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    informed consent is considered an application of which belmont principle?

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    Informed consent is considered an application of which Belmont principle?

    Informed consent is considered to be an application of one of the Belmont principles, which is respect for persons.

    Informed consent is considered an application of which Belmont principle?

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    Informed consent is considered to be an application of one of the Belmont principles, which is respect for persons.

    Explanation:

    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research created the Belmont Report that identifies the ethical principles that might arise from healthcare research with human subjects. The basic ethical principles included in the Belmont report are respect for persons, beneficence, and justice. The principle of respect for persons has two major requirements, which are the need to recognize the autonomy and the protection of those whose autonomy is diminished. This principle also requires the human subjects to have the opportunity of choice of what will happen to them, to the degree of their capability. Therefore, this opportunity exists when the standards of informed consent are fulfilled. The Belmont report suggests that the significance of informed consent is unquestionable. Still, controversies might arise due to the possibility and the essence of the consent. In such a way, the principle of respect for persons suggests the three most significant elements of the consent process, which are information, comprehension, and voluntariness.

    The subjects of the research should be provided with sufficient information about the study, such as the procedure, the purpose, potential risks and benefits, and alternative procedures. It is also crucial to include the statement, which gives a possibility for the human subjects to ask questions and be able to withdraw from the study. The next critical point in informed consent is the way the information is comprehended. It is essential to present the information understandably so that the subject of the research can make an informed choice. The last element of the consent is that the agreement to participate in the study was given voluntarily. Thus, the Belmont principle of respect for persons requires each research to provide those elements for informed consent.

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    Read the Belmont Report

    Read the Belmont Report

    THE

    BELMONT REPORT

    The Belmont Report

    Office of the SecretaryEthical Principles and Guidelines for the Protection of Human Subjects of ResearchThe National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

    April 18, 1979

    AGENCY: Department of Health, Education, and Welfare.ACTION: Notice of Report for Public Comment.SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.

    The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

    Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.

    National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

    Members of the Commission

    *** *** *** *** Deceased.

    Table of Contents

    Ethical Principles and Guidelines for Research Involving Human Subjects

    A. Boundaries Between Practice and Research

    B. Basic Ethical Principles

    Respect for Persons Beneficence Justice C. Applications Informed Consent

    Assessment of Risk and Benefits

    Selection of Subjects

    Ethical Principles & Guidelines for Research Involving Human Subjects

    Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions. Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype of many later codes[1] intended to assure that research involving human subjects would be carried out in an ethical manner.

    The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may be formulated, criticized and interpreted.

    Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement. Other principles may also be relevant. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.

    This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles.

    Source : www.hhs.gov

    History and Ethics of Human Research Flashcards

    Start studying History and Ethics of Human Research. Learn vocabulary, terms, and more with flashcards, games, and other study tools.

    History and Ethics of Human Research

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    Which of the following was the result of the Beecher article?

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    Realization that ethical abuses are not limited to the Nazi regime

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    Which of the following concerns is related to the Belmont Principle of Justice:

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    Prisoners participating in research that only benefits the larger society

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    Terms in this set (7)

    Which of the following was the result of the Beecher article?

    Realization that ethical abuses are not limited to the Nazi regime

    Which of the following concerns is related to the Belmont Principle of Justice:

    Prisoners participating in research that only benefits the larger society

    Informed consent is considered an application of which Belmont principle?

    Respect for persons

    Which of the following is included in the Nuremberg Code:

    Voluntary Consent

    The National Research Act of 1974

    Established the National Commission.

    Which of the following brought increased public attention to the problems with the IRB system?

    Death of Jesse Gelsinger

    Issued in 1974, 45 CFR 46 raised which of the following to regulatory status?

    US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".)

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