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.

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.

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.

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.

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.

In July 1997, the voting representatives at the National Consensus Conference (NCC) on Bioethics in Health Research voted unanimously to adopt the proposed Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda (Guidelines). This vote represented the culmination of a three-year journey towards the development of a coherent and cohesive framework for the ethical review of health research involving human subjects in Uganda.

Attendees at the NCC included both voting representatives and non-voting participants. Voting representatives had been designated by the institutional entity with which they were affiliated to represent that entity at the NCC and to voice the concerns and opinions of the entity and its constituents.

The first meeting of the Global Forum for Bioethics in Research was initiated by the Fogarty International Centre of the National Institutes of Health (NIH) and sponsored by the World Health Organisation (WHO), the Pan American Health Organisation (PAHO) and the NIH. Held in Bethesda on November 7-10,1999, the intent was to bring together individuals involved in medical research in low- and middle-income nations to share views with each other and with organisations that support clinical research. Approximately 120 persons from 34 countries participated, including individuals from developing countries, pharmaceutical organisations, and communities where medical research is under way.

The participants addressed the partnerships required between research sponsors and investigators involved in clinical trials in developing countries and the long-term needs for international multicentred training programs.

The German Nazi regime has become a standard model for unspeakable things that one should reject. Contemporary people will characterize political opponents, benighted policies, and other undesirable things as “fascist” or “Nazi.” In ethics, and medical ethics in particular, this analogy arises regularly. Therefore, it is not surprising that German people are particularly sensitive about their history. For example, the German high court regularly refers to the Nazi era in its reluctance to accept lethal social activities. This sensitivity surfaced again in 1988, when influential applied ethicist Peter Singer accepted a German invitation to speak to a Symposium on “Bioengineering, Ethics, and Mental Disability.” Singer had also agreed to deliver a separate lecture on the topic “Do severely disabled newborn infants have a right to life?”

The Office of Inspector General (OIG), Department of Health and Human Services, has issued a proposed rule under section 5201 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act for Fiscal Year 1999 (OCESAA) that would provide a safe harbor from civil sanctions under section 1128A(a)(5) of the Social Security Act for independent dialysis facilities that pay premiums for Supplementary Medical Insurance (Medicare Part B) or Medicare Supplemental Health Insurance Policies (Medigap) for financially needy Medicare beneficiaries with end-stage renal disease (ESRD).

End-stage renal disease is a chronic disease that requires regular dialysis treatments and monitoring of laboratory values, diet and medication. ESRD patients suffer from irreversible renal failure, often accompanied by diabetes, anemia, hypertension and congestive heart failure.

On April 6, 2000, Dr. J. Craig Venter of Celera Genomics told a Congressional committee that his company finished its analysis of the human DNA and would have a completed map of the human genome by early summer, 2000. Scientists expect the completed human genome to revolutionize drug therapies through the creation of treatments tailored to specific genetic makeups. In order to create a map of the human genome, three billion letters of DNA that encode eighty thousand genes must be identified and ordered. In March, 2000, Celera released a successful sequence of the fruit fly genome, and it employed the same methods in creating the human genome.

The U.S. Supreme Court held 7-2 that an individual harmed by an overt act that is not tortious under the Racketeer Influenced and Corrupt Organizations Act (RICO) does not have a civil cause of action under RICO. Therefore, an individual terminated from his job in furtherance of a racketeering conspiracy does not have a civil cause of action, since such termination is not an “independently wrongful” act under RICO.

The plaintiff, Robert Beck, was the president, CEO, director, and shareholder of Southeastern Insurance Group (SIG). The defendants, including Ronald Prupis, were senior officers and directors of SIG. In 1998, the plaintiff discovered that the defendants were engaged in racketeering. The racketeering activities included refusing to qualify contractors for SIG surety bonds unless they paid fees to SIG; diverting corporate funds for their personal use; and providing regulators, shareholders, and creditors with false financial statements.

The United States Court of Appeals for the Eighth Circuit held that ERISA did not preempt a Minnesota tort claim alleging fraud and negligent misrepresentation against primary-care physicians who failed to disclose their financial incentives to minimize specialist referrals. The original action (“Shea I”) was filed in state court after the plaintiff's husband died of heart failure, alleging that his family doctors had assured him that referral to a cardiologist was unnecessary. The plaintiff filed a wrongful death suit against the doctors, their clinic, and her husband's HMO. Her complaint against the HMO alleged that certain financial incentives built into the HMO-physician contract were designed to minimize referrals to specialists. The HMO removed the case to the District of Minnesota, contending that ERISA preempted the plaintiff's wrongful death claim.

