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Nonfinancial Conflict Of Interest In Medical Research: Is Regulation The Right Answer, Nehad Mikhael Apr 2024

Nonfinancial Conflict Of Interest In Medical Research: Is Regulation The Right Answer, Nehad Mikhael

Journal of Law and Health

Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, …


Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton May 2023

Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton

Journal of Law and Health

Suffering through substance withdrawal is a major problem for the majority of individuals in custody, yet there are no guidelines or standards to ensure their safety. Instead, individuals in custody are having their Constitutional rights violated and many die at the hands of the justice system. When their families seek accountability for the lack of adequate care provided by correctional facilities and employees, families are faced with a lack of consistency from one circuit to the next for knowing as to the correct standard to have a successful claim. Strain v. Regalado was a chance for the Supreme Court to …


Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka Dec 2021

Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka

Journal of Law and Health

The Center for Disease Control and Prevention (CDC) has reported that the use of assisted reproductive technology (ART) has doubled over the past decade. In vitro fertilization (IVF) is the most prevalent form of ART. During IVF, a woman’s eggs are extracted, fertilized in a laboratory setting, and then implanted in the uterus. Many IVF procedures use eggs or sperm that were stored using a process called cryopreservation. A recent survey reported that cryopreservation consultations increased exponentially during the coronavirus pandemic, rising as much as 60 percent. It is estimated that more than one million embryos are stored in cryopreservation …


Hacking Hipaa: "Best Practices" For Avoiding Oversight In The Sale Of Your Identifiable Medical Information, Riyad A. Omar Nov 2020

Hacking Hipaa: "Best Practices" For Avoiding Oversight In The Sale Of Your Identifiable Medical Information, Riyad A. Omar

Journal of Law and Health

In light of the confusion invited by applying the label "de-identified" to information that can be used to identify patients, it is paramount that regulators, compliance professionals, patient advocates and the general public understand the significant differences between the standards applied by HIPAA and those applied by permissive "de-identification guidelines." This Article discusses those differences in detail. The discussion proceeds in four Parts. Part II (HIPAA’s Heartbeat: Why HIPAA Protects Identifiable Patient Information) examines Congress’s motivations for defining individually identifiable health information broadly, which included to stop the harms patients endured prior to 1996 arising from the commercial sale of …


The Public Health Demand For Revoking Non-Medical Exemptions To Compulsory Vaccination Statutes, Emma Tomsick Nov 2020

The Public Health Demand For Revoking Non-Medical Exemptions To Compulsory Vaccination Statutes, Emma Tomsick

Journal of Law and Health

In 2019, the United States saw the single largest outbreak of measles in recent history. The measles crisis has prompted state legislative bodies to face a seemingly impossible dilemma: eliminate both religious and philosophical exemptions to mandatory school vaccination statutes or sit by idly and allow measles to continue to run its course. As of June 2019, five states have neither religious nor philosophical exemptions to their mandatory vaccination statutes. This Note argues that states should remove all religious and philosophical exemptions to compulsory vaccination statutes. The 2019 measles outbreak demonstrates that the anti-vaccination movement poses a legitimate risk to …


International Law And The Legalization Of Abortion In Northern Ireland, Emily Uterhark Nov 2020

International Law And The Legalization Of Abortion In Northern Ireland, Emily Uterhark

Journal of Law and Health

On July 24, 2019, the Parliament of the United Kingdom passed an act that included an amendment requiring Northern Ireland to implement recommendations from the Committee on the Elimination on Discrimination Against Women. The amendment required Northern Ireland to repeal the 1861 abortion act and requires the decriminalization of abortion. The law went into effect on October 22, 2019, since the Northern Ireland power-sharing government (Stormont) did not reconvene before October 21, 2019. Since the law did go into effect, it gave women the right to obtain abortions under the CEDAW recommendations; however, when the Northern Irish government (Stormont) reconvenes, …


