Module 2 Principles

Question 1

Who is the Declaration of Helsinki mainly meant to address?

Answer 1

Physicians

Question 2

What are the three ethical principles in the Belmont Report that constitute the basis for the HHS Human Subjects Regulations? (45 CRF 46)

Answer 2

Respect for persons, beneficence, justice

Question 3

Which agency is responsible for protecting the public health by assuring the safety, efficacy, and security of human and vet drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation?

Answer 3

Food and Drug Administration (FDA)

Question 4

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions?

Answer 4

European Union, Japan, United States

Question 5

What important ethical principles were the result of experimentation in concentration camps during WWII?

Answer 5

Nuremberg Code

Question 6

A primary purpose of the ICH is to ___

Answer 6

Minimize the need for redundant research