scholarly journals A Belmont Report for Animals?

2019 ◽  
Vol 29 (1) ◽  
pp. 19-37 ◽  
Author(s):  
HOPE FERDOWSIAN ◽  
L. SYD M JOHNSON ◽  
JANE JOHNSON ◽  
ANDREW FENTON ◽  
ADAM SHRIVER ◽  
...  
Keyword(s):  
Ethical Issues ◽  
Human Subjects ◽  
The United States ◽  
Animal Research ◽  
Ethical Principles ◽  
Belmont Report ◽  
National Commission ◽  
Research Subjects ◽  
Human Research ◽  
Respect For Autonomy

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 current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability.

Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research

2011 ◽  
Vol 39 (3) ◽  
pp. 488-501 ◽  
Author(s):  
Ana S. Iltis
Keyword(s):  
United States ◽  
Human Subjects ◽  
United States Public Health ◽  
The United States ◽  
National Commission ◽  
Human Research ◽  
Common Rule ◽  
Department Of Health ◽  
The Common ◽  
Protection Of Human Subjects

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 Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

scholarly journals Some Questions of Ethics in RCTs

2021 ◽  
Author(s):  
Reetika Khera
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Belmont Report ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

The Ethical Challenges of Animal Research

2015 ◽  
Vol 24 (4) ◽  
pp. 391-406 ◽  
Author(s):  
HOPE R. FERDOWSIAN ◽  
JOHN P. GLUCK
Keyword(s):  
England Journal ◽  
Informed Consent ◽  
New England ◽  
Animal Research ◽  
Ethical Challenges ◽  
Research Subjects ◽  
Human Research ◽  
Ethical Justification ◽  
Influential Paper ◽  
Moral Problems

Abstract:In 1966, Henry K. Beecher published an article entitled “Ethics and Clinical Research” in the New England Journal of Medicine, which cited examples of ethically problematic human research. His influential paper drew attention to common moral problems such as inadequate attention to informed consent, risks, and efforts to provide ethical justification. Beecher’s paper provoked significant advancements in human research policies and practices. In this paper, we use an approach modeled after Beecher’s 1966 paper to show that moral problems with animal research are similar to the problems Beecher described for human research. We describe cases that illustrate ethical deficiencies in the conduct of animal research, including inattention to the issue of consent or assent, incomplete surveys of the harms caused by specific protocols, inequitable burdens on research subjects in the absence of benefits to them, and insufficient efforts to provide ethical justification. We provide a set of recommendations to begin to address these deficits.

Developing an ethics framework for living donor transplantation

2018 ◽  
Vol 44 (12) ◽  
pp. 843-850 ◽  
Author(s):  
Lainie F Ross ◽  
J Richard Thistlethwaite
Keyword(s):  
Living Donor ◽  
Human Subjects ◽  
Well Being ◽  
Vulnerable Groups ◽  
Belmont Report ◽  
National Commission ◽  
Research Participants ◽  
Ethics Framework ◽  
Living Donor Transplantation ◽  
Clinical Benefits

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 ethics framework for living donor transplantation which we supplement with the principles of vulnerability and responsibility. The National Commission supported additional protections for vulnerable groups of potential research participants. In 2001, Kenneth Kipnis effectively argued that the concept of vulnerable groups failed to explore in what ways particular groups of people were vulnerable, thereby risking unnecessary protections for some and inadequate protections for others. He proposed a taxonomy that explored different types of vulnerabilities that all research participants may experience to provide a more robust framework for human subjects protections, which we adapt to living donors. Robert Goodin claims that health professionals, who stand in special relationship with patients, are responsible for promoting and protecting their well-being. In living donor transplantation, the donor transplant team is responsible for empowering prospective donors to address their vulnerabilities and/or for protecting those who cannot by disqualifying them from donation.

