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Contents - JLME - 2011 Volume 39: 4
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
  1. Introduction: Return of Research Results: How Should Research Results Be Handled?
Symposium Articles
  1. Return of Results: Towards a Lexicon?
  2. Return of Research Results: General Principles and International Perspectives
  3. Pediatric Research and the Return of Individual Research Results
  4. Familial Communication of Research Results: A Need to Know?
  5. Biobanks and the Return of Research Results: Out with the Old and In with the New?
  6. The Return of Results of Deceased Research Participants
  7. The Needle in the Haystack: International Consortia and the Return of Individual Research Results
Independent Articles
  1. Conflicts over Control and Use of Medical Records at the New York Hospital before the Standardization Movement
  2. An Ethics Expertise for Clinical Ethics Consultation
  3. Reforming Pharmaceutical Industry-Physician Financial Relationships: Lessons from the United States, France, and Japan
  4. Me and My Body: The Relevance of the Distinction for the Difference between Withdrawing Life Support and Euthanasia
  5. Communitarianism and the Ethics of Communicable Disease: Some Preliminary Thoughts
  1. Currents in Contemporary Bioethics: Physicians' Duty to Inform Patients of New Medical Discoveries: The Effect of Health Information Technology
  2. Teaching Health Law: Problem-Based Learning Regarding "Fractious Problems" in Health Law: Reflections on an Educational Experiment
  3. Reviews: Reconsidering Law and Policy Debates: A Public Health Perspective by John G. Culhane (Cambridge University Press, 2011)
Table of Contents
Table Of Contents
ASLME - [PDF] (Free Download)
THE JOURNAL OF LAW, MEDICINE & ETHICS CONTENTS VOLUME 39:4 Winter 2011 Symposium Articles 574 Introduction Bartha Maria Knoppers and Emmanuelle Lèvesque 577 Return of Results: Towards a Lexicon? Bartha Maria Knoppers and Amy Dam Currently, the return of results in the domain of biobanking constitutes an ethical and legal quagmire, whether it involves population or specific clinical research studies. In light of the fact that population biobanks are often not seen as distinct from those biobanks created for disease research, as well as the uncertainty as to what "return of results" means concretely, this lexicon attempts to demystify the terminology. The terms - results, return, clinical significance, and utility - are discussed. Through an analysis of international and national normative guidance on this issue, the authors propose a concordance of meaning and a simplified lexicon. 583 Return of Research Results: General Principles and International Perspectives Emmanuelle Lèvesque, Yann Joly, and Jacques Simard Five years ago, an article co-written by two of us (Joly and Simard) presented an emerging trend to disclose certain individual genetic results to research participants. Since then, both technologies and research practices have evolved significantly. Given this rapid evolution, our goal is to provide updated and thorough guidance on this issue. Our paper begins by identifying the ethical principles that support the return of results: justice, beneficence, and respect for persons. Then, it presents the results of an analysis of international norms on the return of results, covering both general and individual research results. It reveals existing divergence and consensus on these topics within the international community. With the goal of promoting greater harmonization, we conclude by proposing a flexible framework for the return of individual research results.
Letter From the Editor
Letter From The Editor

In this issue we are proud to present the symposium, "The Return of Research Results: How Should Research Results Be Handled?," guest edited by Bartha Maria Knoppers and Emmanuelle Lèvesque. The editors and their authors examine the vexing questions that are raised when research is conducted both in the clinical and pure research settings, and how the results of that research should be disseminated. The thoughtful questioning of the articles reflects an interdisciplinary perspective for how and when to best return research results to communities at large, the participants in the study, and if appropriate, their families - all while protecting the rights of those being researched. Although the authors show that little consensus currently exists in such various contexts, they aim to open the door for further communication on this topic before implementation of future practices. This symposium is also decidedly international in flavor, reflecting the growing interest of JLME and its parent organization, the American Society of Law, Medicine & Ethics, in discussions of global medicine and law. It is a path that JLME has actually been on for many years, and it is one we shall continue to follow in the future.
Introduction: Return of Research Results: How Should Research Results Be Handled?
Bartha Maria Knoppers and Emmanuelle Lèvesque - [PDF]

