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Back Issues and Articles

Table of Contents
Table Of Contents
Letter From the Editor
Letter From The Editor

If the packet containing this issue of the Journal of Law, Medicine & Ethics seems to be of the heavy variety, that is because it is. And it is likely a familiar feeling. We are currently in the middle of a particularly grueling stretch of production where we are publishing eight stand-alone issues of JLME in roughly a 10-month period. Our fall and winter issues of 2014 and our spring and summer issues of 2015 all contain a very robust regular issue of the journal, as well as a special supplement. The late nights necessary to produce these issues are tempered, however, by the excitement of bringing our readers these important works of scholarship. Last year, we brought you supplements on genome sequencing and interprofessional global health education. Now, this spring we bring you a supplemental issue containing the papers delivered at the 2014 Public Health Law Conference, which was co-sponsored by the Network for Public Health Law and our parent organization, the American Society of Law, Medicine & Ethics. These important papers give us a window into the cutting-edge work happening in the field of public health law, and their inclusion in this issue is an effective way to preserve the work that is shaped and developed at these vital live conferences.
Wendy Parmet - [PDF]

In 1914, Margaret Sanger was indicted under the Comstock Law for advocating the use of birth control. Rather than face trial, she fled to England, only to return to open the nation's first contraceptive clinic.
Acoustic Separation and Biomedical Research: Lessons from Indian Regulation of Compensation for Research Injury
Megan E. Larkin - [PDF]

In early 2013, the Indian Central Drugs Standard Control Organisation, under supervision of the Health Secretary, introduced new rules governing the conduct of clinical trials involving human participants. Among other provisions, the rules require that sponsors of research compensate participants who are injured during the course of their research participation. The rules presumably were drafted to protect citizens from harm caused by biomedical research without unduly restricting access to the benefits that research can provide. While requiring compensation for injury is widely-acknowledged as a critical component of ensuring ethical conduct of human subjects research, in this case the legal restrictions do not match the ethical justifications that support a compensation requirement.3 To see this, it is important to examine the context in which the rules were written, the justifications for rules of this type, and what mechanisms are available to bring the effects of the rules into alignment with the norms their passage sought to promote. The Indian regulations, as originally written, overreached in ways that are not aligned with the ethical justifications for provision of compensation for research related injuries.
Symposium Articles
Abortion and Compelled Physician Speech
David Orentlicher - [PDF]

As states increasingly impose informed consent mandates on abortion providers, the required disclosures bring two well-established legal doctrines into conflict - the First Amendment's freedom of speech and the physician's duty to obtain informed consent.
The First Amendment and Physician Speech in Reproductive Decision Making
Sonia M. Suter - [PDF]

The regulation of medicine has long been recognized as within the state's police powers. Yet when the state regulates physicians' professional speech, it potentially raises First Amendment concerns. Nowhere is this truer than in the abortion context, where state legislatures have attempted to influence women's reproductive decisions with informed consent requirements. Although the Supreme Court, in Planned Parenthood of Se. Pa. v. Casey, found a mandated disclosure provision constitutional some 20 years ago, it offered little to clarify the scope and reach of the First Amendment issues that arise with abortion informed consent laws.
A Matter of Context: Casey and the Constitutionality of Compelled Physician Speech
Scott W. Gaylord - [PDF]

The First Amendment states that "Congress shall make no law...abridging the freedom of speech." Given the myriad ways in which freedom of speech can be implicated, the United States Supreme Court has not adopted a single standard for reviewing First Amendment speech claims. With respect to compelled speech, the Court has instructed that "context" is dispositive. When the government attempts to "prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein," the Court applies strict scrutiny. When, however, "the State has a significant role to play in regulating" a particular context, government-compelled disclosures may be subject to a lower standard of review: "When a state regulation implicates First Amendment rights, the court must balance those interests against the State's legitimate interest in regulating the activity in question."
Informed Decision Making and Abortion: Crisis Pregnancy Centers, Informed Consent, and the First Amendment
Aziza Ahmed - [PDF]

Shifting laws and regulations increasingly displace the centrality of women's needs in the provision of abortion services. Lawmakers and judges contribute to this environment in two ways: by protecting the right of "Crisis Pregnancy Centers" (CPCs) to give false and misleading information about abortion and by supporting legislation mandating that abortion providers give misleading and unnecessary information for the purposes of informed consent. Litigation on informed consent is further complicated through the mobilization of facts - such as the gestational age or sonogram of the fetus - delivered with the intent to dissuade women from accessing abortion. In other words, factual information utilized for ideological purpose.
Casey Meets the Crisis Pregnancy Centers
B. Jessie Hill - [PDF]

