Nuremburg, Helsinki, Belmont

Question 1

Year of Nuremburg Code

Answer 1

1947

Question 2

Year of Declaration of Helsinki

Answer 2

1964

Question 3

Year of Belmont Report

Answer 3

1978

Question 4

What are the 3 basic ethical principles outlined in the Belmont Report?

Answer 4

Respect (for persons), Beneficence, Justice

Question 5

What does Respect for Persons mean?

Answer 5

• Implemented via Informed consent
• Minimum components of consent = Information, comprehension, voluntariness
• INFORMATION: Is the information sufficient to decide if they want to participate? Subjects must understand risks, that research is voluntarily, that they can withdraw if they choose.
• COMPREHENSION: Does the subject understand adequately? Give them the opportunity to the extent they’re able, to choose whether to participate

Question 6

What is Beneficence?

Answer 6

Helping or benefiting the patients according to best judgement. When is it justifiable to seek certain benefits given the risks? (Assessment of risk/benefits)

Question 7

What does the principle of Justice look like?

Answer 7

Who should receive the benefits and who should bear the burdens of research? We must scrutinize the selection of subjects.

Question 8

According to the Belmont Report, what are the minimum requirements for consent?

Answer 8

Information, comprehension, and voluntariness.

Question 9

What ethical standards are the ICH document based on?

Answer 9

Declaration of Helsinki

Question 10

Purpose of the Nuremburg Code?

Answer 10

Protect human subjects following the Nuremberg trials in which WWII Nazis were tried for human experimentation

Question 11

What was the purpose of the Declaration of Helsinki?

Answer 11

Provide ethical principles for the World Medical Association

Question 12

What was the purpose of the Belmont Report

Answer 12

Provide basic ethical principles, boundaries between practice and research