Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of protection around the latter.

As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence.

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.

Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These relationships have become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America (PhRMA), adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges (AAMC), the American Board of Internal Medicine (ABIM) and the Institute on Medicine as a Profession (IMAP), and government bodies such as the Institute of Medicine (IOM) have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products.

These comments seek to take issue with the contention that society has a responsibility to provide its members with any needed health care. In order to deal with this claim, we must first make clear exactly what it meant by the proposition. I take it that those who embrace this view mean considerably more than that each of us has a moral obligation to contribute to those in need of medical attention who are unable, for one reason or another, to afford the necessary care. This is a moral proposition and is traditionally dealt with under the heading of charity. But the contention, as here used, means considerably more since its main implications are not moral but primarily political.

Markets have long had a whiff of sulphur about them. Plato condemned innkeepers, whose pursuit of profit he believed led them to take advantage of their customers, Aristotle believed that the pursuit of profit was indicative of moral debasement, and Cicero held that retailers are typically dishonest as this was the only path to gain. And even those who are more favorably disposed towards markets in general are frequently inclined to be suspicious of markets in medical goods and services. For example, Margaret Thatcher (to take someone far removed — in many respects! — from Plato, Aristotle, and Cicero) supported the legal prohibition of markets in kidneys despite being arguably the most pro-market Prime Minister the United Kingdom saw in the 20th century.

Stem cell science, using both embryonic and a variety of tissue-specific stem cells, is advancing rapidly and offers promise to improve medical care in the future. Yet, with the notable exception of hematopoietic stem cell transplantation, a long-established approach to treating certain cancers of the blood system, this promise is long term and most stem cell research focuses on basic scientific questions or the collection of pre-clinical data. Although some clinical trials are underway, most are focused on safety, and novel effective therapy is likely a long way off. Despite the preliminary nature of most stem cell research, however, numerous clinics around the world offer stem cell “therapies” to patients today outside the context of a clinical trial. Although the number of patients who have received these stem cell-based interventions (SCBIs) is unknown, anecdotal reports suggest a substantial population of patients is willing to try them, despite unresolved questions about their safety and efficacy.

In her opening address to the 2011 session of the World Health Organization's (WHO) governing body, the World Health Assembly, WHO's Director-General, Dr. Margaret Chan, noted that WHO's job was much more straightforward when it was dealing mainly with germs, hygiene, medicines, vaccines and sister sectors, like water supply and sanitation. Today, international public health governance is much more complex. It is not only about forging agreement around shared health problems, but also being concerned with health as an outcome of global policies in areas such as trade, intellectual property, and human rights and, nationally, as an outcome of work in other sectors such as education, agriculture and the environment. Global health governance is increasingly fragmented, and WHO is not the only health game in town.

The Common Rule (45 CFR 46, subpart A) is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services (DHHS), which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A (general protections for human research participants), Subpart B (additional protections for pregnant women, fetuses, and neonates), Subpart C (additional protections for prisoners), and Subpart D (additional protections for children). The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration (FDA) has adopted its own regulations for the protection of human participants, which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board (IRB), and the criteria for approving research.

The intensity of the opposition to health reform in the United States continues to shock and perplex proponents of the Patient Protection and Affordable Care Act (PPACA). The emotion (“Abort Obama”) and the apocalyptic rhetoric (“Save our Country, Protect our Liberty, Repeal Obamacare”), render civil and evidence-based debate over the implications and alternatives to specific provisions in the law difficult if not problematic. The public debate has largely barreled down two non-parallel yet non-intersecting paths: opponents focus on their fear of government expansion in the future if PPACA is implemented now, while proponents focus on the urgency and specifics of our health care market problems and the limited number of tools we have to address them. Frustration on both sides has led opponents to deny the seriousness of our health system’s problems and proponents to ignore the risk of governmental overreach. These non-intersecting lines of argument are not moving us closer to a desired and necessary resolution.

Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. The European Medicines Agency (EMA) reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health (NIH) data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast-enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells.

