Stephanie A Kraft1, Kathryn M Porter2, Devan M Duenas2, Claudia Guerra3, Galen Joseph3, Sandra Soo-Jin Lee4, Kelly J Shipman2, Jake Allen5, Donna Eubanks5, Tia L Kauffman6, Nangel M Lindberg6, Katherine Anderson7, Jamilyn M Zepp6, Marian J Gilmore6, Kathleen F Mittendorf6, Elizabeth Shuster8, Kristin R Muessig6, Briana Arnold6, Katrina A B Goddard6, Benjamin S Wilfond1. 1. Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, and Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA. 2. Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, Seattle, Washington, USA. 3. Department of Anthropology, History and Social Medicine, University of California, San Francisco, California, USA. 4. Division of Ethics, Department of Medical Humanities and Ethics, Columbia University, New York, New York, USA. 5. IT (Information Technology) Department, Kaiser Permanente Northwest, Center for Health Research, Portland, Oregon, USA. 6. Department of Translational and Applied Genomics, Kaiser Permanente Northwest, Center for Health Research, Portland, Oregon, USA. 7. Denver Health Ambulatory Care Services, Denver, Colorado, USA. 8. Research Data and Analysis Center, Kaiser Permanente Northwest, Center for Health Research, Portland, Oregon, USA.
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.
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.
Authors: Laura M Amendola; Jonathan S Berg; Carol R Horowitz; Frank Angelo; Jeannette T Bensen; Barbara B Biesecker; Leslie G Biesecker; Gregory M Cooper; Kelly East; Kelly Filipski; Stephanie M Fullerton; Bruce D Gelb; Katrina A B Goddard; Benyam Hailu; Ragan Hart; Kristen Hassmiller-Lich; Galen Joseph; Eimear E Kenny; Barbara A Koenig; Sara Knight; Pui-Yan Kwok; Katie L Lewis; Amy L McGuire; Mary E Norton; Jeffrey Ou; Donald W Parsons; Bradford C Powell; Neil Risch; Mimsie Robinson; Christine Rini; Sarah Scollon; Anne M Slavotinek; David L Veenstra; Melissa P Wasserstein; Benjamin S Wilfond; Lucia A Hindorff; Sharon E Plon; Gail P Jarvik Journal: Am J Hum Genet Date: 2018-09-06 Impact factor: 11.025
Authors: Fay Kastrinos; Hajime Uno; Chinedu Ukaegbu; Carmelita Alvero; Ashley McFarland; Matthew B Yurgelun; Matthew H Kulke; Deborah Schrag; Jeffrey A Meyerhardt; Charles S Fuchs; Robert J Mayer; Kimmie Ng; Ewout W Steyerberg; Sapna Syngal Journal: J Clin Oncol Date: 2017-05-10 Impact factor: 44.544
Authors: Paul A Harris; Robert Taylor; Brenda L Minor; Veida Elliott; Michelle Fernandez; Lindsay O'Neal; Laura McLeod; Giovanni Delacqua; Francesco Delacqua; Jacqueline Kirby; Stephany N Duda Journal: J Biomed Inform Date: 2019-05-09 Impact factor: 6.317
Authors: Adam Nishimura; Jantey Carey; Patricia J Erwin; Jon C Tilburt; M Hassan Murad; Jennifer B McCormick Journal: BMC Med Ethics Date: 2013-07-23 Impact factor: 2.652
Authors: Stephanie A Kraft; Carmit McMullen; Nangel M Lindberg; David Bui; Kelly Shipman; Katherine Anderson; Galen Joseph; Devan M Duenas; Kathryn M Porter; Tia L Kauffman; Alyssa Koomas; Chelese L Ransom; Paige Jackson; Katrina A B Goddard; Benjamin S Wilfond; Sandra Soo-Jin Lee Journal: Genet Med Date: 2020-02-24 Impact factor: 8.822
Authors: Devan M Duenas; Kelly J Shipman; Kathryn M Porter; Elizabeth Shuster; Claudia Guerra; Ana Reyes; Tia L Kauffman; Jessica Ezzell Hunter; Katrina A B Goddard; Benjamin S Wilfond; Stephanie A Kraft Journal: Genet Med Date: 2021-11-23 Impact factor: 8.822
Authors: Elizabeth G Liles; Michael C Leo; Amanda S Freed; Kathryn M Porter; Jamilyn M Zepp; Tia L Kauffman; Erin Keast; Carmit K McMullen; Inga Gruß; Barbara B Biesecker; Kristin R Muessig; Donna J Eubanks; Laura M Amendola; Michael O Dorschner; Bradley A Rolf; Gail P Jarvik; Katrina A B Goddard; Benjamin S Wilfond Journal: Genet Med Date: 2022-05-06 Impact factor: 8.864
Authors: Kathleen F Mittendorf; Tia L Kauffman; Laura M Amendola; Katherine P Anderson; Barbara B Biesecker; Michael O Dorschner; Devan M Duenas; Donna J Eubanks; Heather Spencer Feigelson; Marian J Gilmore; Jessica Ezzell Hunter; Galen Joseph; Stephanie A Kraft; Sandra Soo Jin Lee; Michael C Leo; Elizabeth G Liles; Nangel M Lindberg; Kristin R Muessig; Sonia Okuyama; Kathryn M Porter; Leslie S Riddle; Bradley A Rolf; Alan F Rope; Jamilyn M Zepp; Gail P Jarvik; Benjamin S Wilfond; Katrina A B Goddard Journal: Contemp Clin Trials Date: 2021-05-11 Impact factor: 2.261
Authors: Karriem S Watson; Elizabeth G Cohn; Alecia Fair; Usha Menon; Laura A Szalacha; Selena M Carpenter; Consuelo H Wilkins Journal: Health Expect Date: 2022-03-30 Impact factor: 3.318
Authors: Stephanie A Kraft; Erin Rothwell; Seema K Shah; Devan M Duenas; Hannah Lewis; Kristin Muessig; Douglas J Opel; Katrina A B Goddard; Benjamin S Wilfond Journal: J Med Ethics Date: 2020-10-06 Impact factor: 2.903