You're currently on:

Back Issues and Articles
Back Issues and Articles

Table of Contents
Table Of Contents
ASLME - [PDF] (Free Download)
THE JOURNAL OF LAW, MEDICINE & ETHICS VOLUME 41:2 - Summer 2013 386 INTRODUCTION Leslie Meltzer Henry 390 What the ANPRM Missed: Additional Needs for IRB Reform Charles W. Lidz and Suzanne Garverich 397 Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors? Seema K. Shah 411 Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects Leslie Meltzer Henry 424 Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens Gail H. Javitt 440 Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water? Brett A. Williams and Leslie E. Wolf 454 Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project Diane E. Hoffmann, J. Dennis Fortenberry, and Jacques Ravel 470 The Apomediated World: Regulating Research When Social Media Has Changed Research Dan O'Connor Independent Articles 484 Advance Directives, Dementia, and Physician-Assisted Death Paul T. Menzel and Bonnie Steinbock 501 Caring for Elder Parents: A Comparative Evaluation of Family Leave Laws Y. Tony Yang and Gilbert Gimm 514 Social Security Survivors Benefits: The Effects of Reproductive Pathways and Intestacy Law on Attitudes Jason D. Hans and Martie Gillen Columns 525 HIPAA Privacy Rule 2.0 Mark A. Rothstein 529 Legal Responses to Communal Rejection in Emergencies James G. Hodge, Jr., Daniel G. Orenstein, Kim Weidenaar, Nick Meza, Laura Van Buren, Nick Wearne, and Kristin Penunuri
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

Over the last few months you may have noticed that the Journal of Law, Medicine & Ethics has been growing at an almost exponential rate. Our fall and winter 2012 issues both contained two symposiums, and our spring 2013 issue - in addition to being published with a special supplement - was the single largest issue of JLME ever produced. These massive page counts were necessitated by the fact that our journal continues to draw unprecedented numbers of submissions and symposium proposals; the number of potential papers is particularly unusual in light of the persistent challenges facing the publishing industry generally, where finding suitable material is, for some publications, a full-time job. While having too much good material can present its own challenges (and I do wish we could accept many more articles submitted for peer review), this richness of very fine submissions ensures that JLME publishes quality, cutting-edge research and ideas in the fields of law, medicine, public health, ethics, and philosophy. The flood of submissions and symposiums are "problems" that JLME will welcome for many years to come.
Introductions
Introduction: Revising the Common Rule: Prospects and Challenges
Leslie Meltzer Henry - [PDF]

The Federal Policy for the Protection of Human Subjects, known as the "Common Rule," has remained virtually unchanged since it was adopted in 1991 by 15 federal departments and agencies, including the Department of Health and Human Services (HHS). During the last two decades, however, the volume and nature of clinical research have undergone significant transformation. Cumulative spending on health-related research by the federal government and the pharmaceutical industry has tripled; clinical research is frequently conducted at multiple sites worldwide, not just at U.S. academic medical centers; the traditional research enterprise of investigators and sponsors has expanded to include community based organizations, recruitment firms, and contract research organizations; and modern technologies, ranging from neuroimaging to the Internet, have created new fields of research inquiry and previously unimaginable access to information. These changes raise significant questions about whether the Common Rule, as currently structured, can adequately address the ethical issues posed by contemporary research.
Symposium Articles
What the ANPRM Missed: Additional Needs for IRB Reform
Charles W. Lidz and Suzanne Garverich - [PDF]

Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.
Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?
Seema K. Shah - [PDF]

The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.
Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects
Leslie Meltzer Henry - [PDF]

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone.
Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens
Gail H. Javitt - [PDF]

This article reviews the history of the debate over use of biospecimens in research, the legal and ethical arguments that have been presented both in support of and in opposition to such use, court cases and judicial opinions involving disputes between specimen contributors, researchers, and institutions, and public attitudes regarding the use of biospecimens in research. The paper argues that proposed changes to the Common Rule are inadequate to resolve the legal and ethical concerns that have been raised with respect to the use of biospecimens. It argues that there is a need to distinguish between the dual roles - subject and donor - played by contributors of biospecimens.
Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?
Brett A. Williams and Leslie E. Wolf - [PDF]

In its Advanced Notice of Proposed Rule Making (ANPRM), the U.S. Department of Health and Human Services proposed substantial changes to how biospecimen research is treated under the regulations governing human subjects research. Currently, much of this research can be conducted without consent because it may not be considered "human subjects" research, is considered exempt, or consent may be waived. Responding to criticisms that scientific changes have made biospecimen research riskier than contemplated when the Common Rule was last amended, the ANPRM proposes to require written consent for biospecimen research, even if they have been stripped of identifiers or initially collected for a non-research purpose.
Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project
Diane E. Hoffmann, J. Dennis Fortenberry, and Jacques Ravel - [PDF]

