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An Introduction to Ethical Reasoning

EATG Ethics Training

December 8-9, 2005

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Origin of Biomedical

Ethics

Origin of Biomedical

Ethics

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What is Biomedical Ethics?

Ethics is a branch of philosophy that attempts to assist us in deciding what is right and wrong in human conduct

Ethical reasoning takes place whenever there is a need to provide moral reflection on a specific action or behavior, such as a research project or a procedure

The term “bio-medical ethics” was coined in the early 1970s to refer to the application of moral reasoning to vexing questions at the frontiers of biology and medicine

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The Evolution of Research Ethics

Ethical review and bio-medical ethics evolved in response to a history of medical abuses

– Medical abuses by Nazi doctors (Nuremburg Trial and code of 1947)

– Public revelation of the Tuskegee syphilis study in 1974

These abuses prompted the creation of a series of norms, guidelines, and regulations to help guide the conduct of research

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The Evolution of Research Guidelines

Nuremberg Code

Declaration of Helsinki

WHO/CIOMS

1947

1964

1993

UNAIDS Vaccine

Guidance

2000

European Commission

Directive

UgandaIndia

Brazil

2003

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Limitations of Existing Guidance

Most have only persuasive force and are enforceable only via sanctions imposed by the professional association that created them

Some have been enshrined in national laws (e.g. US Policy for the Protection of Human Subjects, Ethics Law in Denmark, Brazil and Uganda)

Several take conflicting positions

Few take into account the special circumstances that characterize externally sponsored research in developing countries (p. 54 Nuffield Council).

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Ethics Committees: Review of Research

“Ethical review” is now a standard part of approval for most publicly funded scientific research involving human beings

Primary role is to protect people participating in research

– Scientific design and conduct of study– Care and protection of research participants– Community participation– Appropriate of informed consent– Confidentiality issues

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The Art of “Doing Ethics”

The Art of “Doing Ethics”

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Principles of Research Ethics

Research ethics rests on a set of fundamental ethical principles

These principles are the most fundamental unit of ethical analysis – all norms and guidelines derive from them

Nonetheless, like constitutions, ethical principles and guidelines need interpretation and debate

Different ethical principles can at times be in conflict

Ethics is not a formula, but a process of reflection and weighing of choices

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Ethics is a process Not a rule

How decisions are arrived at is ethically relevant

Different conclusions may result from different ethical reviews of the same issue or proposal and each conclusion may be ethically reached

A conclusion is ethical not merely because of what has been decided but also because of the process of conscientious reflection and assessment by which it is reached

Whose voice is represented in the debate is also important

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Core Ethical Principles

Belmont Report (1978)

– Respect for Persons•Autonomy•Protection of vulnerable or

persons with diminished capacity– Beneficence

•Maximizing benefits•Minimizing harms

– Justice

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Respect for Persons

Autonomy, self-determination– Those capable of deliberation should

be treated with respect for their capacity for self determination

– Underlies requirement for “informed consent”

Special measures for the vulnerable– Those whose decision-making

capacity is impaired or diminished due to intrinsic factors or circumstance

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Beneficence

Maximize possible benefits

Minimize possible harms or wrongs

This principle gives rise to norms requiring:

– On balance, the research should generate more good than harm

– Risks of research to be reasonable in light of the expected benefits

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From Protectionism to Access

Traditionally, much of the debate over “beneficence” has focused on protecting research participants from harm

But a second major reason for ethical review is to ensure equitable distribution of the potential benefits of research

During the 1980s, emphasis in global ethics discourse shifted from concern with the potential harms of research to a demand for greater access to its benefits.

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Justice

People should receive what is due to them

Benefits and risks of research should be fairly distributed

Research participants and sites should be fairly selected

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An alternative Articulation of Core Ethical Principles

The duty to alleviate suffering The duty to show respect for persons The duty to be sensitive to cultural difference The duty not to exploit the vulnerable or less

powerful

Nuffield Council on Bioethics (2002)

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Duty to Alleviate Suffering

The duty to alleviate suffering enjoins us to do what we can to reduce the amount of suffering in the world.

The more suffering we help to eliminate, the better our action

Acknowledging the duty, however, does not mean that it overrides all other claims

In situations were resources are limited, the challenge is to strike an acceptable balance between competing demands

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“Ought” implies “Can”

A person’s duty to benefit another is related to his or her capacity to do so, whether financial or practical.

– If a benefit cannot be provided for reasons of practical constraint, the duty to do so is weakened.

– Conversely, if a country’s wealth allows it to confer a benefit on the inhabitants of another country, the wealthier country has a stronger duty to provide that benefit.

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“Can” implies “should”

“ If it is in our power to prevent something bad from happening without thereby sacrificing anything of comparable moral importance, we ought morally to do it.”

Peter Singer, Philosophy and Public Affairs

1972:1:229-43

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Informed Consent is a process

Informed consent is a process of collaborative communication and decision making, not the signing of a form

Informed consent requires that prospective participants:– Be appropriately informed about the

nature of the research– Adequately understand this information

and its implications– Voluntarily decide to participate, without

coercion– Explicitly consent to participate, orally or

in writing

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Legal and moral agenda can sometimes conflict

Indemnify the research institution

Facilitate collaborative decision making

VS.

Length of formsDegree of technical information impartedWritten versus oral consentEmphasis on right to withdraw

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Therapeutic Misconception

“Therapeutic misconception” refers to the tendency of some research participants to wrongly assume that whatever drug or intervention they are offered must work or be beneficial (or why would it be offered?)

It occurs when the goals of research and those of therapy or “health care” become confused in the participants mind.

The therapeutic misconception is a major threat to “informed consent.”

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Putting it all together: What makes research

ethical?

Putting it all together: What makes research

ethical?

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What Makes Research Ethical?

Social or scientific value Scientific validity Fair subject selection Favorable risk-benefit ratio Independent review Informed consent Respect for potential and enrolled subjects Collaborative partnership

Emanual et al., JAMA, 283, 2000

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Seven Steps for Ethical Research

1. Priorities: Did the study address a priority issue? Whose?

2. Planning: Was the study well designed to optimize the chances of generating useful knowledge and protecting subjects?

3. Permission: Was the project reviewed and cleared by the relevant institutions? Did the investigators obtain informed consent?

4. Performance: Was the study conducted in a way that respected the rights of the subjects and minimized the risks to them?

5. Processing: Were the results correctly analyzed and interpreted?

6. Publication: Were the results published and disseminated?7. Programming: Have the findings been translated to policy and

action?