Whenever health care reform is debated, the state of the medical professional liability (MPL) system (i.e., medical malpractice system) in the United States re-emerges as an issue of importance. What exactly is broken with the MPL system and what the implications are is a point of contention among different stakeholder groups. Recent data demonstrate that medical liability premiums have been improving in recent years and the majority of premiums remained flat in 2010. General agreement still exists, however, that medical professional liability insurance premiums have become unaffordable for many physicians, and coverage has become less available, especially for certain medical specialties and in specific areas of the country.

Multiple factors go into the determination of medical professional liability insurance premiums including return on investments, reinsurance costs, claims frequency, average amount paid out on malpractice claims, defense expenses, and administrative costs such as underwriting expense.

Individual research protections provided by bioethical principles can be extended to group protections, particularly for place-based (geographic) communities and cultural groups who may share a common harm or burden. In this article, an argument is made for the need to consider the group conditions of individual research subjects in the ethics of individual report-backs of human biomonitoring results. Human biomonitoring, the measuring of concentration of chemicals or their metabolites in blood, urine, breast milk, hair, and other biological samples, can provide an assessment of an individual's exposure to a chemical(s) and can integrate exposures from multiple pathways and sources. Biomonitoring studies have been increasing in the past decade for such purposes as measuring the levels of chemicals that are ingested by members of the general population and at what concentrations, to determine if exposure levels are higher in some groups vs. others, to track temporal trends to establish reference ranges for chemical exposures, and to investigate an association with health.

The Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) is the law of the land. But it faces an uncertain future.

During congressional deliberations on the 2,700-page legislation leading up to its enactment, from February to March 2010, not one major survey recorded majority support for the legislation. Since its enactment, popular opposition to the Affordable Care Act has hardened, and was a significant factor in the 2010 congressional election, in which Democrats lost 63 seats and Republicans regained the majority in the House of Representatives. Ballot initiatives in Missouri and Ohio, showcasing popular opposition to the individual mandate, passed in 2010 with overwhelming majorities. While the United States Supreme Court in National Federation of Independent Business et al. v. Sebelius, 132 S. Ct. 2566 ( 2012), declared the mandate on the states to expand Medicaid unconstitutionally coercive, the majority of the Justices also upheld the individual mandate as a permissible tax. The new law thus emerged as a central topic in the 2012 election.

In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.

However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully.

Various kinds of consumer-driven reforms have been attempted over the last 20 years in an effort to rein in soaring costs of health care in the United States. Most are based on a theory of moral hazard, which holds that patients will over-utilize health care services unless they pay enough for them. Although this theory is a basic premise of conventional health insurance, it has been discredited by actual experience over the years. While ineffective in containing costs, increased cost-sharing as a key element of consumer-driven health care (CDHC) leads to restricted access to care, underuse of necessary care, lower quality and worse outcomes of care. This paper summarizes the three major problems of U.S. health care urgently requiring reform and shows how cost-sharing fails to meet that goal.

A wide range of medical institutions have developed and implemented policies to mitigate the adverse consequences of conflicts of interest. These newly implemented policies, which include regulation of industry contact with physicians and hospitals, controls on gifts from industry, and greater transparency in industry sponsored activities, have generated considerable controversy.

Formulating and evaluating policies in a neutral, unbiased fashion can be difficult for those personally affected. When people have a stake in an issue, they tend to process information in a selective fashion that supports their personal interests, a phenomenon known as “motivated reasoning.” When decision makers with preexisting opinions are exposed to information, they are inclined to selectively use the information to arrive at conclusions that justify their prior beliefs. When confronted with information that contradicts existing views, people evaluate it with greater skepticism. Additionally, once decision makers have reached a decision, they are likely to evaluate subsequent evidence in a biased manner that supports their decision.

Historian James H. Jones published the first edition of Bad Blood, the definitive history of the Tuskegee Syphilis Experiment, in 1981. Its clear-eyed examination of that research and its implications remains a bioethics classic, and the 30-year anniversary of its publication served as the impetus for the reexamination of research ethics that this symposium presents. Recent revelations about the United States Public Health Service study that infected mental patients and prisoners in Guatemala with syphilis in the late 1940s in order to determine the efficacy of treatment represent only one of the many attestations to the persistence of ongoing, critical, and underaddressed issues in research ethics that Bad Blood first explored. Those issues include, but are not limited to: the complex and contested matters of the value of a given research question, the validity of the clinical trial designed to address it, and the priorities of science.