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a "reference catalogue" of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.
The Apomediated World: Regulating Research When Social Media Has Changed Research
Dan O'Connor - [PDF]

Social Media, like Facebook and Twitter, are having a profound effect on the way that human subjects research is being conducted. In light of the changes proposed in ANPRM, in this article I argue that traditional research ethics and regulations may not easily translate to the use of social media in human subjects research. Using the conceptual model of apomediation, which describes the peer-to-peer way in which health information is shared via social media, I suggest that we may need to think again about the suitability of current regulations to deal with social media research.
Independent Articles
Advance Directives, Dementia, and Physician-Assisted Death
Paul T. Menzel and Bonnie Steinbock - [PDF]

Physician-assisted suicide laws in Oregon and Washington require the person's current competency and a prognosis of terminal illness. In The Netherlands voluntariness and unbearable suffering are required for euthanasia. Many people are more concerned about the loss of autonomy and independence in years of severe dementia than about pain and suffering in their last months. To address this concern, people could write advance directives for physician-assisted death in dementia. Should such directives be implemented even though, at the time, the person is no longer competent and would not be either terminally ill or suffering unbearably? We argue that in many cases they should be, and that a sliding scale which considers both autonomy and the capacity for enjoyment provides the best justification for determining when: when written by a previously well-informed and competent person, such a directive gains in authority as the later person's capacities to generate new critical interests and to enjoy life decrease. Such an extension of legalized death assistance is grounded in the same central value of voluntariness that undergirds the current more limited legalization.
Caring for Elder Parents: A Comparative Evaluation of Family Leave Laws
Y. Tony Yang and Gilbert Gimm - [PDF]

As the baby boomer generation ages, the need for laws to enhance quality of life for the elderly and meet the increasing demand for family caregivers will continue to grow. This paper reviews the national family leave laws of nine major OECD countries (Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, and the United Kingdom) and provides a state-by-state analysis within the U.S. We find that the U.S. has the least generous family leave laws among the nine OECD countries. With the exception of two states (California and New Jersey), the U.S. federal Family Medical Leave Act of 1993 provides no right to paid family leave for eldercare. We survey the current evidence from the literature on how paid leave can impact family caregivers' employment and health outcomes, gender equality, and economic arguments for and against such laws. We argue that a generous and flexible family leave law, financed through social insurance, would not only be equitable, but also financially sustainable.
Social Security Survivors Benefits: The Effects of Reproductive Pathways and Intestacy Law on Attitudes
Jason D. Hans and Martie Gillen - [PDF]

Most minor children are eligible for Social Security survivors benefits if a wage-earning parent dies, but eligibility of children not in utero at the time of death is more nuanced. The purpose of this study was to examine attitudes concerning access to Social Security survivors benefits in the context of posthumous reproduction. A probability sample of 540 Florida households responded to a multiple-segment factorial vignette designed to examine the effects of state intestacy laws and five reproductive pathways - normative, posthumous birth, cryopreserved embryo, cryopreserved gametes, and posthumous gamete retrieval - on attitudes toward eligibility for the Social Security survivors benefits. Broad support was found for the survivors benefits following normative and posthumous birth pathways, but attitudes were decidedly less favorable when the child was not in utero at the time of parental death. In addition, in stark contrast to the recent U.S. Supreme Court decision in Astrue v. Capato, the vast majority of respondents did not believe state intestacy laws should determine eligibility for Social Security survivors benefits.
Columns
Currents in Contemporary Bioethics: HIPAA Privacy Rule 2.0
Mark A. Rothstein - [PDF]

On January 25, 2013, the Federal Register published the Department of Health and Human Services (HHS) omnibus amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and the Genetic Information Nondiscrimination Act (GINA). Although the amended rules were effective on March 26, 2013, covered entities and their business associates (which now have direct liability for violations of the regulations) have a compliance date of September 23, 2013.
Public Health and the Law: Legal Responses to Communal Rejection in Emergencies
James G. Hodge, Jr., Daniel G. Orenstein, Kim Weidenaar, Nick Meza, Laura Van Buren, Nick Wearne, and Kristin Penunuri - [PDF]

Major disasters and public health emergencies constantly test the nation's resolve to rally and recover from tragedy. Public health crises stemming from prolonged threats like the 2009/2010 H1N1 influenza pandemic require sustained preparedness and response over many months. Even shorter-duration events, like tornados, earthquakes, or hurricanes, leave lasting impacts for which full recovery may take years. Telling examples include the displacement of thousands of persons across the Gulf Coast states following Hurricane Katrina in 2005 and difficulties obtaining basic housing and services that persisted in the Northeast months after Hurricane Sandy in 2012. Whether the result of natural disasters, infectious disease outbreaks, bioterrorism, or other causes, these events can change the societal landscape in affected regions.