The Declaration of Helsinki (1964)

Question 1

What is the purpose of the Declaration of Helsinki?

Answer 1

To provide ethical guidelines for medical research involving human subjects.

Question 2

Who developed the Declaration of Helsinki?

Answer 2

The World Medical Association (WMA).

Question 3

What are key principles of the Declaration of Helsinki?

Answer 3

• Respect for Individuals
• Right to Make Informed Decisions
• Research Must Be Based on Scientific Knowledge
• Risks Should Be Minimized and Benefits Maximized
• Vulnerable Groups Must Be Protected

Question 4

What does the Declaration say about informed consent?

Answer 4

Participants must be informed about the purpose, risks, and benefits of the study and must give voluntary consent.

Question 5

What does the Declaration say about research risks?

Answer 5

Risks should never exceed the potential benefits to society.

Question 6

What does the Declaration say about placebo use?

Answer 6

Placebos can only be used when no proven treatment exists, unless withholding treatment poses no serious risk to participants.

Question 7

What does the Declaration say about ethics committees?

Answer 7

Research proposals must be reviewed and approved by an independent ethics committee before the study begins.

Question 8

What is the role of researchers in ensuring participant safety?

Answer 8

Researchers must stop the study if they find that risks are too high or if participants are at serious risk of harm.

Question 9

How does the Declaration address post-study care?

Answer 9

Researchers must ensure that participants have access to the best proven treatments after the study ends.