Rosamond Rhodes

Rethinking research ethics.

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for researchs social purpose, and the introduction of an untenable distinction between innovation and research.

Whistleblowing in academic medicine

Although medical centres have established boards, special committees, and offices for the review and redress of breaches in ethical behaviour, these mechanisms repeatedly prove themselves ineffective in addressing research misconduct within the institutions of academic medicine. As the authors see it, institutional design: (1) systematically ignores serious ethical problems, (2) makes whistleblowers into institutional enemies and punishes them, and (3) thereby fails to provide an ethical environment. The authors present and discuss cases of academic medicine failing to address unethical behaviour in academic science and, thereby, illustrate the scope and seriousness of the problem. The Olivieri/Apotex affair is just another instance of academic medicine’s dereliction in a case of scientific fraud and misconduct. Instead of vigorously supporting their faculty member in her efforts to honestly communicate her findings and to protect patients from the risks associated with the use of the study drug, the University of Toronto collaborated with the Apotex company’s “stalling tactics,” closed down Dr Olivieri’s laboratory, harassed her, and ultimately dismissed her. The authors argue that the incentives for addressing problematic behaviour have to be revised in order to effect a change in the current pattern of response that occurs in academic medicine. An externally imposed realignment of incentives could convert the perception of the whistleblower, from their present caste as the enemy within, into a new position, as valued friend of the institution. The authors explain how such a correction could encourage appropriate reactions to scientific misconduct from academic medicine.

Trust and Transforming Medical Institutions

Medicine needs our trust. We need to be able to rely on individual clinicians and researchers, and we need to be able to have confidence in hospitals and clinics. Yet the organization of our healthcare institutions is not designed to promote that trust. In fact, the structure of our medical institutions seems to undermine our faith.

The Blackwell guide to medical ethics

Notes on Contributors. Introduction: Rosamond Rhodes (Mount Sinai School of Medicine), Leslie P. Francis (University of Utah) and Anita Silvers (San Francisco State University). Part I: Individual Decisions About Clinical Issues. I.1: Patient Decisions. 1. Autonomy, the Good Life and Controversial Choices: Julian Savulescu (University of Oxford). 2. Individual Responsibility and Reproduction: Rachel A. Ankeny (University of Sydney). 3. Patient and Family Decisions about Life-Extension and Death: Felicia Nimue Ackerman (Brown University). I.2: Individual Decisions of Physicians and Other Health Care Professionals. 4. The Professional Responsibilities of Medicine: Rosamond Rhodes (Mount Sinai School of Medicine). 5. Truth telling: Roger Higgs (Emeritus, Kings College, London). 6. Medical Confidentiality: Kenneth Kipnis (University of Hawaii at Manoa). 7. Patient Competence and Surrogate Decision-Making: Dan W. Brock (Harvard Medical School). 8. Ending Life: F.M. Kamm (Harvard University). 9. Discrimination in Medical Practice: Justice and the Obligations of Health Care Providers to Disadvantaged Patients: Leslie P. Francis (University of Utah). 10. Institutional Practices, Ethics, and the Physician: Mary V. Rorty (Stanford University), Ann E. Mills (University of Virginia), and Patricia H. Werhane (DePaul University). Part II: Legislative and Judicial Decisions About Social Policy. II.2: Liberty. 11. Reproductive Choice: Rebecca Bennett (University of Manchester) and John Harris (University of Manchester). 12. Public Policy and Ending Lives: Evert van Leeuwen (Vrije Universiteit Medisch Centrum), and Gerrit Kimsma (Vrije Universiteit Medisch Centrum). 13. Drug Legalization: Douglas N. Husak (Rutgers University). 14. Selling Organs, Gametes, and Surrogacy Services: Janet Radcliffe Richards (University College, London). 15. The Patient as Victim and Vector: The Challenge of Infectious Disease for Bioethics: Margaret P. Battin (University of Utah), Leslie P. Francis (University of Utah), Jay A. Jacobson (University of Utah), Charles B. Smith (Emeritus, University of Utah). 16. Uses of Science in Medical Ethics: Glenn McGee (Albany Medical College) and Dyrleif Bjarnadottir. 11.2: Justice. 17. Allocation of Scarce Resources: Paul Menzel (Pacific Lutheran University). 18. Just Caring: The Challenges of Priority-Setting in Public Health: Leonard M. Fleck (Michigan State University). 19. Justice and the Financing of Health Care: Stephen R. Latham (Quinnipiac University). 20. Judgment and Justice: Evaluating Health Care for Chronically Ill and Disabled Patients: Anita Silvers (San Francisco State University). 21. Justice in Research on Human Subjects: David R. Buchanan (National Cancer Institute, Bethesda), and Franklin G. Miller (National Institutes of Health, Bethesda). 22. Ethics of Disclosure Following a Medical Injury: Time for Reform?: Troyen Anthony Brennan (Emeritus, Harvard Medical School). 23. Pre-existing Conditions: Genetic Testing, Causation and the Justice of Medical Insurance: Robert T. Pennock (Michigan State University). Index