The debate on the return of research results has reached a turning point. Five years ago, the possible emergence of ethical duties to return results in international guidelines due to a prevailing confusion between the research and clinical domains was questioned. The authors stressed the importance of distinguishing between the responsibilities of clinician-researchers from those of researchers involved in fundamental, epidemiological research, such as the building of population biobanks resources. Parallel to this international study, others analyzed the advisability of the return of genetic results and incidental results. Recently, three noteworthy reports have provided further insight: the National Cancer Institute's Workshop on Release of Research Results to Participants in Biospecimen Studies, the National Heart, Lung, and Blood Institute Working Group's updated guidelines, and a 2011 "Consensus Statement" from a consortium of scholars. The contents of this symposium issue began with a fall 2010 symposium at McGill University on the "Return of Research Results: How Should Research Results Be Handled?". Organized by the Centre of Genomics and Policy and supported by Quèbec Network of Applied Genetic Medicine (RMGA), the need for further discussion became evident. This request for further analysis resulted not only from the (mostly indecipherable) information tsunami created by the increased use of both next generation sequencing and direct-to-consumer testing, but also because we considered certain related and important topics to be missing from the debate. The analysis published in this symposium issue will hopefully contribute to the elaboration of clear guidelines on the return of research results.
Symposium Articles
Return of Results: Towards a Lexicon?
Bartha Maria Knoppers and Amy Dam - [PDF]

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. The term "results" is not universally used in such ethics guidance. Indeed, reflecting on the multidisciplinary nature of the committees advising international and national policymakers as well as health professionals, the terms "findings" and "information" are also interchangeably used with the term "results." Likewise, "return" of results is sometimes replaced by "feedback," "disclosure," "reporting back," and "sharing." "Return of results" is also used by large population infrastructures that require those accessing such resources for specific research projects to send back their enriched data. One set of terms is almost universally shared: scientific/analytical validity and clinical utility/significance. But even these scientific concepts lose precision when combined with less-defined terms like those just mentioned. Is there a possibility of simplifying this Babelic tower of terminology and reaching clarification, if not consensus? Actual and future legal and ethical obligations are affected as is the trust of the most important contributor to these public research infrastructures -- the participating citizen.
Return of Research Results: General Principles and International Perspectives
Emmanuelle Lèvesque, Yann Joly, and Jacques Simard - [PDF]

Introduction: 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. Often, these biobanks target a large population (sometimes more than 100,000 individuals), offer worldwide access, and are intended for long-term storage and use of data and samples. The constitution of large-scale biobanks and the advent of international data sharing have made research data management and security more complicated. Finally, research increasingly involves international collaboration, requiring data or sample exchange between research teams from distinct jurisdictions. In this continuously evolving context, we have revisited the original article from five years ago in order to provide a comprehensive and current international perspective on the disclosure of research results.
Pediatric Research and the Return of Individual Research Results
Denise Avard, Karine Sènècal, Parvaz Madadi, and Daniel Sinnett - [PDF]

Introduction: 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. This mixture constitutes fertile ground for unique ethical dilemmas. Moreover, the participation of children in genetic, longitudinal research and the long-term storage of samples in biobanks can impact the future autonomy of the child. It also raises important privacy and confidentiality concerns as it could negatively impact social and behavioral functioning, or lead to discrimination by those parties with access to the sensitive research results. Other socio-ethical considerations related to genetic and longitudinal pediatric research include whether parents could access newly discovered health information that will be relevant to the child only later in life or access such information for their own use. Finally, the issue of returning individual research results has not been extensively studied except in the field of pediatric cancers. Viewed in this context, such issues accentuate the fact that children are deemed "normative orphans."
Familial Communication of Research Results: A Need to Know?
Lee Black and Kelly A. McClellan - [PDF]

