What documents form the Declaration of Helsinki?

What documents form the Declaration of Helsinki?

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

Is the Declaration of Helsinki legally binding?

The Declaration of Helsinki is not legally binding, but has had major impact on national legislation. Since 2000, it refers explicitly to research using identifiable samples and data.

Why is it called the Declaration of Helsinki?

The document on “Recommendations guiding doctors in clinical research” came to be known as the “Declaration of Helsinki”. It was the first international set of ethical principles for research involving human subjects. In the following years this guideline became the most influential one and still is.

What brought about the Helsinki Declaration?

That was followed in 1948 by the WMA’s Declaration of Geneva, a document outlining every physician’s ethical duties, which included pledges to focus on the health of the patient and not to use medical knowledge to violate human rights. Both documents influenced the development of the Declaration of Helsinki.

What is the legal significance of the Declaration of Helsinki?

Principles. The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter. Investigators still have to abide by local legislation but will be held to the higher standard …

Why is the Declaration of Helsinki important?

The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. It is the duty of the physician to promote and safeguard the health of the people.

Why was Helsinki Declaration developed?

The Declaration of Helsinki (DoH, Finnish: Helsingin julistus, Swedish: Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA).

How many principles are there in Declaration of Helsinki?

ten principles
The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians’ ethical duties.

What is the declaration of Helsinki and why is it important?

INTRODUCTION  The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

How many times has the declaration of Helsinki been revised?

4.  The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008.

What are the main principles of Helsinki Convention?

The basic principles include respect for individuals, the right to make informed decisions, recognition of vulnerable groups, and more. 3 4.  The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008.

What should be included in a protocol declaration?

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed.