Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study

Digital informed consent may better inform individuals about health research and increase participation. In the United States and elsewhere, minorities and rural populations are underrepresented in health research and may benefit from well-designed electronic informed consent (eIC). Seven focus groups were conducted with 50 Caucasian, African American, and rural patients in the United States. Participants were asked their preferences for a paper versus electronic informed consent document. Participants found the e-version easier to use, more interesting, and better for understanding. Minority participants emphasized limited access, computer literacy, and trust barriers to eIC. Rural participants were concerned about accessibility, connectivity, privacy, and confidentiality. People see value in electronic consenting. Researchers should consider barriers to eIC among underrepresented populations before recruitment.

[1]  Robert Levine,et al.  Enhancing patient understanding of medical procedures: Evaluation of an interactive multimedia program with in-line exercises , 2014, Int. J. Medical Informatics.

[2]  J. Botkin,et al.  A Randomized Controlled Trial of an Electronic Informed Consent Process , 2014, Journal of Empirical Research on Human Research Ethics.

[3]  Janet Mancini Billson,et al.  Focus Groups: A Practical Guide for Applied Research , 1989 .

[4]  N. Powe,et al.  Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled , 2015, bioRxiv.

[5]  L. Siminoff,et al.  Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  C. Simon,et al.  Traditional and electronic informed consent for biobanking: a survey of U.S. biobanks. , 2014, Biopreservation and biobanking.

[7]  J. Fisher,et al.  Challenging assumptions about minority participation in US clinical research. , 2011, American journal of public health.

[8]  James Flory,et al.  Interventions to improve research participants' understanding in informed consent for research: a systematic review. , 2004, JAMA.

[9]  S Holm,et al.  Principles of Biomedical Ethics, 5th edn. , 2002 .

[10]  C Rayner,et al.  Informed consent. , 2000, British journal of plastic surgery.

[11]  Shari Bolen,et al.  Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review , 2008, Cancer.

[12]  F. Camacho,et al.  Measuring Trust in Medical Researchers , 2006, Medical care.

[13]  Vikki S. Katz.  What it means to be “under-connected” in lower-income families , 2017, The State of Families.

[14]  Peter E. Doolittle,et al.  Effects of degree of segmentation and learner disposition on multimedia learning , 2012, Br. J. Educ. Technol..

[15]  Shiraz I Mishra,et al.  Recruitment and participation in clinical trials: socio-demographic, rural/urban, and health care access predictors. , 2006, Cancer detection and prevention.

[16]  Joseph M. Plasek,et al.  A rural community's involvement in the design and usability testing of a computer‐based informed consent process for the personalized medicine research project , 2014, American journal of medical genetics. Part A.

[17]  Hsiu-Fang Hsieh,et al.  Three Approaches to Qualitative Content Analysis , 2005, Qualitative health research.

[18]  S. Athar.  Principles of Biomedical Ethics , 2011, The Journal of IMA.

[19]  Adam A. Nishimura,et al.  Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials , 2013, BMC Medical Ethics.

[20]  S. Cummings,et al.  Interactive Informed Consent: Randomized Comparison with Paper Consents , 2013, PloS one.

[21]  Lorilei M. Richardson,et al.  Older Veteran Digital Disparities: Examining the Potential for Solutions Within Social Networks , 2016, Journal of medical Internet research.