Table Of Content

Philosophy and Medicine P&M132 Tomas Zima David N. Weisstub Editors Medical Research Ethics: Challenges in the 21st Century Philosophy and Medicine Founding Editors H. Tristram Engelhardt Jr. Stuart F. Spicker Volume 132 Series Editors Søren Holm, The University of Manchester, Manchester, UK Lisa M. Rasmussen, UNC Charlotte, Charlotte, USA Editorial Board George Agich, National University of Singapore, Singapore, Singapore Bob Baker, Union College, Schenectady, NY, USA Jeffrey Bishop, Saint Louis University, St. Louis, USA Ana Borovecki, University of Zagreb, Zagreb, Croatia Ruiping Fan, City University of Hong Kong, Kowloon, Hong Kong Volnei Garrafa, International Center for Bioethics and Humanities, University of Brasília, Brasília, Brazil D. Micah Hester, University of Arkansas for Medical Sciences, Little Rock, AR, USA Bjørn Hofmann, Norwegian University of Science and Technology, Gjøvik, Norway Ana Iltis, Wake Forest University, Winston-Salem, NC, USA John Lantos, Childrens’ Mercy, Kansas City, MO, USA Chris Tollefsen, University of South Carolina, Columbia, USA Dr Teck Chuan Voo, Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore The Philosophy and Medicine series is dedicated to publishing monographs and collections of essays that contribute importantly to scholarship in bioethics and the philosophy of medicine. The series addresses the full scope of issues in bioethics and philosophy of medicine, from euthanasia to justice and solidarity in health care, and from the concept of disease to the phenomenology of illness. The Philosophy and Medicine series places the scholarship of bioethics within studies of basic problems in the epistemology, ethics, and metaphysics of medicine. The series seeks to publish the best of philosophical work from around the world and from all philosophical traditions directed to health care and the biomedical sciences. Since its appearance in 1975, the series has created an intellectual and scholarly focal point that frames the field of the philosophy of medicine and bioethics. From its inception, the series has recognized the breadth of philosophical concerns made salient by the biomedical sciences and the health care professions. With over one hundred and twenty five volumes in print, no other series offers as substantial and significant a resource for philosophical scholarship regarding issues raised by medicine and the biomedical sciences. · Tomas Zima David N. Weisstub Editors Medical Research Ethics: Challenges in the 21st Century Editors Tomas Zima David N. Weisstub Charles University International Academy of Law and Prague, Czech Republic Mental Health Montreal, QC, Canada ISSN 0376-7418 ISSN 2215-0080 (electronic) Philosophy and Medicine ISBN 978-3-031-12691-8 ISBN 978-3-031-12692-5 (eBook) https://doi.org/10.1007/978-3-031-12692-5 © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland Preface Governments for three quarters of a century have elucidated legislation with the aim of reflecting public attitudes while simultaneously accommodating to scientific needs. In the earliest period following the Second World War, there were signals towards the international community that respect for persons was the uncompromising value for every form of experimentation. The grand statement of this value occurred in the trials of the Nazi doctors and became a reference point for subsequent codes and judicial decisions. Regrettably though it behoves us to confront the actual impact of this much-acclaimed protection because a close look reveals some disturbing features. The ethical guidelines proclaimed in the Weimar Republic were well articulated in the period preceding the Nazi regime. In fact, the ‘Richtlinien’ was binding law through the end of 1945. The law was stricter and in greater detail than the Nuremberg Code of 1947 and the Helsinki Code of 1964. What then is the significance of such a powerful detail? It is that legal regulations without application are irrelevant if the political arm is disrespectful and even worse. The celebration of the Nuremberg Code is not borne out by the subsequent conduct of American authorities. Approximately, 760 Austrian and German scientists were employed by the American ‘Project Paperclip’ that ended in 1955. Four of the accused, although exonerated at the Nuremberg trials, were employed by the US military. There were a number of defendants taken on by the US Air Force until their arrest. Among them was Hermann Becker-Frieyzing, who was sentenced for his experiments on freezing, high altitude, and sulfanilamide. Blome, who infamously did plague experiments in the concentration camps, was given a job in 1951 with the US Chemical Corps on Project 63. Having been denied US immigration clear- ance, he then was taken on as a camp doctor at Oberusal at the European Command Intelligence Center. In addition, a substantial number of the accused were integrated into the phar- maceutical companies of post-war Germany. Finally, in the Tokyo war crime trials, Japanese doctors who experimented on prisoners of war in China during World War II to test the effects of biological weapons were not prosecuted because an agreement v vi Preface was made for them to disclose the results of their experiments to the US military officials. Are the aforementioned a testimonial to the propensity even of liberal democracies to identify worthiness wherever needed in the so-called public interest, with technical science achieved at the expense of vulnerable citizens? The Nuremberg trial was mainly avoided