historical reports

Question 1

when was the nuremberg code developed?

Answer 1

1947

Question 2

when was the declaration of helsinski adopted?

Answer 2

adopted by World Medical Association in 1964

Question 3

when was the belmont report signed into law?

Answer 3

1974

Question 4

when was the belmont report added to the US federal registar?

Answer 4

April 1979

Question 5

the FDA’s medical device amendments was developed in ___

Answer 5

1976

Question 6

___ and ____ claimed “dubious experiments have NO therapeutic purpose”

Answer 6

Stauder and Von Muller

Question 7

What are the 10 principles of the NUREMBERG CODE?

Answer 7

(V-F-A-U-D-R-P-Q-W-T)
(Vy-Finds-An-Ugly-Dumb-Round-Pug-Quietly-Walking-Today)

1. voluntary consent
2. experiment should be to yield fruitful results for the good of society, unprocurable by other methods and not random
3. design was based on results of animal experimentation and must have a knowledge of the natural history of the disease
4. avoid all unnecessary physical or mental suffering and/or injury
5. should not be conducted if there is reason to believe that death or disablement will occur (unless physicians also serve as subjects)
6. degree of risk should NOT exceed that of the problem
7. proper preparations should be made and adequate facilities provided to protect subjects against even remote possibilities of injury, disability or death
8. experiment should only be conducted by scientifically qualified persons
9. subject should be able to bring experiment to the end if they have reached physical/mental state where continuing is impossible
10. scientist in charge must be prepared to terminate experiment at any stage if they have cause to believe that continuing would likely result in injury, disability or death

Question 8

What are the 3 principles of the BELMONT REPORT?

Answer 8

1. Respect for persons
2. Beneficence
3. Justice

Question 9

What topics do the DECLARATION OF HELSINSKI address?

Answer 9

(R-V-R-E-P-P-P-R-U-I)
(Rachel-Vy-Raced-Eliana-P-P-P-R-U-I)

1. risks, burdens and benefits
2. vulnerable populations
3. scientific requirements and research protocols
4. research ethics committees
5. privacy and confidentiality
6. placebo use
7. post trial provisions
8. research registration and publication and dissemination of results
9. unproved interventions in clinical practice
10. informed consent