Declaration of Helsinki

Question 1

According to the Declaration of Helsinki, which of the following should be the first consideration of a physician?

a) obtaining informed consent for research
b) developing the aims of a research study
c) the health of the physician’s patient
d) publications of novel data produced from research

Answer 1

c) the health of the physician’s patient

The Declaration of Geneva of the WMA: “The health of my patient will be my first consideration.”
The International Code of Medical Ethics: “A physician shall act in the patient’s best interest when providing medical care.”

Question 2

The Declaration of Helsinki states that medical research to generate new knowledge can take precedence over the rights and interests of individual research subjects.

true
false

Answer 2

false

Question 3

The Declaration of Helsinki was created in:

a) 1947
b) 1964
c) 1971
d) 1979
e) 1991

Answer 3

b) 1964

Question 4

The World Medical Association (WMA) ethical principles for medical research involving human subject is called:

a) The Belmont Report
b) The Declaration of Helsinki
c) The International Research Act
d) The Nuremburg Code

Answer 4

b) The Declaration of Helsinki

Question 5

The Declaration of Helsinki was created at/by:

a) Food and Drug Administration
b) International Conference on Harmonisation
c) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
d) Trials of War Criminals
e) World Medical Association

Answer 5

e) World Medical Association

Question 6

According to the Declaration of Helsinki, research protocol should contain information regarding: (n=6)

Answer 6

1) funding
2) sponsors
3) institutional affiliations
4) potential conflicts of interest
5) incentives for subjects
6) provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study

Question 7

Use of Placebo
The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s).

true
false

Answer 7

false

except in the following circumstances:

1) where no proven intervention exists
2) where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention

Question 8

The Declaration of Helsinki contains recommendations guiding doctors in clinical research that have been adopted by the World Medical Association.

true
false

Answer 8

true

Guide to Clinical Trials
p. 246

Question 9

The Declaration of Helsinki has three sections:
Basic Principles
Clinical Research
Nonclinical Biomedical Research

true
false

Answer 9

true

Clinical Research -> medical research combined with professional care
Nonclinical Biomedical Research -> nontherapeutic biomedical research involving human subjects

Guide to Clinical Trials
p. 256-257