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Adverse selection and moral hazard in the provision of clinical trial ancillary care

Published online by Cambridge University Press:  02 April 2012

Michael R. Richards*
Affiliation:
Doctoral Student, Division of Health Policy and Administration, School of Public Health, Yale University, New Haven, CT, USA
Lorens A. Helmchen
Affiliation:
Associate Professor, Department of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, VA, USA
*
*Correspondence to: Michael R. Richards, Division of Health Policy and Administration, School of Public Health, Yale University, 60 College Street, New Haven, CT 06520, USA. Email: michael.richards@yale.edu

Abstract

As more and more clinical trials are conducted in developing countries, concerns arise about non-trial medical care available to study participants. Recent work argues for ancillary care – medical care not part of the clinical trial per se – to be formally incorporated into these studies. Although the provision of ancillary care is often justified on ethical grounds, a number of crucial implementation issues remain unresolved, including its scope, duration and financing. Drawing on lessons from health insurance benefit design, we highlight two overlooked challenges for ancillary care adoption – adverse selection and moral hazard – and offer recommendations that could attenuate their consequences. Specifically, adverse selection and moral hazard could be reduced by offering a choice between ancillary medical care and monetary compensation or rewarding low ancillary care utilization. Alternatively, researchers’ financial risk due to ancillary care could be shifted to a third-party insurer. Recognizing participants’ behavioral responses to prospective offers of ancillary medical care would allow funders and research teams to forecast the demand for ancillary care more accurately and to prepare for its provision more adequately.

Type
Perspective
Copyright
Copyright © Cambridge University Press 2012

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References

Barsdorf, N., Maman, S., Kass, N.Slack, C. (2010), ‘Access to treatment in HIV prevention trials: perspectives from a South African community’, Developing World Bioethics, 10(2): 7887.CrossRefGoogle ScholarPubMed
Belsky, L.Richardson, H. S. (2004), ‘Medical researchers’ ancillary clinical care responsibilities’, British Medical Journal, 328(7454): 14941496.CrossRefGoogle ScholarPubMed
Benatar, S. R.Singer, P. A. (2000), ‘A new look at international research ethics’, British Medical Journal, 321(7264): 824826.CrossRefGoogle Scholar
Brownsword, R. (2007), ‘The ancillary-care responsibilities of researchers: reasonable but not great expectations’, The Journal of Law Medicine and Ethics, 35(4): 679691.CrossRefGoogle Scholar
Cutler, D. M.Reber, S. J. (1998), ‘Paying for health insurance: the trade-off between competition and adverse selection’, Quarterly Journal of Economics, 113(2): 433466.CrossRefGoogle Scholar
Dickert, N.Wendler, D. (2009), ‘Ancillary care obligations of medical researchers’, Journal of the American Medical Association, 302(4): 424428.CrossRefGoogle ScholarPubMed
Dickert, N., DeRiemer, K., Duffy, P. E., Garcia-Garcia, L., Mutabingwa, T. K., Sina, B. J., Tindana, P.Lie, R. (2007), ‘Ancillary-care responsibilities in observational research: two cases, two issues’, Lancet, 369(9564): 874877.CrossRefGoogle ScholarPubMed
Eisele, T. P., Mathews, C., Chopra, M., Brown, L., Silvestre, E., Daries, V.Kendall, C. (2008), ‘High levels of risk behavior among people living with HIV initiating and waiting to start antiretroviral therapy in Cape Town South Africa’, AIDS and Behavior, 12(4): 570577.CrossRefGoogle ScholarPubMed
Hooper, C. R. (2010), ‘Ancillary care duties: the demands of justice’, Journal of Medical Ethics, 36(11): 708711.CrossRefGoogle ScholarPubMed
Huebner, D. M.Gerend, M. A. (2001), ‘The relation between beliefs about drug treatments for HIV and sexual risk behavior in gay and bisexual men’, Annals of Behavioral Medicine, 23(4): 304312.CrossRefGoogle ScholarPubMed
Hyder, A. A.Merritt, M. W. (2009), ‘Ancillary care for public health research in developing countries’, Journal of the American Medical Association, 302(4): 429431.CrossRefGoogle ScholarPubMed
Merritt, M. W., Taylor, H. A.Mullany, L. C. (2010), ‘Ancillary care in community-based public health intervention research’, American Journal of Public Health, 100(2): 211216.CrossRefGoogle ScholarPubMed
Richardson, H. S. (2007), ‘Gradations of researchers’ obligation to provide ancillary care for HIV/AIDS in developing countries’, American Journal of Public Health, 97(11): 19561961.CrossRefGoogle ScholarPubMed
Richardson, H. S. (2008), ‘Incidental findings and ancillary-care obligations’, The Journal of Law, Medicine & Ethics, 36(2): 256270.CrossRefGoogle ScholarPubMed
Richardson, H. S.Belsky, L. (2004), ‘The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects’, Hastings Center Report, 34(1): 2533.CrossRefGoogle ScholarPubMed
Shaffer, D. N., Yebei, V. N., Ballidawa, J. B., Sidle, J. E., Greene, J. Y., Meslin, E. M., Kimaiyo, S. J.Tierney, W. M. (2006), ‘Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in Western Kenya’, Journal of Medical Ethics, 32(1): 5560.CrossRefGoogle ScholarPubMed
Shapiro, K.Benatar, S. R. (2005), ‘HIV prevention research and global inequality: steps towards improved standards of care’, Journal of Medical Ethics, 31(1): 3947.CrossRefGoogle ScholarPubMed
Simon, K. I. (2005), ‘Adverse selection in health insurance markets? Evidence from state small-group health insurance reforms’, Journal of Public Economics, 89(9–10): 18651877.CrossRefGoogle Scholar
Suarez, T. P., Kelly, J. A., Pinkerton, S. D., Stevenson, Y. L., Hayat, M., Smith, M. D.Ertl, T. (2001), ‘Influence of a partner's HIV serostatus, use of highly active antiretroviral therapy, and viral load on perceptions of sexual risk behavior in a community sample of men who have sex with men’, Journal of Acquired Immune Deficiency Syndromes, 28(5): 471477.CrossRefGoogle Scholar