Declaration of Helsinki Purpose
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Report on the 2014 National Summit of Investigator-Initiated Clinical Trials Networks
REPORT ON THE 2014 NATIONAL SUMMIT OF INVESTIGATOR-INITIATED CLINICAL TRIALS NETWORKS 28 – 29 MARCH 2014 Supported by the National Health and Medical Research Council Acknowledgements The National Summit of Investigator-Initiated Clinical Trials Networks (ACTA Summit) held 28–29 March 2014, Melbourne, was supported by the National Health and Medical Research Council. ACTA gratefully acknowledges the generous support received from Bellberry Limited, major sponsor of the ACTA Summit 2014. Thank you to all members of the faculty and to everyone who attended and participated in the ACTA Summit. Summit Organising Committee Professor Steve Webb (Convenor) Immediate Past Chair, ANZICS Clinical Trials Group Professor Andrew Davidson Chair, Paediatric Trials Network Australia Professor Tony Keech Deputy Director, NHMRC Clinical Trials Centre Ms Imelda Lynch Director, Bellberry Limited Dr Gordon McGurk ISBN 978-0-9941667-0-8 Director, Strategic Policy Group, NHMRC Dr Clive Morris, © Copyright Australian Clinical Trials Alliance Limited (ABN 60 168 693 972), September 2014. Head, Strategic Policy Group, NHMRC This work is subject to copyright. Apart from any use as permitted under the Professor John Simes Copyright Act, no part may be reproduced without the permission of Australian Director, NHMRC Clinical Trials Centre Clinical Trials Alliance Limited (ACTA). Opinions expressed in this report are not necessarily those of ACTA. ACTA cannot accept responsibility for any errors Ms Rhiannon Tate and omissions. Executive Officer, ACTA This publication -
Declaration of Helsinki (1964)
Declaration of Helsinki (1964) [CIRP Note: Ethical research on human subjects into or about the effects of circumcision must be conducted under the provisions of this declaration and those of the Nuremberg Code.] Recommendations guiding physicians in biomedical research involving human subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland,June 1964, amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975, and the 35th World Medical Assembly, Venice, Italy, October 1983. Introduction It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfilment of this mission. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration,"and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient. " The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. In the field of biomedical research a fundamental distinction must be recognised between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research. -
Alex John London, Ph.D. Clara L
Alex John London, Ph.D. Clara L. West Professor of Ethics and Philosophy Carnegie Mellon University Curriculum Vitae Department of Philosophy & 4/24/20 Work: 412-268-4938 Center for Ethics and Policy Fax: 412-268-1440 Carnegie Mellon University [email protected] Pittsburgh, PA 15213-3890 https://orcid.org/0000-0002-6450-0309 https://www.scopus.com/authid/detail.uri?authorId=7005248959 EDUCATION Ph.D. Philosophy, The University of Virginia, May 1999. Dissertation: Virtue, Wisdom, and the Art of Ruling in Plato. M.A. Philosophy, The University of Virginia, May 1996. B.A. Philosophy and Literature, Bard College, May 1994. AREAS OF SPECIALIZATION AREAS OF COMPETENCE Bioethics, Ethical Theory, Ancient Philosophy, Conflict Resolution AI Ethics, Political Philosophy Wittgenstein, Criminal Justice Ethics FACULTY APPOINTMENTS 2017—Clara L. West Professor of Ethics and Philosophy, Carnegie Mellon University 2015-2020 Director, Ethics History and Public Policy Major. 2012— Professor of Philosophy, Carnegie Mellon University. 2007— Director, Center for Ethics and Policy, Carnegie Mellon University. 2005-2012 Associate Professor of Philosophy, Carnegie Mellon University. 2001— Affiliate Faculty Member, University of Pittsburgh, Center for Bioethics and Health Law. 2000-2005: Assistant Professor of Philosophy, Carnegie Mellon University. 1999-2000: Post-Doctoral Fellow, Center for Bioethics, University of Minnesota 1999: Instructor in Philosophy, The University of Virginia. HONORS AND AWARDS John & Marsha Ryan Bioethicist-in-Residence, Southern Illinois University School of Law, March 20-22, 2019. Bruce E. Siegel Memorial Lecture, Mount Carmel Health System, Columbus Ohio, Nov. 14, 2018 Elliot Dunlap Smith Award for Distinguished Teaching and Educational Service, 2016 (college wide award for excellence in teaching). -
Informed Consent and Shared Decision Making in EBM
