Imagine that you are a teenager and have cancer. You undergo a year of chemotherapy and after a brief return to normal life, you have a relapse. Your physician says that chemotherapy and radiation therapy could be tried, but a bone marrow transplant (BMT) is your only chance of a real cure. He tells you and your parents that you could die as a result of complications from the transplant, but without it you would only be expected to live one year. You and your family discuss the alternatives and decide to have the transplant. You ask what will happen if the BMT fails, but both your physician and your family tell you that right now you must fight to get better and not think negative thoughts. You do not ask any more questions.

In the theater the fictional Dr. Kelekian’s relief that he does not have to talk to family members about his patient’s cancer treatment draws uneasy laughter from the audience. Doctors, patients, and family members alike recognize the situation, even if hearing it so baldly expressed discomfits them.

Why do physicians and other health care professionals, including lawyers and bioethicists, so often view families as “trouble”? And why do families so often see medical professionals as uncaring and uncommunicative? Presumably everyone wants the same goal—recovery or the best possible outcome for the patient. And yet trouble clearly exists. We do not see the problem as one of “dysfunctional families” or “callous doctors,” although there are undoubtedly many of each.

Over ten years have elapsed since Virginia passed the nation's first criminal DNA banking law, which authorized law enforcement authorities to collect DNA samples from certain categories of offenders for the purposes of performing profile analysis. Within nine years, Rhode Island became the fiftieth state to enact a similar statute. The passage of a decade since the first enactment provides a convenient opportunity to assess the strengths and weaknesses of ethical safeguards under present law as well as predict the likely direction of future developments.

DNA forensics are merely the latest in a long line of biologically based identifying law enforcement technologies that include fingerprints and serotyping. Nevertheless, DNA has properties that make it significantly different than its predecessors with respect to the ethical and social concerns it raises.

Managed care is evolving in ways that pose unique ethical challenges to those interested in the intersection of clinical and organizational ethics. For example, Disease Management (DM) is a form of managed care that has emerged in response to chronic illness. DM is a healthcare management tool that coordinates resources across an entire health care delivery system and throughout the life cycle of chronic disease. Health Maintenance Organizations have reduced some costs in the delivery of acute care, but real cost savings will result only with greater efficiencies in the delivery of costly chronic care. DM is a systematic, population-based approach that identifies persons at risk of chronic ailment, intervenes with specific programs of care, measures clinical and other outcomes, and provides continuous quality improvement. Characterized as a movement to patient-driven services, DM involves a complex web of provider relations.

A generation ago, we adopted a national system for the protection of human subjects in research. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in the research environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of policies and compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of human research.

Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe.

In a familiar moral dilemma faced by physicians who care for the dying, some patients who are within days or hours of death may experience suffering in a degree that cannot be relieved by ordinary levels of analgesia. In such cases, it may sometimes be possible to honor a competent patient's request for pain relief only by giving an injection of narcotics in a dosage so large that the patient's death is thereby hastened. Doctors rightly worry that taking an action likely to result in a patient's death may violate the Hippocratic injunction against the direct killing of anyone in their care.

Institutional review boards (IRBs) and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.

Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal.

In February 1999, I received a call from a lawyer at Hill Abra Dewar stating that she had instructions to retain my services as an expert witness in the case of Sawatzky v. Riverview Health Centre. She was representing the Manitoba League of Persons with Disabilities which had intervenor status.

In Canada the admission of expert testimony depends upon the application of four criteria outlined in R. v. Mohan by Justice Sopinka. These criteria are: (a) relevance; (b) necessity in assisting the trier of fact, (c) the absence of any exclusionary rule; and (d) a properly qualified expert. The lawyer believed that I could provide the court with relevant, reliable ethics testimony about surrogate decision-making and about medical futility-information that likely would be outside the experience and knowledge of the trier of fact.

Physicians treating newly incapacitated patients often must navigate surrogate decision-makers through a difficult course of treatment decisions. Such a process can be complex. Physicians must not only explain the medical facts and prognosis to the surrogate, but also attempt to ensure that the surrogate arrives at decisions that are consistent with the patient's own values and wishes. Where these values and wishes are unknown, physicians must help surrogates make decisions that reflect the patient's best interests.

The institutional review board (IRB) is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality (142 articles) and considerably fewer on the assessment of risks and potential harms (40), study design (20), and subject-selection procedures (5).

In recent years a number of commentators have discussed the importance of measuring quality of life (QL) in health care. We want to know whether an intervention will help people to live better, not just longer, and whether some treatments cause more trouble than they are worth. New technologies promise wondrous benefits. But when millions of people have no insured access to health care, and when many others face increasingly stringent limits on care, technologies’ high costs require us to choose what we should do from the broader universe of what we can do.

The challenges to measuring QL are formidable. Researchers debate whether to measure general QL or disease-specific QL; whether to focus on functional status such as the patient's ability to walk and dress himself, or on the value people ascribe to that functional status; whether to seek the values of the general public, or to concentrate on people actually affected by a given disease or disability.

A significant amount of discussion in the bioethics community has been devoted to the question of whether individuals performing ethics consultations in healthcare institutions have any special expertise. In addition, articles in the lay press have questioned the “added value” that bioethicists bring to ethical dilemmas. Those at the forefront of the bioethics community have argued repeatedly that those doing ethics consults cannot simply be well-intentioned individuals, that some training in bioethics, group process, and facilitation is necessary to competently execute a consult. As one bioethicist commented:

if you approach any endeavor as an amateur activity, you will get, in the end, an amateurish version of the activity. Without a sufficient commitment of personnel, time, support, and financial resources, a healthcare organization will get the ‘ethics’ program … it set out to create: an inept, unskilled, inefficient, and highly risky ‘program’ in healthcare ethics and bioethics.

Evaluating the risks and anticipated benefits of medical, behavioral and, social research is a central function of institutional review boards (IRBs). The calculation that IRBs undertake ultimately determines whether a particular research project involving human participants is permitted to proceed. In medical research the physical harms and even the anticipated benefits of a new procedure or drug are often apparent and quantifiable. In contrast, for social/behavioral research that may involve probing the most intimate feelings, thoughts, and actions of participants, the weighing of risks and anticipated benefits, the calculation of possible harms and the acceptability of that harm require a more intense level of scrutiny.

Even the early step of identifying and recruiting participants for a research endeavor may potentially cause harm, making participant selection a focus of IRB analysis.

Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in the AIDS epidemic. These social forces have shifted the core ethical question from whether children should be research subjects to when children should be research subjects.

The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration (FDA) that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults.

Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take.