Developing Psychologically Compelling Understanding of the Involvement of Humans in Research
Tóm tắt
Research conducted on humans has a long history of ethical protections, with the Nuremberg trials in 1945 and 1946 triggering stronger protection across most jurisdictions. While there have been many reorientations and corrections in the emphasis of codes protecting human research participants, all have implicitly assumed a conception of human decision-making and the person that are psychologically not feasible. In this paper, we examine two problematic assumptions dominant in many research ethics guidelines: (1) implicit reliance on a model of classical rationality in conceptualizing the process whereby individuals make a decision of whether to give consent to participate in a study and (2) the assumption of autonomous subjects in the bioethical principle of autonomy and in operationalizing informed consent processes. For both of these problems, we outline theoretical psychological work that provides more compelling accounts of (1) human decision-making and rationality as bounded and ecological and (2) of personhood and agency as relational and emergent. We conclude by considering approaches to bioethics that are compatible with such conceptions of personhood and therefore provide a more satisfactory framework for a relational ethics.
Tài liệu tham khảo
Appelbaum, P. S., Roth, L. H., & Lidz, C. (1982). The therapeutic misconception: informed consent in psychiatric research. International Journal of Law and Psychiatry, 5(3–4), 319–329.
Baylis, F. (2012). The self in situ: a relational account of personal identity. In J. Downie & J. J. Llewelyn (Eds.), Being relational: reflections on relational theory and health law (pp. 109–131). Vancouver: UBC Press.
Beauchamp, T. L., & Childress, J. F. (2013). Principles of biomedical ethics (7th ed.). New York: Oxford University Press.
Beecher, H. K. (2001). Ethics and clinical research, 1966. Bulletin of the World Health Organization, 79(4), 367–372.
Broome, M. E., Richards, D. J., & Hall, J. M. (2001). Children in research: the experience of ill children and adolescents. Journal of Family Nursing, 7(1), 32–49.
Burgess, M. M., & d’Agincourt-Canning, L. (2001). Genetic testing for hereditary disease: attending to relational responsibility. Journal of Clinical Ethics, 12(4), 361–372.
Canadian Institutes of Health Research (2010) Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf. Accessed May 26 2019.
Christofides, E., Dobson, J. A., Solomon, M., Waters, V., & O’Doherty, K. C. (2016). Heuristic decision-making about research participation in children with cystic fibrosis. Social Science & Medicine, 162, 32–40.
Christofides, E., Stroud, K., Tullis, D. E., & O’Doherty, K. (2017). The meanings of helping: an analysis of cystic fibrosis patients’ reasons for participating in biomedical research. Journal of Empirical Research on Human Research Ethics, 12(3), 180–190.
d’Agincourt-Canning, L. (2001). Experiences of genetic risk: disclosure and the gendering of responsibility. Bioethics, 15(3), 231–147.
Dixon-Woods, M., Young, B., & Ross, E. (2006). Researching chronic childhood illness: the example of childhood cancer. Chronic Illness, 2(3), 165–177.
Dobson, J. A., Christofides, E., Solomon, M., Waters, V., & O’Doherty, K. (2015). How do young people with cystic fibrosis conceptualize the distinction between research and treatment? A qualitative interview study. AJOB Empirical Bioethics, 6(4), 1–11. https://doi.org/10.1080/23294515.2014.997898.
Faden, R. R., & Beauchamp, T. L. (1995). A history and theory of informed consent. Oxford: Oxford University Press.
Fox, R. C., & Swazey, J. P. (2008). Observing bioethics. Oxford: University of Oxford University Press.
Freedman, B. (1987). Equipoise and the ethics of clinical research. The New England Journal of Medicine, 317(3), 141–145.
Garrison, N. A. (2013). Genomic justice for Native Americans: impact of the Havasupai case on genetic research. Science, Technology & Human Values, 38(2), 201–223. https://doi.org/10.1177/0162243912470009.
Gergen, K. J. (2009). Relational being: beyond self and community. Oxford: Oxford University Press.
Gigerenzer, G. (2000). Adaptive thinking: rationality in the real world. Oxford: Oxford University Press.
Gigerenzer, G. (2008). Rationality for mortals: how people cope with uncertainty. Oxford: Oxford University Press.
Gigerenzer, G., & Gaissmaier, W. (2011). Heuristic decision making. Annual Review of Psychology, 62, 451–482. https://doi.org/10.1146/annurev-psych-120709-145346.
Gigerenzer, G., & Todd, P. M. (2012). Ecological rationality: the normative study of heuristics. In P. M. Todd & G. Gigerenzer (Eds.), Ecological rationality: intelligence in the world. Oxford: Oxford University Press.
Gilligan, C. (1982). In a different voice: psychological theory and women’s development (2nd ed.). Cambridge: Harvard University Press.
Hallowell, N., Cooke, S., Lucassen, A., & Parker, M. (2009). Distinguishing research from clinical care in cancer genetics: theoretical justifications and practical strategies. Social Science & Medicine, 68(11), 2010–2017.
Held, V. (2006). The ethics of care: personal, political, and global. Oxford: Oxford University Press.
Hoffmaster, B. (Ed.). (2001). Bioethics in social context. Philadelphia: Temple University Press.
Horng, S., & Grady, C. (2003). Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, & therapeutic optimism. IRB: Ethics & Human Research, 25(1), 11–16.
Jonsen, A. R. (2003). The birth of bioethics. New York: Oxford University Press.
Jonsen, A. R., Seigler, M., & Winslade, W. J. (2015). Clinical ethics (8th ed.). New York: McGraw Hill.
