1. World Health Organization
19 July, 2018
WHO Training Manual
Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care
Learning Objective 3.2
Assess the factors to be considered in determining when public health surveillance requires explicit informed consent from individuals or communities
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2. Outline Informed Consent Surveillance
Informed Consent & Surveillance: Current Practices & Ethical Issues
Community Consultation
Case Study
Summary/Conclusion
Suggested time (Total 60 min)
0-15
(15 min)
16-20
(5 min)
21-35
36-55
(20 min)
56-60
Activity
Introduction
Reading
Team preparation
Team presentations and discussion
Summary and conclusion
Please add the timeline provided in the L.O.
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3. Informed Consent
A competent individual’s agreement to accept a particular intervention after being adequately informed of the risks, benefits, and alternatives
Both a legal and ethical obligation
Does not necessarily have to be in writing
Justifications
Individual autonomy
Engages individuals in the process, thereby promoting better outcomes
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4. When Is Informed Consent Required?
Clinical care
For minor interventions, consent can be implied or presumed
For more significant interventions, a specific consent process is necessary
Medical research
Most research interventions require formal written consent
In some cases, consent can be oral
Consent can be waived if the risks are minimal and the research otherwise could not be conducted, or in other limited circumstances
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5. Surveillance
The ongoing, systematic collection, analysis, and interpretation of health-related data essential to the planning, implementation, and evaluation of public health practice.
In many international guidelines, the distinction between surveillance and research rests on the intent of the activity:
Surveillance: intent to provide immediate benefit to the population from which data are collected
Research: intent to develop generalizable knowledge (applicable to other situations)
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6. Informed Consent and Surveillance: Current Practices
Typically, informed consent is not obtained in surveillance activities.
Common rationales:
Surveillance is conducted by government officials pursuant to legal obligations
Individuals often do not have the right to refuse, so there is no reason to ask permission
Risks are often seen as minimal
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7. Informed Consent and Surveillance: Ethical Issues
But sometimes, informed consent may be appropriate:
Surveillance can be risky
Disclosure of individually-identifiable data
Stigmatization of communities
The line between surveillance and research is blurry
Even if surveillance is legally required, individuals should have the right to petition for an exception
Seeking I/C shows respect
Seeking I/C can promote individual and community trust and engagement
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8. Community Consultation
Even if individual I/C is not appropriate/feasible, consultation with community leaders may be advisable.
Sometimes, risks to the community can be more significant than risks to specific individuals
Local cultural values may require consultation with community leaders
Consultation can promote participation and engagement
Issue: who to consult with; what if they say no?
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9. Case Study MDR-TB
The Republic of Coconut Paradise is a low-income island nation that has historically had high rates of tuberculosis (TB). In the past couple of years, rates of multi-drug resistant TB (MDR-TB) have been increasing dramatically in Coconut Paradise. MDR-TB is highly contagious and often fatal, and individuals who are thought to be infected are often shunned from their communities. Household members of persons with MDR-TB also face stigmatization. While some treatments exist for MDR-TB, they are not accessible to most people on the island. Most patients who are infected eventually die of the condition…
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10. Case Study MDR-TB
…Public health officials, concerned about the spread of MDR-TB, have proposed to conduct tests on patients at the national TB centre, to determine how many are infected with a drug-resistant strain. They believe that, by gathering data on the actual rate of MDR-TB in the country, they will be in a better position to negotiate with international donors for assistance in obtaining MDR-TB treatment and improving local treatment facilities. The officials propose to conduct the survey by approaching a randomly selected sample of TB patients (one out of every ten patients who appears at the main site of the national clinic over a period of two months). Clinic staff will be instructed to take blood samples from these patients and to send them to the national reference laboratory, which will conduct testing to determine whether the patient is resistant to standard TB drugs. The samples will be identified only by the date they were collected; no patient names will be recorded. Results of the survey will be reported in aggregate form.
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11. Case Study Questions
Is the activity described surveillance, research, or both?
What are the risks to the patients whose blood is taken for the survey?
Should patients be asked to provide informed consent to the survey? If so, what information should be disclosed as part of the consent process?
Should patients have the right to refuse to participate in the survey?
Should a process of community consultation be instituted before the survey is initiated? If so, why? Who should be consulted, what should they be asked, and how should the information obtained be used?
Hint: The Training Manual includes hints
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12. Summary
Informed consent allows individuals to make an explicit choice about an intervention after being fully informed of the risks, benefits, and alternatives
Often not obtained in public health practices, including surveillance
But providing information and seeking agreement can play an important role in public health
The informed consent process can protect individuals from risk while demonstrating respect, promoting trust, and generating the support of individuals and communities
Where individual consent is not appropriate or feasible, community consultation should be considered
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13. Sources
CIOMS Council of International Organizations of Medical Sciences (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS.
CIOMS Council of International Organizations of Medical Sciences. Commentary on Guideline 4 International ethical guidelines for epidemiological studies. First Edition. World Health Organization. Geneva: CIOMS, 2009:
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp The Nuremberg Code (1949).
U.S. Department of Health and Human Services (2009) Basic HHS Policy for the Protection of Human Research Subjects.
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14. Chapter author Acknowledgements
Coleman, Carl H., Seton Hall University School of Law, Newark, New Jersey, United States of America
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