The last few years have witnessed the growth of large-scale, population genomics biobanks, which serve as longitudinal, gene-environment databases for future yet unspecified research. An international consortium, the Public Population Project in Genomics (P3G), builds harmonization tools for such biobanks and has catalogued numerous studies — at least 139 with over 10,000 banked participants and 34 with over 100,000. As their potential use for translational, clinical research draws near, it is opportune to clarify the duties of such biobanks to communicate results to participants. To identify the potential obligations, some demystification of the terminology surrounding the return of results as found in international and national norms on biobanking generally is essential. On the whole, our proposed lexicon is based on a study of norms as found in national and international policies but excludes debates found in the literature.

Five years ago, an article co-written by some of us (Joly and Simard) presented an emerging trend to disclose some individual genetic results to research participants within the international research community. At the time, ethical norms and scholarly publications on the return of results often did not distinguish between the return of research results in general and the return of unexpected results (also called incidental findings). Both technologies and research practices have evolved significantly. Today whole genome and exome sequencing are increasingly affordable and frequently used in genetic research. Because these techniques produce a vast amount of interpretable and non-interpretable data (i.e., data of unproven significance) about an individual, the issue of how to manage information generated by such technologies needs to be considered. However, the development of international ethical guidelines has not kept up with the rapid pace of technological progress. Indeed developments in genomic biobanking also challenge the duty to disclose research results.

As a matter of respect for the person, it is considered an ethical duty to offer to return research results to participants where appropriate. Nevertheless, the return of individual research results to participants raises many socio-ethical issues and greater challenges when the participant is a child. This discrepancy arises partly because the return of individual pediatric research results entails a tripartite relationship between researcher, child, and parent(s) and is embroiled in numerous considerations (e.g., acting in the best interest of the child, respect for the person, and respect for the autonomy of the parents/child).

Extra caution is required in the pediatric research context because children cannot generally decide (consent) whether they want to be informed of their own research results or whether the results should be disclosed to parents. Children have long been considered a special and vulnerable group, and their parents, as guardians, play a critical role in the consent process. However, with regards to the return of individual research results, this might pose a potential conflict of interest between the current or future desires of the child and those of the parents.

In recent years, the research participant’s family’s need, if not right, to know their disease risk has comprised a great deal of the genetic testing discourse. This most often arises in the context of clinical genetic tests for hereditary cancers, especially colorectal and breast cancer, and other genetic disorders where the presence of a genetic mutation greatly increases the likelihood of the disease’s manifestation (such as Huntington’s Disease). However, this discussion has not led to comprehensive or cohesive guidance for health care professionals or patients. Indeed, various governmental and professional bodies run the gamut of possibilities, from no disclosure to family without the consent of the patient, to recognition that genetic risk information is important enough to the family to allow exception to traditional notions of confidentiality.

In 2009, Time magazine named “biobanks” as one of the 10 ideas changing the world. These organized collections of human biological material and associated data have been identified as “vital research tools in the drive to uncover the consequences of human health and disease.” Since their inception, however, biobanks have faced ethical and legal challenges. Whether these pertain to informed consent, access by researchers, commercialization, confidentiality, or governance, biobanks must continue to address jurisdictional matters, operational difficulties, and normative frameworks that strive to stay abreast of current scientific innovation. Yet, with some biobanks now having completed their recruitment objectives and with research currently being performed on their data and samples, one topic has become the focus of ongoing debates: the return of research results to participants.

Until the mid-20th century, biomedical research centered on the study of specific diseases, concerned with short periods of time and small groups of living research participants. However, the growth of longitudinal population studies and long-term biobanking now forces the research community to examine the possibility of the death of their research participants.

The death of a research participant raises numerous ethical and legal issues, including the return of deceased individuals’ research results to related family members. As with the return of individual research results for living research participants, the question of the obligation to return a deceased person’s research results to family members has yet to be settled. This question is particularly acute in the context of genetic research since the research results from one individual may have health implications for all biological relatives.

Where research was once strictly confined to one laboratory or office, investigators now widely share and compare their plans, analyses, and results. With the advent of genomic knowledge, researchers are seeking to understand the genetics and genomics of complex human disease. They are combining their efforts into international consortia in order to take on problems that face individuals around the world, such as cancer and malaria — problems that are too large to solve by one country alone. These consortia bring together diverse research groups from different parts of the world to focus on a common goal. Their projects may all focus on one disease or condition, but examine it from different perspectives (i.e., disease subset or methods of transmission) and share the newly gained information with each other and the wider scientific community.

