The Journal of Law, Medicine and Ethics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Take Another Little Piece of My Heart1: Regulating the Research Use of Human Biospecimens
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 — subj...
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Gail H. Javitt Source Type: research

Moral Gridlock: Conceptual Barriers to No‐Fault Compensation for Injured Research Subjects
This article asks why, despite decades of federal‐level panels recommending no‐fault compensation for research‐related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees' articulation of mu...
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Leslie Meltzer Henry Source Type: research

Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?
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. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Seema K. Shah Source Type: research

What the ANPRM Missed: Additional Needs for IRB Reform
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. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 26, 2013 Category: Medical Law Authors: Charles W. Lidz, Suzanne Garverich Source Type: research

INTRODUCTION: Revising the Common Rule: Prospects and Challenges
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - June 1, 2013 Category: Medical Law Authors: Leslie Meltzer Henry Source Type: research

Calendar of Events
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Source Type: research

The Barnes Case: Taking Difficult Futility Cases Public
Futility disputes are increasing and courts are slowly abandoning their historical reluctance to engage these contentious issues, particularly when confronted with inappropriate surrogate demands for aggressive treatment. Use of the judicial system to resolve futility disputes inevitably brings media attention and requires clinicians, hospitals, and families to debate these deep moral conflicts in the public eye. A recent case in Minnesota, In re Emergency Guardianship of Albert Barnes, explores this emerging trend and the complex responsibilities of clinicians and hospital administrators seeking to replace an unfaithful s...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Ruth A. Mickelsen, Daniel S. Bernstein, Mary Faith Marshall, Steven H. Miles Source Type: research

Reconsidering the Legality of Cigarette Smoking Advertisements on Television Public Health and the Law
Television advertisements depicting the use of electronic cigarettes have recently exposed minors to images of smoking behaviors. While these advertisements are currently legal, existing laws should be interpreted or expanded to ban the commercial depiction of smoking behaviors with any product that resembles a cigarette to shield minors from potentially influential advertising. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: James G. Hodge, Veda Collmer, Daniel G. Orenstein, Chase Millea, Laura Van Buren Source Type: research

Abuses and Apologies: Irresponsible Conduct of Human Subjects Research in Latin America
This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Julie M. Aultman Source Type: research

Physician Participation in Executions, the Morality of Capital Punishment, and the Practical Implications of Their Relationship
Evidence that some executed prisoners suffered excruciating pain has reinvigorated the ethical debate about physician participation in executions. In widely publicized litigation, death row inmates argue that participation of anesthesiologists in their execution is constitutionally required to minimize the risk of unnecessary suffering. For many years, commentators supported the ethical ban on physician participation reflected in codes of professional medical organizations. However, a recent wave of scholarship concurs with inmate advocates, urging the law to require or permit physician participation. Both the anti‐ and ...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Paul Litton Source Type: research

Transparent Vessels?: What Organ Donors Should Be Allowed to Know about Their Recipients
A live organ donor needs to be informed carefully about the risks and benefits of her donation for both herself and her recipient, but a key ethical question is how much the donor is allowed to know about the recipient. To decide this question, we must first decide whether, out of respect for autonomy, the donor should decide how much she wants to know, or whether the transplant team, as the professionals, should decide what information is relevant to the donor's decision. I argue that the transplant team should control the process. While the donor has the right to know enough about her recipient to assess the risk to hers...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Richard H. Dees Source Type: research

Brightening Up: The Effect of the Physician Payment Sunshine Act on Existing Regulation of Pharmaceutical Marketing
With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Igor Gorlach, Genevieve Pham‐Kanter Source Type: research

Making Residency Work Hour Rules Work
In July 2011, the ACGME implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd‐year and higher resident physicians to work for up to 28 consecutive hours. Whether the ACGME's 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re‐open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its ...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: I. Glenn Cohen, Charles A. Czeisler, Christopher P. Landrigan Source Type: research

Evaluating Equity Critiques in Food Policy: The Case of Sugar‐Sweetened Beverages
Many anti‐obesity policies face a variety of ethical objections. We consider one kind of anti‐obesity policy — modifications to food assistance programs meant to improve participants' diet — and one kind of criticism of these policies, that they are inequitable. We take as our example the recent, unsuccessful effort by New York State to exclude sweetened beverages from the items eligible for purchase in New York City with Supplemental Nutrition Support Program (SNAP) assistance (i.e., food stamps). We distinguish two equity‐based ethical objections that were made to the sweetened beverage exclusion, and analyze t...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Anne Barnhill, Katherine F. King Source Type: research

Medical Tourism's Impact on Health Care Equity and Access in Low‐ and Middle‐Income Countries: Making the Case for Regulation
This article reviews relevant evidence that exists and concludes that there are signs of correlation between medical tourism and the expansion of private, technology‐ intensive health care in LMICs, which has largely remained out of reach for the majority of the local patients. In light of this health care inequity between local residents and medical tourists in LMICs, we argue that the presumption should not be in favor of medical tourism and that governments have a legitimate interest in seeking to regulate this industry to ensure that the net effects for their citizens is positive. Moreover, sending countries, particu...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Y.Y. Brandon Chen, Colleen M. Flood Source Type: research