Chapter 3 - Regulations and Good Clinical Practices

What is the Nuremberg Code?

Ethical principles for human experimentation that was developed in 1947 after World War II, in response to the Nazi medical atrocities committed during the Holocaust.

What is the key principle of the Nuremberg Code?

Voluntary, informed consent of the human subject is essential.

What is the Declaration of Helsinki?

A set of ethical principles for medical research involving human subjects, developed by the World Medical Association (WMA) in 1964 and updated multiple times (most recently in 2013).

What are the key principles of the Declaration of Helsinki?

Human rights, safety, and well-being.

What are the key principles of the Belmont Report (1979)?

Respect for Persons, Beneficence, Justice.

Define “Respect for Persons”.

Individuals should be treated as autonomous agents, capable of making their own informed decisions. Special protections are required for those with diminished autonomy (e.g., children, prisoners, people with cognitive impairments).

What is the application of Respect for Persons?

Informed Consent.

Define “Beneficence”.

Researchers have a duty to maximize possible benefits and minimize possible harms to participants.

What is the application of Beneficence?

Risk-Benefit Analysis.

Define “Justice”.

The benefits and burdens of research should be distributed fairly (“equal people treated equally”).

What is the application of Justice?

Selection of Subjects.