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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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Published: 4 June 2021

Last updated: 28 July 2025

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1

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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2

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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3

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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4

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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6

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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7

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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8

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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9

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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10

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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11

FERDOWSIAN, HOPE, L. SYD M. JOHNSON, JANE JOHNSON, ANDREW FENTON, ADAM SHRIVER, and JOHN GLUCK. "A Belmont Report for Animals?" Cambridge Quarterly of Healthcare Ethics 29, no. 1 (2019): 19–37. http://dx.doi.org/10.1017/s0963180119000732.

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Abstract:Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and populations. While

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12

Casanova Moreno, Maria de la Caridad, Francisco Machado Reyes, Wagner González Casanova, Daimy Casanova Moreno, and Diana Belkis Gómez Guerra. "Tuskegee experiment, bioethical violation as present and future in the development of human society." Seminars in Medical Writing and Education 3 (December 30, 2024): 612. https://doi.org/10.56294/mw2024612.

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Introduction. The Tuskegee Experiment was a clinical study between 1932 and 1972 in the American city of Tuskegee, by the United States Public Health Service. Objective. Describe the history of the Tuskegee experiment, as a violation of bioethics for the present and future in the development of human society. Material and method. A retrospective historical study was carried out where theoretical methods such as documentary and historical-logical analysis were used. Development. Six hundred African-American sharecroppers, mostly illiterate who did not give informed consent, were studied to obse

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13

Gathron, Erika. "Vulnerability in Health Care: A Concept Analysis." Creative Nursing 25, no. 4 (2019): 284–91. http://dx.doi.org/10.1891/1078-4535.25.4.284.

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This article introduces the concept of vulnerability in health care and explores the extant literature to determine its tenets. The debate over what constitutes ethical research is centered in part on the concept of vulnerability. The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978), the first human research ethics guideline to identify vulnerable groups, specified that those identified as vulnerable need extra protections during research participation. Identified limitations of the Belmont Report, especially with regard to r

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14

Jacobs, Frederic, and Arina Zonnenberg. "Tangible and intangible costs of "protecting human subjects": The impact of the National Research Act of 1974 onuniversity research activities." education policy analysis archives 12 (November 24, 2004): 65. http://dx.doi.org/10.14507/epaa.v12n65.2004.

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This article (1) examines the overall structure of regulatory research oversight in the United States; (2) details the origins and evolution of federal legislation pertaining to the protection of human subjects in biomedical and behavioral treatment and research; and (3) describes the expansion of oversight regulation from biomedical and behavioral treatment areas to the social sciences. In addition, the paper describes three areas identified by compliance administrators as susceptible to abuse: (1) informed consent, (2) assessment of risks and benefits, and (3) equitable selection of human su

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15

Ross, Lainie F., and J. Richard Thistlethwaite. "Developing an ethics framework for living donor transplantation." Journal of Medical Ethics 44, no. 12 (2018): 843–50. http://dx.doi.org/10.1136/medethics-2018-104762.

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Both living donor transplantation and human subjects research expose one set of individuals to clinical risks for the clinical benefits of others. In the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (National Commission) articulated three principles to serve as the basis for a research ethics framework: respect for persons, beneficence and justice. In contrast, living donor transplantation lacks a framework. In this manuscript, we adapt the three principles articulated in the Belmont Report to serve as the foundation for an et

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16

Deruelle, Fabien. "Microwave radiofrequencies, 5G, 6G, graphene nanomaterials: Technologies used in neurological warfare." Surgical Neurology International 15 (November 29, 2024): 439. http://dx.doi.org/10.25259/sni_731_2024.

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Background: Scientific literature, with no conflicts of interest, shows that even below the limits defined by the International Commission on Non-Ionizing Radiation Protection, microwaves from telecommunication technologies cause numerous health effects: neurological, oxidative stress, carcinogenicity, deoxyribonucleic acid and immune system damage, electro-hypersensitivity. The majority of these biological effects of non-thermal microwave radiation have been known since the 1970s. Methods: Detailed scientific, political, and military documents were analyzed. Most of the scientific literature

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17

Serpico, Kimberley. "The Belmont Report doesn’t need reform, our moral imagination does." Research Ethics, March 4, 2024. http://dx.doi.org/10.1177/17470161241235772.

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In 1974, the United States Congress asked a question prompting a national conversation about ethics: which ethical principles should govern research involving human participants? To embark on an answer, Congress passed the National Research Act, and charged this task to the newly established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission’s mandate was modest however, the results were anything but. The outcome was The Belmont Report: a trio of principles - respect for persons, beneficence, and justice - serving as an ethical compas

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18

Bowers, Olivia, and Mifrah Hayath. "Cultural Relativity and Acceptance of Embryonic Stem Cell Research." Voices in Bioethics 10 (May 16, 2024). http://dx.doi.org/10.52214/vib.v10i.12685.

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Photo ID 158378414 © Eduard Muzhevskyi | Dreamstime.com ABSTRACT There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities. INTRODUCTION Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding

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19

Pirzada, Nefes. "The Ethical Dilemma of Non-Human Primate Use in Biomedical Research." Voices in Bioethics 8 (February 27, 2022). http://dx.doi.org/10.52214/vib.v8i.9348.

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Photo by Ricky Kharawala on Unsplash INTRODUCTION When people think of biomedical research, they often envision rats kept in cages with scientists in white coats and blue gloves checking on them, taking notes, and injecting them with substances. The images make some people uncomfortable, evoking a twinge of guilt as they think of the rats suffering. However, the idea that the sacrifice of a few mice saves thousands of human lives may outweigh their guilty conscience. Based on arguments for and against non-human primate (NHP) use in research, this paper concludes that NHP use is scientifically

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20

Caesar Dib, Caio. "Bioethics-CSR Divide." Voices in Bioethics 10 (March 21, 2024). http://dx.doi.org/10.52214/vib.v10i.12376.

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Photo by Sean Pollock on Unsplash ABSTRACT Bioethics and Corporate Social Responsibility (CSR) were born out of similar concerns, such as the reaction to scandal and the restraint of irresponsible actions by individuals and organizations. However, these fields of knowledge are seldom explored together. This article attempts to explain the motives behind the gap between bioethics and CSR, while arguing that their shared agenda – combined with their contrasting principles and goals – suggests there is potential for fruitful dialogue that enables the actualization of bioethical agendas and provid

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21

Angela, Mitt. "education human capital and economic growth in Nigeria." August 13, 2020. https://doi.org/10.5281/zenodo.3982749.

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<strong>Gyeongsang University Turnitin Trash Files</strong> <strong>HUMAN CAPITAL NEXUS AND GROWTH OF NIGERIA ECONOMY</strong> <strong>CHAPTER ONE</strong> <strong>INTRODUCTION</strong> <strong>Background to the Study </strong> Government expenditure equally known as public spending simply refers to yearly expenditure by the public sector (government) in order to achieve some macroeconomic aims notably high literacy rate, skilled manpower, high standard of living, poverty alleviation, national productivity growth, and macro-economic stability. It is also expenditure by public authorities at va

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