in medical journals because the horrors of Nazi Germany were perceived as being far away from the practices of post-war scientists in the Western democracies. Researchers distinguished themselves away from the unspeakable acts and thought that there was little to learn in the consolidation of rules that could be relevant to their ongoing work. The national interests prevailed in the US and elsewhere. On the judicial side of the equation, the record of the lack of identification with the harmed parties substantiates this. The US Supreme Court decision of 1987, under- lined by Justice Scalia for the majority, pushed away ‘Stanley’1 who was a victim of LSD experimentation. This was the infamous CIA project named MKUltra, where brainwashing techniques involving some two hundred researchers were conducted in eighty institutions. Incidentally, the MKUltra records were evacuated by the head of the CIA in 1973. Justice Scalia concluded that ‘Stanley’ suing the armed forces would undermine military discipline and decided that the CIA activities were protected in the name of national defence and security. Admittedly, there were a number of stinging dissents in this case. Justice Brennan noted that ‘the government of the United States treated thousands of its citizens as though they were laboratory animals’. In his view, this exposed the extent to which American legal bodies at the highest level sacrificed the abuse of citizens under the penumbra of national security. Sadly, the perpetration of indefensible acts against ‘Stanley’ and a host of others were most likely conducted by civilians whose activities were covered up by the US military. There has been much publicity given to the radiation experiments which involved the Navajo Indian Miners, who were not warned of the dangers of uranium. The US public health service failed to inform the miners even after the dangers were known; this was also done with the cooperation of the mine owners. The Court in Begay versus USA2 superseded the claim to human rights violations by rendering its decision in favour of the Federal Tort Claims Act which protected defendants as acting based on a discretionary function. In addition to the Navajo community, radiation exposure cases involved prisoners, patients with a limited lifespan, and citizens at large. Canada no less participated in horrific experimentation at the Royal Victoria Hospital connected to McGill University. Deep patterning experiments were conducted by Prof. Donald Ewen Cameron of the Allan Memorial Institute. This was denounced in recent decades as highly destructive, unprofessional, and tanta- mount to torture. Although there were reparation payments made by the Government 1 US vs. Stanley, 107 US 3054 (1987). 2 Begay vs. US, 768F. 2D. 1049, 4th Cir. 1985. Preface vii of Canada in the late eighties, there appears to have been no settlements from the American government. Dr. Cameron held such positions as president of both the Canadian and American Psychiatric Associations as well as the World Psychiatric Association. His case has stood out as what can occur when a powerful figure is given official grant money, in this case by the CIA, which led to extraordinary violations. It is interesting to observe that in his defense leading psychiatric experts came forward to excuse his excesses as errors or misadventures but not rising to the level of negligence or professional misconduct. Following these post-war histories that reached into the 1960s, there were certain milestone contributions such as Jay Katz’s pioneer ‘Experimentation with Human Beings’ published in 1972. The late sixties and seventies heralded the onset of exten- sive works by bioethicists dedicated to elevating the principle of autonomy as the core value for the protection of vulnerable populations. In this regard, we should take note of the National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioural Research, identified as the Belmont report of 1979. No less the Council for International Organizations of Medical Sciences and the World Health Organization issued guidelines in 1982. Moving further in time the European Council in what was called the Oviedo Conven- tion in 1997 enunciated that the human being must supersede the interests of society and/or science. The modern world has taken us into the sphere of breakthrough technology, rapidly evolving, for example, in the instance of gene editing. Leading institutions have jumped into the fray, such as the UK Nuffield Council in 2018 and the US National Academies in 2017, demanding that regulatory frameworks be put into place to guard against unsatisfactory violations with regard to risks. Medical interventions which have had a massive play in the public media have announced a new era begging for international accords and for liberal democracies to take the lead in controlling what may be termed questionable ‘morally defensible advances’. Shadowing this has been imposing political movements involving gender and race. This has frequently been accompanied by multicultural claims connected to religious identity and so-called ethnic minorities. Such pressures have contempo- raneously amounted to a mushrooming almost to the level of the industrialization of bioethics. With the rapid advancement of biotechnology, areas such as genetics, neuroscience, and artificial intelligence have put into place a dramatic upheaval of the well-worn bioethical liberal mantras, now reduced to very practical questions of the applicability of abstractions to practicality. This