Equality Trust AUTHENTICITY Diversity FAIRNESS Beneficencefair Responsibilityautonomy Accountability S Integrity Courage O Balance C Respect Truth I SINCERITY
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Interfaces Between Bioethics and the Empirical Social Sciences
Interfaces between bioethics and the empirical social sciences Publication Series – 2002 Regional Program on Bioethics Division of Health and Human Development Pan American Health Organization World Health Organization Third Meeting of the International Advisory Board on Bioethics Pan American Health Organization World Health Organization October 2nd – 3th, 2001 Buenos Aires, Argentina INTERFACES BETWEEN BIOETHICS AND THE EMPIRICAL SOCIAL SCIENCES Fernando Lolas S. Lorenzo Agar C. Editors 3 Regional Program on Bioethics OPS/OMS Publication Series - 2002 The present edition belongs to Publication Series - 2002 of Regional Program on Bioethics. Under the title: Interfaces of Bioethics and the Social Science. It contains the documents elaborated by the members of the International Bioethics Advisory Committee of PAHO, that was established in the first official meeting held on October 2-3, 2001 in Buenos Aires, Argentina. N° de Inscripción 127-372 ISBN 956-7938-02-4 This publication of 1.000 copies was printed at august of 2002 PRINTED IN CHILE 4 Interfaces between bioethics and the empirical social sciences CONTENTS • Foreword 9 George A. O. Alleyne • Empirical Social Science Studies and Bioethics. An Interface for the Regional 11 Program on Bioethics Fernando Lolas Stepke • What is Bioethics? A history 15 James F. Drane • Equity, Quality, and Patients Rigths: Can They Be Reconciled? 33 Daniel Callahan • Why Justice is Good for our Health 37 Norman Daniels • Pharmacogen-ethics 53 Diego Gracia Guillén • Unresolved Issues in Social Science Research 67 Ruth Macklin • Placebo Controls in Clinical Trials when there are Known Effective Treatments 79 Robert J. Levine • Polls and Focus Groups in Bioethics: The Case of Resource Allocation 91 Daniel Wikler • The Relevance of Empirical Research for Bioethics 99 Ezekiel J. -
The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research
THE BELMONT REPORT ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979 SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. -
Curriculum Vitae
DANIEL CALLAHAN January 2008 Director International Program The Hastings Center Garrison, N.Y. 10524-5555 (914) 424-4040 BIOGRAPHICAL Born July 19, 1930, Washington, D.C. Married to Sidney deShazo Callahan, Ph.D. (a social psychologist); six children: Mark, Stephen, John, Peter, Sarah and David. Address: Box 260, Hudson House, Ardsley-on- Hudson, New York 10503. Sgt., U.S. Army, 1952-55 (Counterintelligence Corps). EDUCATION B.A. Yale University (1952), English and Psychology major M.A. Georgetown University (1957), Philosophy Ph.D. Harvard University (1965), Philosophy ADMINISTRATIVE, RESEARCH AND EDITORIAL POSITIONS Director, International Programs, The Hastings Center, 1997- Fellow, Institution for Social and Policy Studies, Yale University, 2004- Senior Research Fellow, Department of Philosophy, Yale University, 2004- Senior Lecturer, Harvard Medical School, 1998- Visiting Fellow, Harvard Center for Population and Development Studies, 1996 President and Co-Founder, The Hastings Center, 1969-1996 Staff Associate, The Population Council, 1969-1970 Executive Editor, Commonweal, 1961-1968 PROFESSIONAL ACTIVITIES Special Consultant, Presidential Commission on Population Growth and the American Future (1970-71) Consultant, Ad Hoc Committee on S-hemoglobinopathies, National Academy of Sciences - National Research Council (1972) Selection Committee, Ford-Rockefeller Program in Population Policy (1972-75) Selection Committee, National Book Awards (1975) Council Member, New York Council for the Humanities (1975-79) Member, New York Health Advisory -
2017 Annual Report
