Works by Robert J. Levine
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- Informed Consent: Some Challenges to the Universal Validity of the Western Model.Robert J. Levine -1991 -Journal of Law, Medicine and Ethics 19 (3-4):207-213.
- Clarifying the Concepts of Research Ethics.Robert J. Levine -1979 -Hastings Center Report 9 (3):21-26.
- Building a New Consensus: Ethical Principles and Policies for Clinical Research on HIV / AIDS.Carol Levine,Nancy Neveloff Dubler &Robert J. Levine -1991 -IRB: Ethics & Human Research 13 (1/2):194-210.
- Pharmaceutical research involving the homeless.Tom L. Beauchamp,Bruce Jennings,Eleanor D. Kinney &Robert J. Levine -2002 -Journal of Medicine and Philosophy 27 (5):547 – 564.Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, (...) and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. (shrink)
- The Impact of HIV Infection on Society's Perception of Clinical Trials.Robert J. Levine -1994 -Kennedy Institute of Ethics Journal 4 (2):93-98.All international codes of research ethics and virtually all national legislation and regulation in the field of research involving human subjects project an attitude of protectionism. Written with the aim of avoiding a repetition of atrocities like those committed by the Nazi physician-researchers, calamities like the thalidomide experience, or ethical violations like those of the Tuskegee syphilis study, their dominant concerns are the protection of individuals from injury and from exploitation. In recent years, however, society's perception of clinical research has (...) shifted dramatically. Now, largely as a consequence of the efforts of the AIDS activists, clinical research is widely perceived as benign and beneficial. Although this shift in attitude has resulted in some important improvements in research policies and practices, this new perception is just as wrong-headed as was the earlier excessive protectionism. It is necessary to maintain a balanced perspective; our policies should encourage the conduct of ethical research while maintaining the vigilance necessary to safeguard the rights and welfare of the subjects. (shrink)
- Social Contexts Influence Ethical Considerations of Research.Robert J. Levine,Carolyn M. Mazure,Philip E. Rubin,Barry R. Schaller,John L. Young &Judith B. Gordon -2011 -American Journal of Bioethics 11 (5):24-30.This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. ?Social context? refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is (...) introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)
- (1 other version)The “Best Proven Therapeutic Method” Standard in Clinical Trials in Technologically Developing Countries.Robert J. Levine -1998 -Journal of Clinical Ethics 9 (2):167-172.No categories
- The Use of Placebos in Randomized Clinical Trials.Robert J. Levine -1985 -IRB: Ethics & Human Research 7 (2):1.
- Research ethics committees.Robert J. Levine -1995 -Encyclopedia of Bioethics 3:2311-2316.
- Uncertainty in Clinical Research.Robert J. Levine -1988 -Journal of Law, Medicine and Ethics 16 (3-4):174-182.
- The Nature, Scope, and Justification of Clinical Research.Robert J. Levine -2008 - In Ezekiel J. Emanuel,The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 211.
- (1 other version)Advice on Compensation: One IRB's Response to DHEW's 'Interim Final Regulation'.Robert J. Levine -1979 -IRB: Ethics & Human Research 1 (1):5.No categories
- FDA's New Rule on Treatment Use and Sale of Investigational New Drugs.Robert J. Levine -1987 -IRB: Ethics & Human Research 9 (4):1.
- Research that could yield marketable products from human materials: the problem of informed consent.Robert J. Levine -1985 -IRB: Ethics & Human Research 8 (1):6-7.
- What Should Consent Forms Say about Cash Payments?Robert J. Levine -1979 -IRB: Ethics & Human Research 1 (6):7.No categories
- Commentary: The Ambiguities of 'Deferred Consent'.Tom L. Beauchamp &Robert J. Levine -1980 -IRB: Ethics & Human Research 2 (7):6.No categories
- Case Studies: Can a Healthy Subject Volunteer to Be Injured in Research?Anthony Breuer,Robert J. Levine,George A. Kanoti &Douglas P. Lackey -1986 -Hastings Center Report 16 (4):31.
- Research on Human Populations: National and International Ethical Guidelines.Bernard M. Dickens,Larry Gostin &Robert J. Levine -1991 -Journal of Law, Medicine and Ethics 19 (3-4):157-161.
- More on Making Consent Forms More Readable.T. M. Grundner,Robert J. Levine &Alan Meisel -1982 -IRB: Ethics & Human Research 4 (1):8.No categories
- An IRB-approved protocol on the use of human fetal tissue.Robert J. Levine -1988 -IRB: Ethics & Human Research 11 (2):7-8.
- A Novelist's View of Scientific Fraud.Robert J. Levine &Carl Djerassi -1990 -Journal of Law, Medicine and Ethics 18 (4):422-422.
