Declaration Of Helsinki Flashcards
What is the Declaration of Helsinki?
The Declaration of Helsinki is a set of ethical principles and guidelines for conducting clinical trials involving human subjects. It provides guidance on the rights, safety, and well-being of research participants.
When was the Declaration of Helsinki first adopted?
The Declaration of Helsinki was first adopted in 1964 and has undergone several revisions, with the latest being in 2013.
Who developed the Declaration of Helsinki?
The Declaration of Helsinki was developed by the World Medical Association (WMA), an international organization representing physicians.
Explain the significance of the “Nuremberg Code” in relation to the development of the Declaration of Helsinki.
The Nuremberg Code, developed in 1947 in response to unethical human experimentation during World War II, laid the foundation for the principles later incorporated into the Declaration of Helsinki.
What are the key principles outlined in the Declaration of Helsinki?
The key principles include respect for individuals, beneficence, justice, scientific and social value of the research, informed consent, and ethical review by an independent committee.
Describe the principle of “Respect for Persons” as outlined in the Declaration of Helsinki.
Respect for persons emphasizes the right of individuals to make autonomous decisions about participating in research and the obligation to protect those with diminished autonomy.
What is the principle of “Beneficence” in the context of the Declaration of Helsinki?
Beneficence involves maximizing benefits and minimizing harm to research participants. Researchers must ensure that the potential benefits justify the risks of the research.
Explain the principle of “Justice” as articulated in the Declaration of Helsinki.
Justice requires the fair distribution of the benefits and burdens of research. Participants should be selected based on scientific objectives and societal needs, and vulnerable groups should not be exploited.
How does the Declaration of Helsinki address the scientific and social value of research?
Research should have scientific and social value, contributing to knowledge and the well-being of society.
Describe the Declaration of Helsinki’s stance on the necessity of ethical review by an independent committee.
All research involving human subjects undergo ethical review by an independent committee, such as an Institutional Review Board (IRB) or Ethics Committee.
How does the Declaration of Helsinki address the use of placebo in clinical trials?
The Declaration requires that new treatments be tested against the best current treatment, and the use of a placebo should be justified, especially when no proven intervention exists.
Describe the Declaration of Helsinki’s stance on the confidentiality of participant data.
The Declaration mandates that the privacy and confidentiality of research participants must be protected, and identifiable information should not be disclosed without explicit consent.
What is the Declaration of Helsinki’s guidance on the withdrawal of participants from research?
Participants have the right to withdraw from research at any time, and their decision to withdraw should not affect their medical care or relationship with the investigator.
How does the Declaration of Helsinki address compensation for research-related injuries?
The Declaration requires that arrangements should be made for compensation and treatment for participants who are harmed as a result of participating in research.
Explain the Declaration of Helsinki’s stance on post-trial access to interventions.
Participants who participated in a research study should have access to the interventions identified as beneficial in the study, even after the study is completed.
