Abstract
The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients.
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References
Olson, LeighAnne, Dara Aisner, and J. Michael McGinnis. 2007. The learning healthcare system: workshop summary. Washington, DC: National Academies Press.
Grossman, Clauda, Brian Powers, and Julia Sanders. 2012. Digital data improvement priorities for continuous learning in health and health care. Washington, DC: National Academies Press.
Etheredge, Lynn. 2007. A rapid-learning health system. Health Affairs 26: w107–w118.
Larson, Eric B. 2013. Building trust in the power of “big data” research to serve the public good. JAMA 309: 2443–2444.
Wendler, David, and Seema Shah. 2006. How can medical training and informed consent be reconciled with volume-outcome data? Journal of Clinical Ethics 17: 149–157.
Danis, Marion, Samia Hurst, Leonard M. Fleck, Reidun Forde, and Anne Slowther. 2015. Fair resource allocation and rationing at the bedside. Oxford: Oxford University Press.
The Joint Commission. n.d. About the Joint Commission. http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx. Accessed April 27, 2016.
Kass, Nancy E., Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. 2013. The research-treatment distinction: A problematic approach for determining which activities should have ethical oversight. Hastings Center Report 43: S4–S15.
Menikoff, Jerry. 2013. The unbelievable rightness of being in clinical trials. Hastings Center Report Special Report 43: S30–S31.
Simon, Harvey B. 2002. The Harvard medical school guide to men’s health. New York: Free Press.
Brown, Stephen R. 2003. Scurvy: How a surgeon, a mariner, and a gentleman solved the greatest medical mystery of the age of sail. New York, NY: St. Martin’s Press.
Faden, Ruth, Nancy Kass, Steve N. Goodman, et al. 2013. An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics. Hastings Center Report 43: S16–S27.
Miller, Franklin G., and Ezekiel J. Emanuel. 2008. Quality improvement research and informed consent. New England Journal of Medicine 358: 765–767.
Smith, Mark, George Halvorson, and Gary Kaplan. 2012. What’s needed is a health care system that learns. JAMA 308: 1637–1638.
Fried, Charles. 1974. Medical experimentation: Personal integrity and social policy. New York: American Elsevier.
Freedman, Benjamin. 1987. Equipoise and the ethics of clinical research. New England Journal of Medicine 317: 141–145.
Miller, Franklin G., and Howard Brody. 2003. A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. Hastings Center Report 33: 19–28.
Miller, Franklin G., and Howard Brody. 2003. The clinician-investigator: unavoidable but manageable tension. Kennedy Institute of Ethics Journal 13: 329–346.
Wendler, David. 2010. Are physicians obligated always to act in the patient’s best interests? Journal of Medical Ethics 36: 66–70.
Weijer, Charles, and Paul B. Miller. 2004. When are research risks reasonable in relation to anticipated benefits? Nature Medicine 10: 570–573.
Konrad, Christoph J., Guido Schüpfer, Markus Wietlisbach, and Helmut Gerber. 1998. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesthesia & Analgesia 86: 635–639.
Williams, Alison C., Sandy S. Thomas, Debbie Sell, and Jac Sterne. 1999. Influence of surgeon’s experience on speech outcome in cleft lip and palate. Lancet 354: 1697–1698.
Brown, H.Shelton. 1996. Physician demand for leisure: Implications for cesarean section rates. Journal of Health Economics 15: 233–242.
NIH Collaboratory. n.d. UH2 Project: blood pressure medication timing study (BPMedTime). https://www.nihcollaboratory.org/demonstration-projects/Pages/BPMedTime.aspx. Accessed April 27, 2016.
Smith, Mark, Robert Saunders, Leigh Stuckhardt, and J. Michael McGinnis (eds.). 2012. Best care at lower cost: The path to continuously learning health care in America. Washington, DC: National Academies Press.
Glasgow, Russell E. 2012. Commentary: Electronic health records for comparative effectiveness research. Medical Care 50: S19–S20.
Pallin, Daniel J., Rachel Harris, Camile I. Johnson, and Ediza Giraldez. 2008. Is consent informed when patients receive care from medical trainees? Academic Emergency Medicine 15: 1304–1308.
Hemphill, Robin R., Sally A. Santen, C. Bart Rountree, and Andrew R. Szmit. 1999. Patients’ understanding of the roles of interns, residents, and attending physicians in the emergency department. Academic Emergency Medicine 6: 339–344.
Largent, Emily, Steve Joffe, and Franklin G. Miller. 2011. Can research and care be ethically integrated? Hastings Center Report 41: 37–46.
Kupersmith, Joel. 2013. Advances in the research enterprise: Ethical oversight of learning health care systems. Hastings Center Report Special Report 43: S43–S44.
Schaefer, G.Owen, Ezekiel J. Emanuel, and Alan Wertheimer. 2009. The obligation to participate in biomedical research. JAMA 302: 67–72.
Acknowledgments
Thanks to Christine Grady, Steven Pearson, and Franklin Miller for their helpful comments on early versions of the manuscript. This work was supported by NIH Clinical Center intramural funds. However, the views expressed are those of the authors. They do not represent the position or policy of the NIH or DHHS.
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Wendler, D., Johnson, R. When clinical care is like research: the need for review and consent. Theor Med Bioeth 37, 193–209 (2016). https://doi.org/10.1007/s11017-016-9364-x
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DOI: https://doi.org/10.1007/s11017-016-9364-x