Forensic data banks contain biological samples and DNA extracts as well as computerized databases of coded DNA profiles of convicted offenders, arrestees and crime scene samples. When used for investigative and law enforcement purposes, DNA data banks have been successful in providing key investigative leads in hundreds of criminal investigations. A number of these crimes would never have been resolved without use of such data banks. In addition, in some limited number of investigations, the exclusion of known suspects whose DNA profiles are known to be in an offender database can save valuable investigative time.

Despite the above benefits, in hundreds of cases DNA samples are never collected and administrative and laboratory logjams delay prompt database searches. Furthermore, hundreds of DNA database matches (hits) languish, without any followup by law enforcement or prosecutors. These prevent or delay DNA matches and therefore can leave the public in grave risk of potential harm from recidivistic offenders who otherwise could have been apprehended and convicted if the process functioned more effectively.

The institutional ethics committee an entity that many have long believed capable of solving many of the medical, legal, and ethical problems that exist in modern health care-is now being adopted by increasing numbers of institutions. Utilized sporadically since the 1970s, ethics committees began to receive renewed and heightened attention in late 1982. Cases such as those in Los Angeles where two physicians who were charged with first degree murder for removing, at the request of the family, intravenous feeding tubes, from a comatose, severely brain-damaged patient, the Infant Doe case from Bloomington, Indiana, and the more recent case of Baby Jane Doe from New York State, have generated an enormous amount of interest and publicity and provided a new impetus toward institutional ethics committees.

Jay Katz has been a pioneer in exploring the ethics of human subjects research. We are all the more grateful because he has given us a map of the landmarks along the path of what he has called his personal odyssey. That intellectual journey, from the horrors of Auschwitz to the callous disregard of human rights in the Tuskegee syphilis study, can serve as a guide to us today as we attempt to measure and direct the impact of AIDS on the ethics and regulation of research.

Professor Katz's account of his odyssey begins with the sources of his concern. At Yale Law School in 1966, with his colleague Richard Donnelly, he began teaching what was probably the first semester-long seminar on human experimentation. In preparation he read for the first time the trial transcripts of the Nuremberg proccedings against the Nazi physicians. I had lost most of my cousins, aunts, and uncles in the Holocaust, he writes. How many of them, I wondered, had been condemned to participation in these experiments?

Innovative therapy is the name we give to novel medical interventions, radically different from the standard of care, provided in order to benefit a patient, rather than to acquire new knowledge. They are paradigmshifting, not incremental, responses to serious patient problems that standard medical care inadequately addresses. Innovative therapies are often devised by clinicians, not basic science researchers; they do not follow the linear model of basic research, to translation, to clinical research, to application. Instead, they come from thinking backwards from the patient’s circumstances, and forward from deep knowledge of how the body functions, to challenge the limits of current mechanisms for effecting cures.

This paper seeks to understand the treatment effect of Prescription Drug Monitoring Programs (PDMPs) on opioid prescription rates. Using county-level panel data on all opioid prescriptions in the U.S. between 2006 and 2015, we investigate whether state interventions like PDMPs have heterogeneous treatment effects at the sub-state level, based on regional and temporal variations in policy design, extent of urbanization, race, and income. Our models comprehensively control for a set of county and time fixed effects, countyspecific and time-varying demographic controls, potentially endogenous time-series trends in prescription rates, and other state-level opioid interventions such as Naloxone Access and Good Samaritan laws, Medicaid expansion, and the provision of Methadone Assistance Treatment. We find that PDMPs are only effective in reducing prescription rates if they obligate doctors to check for patients' history prior to filling out a prescription, but the frequency at which a state requires its PDMP to be updated is irrelevant to its effectiveness. Moreover, the significant treatment effects of PDMPs are almost exclusively driven by urban and predominantly white counties, with the relatively more affluent regions showing greater responsiveness than their less affluent counterparts.

Research on the use of genome and exome sequencing for diagnosis, identification of potential therapies, precision prescribing of pharmaceuticals, and identification of disease risk is progressing rapidly. Research projects now commonly yield findings of potential health importance for the individuals sequenced as well as their relatives, raising difficult questions about investigator responsibilities to offer those research findings for potential clinical work-up. As sequencing is moving into clinical application, the ethical questions are further multiplying. The ethical quandaries will only proliferate as use of sequencing in screening to achieve public health goals is debated more widely.

This paper focuses on the most common state policy responses to the opioid crisis, dividing them into six broad categories. Within each category we highlight the rationale behind the group of policies within it, discuss the details and support for individual policies, and explore the research base behind them. The objective is to better understand the most prevalent state responses to the opioid crisis.

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction (e.g., craving, impaired control, and compulsive use) cannot be observed in non-drug-dependent humans, it is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans.

Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both health care and legal actors to address and manage those liability risks.

Slippery slope arguments appear regularly whenever morally contested social change is proposed. Such arguments assume that all or some consequences which could possibly flow from permitting a particular practice are morally unacceptable.

Thus the legalization of abortion in limited circumstances is asserted to lead down the slippery slope towards abortion on demand and even infanticide; and the legalization of assisted suicide to lead inexorably to the acceptance of voluntary euthanasia and subsequently to the sanctioning of the practice of nonvoluntary euthanasia – even involuntary euthanasia of “undesirable” individuals.