Medical records contain important clues about the history of medicine. These documents, which ostensibly describe the course of a patient's illness, are “unique constructions that allow us to observe the social and technical structure of contemporary healing.” As such, the 21st-century hospital medical record reflects the many components of inpatient care: medical interventions, billing, legal documentation, research, and education. It is comprised of a wide array of elements: professionals' notes; vital signs and other descriptive information; laboratory data and test results; demographic information; orders, charges, diagnostic and treatment codes; and other utilization data. It is well understood that many people share and need this information. Current controversies over records involve not control, but computerization, security, and accessibility. Although health professionals offer input, decisions about hospital medical records have been considered largely an administrative responsibility.

A major obstacle to broad support of clinical ethics consultation (CEC) is suspicion regarding the nature of the moral expertise it claims to offer. The suspicion seems to be confirmed when the field fails to make its moral expertise explicit. In this vacuum, critics suggest the following:

1. (1) Clinical ethics consultation's legitimacy depends on its ability to offer an expertise in moral matters.

2. (2) Expertise in moral matters is knowledge of a singular moral truth which applies to everyone.

3. (3) The claim that a clinical ethics consultant can offer knowledge of a singular moral truth in virtue of her professional training is absurd, false, or gravely immoral.

   Therefore,

4. (4) The field is illegitimate.

Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: (1) kickbacks, (2) gifts, and (3) financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent judgment and rational prescribing.

Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs.

In a paper that has recently attracted discussion, David Shaw has attempted to criticize the distinction the law has drawn between withdrawing and withholding life-sustaining measures on the one hand, and euthanasia on the other, by claiming that the body of a terminally ill patient should be seen as akin to life support. Shaw compares two cases that we might, at least at first, regard as distinct, and argues that they are not. In the first case, Adam, who is dying of lung cancer, is connected to a ventilator and requests to be disconnected. In the second case, Brian, also dying of cancer, is not connected to anything, and so he requests his doctor to provide him with a lethal injection. In the first case, Shaw contends, Adam is being kept alive by a ventilator. In the second case, Brian is being kept alive by his body.

Communicable diseases, especially those that are readily contagious, are on the rise as evidenced by the emergence of viruses like severe acute respiratory syndrome (SARS), the global resurgence of resistant forms of ancient mycobacteria such as extensively drug resistant tuberculosis (XDR TB), and the 2009 swine flu outbreak in Mexico. Moreover, each of us, no matter who we are or where we live, is just as likely to transmit contagious diseases to others as we are to contract such diseases from others. As cogently described in the title of a recent book by Margaret Battin et al., we are all potential “victims and vectors.”

Just as contagious diseases are readily passed person to person, so too can they readily be passed across local and national boundaries. We therefore all have a stake in the development of effective infectious disease control policies on a national scale, with “effective” being the operative term: regulations and statutes that are neither enforceable nor likely to be complied with may do more harm than good.

Physicians' duties to their patients traditionally have been construed narrowly in time and scope to focus on the specific episode of care or clinical encounter. Physicians generally have had no ethical or legal duty to notify patients about new medical information discovered after a visit, notwithstanding the health care benefits to patients that might flow from receiving the information. The rule was based on the relatively high burdens that notification would impose on physicians compared with the likelihood of benefits to patients. This established view, however, no longer may be appropriate in light of new physician-patient relationships and the reduced burden of patient notification using new types of health information technology (HIT). This article explores the duty to inform patients and former patients about relevant, medical developments subsequent to their episode of care. It concludes by recommending the recognition in ethics and law of a limited, ongoing duty to notify patients of significant information relevant to their health.

This essay describes an interdisciplinary educational experiment in health law. The experiment was funded by the National Science Foundation (NSF), received Institutional Review Board approvals, incorporated inter-disciplinary faculty and graduate students from several universities in Atlanta, and employed problem-based learning (PBL). After discussing my motivation to undertake this experimental approach to teaching health law, I explain how the course was developed and structured and how we are assessing its results. I also offer some reflections on why other health law teachers might be motivated to incorporate some features of our experimental approach into their own classes, and some thoughts on how they might do so based on lessons learned.

I undertook this experiment to test in an educational setting an approach to problem solving that I have developed for addressing certain kinds of seemingly intractable policy problems. I call this a “navigational approach” to “fractious problems.”