Clinical Care and Research: Are There Global Bioethical Standards?
Clinical care and research of all types are increasingly global matters. The fact is, however, that conditions and resources for both care and research vary greatly around the world. It is not hard to think of examples where a particular form of care is available in North America or Western Europe, but not in a resource poor Central and South American, African, or Asian country. For example, there are many parts of the world where life-saving dialysis for people with end-stage kidney disease is simply not available. Is this acceptable? Even within a country like the United States, there are areas of poverty and low resources where the same care that is available in one region is not available in another – or even in different parts of the same city. In the increasingly globalized world of clinical research, how can we be certain that a subject in a trial of an experimental drug or other treatment in a poor country or region within a country is treated just the same as another subject in a resource-rich area – and whether the experimental therapy is indeed as safe in a setting where nutrition and other basic health issues are not as well addressed?
This lecture will consider the bioethical issues associated with both obvious and subtle inequities in clinical care and research and what we as health professionals representing various disciplines can do about the evident inequities in both potential benefits and risks. The question as to our responsibilities as individuals in high-resource settings to assisting colleagues and patients in low-resource settings is one that needs to be addressed. What short- and long-term approaches and/or solutions should be considered? Do we need new models? Although different models will be considered, the lessons learned from more than 25 years of use of the Problem Solving for Better Health methodology will be considered.
Barry Smith, M.D., CEO of The Rogosin Institute; Director of The Rogosin Institute Dreyfus Health Foundation, and The Rogosin Institute Xenia Division; Professor of Surgery, Weill Cornell Medicine, Attending Surgeon, New York-Presbyterian/Weill Cornell Medical Center
Benatar, S. R. & Singer, P. A. “A new look at international research ethics” British Medical Journal (2000).
Emanuel, E. J., Wendler, D., Killen, J., and Grady, C. “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research” The Journal of Infectious Diseases (2004).
Faden, R.R., Kass, N.E., Goodman, S.N., Pronovost, P., Tunis, S., and Beauchamp, T.L. “An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.” The Hastings Center Report (2013).
Freire, P. “Pedagogy of the Oppressed” The Continuum International Publishing Group Inc. (2000).
Grady, C. “Clinical Trials,” in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 21-24.
Henderson, G. E., Churchill, L. R., Davis, A. M., Easter, M. M., Grady, C., Joffe, S., Kass, N., King, N. M. P., Lidz, C. W., Miller, F. G., Nelson, D. K., Peppercorn, J., Rothschild, B. B., Sankar, P., Wilfond, B. S., and Zimmer, C. R. “Clinical Trials and Medical Care: Defining the Therapeutic Misconception” PLOS Medicine (2007).
Mello, M. M., Goodman, S. N., & Faden, R. R. “Ethical Considerations in Studying Drug Safety – The Institute of Medicine Report” The New England Journal of Medicine (2012).
Miller, F. G. & Brody, H. “A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials” The Hastings Center (2003).
Millum, J., Sina, B., & Glass, R. “International Research Ethics Education” The Journal of American Medical Association (2015).
Rid, A., Saxena, A., Baqui, A. H., Bhan, A., Bines, J., Bouesseau, M., Caplan, A., Colgrove, J., Dhai, A., Gomez-Diaz, R., Green, S. K., Kang, G., Lagos, R., Loh, P., London, A. J., Mulholland, K., Neels, P., Pitisuttithum, P., Sarr, S. C., Selgelid, M., Sheehan, M., & Smith, P. G. “Placebo use in vaccine trials: Recommendations of a WHO expert panel” PubMed Central (2014).
Solomon, M. Z. & Bonham, A. C. “Ethical Oversight of Research on Patient Care” The Hastings Center Report (2013).
Vallely, A., Lees, S., Shagi, C., Kasindi, S., Soteli, S., Natujwa, K., Vallely, L., McCormack, S., Pool, R., & Hayes, R. J. “How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania” BioMed Central Medical Ethics (2010).
Walter, M. “First, Do Harm” Nature (2012).
Williams, J. R., Sprumont, D., Hirtle, M., Adebamowo, C., Braunschweiger, P., Bull, S., Burri, C., Czarkowski, M., Fan, C. T., Franck, C., Gefenas, E., Geissbuhler, A., Klingmann, I., Kouyate, B., Kraehenbhul, J., Kruger, M., Moodley, K., Ntoumi, F., Nyirenda, T., Pym, A., Silverman, H., & Tenorio, S. “Consensus standards for introductory e-learning courses in human participants research ethics” Journal of Medical Ethics (2014).