Participant Reactions to a Literacy-Focused, Web-Based Informed Consent Approach for a Genomic Implementation Study

Abstract

Background: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. Methods: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. Results: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. Conclusions: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges.

Keywords:

• Interview
• qualitative research
• informed consent
• multimedia
• understanding
• bioethics

Acknowledgements

The authors would like to thank the many members of the CHARM study team who contributed to this project. The authors also thank Gary Ashwal and Alex Thomas of Booster Shot Media for their work conceptualizing and creating the cartoon illustrations included in the consent materials. This work was funded as part of the Clinical Sequencing Evidence-Generating Research (CSER) consortium funded by the National Human Genome Research Institute with co-funding from the National Institute on Minority Health and Health Disparities and the National Cancer Institute. This work was supported by grant U01HG007292 (MPIs: Wilfond, Goddard), with additional support from U24HG007307 (Coordinating Center). The CSER consortium represents a diverse collection of projects investigating the application of genome-scale sequencing in different clinical settings including pediatric and adult subspecialties, germline diagnostic testing and tumor sequencing, and specialty and primary care. The contents of this paper are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. The CSER consortium thanks the staff and participants of all CSER studies for their important contributions. More information about CSER can be found at https://cser-consortium.org/.

Author contributions

SAK, KMP, DMD, CG, GJ, SSL, JA, DE, TLK, NML, KA, JMZ, MJG, KFM, KABG, and BSW contributed substantially to the conception and/or design of this study. SAK, KMP, DMD, CG, KJS, TLK, KRM, and BA contributed substantially to data collection. SAK, KMP, DMD, CG, GJ, SSL, KJS, KFM, ES, KABG, and BSW contributed substantially to data analysis and/or interpretation. All authors contributed significantly to drafting and/or critically revising the manuscript, gave final approval of the version to published, and agree to be accountable for all aspects of the work.

Conflicts of interest

The authors have no conflicts of interest to disclose.

Ethical approval

This study was approved by the institutional review board(s) at Kaiser Permanente Northwest.

Additional information

Funding

This work was supported by grant U01HG007292 (MPIs: Wilfond, Goddard), with additional support from U24HG007307 (Coordinating Center).