Relevant bibliographies by topics / National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

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Academic literature on the topic 'National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research'

Author: Grafiati
Published: 4 June 2021
Last updated: 28 July 2025

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Journal articles on the topic "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research"

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Morreim, E. Haavi. "Litigation in Clinical Research: Malpractice Doctrines versus Research Realities." Journal of Law, Medicine & Ethics 32, no. 3 (2004): 474–84. http://dx.doi.org/10.1111/j.1748-720x.2004.tb00160.x.

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Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice s
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Iltis, Ana S. "Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research." Journal of Law, Medicine & Ethics 39, no. 3 (2011): 488–501. http://dx.doi.org/10.1111/j.1748-720x.2011.00616.x.

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Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Comm
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Glantz, Leonard H. "Informed Consent Forms for Research with Human Subjects: Time to End the Charade." American Journal of Law & Medicine 50, no. 3-4 (2024): 204–21. https://doi.org/10.1017/amj.2025.6.

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AbstractIn 1974, the Center for Law and Health Sciences at the Boston University School of Law provided legal background papers on informed consent to research to the newly created National Commission for the Protection of Human Subjects of Biomedical and Behavioral Sciences. These papers were written by George J. Annas, the Center’s Director, as well as Barbara F. Katz and I, who were staff attorneys at the time. These papers can be found in the appendices to the Commission reports1 and in our book Informed Consent to Human Experimentation: The Subject’s Dilemma,2 in which we present a refine
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Berlin, Ivan, and David A. Gorelick. "The French Law on “Protection of Persons Undergoing Biomedical Research”: Implications for the U.S." Journal of Law, Medicine & Ethics 31, no. 3 (2003): 434–41. http://dx.doi.org/10.1111/j.1748-720x.2003.tb00106.x.

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Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human researc
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Joffe, Steven. "Revolution or Reform in Human Subjects Research Oversight." Journal of Law, Medicine & Ethics 40, no. 4 (2012): 922–29. http://dx.doi.org/10.1111/j.1748-720x.2012.00721.x.

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Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health
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Abramson, Norman, Alan Meisel, and Peter Safar. "Ethical and Legal Problems in Resuscitation Research." Prehospital and Disaster Medicine 1, S1 (1985): 59–60. http://dx.doi.org/10.1017/s1049023x00043788.

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Medicine has made great advances in the past decade, and is now opening the frontiers of brain resuscitation. Coinciding with the advances in medicine, society has witnessed great changes. There is an increasing awareness of patients' rights, an increasing desire for self determination, a rejection of the once-accepted paternal role of the physician, and an increasing willingness to challenge physicians in the courts. At the same time, government regulation of biomedical research has been expanding rapidly. The origin of this regulation dates back to the post-World War II Nuremburg trials. In
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Engelhardt, H. Tristram. "THE ORDINATION OF BIOETHICISTS AS SECULAR MORAL EXPERTS." Social Philosophy and Policy 19, no. 2 (2002): 59–82. http://dx.doi.org/10.1017/s026505250219203x.

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The philosophy of medicine cum bioethics has become the socially recognized source for moral and epistemic direction in health-care decision-making. Over the last three decades, this field has been accepted politically as an authorized source of guidance for policy and law. The field's political actors have included the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Department of Health, Education, and Welfare, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (hereinafter, “the P
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Morris, Marilyn C. "Pediatric Participation in Non-Therapeutic Research." Journal of Law, Medicine & Ethics 40, no. 3 (2012): 665–72. http://dx.doi.org/10.1111/j.1748-720x.2012.00697.x.

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Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical and Behav
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Ross, Lainie Friedman, and Catherine Walsh. "Minority Children in Pediatric Research." American Journal of Law & Medicine 29, no. 2-3 (2003): 319–36. http://dx.doi.org/10.1017/s0098858800002860.

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Medical research is heavily funded: the National Institutes of Health had a budget of over $20 billion in 2001, and even more money was spent by the pharmaceutical industry on research. Children's health issues, however, receive only a small fraction of these funds. In 2001, for example, less than $1 billion of NIH funding was allocated to the National Institute of Child Health and Human Development (NICHD). In part, the problem stems from a modern predisposition to protect children from participating in research.Several federal policies in the 1990s changed the face of the “typical research s
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Hatfield, Amy J., and Shana D. Kelley. "Case study: lessons learned through digitizing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Collection*†." Journal of the Medical Library Association 95, no. 3 (2007): 267–70. http://dx.doi.org/10.3163/1536-5050.95.3.267.

