Abstract
Palliative care research can be defined as research related to understanding and improving the quality of life of patients near the end of life. There is a paucity of research in this field for two overarching reasons. Medical interest related to relieving burden of illness is relatively new, and patients nearing the end of life have either been marginalized (i.e., viewed as not worthy of “investment” of scarce research dollars) or viewed as too vulnerable to undergo the rigorous processes of formalized research. Concerns about such vulnerabilities have created an ethical paradox. In order to protect this patient population from potential harms, including coercion, exploitation, and the possibility of imposing additional suffering at the end of life, terminally ill patients have been deprived of the opportunity to participate in research afforded to other patient populations: the frank withholding of an ethical prerogative. As a result, innovation and empirical developments in the field have been seriously curtailed.
This chapter will explicate these barriers and misconceptions and address the ways in which research can and should proceed, following normative ethical imperatives. Patients with far-advanced medical illness provide a good paradigm to explore ethical concerns about vulnerable populations insofar as they embody some of the greatest challenges to unencumbered decision-making: a high symptom burden (including fatigue, pain, mood disturbance, nausea, dyspnea), cognitive impairment, and imminent mortality. As such, the tenets brought forth in this chapter may pertain to barriers to, and the provision of, ethical research in other vulnerable populations.
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References
Abernethy, A. P., Capell, W. H., Aziz, N. M., Ritchie, C., Prince-Paul, M., Bennett, R. E., & Kutner, J. S. (2014). Ethical conduct of palliative care research: Enhancing communication between investigators and institutional review boards. Journal of Pain and Symptom Management, 48(6), 1211–1221. https://doi.org/10.1016/j.jpainsymman.2014.05.005.
Agar, M., Ko, D. N., Sheehan, C., Chapman, M., & Currow, D. C. (2013). Informed consent in palliative care clinical trials: Challenging but possible. Journal of Palliative Medicine, 16(5), 485–491. https://doi.org/10.1089/jpm.2012.0422.
Agrawal, M. (2003). Voluntariness in clinical research at the end of life. Journal of Pain and Symptom Management, 25(4), S25–S32.
Appelbaum, P. S., Lidz, C. W., & Klitzman, R. (2009). Voluntariness of consent to research: A preliminary empirical investigation. IRB, 31(6), 10–14.
Berg, J. W., Appelbaum, P. S., & ebrary Inc. (2001). Informed consent legal theory and clinical practice (pp. xii, 340 p.). Retrieved from http://site.ebrary.com/lib/yale/Doc?id=10375104
Brechtl, J. R., Murshed, S., Homel, P., & Bookbinder, M. (2006). Monitoring symptoms in patients with advanced illness in long-term care: A pilot study. Journal of Pain and Symptom Management, 32(2), 168–74.
Bingel, U., Lorenz, J., Schoell, E., Weiller, C., & Buchel, C. (2006). Mechanisms of placebo analgesia: rACC recruitment of a subcortical antinociceptive network. Pain, 120(1–2), 8–15. https://doi.org/10.1016/j.pain.2005.08.027.
Casarett, D. J. (2003). Assessing decision-making capacity in the setting of palliative care research. Journal of Pain and Symptom Management, 25(4), S6–S13.
Casarett, D. (2005). Ethical considerations in end-of-life care and research. Journal of Palliative Medicine, 8(Suppl 1), S148–S160. https://doi.org/10.1089/jpm.2005.8.s-148.
Covarrubias-Gomez, A., Hernandez-Martinez, E. E., Ruiz-Ramirez, S., & Lopez Collada-Estrada, M. (2014). Assessment of pain and other symptoms in Mexican patients with advanced illness. Journal of Pain & Palliative Care Pharmacotherapy, 28(4), 394–398. https://doi.org/10.3109/15360288.2014.959235.
Eippert, F., Bingel, U., Schoell, E. D., Yacubian, J., Klinger, R., Lorenz, J., & Buchel, C. (2009). Activation of the opioidergic descending pain control system underlies placebo analgesia. Neuron, 63(4), 533–543. https://doi.org/10.1016/j.neuron.2009.07.014.
Emanuel, E. J., & Miller, F. G. (2001). The ethics of placebo-controlled trials–a middle ground. The New England Journal of Medicine, 345(12), 915–919. https://doi.org/10.1056/NEJM200109203451211.
Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? JAMA, 283(20), 2701–2711.
Enserink, M. (2000). Bioethics. Helsinki's new clinical rules: Fewer placebos, more disclosure. Science, 290(5491), 418–419.
Field, M. J., Cassel, C. K., & Institute of Medicine (U.S.). Committee on Care at the End of Life. (1997). Approaching death: Improving care at the end of life. Washington, DC: National Academy Press.
Fine, P. G. (2003). Maximizing benefits and minimizing risks in palliative care research that involves patients near the end of life. Journal of Pain and Symptom Management, 25(4), S53–S62.
Fine, P. G., & Peterson, D. (2002). Caring about what dying patients care about caring. Journal of Pain and Symptom Management, 23(4), 267–268.
Fine, P. G., Roberts, W. J., Gillette, R. G., & Child, T. R. (1994). Slowly developing placebo responses confound tests of intravenous phentolamine to determine mechanisms underlying idiopathic chronic low back pain. Pain, 56(2), 235–242.
Foley, K., & Gelband, H. (2001). Improving Palliative Care for Cancer, National Cancer Policy Board, National Research Council. National Academy of Sciences, 10.
Gamondi, C., Galli, N., Schonholzer, C., Marone, C., Zwahlen, H., Gabutti, L., et al. (2013). Frequency and severity of pain and symptom distress among patients with chronic kidney disease receiving dialysis. Swiss Medical Weekly, 143, w13750. https://doi.org/10.4414/smw.2013.13750.