Recent cases about the constitutionality of compelled speech in the reproductive health care context contain an irony that is difficult to ignore. Whereas courts tend to be highly permissive when considering governmentally-mandated speech by physicians to patients seeking abortions, they have often been more skeptical of disclosure requirements imposed on crisis pregnancy centers (CPCs), which are nonmedical centers whose entire mission is to dissuade women from choosing abortion, and which have at least in some cases utilized deceptive techniques to accomplish that goal. In other words, it appears that non-physicians seeking to keep women from seeking a legal form of medical treatment have greater First Amendment protections than physicians who care directly for those women and who are generally entrusted by the state to exercise professional judgment.
When States Regulate Emergency Contraceptives Like Abortion, What Should Guide Disclosure?
Cameron O'Brien Flynn and Robin Fretwell Wilson - [PDF]

State law efforts to regulate abortions have accelerated. Between 2011 and 2013, state legislatures enacted 205 abortion laws - 16 more than in the entire decade before. Most laws take direct aim at surgical abortions, although some also target chemical abortions that use drugs like RU-486, a common chemical abortifacient sold under the trade name Mifeprex.
Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?
I. Glenn Cohen - [PDF]

There was a moment in the 2012 campaign, when Mitt Romney attempted to "pivot" to the center and get away from the statements of those like Todd Akin who made comments about how in cases of "legitimate rape," the victims' bodies "have ways to try and shut that whole thing down." The way Romney did it was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy to those who oppose abortion. Abortion should be criminalized, yes, but with these exceptions carved out. This shibboleth has found its way not only in the public position taken by many Pro-Life politicians, but also in legislation across several U.S. states, and even the Hyde Amendment, which prohibits federal funding for abortion, makes an exception for these kinds of abortions. Many legal writers have also accepted, to some extent, this compromise position either by praising it as their own or particularly attacking those who would not make this exception.
Independent Articles
Detecting, Preventing, and Responding to "Fraudsters" in Internet Research: Ethics and Tradeoffs
Jennifer E. F. Teitcher, Walter O. Bockting, Jose A. Bauermeister, Chris J. Hoefer, Michael H. Miner, and Robert L. Klitzman - [PDF]

Research that recruits and surveys participants online is increasing, but is subject to fraud whereby study respondents - whether eligible or ineligible - participate multiple times. Online Internet research can provide investigators with large sample sizes and is cost efficient. Internet- based research also provides distance between the researchers and participants, allowing the participant to remain confidential and/or anonymous, and thus to respond to questions freely and honestly without worrying about the stigma associated with their answers. However, increasing and recurring instances of fraudulent activity among subjects raise challenges for researchers and Institutional Review Boards (IRBs). The distance from participants, and the potential anonymity and convenience of online research allow for individuals to participate easily more than once, skewing results and the overall quality of the data.
On the Justifiability of ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing
Thomas May - [PDF]

In spring 2013 the American College of Medical Genetics and Genomics (ACMG) Working Group on Incidental Findings in Clinical Exome and Genome Sequencing (hereafter "Working Group") released a report of "Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing," the culmination of a three-year long consensus project. The Working Group recommended that a number of incidental findings, which they define as "the results of a deliberate search for pathogenic or likely pathogenic alterations in genes that are not apparently relevant to a diagnostic indication for which the sequencing test was ordered," be returned to clinicians (and patients) independent of patient preferences. The Working Group recognized that their recommendations may violate existing ethical norms, but believe this is justified by a fiduciary duty on the part of clinicians and laboratory personnel to prevent harm by warning patients about certain findings, a duty they claim "supersedes concerns about autonomy." The recommendations met with widespread criticism in the press and science literature, perhaps best summarized in a statement from Susan Wolf in the Boston Globe: "I'm troubled by them going that far in demoting these core concerns of [patient] autonomy, which in the clinical sphere have been such important bedrocks."
Global Justice and Health Systems Research in Low- and Middle-Income Countries
Bridget Pratt and Adnan A. Hyder - [PDF]

More than a decade ago, Solomon Benatar and Peter Singer argued that "a new, proactive research ethics...must ultimately be concerned with reducing inequities in global health and achieving justice in health research and health care." Towards this objective, a limited amount of recent scholarship has started to consider whether a theoretical basis exists for the position that international research should help promote global health equity and, if so, what the implications are for its conduct. Theories of justice from political philosophy establish obligations for parties in high-income countries to improve the health of parties in low- and middle-income countries (LMICs). These theories have been shown to provide grounds for the claim that international research should be conducted to advance justice in global health. What this means for research actors from high-income countries is the focus of a recently proposed ethical framework: "research for health justice."
Currents in Contemporary Bioethics: The Patient as Consumer: Empowerment or Commodification?
Melissa M. Goldstein and Daniel G. Bowers - [PDF]

Discussions surrounding patient engagement and empowerment often appear to use the terms "patient" and "consumer" interchangeably. But do the two terms hold the same meaning, or is a "patient" a passive actor in the health care arena and a "consumer" an informed, rational decision- maker? Has there been a shift in our usage of the two terms that aligns with the increasing commercialization of health care in the U.S. or has the patient/consumer dynamic always been a part of the buying and selling of health care in the American system? What implications does this language have for health care users? Are cost and quality of care affected by this shift in terminology? This article analyzes our current usage of the terms and the evolution of the patient/consumer dynamic and discusses the ethical and policy implications of this simple terminology for the physician-patient relationship and the health care system.
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