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WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 7.2 Explain what is meant by “therapeutic misconception” and how it could affect the duties of health care workers in emergencies Outline 1. Introduction to therapeutic misconceptions – why is it an ethical problem? 2. Discussion of risks and strategies to reduce them 3. Case study and discussion – HIV/AIDS 4. Role-play – Brazilian dengue fever 5. Summary and wrap up discussion Suggested time ( 75 minutes) Activity L.O. 7.2 0-10 (10 min) 11-25 (15 min) 26-45 (20 min) 46-65 (20 min) 66-75 (10 min) Introduction Discussion Case study and discussion Role-play Summary and conclusion Therapeutic misconception (TM) “The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures.” (Lidz & Appelbaum 2002: V55) L.O. 7.2 Why might TMs arise in public health emergency? Increased vulnerability People potentially less able to fully discern differences between research and emergency care in public health crisis Increased authority of healthcare professionals in emergencies – increased likelihood of potential research participants having unchecked TMs Authority, reputation or resources of international/private research teams may increase TM L.O. 7.2 Recommendations Potential participants should not be excluded from participating because they have a TM However, researchers have responsibilities to dispel unrealistic hopes of TM Researchers have duty to ensure decision to participate is well-informed and as voluntary as possible Must differentiate medical attention received as study participant from normal medical attention L.O. 7.2 Strategies to reduce risk of therapeutic misconceptions Augmented informational process using a neutral discloser – a ‘neutral’ individual (not involved in study) explains methodology to patients Community consultation – allows explanation of study goals, procedures, potential risks and benefits while considering educational, cultural and linguistic differences Pre-study community information sessions – increase community understanding, reduce misconceptions, encourage informed and voluntary decision-making, and build trust L.O. 7.2 Discussion on strategies to reduce risk Consider the three strategies discussed for improving individuals’ understanding of the differences between clinical research and medical care. Are these realistic in every setting? How might language barriers, trauma, and scarce resources impact the effectiveness of each of these strategies? Would one or more of the three strategies be helpful in settings where you have worked or lived? Why? L.O. 7.2 Case study – HIV/AIDS trial Justin is a 29-year-old bartender who lives in downtown Los Angeles. Despite holding a steady job, Justin is a long-time, chronic IV drug user. Although he has always done his best to use clean needles, nearly three years ago Justin acquired the HIV virus from an unsterile heroin injection. His symptoms have been managed to date by highly active antiretroviral therapy (HAART), however he has recently developed several red-purple nodules on his legs and back. During his most recent appointment with his physician, Justin learns that these were evidence of Kaposi’s sarcoma, indicating that his HIV has developed resistance to his ARV medications. Unfortunately, Justin has now exhausted the last line of possible ARV treatment. Desperate for further treatment options, Justin urges his physician to find another solution to help manage his disease. Justin’s physician proposes the possibility of enrolling in the hospital’s Phase III clinical trial for a new ARV cocktail, of which the physician is a primary investigator. L.O. 7.2 Case study background – HIV/AIDS Acquired immunodeficiency syndrome (AIDS) develops from HIV HIV virus is spread easily through fluid exchange, Previously more predominant certain groups e.g. intravenous drug users, homosexual males, now wider spread e.g. women and children, particularly in low- and middle-income countries HIV/AIDS patients are immunocompromised so often present with opportunistic infections Example is Kaposi’s sarcoma (cancer that develops when an immunodeficient person is infected by a specific strain of herpes virus L.O. 7.2 Case study discussion In what ways does this case create the possibility for therapeutic misconception? What strategies could the physician have employed to decrease the possibility of therapeutic misconception—if it is even avoidable? If Justin seems incapable of differentiating between his participation in research and his treatment, would the doctor’s most ethical course of action be to deny his patient access to the study? Why or why not? Are there circumstances in which the therapeutic misconception is ethically tolerable? L.O. 7.2 Role play Unusual torrential rains have been