Transplant Tourism in China: A Tale of Two Transplants

The use of organs obtained from executed prisoners in China has recently been condemned by every major transplant organization. The government of the Peoples Republic of China has also recently made it illegal to provide transplant organs from executed prisoners to foreigners transplant tourists. Nevertheless, the extreme shortage of transplant organs in the U.S. continues to make organ transplantation in China an appealing option for some patients with end-stage disease. Their choice of traveling to China for an organ leaves U.S. transplant programs with decisions about how to respond to the needs of patients who return after transplantation. By discussing two cases that raised this dilemma, we argue for upholding medicines commitments to traditional principles of beneficence and nonjudgmental regard in sorting out the policies that a transplant program should adopt. We also explain how position statements that aim for the high ground of moral purity fail to give appropriate weight to the needs and suffering of present and future patients in the U.S. and in China.

Surrogate consent for research involving adults with impaired decision making: Survey of Institutional Review Board practices

Objectives:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rules call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research. Design, Settings, and Participants:A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008. Interventions:None. Measurements:Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults. Main Results:Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%–21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives. Conclusions:Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

De Minimis Risk: A Proposal for a New Category of Research Risk

De Minimis Risk: A Proposal for a New Category of Research Risk Rosamond Rhodes a , Jody Azzouni b , Stefan Bernard Baumrin c , Keith Benkov a , Martin J. Blaser d , Barbara Brenner a , Joseph W. Dauben c , William J. Earle c , Lily Frank c , Nada Gligorov a , Joseph Goldfarb a , Kurt Hirschhorn a , Rochelle Hirschhorn d , Ian Holzman a , Debbie Indyk a , Ethylin Wang Jabs a , Douglas P. Lackey c , Daniel A. Moros a , Sean Philpott e , Matthew E. Rhodes f , Lynne D. Richardson a , Henry S. Sacks a , Abraham Schwab g , Rhoda Sperling a , Brett Trusko a & Arnulf Zweig h a Mount Sinai School of Medicine b Tufts University c The Graduate Center, CUNY d New York University Medical School, CUNY e Union Graduate College f Pennsylvania State University g Indiana University, Purdue h University of Oregon (Emeritus)

The role of community consultation in the ethical conduct of research without consent.

In 1996, the federal government finalized regulations that permit certain types of emergency research without obtaining prospective informed consent from participants or their surrogates (U.S. Food...

Understanding the Trusted Doctor and Constructing a Theory of Bioethics

This paper offers a constructivist account of bioethics as an alternative to previous discussions that explained the ethics of medicine by an extrapolation of principles or virtues from ordinary morality. Taking medicine as a higher and special calling, I argue that the practice of medicine would be impossible without the trust of patients. Because trust is a necessary condition for medical practice, the ethics of the profession must provide the principles for guiding physician behavior and the profession toward promoting trust and being trustworthy. In a phrase, that principle is “seek trust and deserve it.” I sketch out how the concept of trust provides a different justification for common sense principles of bioethics and explain how the concept of trust provides reasonable guidance for resolving moral conflicts within medicine. The trust-seeking approach provides a new and unexpected ordering of some traditional medical values, it reveals the weightiness of previously undervalued bioethical precepts, and illuminates the centrality of some largely ignored obligations of medicine. It also has the power to guide clinical practice and to inform the profession about standards for medical institutions.

The dilemma and reality of transplant tourism: An ethical perspective for liver transplant programs

Transplant programs are likely to encounter increasing numbers of patients who return after receiving an organ transplant abroad. These patients will require ongoing medical care to monitor their immunosuppression and to provide treatment when the need arises. Transplant societies have condemned transplantation with organs purchased abroad and with organs procured from executed prisoners in China. Nevertheless, transplant programs require guidance on how to respond to the needs of returning transplant tourists and to the needs of patients who may choose to become transplant tourists. This discussion presents a case that raised such issues in our program. It goes on to offer reasons for considering a programs responses in terms of the most relevant principles of medical ethics, namely beneficence and nonjudgmental regard. Liver Transpl 16:113–117, 2010.