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Chapter Five

Ethical and Human Rights Concerns in Global Health

Learning Objectives

Review key ethical and human rights concerns as they relate to global health

Discuss some of the central treaties and conventions related to human rights

Use the most important ethical guidelines for research with human subjects

Learning Objectives

Discuss some historically significant cases in research with human subjects

Identify key ethical principles for priority setting in health

The Importance of Ethical and Human Rights Issues in Global Health

International conventions and treaties recognize access to health services and health information as human rights

Failure to respect human rights is often associated with harm to human health

Health research with human subjects puts people at risk for the sake of other people’s health

Health investments must be made fairly, because resources are limited

The Foundations for Health and Human Rights

Universal Declaration of Human Rights and other legally binding multilateral treaties

Governments are obliged to respect, protect, and fulfill the rights they state

Resource-poor countries are required to “take steps” toward realization of positive rights

Selected Human Rights Issues

The Rights-Based Approach

Assess health policies, programs, and practices in terms of impact on human rights

Analyze and address the health impacts resulting from violations of human rights when considering ways to improve population health

Prioritize the fulfillment of human rights

Selected Human Rights Issues

Limits to Human Rights

Circumstances in which someone’s rights may be suspended; for example, outbreak of an emerging or a reemerging disease

Suspension of rights should be as narrow as possible

Suspension should be carried out with due process and monitored

Selected Human Rights Issues

Human Rights and HIV/AIDS

Health condition that is stigmatized and discriminated against

Associated issues:

Protecting the rights of people who are HIV-positive to employment, schooling, and participation in social activities

Ensuring access to care

Policies regarding testing

Protection of confidentiality

Research on Human Subjects

Research is essential for improving global health

However, most research studies do not benefit the people who participate in them

Ethical concerns about putting participants at risk for the sake of other people’s health

Key Human Research Cases

Nazi Medical Experiments

Experiments on euthanasia victims, prisoners of war, occupants of concentration camps

International Scientific Commission investigated and documented abuses after war

Questions over whether it is ethical to use data the Nazis generated

Key Human Research Cases

The Tuskegee Study

U.S. Public Health Service conducted a study on the natural history of syphilis in African American men

Study went on for 40 years

Subjects were never given treatment

Eventually led to regulations for the protection of human research subjects

Key Human Research Cases

The “Short-Course” AZT Trials

Trials of a “short-course” AZT regimen to prevent mother-to-child transmission of HIV

Opponents noted trials not permitted in high-income countries, where a more complex “076 regimen” was the standard of care

Debated ethical double standard

Studies remain controversial

Research Ethics Guidelines

The Nuremberg Code

First document to specify ethical principles that should guide physicians engaged in human research

“Voluntary consent of the human subject is absolutely essential”

Human subjects should only be involved in research if it is necessary for an important social good

Requires limits on and safeguards against risks to participants

Research Ethics Guidelines

The Declaration of Helsinki

World Medical Association

Developed ethical principles to guide physicians/non-physicians conducting biomedical research on humans

Most influential and most cited set of international research ethics guidelines

Research Ethics Guidelines

The Belmont Report

U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Identified basic ethical principles

Developed research guidelines

Evaluating the Ethics of Human Subjects Research

Clinical research protocol must satisfy at least six conditions:

Social value

Scientific validity

Fair subject selection

Acceptable risk/benefit ratio

Informed consent

Respect for enrolled subjects

Evaluating the Ethics of Human Subjects Research

Research in Low- and Middle-Income Countries

Important issues when the subjects are likely to be poor, under-educated, and without access to good care:

Standard of care

Post-trial benefits

Ancillary care

Evaluating the Ethics of Human Subjects Research

Human Subjects Research Oversight Today

In most countries, it is a legal requirement to undergo independent ethical review by a research ethics committee if human subjects are involved

Safeguard against exploitation

Regulations vary from country to country

Evaluating the Ethics of Human Subjects Research

The Andean countries are characterized by substantial disparities between the highlands and lowlands and between indigenous people and people of European decent

Courtesy of Mark Tuschman.

Ethical Issues in Making Investment Choices in Health

Resources will always be fewer than needed to meet all needs, so choices must be made

Better that the choices be made according to explicit, publicly justified criteria

Cost-effectiveness analysis is useful but rarely sufficient

Judgments must be made about what is fair, using a fair process

Ethical Issues in Making Investment Choices in Health

Principles for Distributing Scarce Resources

Health maximization

Equality

Priority to the worst off

Personal responsibility

Ethical Issues in Making Investment Choices in Health

Fair Processes

Transparency about how decisions are made

Representation from affected stakeholders

Appropriate use of scientific data

Challenges for the Future

Students of global health get insufficient exposure in their training to ethical issues

No mechanisms for enforcing human rights

Shortage of trained personnel for reviewing research

Lack of reviews of how investments are made

Unsolved ethical problems