L7 GCP

Question 1

What is GCP?

Answer 1

Slide 6 and 7

Question 2

What does the GCP guideline highlights?

Answer 2

Slide 8 and 9

Question 3

What is the history of GCP?

Answer 3

**Slide 10

Question 4

What is the Hippocratic Oath?

Answer 4

Slide 11, 12
- Non-maleficence (do no harm)

Question 5

What is the main purpose for the 1938 US Food Drugs and Cosmetic Act?

Answer 5

Slide 13, 14, 15

Question 6

What is the main purpose of the 1947 Nuremberg Code?

Answer 6

Slide 16 - Nuremberg Code 1947: Voluntary consent from subjects is absolutely essential; must be beneficial to society and animal experiments must be done before starting trials (show efficacy)
Slide 17, 18

Question 7

What is the main purpose of 1964/2000 Declaration of Helsinki?

Answer 7

Slide 19, 20
- IC, risk benefit assessment, selection of subjects for study
- 1964: Well-being of subjects takes precedence (Respect), Protection of subjects health and rights (Special protection for vulnerable population)
- Set standard between nations

Question 8

Evaluate what was wrong about the Syphilis Experiment (with regards to Declaration of Helsinki)

Answer 8

Slide 21, 22, 23, 24, 25
- No ethics, justice or respect
Beneficence/Non-maleficence: the researchers allowed the participants to suffer the debilitating effects of untreated syphilis, leading to severe health complications, including death.
- Treatment was found during the course of the treatment but the participants were not given treatment
- IC: Were not informed of the risks of the study/what was it about, misled by receiving treatment for ‘bad blood’ - No informed consent/voluntary consent
Respect for Persons: The study demonstrated a profound disrespect for the autonomy and dignity of the participants, who were denied the opportunity to make informed decisions about their health and well-being.
Justice: The study exhibited a blatant disregard for principles of justice by targeting a vulnerable population—African American men in rural Alabama—with limited access to healthcare and educational resources. The participants were exploited for the sake of scientific curiosity without regard for their rights or welfare.

Question 9

What is the main purpose/gist of the Belmont Report 1979?

Answer 9

Slide 26
- Respect for person
- Beneficence
- Justice - equitable selection and recruitment and fair treatment of subjects

Question 10

What is the purpose of the International Guidelines of Biomedical Research Involving Human Research 1982?

Answer 10

Slide 30
- help DEVELOPING countries apply the Nuremberg Code and Declaration of Helsinki

Question 11

What is the purpose of the International Conference on Harmonisation’s Guideline for Good Clinical Practice (ICH GCP) 1996?

Answer 11

Slide 31
- Overcome inconsistencies in GCP internationally

Question 12

What are the 13 principles of GCP?

Answer 12

Slide 32 - 40 (Main points)

Question 13

What is the purpose of each trial?

Answer 13

Slide 43

Question 14

What is the key responsibility for each role in the trial?

Answer 14

Slide 44

Question 15

What is the protocol structure/What do you include in the protocol?

Answer 15

Slide 45