Professor of Modern History - University of Kent
Histoire de la médecine
Human Research Ethics and the Declaration of Helsinki, 1964-2014
The articles published as part of this project will raise and address a series of fundamental questions: Is our current human protection regime – which effectively originates from the mid-1960s – adequately equipped to deal with new ethical challenges resulting from advances in high-tech biomedical science that were unknown to, and perhaps even unforeseeable by, those who drew up the first Declaration? For example, is the Declaration the appropriate framework for scientists and organisations trying to create hybrid organisms or human/non-human chimeras? Is it ethical to inject human brain stem cells into the brains of mice to study neurodegenerative diseases? What changes to our ethical and legal framework have been made in the past, and how effective are they? How can we explain the ever more frequent revision process? What is the legal status of the Declaration, and how does it interact or conflict with other regulatory systems? Does the Declaration have universal application, or is it ‘culture-relative’ and of questionable value to scientists and participants in developing nations? Does the Declaration achieve a fair and just balance between facilitating the development of biomedical science and protecting vulnerable participants?
For all those questions, the Declaration of Helsinki is currently the main reference points from which to begin the search for answers. Over half-a-century, this ‘living document’ has been criticised and revised many times, most recently in 2013, yet its standing as of one the most globally-accepted ethical codes remains largely undisputed. At the same time, it is far from certain whether today’s existing global framework provides sufficient guidance for tomorrow’s research practices. The book gives an overview of some of the major achievements in the field, and addresses future challenges in, and visions for, biomedical research ethics. Those working in the field are only just beginning to realise the enormous implications of – and demands on – our existing system of research governance. Today, an expanded remit of the Declaration attempts to offer ethical leadership in an increasingly complex environment, a process which at times has been equally disconcerting for those advocating freedom of science as it has been for those trying to protect vulnerable and disadvantaged populations.
Given its reach and significance, the Declaration not only provides an ideal ‘vehicle’ to study the ethical, legal and social implications of biotechnology in a fast-evolving global economy; the debates which surround it also reflect those developments. A more informed understanding of biomedical research ethics will help to tackle present challenges in health and medical care, biosecurity, civilian and military research contexts. The book will explore the ethics of clinical trials, particularly in relation to placebo-controlled trials, and address current debates on genetic screening, stem cell research and reproductive technologies, thus making an important contribution to contemporary debates on bioethics and human rights in medical science. By placing the Declaration into a broader, multi-disciplinary context, it will also offer greater insights into the way in which researchers, national governments, funding bodies and non-state actors respond to newly-formulated ethical codes, and thus enrich our understanding of the merits and effectiveness of the existing regulatory system.
Secret Science of Man: A History of Chemical and Biological Weapons' ResearchThis book project addresses a series of inter-related questions: To what extent are medical ethics applied, and are they applied equally, in all research contexts, including those which are generally hidden from public view because of their military relevance or national security classifications? What role does secrecy play as one of many justification strategies for ethical decision making in military research contexts? In other words, are medical ethics standards monitored and enforced uniformly in both civilian and military science? Historically, we still know surprisingly little about the factors and forces responsible for shaping the formation of different medical ethics cultures and practices in past societies. For example, do the risks involved for those participating in human experiments increase during times of war, and if so, how are these risks justified by military and medical experts and the agencies of the state? How does the potential threat of war, a recurring feature of the Cold War, effect military and civilian research ethics? What are the similarities and differences in applied research ethics in war, in which military forces are involved in active combat operations, compared to periods of heightened military preparedness? Can we detect a decline in upholding professional ethics standards in non-therapeutic research on humans in national emergencies, especially in relation to bioethical principles such as informed consent, non-humiliation, beneficence and non-maleficence (to do no harm)? Or, seen in more general terms, is it true that ‘things can happen in war that would not be tolerated in peacetime’, as some scholars have suggested? Answering these questions will offer insight into the ethics of clinical trials and research on human subjects, and into the way in which politics and law shaped the practice of research ethics during the Cold War. Given the public interest in this subject, the project is likely to make a substantial contribution to the history of chemical weapons’ programmes, and create fruitful debate among public policy makers and the wider public.
Medical ethics and human rights in medicine: reassessing 50 years of the Declaration of Helsinki, 1964-2014
ULF SCHMIDT is Professor of Modern History at the University of Kent, Canterbury, Founding Director of Kent’s Center for the History of Medicine, Ethics and Medical Humanities, and a Fellow of the Royal Historical Society. He was previously Wellcome Trust Post-Doctoral Research Fellow, Senior Associate Member of St Antony’s College, Oxford, and Research Associate at the Wellcome Unit for the History of Medicine at the University of Oxford. His research interests are in the area of the history of modern medical ethics, warfare and policy in twentieth-century Europe and the United States. He has published widely on the history of Nazi Germany, the history of human experimentation during the Cold War, the Nuremberg Doctors’ Trial and the Nuremberg Code, the history of eugenics and euthanasia, and the history of medical film and propaganda. He is the author, among others, of “Medical Films, Ethics and Euthanasia in Germany, 1933–1945” (2002), of “Justice at Nuremberg: Leo Alexander and the Nazi Doctors’ Trial” (2004), of (together with Andreas Frewer) “History and Theory of Human Experimentation. The Declaration of Helsinki and Modern Medical Ethics” (2007), of (together with Andreas Frewer) Standards der Forschung. Historische Entwicklung und ethische Grundlagen klinischer Studien (2007), and of “Karl Brand: The Nazi Doctor. Medicine and Power in the Third Reich” (2007), recently published in German as “Hitlers Arzt Karl Brandt. Medizin und Macht im Dritten Reich” (2009). Professor Schmidt has received awards and fellowships from various funding bodies (DAAD, KIASH, CHF, Wellcome Trust, Leverhulme Trust, Conanima Foundation etc.) and is currently the principal investigator of a Wellcome Trust-funded project on “Cold War at Porton Down: Medical Ethics and the Legal Dimension of Britain’s Biological and Chemical Warfare Programme, 1945–1989”. During his 2012 stay at the Brocher Foundation, Switzerland, he will jointly work with Professor A. Frewer (Erlangen-Nürnberg University) on the project “Medical Ethics and Human Rights in Medicine: Reassessing 50 Years of the Declaration of Helsinki, 1964-2014” which will involves archival and library work at the World Medical Association and World Health Organisation. The findings will be published, among others, in an edited collection of articles to mark the 50th anniversay of the Declaration of Helsinki in 2014.
For full details see http://www.kent.ac.uk/history/staff/profiles/Schmidt.html
Professor of Modern History - University of Kent (UK)