The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, in recognition that there may be personal benefit from participation in some studies?

The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

Public Health Science and practice expanded during the course of the 20th century. Initially focused on controlling infectious disease through basic public health programs regulating water, sanitation and food, by 1988 the Institute of Medicine broadly declared that “public health is what we, as a society, do collectively to. assure the conditions for people to be healthy.” Commensurate with this definition, public health practitioners and policymakers today work on ;in enormous range of issues. The 2002 policy agenda of the American Public Health Association reflects positions on genomics’ role in public health; national health and safety standards for child care programs; sodium in Americans’ diets; the health and safety of emergency rescue workers; and war in Central Asia and the Persian Gulf.

Complementary and alternative medicine (CAM) is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper.

Uncertainty regarding potential disciplinary action may give physicians pause when considering whether to accept a chronic pain patient or how to treat a patient who may require long-term or high doses of opioids. Surveys have shown that physicians fear potential disciplinary acrion for prescribing controlled substances and that physicians will, in some cases, inadequately prescribe opioids due to fear of regulatory scrutiny. Prescribing opioids for long-term pain management, particularly noncancer pain management, has been controversial; and boards have investigated and, in some cases, disciplined physicians for such prescribing. While in virtually all of these cases the disciplinary actions were successfully appealed, news of the success was not often as well-publicized as news of the disciplinary actions, leaving some physicians confused about their potential liability when prescribing opioids for pain. The confusion has perhaps increased as a result of two relatively recent cases, one where a physician was successfully disciplined by a state medical board for undertreatment of his patients’ pain, and another where the physician was successfully sued for inadequate pain treatment.

Public health preparedness must use a comprehensive approach that includes both communities and public health systems. There are three basic questions that should be asked when evaluating public health preparedness in communities of color: 1) Is the community basically healthy?; 2) Does the community have access, to necessary information, resources and services?; and 3) Are the information, resources and services available and provided to the community in a nondiscriminatory manner?

Racial-based health disparities is a well documented fact for many communities of color. Individuals from these communities tend to have more morbidity and higher mortality. This health disparity is race based and not just a function of social class. Similarly, access to basic goods and health care is racialized and class based.

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies.

In March 2000, President William Clinton signed Executive Order 13,147, establishing the White House Commission on Complementary and Alternative Medicine, to develop public policy proposals geared toward maximizing “the benefits to Americans of complementary and alternative medicine.” Disconcertingly, the Commission's charge presumed the safety and efficacy of complementary and alternative medicine (CAM). In so doing, it placed the proverbial cart before the horse by setting the Commission on a mission to “address education and training of health care practitioners in CAM; [coordinate] research to increase knowledge about CAM products; [provide] reliable and useful information on CAM to health care professions, and [provide] guidance on the appropriate access to and delivery of CAM.”

The Commission's final report (“Commission Report”), issued in March 2002, similarly skirts the fundamental question of whether evidence exists that CAM interventions are safe or offer sufficient benefit to justify their proliferation.

In 2000, the Center for Disease Control and Prevention’s National Center for Environmental Health issued a report that explored some of the ways in which “sprawl” impacts public health. The report has generated great interest, and state health officials are beginning to discuss the relationship between land use and public health. The CDC report has also produced a backlash. For example, the Southern California Building Industry Association labeled the report “a ludicrous sham” and argued that the CDC should stick to “fighting physical diseases, not defending political ones.”

In retrospect, it is probably unfortunate that this report was funded by an organization called “Sprawl Watch.” “Spraw” is a word that has no clear meaning but is applied to a huge range of issues involving suburban development.

There is general agreement that the “principle of balance” should guide controlled substance policy and regulation in the United States. Although the diversion of controlled substances from medical to nonmedical purposes is a significant public health problem, overly aggressive controlled substance regulation has been shown to have an unintended deterrent effect on appropriate controlled substance use, including pain management with opioid analgesics. The promotion of effective pain management and the reduction of substance abuse are equally important regulatory objectives. Neither regulatory objective need be sacrificed to achieve the other. Rather, the two objectives must be balanced with each other to assure that necessary pain management is encouraged while drug abuse is curtailed.

Approximately 75 million people in the United States suffer from severe pain. Fifty million of these suffer chronic pain, and 25 million suffer acute pain from trauma or surgery. Pain is not merely an uncomfortable symptom.

The Department of Health and Human Services, Office for Civil Rights (OCR) enforces Section 504 of the 1973 Rehabilitation Act and Title II of the Americans with Disabilities Act. OCR works through complaint investigations and compliance reviews, as well as outreach, technical assistance, and public education to promote voluntary compliance. In the Olmstead decision of June 1999, the Supreme Court held that the ADA’s “integration regulation” requires state and local government to administer services, programs, and activities in the most integrated setting appropriate to the needs of qualified individuals with disabilities. The decision changed the focus from whether a right to more integrated services exists, to under what circumstances and how services will be provided. The New Freedom Initiative announced by President Bush in February 2001 is a broadbased initiative to remove barriers to community living for people with disabilities and promote swift implementation of the Olmstead decision.

