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Prior to the Nuremberg Code, there was no generally accepted code of conduct which governed the ethical aspects of human research.
As a direct result of this trial, The Nuremberg Code was established.
This stated that the voluntary consent of a participant is essential, and any benefits of that participant's involvement in the study should outweigh the risks.
The Nuremberg Code was the first international document which advocated voluntary participation and informed consent.
On December 9, 1946, criminal proceedings were opened against leading German administrators and physicians for their voluntary participation in war crimes and crimes against humanity.
These German physicians conducted medical experiments on thousands of prisoners in concentration camps without their consent. The majority of these uninformed subjects and victims died or were permanently crippled as a result.
Principles of The Belmont Report
This principle is
1. to protect the participant from exploitation
The Belmont Report was created following a series of unethical research practices, most importantly being the...
2. ensure that subjects enter into research studies voluntarily and with enough information regarding the study
3. participants should be treated as individuals capable of acting under their own decisions
4. people with "diminished autonomy" (young children, mentally disabled people, the very ill) are entitled to protection from exploitation and activities that may harm them
The system the U.S. currently uses for their protection of human research subjects was influenced by The Belmont Report
Assesses the willingness of participation in a study by people who are
OR
Assent is not sufficient by itself. Informed consent must also be obtained from the parents or primary caregiver.
written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
1932-1972
600 African American males took part in a study which investigated the effects of syphilis.
They were given free medical care, meals, and free burial insurance in exchange for their participation in the study.
None of the subjects were ever told he had the disease, nor were they treated for it with penicillin, a proven effective treatment for syphilis.
This experiment led to major changes in U.S. laws and regulation on the protection of participants in clinical studies.
• A statement that the study involves research
• An explanation of the purposes of the research
• The expected duration of the subject's participation
• A description of the procedures to be followed
• Identification of any procedures which are experimental
• A description of any reasonably foreseeable risks or discomforts to the subject
Often times, assent takes place as a conversation rather than a document-based procedure.
It includes the nature of the study, the risks and benefits of participating and all the information necessary to make an educated decision about participating.
Participants must not be selected based on any single criteria (easy availability, compromised position, or racial, sexual, economic, or cultural biases)
Inclusion and exclusion criteria must be related solely on factors that most effectively address the research problem.
Readability- Consent must be provided in a way that is comprehensible to the patient.
Factors Influencing Readability
Created in 1966, in order to protect human subjects before, during, and after the research has been completed.
Adhere to the principles of the ~Belmont Report~
People are to be treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being
An obligation to do no harm and to
to the individual research participant
Asking individuals who are potential research subjects to sign a consent form once the procedures & risks written within it have been explained & their privacy acts have been assured
IRB's determine whether or not the research is safe for the participants and if the research contributes to general knowledge.
Central IRB's review a variety of research. Local IRB's only review research conducted at their own specific academic institution.
The Declaration of Helsinki is developed for the medical community by the World Medical Association.
As a collection of ethical principles regarding human experimentation, it addresses clinical research, reflecting changes in medical practice.
The fundamental principles are respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research.