extincti De- on natal Scree Pre ning Sequen Gene cing R I T O R Y E R T D cial Intelligen E rtifi ce T A R A H C N Gene Editing U mous V tono ehicl Au es GUIDGUIDANCEANCE Data Privacy The Hastings Center ANNUAL REPORT 2017 P opulation Aging TABLE OF CONTENTS 1 From the President 2 Guiding the Future of the Human Species • Public Engagement around the World 6 Guiding the Fate of the Earth 8 Guiding the Way to More Just and Compassionate Health Care 10 2017 Projects and Scholars 11 2017 Visiting Scholars 12 2017 Board of Directors 13 2017 Hastings Center Events and Meetings 14 Hastings Center Advisory Council 16 Donors 20 Statement of Financial Position inside back cover Current Staff FROM THE PRESIDENT Dear Friends and Colleagues, The year 2017 at The Hastings Center was one of expanding reach and impact. Our scholars traveled the globe, speaking to audiences across and beyond the United States, from Boston to Denver, from Serbia to New Zealand. We published our analyses and recommendations in top-flight scientific and medical journals, but made sure our ideas went far beyond the academy. We advised journalists, scientists, policymakers, health care practitioners, and individuals facing hard choices in their own lives. We convened meetings that brought together experts from diverse disciplines who are rarely in the same room, as well as stakeholders with vastly different perspectives. As this report’s cover design illustrates, through these events and con- Mildred Z. Solomon venings, The Hastings Center serves as a compass. -
EMERGING Technologies the Wise Use Of
2015 Annual Report THE WISE USE OF EMERGING TECHNOLOGIES The Hastings Center is an independent, Director of Communications and nonpartisan, and nonprofit bioethics research Development: Bill Jeffway institute founded in 1969. Hastings’ mission Writer: Susan Gilbert is to address fundamental ethical issues in Art Director: Nora Porter the areas of health, health care, life sciences Hastings Photography: Siofra Vizzi research, and the environment as they affect individuals, communities, and societies. ©2016 The Hastings Center To obtain a copy of The Hastings Center’s complete financial statement for 2015, please write to the Development Department, The Hastings Center, 21 Malcolm Gordon Road, Garrison, NY 10524. The Hastings Center 21 Malcolm Gordon Road Garrison, NY 10524 Tel 845-424-4040 Fax 845-424-4545 [email protected] www.thehastingscenter.org @hastingscenter facebook.com/hastingscenter 2015 HASTINGS CENTER ANNUAL REPORT TABLE OF CONTENTS 2 From the President 3 The Wise Use of Emerging Technologies l New Genetics Technologies l Artificial Intelligence l Big Data l Brain Science l Prenatal Testing 14 Significant Scholarship on Other Topics 18 Our Scholars and Projects at a Glance 19 Hastings Center Fellows Retreat 20 Donors 24 Statement of Financial Position inside back cover Hastings Center Board of Directors and Staff FROM THE PRESIDENT Shaping the future ~ wisely Dear Friends and Colleagues, We live in an age of transformative scientific powers, capable of changing the very nature of the human species and radically remaking the planet itself. These new powers hold great promise for enhancing health and well-being. However, no technology is neutral. As Stephen Hawking recently put it, “Our future is a race between the growing power of technology and the wisdom with which to use it.” The Hastings Center’s goal is to help forge that wisdom. -
Code Gray.Pub
Written by Christine Mitchell, RN, FAAN and Ben Achtenberg with a historical commentary by Susan Reverby, PhD and assistance from Joan Sawyer and Karen Wolf, RN, MS Contents INTRODUCTION ....................................................................................... 3 Background ............................................................................................3 Synopsis of the Film ..............................................................................3 Suggested Uses .......................................................................................4 Scheduling ..............................................................................................4 FILM AS A TOOL FOR DISCUSSION .......................................................4 WHAT IS NURSING ETHICS? ...................................................................5 GLOSSARY ...................................................................................................5 SOME GENERAL DISCUSSION QUESTIONS ........................................6 CASE 1: BENEFICENCE ............................................................................7 Description of the Case .........................................................................7 The Principle: Beneficence ...................................................................7 Questions for Discussion ......................................................................8 CASE 2: AUTONOMY ................................................................................9 Description -
Institutional Review Board (IRB)