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Books on the topic "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research"

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Velasco, Juan María de. La bioética y el principio de solidaridad: Una perspectiva desde la ética teológica. Universidad de Deusto, 2003.

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Book chapters on the topic "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research"

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Beauchamp, Tom L. "The Belmont Report." In The Oxford Textbook of Clinical Research Ethics. Oxford University PressNew York, NY, 2008. http://dx.doi.org/10.1093/oso/9780195168655.003.0015.

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Abstract The Belmont Report is a short document on moral principles that was published in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). Since that time it has provided a basic framework for analyzing ethical issues that arise during medical research in the United States and in many other countries.
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"Government Standards for Human Experiments: The 1960s and 1970s." In Final Report Of The Advisory Committee On Human Radiation Experiments. Oxford University PressNew York, NY, 1996. http://dx.doi.org/10.1093/oso/9780195107920.003.0004.

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Abstract The year 1974 marks the upper bound for the period of the Advisory Committee’s historical investigation. That year two landmark events in the history of government policy on research involving human subjects took place: the promulgation by the Department of Health, Education, and Welfare (DHEW) of comprehensive regulations for oversight of human subject research and passage by Congress of the National Research Act. The DHEW regulations set rules for oversight of human subject research supported by the single largest funding source for such research, and the National Research Act autho
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Jonsen, Albert R. "Commissioning Bioethics: The Government in Bioethics, 1974-1983." In The Birth of Bioethics. Oxford University PressNew York, NY, 1998. http://dx.doi.org/10.1093/oso/9780195103250.003.0004.

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Abstract The 1960s was the era of conferences, when scientists and a few other scholars gathered, as Rene Dubos had said, “to air” the issues. The speakers at those conferences were enthusiastic about the achievemimts of biomedicine and agonized over their attendant adverse effects on society. In 1968, that enthusiasm and agony moved momentarily from academic auditoria into the halls of Congress. This chapter reviews the federal government’s entry into bioethics, beginning with Congressional hearings and moving to legislation establishing two federal commissions to study bioethical issues, The
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Hurlbut, J. Benjamin. "New Beginnings." In Experiments in Democracy. Columbia University Press, 2017. http://dx.doi.org/10.7312/columbia/9780231179546.003.0002.

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Chapter 1 examines the period from the mid-1960s to 1980. During this period, scientific advances made in human in vitro fertilization and embryo culture led to the birth of Louise Brown, the first child conceived through IVF, in 1978. The chapter examines the deliberations of two federal bioethics bodies: the National Commission for the protection of Human Subjects of Behavioral and Biomedical research, and the Ethics Advisory Board of the Department of Health, Education and Welfare.
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Annas, George J. "The Politics of Fetal Tissue Transplants." In Standard Of Care. Oxford University PressNew York, NY, 1993. http://dx.doi.org/10.1093/oso/9780195072471.003.0014.

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Abstract Research involving human fetal tissue has been the subject of intense political debate in the United States for two decades, and the use of fetal tissue for transplant continues this controversy in another forum. ‘ Since Roe v. Wade, the federal government has focused public attention on fetal re search by creating panels of experts. For example, in 1974 Congress created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and put the formulation of regulations on fetal research first on its agenda. The resulting regulations were reason ab
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Annas, George J. "The Nuremberg Code in U.S. Courts: Ethics versus Expediency." In The Nazi Doctors And The Nuremberg Code. Oxford University PressNew York, NY, 1992. http://dx.doi.org/10.1093/oso/9780195070422.003.0012.

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Abstract “The most complete and authoritative statement of the law of informed consent to human experimentation is the Nuremberg Code.”1 That was the conclusion Leonard Glantz, Barbara Katz, and I reached 15 years ago in our study of informed consent to human experimentation for the National Commission for the Protection of Subjects of Biomedical and Behavioral Research. We went on to say, “This Code is part of international common law and may be applied in both civil and criminal cases, by state, federal and municipal courts in the United States.”2 I still believe these two statements are tru
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