Kahneman, D. (2003). Maps of bounded rationality: psychology for behavioral economics. The American Economic Review, 93(5), 1449–1475.
Kass, N. E., Faden, R. R., Goodman, S. N., Pronovost, P., & Beauchamp, T. L. (2013). The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Center Report, 43(1), S4–S15. https://doi.org/10.1002/hast.133.
Kimmelman, J. (2007). The therapeutic misconception at 25: treatment, research, and confusion. Hastings Center Report, 37(6), 36–42.
Lindemann, H., Verkerk, M., & Walker, M. U. (Eds.). (2009). Naturalized bioethics: toward responsible knowing and practice. New York: Cambridge University Press.
Manson, N. C., & O’Neill, O. (2007). Rethinking informed consent in bioethics. Cambridge: Cambridge University Press.
Martin, J., & Sugarman, J. H. (2003). A theory of personhood for psychology. In D. Hill & M. Kral (Eds.), About psychology: essays at the crossroads of history, theory, and philosophy (pp. 73–87). Albany: SUNY.
Miller, F. G., & Brody, H. (2003). A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. The Hastings Center Report, 33(3), 19–28.
Miller, P.B., Choudhry, S., & Campbell, A. (2018). Legal regulation of the physician–patient relationship. Royal College of Physicians and Surgeons of Canada. Retrieved from http://www.royalcollege.ca/rcsite/bioethics/primers/legal-regulation-physician-patient-relationship-e. Accessed May 26, 2019.
Moore v (1990) Regents of University of California (1990) no. S006987. Supreme Court of California. https://law.justia.com/cases/california/supreme-court/3d/51/120.html. Accessed May 26, 2019.
Noddings, N. (2003). Caring: a feminine approach to ethics & moral education (2nd ed.). Berkeley: University of California Press.
Office for Human Research Protections, US Department of Health & Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. Accessed May 26, 2019.
Osler, W. (1907). The evolution of the idea of experiment in medicine. Transactions of the Congress of American Physicians and Surgeons, 7, 1–8.
Pellegrino, E. D. (1993). The metamorphosis of medical ethics: a 30-year retrospective. Journal of the American Medical Association, 269(9), 1158–1162.
Reynolds, W. W., & Nelson, R. M. (2007). Risk perception and decision processes underlying informed consent to research participation. Social Science & Medicine, 65(10), 2105–2115.
Reverby, S. (2009). Examining Tuskegee: the infamous syphilis study and its legacy. Chapel Hill: University of North Carolina Press.
Rodney, P., Burgess, M. M., Pauly, B., & Phillips, J. C. (2013). Our theoretical landscape: complementary approaches to health care ethics. In J. Storch, P. Rodney, & R. Starzomski (Eds.), Ethical leadership for practice: an advanced sourcebook for nurses and colleagues in health care (2nd ed., pp. 84–106). Upper Saddle River: Prentice Hall Health.
Roland, P. (2012). Nuremberg trials: the Nazis and their crimes against humanity. London: Arcturus Publishing Ltd.
Rutherford, A. (2018). Feminism, psychology, and the gendering of neoliberal subjectivity: from critique to disruption. Theory & Psychology, 28(5), 619–644.
Schloendorff, M. E., Appellant, v (1914) The Society of the New York Hospital, Respondent. Court of Appeals of New York. 211 N.Y. 125; 105 N.E. 92. Decided April 14, 1914. https://biotech.law.lsu.edu/cases/consent/schoendorff.htm. Accessed May 26, 2019.
Sherwin, S. (1992). No longer patient: feminist ethics and health care. Philadelphia: Temple University Press.
Skloot, R. (2010). The immortal life of Henrietta Lacks. New York: Crown Publishers.
Slote, M. A. (2007). The ethics of care and empathy. London: Routledge.
Slife, B. D. (2004). Taking practice seriously: toward a relational ontology. Journal of Theoretical and Philosophical Psychology, 24(2), 157–178.
Stephenson, P. (1999). Expanding notions of culture for cross-cultural ethics in health and medicine. In H. Coward & P. Ratanakul (Eds.), A cross-cultural dialogue on health care ethics (pp. 68–91). Waterloo: Wilfrid Laurier Press.
Teo, T. (2018). Homo neoliberalus: from personality to forms of subjectivity. Theory & Psychology, 28(5), 581–599.
Truog, R. D. (2012). Patients and doctors: the evolution of a relationship. The New England Journal of Medicine, 366(7), 581–585.
Ursin, L. Ø., & Steinsbekk, K. S. (2012). Peeking into the black box of privacy - biobank participants on the importance of recognition. Norsk Epidemiologi, 21(2), 269–276.
Veatch, R. (2007). The irrelevance of equipoise. The Journal of Medicine and Philosophy, 32(2), 167–183.
Vollman, J., & Winau, R. (1996). Informed consent in human experimentation before the Nuremberg code. British Medical Journal, 313, 1445–1449.
Weish, G. (Ed.). (1990). Social science perspectives on medical ethics. Philadelphia: University of Pennsylvania Press.
Williams, B. (1981). Persons, character, and morality. In J. Rachels (Ed.), Moral Luck. Cambridge: Cambridge University Press.
Winkler, E. R. (1996). From Kantianism to contextualism: the rise and fall of the paradigm theory in bioethics. In L. W. Sumner & J. Boyle (Eds.), Philosophical perspectives on bioethics (pp. 50–78). Toronto: University of Toronto Press.
Woodgate, R. L., & Edwards, M. (2010). Children in health research: a matter of trust. Journal of Medical Ethics: Journal of the Institute of Medical Ethics, 36(4), 211–216.