Ethical Considerations in Public Health

Overview

• Ethical principles in public health• Research vs. non-research activities• Public health

Factors affecting public health ethics

Ethical Values

KEY ISSUES IN PUBLIC HEALTH ETHICS

Disparities in health status, access to • health care and to the benefits of medical research • – For example, questions about

resource allocation depend in part on value judgments about the relative importance of small improvements in quality of life for a large portion of the population as compared with a life-saving intervention that would benefit only a few people.

Responding to the threat of infectious diseases

• – Efforts to contain the spread of infectious diseases raise difficult questions about the appropriateness of restricting individual choices to safeguard other people’s welfare. Examples include the use of isolation and quarantine for tuberculosis and pandemic influenza.

International cooperation in health monitoring and surveillance

• – The implementation of the International Health Regulations4 reflects the commitment of countries to collective action in the face of public-health emergencies.

• Defining the scope of countries’ obligations to act collectively, and determining how those obligations should be enforced, will inevitably raise difficult ethical dilemmas.

Exploitation of individuals

• – Current practices in medical research, for example, may expose participants to significant risks without a benefit for themselves or their communities.

• In the area of organ transplantation, the growing practice of “transplant tourism” exposes individuals living in poverty to significant health risks.

Health Promotion

• The growing public-health threats of noncommunicable diseases, including those caused in part by unhealthy behaviours such as smoking, poor diet or lack of exercise, have raised the question of the extent to which public-health authorities should interfere with personal choices on health.

Participation, transparency, and accountability

• – As an ethical matter, the process by which decisions are made is as important as the outcome of the decisions.

• Strengthening systems for informed consent and community oversight.

• To develop mechanisms for evaluating their effectiveness.

RESEARCH VS. SURVEILLANCE AND OTHER PUBLIC HEALTH PRACTICES

From presentation by Alex John London Ph.D.Associate Professor of Philosophy & Director

Ethical Forrest, Regulatory Trees• Ethical, regulatory, and legal categories– Research, Public Health Practice, Emergency Response• May give clues to relevant ethical issues.– But activities in different categories can raise similar issues.– Activities in the same category can be very dissimilar.• Primary value: specifying which ethical,

regulatory or legal processes will be used to address ethical issues that do arise.

Research Activities• Some Common Ethical Tensions: – Interests of present participants • Privacy, autonomy • Avoidance of harm, receiving optimal diagnosis, treatment, prevention

– Demands of sound science to generate generalizable knowledge.

• Collection of potentially sensitive data • Limitations on autonomy (blinding, randomization) • Study-related procedures (extra tests, opportunity costs, controls…)

– Interests of community: • Reducing uncertainty. • Improving the standard of care for future recipients. • Respecting the rights and welfare of all community members.

• Oversight mechanisms:– IRB/REBs

(Routine) Public Health Practice• Some Common Ethical Tensions: – Community interests • Eliminating uncertainty about disease prevalence,

severity… • Preventing, mitigating, halting spread of contagion • Robust and resilient health infrastructure to cope with diverse determinants of health and threats to health. – Interests of individuals • Avoidance of harm, burden or risk (Free rider

incentives) • Privacy • Individual liberty, autonomy

• Oversight mechanisms:– Public health authorities, law, courts

What is an epidemiological surveillance system?• The systematic collection, analysis,

interpretation, and dissemination of health data on an ongoing basis, to gain knowledge of the pattern of disease occurrence and potential in a community, in order to control and prevent disease in the community.

• Epidemiological surveillance is a process of watchfulness over health events which may occur in a population.

• A set of interconnected elements and activities that are usually established as an integral part of a health care system in order to monitor priority health events.

Ghaiath Surveillance (JPFCM, Jan. 2010)

Surveillance: General principle

Health Care System Public Health Authority

Data Information

DecisionAction

Feedback

Reporting

EvaluationAnalysis & Interpretation

Ghaiath Surveillance (JPFCM, Jan. 2010)

Research vs. non-research activities

Research Non-research (surveillance)

Goal Producing generalizable knowledge Monitoring & evaluation

Population Limited, selected by investigator Public, large groups

Time Limited by the time of study Usually ongoing

Objective Test hypothesis No hypothesis tested

Owners Researchers, funders Public health authorities

Methods Novel, not always validated Validated

Outcomes Knowledge, product PH intervention

Review IRB/REB/REC review Usually none

Ethical issues Consent, privacy and confidentiality, access to benefit,

Privacy and confidentiality, human rights, infringement to liberty

Surveillance as Research

• Collection of additional information to what is necessary for public health responsibilities in the population from which data is collected.• Goal is to clarify general features of a pathogen or problem.• Research methods are employed to permit generalization of data to other populations.

RESEARCHING THE QUARANTINEDAND ISOLATED

From Jerome Singh

Researching contagious diseases in the confined• Isolation – the separation and confinement of those

who are infected from the uninfected.• Quarantine • the separation and confinement of those

who have been exposed to infected people but who are not confirmed to have been infected, from the uninfected.

Challenges

• Legal• International law• Local laws• Human rights

o International human rightso Local human rights

Ethical Challenges

Cultural and Social Challenges

• Group identity:• This is one reason why observational

research or questionnaires can also involve risks.

• Risks run by communities are not simply aggregates of individual risks.

• Examples: stigmatisation, disruption of group structures, hijacking group resources, or health care providers…

• This was realized rather later than the other risks

PRACTICAL IMPLICATIONS

Community Consent

– To know community priorities– To inform individuals better– To respect the structures that are in place and obtain permission to ask individual potential subjects for consent– To determine ways to collaborate with local health care providersDiallo D., Doumbo O., Plowe C., Wellems Th., Emanuel E, Hurst S.: Community Permission for Research in Developing Countries. Clinical Infectious Diseases. 2005, 41(2), pp 255-9

Practical considerations

Practical considerations

• Research ethics review should be conducted by independent and accountable boards

• Inter-jurisdictional issues should be anticipated given the likely international nature of research endeavours

• Special attention should be given to ensure appropriate evaluation of the risks and potential benefits of any proposed research (including any possible increase in vulnerability of prospective research participants)

Practical considerations

• Duplication• Overburdening/ Over-investigating

population• Need for Registry?• How to manage existing research

protocols/reviews• Risks to research workers

DISCUSSION