scholarly journals Facebook Recruitment and the Protection of Human Subjects

2019 ◽  
Vol 41 (9) ◽  
pp. 1270-1281 ◽  
Author(s):  
Kendra Kamp ◽  
Kayla Herbell ◽  
William H. Magginis ◽  
Donna Berry ◽  
Barbara Given
Keyword(s):  
Social Media ◽  
Data Security ◽  
Human Subjects ◽  
Ethical Principles ◽  
Belmont Report ◽  
Respect For Persons ◽  
Ethical Challenges ◽  
Recruitment Method ◽  
Research Participants ◽  
Protection Of Human Subjects

Social and behavioral scientists increasingly use Facebook to recruit research participants. Given the everchanging social media landscape, it is important to consider the ethical principles of using such a strategy. The aims of this methodological article are to (a) examine Facebook recruitment in light of the ethical principles of the Belmont Report (respect for persons, beneficence, and justice), (b) describe ethical challenges that may be faced in Facebook recruitment, and (c) provide recommendations for researchers interested in adopting this recruitment method. Ethical challenges inherent in Facebook recruitment include selecting subjects fairly, privacy, and data security. Overall, Facebook is a beneficial resource for recruiting participants into research; however, researchers need to be aware of their responsibility in protecting human subjects.

The Quest for Compensation for Research-Related Injury in the United States: A New Proposal

2019 ◽  
Vol 47 (4) ◽  
pp. 732-747 ◽  
Author(s):  
Carolyn Riley Chapman ◽  
Sangita Sukumaran ◽  
Geremew Tarekegne Tsegaye ◽  
Yelena Shevchenko ◽  
Arthur L. Caplan
Keyword(s):  
The United States ◽  
Compensation System ◽  
Research Subjects ◽  
Multiple Stakeholders ◽  
Additional Advantage ◽  
Human Research ◽  
Advantages And Disadvantages ◽  
Moral Justifications ◽  
Human Research Subjects ◽  
The U.S

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.

scholarly journals Responsible research for the construction of maximally humanlike automata: the paradox of unattainable informed consent

2017 ◽  
Vol 22 (4) ◽  
pp. 297-305 ◽  
Author(s):  
Lantz Fleming Miller
Keyword(s):  
Informed Consent ◽  
Research And Development ◽  
Human Subjects ◽  
Moral Rights ◽  
Human Beings ◽  
Research Subjects ◽  
Nuremberg Code ◽  
Human Research ◽  
Ethical Codes ◽  
Responsible Research

Abstract Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical codes become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically.

scholarly journals Neuroethics and Animals: Report and Recommendations From the University of Pennsylvania Animal Research Neuroethics Workshop

ILAR Journal ◽  
2021 ◽  
Author(s):  
Adam J Shriver ◽  
Tyler M John
Keyword(s):  
Animal Models ◽  
Ethical Issues ◽  
The United States ◽  
Animal Research ◽  
Early Years ◽  
University Of Pennsylvania ◽  
Ethical Implications ◽  
Neuroscience Research ◽  
Nonhuman Animals ◽  
The University

Abstract Growing awareness of the ethical implications of neuroscience in the early years of the 21st century led to the emergence of the new academic field of “neuroethics,” which studies the ethical implications of developments in the neurosciences. However, despite the acceleration and evolution of neuroscience research on nonhuman animals, the unique ethical issues connected with neuroscience research involving nonhuman animals remain underdiscussed. This is a significant oversight given the central place of animal models in neuroscience. To respond to these concerns, the Center for Neuroscience and Society and the Center for the Interaction of Animals and Society at the University of Pennsylvania hosted a workshop on the “Neuroethics of Animal Research” in Philadelphia, Pennsylvania. At the workshop, expert speakers and attendees discussed ethical issues arising from neuroscience research involving nonhuman animals, including the use of animal models in the study of pain and psychiatric conditions, animal brain-machine interfaces, animal–animal chimeras, cerebral organoids, and the relevance of neuroscience to debates about personhood. This paper highlights important emerging ethical issues based on the discussions at the workshop. This paper includes recommendations for research in the United States from the authors based on the discussions at the workshop, loosely following the format of the 2 Gray Matters reports on neuroethics published by the Presidential Commission for the Study of Bioethical Issues.

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