231 Final - Ethics Module

The Nuremberg Code (1947)

The Nuremberg Code (1947)

Ten guidelines for the ethical treatment of human subjects in research

Guidlines from the Nuremberg Code

• Voluntary consent without coercion

• Good science, done by good scientists

• Benefits justify experiments

• Degree of risk less than potential benefit

• Harms minimized

Limitations to The Nuremberg Code

includes focus on medical research, no consideration of vulnerable participants

Declaration of Helsinki (1964)

Issued by World Medical association to expand on limitations of Nuremberg Code. Additions included:

• Peer review

• Attention to vulnerable groups

• Most recent was 2013

The Belmont Report (1978)

Important Code of ethics developed by the US National Commission for Protection of Human Subjects in Biomedical and Behavioral Research

Three primary ethical principles of Belmont Report

Beneficence, Respect for human dignity, Justice

Tri-Council Policy Statement

Canadian statements on the ethical conduct of research involving humans. Describes that research involving humans should be conducted in a manner consistent with three core principles

three core principles of Tri-Council Policy Statement

Respect for persons, concern for welfare, justice

Beneficence/Concern for Welfare

The right to freedom from harm and discomfort.

The right to protection from exploitation

Respect for human dignity/persons

The right to self-determination

The right to full disclosure

Justice

The right to fair treatment

The right to privacy

risk/benefit assessment

the potential benefits of the study to individual participants and to society are weighed against the costs to individuals

informed consent

an ethical principle that research participants be told enough to enable them to choose whether they wish to participate

confidentiality procedures

developed by researchers to ensure confidentiality of research subjects

Debriefing

the post-experimental explanation of a study, including its purpose and any deceptions, to its participants

Referrals

recommending that participants who may be showing negative health outcomes see a HCP

Treatment of vulnerable groups

Vulnerable subjects are study participants who require special protections.

May be incapable of giving fully informed consent (e.g., cognitively impaired people) or may be at high risk for unintended side effects (e.g., pregnant women)

Some (e.g., children) cannot make a truly informed decision about voluntary participation.

external reviews

review from an outside source that the study is ethical

Protection of Human Rights

Includes self-determination, privacy, anonymity and confidentiality, fair treatment, and protection from discomfort and harm

Mi'kmaq Ethics Watch

Committee established at Chapel island (1999)

developed principles and guidelines to protect Mi'kmaq peoples and guarantees right of ownership over the research/knowledge