I. Introduction: 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. Given the discordance of opinion on sharing the results of clinical genetic testing, it is not surprising that there is little guidance as well for sharing research findings that implicate family members of a participant. Recent advances in technology used in genetic research increase the prospect of clinically valid findings in genetic research, especially incidental findings, which hold more meaning for participants and their families than they might have had in past years. How should these be dealt with? Any analysis of a responsibility (in this instance, for either researchers or participants) to disclose research results to family must first begin with the recognition that such disclosure can only occur following a return of results to the participant. If the researchers, or the relevant ethical or legal authorities, determine that returning results to the participant is inappropriate, then it follows that these results should not be provided to family members.
Biobanks and the Return of Research Results: Out with the Old and In with the New?
Ma'n H. Zawati and Amèlie Rioux - [PDF]

Introduction: 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. One of the driving forces behind the continued presence of discussion on this issue is the use of innovative technologies, such as next-generation sequencing and the noticeable advancement in "omics" practices. As one author indicates, "deciding how to deal with genomic research results has become increasingly pressing as technologies for genome-wide analysis have become readily available."
The Return of Results of Deceased Research Participants
Anne Marie Tassè - [PDF]

Introduction: 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. This paper looks at the legal and ethical issues raised by the return of a deceased research participant's individual research results to related family members. In Part I, we examine the current legal and ethical frameworks governing the return of results of deceased participants. Although most international guidelines do not directly address this issue, an analysis of these documents may provide an indication as to how they would apply. Since guidelines may not be sufficient, an analysis of current Canadian, American, and French legislation is also undertaken. In Part II, we try to balance the rights and interests of both the deceased individual and related family members in order to identify key ethical elements underlying such returns of results. To do so, we examine how death modulates the rights and interests of a person and the living relatives. Then, we use two ethical theories (principlism and consequentialism) to assess whether or not the disclosure of research results to family members could be ethically acceptable, before concluding.
The Needle in the Haystack: International Consortia and the Return of Individual Research Results
Susan E. Wallace - [PDF]

Introduction: 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. Tackling these research challenges, ...require[s] the coordination and cooperation of a large group of scientists from various fields, including biology, molecular and computational biology, bioinformatics, quantitative genetics and genomics, bioinformatics, mathematics, clinical research, medicine and several other areas of science. International consortiums with the participation of tens of hundreds of scientists in large-scale research projects provide an almost essential approach to unveiling the complexity of living organisms and disease heterogeneity. However, the inherent diversity between the projects involved can affect the alignment of goals and activities. As international consortia necessarily involve differing legal, ethical, and cultural norms, depending on the countries involved, harmonizing the consortia's activities in light of these differences is a major consideration. How activities are carried out will differ from country to country, yet the consortium needs to have overarching policies and guidelines in place in order for their work to be executed.
Independent Articles
Conflicts over Control and Use of Medical Records at the New York Hospital before the Standardization Movement
Eugenia L. Siegler and Andrew B. Cohen - [PDF]

Introduction: 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. Such has not always been the case. In the 19th and early 20th centuries, summary data important for the hospital's governance were distinct from the descriptions of patient care, known as case records. Control over the different kinds of records was separate. Hospital boards oversaw the demographic and organizational information, and physicians controlled the clinical descriptions, which were recorded in bound volumes called casebooks. While governing boards may have had a general interest in the quality of the casebooks, physicians determined what they would describe and how the records would be maintained.
An Ethics Expertise for Clinical Ethics Consultation
Lisa M. Rasmussen - [PDF]

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) Clinical ethics consultation's legitimacy depends on its ability to offer an expertise in moral matters. (2) Expertise in moral matters is knowledge of a singular moral truth which applies to everyone. (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) The field is illegitimate. My aim is to articulate an expertise for clinical ethics consultation, which I call "ethics expertise" to distinguish it from a more robust, singular "moral expertise," and to suggest that it avoids many of the problems critics cite. I forward the argument as a proposal for explaining and asserting the ethical expertise involved in clinical ethics consultation. In doing so, I accept premise (1), because to reject it would be to argue that CEC without a coherent, justified account of expertise in ethical matters would still be clinical ethics consultation. I reject (2), offering "ethics expertise" instead of "moral expertise" as a way of articulating the expertise in ethical matters that CEC can offer. I will also reject (3), because the "ethics expertise" I articulate is something that can be conveyed by training. My arguments should be understood as trying to carve out a conceptual space for the use of expertise on ethical matters in clinical ethics consultation which avoids serious critiques of moral expertise, merits the term "expertise," and captures what clinical ethics consultants might do (and which some, though not all, consultants say they currently do or ought to do). I begin by distinguishing between "ethics expertise" and "moral expertise" as a way of distinguishing between the kinds of claims CECs might make, advocating the former and eschewing the latter.
Reforming Pharmaceutical Industry-Physician Financial Relationships: Lessons from the United States, France, and Japan
Marc A. Rodwin - [PDF]