Parens Patriae And Parental Rights: When Should The State Override Parental Medical Decisions?, Elchanan G. Stern Dec 2019

Parens Patriae And Parental Rights: When Should The State Override Parental Medical Decisions?, Elchanan G. Stern

Journal of Law and Health

Alfie Evans was a terminally ill British child whose parents, clinging to hope, were desperately trying to save his life. Hospital authorities disagreed and petitioned the court to enjoin the parents from removing him and taking him elsewhere for treatment. The court stepped in and compelled the hospital to discontinue life support and claimed that further treatment was not in the child’s best interest. This note discusses the heartbreaking stories of Alfie and two other children whose parents’ medical decisions on their behalf were overridden by the court. It argues that courts should never decide that death is in a …


A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy May 2018

A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy

Journal of Law and Health

This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify …


Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen Jul 2017

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …


Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S. Jul 2017

Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S.

Journal of Law and Health

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.


Expansion Of Employee Wellness Programs Under Ppaca Creates Additional Barriers To Healthcare Insurance For Individuals With Disabilities, Amy B. Cheng Dec 2016

Expansion Of Employee Wellness Programs Under Ppaca Creates Additional Barriers To Healthcare Insurance For Individuals With Disabilities, Amy B. Cheng

Journal of Law and Health

There are many barriers to healthcare for the general population that has been documented throughout the years, with one particularly affected group being individuals with disabilities. One identified healthcare barrier for individuals with disabilities is the inability to gain access to the healthcare system through health insurance. While many attempts have been made to resolve this issue, serious problems have yet to be resolved. The Patient Protection Affordable Care Act (PPACA) attempted to solve the issue by expanding Health Insurance Portability and Accountability Act of 1996’s (HIPAA) current regulations on employee wellness programs. The relevant regulations govern employee wellness programs …


Save Thousands Of Lives Every Year: Resuscitate The Peer Review Privilege, Alan G. Williams Dec 2016

Save Thousands Of Lives Every Year: Resuscitate The Peer Review Privilege, Alan G. Williams

Journal of Law and Health

Doctors make mistakes—preventable medical mistakes—that kill or seriously injure patients. The best way to reduce these preventable errors is through a medical peer review process typically referred to as a "morbidity and mortality conference." However, over the past twenty years, federal and state courts, state legislatures, and state voters have effectively gutted the morbidity and mortality conference (M&M) as a remedial and preventative tool, resulting in tens of thousands of unnecessary deaths every year. Doctors need our help restoring the effectiveness of M&Ms. Congress has created the means to do so; now, all the courts need do is use it. …


Quintavalle: The Quandary In Bioethics, Lisa Cherkassky Dec 2016

Quintavalle: The Quandary In Bioethics, Lisa Cherkassky

Journal of Law and Health

The case of R. (Quintavalle) v. Human Fertilisation Embryology Authority (and Secretary of State for Health) presents a handful of legal problems. The biggest legal query to arise from the case is the inevitable harvest of babies, toddlers and very young children for their bone marrow. This article unpacks the judicial story behind Quintavalle to reveal how the strict provisions of the Human Fertilisation and Embryology Act 1990 - namely ‘suitable condition’ under schedule 2 paragraph 1(1)(a) and ‘treatment services’ and ‘assisting’ under section 2(1) - were widely misinterpreted to introduce the social selection of embryos into law. The legal …


Healer, Witness, Or Double Agent? Reexamining The Ethics Of Forensic Psychiatry, Matthew U. Scherer Dec 2016

Healer, Witness, Or Double Agent? Reexamining The Ethics Of Forensic Psychiatry, Matthew U. Scherer

Journal of Law and Health

In recent years, psychiatrists have become ever more prevalent in American courtrooms. Consequently, the issue of when the usual rules of medical ethics should apply to forensic psychiatric encounters has taken on increased importance and is a continuing topic of discussion among both legal and medical scholars. A number of approaches to the problem of forensic psychiatric ethics have been proposed, but none adequately addresses the issues that arise when a forensic encounter develops therapeutic characteristics. This article looks to the rules governing the lawyer-client relationship as a model for a new approach to forensic psychiatric ethics. This new model …


Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry Dec 2016

Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry

Journal of Law and Health

Though Veteran Affairs has provided crucial life sustaining—and often lifesaving—treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA’s facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. Addiction is one of the key symptoms of post-traumatic stress disorder (PTSD) and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of …


Shifting Our Focus From Retribution To Social Justice: An Alternative Vision For The Treatment Of Pregnant Women Who Harm Their Fetuses, April L. Cherry Jan 2015

Shifting Our Focus From Retribution To Social Justice: An Alternative Vision For The Treatment Of Pregnant Women Who Harm Their Fetuses, April L. Cherry

Journal of Law and Health

The ways in which society responds to pregnant women whose behavior purportedly harms their fetuses can be explored from a variety of legal vantage points. This article argues that the criminal law model currently used is ineffective. The assignment of criminal liability to pregnant women is often rooted in fetal personhood and maternal deviance discourse. Criminal law solutions fail because they fail to take into account the fact that maternal behavior is often the result of a myriad of the social and economic conditions over which pregnant women have little or no control. The criminal law model, therefore, simply punishes …


Introduction: Issues Of Reproductive Rights: Life, Liberty & The Pursuit Of Policy, Lauren Orrico, Gordon Gantt Jr. Jan 2015

Introduction: Issues Of Reproductive Rights: Life, Liberty & The Pursuit Of Policy, Lauren Orrico, Gordon Gantt Jr.

Journal of Law and Health

On March 7, 2014, the Journal of Law and Health of Cleveland-Marshall College of Law hosted a symposium entitled “Issues of Reproductive Rights: Life, Liberty, and the Pursuit of Policy” in response to recent developments in the regulation of women’s reproductive rights. The discussion about women’s reproductive rights has expanded far beyond the morality of abortion and right to privacy, established by the United States Supreme Court in Roe v. Wade, and has been complicated by new technology, statutory developments, and case law discussing the nature of a corporation. The symposium presenters addressed key legal developments in each stage of …


Reproductive Justice, Public Policy, And Abortion On The Basis Of Fetal Impairment: Lessons From International Human Rights Law And The Potential Impact Of The Convention On The Rights Of Persons With Disabilities, Carole J. Petersen Jan 2015

Reproductive Justice, Public Policy, And Abortion On The Basis Of Fetal Impairment: Lessons From International Human Rights Law And The Potential Impact Of The Convention On The Rights Of Persons With Disabilities, Carole J. Petersen

Journal of Law and Health

This article argues that we should consider not only American constitutional law but also comparative law and emerging international human rights norms, in order to navigate the difficult issue of abortion on the basis of fetal impairment. The United States is a State Party to the International Covenant on Civil and Political Rights (ICCPR)13 and the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (CAT). It is also a signatory (but not a full State Party) to several other relevant treaties, including the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), the …


Proving Medical Child Abuse: The Time Is Now For Ohio To Focus On The Victim And Not The Abuser, Tiffany S. Allison Jan 2012

Proving Medical Child Abuse: The Time Is Now For Ohio To Focus On The Victim And Not The Abuser, Tiffany S. Allison

Journal of Law and Health

Part I of this Note will discuss the history of Munchausen's Syndrome by Proxy and how the medical community is trying to make the general public aware of medical child abuse. Part II provides a history of Munchausen's Syndrome by Proxy and medical child abuse. It also highlights the differences in how litigation was previously handled under the nomenclature of Munchausen's Syndrome by Proxy and how litigation should be handled in the future under the nomenclature of medical child abuse. Part III identifies Ohio's current statutes and federal legislation that have an effect on child abuse. Part III also identifies …


Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman Jan 2012

Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman

Journal of Law and Health

This Article discusses the history of informed consent, critically analyzes this principle, and suggests an alternative approach to informed consent. Part II explores the concept of informed consent, including its philosophical bases, its implementation through FDA regulations, and current proposals on how to protect the principle in drug testing conducted abroad. Part III performs a critical analysis of the principle of informed consent; first providing an empirical examination of the realities of Third World human subject research, and then questioning both the coherence of an abstract “right” to informed consent, as well as the possibility of truly autonomous “consent” to …


Organ Conscription: How The Dead Can Save The Living, David Schwark Jan 2011

Organ Conscription: How The Dead Can Save The Living, David Schwark

Journal of Law and Health

This Note will examine the failures of uncompensated and voluntary donation and argue that the only way to meet our country's organ needs is to make donation mandatory. Part II of this Note examines the history of voluntary organ donation in the United States. This history describes the evolution of organ donation laws from the first transplant until the present day. Part II also details the consequences and shortcomings of the current system. Part III examines three other proposed solutions to the organ deficit. These possible solutions include routine requests, an organ market, and presumed consent. However, none of these …


Not Of Woman Born: How Ectogenesis Will Change The Way We View Viability, Birth, And The Status Of The Unborn, Eric Steiger Jan 2010

Not Of Woman Born: How Ectogenesis Will Change The Way We View Viability, Birth, And The Status Of The Unborn, Eric Steiger

Journal of Law and Health

Over seventy-five years ago, Aldous Huxley envisioned a future in which the creation of human individuals is not left to chance and sweaty biology, but is a feat of engineering individuals to established specifications. Huxley described a process by which human ova are fertilized in-vitro, then "budded" through an imaginary technique into multiple copies, and finally into identical twins in incubators, entirely absent of a mother's womb. While many of Huxley's predictions about the future have come to pass, such as helicopters, the assembly line, and indeed, in-vitro fertilization, the prospect of ectogenesis, of gestating a child completely outside of …


Lines Of Communication: Advances In Stem Cell Policy, Dena Davis, Debra Grega Jan 2010

Lines Of Communication: Advances In Stem Cell Policy, Dena Davis, Debra Grega

Journal of Law and Health

This is a transcription of the Journal of Law and Health's Speaker Series event held on November 17, 2009 at the Joseph W. Bartunek III Moot Court Room, Cleveland-Marshall College of Law. The speakers discussed stem cell policy, ethics, oversight, funding restrictions and research restrictions.


Through A Scanner Darkly: The Use Of Fmri As Evidence Of Mens Rea, Teneille Brown, Emily R. Murphy Jan 2009

Through A Scanner Darkly: The Use Of Fmri As Evidence Of Mens Rea, Teneille Brown, Emily R. Murphy

Journal of Law and Health

Tonight we are pleased to host an event exploring fMRI and its legal significance. Although [neuroimaging] is still an emerging technology, it has proven to be very consequential in at least one situation. In September 2008, the New York Times reported that a court in India allowed the use of brain scan images in a criminal case, which ultimately led to the conviction of an Indian woman accused of poisoning her fiance. To this day, the Indian woman maintains her innocence. Hank Greely, a bioethicist at Stanford Law School and a colleague of our speakers, commented on the verdict, [characterizing …


Inconsistent State Court Rulings Concerning Pregnancy-Related Behaviors, Lidia Hoffman, Monica K. Miller Jan 2009

Inconsistent State Court Rulings Concerning Pregnancy-Related Behaviors, Lidia Hoffman, Monica K. Miller

Journal of Law and Health

State courts vary in their willingness to protect pregnant women's rights to self-determination, bodily integrity, privacy, and religious freedom; these rights are sometimes outweighed by fetal rights to live. Different state courts have issued many competing decisions, which emphasizes a lack of unification in this area of law. This inconsistency in the law creates confusion for women concerning the scope of their legal protections and alters women's selection of prenatal care and decision to give birth. Thus, it is important to recognize the prevailing themes and grounds on which courts have rested their opinions. An analysis of these state court …


