An Institute of Medicine (IOM) panel charged with reviewing the system for overseeing research involving children concluded in 2004 that Institutional Review Boards (IRBs), institutions engaged in research, and study sponsors should “adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to [children’s] research participation.” We previously reported data on practices and policies in the U.S. regarding payments to children who participate in research and their parents. Here, we report additional results from our study and identify some of the decisions that must be made in developing payment plans and on which payment policies will be expected to offer guidance. We conclude that further conceptual analysis and empirical research are necessary before IRBs, institutions, and sponsors can develop specific rules on numerous aspects of payment. Nevertheless, payment policies that promote the ethical treatment of children in research and their parents can be developed. We propose a structure for such policies.

What the Doctor Didn’t Say, by Jerry Menikoff and Edward P. Richards, is a courageous and well-written volume that examines some of the fundamental debates pertaining to the ethics of clinical research. The volume deserves a careful reading by anyone with a potential role in clinical research: clinicians who might serve as investigators or refer patients to clinical trials; research staff; Institutional Review Board (IRB) members and administrators; sponsors who design clinical trials; and the book’s intended audience, namely, potential research participants and their families. A cursory reading of this volume might lead one to think that Menikoff and Richards have declared war on clinical research. They have not. Instead, they offer an in-depth study of the conduct and oversight of clinical research through the lens of law and ethics. They shed light on old issues and initiate discussion of new questions, challenging readers to think critically about the relationship between medical ethics, research ethics, the law, and the conduct of clinical research.

The several articles in this special issue on organ donation after circulatory determination of death or, as it is often put, donation after cardiac death (DCD), draw lessons from different kinds of experience in order to guide efforts in the U.S. to develop or refine policies for DCD. One lesson comes from a major and, by many measures, successful experimental DCD program in Washington, D.C. in the 1990s. Another lesson comes from European countries that have adopted presumed-consent legislation, a form of “opt out” that facilitates DCD as well as donation after neurological determination of death (DND). Another lesson, from the perspective of critical care medicine in Canada, attends to the implications of viewing a dying patient, undergoing resuscitative procedures, as a potential organ donor. A final lesson sketches implications of legislation and court cases in the U.S., often involving DND, for initiating temporary organ preservation (TOP) in DCD programs before consent has been obtained for organ donation. Some of these lessons are optimistic about the prospects for DCD, especially if certain steps are taken, while others are more cautious, particularly because of the costs and risks involved in DCD.

Despite exponential growth in the past decades, most aspects of the assisted reproductive technology (ART) industry remain largely unregulated; recently, pressure has been mounting for coordinated study and regulation of this developing industry. On March 28, 2008, lawyers, health care professionals, representatives from sperm banks, consumers of ART services, and other stakeholders in ART industry gathered at DePaul University College of Law for its Health Law Institute’s symposium titled “Tracking Change: The Feasibility of a Voluntary Gamete Donor Registry in the United States.” The implementation of a registry would mark the first effort in the United States to centralize, maintain, and disseminate information about gamete donors by collecting and storing genetic and identifying information about egg and sperm donors. Establishing a registry requires balancing the interests of donor-conceived individuals, their parents, gamete donors, health care professionals, and society as a whole, as well as ensuring the privacy and safety of all involved.

Worldwide, obesity has become a major cause of preventable death, disease, and disability. While the epidemic of obesity is a significant public health issue in many developed nations, the United States has the highest prevalence of obesity among adults and children internationally. The National Health and Nutrition Examination Survey (NHANES) estimates that over 60 percent of U.S. adults are overweight or obese. According to the Centers for Disease Control and Prevention, “overweight” refers to adults whose body mass index (BMI), a number calculated using weight and height measurements, is between 25 and 29.9. “Obese” refers to adults whose BMI is 30 or higher. Among American children and adolescents, approximately 17 percent are overweight.

With new, effective, and expensive health care services, the American health care sector has become an even greater source of business and wealth opportunities. All kinds of health care providers and suppliers are competing for patients and dollars. The key to wealth in today’s health care sector is the physician. Only physicians can certify to third-party payers that health care services, medical devices, or pharmaceutical products are necessary for patient care. That certification initiates the process by which the item, service, or treatment modality is ordered, delivered, and paid for. Thus, organizations that can exert control over physicians stand to gain financially.

Pharmacists with religious or ethical objections to prescribing emergency contraception won the latest round in the fight over conscience clauses in a case that could have broader implications for attempts to restrict access to contraception. In Stormans, Inc. v. Selecky, a federal District Court in Washington State granted an injunction to block the enforcement of regulations that would have forbidden pharmacists to refuse to dispense emergency contraception on the grounds of religious or ethical objections. In its decision, the court applied Supreme Court abortion precedent without explicitly ruling whether emergency contraception should be legally categorized as a form of abortion or as contraception. However, the legal status of emergency contraception affects the strength of the defendants’ claims that the law was justified on the grounds of preventing sex discrimination. In neglecting to rule one way or the other, the court not only failed to adequately consider the sex discrimination claim but also may have opened the door to more restrictive regulation on contraceptives generally.

The Helsinki Declaration, first published in 1964, is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration was formulated in response to the abuses of human subjects by the scientists in Nazi Germany and to update the Nuremberg Code. Amended in 1975, 1983, 1989, 1996, and 2000, the Declaration provides the foundation for the United States federal regulations for research involving human subjects.

To conform to standards developed in the Declaration, a researcher must fulfill the following: (1) respect the autonomy of the individual; (2) promote and safeguard the individual’s health; (3) provide informed consent without coercion; (4) take special measures with vulnerable populations; (5) compare new therapies to the best current therapies; (6) have a thorough scientific knowledge of the subject; (7) assess risk versus benefit of the intervention; (8) perform studies that will ultimately benefit the population involved in the research; (9) accurately report their findings; and (10) fully disclose ethical concerns in their research protocols.

If Justice Louis Brandeis were alive to witness San Francisco’s recent experiment with universal health care legislation, he might amend his famous characterization of the states as “laboratories of democracy” to include municipalities as well. In San Francisco, where ten percent of residents have no health insurance and where fifteen percent of businesses provide no health coverage for their employees, the Board of Supervisors recently passed the San Francisco Health Care Security Ordinance (Ordinance), which funds a network of primary care services for uninsured residents. While the Ordinance has, in the main, met with general approval, its provision mandating contributions from local businesses that do not meet minimum health spending requirements is the subject of ongoing litigation. The Ninth Circuit Court of Appeals recently ruled in the city’s favor, thereby allowing the spending provision to go forward pending a full appeal on the merits of the case.

The concept of brain death evolved because advancements in medical science permitted unprecedented artificial maintenance of vital body functions by external means. Although the concept of brain death is accepted clinically, ethically, and legally in the United States, there is no national standard for the determination of brain death. There is evidence that variability and inconsistency in the process of determining brain death exist both in clinical settings and in State statutes. Several studies demonstrate that medical personnel determine brain death in variable ways, and have variable understandings of the definition of brain death. The declaration of death has significant legal consequences such as probate proceedings and liability issues for wrongful death. Inconsistencies in the determination of death may therefore be medically, ethically, and legally problematic.