The marriage of academic research laboratories to the biotechnology industry has raised some very complex ethical and legal issues regarding commercialization of human body parts, products and derivatives thereof. Current statutes prohibit the sale of one's body or bodily organs although people may legally sell their blood or semen and are generally encouraged to donate certain body parts for transplantation or research both in life and death. No existing legislation, however, clearly addresses ownership rights with respect to human cells and tissues used in research, Commercialization of human biological material, either by the donor or by the recipient, e.g., researcher and/ or pharmaceutical company, is an uncharted area of the law.

The question of proprietary rights to one's own cells and tissues did not arise until the biotechnology industry rapidly expanded in the 1980s. Now, human organs, tissues and cells are used in research that may lead to the development of products with tremendous commercial value.

The last several years have witnessed a growing intensity in the debate over abortion in the United States. Although the issue has never been far from the public eye, with the Supreme Court's decision in Webster v. Reproductive Health Services in 1989, it assumed a new urgency as it appeared more possible that the Court might reverse Roe v. Wade, the 1973 case guaranteeing a woman a right to an abortion. Moreover, this urgency was not confined to the United States. The same several years also saw an increase in abortion-related legal developments in other industrialized countries of the world: Belgium, Canada, Romania, and Bulgaria significantly liberalized abortion laws; England made changes that take notice of recent medical knowledge on fetal survival and fetal handicap; France became the first country in the world to approve the potentially revolutionary abortion drug RU 486; and Ireland reaffirmed its opposition to abortion.

When the Linares case broke in Chicago, the media immediately began contacting ethicists and hospital lawyers in the area. Eventually, and somewhat wistfully as one paper reported, they were unable to find a single ethicist who did not think that the decision should have been made to withdraw treatment from Samuel far earlier in his treatment. Furthermore, ethicists argued that the family and physician should have made that decision. There was no need to consult with lawyers and especially not with courts.

On the other hand, most lawyers contacted felt it was necessary to go to court to obtain permission to withdraw the respirator, since the legal status of such decisions in Illinois (as in most other states) was terribly unclear. Lack of “clarity” was a catchword in these interviews.

This dichotomy between the instinctive reactions of ethicists and lawyers is natural. It should be so. The ethicists consulted, philosophers, theologians, and physicians, are all skilled in clinical ethics.

Proponents of the new reproductive arrangements tend to speak in terms of reproductive freedom, the right to be a parent, contractual obligation, and infertility therapy, while opponents speak of the natural bond of motherhood, the gift of a child, the integrity of the family, and playing God with the reproductive process. Underlying the rhetorical slogans are deep differences about the values that should guide evaluation of the disputed practices and policies. The proponents of surrogacy contracts place a high value on freedom and autonomy, and consequently on legally binding agreements to embark on birth projms that will alleviate for some the physiological blight of infertility. The opponents of surrogacy and other forms of nontraditional reproduction, on the other hand, defend the physical and genetic foundations not only of parenthood but also of marriage and family. The right to self-determination, they hold, should not extend beyond the personal relationships derived from the basic biological realities of marriage cemented sexually and natural parenthood.

The Infertility (Medical Procedures) Act passed by the Parliament of Victoria, Australia in 1984 was the first legislation anywhere in the world to deal specifically with the regulation of in vitro fertilization and embryo experimentation. As with any pioneering legislation, it has had its problems. Prominent among them was the question of precisely when an embryo comes into existence. This question, which may seem mere semantics, gave rise to a heated controversy with real practical consequences for researchers and infertile couples. The issue was only resolved by the Victorian parliament passing an amendment which specified, more precisely than any legislature had done before, the moment at which egg and sperm become an embryo. This enactment could be seen as a legal declaration of when a life begins—although it remains an open question what legal or ethical significance such a starting point possesses.

In his foreword to a forthcoming issue of the American Journal of Law & Medicine dedicated to Harry A. Blackmun, Supreme Court Justice William J. Brennan calls it “superbly right that the American Society of Law & Medicine honors Mr. Justice Harry A. Blackmun with this edition of its Journal.” Last October the Society presented its first Presidents' Award for Outstanding Contributions to Law and Medicine to Justice Blackmun. Justice Blackman attended our Annual General Meeting and a banquet at Boston University School of Law, where he was presented with the award. We found Justice Blackmun to be a gentle, modest man despite the unique illumination and perception that he has contributed to health law in America. “That makes it only the more fitting,” as Justice Brennan says, “that the American Society of Law & Medicine should award this richly deserved honor, in Learned Hand's words, to ‘Acclaim one who—all unaware of his deserts—has so richly earned our gratitude.’”

Third party payment for health services in the United States has created an environment which offers little incentive to health care providers to be efficient. In response, health care policymakers have suggested that increased competition in the health care sector would encourage good managerial practices and improved cost efficiency. In recent years, health care providers that have the ability to provide services in a more cost-efficient manner have emerged; some, including health maintenance organizations and ambulatory surgical centers, have been encouraged by regulatory policy. In addition, a new alternative for the provision of emergency medical services has developed and has generated substantial controversy among physicians, hospitals, government officials, and the public. The entities that comprise this alternative are often collectively referred to as freestanding emergency care centers or “emergicenters.”

