP declares that she has no conflict of interest. SMS declares that she has no conflict of interest. WRU declares that she has no conflict of interest. AMS declares that he has no conflict of interest.
Ethics Approval Statement: This study was deemed as exempt by the University of Iowa Institutional Review Board (202002765). The first page of the survey included consent information, such as the voluntary nature of the study, contact information for the principal investigator and IRB, and assurances that no personal information would be collected. Those who consented could click to continue to the survey questions.
Keywords: informed consent; discrimination; policy; genetic testing; genetic research
JEL Classification: I19, K19
Suggested Citation: Suggested Citation