Sponsored genetic testing and informed consent implications: Experience and attitudes of genetic counselors

Sponsored genetic testing is where a non-traditional payer (e.g., pharmaceutical company, patient advocacy group) covers the cost of diagnostic genetic testing for a qualified individual in exchange for patient data. Although previous research has shown the public is hesitant when sharing medical information with for-profit researchers, there has been little research on genetic counselor (GC) attitudes toward sponsored testing. This study used mixed methods to assess GCs' awareness of and attitudes toward sponsored testing and perceived implications on informed consent processes. Board-certified GCs were eligible to complete an online survey. Respondents with experience ordering sponsored testing were invited to participate in a focus group. Descriptive statistics were performed for survey data. Qualitative data were iteratively analyzed using codebook thematic analysis. The survey was completed by 68 GCs, of which 97% were female, 41% had 1-4 years of GC experience, and 75% had experience ordering sponsored testing. 61% (n = 41/67) of survey respondents felt the advantages of sponsored testing outweigh the disadvantages, and that there are additional components of informed consent for sponsored testing compared with standard practice. Of those who completed the survey, 12 participated in one of four focus groups. Most focus group participants felt that the lack of monetary cost and insurance billing were advantages of sponsored testing, as they increased access to testing for their patients. Perceived disadvantages included lack of transparency surrounding data sharing practices and the inability to customize sponsored panels. Many focus group participants felt that additional components of informed consent should be discussed with the patient when ordering sponsored testing, such as secondary use of data and future contact for research contribution. The majority of focus group participants described that when discussing sponsored testing with patients, they offer multiple test options and use shared decision-making to explore patients' perceptions of sponsored testing. Our study suggested that it is important for providers to thoughtfully approach conversations on sponsored testing.