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The Declaration of Helsinki

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Added on  2022/08/14

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Human experimentation and other types of research were also covered in this declaration and the rights of the subjects participating in the research were redefined while re-stating the definitions of the best interest of the patients and informed consent (18th WMA General Assembly, Helsinki, Finland, 1964). It was the first time when the scope of the human experimentation was discussed ahead of the interests and responsibilities of Medical authorities, Helsinki declaration promoted the research ethics as the document designed to serve the best interests of the humanity rather than

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The declaration of the Helsinki
The declaration of the Helsinki can be considered as the best revision of the previous works that
have been done to standardize the moral and ethical principles associated with the WMA and
other bodies in the past. This declaration re-stated the commitment of Medical experts to abide
by the good faith and serve the best interests of the patients. Human experimentation and other
types of research were also covered in this declaration and the rights of the subjects participating
in the research were redefined while re-stating the definitions of the best interest of the patients
and informed consent (18th WMA General Assembly, Helsinki, Finland, 1964).
It was the first time when the scope of the human experimentation was discussed ahead of the
interests and responsibilities of Medical authorities, Helsinki declaration promoted the research
ethics as the document designed to serve the best interests of the humanity rather than the
medical fraternity alone.
This declaration also promotes a framework associated with the risks and burdens that can make
an entry during the process of human research. The guidelines clearly state that medical experts
should ensure minimum risk for the subjects and various committees and different levels should
approve the research project while considering numerous factors that should be taken into an
account. The point of withdrawing an informed consent during the middle part of a research
program is another feature that makes it special. Helsinki declaration ensures an unconditional
withdrawal of informed consent without giving any substantial reason (18th WMA General
Assembly, Helsinki, Finland, 1964).
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Under this declaration, the spectrum of the powers for the ethical research committee was
increased exponentially and it was recommended that the culture of the “ethical research
committee should be promoted at all levels of the research where humans or animals are
involved. Helsinki declaration also redefined the periphery of the rules associated with the
publication of the research findings and the terms of the confidentiality attached to the research
subjects. The authorship claims and other claims were also settled with the help of some legal
interventions following the natural flow of justice.
One of the most significant interventions in the publication of the reports was related to the
credentials of the report. Certain entries like the funding of the research, promotion of the
research and positive outcomes should be mentioned in the research with due mention. The post-
trial provisions of the Helsinki declaration, add this process with the concept of the informed
consent. According to this provision, a subject has all the rights to know about the findings and
other details of the happening that took place during the trial.
On a conclusive note, it can be said that the Helsinki Declaration added a strong legal framework
with the human research endeavors by defining them under proper legal terms. Apart from it,
this declaration also added a human side into the endeavors of the research where the interests of
the research subjects were guarded with great precision.
The Nuremberg Code
The Nuremberg Code is a set of regulations that are designed to ensure maximum transparency
and accuracy in the process of research to ensure that the researcher is adhering to the ethical
frameworks to its very core. Divided into ten major points this code ensures an interface of the
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transparency between the researchers and the subjects. This code reaffirms the commitments
related to the informed consent and establishes the guidelines of the unconditional withdrawal of
the subjects Trials of War Criminals before the Nuremberg Military Tribunals under Control
Council Law No. 10,1949).
The Nuremberg code defines the conduct of Good faith for researchers where they are duty-
bound to end the experiments in the case of probable harm that may occur to the subjects. This
code follows a great adherence to the Helsinki declaration, the origin of this code lies in the “war
crimes” and other immoral human trials during the phase of a war. Most of the regulations,
practices, and commitments are drawn from the mishaps and the violation of the bio-ethics
during that phase.
This code also defines the eligibility of a person conducting an experiment. This code also
defines the degree of the risk associated with each experiment, the responsibility of probable
harm or remote harm is solely on the researcher and he should take care of all the necessary
formalities.
Belmont Report
Belmont Report can be considered as a document where humanitarian concerns related to
bioethics have been described from a social, moral and ethical point of view. This report
primarily promotes a strong framework of three principles of beneficence, justice, and respect for
the individuals that are involved under the capacity of a subject in the process of research (The
Belmont Report: Formal birth of the bio-ethics , 1974).
The principle of beneficence collectively refers to the basic oaths taken by the doctors and other
experts, oaths related to the best benefits of the patients, maximum security and the Hippocratic

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oath of “do not harm “ forms the basic crux of this arrangement. The next most important factor
is related to the respect and honor of the subject which is participating in the process. Belmont
report promotes good faith and allows an expert to abide by the best judgment of the condition
based on the evidence-based practices as prescribed by the approved scientific patterns.
Belmonte's report also promotes the concept of justice where the burdens of the mishap and
“fairness of the distribution” holds the primary concerns. These two principles are in coherence
with the concept of respect of the subject and their human rights while participating in a research
program that is designed to serve a greater interest for humanity. Principles like “each according
to capacity and each according to the necessity” also form the highlight of this report. Apart from
safeguarding the interests of the subjects, the Belmonte report also promotes a harmonious
research environment for all the stakeholders and safeguards the interests of all the parties with
equal footing.
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References
18th WMA General Assembly, Helsinki, Finland. (1964). The declaration,
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
medical-research-involving-human-subjects/.
The Belmont Report: Formal birth of the bio-ethics. (1974). OHRP,
http://archive.hhs.gov/ohrp/humansubjects/guidance/belmont.htm.
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law
No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949
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