has been exacerbated by a turn towards autocratic political regimes and the leap frogging, for example, of the Chinese economy, which many observers now believe can potentially lay waste to the consensus morality of Western liberal democracies on questions of human rights in the medical sphere. What was accomplished in a period of anti-paternalism and the respect for autonomy may conceivably, and even predictably, go into retreat in a world of viii Preface shrinking economic efficacy. One at this point can be justified to be fearful of domi- nance by newly emerging economic elites who might wish to produce a new morality or at least a profoundly different one from the prevailing liberal reference points. Are we on the verge of transforming our very notion of personhood? For colleagues with a philosophical bent, the looming question may become how the core values of the enlightenment are in the course of being displaced by the reckoning of collective survival. In the world of bioethics, we can see this highlighted in the emotionally charged debates on the right to secure medically assisted dying. Finally, in the face of managed care and corporate provider organizations, much of what we have known as the core values of the liberal traditions in bioethics are being put to demanding tests. If it is the case that the health systems will be compromised in being answerable to cost-saving governments and/or shareholders in insurance endeavours, the threats and burdens upon philosophers and practitioners alike can already be acknowledged to be formidable. This volume is aimed to engage a diverse multidisciplinary readership in reviewing multinational perspectives on pressing ethical issues in medical research. The founda- tional essays are meant to engage readers at every level, from students to professional researchers, in revisiting philosophical premises that still remain both controversial and significant to working out the fundamentals of bioethics. Vulnerability, which is a concept that lies at the bedrock of applied bioethics, is treated historically and philosophically. This is a mirror of contest and debate within research ethics committees, seminars from the beginning to the advanced, and thereby offering a research tool to lead the reader to associated writings. The ultimate purpose is to lead off discussions where answers are subject to reflection rather than uncontested conclusions. A number of authors have ventured novel inroads to understanding how to approach the categorization of subjects, such as in neuroscience, showing the rele- vance of epidemiology for the future of research undertakings. In the field of repro- ductive research, which is an area of profound differentiation, authors have presented a point of view that is deserving of respectful responses from thinkers who will oppose the premises. What motivates medical research is dealt with once again as a position which should engage the perennial debates about the very foundations of the ethics of medical research. Chapters are directed to tackle how the benefits and risks are weighed in the course of medical research. A powerful question is how this applies to the world of the non-consenting and what the significance of state-of-the-art areas such as stem cell research hold out for bioethics now and in future projections. The pathway towards a sensitive reaction to dementia research is treated creatively in order to introduce justifiable inclusions of dementia suffers in research. Exagger- ated claims of stem cell and regenerative medicine research are deconstructed and presented for cautious consideration. The problem of shared information which is an escalating intervention into privacy rights is so threatening in the short term that all citizens may become research subjects without acceptance or even awareness. Neuroscience research where enormous interest and investments are now norma- tive is given an in depth look at the ethical mishaps that are now intrinsic to the Preface ix evolution in process. A repetitious and gnawing ethical dilemma is addressed about the role of prisoners in the world of medical research. An innovative area to date under-researched is dealt with in investigating the special problems that occur in the field of surgery. The essential banning of research into the world of psychedelic experiences is revisited through an elaborate philosophical raising of compelling questions that invite major philosophical and empirical analyses. Risk assessment is a loaded inquiry, and the role and function of healthcare professionals is put under a magnifying glass in terms of the rights and obligations that occur in a world disturbed by rising acts of violence and terrorism. The limitations of the bioethical model are addressed by the manner in which PTSD is currently dealt with in research. The coro- navirus pandemic is introduced through the intriguing vantage point of constitutional law and ethics. A number of chapters continue the timely response to COVID-19 and its association to the mounting of research and the ambiguities of physicians’ moral duties about access to care. This work has attempted to avoid parochialism and in this vein has reached out to introduce the readership to European, African, and Asian experiences. It is foreseen that these chapters in particular will introduce researchers and students alike to bodies of knowledge of law, philosophy, and social policy which are otherwise not readily available. Prague, Czech Republic Tomas Zima Montreal, Canada David N. Weisstub