scholarly journals THE NUREMBERG TRIALS AND THEIR LEGACY FOR THE RIGHTS OF PATIENTS AND RESEARCH SUBJECTS

2015 ◽  
Vol 27 ◽  
pp. 258-278
Author(s):  
Paul Weindling
Keyword(s):  
Twentieth Century ◽  
Clinical Research ◽  
Human Subjects ◽  
Crimes Against Humanity ◽  
Research Subject ◽  
Research Subjects ◽  
Military Tribunal ◽  
Nuremberg Trials ◽  
The Voice ◽  
Nazi Doctors

When does clinical research designed to save lives and advance medicine become assault and murder? In the twentieth century the line between legitimate research on human subjects and criminal assault has been variously drawn. The demands of the researcher and the voice of the research subject and patient have received varying recognition. With the upswing of clinical research in the early twentieth century and some dramatic breakthroughs in medicine there was a tendency to heroise the researcher in the ‘fight’ against disease. In Nazi Germany, there were strong pressures to conduct research on lives deemed worthless in the hope of producing valuable breakthroughs in medical research to benefit the nation and race. After all, if the mentally ill and racially inferior Jews and Gypsies were going to be killed, their bodies might still serve a useful purpose. After WW2 the Nuremberg Trials were conducted on the basis of ‘crimes against humanity’, and by documenting wartime atrocities did much to safeguard human rights and dignity. After the four-power International Military Tribunal at Nuremberg came the trial against 20 Nazi doctors and three SS administrators: this concluded with a declaration on the conduct of research based on the autonomy and consent of the research subject.

Dubious Premises—Evil Conclusions: Moral Reasoning at the Nuremberg Trials

2000 ◽  
Vol 9 (2) ◽  
pp. 261-274 ◽  
Author(s):  
EDMUND D. PELLEGRINO ◽  
DAVID C. THOMASMA
Keyword(s):  
Moral Reasoning ◽  
Human Experimentation ◽  
Crimes Against Humanity ◽  
Free World ◽  
Military Tribunal ◽  
The Holocaust ◽  
The World ◽  
Medical Morality ◽  
Nuremberg Trials ◽  
Nazi Physicians

Fifty years ago, 23 Nazi physicians were defendants before a military tribunal in Nuremberg, charged with crimes against humanity. During that trial, the world learned of their personal roles in human experimentation with political and military prisoners, mass eugenic sterilizations, state-ordered euthanasia of the “unfit,” and the program of genocide we now know as the Holocaust. These physicians, and their colleagues who did not stand trial, were universally condemned in the free world as ethical pariahs. The term “Nazi doctor” became the paradigm for total defection from the most rudimentary elements of medical morality. The caduceus literally became the instrument of the swastika.

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines

2012 ◽  
Vol 40 (4) ◽  
pp. 841-847 ◽  
Author(s):  
Jonathan Kimmelman
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Clinical Development ◽  
Nuremberg Code ◽  
Human Research ◽  
Clinical Investigator ◽  
Nazi Doctors ◽  
Personal Interests

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of protection around the latter.As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence.

Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?

2009 ◽  
Vol 16 (4) ◽  
pp. 271-276
Author(s):  
CSK Tay
Keyword(s):  
Patient Safety ◽  
Informed Consent ◽  
Medical Ethics ◽  
Clinical Research ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Well Being ◽  
Research Subjects ◽  
Medical Research Ethics

Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.

Litigation in Clinical Research: Malpractice Doctrines versus Research Realities

2004 ◽  
Vol 32 (3) ◽  
pp. 474-484 ◽  
Author(s):  
E. Haavi Morreim
Keyword(s):  
Clinical Research ◽  
Human Subjects ◽  
New Drugs ◽  
National Commission ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Public Attention ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
Clinical Research Trials

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 setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.

scholarly journals Normative framework of informed consent in clinical research in Germany, Poland, and Russia

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcin Orzechowski ◽  
Katarzyna Woniak ◽  
Cristian Timmermann ◽  
Florian Steger
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Biomedical Research ◽  
Human Subjects ◽  
Ethical Conduct ◽  
Vulnerable Groups ◽  
Research Subjects ◽  
Normative Framework ◽  
Declaration Of Helsinki ◽  
Normative Requirements

Abstract Background Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. Trial registration: Not applicable.

