Declaration of Helsinki

Question 1

What is the Declaration of Helsinki?

Answer 1

A set of ethical principles for medical research involving human subjects

Question 2

When was the Declaration originally adopted?

Answer 2

June 1964

Question 3

What organization developed the Declaration of Helsinki?

Answer 3

The World Medical Association (WMA)

Question 4

Who is the primary audience of the Declaration of Helsinki?

Answer 4

Physicians

Question 5

Who is responsible for the protection of research subjects?

Answer 5

The physician or other health care professionals

Question 6

Medical research should be conducted in a manner that minimizes possible harm to the ____________.

Answer 6

Environment

Question 7

Placebos should only be utilized where:

Answer 7

1) No proven intervention exists
OR
2) For compelling and scientifically sound methodological reasons the use of the placebo is necessary to determine the efficacy or safety of an intervention
AND the patients receiving the placebo will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention

Question 8

What are the researcher’s duties when it comes to publication and the dissemination of results?

Answer 8

1) Researchers must make publicly available the results of their research on human subjects
2) Researchers are accountable for the completeness and accuracy of their reports
3) Negative and inconclusive results must also be published or made publicly available
4) Sources of funding, institutional affiliations, and conflicts of interest must be declared in the publication