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. They also shower gifts on opinion leaders, including physicians who advise the Food and Drug Administration (FDA) on drug safety, draft practice guidelines, and set drug formularies for hospitals and health plans. Gifts include: cash; gift certificates; invitations to resorts; entertainment such as theatre, golf, or sporting events; computers; cases of wine; artwork; consumer goods; meals; medical and office supplies; assistance on literature reviews and research; and help with personal errands. Pharmaceutical firms also fund physician activities. They subsidize professional meetings, providers of continuing medical education (CME), and professional associations. They sometimes reimburse physician expenses related to attending professional meetings and CME, payments which are sometimes treated as gifts rather than funding.
Me and My Body: The Relevance of the Distinction for the Difference between Withdrawing Life Support and Euthanasia
Andrew McGee - [PDF]

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. When Adam requests to be disconnected from the ventilator, and Brian requests a lethal drug, both are doing so on the basis that their autonomy is being violated. "Brian's lungs, like Adam's ventilator, are violating his autonomy by prolonging his life against his will." In this way, a request for a lethal injection can be seen as analogous to -- indeed an instance of -- a request to have life support, such as an artificial ventilator, removed. If this is correct, then "it is clear that there is no substantive moral difference between turning off a ventilator ...and providing or administering a lethal drug."
Communitarianism and the Ethics of Communicable Disease: Some Preliminary Thoughts
Cara M. Cheyette - [PDF]

I. Introduction: 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. One means of developing effective policies might therefore be to promulgate ones that are grounded in shared values, since such an approach is more likely to foster a sense of investment that will, in turn, be more likely to ensure enforcement and compliance. This paper is a preliminary attempt to determine which of two ethical theories, principlism or communitarianism, provides the better foundation for crafting infectious diseases control policies along these lines.
Currents in Contemporary Bioethics: Physicians' Duty to Inform Patients of New Medical Discoveries: The Effect of Health Information Technology
Mark A. Rothstein - [PDF]

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.
Teaching Health Law: Problem-Based Learning Regarding "Fractious Problems" in Health Law: Reflections on an Educational Experiment
Roberta M. Berry - [PDF]

Introduction: 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 interdisciplinary 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.
Reviews: Reconsidering Law and Policy Debates: A Public Health Perspective by John G. Culhane (Cambridge University Press, 2011)
Review by James G. Hodge, Jr. - [PDF]

On the cusp of yet another highly contentious presidential election, amidst an economy that has lapsed into another recession, and in the throes of ongoing efforts to reform national health and public health systems in the United States, it is fair to say that this nation has some problems. In his new book, Reconsidering Law and Policy Debates: A Public Health Perspective, John G. Culhane edits a series of critical chapters that take on some of the most polarizing and politically-defining societal problems in modern America -- abortion and other reproductive rights, euthanasia and other end-of-life issues, health disparities, gay marriage, domestic violence, rights to carry guns, and spiraling tort litigation. Beyond merely describing the multi-faceted scope of these complex issues (as many others have done), Culhane and his contributors offer a differing vision. The nation's problems, it seems, are not themselves the primary issue as much as our approach in debating and solving them through existing law and policy. As a nation, we tend to view these and other controversial issues from an overly individualistic, myopic perspective. We personalize them, frame them in terms of impacts on individual rights, and contest various sides from inapposite political camps that can only "win the day" if their particular views are expressed in terms of individual interests.