Video education about genetic privacy and patient perspectives about sharing prenatal genetic data: a randomized trial

• Published in: American journal of obstetrics and gynecology Vol. 227; no. 1; pp. 87.e1 - 87.e13
• Main Authors: Parobek, Christian M., Thorsen, Margaret M., Has, Phinnara, Lorenzi, Paula, Clark, Melissa A., Russo, Melissa L., Lewkowitz, Adam K.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-07-2022
• Subjects: aneuploidy screening; Audiovisual Aids; Cell-Free Nucleic Acids; confidentiality; data use; deidentification; Female; fetal genetics; genetic counseling; Genetic Privacy; Humans; medical ethics; Patient Education as Topic; Pregnancy; prenatal care; protected health information; reidentification; genetic counseling; fetal genetics; reidentification; medical ethics; protected health information; confidentiality; deidentification; data use; aneuploidy screening; prenatal care
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/j.ajog.2022.03.047

Laboratories offering cell-free DNA often reserve the right to share prenatal genetic data for research or even commercial purposes, and obtain this permission on the patient consent form. Although it is known that nonpregnant patients are often reluctant to share their genetic data for research, pregnant patients’ knowledge of, and opinions about, genetic data privacy are unknown.
We investigated whether pregnant patients who had already undergone cell-free DNA screening were aware that genetic data derived from cell-free DNA may be shared for research. Furthermore, we examined whether pregnant patients exposed to video education about the Genetic Information Nondiscrimination Act—a federal law that mandates workplace and health insurance protections against genetic discrimination—were more willing to share cell-free DNA-related genetic data for research than pregnant patients who were unexposed.
In this randomized controlled trial (ClinicalTrials.gov Identifier: NCT04420858), English-speaking patients with singleton pregnancies who underwent cell-free DNA and subsequently presented at 17 0/7 to 23 6/7 weeks of gestation for a detailed anatomy scan were randomized 1:1 to a control or intervention group. Both groups viewed an infographic about cell-free DNA. In addition, the intervention group viewed an educational video about the Genetic Information Nondiscrimination Act. The primary outcomes were knowledge about, and willingness to share, prenatal genetic data from cell-free DNA by commercial laboratories for nonclinical purposes, such as research. The secondary outcomes included knowledge about existing genetic privacy laws, knowledge about the potential for reidentification of anonymized genetic data, and acceptability of various use and sharing scenarios for prenatal genetic data. Eighty-one participants per group were required for 80% power to detect an increase in willingness to share data from 60% to 80% (α=0.05).
A total of 747 pregnant patients were screened, and 213 patients were deemed eligible and approached for potential study participation. Of these patients, 163 (76.5%) consented and were randomized; one participant discontinued the intervention, and two participants were excluded from analysis after the intervention when it was discovered that they did not fulfill all eligibility criteria. Overall, 160 (75.1%) of those approached were included in the final analysis. Most patients in the control group (72 [90.0%]) and intervention (76 [97.4%]) group were either unsure about or incorrectly thought that cell-free DNA companies could not share prenatal genetic data for research. Participants in the intervention group were more likely to incorrectly believe that their prenatal genetic data would not be shared for nonclinical purposes than participants in the control group (28.8% in the control group vs 46.2% in the intervention; P=.03). However, video education did not increase participant willingness to share genetic data in multiple scenarios. Non-White participants were less willing than White participants to allow sharing of genetic data specifically for academic research (P<.001).
Most participants were unaware that their prenatal genetic data may be used for nonclinical purposes. Pregnant patients who were educated about the Genetic Information Nondiscrimination Act were not more willing to share genetic data than those who did not receive this education. Surprisingly, video education about the Genetic Information Nondiscrimination Act led patients to falsely believe that their data would not be shared for research, and participants who identified as racial minorities were less willing to share genetic data. New strategies are needed to improve pregnant patients’ understanding of genetic privacy.