Alzheimer disease (AD) is a huge and growing societal problem with upwards of 35% of the population over the age of 80 developing the disease. AD results in a loss of memory, the ability to make reasoned and sound decisions, and ultimately the inability to take care of oneself. AD has an impact not only on the sufferer, but their caretakers and loved ones, who must take on a costly and time-consuming burden of care. AD is found in virtually all racial and ethnic groups. Genetic influences on AD are substantial, and there has been a 30 year history of both success and failure. Mutations for rare early onset forms of the disease have been identified, but this information has not yet led to an effective treatment. Multiple common genetic variations have also been identified, and have led to new insights into the potential role of microglia cells in addition to neuronal cells in the brain. Despite intensive efforts, a significant portion of the genetic etiology of AD remains unknown and must be identified.

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his medical patients, or whether they differ in any fundamental way.

Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior.

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate against soliciting consent for population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients.

In discussions of medical decision making as it applies to people with disabilities, a major obstacle stands in the way: the perceptions and values of disabled people (particularly disability rights advocates and disabled social scientists) and of many nondisabled people (particularly health care professionals, ethicists, and health policy analysts), regarding virtually the whole range of current health and medical-ethical issues (treatment decision making, health care access and health care rationing, medical costcontainment, and assisted suicide), seem frequently to conflict with one another. This divergence in part grows out of the sense, common among people with disabilities, that their interactions with “the helping professions,” medical and social service professionals, are adversarial. But those differences of opinion also stem more basically from a clash of fundamental values.

This paper addresses, in historical perspective, the ways in which the status of persons with disabilities as a stigmatized minority group affects medical decision making. It also examines the efforts of disability rights activists to prevent discrimination against persons with disabilities in current medical culture. Finally, it raises questions about how the rights of people with disabilities will fare as new care standards are developed and implemented.

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations.

Empirical research in bioethics can be defined as the application of research methods in the social sciences (such as anthropology, epidemiology, psychology, and sociology) to the direct examination of issues in [bioethics]. As such, empirical work is a form of descriptive ethics, focused on describing a particular state of affairs that has some moral or ethical relevance. For example, empirical research can help to describe cultural beliefs about the appropriateness of providing health-related information, such as the diagnosis of a life-threatening illness, which informs deliberations about the extent to which it is morally important for clinicians to provide comprehensive information to patients in different cultural contexts. Similarly, empirical research can delineate popular attitudes and experiences related to contentious issues such as abortion, cloning, stem-cell research, and physician-assisted suicide to enlighten discussions and policy formulations regarding them.

Wanzer, et al., have noted that “all too frequently, physicians are reluctant to withdraw aggressive treatment from hopelessly ill patients, despite clear legal precedent.” Our collective clinical experience confirms that this reluctance persists among some physicians. In this study, we investigated physicians’ attitudes, knowledge, and reported practices regarding the effects of perceived legal constraints on the abatement of life-sustaining treatment from patients who are clearly dying. A factor in assessing these issues is the concept of defensive medicine-that is, the perception that doctors are being forced to order every possible laboratory test and second opinion, or to continue providing non-beneficial life-sustaining treatment, solely to protect themselves from future legal claims. This perception appears widespread among practicing physicians. However, we believe that defensive medicine represents only part of a complex constellation of factors that comprise physicians’ reluctance to abate treatment. This phenomenon encompasses medical, ethical, legal, social, psychological, and spiritual factors interacting in ways that are not fully understood.

Language matters. Thus when market language is imposed on the health care system, it seems natural to transform patients into consumers, and patient rights into consumer rights. But patients are not consumers who pick and choose among physicians and treatments on the basis of price and quality. Patients are sick and vulnerable people who are truly not themselves and are incapable of shopping around for the best deal.

Discussions surrounding patient engagement and empowerment often appear to use the terms “patient” and “consumer” interchangeably. But do the two terms hold the same meaning, or is a “patient” a passive actor in the health care arena and a “consumer” an informed, rational decision-maker? Has there been a shift in our usage of the two terms that aligns with the increasing commercialization of health care in the U.S.

Mounting evidence documents the extraordinary toll on human health resulting from the consumption of unhealthy food products and physical inactivity. Diseases related to poor nutrition – such as diabetes, heart disease, stroke, and some cancers – are among the leading causes of disability and death in the United States. Poor diet and lack of exercise come second only to tobacco use in actual causes of preventable death in this country. It is estimated that 6% of all adult health care, 7% of Medicare, and 11% of Medicaid expenditures are attributable to obesity. According to the Centers for Disease Control and Prevention, the direct medical cost associated with physical inactivity was nearly $76.6 billion in 2000.

In response to America's growing obesity problem, local policymakers have been looking for legal strategies to adopt in their communities to encourage healthful behaviors. Taking the lead from the successful tobacco control movement, nutrition advocates are seeking strategies to “denormalize” unhealthy behaviors, rather than pursuing education-based approaches that encourage individuals to change their own personal behavior.