3 Informed Consent and shared decision making in EBM 3.1 ‘Informed consent’ in regular medical practice ‘Consent’ as it is understood in the medical context has to be asked from the pa- tient and is the explicit agreement to waive a right to certain rules and norms which are normally expected in the treatment of other people and of ourselves as patients. Every surgical procedure would, without consent from the patient, be legally un- derstood as assault and battery and the physician could be prosecuted for perform- ing it. ‘Informed consent’ therefore in its most simple form means that the patient has received a good explanation about a medical procedure, understands what is happening to him or her and then can make an informed choice to accept or refuse, in the latter case the so called ‘informed refusal.167 In order to give ‘informed con- sent the patient has to be capable of understanding the information given by the physician. He or she must be competent to decide and to give consent voluntarily without being coerced by any means into giving consent.168 ‘Autonomy’ of the patient, hereby equated with ‘person’ plays the overarching role in ‘informed con- sent.’ A competent person who exercises autonomy will have the final say about their own life. ‘Autonomy’ itself is a contested term in the philosophy of science and interpretations therefore vary. According to Dworkin, “Liberty (positive or negative) ... dignity, integrity, individuality, independence, responsibility and self knowledge ... self assertion ... critical reflection ... freedom from obligation ... ab- sence of external causation ... and knowledge of one’s own interests.”169 all fall under the definition of autonomy. -
Ethics of Clinical Research- Potential and Enrolled Subjects' Protection
Texila International Journal of Clinical Research Volume 6, Issue 1, Aug 2019 Ethics of Clinical Research- Potential and Enrolled Subjects’ Protection Article by Alpana Razdan Head Genekart Research and Diagnostics Laboratory New Delhi E-mail: [email protected] Abstract This paper examined the ethics of Clinical Research and the protection of potential and enrolled human subjects. Clinical research is a lengthy and costly process. Subject recruitment and retention are an essential step to help lowering the cost and the length of clinical trials. Good quality research is crucial for determining the clinical and cost effectiveness of health care systems, at the same time recruitment of sufficient participants is a cornerstone for good quality research that tests hypotheses with confidence and minimizes bias. In this paper, I had the opportunity to highlight some ethical concerns and considerations that are related to recruiting human subjects in clinical research. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. This report serves as guidance for biomedical and behavioural researchers to find a summary of the basic ethical principles to protect human subjects basically: beneficence, justice, and respect for individuals. The existing literature on the subject was reviewed all along to contextualize the study. I have used observation during the field trips and hands on knowledge of recruiting human subjects carried in my job. The process of informed consent is crucial in achieving these principles. In order to protect human subjects, the informed consent process involves the verbal discussion with the possible subject along with the paper document. -
(IRBS) and the Globalization of Clinical Research: Can Ethical Oversight of Human Subjects Research Be Standardized?
Washington University Global Studies Law Review Volume 15 Issue 2 2016 Research Ethics Committees (RECS)/Institutional Review Boards (IRBS) and the Globalization of Clinical Research: Can Ethical Oversight of Human Subjects Research be Standardized? Andrea S. Nichols Follow this and additional works at: https://openscholarship.wustl.edu/law_globalstudies Part of the Biochemistry, Biophysics, and Structural Biology Commons, Bioethics and Medical Ethics Commons, Health Law and Policy Commons, Laboratory and Basic Science Research Commons, Medical Jurisprudence Commons, and the Science and Technology Law Commons Recommended Citation Andrea S. Nichols, Research Ethics Committees (RECS)/Institutional Review Boards (IRBS) and the Globalization of Clinical Research: Can Ethical Oversight of Human Subjects Research be Standardized?, 15 WASH. U. GLOBAL STUD. L. REV. 351 (2016), https://openscholarship.wustl.edu/law_globalstudies/vol15/iss2/8 This Note is brought to you for free and open access by the Law School at Washington University Open Scholarship. It has been accepted for inclusion in Washington University Global Studies Law Review by an authorized administrator of Washington University Open Scholarship. For more information, please contact [email protected]. RESEARCH ETHICS COMMITTEES (RECS)/INSTITUTIONAL REVIEW BOARDS (IRBS) AND THE GLOBALIZATION OF CLINICAL RESEARCH: CAN ETHICAL OVERSIGHT OF HUMAN SUBJECTS RESEARCH BE STANDARDIZED? INTRODUCTION Current United States’ policy requires federally funded research studies involving human subjects to be approved by an interdisciplinary committee called an institutional review board (IRB).1 IRBs exist to protect the safety and welfare of human subjects participating in research studies. Although oversight of human subjects research and, consequently, IRBs, is governed by federal regulations, the operation of IRBs remain largely mysterious to those other than IRB members themselves. -
Revised Ethical Guidelines in Indian Biobanking
