What are the primary principles of the Helsinki Declaration?
The basic principles include respect for individuals, the right to make informed decisions, recognition of vulnerable groups, and more. The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008.
What is the Declaration of Helsinki 2008?
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.
What is the Helsinki Declaration of 1964?
Declaration of Helsinki, formal statement of ethical principles published by the World Medical Association (WMA) to guide the protection of human participants in medical research. The Declaration of Helsinki was adopted in 1964 by the 18th WMA General Assembly, at Helsinki.
What are 3 main principles that came from the Declaration of Helsinki?
The Declaration of Helsinki’s General Guiding Principles
- Protection of patients’ health.
- The pursuit of knowledge can never supersede the rights of patients.
- Additional considerations.
- The risks and burdens vs.
- Protection of vulnerable groups and persons.
- The need for sound scientific inquiry.
What does the Declaration of Helsinki state?
1. 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.
What is the common rule in clinical research?
The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.
What did the Declaration of Helsinki aim to protect?
Like the Nuremberg Code, the goal of the Declaration of Helsinki was to prevent human subjects from being mistreated. The Declaration of Helsinki provided guidance for physicians who were conducting clinical research and focused on researchers’ roles and responsibilities when it comes to protecting human subjects.
Who does the Declaration of Helsinki protect?
The World Medical Association
1. 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.
What are the 3 main GCP principles?
Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.
What is 45 CFR 46 Subpart A?
Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration. The Common Rule, subpart A, was revised in recent years.
What is the Common Rule in healthcare?
For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency.
How frequently is the Declaration of Helsinki reviewed?
In its 40-year lifetime the Declaration has been revised five times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research.
