Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Increasingly, the world seems to shrink due to our ever-expanding technological and communication capacities. Correspondingly, our awareness of other cultures increases. This is especially true in the field of bioethics because the technological progress of medicine throughout the world is causing dramatic and challenging intersections with traditionally held values. Think of the use of pregnancy monitoring technologies like ultrasound to abort fetuses of the “wrong” sex in India, the sale of human organs in and between countries, or the disjunction between (...) the haves and the have-nots in South America when it comes to bone marrow transplants, while thousands of other children die for want of fundamental goods and services like clean water, basic inoculations, and food itself. (shrink)

Death of a normal volunteer highlights problems with research review and protection of subjectsHealthy volunteer dies in asthma studyOn July 19, after investigating the death of a previously healthy volunteer, the United States Office for Human Research Protections suspended nearly all federally funded medical research involving human subjects at Johns Hopkins University. The death has been described as “particularly disturbing” because 24 year old Ellen Roche was a healthy volunteer who had nothing to gain by taking part in the study.1 (...) Her death has revived debate about the adequacy of oversight of medical research that followed the death of 18 year old Jesse Gelsinger who volunteered for a gene therapy experiment.Ellen Roche was a 24 year old technician from the Johns Hopkins Asthma and Allergy Centre who volunteered to take part in a study designed to provoke a mild asthma attack in order to help doctors discover the reflex that protects the lungs of healthy people against asthma attacks. After inhaling hexamethonium, a medication used for treating high blood pressure in the 1950s and 60s, Ms Roche became ill. She developed a cough and her condition worsened over the next week until she was put on a ventilator. With her lung tissue breaking down, blood pressure falling and her kidneys beginning to fail, nothing could be done to save her.2 She died on June 2, about a month after entering the study.The Office for Human Research Protections investigated the circumstances of Ms Roche's death and accused the Hopkins Institutional Review Board of failing to take proper precautions. It also evaluated the human subject protection system at Hopkins. The OHRP found that prior to approving the study, Hopkins researcher …. (shrink)

Following in the fashion of Stephen Jay Gould and Peter Medawar, one of the world's leading scientists examines how "pure science" is in fact shaped and guided by social and political needs and assumptions.

The recent tragic and widely publicised death of Jesse Gelsinger in a gene therapy trial has many important lessons for those engaged in the ethical review of research. One of the most important lessons is that ethics committees can give too much weight to ensuring informed consent and not enough attention to minimising the harm associated with participation in research. The first responsibility of ethics committees should be to ensure that the expected harm associated with participation is reasonable. Jesse was (...) an 18-year-old man with a mild form of ornithine transcarbamylase (OTC) deficiency, a disorder of nitrogen metabolism. His form of the disease could be controlled by diet and drug treatment. On September 13 1999 a team of researchers lead by James Wilson at the University of Pennsylvania's Institute for Human Gene Therapy (IHGT) injected 3.8 X 1013 adenovirus vector particles containing a gene to correct the genetic defect. He was the eighteenth and final patient in the trial. The virus particles were injected directly into the liver. He received the largest number of virus particles in a gene therapy trial.1 Four days later he was dead from what was probably an immune reaction to the virus vector. This was the first death directly attributed to gene therapy. It resulted in worldwide publicity, an independent investigation, the Federal Drug Administration (FDA) suspending all trials at the IHGT, an FDA, and a senate subcommittee investigation. At a special public meeting at the National Institutes of Health (NIH) in December 1999, James Wilson, also the director of the IHGT, said they still did not understand fully what had gone wrong.2 Even though a massive dose had been used, only 1% of transferred genes reached the target cells. (None of the patients in the trial showed significant gene expression. Art …. (shrink)

The symposium in this issue, on equality and disability, helps to clarify some areas of continuing disagreement in disability studies, but also uncovers substantial consensus. All of the contributors appear to endorse John Harris's statement that “No disability, however slight, nor however severe, implies lesser moral, political or ethical status, worth, or value”.1 It seems safe to assume, moreover, that few if any readers of the Journal of Medical Ethics are likely to disagree with this, or indeed to challenge Kate (...) Diesfeld's initial assumption that “Generally speaking, it is both immoral and unlawful to discriminate between people on the ground of disability”.2Some, of course, might challenge Diesfeld's choice of the word “between” rather than “against”. What is generally agreed to be both immoral and unlawful is discrimination in the modern sense of treating people unjustly on the basis of distinctions that are not morally relevant to the matter in hand. It is neither immoral nor illegal, for example, for a transport employee to discriminate between members of the travelling public in order to offer some but not others the use of a wheelchair or a wheelchair ramp. Nor is it immoral or illegal for society to discriminate between its members through legislation which offers, to some but not others, special forms of aid or protection, based on the recognition of their respective disabilities.Legislation designed to protect people …. (shrink)

In March 1997, 60 Minutes, a nationally syndicated news magazine program, featured a story in which it was claimed that The Cleveland Clinic Foundation had in place a non-heart-beating donor protocol that involved killing patients for their organs. These charges were brought by a philosopher from a local university. A student who worked at LifeBanc, the northeastern Ohio organ procurement agency where the organ donation protocol originated, was given the protocol by LifeBanc with the understanding that it was to be (...) used in class; the student and professor charged that the protocol involved killing patients for their organs. These claims were advanced without noting that the protocol was a draft that was being reviewed and revised and had not been implemented. (shrink)

Recent ethics literature suggests that issues involved in non-heart-beating organ procurement are both highly charged and rather urgent. Some fear that NHB is a public relations disaster waiting to happen or that it will create a backlash against organ donation. The purpose of the study described below was to assess ethics committees' current level of involvement in and readiness for addressing the difficult issues that NHB organ retrieval raises—either proactively through policy development or concurrently through ethics consultation.

The question of whether physicians or other healthcare workers are ethically entitled to strike is troubling in that it entails a conflict in obligations. This question of a conflict of obligations (and the answer to it) has wider implications for many other workers.

While there is increasing pressure on scarce health care resources, advances in medical science have blurred the boundary between life and death. Individuals can survive for decades without consciousness and individuals whose whole brains are dead can be supported for extended periods. One suggested response is to redefine death, justifying a higher brain criterion for death. This argument fails because it conflates two distinct notions about the demise of human beings--the one, biological and the other, ontological. Death is a biological (...) phenomenon. This view entails the rejection of a higher brain criterion of death. Moreover, I claim that the justification of the whole brain (or brain stem) criterion of death is also cast into doubt by these advances in medical science. I proceed to argue that there is no need to redefine death in order to identify which treatments ought to be provided for the permanently and irreversibly unconscious. There are already clear treatment guidelines. (shrink)

Open any standard bioethics textbook, and therein can be found a host of subjects ranging from the abortion rights controversy to the morality of xenographic tissue transplantation. Just as there is a wide scope to the subject matter of bioethics, its practitioners come from a multitude of disciplines, including law, medicine, nursing, theology, philosophy, sociology, and anthropology. And yet, despite a rich variety of investigators and methods, bioethicists overlook numerous subjects that deserve to be addressed. In particular, they neglect issues (...) of public health, preventive medicine, and social medicine. Although topics such as physician-assisted suicide, prenatal genetic testing, and the ethics of new reproductive technologies constitute the contemporary canon of bioethics and deserve sustained analysis, these subjects are not so significant that they should eclipse other issues. For example, gun control policies, the regulation of food additives. immunization programs, prenatal care, leave programs enabling employees to care for dying relatives, the provision of nutrition and medical care to the homeless, and the use of emergency rooms by the most impoverished citizens are all topics neglected by bioethicists. (shrink)