Revised Ethical Guidelines In Indian Biobanking: Do We Need To Downregulate the Proposed Frameworks? Juhi Tayal1, Anurag Mehta2 and Alok Kumar1 1 Biorepository, Department of Research, Rajiv Gandhi Cancer Institute and Research Centre, India 2 Department of Laboratory Sciences and Molecular Diagnostics, RGCI&RC, India 1,2 Sec-5,Rohini, New Delhi, India-110085 Email: [email protected]/ [email protected] BACKGROUND Guideline for Indian Biobanks ABSTRACT • Clinical biobanks are gaining popularity in India and are also revolutionizing research. Indian • Biomedical research in India has revolutionized with the changing times. This Council for Medical Research(ICMR),Council for Scientific and Industrial Research (CSIR) and paradigm shift has not only bought greater complexities but also greater Department of Biotechnology (DBT) are the major agencies supporting research in India. The ICMR responsibilities for policy makers ,researchers and stakeholders. The is the national organization and also the apex body for developing ethical frameworks and guidelines advancement is not limited to basic research or clinical research ,it has now and also enforcing them. The ICMR issued the Policy Statement on Ethical Considerations Involved taken a foothold into Digital imaging and Artificial intelligence platforms as in Research on Human Subjects in 1980. Due to rapid advancement in biomedical sciences new well. ethical dimensions have emerged and nesseciated the updation of these guidelines time and again in • The aim of policy makers worldover was to safeguard four basic ethical 2000,2003, 2013 and very recently in 2017. The revision has introduced many new sections and principles for research involving human subjects: respect for persons, also revamped the existing sections .A new Section 11 was dedicated to Biological materials, beneficence, non-maleficence and justice. -
Position on Physician Participation in Torture
Society of General Internal Medicine Position on Physician Participation in Torture 2018 Prepared by Carolyn Kreinsen, P. Preston Reynolds, Katherine McKenzie, Tom Comerci, Oliver Fein on behalf of Global Health and Human Rights Interest Group, Ethics Committee, and Health Policy Committee The Society of General Internal Medicine resolves that health care professionals, with a specific focus on physicians, • Shall not knowingly provide any research, instruments, or knowledge that facilitates the practice of torture or other forms of cruel, inhuman, or degrading treatment or cruel, inhuman, or degrading punishment; • Shall not knowingly participate in any procedure in which torture or other forms of cruel, inhuman, or degrading treatment or punishment is used or threatened; • Shall attempt to stop torture or other cruel, inhuman, or degrading treatment or punishment, where a health care professional is present, and failing that, exit the procedure; • Shall be alert to acts of torture and other cruel, inhuman, or degrading treatment or punishment and have the ethical responsibility to report these acts to the appropriate authorities. • Shall not participate in interrogation of detainees. This includes providing medical clearance for interrogation, treating or reviving interrogates during questioning, monitoring interrogations or helping design interrogations(1) • Shall not force feed detainees participating in voluntary protest fasting (“hunger strikes”)(2-5) The Society of General Internal Medicine believes the Department of Defense should • ensure that military health care provider’s first ethical obligation is to the patient. • excuse health care professionals from performing medical procedures that violate their professional code of ethics (6) • implement the recommendations of the Defense Health Board Ethics Subcommittee related to training of military health professionals in concepts of dual loyalty and ethics of combat to ensure maintenance of high ethical standards of health professionals in the field of operation. -
Ethical Considerations in Treatment and Research in Spinal Injuries
ETHICAL CONSIDERATIONS IN TREATMENT AND RESEARCH IN SPINAL INJURIES By Dr. H. L. FRANKEL National Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury, England As specialists in spinal injuries we take our teaching on ethics from the main stream of medical opinion. The portion of the Hippocratic Oath relevant to today's discussion in an English version is 'I will use treatment to help the sick according to my ability and judgement, but never with a view to injury or wrong-doing'. Medical ethics throughout the world were based to a greater or lesser extent on the Hippocratic Oath, depending on local customs. Following World War II and the Nuremberg War Crimes Commission, the World Health Organisation set up a commission in Paris in 1947 which was extended and became the Declaration of Geneva 1948 (fig. 1). This is very similar to the Hippocratic Oath and is of a very general nature. DECLARATION OF GENEVAl 'At the time of being admitted as a member of the Medical Profession: I solemnly pledge myself to consecrate my I ife to the service of humanity. I will give to my teachers the respect and gratitude which is their due; I will practise my profession with conscience and dignity; The health of my patient will be my first consideration; I will respect the secrets which are confided to me; I will maintain by all the means in my power, the honour and the noble traditions of the medical profession; My colleagues will be my brothers; I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient; I will maintain the utmost respect for human life, from the time of conception; even under threat, I will not use my medical knowledge contrary to the laws of humanity. -
