Appendix E: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

2010 ◽  
pp. 233-243
Keyword(s):  
Human Subjects ◽  
Ethical Principles ◽  
Belmont Report ◽  
Protection Of Human Subjects

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.

Integrity in Research

2018 ◽  
pp. 397-416
Author(s):  
Sandra Carvalho ◽  
Gustavo Rivara ◽  
Andre Brunoni ◽  
Felipe Fregni
Keyword(s):  
Human Subjects ◽  
Research Misconduct ◽  
Research Integrity ◽  
Research Process ◽  
International Committee ◽  
Ethical Principles ◽  
Belmont Report ◽  
Subject Selection ◽  
Scientific Report ◽  
Ethics In Research

This chapter discusses authorship, ethics in research, plagiarism, and misconduct. It summarizes the general criteria for scientific report authorship according to the International Committee of Medical Journal Editors (ICMJE) and Ethics in Research. It discusses ethics in research, based on the famous Tuskegee syphilis study, and the Belmont Report that followed it. Three basic ethical principles derived from the Belmont Report—respect for persons, beneficence, and justice—and their impact on research with human subjects are discussed, along with the direct applications of these three ethical principles: informed consent, risk/benefit ratio, and subject selection. Finally, the chapter reviews the main aspects of research misconduct and presents some examples. Research integrity requires that the research process is governed by honesty, objectivity, and verifiable methods, instead of preconceived ideas and expectations. It is an important topic to be reviewed and discussed before anyone decides to pursue the field of clinical research.

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.

Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Cephalalgia ◽  
2021 ◽  
pp. 033310242110299
Author(s):  
Peer Tfelt-Hansen ◽  
Karsten Jørgensen ◽  
Hans-Christoph Diener
Keyword(s):  
Clinical Research ◽  
Migraine Attack ◽  
Human Subjects ◽  
Second Step ◽  
Controlled Trials ◽  
Scientific Rigor ◽  
Protection Of Human Subjects

Purpose In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo. Conclusion To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with “scientific rigor” in the second step of these trials, and this design is not recommended.

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.

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin
Keyword(s):  
United States ◽  
Human Subjects ◽  
Ethics Committees ◽  
The United States ◽  
Prior Review ◽  
Emerging Trends ◽  
Policies And Procedures ◽  
Behavioural Research ◽  
Individual Informed Consent ◽  
Protection Of Human Subjects

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.

New Beginnings

2017 ◽  
pp. 39-78
Author(s):  
J. Benjamin Hurlbut
Keyword(s):  
Human Subjects ◽  
National Commission ◽  
Vitro Fertilization ◽  
Department Of Health ◽  
Human In Vitro Fertilization ◽  
First Child ◽  
New Beginnings ◽  
Protection Of Human Subjects

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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