- According to Protocol.Robert J. Levine -1982 -IRB: Ethics & Human Research 4 (6):9.No categories
- Biomedical research ethics: updating international guidelines: a consultation: Geneva, Switzerland, 15-17 March 2000.Robert J. Levine,Samuel Gorovitz &James Gallagher (eds.) -2000 - Geneva: CIOMS.Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, especially (...) expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)
- Commentary: A Primary Reviewer System.Robert J. Levine -1981 -IRB: Ethics & Human Research 3 (6):9.No categories
- Changing Federal Regulation of IRBs: The Commission's Recommendations and the FDA's Proposals.Robert J. Levine -1979 -IRB: Ethics & Human Research 1 (1):1.No categories
- Changing Federal Regulation of IRBs, Part II: DHEW's and FDA's Proposed Regulations.Robert J. Levine -1979 -IRB: Ethics & Human Research 1 (7):1.No categories
- Can (Or Should) the IRB Assume the FDA's Functions at Early Stages of the IND Process?Robert J. Levine -1981 -IRB: Ethics & Human Research 3 (10):4.No categories
- Commentary: The IRB and the Virtuous Investigator.Robert J. Levine -1985 -IRB: Ethics & Human Research 7 (1):8.
- Consent to Incomplete Disclosure as an Alternative to Deception.Robert J. Levine -1982 -IRB: Ethics & Human Research 4 (10):9.No categories
- Deceiving Dentists: Health Care Providers as 'Subjects at Risk'.Robert J. Levine -1979 -IRB: Ethics & Human Research 1 (5):7.No categories
- (1 other version)Ethics and regulation of clinical research.Robert J. Levine -1981 - Baltimore: Urban & Schwarzenberg.
- Ethical Principles for the Conduct of Research Involving Human Subjects: Historical Considerations.Robert J. Levine -2004 -Journal of Clinical Ethics 15 (1):13-21.
- (1 other version)[How Many Subjects Are Required for a Study?]: Commentary.Robert J. Levine -1987 -IRB: Ethics & Human Research 9 (5):3.No categories
- Inconsistency and IRBs: Flaws in the Goldman-Katz Study.Robert J. Levine -1984 -IRB: Ethics & Human Research 6 (1):4.No categories
- Medical Ethics and Personal Doctors: Conflicts Between What We Teach and What We Want.Robert J. Levine -1990 -Journal of Clinical Ethics 1 (1):23-29.
- Medical Students as Social Scientists: Are There Role Conflicts?Robert J. Levine -1980 -IRB: Ethics & Human Research 2 (1):6.No categories
- Negotiating with George.Robert J. Levine -1992 -Ethics and Behavior 2 (1):68 – 71.
- Proposed Regulations for Research Involving Those Institutionalized as Mentally Infirm: A Consideration of Their Relevance in 1996.Robert J. Levine -1996 -IRB: Ethics & Human Research 18 (5):1.
- Randomized clinical trials: ethical considerations.Robert J. Levine -1999 -Advances in Bioethics 5:113-145.Export citation
Bookmark - Research Involving Children: An Interpretation of the New Regulations.Robert J. Levine -1983 -IRB: Ethics & Human Research 5 (4):1.No categories
- Research on Prisoners: Why Not?Robert J. Levine -1982 -IRB: Ethics & Human Research 4 (5):6.No categories
- Reflections on 'rethinking research ethics'.Robert J. Levine -2005 -American Journal of Bioethics 5 (1):1 – 3.
- Response to Open Peer Commentaries on “Social Contexts Influence Ethical Considerations of Research”.Robert J. Levine,Judith B. Gordon,Carolyn M. Mazure,Philip E. Rubin,Barry R. Schaller &John L. Young -2011 -American Journal of Bioethics 11 (5):W1-W2.This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. “Social context” refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is (...) introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)
- Such a Bargain!Robert J. Levine -1989 -Hastings Center Report 19 (1):45-45.
- Should I Enroll in a Randomized Clinical Trial? Excerpts from a Patient's Guide.Robert J. Levine -1988 -IRB: Ethics & Human Research 10 (2):10.
- Some reflections on postgraduate medical ethics education.Robert J. Levine -1997 -Ethics and Behavior 7 (1):15 – 26.Three goals of teaching medical ethics to physicians are reviewed., Components of a basic course in medical ethics are described with special attention to the roles of case conferences, ethics rounds, and role modeling. Obstacles to teaching ethics are also addressed.
- [The Doctor's Unproven Beliefs and the Subject's Informed Choice: Another Commentary]: Response.Robert J. Levine -1989 -IRB: Ethics & Human Research 11 (3):9.
- [The Doctor's Unproven Beliefs and the Subject's Informed Choice]: Commentary.Robert J. Levine -1988 -IRB: Ethics & Human Research 10 (3):5.No categories
- The Senate's Proposed Statutory Definition of 'Voluntary and Informed Consent'.Robert J. Levine -1980 -IRB: Ethics & Human Research 2 (4):8.No categories
- What Kinds of Subjects Can Understand This Protocol?Robert J. Levine -1984 -IRB: Ethics & Human Research 6 (5):6.No categories
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David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Area Editors:
David Bourget
Gwen Bradford
Berit Brogaard
Margaret Cameron
David Chalmers
James Chase
Rafael De Clercq
Ezio Di Nucci
Esa Diaz-Leon
Barry Hallen
Hans Halvorson
Jonathan Ichikawa
Monte Johnson
Michelle Kosch
Øystein Linnebo
Paul Livingston
Brandon Look
Manolo Martínez
Matthew McGrath
Michiru Nagatsu
Susana Nuccetelli
Giuseppe Primiero
Jack Alan Reynolds
Darrell P. Rowbottom
Aleksandra Samonek
Constantine Sandis
Howard Sankey
Jonathan Schaffer
Thomas Senor
Daniel Star
Jussi Suikkanen
Aness Kim Webster
Other editors
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