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    which of the following best describes the principle of informed consent as described in the belmont report?

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    How the Belmont Report clarified informed consent

    Sandra Maddock, President & CEO, IMARC Research Imagine being enrolled in a clinical trial without fully understanding the scope or the risks. The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection. […]

    How the Belmont Report clarified informed consent

    FEBRUARY 8, 2019 BY DANIELLE KIRSH

    Sandra Maddock, President & CEO, IMARC Research

    Imagine being enrolled in a clinical trial without fully understanding the scope or the risks.

    The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection.

    In this post, we’ll discuss the key principles of the report, and in particular, how it clarified our understanding of informed consent.

    What is the Belmont Report?

    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.

    Following the Tuskegee study, Congress passed the National Research Act, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission met regularly for nearly four years, culminating in a four-day discussion at the Smithsonian Institution’s Belmont Conference Center in February 1976.

    The resulting Belmont Report summarized the three ethical principles the commission concluded should guide human research:

    Respect for persons: All individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protectionBeneficence: Researchers should maximize possible benefits and minimize possible harmJustice – All persons should be treated equally, and the selection of research subjects should be scrutinized so that no one is systematically selected on the basis of race, ethnicity, class or other factors

    The Belmont Report remains a primary ethical framework for researchers today.

    How the Belmont Report defines informed consent

    The Belmont Report addresses informed consent as a necessary part of showing respect for all persons. It states that all subjects, to the degree that they are capable, should be given the opportunity to choose what shall or shall not happen to them.

    According to the report, informed consent requires three elements:

    Information

    Research subjects “must be given sufficient information about the research procedure, their purposes, risks and anticipated benefits and alternative procedures (where therapy is involved).” They should be given the opportunity to ask questions and have the right to withdraw from the research at any time.

    In cases where informing subjects about some pertinent aspect of the research is likely to impair the validity of the research, the Belmont Report states withholding information is justified only if the following three criteria apply:

    Incomplete disclosure is truly necessary to accomplish the goals of the research

    There are no undisclosed risks to subjects that are more than minimal

    There is an adequate plan for debriefing subjects, when appropriate, and for disseminating research results to them

    Researchers should never withhold information about risks for the purpose of getting a subject to cooperate.

    Comprehension

    The Belmont Report states that “the manner and context in which information is conveyed is as important as the information itself.” For instance, allowing too little time for the subject to consider the information could affect their ability to make an informed choice.

    That means researchers need to consider a subject’s maturity, capacity for understanding, language and literacy when presenting information to obtain informed consent. In some cases, the report states, it may be appropriate to give oral or written tests of comprehension.

    Related: What Does “Understandable Language” Mean In Informed Consent?

    When a subject’s comprehension is severely limited due to age, disability or other factors, researchers need to seek the permission of other parties to protect them from harm.

    Voluntariness

    Informed consent means there is no coercion or undue influence. In other words, researchers cannot threaten harm or offer an “excessive, unwarranted, inappropriate or improper reward” to obtain compliance.

    That means researchers need to take special care when conducting clinical trials involving vulnerable people who are under the authority of someone else, such as inmates or people who are ill.

    Other considerations involving informed consent

    On the surface, informed consent seems like a straightforward concept. However, the evolution of clinical research and the introduction of new technologies continue to raise new questions about its application.

    For instance:

    What additional considerations apply when informed consent is obtained electronically?

    How can researchers avoid overstating the potential benefits of a medical device?

    How can researchers avoid undue influence when enrolling employees in a clinical trial?

    The FDA released its latest guidance on informed consent in 1998 and has drafted an update to that document that has yet to be finalized. While it’s not likely we’ll ever see the “last word” on informed consent, the Belmont Report serves as an important and timeless reminder of the fundamentals of informed consent.

    Source : www.massdevice.com

    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

    The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Biologics Quiz Flashcards

    Study with Quizlet and memorize flashcards terms like Which of the following lists the three principles included in the Belmont Report?, Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?, Which of the following best describes the principle of informed consent as described in the Belmont Report? and more.

    The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Biologics Quiz

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    Which of the following lists the three principles included in the Belmont Report?

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    Respect for Persons, Beneficence, Justice

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    Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

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    Determining that the study has maximized benefits and minimized risks.

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