Grant, M., Elk, R., Ferrell, B., Morrison, R. S., & von Gunten, C. F. (2009). Current status of palliative care–clinical implementation, education, and research. CA: a Cancer Journal for Clinicians, 59(5), 327–335. https://doi.org/10.3322/caac.20032.
Hickman, S. E., Cartwright, J. C., Nelson, C. A., & Knafl, K. (2012). Compassion and vigilance: investigators’ strategies to manage ethical concerns in palliative and end-of-life research. Journal of Palliative Medicine, 15(8), 880–889. https://doi.org/10.1089/jpm.2011.0515.
Johnson, K. S. (2013). Racial and ethnic disparities in palliative care. Journal of Palliative Medicine, 16(11), 1329–1334. https://doi.org/10.1089/jpm.2013.9468.
Karlawish, J. H. (2003). Conducting research that involves subjects at the end of life who are unable to give consent. Journal of Pain and Symptom Management, 25(4), S14–S24.
Kars, M. C., van Thiel, G. J., van der Graaf, R., Moors, M., de Graeff, A., & van Delden, J. J. (2016). A systematic review of reasons for gatekeeping in palliative care research. Palliative Medicine, 30(6), 533–548. https://doi.org/10.1177/0269216315616759.
Kirchhoff, K. T., & Kehl, K. A. (2007). Recruiting participants in end-of-life research. The American Journal of Hospice & Palliative Care, 24(6), 515–521. https://doi.org/10.1177/1049909107300551.
Kolva, E., Rosenfeld, B., Brescia, R., & Comfort, C. (2014). Assessing decision-making capacity at end of life. General Hospital Psychiatry, 36(4), 392–397. https://doi.org/10.1016/j.genhosppsych.2014.02.013.
Mackin, M. L., Herr, K., Bergen-Jackson, K., Fine, P., Forcucci, C., & Sanders, S. (2009). Research participation by older adults at end of life: barriers and solutions. Research in Gerontological Nursing, 2(3), 162–171. https://doi.org/10.3928/19404921-20090421-05.
Nelson, R. M., & Merz, J. F. (2002). Voluntariness of consent for research: An empirical and conceptual review. Medical Care, 40(9 Suppl), V69–V80. https:// doi.org/10.1097/01.MLR.0000023958.28108.9C.
Nuremberg Military, T. (1996). The nuremberg code. JAMA, 276(20), 1691.
Pantilat, S. Z., O'Riordan, D. L., Rathfon, M. A., Dracup, K. A., & De Marco, T. (2016). Etiology of pain and its association with quality of life among patients with heart failure. Journal of Palliative Medicine. https://doi.org/10.1089/jpm.2016.0095.
Petrovic, P., Kalso, E., Petersson, K. M., Andersson, J., Fransson, P., & Ingvar, M. (2010). A prefrontal non-opioid mechanism in placebo analgesia. Pain, 150(1), 59–65. https://doi.org/10.1016/j.pain.2010.03.011.
Pollo, A., & Benedetti, F. (2013). Pain and the placebo/nocebo effect. In R. J. Moore (Ed.), Handbook of pain and palliative care. New York: Springer.
Protection of Human Subjects. (2009). Retrieved from http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/
Romem, A., Tom, S. E., Beauchene, M., Babington, L., Scharf, S. M., & Romem, A. (2015). Pain management at the end of life: A comparative study of cancer, dementia, and chronic obstructive pulmonary disease patients. Palliative Medicine, 29(5), 464–469. https://doi.org/10.1177/0269216315570411.
Seow, H., Barbera, L., Sutradhar, R., Howell, D., Dudgeon, D., Atzema, C., et al. (2013). Trajectory of performance status and symptom scores for patients with cancer during the last six months of life. Journal of Clinical Oncology, 29(9), 1151–1158. https://doi.org/10.1200/JCO.2010.30.7173.
Stone, P. C., Gwilliam, B., Keeley, V., Todd, C., Kelly, L. C., & Barclay, S. (2013). Factors affecting recruitment to an observational multicentre palliative care study. BMJ Supportive & Palliative Care, 3(3), 318–323. https://doi.org/10.1136/bmjspcare-2012-000396.
Temple, R., & Ellenberg, S. S. (2000). Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. Annals of Internal Medicine, 133(6), 455–463.
Todd, A. M., Laird, B. J., Boyle, D., Boyd, A. C., Colvin, L. A., & Fallon, M. T. (2009). A systematic review examining the literature on attitudes of patients with advanced cancer toward research. Journal of Pain and Symptom Management, 37(6), 1078–1085. https://doi.org/10.1016/j.jpainsymman.2008.07.009.
Vase, L., Riley, J. L., 3rd, & Price, D. D. (2002). A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain, 99(3), 443–452.
Wendler, D., & Miller, F. G. (2007). Assessing research risks systematically: The net risks test. Journal of Medical Ethics, 33(8), 481–486. https://doi.org/10.1136/jme.2005.014043.
White, C., & Hardy, J. (2010). What do palliative care patients and their relatives think about research in palliative care? – A systematic review. Support Care Cancer, 18(8), 905–911. https://doi.org/10.1007/s00520-009-0724-1.
White, C., Gilshenan, K., & Hardy, J. (2008). A survey of the views of palliative care healthcare professionals towards referring cancer patients to participate in randomized controlled trials in palliative care. Support Care Cancer, 16(12), 1397–1405. https://doi.org/10.1007/s00520-008-0441-1.
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Gebauer, S., Fine, P. (2018). Recognition and Resolution of Ethical Barriers to Palliative Care Research. In: Moore, R. (eds) Handbook of Pain and Palliative Care. Springer, Cham. https://doi.org/10.1007/978-3-319-95369-4_43
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