Hippocratic Oath and Conversion of Ethico-Regulatory Aspects Onto Doctors As a Physician, Private Individual and a Clinical Inve
REVIEW ARTICLE Hippocratic oath and conversion of ethico-regulatory aspects onto doctors as a physician, private individual and a clinical investigator Mohammed Imran, Shadab Samad1, Mohammad Maaz2, Ashhar Qadeer3, Abul Kalam Najmi4, Mohammed Aqil5 Department of Pharmacology, Hamdard Institute of Medical Sciences and Research, 1Department of Medicine, Maulana Azad Medical College and LNJP Hospital, Departments of 2Moalijat, and 3Kulliyat, Faculty of Medicine, Departments of 4Pharmacology, and 5Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard (Hamdard University), New Delhi, India ABSTRACT Hippocratic Oath is a living document for ethical conduct of the physicians around the world. World Medical Association has been amending the oath as per the contemporary times. Although physicians maintain their ethical standards while treating a patient yet many a times social, administrative and ruling powers either use physicians as their tool of oppression or victimize them for conducting duties as per their oath. The Tuskegee Syphilis Study and Human Radiation Experiments in America, Nazi Experiments in Germany and compulsory sterilization program in India were the studies where States used physicians for the advancement of their rationality or belief. Conversely victimization of physicians in Kosovo, Sri Lanka and incarcerating physicians for treating human immunodeficiency virus/acquired immunodeficiency syndrome patients in some countries is concerning. The Nuremberg code, the Declaration of Geneva, Belmont Report and Declaration of Helsinki -
Considerations for Informed Consent in Clinical Trials Involving Neonates J
Considerations for Informed Consent in Clinical Trials Involving Neonates J. Jina Shah, Omar Khwaja, Sangeeta Jethwa, Tim Seabrook, Ariella Kelman Conducting clinical research in newborns requires special protections due to the high vulnerability of this patient population and their parents. Approaches to informed consent for neonatal research require unique considerations. This paper presents a review of the ethics literature on this topic, including factors such as parental attitudes regarding informed consent, the manner in which a healthcare professional presents a family with the option to participate in a trial, and the role of ethics review bodies. This paper also presents guidance developed from our experience working with a multidisciplinary group of bioethicists and patient advocates to consider patient- and parent-centric approaches to informed consent practices in neonatal research, in the context of an ongoing clinical trial for neonates with spinal muscular atrophy (SMA). Introduction Conducting clinical research in very young children a clinical trial in SMA type 1 (SMA1), the trial sponsor requires special protections and ethical considerations. sought to determine best practices for informed The inclusion of children in research has increased consent of parents of neonates with a new diagnosis substantially in recent history, and advances in genetic of a rare genetic disease. This paper presents a review research have led to an increase in the number of of the clinical research ethics literature on this topic trials for children with genetic diseases, many of and guidance developed from working with a cross- which are rare and affect newborns. A search of the disciplinary group of bioethics advisors and patient clinical trials registry ClinicalTrials.gov revealed 1829 advocates. -
WORLD MEDICAL ASSOCIATION DECLARATION of HELSINKI Adopted by the 18Th World Medical Assembly, Helsinki, Finland, June 1964
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975; 35th World Medical Assembly, Venice, Italy, October 1983; and the 41st World Medical Assembly, Hong Kong, September 1989. O. Introduction I. Basic Principles II. Medical Research Combined with Clinical Care (Clinical Research) III. Non-Therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research) Introduction It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission. The Declaration of Geneva of the World Medical Assembly binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care, which might have the effect of weakening the physical and mental condition of the patient." The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures, and the understanding of the aetiology and pathogenesis of disease. In current medical practice, most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research. Medical progress is based on research, which ultimately must rest in part on experimentation involving human subjects. In the field of biomedical research, a fundamental distinction must be recognized between medical research, in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research.