Institutional IRB Essentials: Review All research team members need to complete the Board (IRB) Human Subjects Research course in CITI before the IRB application can be approved. This includes the Protecting the rights and welfare faculty advisor and students. CITI: of human subjects involved in www.citiprogram.org research activities You need to have final, written IRB approval before you begin. All consent forms and study materials must be approved by the IRB before being used. It’s fine if you’ve already started a literature review, but the IRB review and approval must be completed before you involve any human subjects in your research, including any study advertisement or subject recruitment. Office of Research Assurances (ORA) Morrill114 Hall, Room What is the Institutional Levels of review for IRB How long is the process? Review Board (IRB)? determination Providing that you (and your research team) have done your part in completing As Federally mandated, The University of • Full [convened] Committee Review- the Human Subjects Protection course Idaho IRB is an ethics committee greater than minimal risk through CITI and submitting all of the composed of scientists and non- • Expedited Review-no more than correct documents, then the IRB office scientists who serve as advocates for minimal risk can usually process Exempt reviews human subjects involved in research. • Exempt Review-less than “minimal within one business week and Expedited The IRB is charged with the risk” reviews within two to three business responsibility of reviewing and • Not Human Subjects Research weeks. If we need to contact you for overseeing human subjects research additional information or corrections, conducted by UI researchers. -
Chapter 2 the Underlying Principles of Ethical Patient Care
Chapter 2 The Underlying Principles of Ethical Patient Care Medical ethics is based on a series of ethical principles that are particularly relevant to medical practice and patient care. The principles were first developed by Tom Beauchamp and James Childress in their 1979 book, Principles of Biomedical Ethics, now in its fifth edition. Since then they have become recognized and used by those who work in medical ethics, training medical students and residents, working as eth- ics consultants in health care institutions, and serving on hospital ethics committees. These principles are included in the “common morality,” so they will be accepted by most members of the society. They are derived from classical ethical theories and are presupposed by traditional codes of medical ethics. The principles of medical ethics make several contributions to patient care and decision making in the medical context. They offer a way to approach ethical dilemmas that arise in the course of practicing medicine, making difficult health care decisions, and interacting with patients and their families. The principles pro- vide a way to organize our thinking about ethical issues in patient care and a shared language for health care providers to discuss these issues. Finally, the principles call attention to aspects of a medical situation that might be overlooked, and remind us that medicine is, ultimately, an ethical enterprise. Beauchamp and Childress introduced four basic principles of medical ethics: Principles of 1) Beneficence, 2) Non-Maleficence, 3) Respect for Autonomy, and 4) Justice. In this book we have expanded the original list of four principles to include the Principle of Respect for Dignity and the Principle of Veracity to include elements of patient care and medical decision making that are not explicitly covered by the original four principles, such as emotions and relationships; privacy and bodily integrity; religious, social, and cultural differences; and the importance of good communication skills. -
Protecting Human Research Participants NIH Office of Extramural Research Introduction
Protecting Human Research Participants NIH Office of Extramural Research Introduction Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. Who? This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research. What? This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Why? As a part of NIH's commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000. -
Autonomy in Research: Respect for Persons and Informed Consent