Firearm violence is a major public health problem in the United States. In 2000, firearms were used in 10,801 homicides – two-thirds of all homicides in the U.S. – and 533,470 non-fatal criminal victimizations including rapes, robberies, and assaults. The social costs of gun violence in the United States are also staggering, and have been estimated to be on the order of $100 billion per year.

Illegal gun carrying, usually concealed, in public places is an important risk factor for firearm-related crime. In the 1980s and 1990s, police departments across the country began to develop and implement strategies to address illegal weapons carrying. Often these strategies have involved aggressive efforts to identify and physically search individuals suspected of illegally carrying a firearm.

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). If a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.

The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic.

In July 2000, the Seminole Nation of Oklahoma passed a resolution that would effectively expel a significant portion of its tribal members. The resolution amended the Nation's constitution by changing its membership criteria. Previously, potential members needed to show descent from an enrollee of the 1906 Dawes Rolls, the official American Indian tribal rolls established by the Dawes Commission to facilitate the allotment of reservation land. The amended constitution requires possession of one-eighth Seminole Indian blood, a requirement that a significant portion of the tribe's membership cannot fulfill. The members of the Nation who fail to meet this new membership criterion all have one thing in common: they are black.

Descendents of former slaves who came to live among the Seminole Indians of Florida in the seventeenth and eighteenth centuries, the black Seminoles have been officially recognized by the U.S. government as members of the Seminole Nation of Oklahoma since 1866.

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.

The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Belmont Rept).

Most hospitals are considered charities under common law because they were established for the benefit of the public. The law granted them benefits, but also imposed duties. Under the cy-pres doctrine, if a charitable purpose becomes obsolete or incapable of being carried out, the court could modify those purposes to meet current needs of the organization and the community. Modern laws attempt to find a purpose as near as possible to original purposes set up by donors. In the case of hospital conversion, some regulators say assets must be used to support hospital health care, while others say they can be used in the broad sense of health care. That has been a continuing conflict between communities and regulators.

Since 1996, 30 conversion statutes have been enacted, covering hospitals, HMOs, and insurers.

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access.

The experience of having to suffer debilitating pain is far too common in the United States, and many patients continue to be inadequately treated by their doctors. Although many physicians freely admit that their pain management practices may have been somewhat lacking, many more express concern that the prescribing of heightened levels of opioid analgesics may result in closer regulatory scrutiny, criminal investigation, or even criminal prosecution.

Although several researchers have examined the regulatory environment and the threat of sanction or harm it poses to physicians and patients, few have examined the likelihood of investigation or prosecution stemming from the aggressive use of opioids in physician-directed pain management. Accordingly, in an effort to assess whether the fear of prosecution is realistic and, if so, what factors contribute to its likelihood, we surveyed chief prosecutors in four states about their knowledge, opinions, and attitudes concerning opioids and the prosecution of physicians stemming from the treatment of patients who were either terminally ill or suffering from chronic noncancer pain.

“Smallpox was always present, filling the churchyard with corpses, tormenting with constant fear all whom it had not yet stricken, leaving on those whose lives it spared the hideous traces of its power, turning the babe into a changeling at which the mother shuddered, and making the eyes and cheeks of the betrothed maiden objects of horror to the lover.” In 1848, British historian T.B. Macaulay first captured the picture of the devastation smallpox wreaked on its victims, but the “King of Terrors,” as it was dubbed by future president John Adams, had already decimated populations in the ancient world from Greece to Egypt to China. Smallpox had no respect for authority: the earliest identified victim, Pharaoh Ramses V (d.1157 B.C.) was but the first in a long line of monarchs and rulers who succumbed,. including the Hittite king Suppiluliumas I, Aztec Emperor Cuitlahuac, and Queen Mary II of England.

Diabetes is a chronic and systemic disease that has reached epidemic proportions. An estimated 17 million Americans have diabetes (5.9 million of which are undiagnosed), and an additional 16 million individuals are considered to have pre-diabetes. Studies have shown that timely screening and referral are necessary to maintain healthy blood glucose levels and slow the progression of diabetes-related complications. Furthermore, lifestyle changes (i.e., altered diet and physical activity) can prevent or delay the onset of Type 2 diabetes for high-risk individuals.

The Division of Diabetes Translation at the Centers for Disease Control and Prevention undertook an analysis of diabetes-related legislation across the nation. More specifically, state laws, rules and regulations mandating health insurance coverage for diabetes-related supplies and services were examined according to Sample Purchasing Specifications for Services Related to Diabetes—an evidence-based model of standards of care for persons with diabetes.

Assisted reproductive technology has enabled thousands of infertile couples to experience the joys of parenthood. At various times, however, significant problems have come to light concerning the providing of infertility treatment in the United States. An early problem was misleading advertising by some infertility programs, particularly in regard to pregnancy success rates. This unacceptable activity suggested the need for more oversight of assisted reproductive technology and prompted the passage of a federal law requiring the reporting of success rates in a standardized format. Another problem, one that was especially disturbing, was the transfer of preembryos to infertile women at the University of California, Irvine, without the consent of the progenitor couples. Disclosure of these events added fuel to the debate over whether assisted reproductive technology should be subject to greater governmental regulation.