battering Eastern Brazil for over three weeks. This includes many areas of high urban concentration where dengue has been hyperendemic (continuously circulating) for the past five years. Now, in the face of exploding reported dengue fever hospitalizations, the Brazilian government declares a dengue epidemic and state of emergency. It is announced that in the state of Rio de Janeiro alone, there are 90 000 cases of dengue fever and 112 confirmed deaths, with 50% of deaths in children between the ages of 5 and 9. The epidemic is expected to spread out from the urban centres to rural areas in the next weeks. L.O. 7.2 Case study A Japanese company has been working in collaboration with a Brazilian University on a dengue vaccine for several years. The University has completed Phase I and Phase II testing when the Brazilian epidemic hits. This early testing has shown the vaccine to be 90% effective with minimal non-serious side-effects in 5% of recipients (itching, redness, soreness at the site of injection, mild nausea, headache, sleepiness). It receives approval from both the federal research ethics committee and the municipal government to test the vaccine in a town of 150,000 where the epidemic is expected to hit within the month. It is decided the vaccine will be administered to school age children accompanied by a parent capable in a doubleblind trial: those who do not receive the experimental vaccine will receive a placebo shot. The research team will fund additional health care resources (10 nurses, 5 doctors, 12 extra beds) for the community for the next year as contamination rates are monitored. L.O. 7.2 Role-play – Dengue fever Role Play – Nurse administering vaccines for dengue fever trial faces a very worried parent (Mr. or Mrs. Briceño) L.O. 7.2 Post role-play discussion Would you deem this parent capable of making a decision regarding their children’s participation in this study? Are there any additional strategies the research nurse could have employed in response to this parent’s therapeutic misconception? Do you have any ethical concerns about refusing to include this parent’s children in the study based on uncertainty about the parent’s decision-making capacity? What are the risks in administering the study injection to these children if their parent fails to understand this is a trial? L.O. 7.2 Summary Therapeutic misconception occurs when participant fails to understand difference between research and clinical care Hinders voluntary and informed consent Limits autonomy and agency in decision making Participants more vulnerable in public health emergencies Researchers must exert extra caution in these settings Ethical duty to ensure participants understand known and unknown therapeutic limits and non-therapeutic goals of study procedures L.O. 7.2 Sources PS Appelbaum, LH Roth, and C Lidz, “The Therapeutic Misconception: Informed Consent in Psychiatric Research,” International Journal of Law and Psychiatry 5 (1982):319-29. PS Appelbaum, LH Roth LH, CW Lidz, P Benson, W Winslade. False hopes and best data: consent to research and the therapeutic misconception. Hastings Centre Report 17, no. 2 (1987):20–24. H Henderson. “Kaposi sarcoma is the most common cancer diagnosed in HIV-infected persons.” HIV Clinician, 21(4), (2009):1-2. CW Lidz, PS Appelbaum. “The Therapeutic Misconception: Problems and Solutions.” Medical Care. Vol. 40, no. 9, Supplement (2002):v-55-V63. Médecins Sans Frontieres. “Ethics Framework for Medical Research.” http://fieldresearch.msf.org/msf/bitstream/10144/12364/2/ethics-framework-msf.pdf accessed February 28, 2013. FG Miller, D Wendler. “The Relevance of Empirical Research in Bioethics.” Schizophrenia Bulletin vol. 32, no. 1 (2006): 37-41. FG Miller. “Consent to Clinical Research.” In The Ethics of Consent: Theory and Practice. FG Miller, A Wertheimer (Eds). New York: Oxford University Press, 2009: T Saito, A Kunimitsu. Public health response to the combined Great East Japan Earthquake, tsunami and nuclear power plant accident: perspective from the Ministry of Health, Labour and Welfare of JapanWestern Pacific Surveillance and Response Journal, 2(4) (2011):7-9. doi:10.5365/wpsar.2011.2.4.008 accessed June 7, 2014 WHO. “Dengue and Severe dengue.” (2012) Fact sheet No. 117. http://www.who.int/mediacentre/factsheets/fs117/en/ (accessed March 1, 2013). Zhu, T., Korber, B. T., Nahmias, A. J., Hooper, E., Sharp, P. M., & Ho, D. D. An African HIV-1 sequence from 1959 and implications for the origin of the epidemic. Nature, 391, (1998): 594-597. L.O. 7.2 Acknowledgements Chapter authors Nouvet, Elysée, Humanitarian Health Care Ethics, McMaster University, Hamilton, Ontario, Canada Baxter, Michael, McMaster University, Hamilton, Ontario, Canada Schwartz, Lisa, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada L.O. 7.2