Understanding Informed Consent and Surveillance in Public Health

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

Outline 1. Informed Consent 2. Surveillance 3. Informed Consent & Surveillance: Current Practices & Ethical Issues 4. Community Consultation 5. Case Study 6. Summary/Conclusion 0-15 (15 min) 16-20 (5 min) 21-35 (15 min) 36-55 (20 min) 56-60 (5 min) Suggested time (Total 60 min) Activity Summary and conclusion Introduction Reading Team preparation Team presentations and discussion L.O. 3.2

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 L.O. 3.2

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 L.O. 3.2

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) L.O. 3.2

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 L.O. 3.2

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 L.O. 3.2

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? L.O. 3.2

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 L.O. 3.2

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. L.O. 3.2

Case Study Questions 1. Is the activity described surveillance, research, or both? 2. What are the risks to the patients whose blood is taken for the survey? 3. Should patients be asked to provide informed consent to the survey? If so, what information should be disclosed as part of the consent process? 4. Should patients have the right to refuse to participate in the survey? 5. 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? L.O. 3.2

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 L.O. 3.2

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: 42-44. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. The Nuremberg Code (1949). U.S. Department of Health and Human Services (2009) Basic HHS Policy for the Protection of Human Research Subjects. L.O. 3.2

Acknowledgements Chapter author Coleman, Carl H., Seton Hall University School of Law, Newark, New Jersey, United States of America L.O. 3.2