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this site. Copyright 2006, The Johns Hopkins University and Holly Taylor. All rights reserved. Use of these materials permitted only in accordance with license rights granted. Materials provided “AS IS”; no representations or warranties provided. User assumes all responsibility for use, and all liability related thereto, and must independently review all materials for accuracy and efficacy. May contain materials owned by others. User is responsible for obtaining permissions for use from third parties as needed. Ethical Analysis Holly Taylor, MPH, PhD Johns Hopkins University Ethical Analysis Topics to be covered – Introduction to ethics – Framework for ethical analysis – Supplementing the framework 3 Section A Introduction to Ethics Normative Ethical Theory Person(s) Actions Consequences Continued 5 Normative Ethical Theory Virtue theory Consequentialist theory Non-consequentialist theory 6 Virtue Theory (Aristotle) Focus on person Cultivation of virtuous traits Image Source: www.epistemelinks.com Continued 7 Virtue Theory (Aristotle) “A just person—that is a person with the virtue of fairness—not only has the disposition to act fairly, but when so acting has a morally appropriate desire to do so. The person characteristically has a moral concern and reservation about acting in a way that would be unfair (p. 214).” Source: Beauchamp, -
1 DAN W. BROCK E-Mail
CURRICULUM VITAE DAN W. BROCK e-mail: [email protected] CURRENT POSITION Senior Scientist (2002 -- ) Head, Section on Public Health (2002 -- ) Warren Magnuson Clinical Center National Institutes of Health, Bethesda, Maryland, U.S.A. EDUCATION Ph.D. (Philosophy) - 1970 Columbia University Dissertation: "Authority, Morality and the Possibilities of Unanimity in Political Decision- making," directed by Robert Paul Wolff New York University Graduate School of Business, 1961-1963; no degree B.A. (Economics) - 1960 Cornell University OTHER AND PREVIOUS ACADEMIC POSITIONS COLUMBIA UNIVERSITY Preceptor, September 1966 - January 1969. BROWN UNIVERSITY: Assistant Professor of Philosophy, July 1969 - June 1975. Associate Professor of Philosophy, July 1975 - June 1981. Chair, Department of Philosophy, 1980-86. Professor of Philosophy, July 1981 - 1991 Professor of Human Values in Medicine, July 1986 – 1991 1 Professor of Philosophy and Biomedical Ethics, 1991 – 2002 Director, Center for Biomedical Ethics, 1991 – 2002 University Professor, 1994 – 1997 Charles C. Tillinghast, Jr. University Professor 1997 – 2002 Principal Department Service--Brown University Colloquium Director, 1970-71. Member, Placement Committee, 1971-72, 1973-74 through 1975-76. Undergraduate Concentration Advisor, Ethics and Political Philosophy Concentration, 1971-72 through 1975-76; 1988-1991 Director of Graduate Studies, 1973-74 through 1975-76. Executive Officer, 1976-1980; 1986-89 Chair, Curriculum Committee 1976-1986. Member, Committee on Teaching Evaluation, 1977-78. Acting Department Chair, Spring 1978; Spring 1989. Department Chair, 1980-86. Freshman Advisor, several years. Also service on numerous search, evaluation, screening, graduate admission, promotion and other committees. Principal University Service-- Brown University Secretary, 1971-72. Concentration Committee on Public Policymaking, 1971-72 through 1973-74. -
Violence and the Politics of Research the HASTINGS CENTER SERIES in ETHICS
Violence and the Politics of Research THE HASTINGS CENTER SERIES IN ETHICS ETHICS TEACHING IN HIGHER EDUCATION EdIted by Daniel Callahan and 5155elll Bok MENTAL RETARDATION AND STERILIZATION A Problem of Competency and Paternalism Edited by Ruth Macklm lind WIllard Gllylm THE ROOTS OF ETHICS: Science, Religion, and Values EdIted by Damel Call1lhan and H. TrIStram Engelhllrdt, Jr. ETHICS IN HARD TIMES Edited by Arthur L. Caplan and Damel Callahan VIOLENCE AND THE POLITICS OF RESEARCH EdIted by Wlllllrd Gaylm, Ruth Mackhn, and Tabltlm M. Powledge WHO SPEAKS FOR THE CHILD: The Problems of Proxy Consent EdIted by Wdlard Gllylm and Ruth Mllcklm A Continuahon Order Plan IS available for thIS senes A conhnuahon order will bnng delIvery of each new volume ImmedIately upon publication Volumes are billed only upon actual shIpment For further mformahon please contact the publisher Violence and the Politics of Research Edited by Willard Gaylln The Hastings Center Hastings-an-Hudson, New York Ruth Macklin Albert Einstein College of Medicine Bronx, New York and Tabitha M. Powledge Center for Science and Technology Policy New York University New York, New York PLENUM PRESS • NEW YORK AND LONDON Library of Congress CatalogIng in Publication Data MaIn entry under title' Violence and the politics of research (The Hastings Center series In ethics) Bibliography: p. Includes index. 1 VlOlence-Research-Umted States-Addresses. essays, lectures 2 Aggres· siveness (Psychology)-Addresses, essays, lectures 3. VIOlence-United States Case studies-Addresses, essays,