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.
BaquetC. R.CommiskeyP.Daniel MullinsC.MishraS. I. (2006). Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors. Cancer Detection and Prevention, 30, 24-33.
2.
BeauchampT. L.ChildressJ. F. (2013). Principles of biomedical ethics (7th ed.). New York, NY: Oxford University Press.
3.
DoolittleP. E.BryantL. H.ChittumJ. R. (2015). Effects of degree of segmentation and learner disposition on multimedia learning. British Journal of Educational Technology, 46, 1333-1343.
4.
FisherJ. A.KalbaughC. A. (2011). Challenging assumptions about minority participation in US clinical research. American Journal of Public Health, 101, 2217-2222. doi:10.2105/AJPH.2011.300279
5.
FloryJ.EmanuelE. (2004). Interventions to improve research participants’ understanding in informed consent for research: A systematic review. Journal of the American Medical Association, 292, 1593-1601. doi:10.1001/jama.292.13.1593
6.
Food and Drug Administration. (2016, December). Use of an electronic informed consent in clinical investigations: Questions and answers: Guidance for institutional review boards, investigators, and sponsors (FR Doc. 2016-30146 Filed 12-14-16; 8:45 am). Retrieved from https://www.fda.gov/downloads/drugs/guidances/ucm436811.pdf
7.
FordJ. G.HowertonM. W.LaiG. Y.GaryT. L.BolenS.GibbonsM. C.. . . BassE. B. (2008). Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer, 112, 228-242. doi:10.1002/cncr.23157
8.
FougereB.Aubertin-LeheudreM.VellasB.AndrieuS.DemougeotL.CluzanC.CesariM. (2016). Clinical research for older adults in rural areas: The MINDED study experience. Age, 38(2), Article 30. doi:10.1007/s11357-016-9892-3
9.
GradyC.CummingsS. R.RowbothamM. C.McConnellM. V.AshleyE. A.KangG. (2017). Informed consent. New England Journal of Medicine, 376, 856-867. doi:10.1056/NEJMra1603773
10.
HallM. A.CamachoF.LawlorJ. S.DepuyV.SugarmanJ.WeinfurtK. (2006). Measuring trust in medical researchers. Medical Care, 44, 1048-1053. doi:10.1097/01.mlr.0000228023.37087.cb
11.
HsiehH. F.ShannonS. E. (2005). Three approaches to qualitative content analysis. Qualitative Health Research, 15, 1277-1288. doi:10.1177/1049732305276687
KatzV. S. (2017). What it means to be “under-connected” in lower-income families. Journal of Children and Media, 11, 241-244.
14.
KleinD. W.SchartzH. A. (2012, April). Instructional strategies to improve informed consent in healthcare research: Pilot study of interactivity and multimedia. Paper presented at the American Educational Research Association National Conference, Vancouver, British Columbia, Canada.
15.
KruegerR.CaseyM. (2000). Focus groups: A practical guide for applied research (4th ed.). Thousand Oaks, CA: Sage.
16.
LugerT. M.HoganT. P.RichardsonL. M.Cioffari-BailiffL.HarveyK.HoustonT. K. (2016). Older veteran digital disparities: Examining the potential for solutions within social networks. Journal of Medical Internet Research, 18(11), Article e296.
17.
MahnkeA. N.PlasekJ. M.HoffmanD. G.PartridgeN. S.FothW. S.WaudbyC. J.. . . McCartyC. A. (2014). A rural community’s involvement in the design and usability testing of a computer-based informed consent process for the personalized medicine research project. American Journal of Medical Genetics Part A, 164, 129-140. doi:10.1002/ajmg.a.36220
18.
MartinezC.MoyM.NguyenH.CohenM.KadriR.RomanP.. . . RichardsonC. (2014). Internet-mediated recruitment of rural veterans in a randomized controlled trial of a walking program for COPD. American Journal of Respiratory and Critical Care Medicine, 189, Article A5362.
19.
MayerR. E. (2009). Multimedia learning (2nd ed.). Cambridge, UK: Cambridge University Press.
20.
NishimuraA.CareyJ.ErwinP. J.TilburtJ. C.MuradM. H.McCormickJ. B. (2013). Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics, 14, Article 28. doi:10.1186/1472-6939-14-28
21.
OhS. S.GalanterJ.ThakurN.Pino-YanesM.BarceloN. E.WhiteM. J.. . . BurchardE. G. (2015). Diversity in clinical and biomedical research: A promise yet to be fulfilled. PLoS Medicine, 12(12), Article e1001918. doi:10.1371/journal.pmed.1001918
RothwellE.WongB.RoseN. C.AndersonR.FedorB.StarkL. A.BotkinJ. R. (2014). A randomized controlled trial of an electronic informed consent process. Journal of Empirical Research on Human Research Ethics, 9(5), 1-7. doi:10.1177/1556264614552627
24.
RowbothamM. C.AstinJ.GreeneK.CummingsS. R. (2013). Interactive informed consent: Randomized comparison with paper consents. PLoS ONE, 8(3), Article e58603. doi:10.1371/journal.pone.0058603
25.
SimonC. M.KleinD. W.SchartzH. A. (2014). Traditional and electronic informed consent for biobanking: A survey of US biobanks. Biopreservation and Biobanking, 12(6), 423-429.
26.
SimonC. M.SiminoffL. A.KodishE. D.BurantC. (2004). Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. Journal of Clinical Oncology, 22, 2708-2717. doi:10.1200/JCO.2004.10.034
TaitA. R.Voepel-LewisT.ChetcutiS. J.Brennan-MartinezC.LevineR. (2014). Enhancing patient understanding of medical procedures: Evaluation of an interactive multimedia program with in-line exercises. International Journal of Medical Informatics, 83, 376-384. doi:10.1016/j.ijmedinf.2014.01.011
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