Download Research and Patient Care in Public Health Emergency

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