Ethical Considerations for Public Health Surveillance: Formal Review Criteria

WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 2.2. Identify circumstances in which public health surveillance activities should possibly undergo formal ethics review

Outline 1. Introduction 2. Case Study Discussion Protein calorie malnutrition 3. Debate surveillance and ethics review 4. Summary 0-25 (25 min) 26-30 (5 min) 31-45 (15 min) 46-65 (20 min) 65-75 (10 min) Suggested time Reading Introduction Case study and discussion Debate Summary and wrap-up discussion Activity L.O. 2.2

Introduction How and by what criteria to distinguish public health practice, including surveillance, from research remains among the most interesting, important, and difficult one in bioethics Research requires formal ethics review, surveillance generally does not In research there is usually an intervention exposing participants to quantifiable risk. In surveillance there is information/data collection, often with people not knowing their information is being studied This being the case, what criteria should be in place to identify circumstances under which surveillance activities should undergo a formal process of ethics review? L.O. 2.2

Ethical foundations for formal review of surveillance Risks and benefits shared between individuals and society Autonomy versus common good Information collection Information my be be personal and delicate Large databases store and analyze information Surveillance data must used appropriately by appropriate users this may require a formal process of ethics review L.O. 2.2

Ethical foundations for formal review of surveillance Public trust in surveillance essential to its success When residents or citizens of a region or jurisdiction understand and appreciate the benefits gained from public health services, there is a foundation for trust in those who provide the services Trust can be damaged or diminished (e.g. HIV crisis in 1980s and 90s - some jurisdictions used sero-conversion data to isolate people with HIV - discriminatory use of data undermined the trust in surveillance institutions) Formal ethics review of surveillance may encourage trust by reassuring populations of transparent and inclusive data collection L.O. 2.2

Reasons for formal ethics review in surveillance Valid consent not always essential or possible, but may be useful in demonstrating respect in specific kinds of surveillance Privacy and confidentiality avoid inappropriate use or disclosure, or prejudices in subpopulations Vulnerable populations ensure rights of these populations are respected if such populations are targeted in surveillance L.O. 2.2

Caveats Must balance ethics reviews against benefits from proposed surveillance activities Formal review overused risk discouraging surveillance L.O. 2.2

Group exercise In 2 groups: Why should surveillance sometimes be reviewed by research ethics committees? L.O. 2.2

Case Study Protein calorie malnutrition (PCM) increases patient morbidity and mortality, slows wound healing, and impairs immune response. These effects can increase incidence and duration of hospitalization, readmission, and disease-related complications. The most frequently used laboratory test to detect PCM has been serum albumin levels. The usefulness of serum albumin is limited, however, by its long half-life (changes cannot be detected quickly) and the effects of inflammation and chronic disease (e.g., kidney, liver disease) on albumin levels. Other, more sensitive lab tests include serum prealbumin (PAB), retinolbinding protein (RBP), and C-reactive protein (CRP). Use of these tests allows quicker assessment of the patient s condition. Scientists proposed a project to determine the value added to hospital screening protocols and to patient monitoring by testing for these proteins. All non-maternity, non-palliative, non-parenteral nutrition inpatients at a certain nutrition risk would be eligible and asked to accept the intervention. Patients declining would be offered an opportunity to explain their decision. Responses would be recorded anonymously and used to devise strategies to increase patient participation in future similar activities. L.O. 2.2

Case Study Enrolled patients would receive nutrition care according to the current standard of care at the hospital. If enrolled patients then required parenteral nutrition (PN) or transitioned to palliative care, they would receive enhanced care but would not be withdrawn from the project. All patients would have an initial testing for protein levels using each of the four available tests (i.e., albumin, PAB, RBP and CRP), bedside nutrition assessment, and a treatment plan. They would be scheduled for follow-up testing three times a week during their admission. The patients would be divided into two groups. The control group would receive standard care with additional laboratory testing for the proposed markers, but these results would not be shared with the patients or their caregivers. In the interventional group, the results for prealbumin, RBP, and CRP testing would be shared with the patients and their caregivers. Clinical outcomes (including length of stay in the hospital, days spent on the ventilator, infection rate) would be compared between the two groups to determine if knowing the lab results affects clinical outcomes. Data collection would include patients protein results, cost and demographic information, risk factors, and functionality. (quoted and adapted from Hodge and Gostin 2004) L.O. 2.2

Case Study Discussion 1. Why not conduct such a study without formal review? Consider your answer in terms of both informed consent and confidentiality. 2. The U.S. Centers for Disease Control and Prevention (CDC) determined that the activity constituted research (see hint) and, for that reason, required review. Did the CDC make the right decision for the right reason? L.O. 2.2

Case Study Discussion 3. The intent of the project was not research but an assessment of the value of such testing to hospital screening protocols. Are there epidemiologic or public health practice alternatives that could have achieved the goal without being prone to the CDC s rationale for classifying the activity as research? 4. If so, would formal ethics review still be a useful addition to the process? Why? What questions would you have as an REC member? L.O. 2.2

Debate Split into 3 groups Each group should address one of these 3 questions: 1. Which kinds of surveillance should receive formal ethics review? 2. Which kinds of surveillance should not receive such review? 3. Why not require RECs to review all surveillance studies in addition to research studies? L.O. 2.2

Summary Traditionally, only research has had formal ethics review Increasing discussion of whether public health surveillance activities should also be subject to this Reasons to forgo such review include that: risk of surveillance is minimal process adds to duties of ethics reviews committees (whom may be heavily burdened) requiring review might discourage certain kinds of surveillance important to public health Reasons for formal ethics reviews include that: participants might be exposed to social risks review can build trust between public health organizations and communities ethics reviews can provide those conducting surveillance with useful guidance Risk-based approaches are an alternative L.O. 2.2

Sources Hodge JG, Gostin LO. Public Health Practice vs. Research: A Report for Public Practitioners Including Cases and Guidance for Making Distinctions. Report for the Council of State and Territorial Epidemiologists, May 24, 2004. Available at http://www.cste2.org/webpdfs/CSTEPHResRptHo dgeFinal.5.24.04.pdf. Health L.O. 2.2

Acknowledgements Chapter author Goodman, Kenneth, University of Miami Bioethics Program, University of Miami, Miami, Florida, United States of America L.O. 2.2