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.

Heterogeneity in IRB Policies with Regard to Disclosures about Payment for Participation in Recruitment Materials
Although the Federal Common Rule requires that informed consent documents include all material information, it does not specify the content of materials used to recruit human subjects. In particular, there is no federal regulation relating to how payment for research participation is to be advertised. Rather, the FDA has issued guidance, advising researchers not to emphasize payment information. In order to determine how IRBs have interpreted this guidance, we coded the policies of the top 100 institutions by receipt of NIH funding, in order to determine whether they require, permit, or forbid researchers to disclose the a...
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Megan S. Wright, Christopher T. Robertson Tags: Independents Source Type: research

The Pan American Health Organization and the Mainstreaming of Human Rights in Regional Health Governance
This article explores PAHO's 15‐year effort to mainstream human rights through PASB technical units, national capacity‐building, the Inter‐American human rights system, and the PAHO Directing Council. Through documentary analysis of PAHO policies and semi‐structured interviews with key PASB stakeholders, the authors analyze the understandings and actions of policymakers and technical officers in implementing human rights through PAHO governance. Analyzing the themes arising from this narrative, the authors examine the structural role of secretariat leadership, state support, legal expertise, and technical unit comm...
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Benjamin Mason Meier, Ana S. Ayala Tags: Independents Source Type: research

The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations
This study analyzes nine consent forms used in NIH‐funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data‐sharing. In response to lack of consensus, we offer recommendations. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Gail E. Henderson, Susan M. Wolf, Kristine J. Kuczynski, Steven Joffe, Richard R. Sharp, D. Williams Parsons, Bartha M. Knoppers, Joon‐Ho Yu, Paul S. Appelbaum Tags: Independents Source Type: research

Loss of Possession: Concussions, Informed Consent, and Autonomy
This article considers the cultural context of informed decision making by parents of youth football players and suggests that policy changes designed to lower (although they cannot eliminate) risks of brain injury have the potential to change both the culture of football and the way the benefits and harms of the game are regarded for its players, without loss of its essential excitement and appeal. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Richard Robeson, Nancy M. P. King Tags: Symposium Articles Source Type: research

Youth Sports & Public Health: Framing Risks of Mild Traumatic Brain Injury in American Football and Ice Hockey
The framing of the risks of experiencing mild traumatic brain injury in American football and ice hockey has an enormous impact in defining the scope of the problem and the remedies that are prioritized. According to the prevailing risk frame, an acceptable level of safety can be maintained in these contact sports through the application of technology, rule changes, and laws. An alternative frame acknowledging that these sports carry significant risks would produce very different ethical, political, and social debates. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Kathleen E. Bachynski, Daniel S. Goldberg Tags: Symposium Articles Source Type: research

Perceived Coach Support and Concussion Symptom‐Reporting: Differences between Freshmen and Non‐Freshmen College Football Players
This paper examines college athletes’ perceived support for concussion reporting from coaches and teammates and its variation by year‐in‐school, finding significant differences in perceived coach support. It also examines the effects of perceived coach support on concussion reporting behaviors, finding that greater perceived coach support is associated with fewer undiagnosed concussions and returning to play while symptomatic less frequently in the two weeks preceding the survey. Coaches play a critical role in athlete concussion reporting. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Christine M. Baugh, Emily Kroshus, Daniel H. Daneshvar, Robert A. Stern Tags: Symposium Articles Source Type: research

Requiring Athletes to Acknowledge Receipt of Concussion‐Related Information and Responsibility to Report Symptoms: A Study of the Prevalence, Variation, and Possible Improvements
State concussion laws and sport‐league policies are important tools for protecting public health, but also present implementation challenges. Both state laws and league policies often require athletes provide written acknowledgement of having received concussion‐related information and/or of their responsibility to report concussion‐related symptoms. This paper examines these requirements in two ways: an analysis of the variation in state laws and sport‐league policies and a study of their effects in a cohort of collegiate football players. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Christine M. Baugh, Emily Kroshus, Alexandra P. Bourlas, Kaitlyn I. Perry Tags: Symposium Articles Source Type: research

State Experiences Implementing Youth Sports Concussion Laws: Challenges, Successes, and Lessons for Evaluating Impact
While provisions of youth sports concussion laws are very similar, little is known as to how they are being implemented, factors that promote or impede implementation, or the level of compliance in each jurisdiction. We aimed to describe state experiences with implementation in order to inform ongoing efforts to reduce the harm of sports‐related traumatic brain injury and to guide future evaluations of the laws’ impacts and the development of future public health laws. We conducted key‐informant interviews in 35 states with recently enacted concussion legislation. States varied considerably in their readiness and cap...
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Kerri McGowan Lowrey, Stephanie R. Morain Tags: Symposium Articles Source Type: research

Where Do We Go from Here? An Inside Look into the Development of Georgia's Youth Concussion Law
Currently, all 50 states and the District of Columbia have youth concussion laws based on the core principals of the 2009 Lystedt Law of Washington State. On April 23, 2013, the state of Georgia signed into law House Bill 284, “The Return to Play Act of 2013” and became one of the last states to pass youth concussion legislation. This Act became effective on January 1, 2014. The purpose of this report is to highlight the legislative process of enacting Georgia House Bill 284 and compare it to the legislation of other states. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: Amanda Cook, Harold King, John A. Polikandriotis Tags: Symposium Articles Source Type: research

Introduction
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 26, 2014 Category: Medical Law Authors: David Orentlicher Tags: Symposium Articles Source Type: research

Foreword
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 1, 2014 Category: Medical Law Authors: Alan Schwarz Tags: Symposium Articles Source Type: research

Calendar of Events
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Source: The Journal of Law, Medicine and Ethics - July 16, 2014 Category: Medical Law Tags: Calendar of Events Source Type: research

Active Shooters in Health Care Settings: Prevention and Response through Law and Policy
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - July 16, 2014 Category: Medical Law Authors: James G. Hodge, Kellie Nelson Tags: Columns Source Type: research

Extending the Minimum Necessary Standard to Uses and Disclosures for Treatment
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - July 16, 2014 Category: Medical Law Authors: Julie L. Agris Tags: Columns Source Type: research

Toward a Jurisprudence of Drug Regulation
Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e., product approvals) or negative (i.e., a...
Source: The Journal of Law, Medicine and Ethics - July 16, 2014 Category: Medical Law Authors: Matthew Herder Tags: Independents Source Type: research