A Living Wage for Research Subjects

2011 ◽  
Vol 39 (2) ◽  
pp. 243-253 ◽  
Author(s):  
Trisha B. Phillips
Keyword(s):  
Human Subjects ◽  
Crowding Out ◽  
Living Wage ◽  
Research Subject ◽  
Federal Regulations ◽  
Research Subjects ◽  
Wage Payment ◽  
Study Results ◽  
Undue Inducement ◽  
Protection Of Human Subjects

Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Some critics question whether researchers should be allowed to offer money at all, citing concerns about commodification of the research subject, invalidation of study results, and increased risks to subjects. Other critics are comfortable with the idea of monetary payments but question how much researchers can pay their subjects, citing concerns about undue inducement, crowding out, and monetary exploitation. Focusing only on the amount researchers can pay their subjects, this paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage.

Universal Suffrage as Decolonization

2021 ◽  
pp. 1-17
Author(s):  
KEVIN DUONG
Keyword(s):  
Twentieth Century ◽  
Cultural Revolution ◽  
Political Thought ◽  
Black Atlantic ◽  
Global Order ◽  
Historical Process ◽  
Nation States ◽  
Universal Suffrage ◽  
The Voice

This essay reconstructs an important but forgotten dream of twentieth-century political thought: universal suffrage as decolonization. The dream emerged from efforts by Black Atlantic radicals to conscript universal suffrage into wider movements for racial self-expression and cultural revolution. Its proponents believed a mass franchise could enunciate the voice of colonial peoples inside imperial institutions and transform the global order. Recuperating this insurrectionary conception of the ballot reveals how radicals plotted universal suffrage and decolonization as a single historical process. It also places decolonization’s fate in a surprising light: it may have been the century’s greatest act of disenfranchisement. As dependent territories became nation-states, they lost their voice in metropolitan assemblies whose affairs affected them long after independence.

Reigns of Terror

2005 ◽  
Vol 38 (1) ◽  
pp. 247-249
Author(s):  
Ron Wheeler
Keyword(s):  
Twentieth Century ◽  
Ethnic Conflict ◽  
Authoritarian Regimes ◽  
Crimes Against Humanity ◽  
Queen's University

Reigns of Terror, Patricia Marchak, Montreal: McGill-Queen's University Press, 2003, pp. xi, 306In Reigns of Terror, Patricia Marchak investigates “the causes and conditions that underlie crimes against humanity conducted under the aegis of states” (x). According to Marchak, most works on genocide (attacks on citizens because of their ethnicity or religion) and politicide (the eradication of people for mainly political reasons) are far too simplistic. She maintains that factors such as racism, ethnic conflict, authoritarian regimes or ideologies of intolerance and hatred are usually important, but each is nonetheless insufficient in explaining situations in the twentieth century in which governments attacked their own citizens.

The Social Value of Research and Health Research Priority-Setting

2021 ◽  
Author(s):  
D.M. Wenner
Keyword(s):  
Clinical Research ◽  
Priority Setting ◽  
Health Research ◽  
Human Subjects ◽  
Social Value ◽  
Research Priority ◽  
The Social ◽  
Research Questions ◽  
Social Scientific ◽  
Health Research Priority Setting

This chapter discusses the social value requirement in clinical research and its intersection with health research priority-setting. The social value requirement states that clinical research involving human subjects is only ethical if it has the potential to produce socially valuable knowledge. The chapter discusses various ways to specify both the justification for and the content of the social value requirement. It goes on to consider the implications of various accounts of the content and justification for the requirement for the ethics of health research priority-setting, showing that while some accounts of the requirement are largely silent with respect to how research questions should be prioritized, others entail robust obligations to prioritize research that might benefit particular groups. The chapter also briefly examines potential arguments for something like a social value requirement in other kinds of research, specifically social scientific research.

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