The Declaration of Helsinki (DoH) is the World Medical Association's (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in
October 2013
.
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.
What are the 3 main principles of the Declaration of Helsinki?
- Protecting Patient Health.
- Knowledge Cannot Trample Rights.
- Additional Considerations.
- Following Local Regulatory Norms.
- Risks, Burdens and Benefits.
- Vulnerable Groups and Individuals.
- Scientific Requirements and Research Protocols.
- Research Ethics Committees.
What is the difference between the Nuremberg Code and the Declaration of Helsinki?
The Nuremberg Code focuses on the
human rights of research subjects
, the Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects, and the federal regulations emphasize the obligations of research institutions that receive federal funds.
What is the main purpose of Declaration of Helsinki?
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
.
How many times has the Declaration of Helsinki been revised?
The Declaration of Helsinki (DoH) is the World Medical Association's (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended
seven times
since, most recently at the General Assembly in October 2013.
When and why was the Declaration of Helsinki created?
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.
When was the Helsinki Declaration declared?
The Declaration was originally adopted in
June 1964
in Helsinki, Finland, and has since undergone seven revisions (the most recent at the General Assembly in October 2013) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 2013 version.
Who Helsinki agreement?
The agreement recognized the inviolability of the post-World War II frontiers in Europe and pledged the
35 signatory nations to respect human rights
and fundamental freedoms and to cooperate in economic, scientific, humanitarian, and other areas. The Helsinki Accords are nonbinding and do not have treaty status.
What led to the National research Act of 1974?
This came after several egregious abuses of human subjects in research, including
Nazi Party experiments on prisoners of concentration camps during World War II
(which led to the creation of the Nuremberg Code) and the Tuskegee Syphilis study, in which black men with syphilis were denied life-saving treatment.
What are the 3 Belmont Report principles?
Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects:
the principles of respect of persons, beneficence and justice.
Who wrote the Helsinki Declaration?
The Helsinki Declaration was created by
the World Medical Association
in 1964 (ten years before the Belmont Report) and has been amended several times. The Helsinki Declaration differs from its American version in several respects, the most significant of which is that it was developed by and for physicians.
What was the Declaration of Helsinki in response to?
The Declaration was developed from the
ten principles
first stated in the Nuremberg Code in 1947, which followed horrific experiments Nazi scientists conducted on Jewish concentration camp prisoners during World War II.
What are the 13 principles of ICH GCP?
- Ethics. …
- Trial risk vs trial benefit. …
- Information on the Medicinal Product. …
- Compliance with the study protocol. …
- Medical decisions. …
- Informed consent. …
- Confidentiality. …
- Good Manufacturing Practice.
When was the common rule established?
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in
1991
and codified in separate regulations by 15 Federal departments and agencies, as listed below.
Who signed the Helsinki Final Act?
The United States, the Soviet Union, Canada and every European nation (except Albania)
sign the Helsinki Final Act on the last day of the Conference on Security and Cooperation in Europe (CSCE).
When was the Helsinki Accords signed?
Signed on
1 August 1975
following the Conference on Security and Cooperation in Europe which was launched in 1973, the Helsinki Accords establish the inviolability of European frontiers and reject any use of force or intervention in internal affairs.
What are the 4 important ethical issues IRB guidelines address?
- Respect for persons: respect for patient autonomy.
- Beneficence: maximize benefits and minimize harm.
- Justice: Equitable distribution of research burdens and benefits.
What is the Helsinki incident?
According to a report from Iltalehti, the alleged incident occurred on the evening of 4 July at Helsinki Central Railway Station. The incident
centers on two youths, one white male and one black male
, who were apprehended together for not having a valid ticket.
What brought attention to IRB system?
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
(Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)
Why was the Belmont Report written?
The Belmont Report was written
in response to the infamous Tuskegee Syphilis Study
, in which African Americans with syphilis were lied to and denied treatment for more than 40 years. Many people died as a result, infected others with the disease, and passed congenital syphilis onto their children.
Who created the Belmont Report?
The Belmont Report was written by
the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
.
Who does the Belmont Report protect?
Its primary purpose is to protect
subjects and participants in clinical trials or research studies
. This report consists of 3 principles: beneficence, justice, and respect for persons. This article reviews the Belmont Report and these 3 principles as well as its importance to nurse researchers.
What is justice Belmont Report?
Justice: This principle
advocates fair treatment for all and a fair distribution of the risks and benefits of the research
. It forbids exploitation of vulnerable people (for instance, economically disadvantaged or those with limited cognitive capacity) or those who are easily manipulated as a result of their situation.
What is protocol amendment?
“Protocol Amendment:
Change in Protocol
“
A sponsor of an IND application is expected to submit a protocol amendment in cases when there are changes in the existing protocol that significantly affect safety of subjects, scope of the investigation, or scientific quality of the study.
What is GCP ICH?
ICH-GCP. The ICH-GCP is
a harmonised standard that protects the rights, safety and welfare of human subjects
, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
What is the difference between ICH and GCP?
ICH-GCP states that
the monitor should be the one to verify the legibility of documents
, while Indian GCP states that the monitor also needs to inform the Sponsor and Ethics Committee for any violations from the protocol.