The United States Court of Appeals for the Third Circuit held that when quitam relators file a multi-claim complaint under the Fraudulent Claims Act (FCA), their share of the proceeds must be based on an individual analysis of each claim. More importantly, the court held that relators are not entitled to any portion of the settlement of a specific claim if that claim was subject to dismissal under section 3730(e)(4) Relator Merena filed a quitam suit against his employer, SmithKline Beecham (SKB), claiming, among other things, that SKB defrauded the government by billing for laboratory tests that were not performed, paying illegal kickbacks to health care providers, and participating in an “automated chemistry” scheme. Soon thereafter, additional relators filed suit.

The Office of the Inspector General issued an advisory opinion in April announcing that an arrangement to provide various services free of charge to patients with terminal illnesses who have a prognosis of one year or less to live (the “Program”) does not constitute grounds for sanctions under either the anti-kickback statute, section 1128(b) of the Social Security Act, or under section 1128A(a)(5) of the Act, which prohibits offering of inducements to beneficiaries to influence their selection of a provider for Medicare or Medicaid covered services.

The Hospice Foundation of Martin & St. Lucie, Inc., is a Florida nonprofit organization that acts as the supporting foundation for the Hospice of Martin & St. Lucie, Inc., a nonprofit organization that provides various end-of-life services.

On March 29,2000, in U.S. v. Wood, the U.S. Court of Appeals for the Tenth Circuit held that a physician cannot be convicted of murder simply for adopting, in an emergency setting, a risky course of treatment intended to prolong life that, when carried out, effectively hastened death. Finding the government's evidence flawed, based on several evidentiary errors and an erroneous denial of a motion for judgment of acquittal on murder charges, the court reversed the conviction of involuntary manslaughter and ordered a new trial.

Virgil Dykes, an 86-year-old man, was suffering from severe abdominal pain when he arrived at the Veterans Administration hospital in Muskogee, Oklahoma, on February 5, 1994.

The Court of Appeals of Indiana upheld the trial court's judgment and refused to create a new tort for “wrongful prolongation of life” because existing law offers a remedy to those who do not wish to be kept alive through artificial measures. Specifically, the court affirmed the trial court's dismissal in favor of Muncie Medical Investors, LP, the operator of Woodlands Nursing Home (“Woodlands”) since the plaintiffs could have sought relief under I.C. § 16-36-1-8 which provides for court resolution of disputes regarding an individual's treatment at the end of life.

In 1992, Rebecca Taylor suffered a stroke that left her paralyzed on her left side and confined to a wheelchair. Taylor executed a living will in late 1993 directing that if she was suffering from a terminal illness with “no reasonable possibility of recovery,’’ then no “extraordinary means” to prolong her life should be used.

On April 7,2000 a Florida jury ordered the tobacco industry to pay $12.7 million in compensatory damages to three former smokers who were chosen to represent hundreds of thousands of Florida residents in an unprecedented class action lawsuit. The decision not only marks the first time that a jury has found on behalf of smokers in a class action lawsuit, it also sets the stage for a huge punitive damage award against the industry. The awards followed a finding by the same jury last July that the cigarette manufacturers have “acted with reckless disregard” and “engaged in extreme and outrageous conduct” while conspiring to mislead the public about the health risks of smoking. These previous findings make it likely that there will be punitive damages levied against the tobacco companies when the jury reconvenes in May.

On March 31, 2000, the Massachusetts Supreme Judicial court ruled that a contract awarding custody of frozen pre-embryos to the wife upon divorce was unenforceable because it violates public policy. This is the first reported case to address a contract between the clinic and the parties where the contract would have awarded the pre-embryos to one of the gamete providers. The decision in A.Z. v. B.Z. 431 Mass. 150 (2000) differs from decisions in the two other courts of last resort deciding related cases where enforcement of contracts was supported. This case represents an important development in the legal doctrines associated with frozen pre-embryos as it explicitly differs from the other courts’ decisions in addressing pre-embryos at the same developmental stage.