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Research participants’ views about the process to consent to participate in a genome sequencing study

Friday, September 16, 2016 — Poster Session IV

12:00 p.m. – 1:30 p.m.
FAES Terrace
NHGRI
BEHAV-6

Authors

  • E Turbitt
  • AR Heidlebaugh
  • PP Chrysostomou
  • HL Peay
  • LM Nelson
  • BB Biesecker

Abstract

Background: Due to the lowered cost, genome sequencing has become accessible for a greater number of medical researchers. Despite the increasing use of genome sequencing, inconsistencies in consent processes remain. Methods: A randomized controlled trial (RCT) of two consent interventions was carried out for an NICHD study enrolling women with Primary Ovarian Insufficiency. The RCT compared an evidence-based, short consent format, which allowed more interaction, to a “standard” consent format used in several NIH sequencing studies. A senior genetic counselor implemented consents by telephone. Participants completed a baseline and two follow-up surveys directly after the consent process and six weeks later. Surveys invited open-ended responses exploring participants’ expectations, concerns, hesitations and further questions. Data were coded and analyzed using content analysis. Results: Response frequency varied, from 100 to 209 participants. The major theme arising from the baseline survey was the expectation to learn information of personal benefit, including secondary findings. Most (N=171) decided to participate in the sequencing study prior to consent process, though noted it reassured and confirmed their decision (N=46), and the additional details about the study helped with this feeling of confirmation (N=55). On the follow-up surveys the major theme was anticipated anxiety about personal results, with participants randomized to the shortened consent format voicing this concern more often (N=22) compared to those receiving the “standard” consent (N=7). Discussion/Conclusion: Genome sequencing participants may have high expectations for receiving results of personal benefit. While many decide to participate prior to the consent process, the information provided is appreciated.

Category: Social and Behavioral Sciences