Federally Mandated Informed Consent: Has Government Gone Too Far, Linda P. Mckenzie Jan 2007

Federally Mandated Informed Consent: Has Government Gone Too Far, Linda P. Mckenzie

Journal of Law and Health

Laws mandating disclosure of particular information are known as informed consent laws. They exist primarily in the area of reproductive health and most often apply to women seeking abortion. This article discusses the legal and ethical issues that arise when lawmakers decide what patients must be told before they can access certain medical procedures. Part II examines some of the ethical implications of informed consent laws. Physicians have a duty to obtain a patient's informed consent before acting. Part III discusses legal concerns raised by informed consent laws. These include the First Amendment free speech rights of physicians and patients' …


How We Die: A New Prescription, Martin Bienstock Jan 2006

How We Die: A New Prescription, Martin Bienstock

Journal of Law and Health

The dawn of the twenty-first century brought with it a profound change in the way we experience death. Until the last decades of the twentieth century, our bodies died all at once: when the heart kidneys, lungs, or brain failed, the body's other organs failed with them. Modern medicine now allows us to die in pieces, with failing organs supported or supplanted by technology. Modern death is different not only biologically, but also sociologically. Until the twentieth century, death was a private event that took place in the home with the family. It offered one final opportunity for family members …


The Right Of Refuse: A Call For Adequate Protection Of A Pharmacist's Right To Refuse Facilitation Of Abortion And Emergency Contraception, Donald W. Herbe Jan 2002

The Right Of Refuse: A Call For Adequate Protection Of A Pharmacist's Right To Refuse Facilitation Of Abortion And Emergency Contraception, Donald W. Herbe

Journal of Law and Health

The purpose of this Note is not to argue for or against either the pro-life or pro-choice positions. The purpose of this Note is to shed light on a serious moral dilemma that faces many pharmacists today, to call for universal acceptance in the pharmacy profession of a right of conscience, and to suggest adequate state and national legislative measures that would protect and prevent pharmacists from having to act contrary to their basic moral convictions. Section I provides background regarding present day abortive and contraceptive drug therapies and the role of the pharmacist in providing such medications. Section II …


Resolving Disputes Over Excess Frozen Embryos Through The Confines Of Property And Contract Law, Shelly R. Petralia Jan 2002

Resolving Disputes Over Excess Frozen Embryos Through The Confines Of Property And Contract Law, Shelly R. Petralia

Journal of Law and Health

This Article addresses the conflicts that arise due to the increased number of cryogenically frozen embryos produced during in vitro fertilization (IVF). Part I discusses the IVF process, in general. While it recognizes the man's role in the process, it focuses primarily on the physical and emotional hardships that are placed on the woman. Part I also gives the backdrop of the case law in the area of embryo distribution. Part II introduces the idea that an embryo should be reduced to private property, through utilization of the labor and economic theories of property law. Additionally, an embryo's use, rather …


Lessons Taught By Miss Evers' Boys: The Inadequacy Of Benevolence And The Need For Legal Protection Of Human Subjects In Medical Research , Donald H.J. Hermann Jan 2001

Lessons Taught By Miss Evers' Boys: The Inadequacy Of Benevolence And The Need For Legal Protection Of Human Subjects In Medical Research , Donald H.J. Hermann

Journal of Law and Health

The Tuskegee study is perhaps the most notorious example of abuse in medical research in the United States. It is significant that the project was not ended until twenty-five years after the adoption of the Nuremberg Code of 1948, the first article of which establishes its principle that human subjects should not be experimented on without their consent. Continuing concern about the ethics of medical and scientific research have been fueled by finding about other research abuse such as the radiation experiments in the 1940's and 1950's that involved subjects being injected with plutonium without their knowledge and feeding radioactive …