Much of the controversy surrounding emergicenters is caused by the lack of a definition which can be applied to the various emergicenter structures and operations.

As a nurse and policy analyst, my interest in the subject of active euthanasia lies in the practical consequences of formal policy (for example, ethical guidelines), as well as the consequences of having no formal policy, for therapeutic practice.

The basic assumption underpinning this paper is that policy decisions in the area of euthanasia cannot be simply ‘read off’ from any theoretical body of knowledge, but rather such decisions are always grounded in particular situations and social relationships. In this, I concur with Reedy, Minogue, and Sterk, who argue that:

The lesson of this column is: In an emergency, treat first and ask legal questions later. This is both good medicine and good law.

There is no universally recognized definition of an emergency, and the law will generally accept the determination of health care professionals, if consistent with accepted practice, in defining an emergency condition or situation. The most common definition is that an emergency is any injury or acute medical condition liable to cause death, disability, or serious illness if not immediately attended to.

Obvious examples of emergency conditions that require the immediate attention of a physician or properly trained health professional to prevent loss of life include:

• Massive hemorrhage from major vessels

• Cardiac arrest

• Cessation or acute embarrassment of respiration

• Profound shock from any cause

• Rapidly acting poison

• Anaphylactic reactions

• Acute epidural hemorrhage

• Acute overwhelming bacteremia and

• toxemia

• Severe head injuries

• Penetrating wound of the pleura or pericardium

• Rupture of an abdominal viscus

• Acute psychotic states.

I felt honored when I was invited to contribute to this first issue of Nursing Law & Ethics. Thinking about what I might say, I noted that it is only about two years less than twenty since I began a series entitled, "The Law and The Nurse" in the American Journal of Nursing. It appeared for more than ten years before the AJN and I came to a parting of the ways. The end of my relationship with AJN was not due to what I said in its pages. Rather it was the result of adverse reactions to my views regarding licensure of health personnel.

First, I am a trial judge on D.C. Superior Court—a court of general jurisdiction. Thus, my personal experiences and approach are grounded in the intense and heart-rending world of live testimony and real human beings—not the rarefied appellate atmosphere of cold transcripts and brilliant analytical arguments.

To put some of my remarks in context, and to present a totally atypical situation which raises all the analytical issues of Cruzan, I would like to describe a real case—one that I actually tried—about 10 years ago, involving a committed patient at St. Elizabeths Hospital—a large local hospital for the mentally ill. I will call him Vladimir—he was a real person, not a faceless mental patient. Vladimir had escaped from the repressiveness and brutality of pre-Glastnost Russia—to the freedom of the West. Sometime after locating in America and working here, he became mentally ill and was hospitalized.

This article will discuss the rights of a licensed physician to acquire and retain a hospital medical staff appointment. The focus of the discussion will be the relationship between the independent fee-for-service private practitioner and the community general hospital. The relationship of the organized medical staff to both the hospital and the individual doctor will also be clarified. The hospital involved this discussion may be owned by a governmental unit and hence identified as a “public hospital,” but more likely it will be aprivate, non-profit charitable corporation and will be referred to as a “private” hospital. Specifically, this article will explore the differences, if any, between a physician's rights vis-a-vis the public hospital and his or her rights when a private hospital is involved.

Excluded from this analysis are situations where the doctor is an employee of a hospital or health care institution. Also excluded are cases involving hospitals which limit their service to particular patients (e.g., the mentally ill or children), and university-owned teaching hospitals that impose a faculty appointment in the medical school as a pre-requisite to staff privileges.

There is little argument against the principle that the health care consumer has the right to all pertinent information regarding his condition and treatment. Nevertheless, there is resistance and patients frequently have difficulty obtaining important information.

Generally, it is the responsibility of the physician to inform the patient of his diagnosis and condition, the recommended treatment, its risks and its side effects, and any alternative treatments. This is the essence of obtaining the patient's informed consent, without which treatment is illegal and unethical. An important aspect of the nurse's role is to safeguard the patient's right to receive this information, and, when necessary, to assist the patient in obtaining it. Since she is in frequent close contact with the patient, the nurse should evaluate the patient's understanding and should inform the physician when further information or clarification is needed. Furthermore, when the nurse realizes that the patient has not received or understood the necessary information, the nurse should advise the patient of his right to receive it before consenting to any treatment or procedure.

The random]ized clinical trial is widely accepted as the optimal approach to evaluating the safety and efficacy of medical treatments. Resistance to randomized treatment assignment arises regularly, most commonly in situations where the disease is life-threatening and treatments are either unavailable or unsatisfactory. Historical control designs, in which all participants receive the experimental treatment with results compared to a prior cohort, are advocated by some as more ethical in such circumstances; however, such studies are often highly biased in favor of the new treatment and frequently yield misleading results. Alternative controlled designs motivated by the desire to maximize the number of patients with the treatment ultimately determined to be superior have been proposed, but have been challenged on both methodological and ethical grounds. Debates about appropriate and ethical study designs recurred during the recent Ebola Virus Disease (EVD) epidemic in West Africa. Despite its devastating nature, the EVD epidemic showed the ongoing necessity of conducting randomized trials to obtain convincing evidence of the safety and efficacy of therapeutic interventions.