Abstract
Background
Minorities are an underrepresented population in clinical trials. A potential explanation for this underrepresentation could be lack of willingness to participate. The aim of our study was to evaluate willingness to participate in different hypothetical clinical research scenarios and to evaluate the role that predictors (e.g. health literacy) could have on the willingness of minorities to participate in clinical research studies.
Methods
We conducted a mixed-methods study at the Miami VA Healthcare system and included primary care patients with hypertension. We measured willingness to participate as a survey of four clinical research scenarios that evaluated common study designs encountered in clinical research and that differed in degree of complexity. Our qualitative portion included comments about the scenarios.
Results
We included 123 patients with hypertension in our study. Of the entire sample, ninety-three patients were minorities. Seventy per cent of the minorities were willing to participate, compared to 60 per cent of the non-minorities. The odds ratio (OR) of willingness to participate in simple studies was 0.58; 95 per cent CI 0.18–1.88 p=0.37 and the OR of willingness to participate in complex studies was 5.8; 95 per cent CI 1.10–1.31 p=0.03. In complex studies, minorities with low health literacy cited obtaining benefits (47 per cent) as the most common reason to be willing to participate. Minorities who were not willing to participate, cited fear of unintended outcomes as the main reason.
Conclusions
Minorities were more likely to be willing to participate in complex studies compared to non-minorities. Low health literacy and therapeutic misconception are important mediators when considering willingness to participate in clinical research.
Similar content being viewed by others
References
Allmark, P. 2004. Should research samples reflect the diversity of the population? Journal of Medical Ethics 30(2): 185–189.
Appelbaum, P.S., and C.W. Lidz. 2008. Twenty-five years of therapeutic misconception. The Hastings Center Report 38(2): 5–6; author re ply 6–7.
Britton, A., M. McKee, N. Black, K. McPherson, C. Sanderson, and C. Bain. 1999. Threats to applicability of randomised trials: Exclusions and selective participation. Journal of Health Services Research & Policy 4(2): 112–121.
Brody, H., and F.G. Miller. 2003. The clinician-investigator: Unavoidable but manageable tension. Kennedy Institute of Ethics Journal 13(4): 329–346.
Byrne, M.M., S.L. Tannenbaum, S. Gluck, J. Hurley, and M. Antoni. 2014. Participation in cancer clinical trials: Why are patients not participating? Medical Decision Making: An International Journal of the Society for Medical Decision Making 34(1): 116–126.
Cohen, B.J., E.L. McGarvey, R.C. Pinkerton, and L. Kryzhanivska. 2004. Willingness and competence of depressed and schizophrenic inpatients to consent to research. The Journal of the American Academy of Psychiatry and the Law 32(2): 134–143.
George, S., N. Duran, and K. Norris. 2014. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. American Journal of Public Health 104(2): e16–31.
Hussain-Gambles, M., K. Atkin, and B. Leese. 2004. Why ethnic minority groups are under-represented in clinical trials: A review of the literature. Health & Social Care in the Community 12(5): 382–388.
Joffe, S., E.F. Cook, P.D. Cleary, J.W. Clark, and J.C. Weeks. 2001. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358(9295): 1772–1777.
Katz, R.V., B.L. Green, N.R. Kressin, C. Claudio, M.Q. Wang, and S.L. Russell. 2007. Willingness of minorities to participate in biomedical studies: Confirmatory findings from a follow-up study using the Tuskegee Legacy Project questionnaire. Journal of the National Medical Association 99(9): 1052–1060.
Lavori, P.W., T.J. Wilt, and J. Sugarman. 2007. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clinical Trials 4(6): 638–649.
Lidz, C.W., K. Albert, P. Appelbaum, L.B. Dunn, E. Overton, and E. Pivovarova. 2015. Why is therapeutic misconception so prevalent? Cambridge Quarterly of Healthcare Ethics 24(2): 231–241.
Mounsey, L.A., F.C. Lin, I. Pursell, et al. 2017. Relation of household income to incidence of sudden unexpected death in Wake County, North Carolina. The American Journal of Cardiology 119(7): 1030–1035.
Murthy, V.H., H.M. Krumholz, and C.P. Gross. 2004. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291(22): 2720–2726.
Palacio, A.M., L.J. Tamariz, C. Uribe, et al. 2011. Can claims-based data be used to recruit black and Hispanic subjects into clinical trials? Health Services Research 47(2): 770–782.
Rodriguez, V., A.D. Andrade, R. Garcia-Retamero, et al. 2013. Health literacy, numeracy, and graphical literacy among veterans in primary care and their effect on shared decision making and trust in physicians. Journal of Health Communication 18(Suppl 1): 273–289.
Tamariz, L., A. Palacio, J. Denizard, Y. Schulman, and G. Contreras. 2015. The use of claims data algorithms to recruit eligible participants into clinical trials. The American Journal of Managed Care 21(2): e114–118.
Tamariz, L., A. Palacio, M. Robert, and E.N. Marcus. 2013. Improving the informed consent process for research subjects with low literacy: A systematic review. Journal of General Internal Medicine 28(1): 121–126.
Thong, I.S., M.Y. Foo, M.Y. Sum, et al. 2016. Therapeutic misconception in psychiatry research: A systematic review. Clinical Psychopharmacology and Neuroscience 14(1): 17–25.
Weiss, B.D., M.Z. Mays, W. Martz, et al. 2005. Quick assessment of literacy in primary care: The newest vital sign. Annals of Family Medicine 3(6): 514–522.
Wendler, D., and C. Grady. 2008. What should research participants understand to understand they are participants in research? Bioethics 22(4): 203–208.
Wendler, D., R. Kington, J. Madans, et al. 2006. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 3(2): e19.
Zuniga, M.L., E. Blanco, P. Martinez, S.A. Strathdee, and A.L. Gifford. 2007. Perceptions of barriers and facilitators to participation in clinical trials in HIV-positive Latinas: A pilot study. Journal of Women’s Health 16(9): 1322–1330.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Tamariz, L., Kirolos, I., Pendola, F. et al. Minority Veterans Are More Willing to Participate in Complex Studies Compared to Non-minorities. Bioethical Inquiry 15, 155–161 (2018). https://doi.org/10.1007/s11673-017-9829-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11673-017-9829-2