This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs.

We critically evaluate arguments in a recent Journal of Law, Medicine & Ethics article by Svoboda, Adler, and Van Howe disputing the 2012 affirmative infant male circumcision policy recommendations of the American Academy of Pediatrics. We provide detailed evidence in explaining why the extensive claims by these opponents are not supported by the current strong scientific evidence. We furthermore show why their legal and ethical arguments are contradicted by a reasonable interpretation of current U.S. and international law and ethics. After all considerations are taken into account it would be logical to conclude that failure to recommend male circumcision early in infancy may be viewed as akin to failure to recommend childhood vaccination to parents. In each case, parental consent is required and the intervention is not compulsory. Our evaluation leads us to dismiss the arguments by Svoboda et al. Instead, based on the evidence, infant male circumcision is both ethical and lawful.

Gamete donation offers a unique opportunity to compare men and women's relationships to reproductive decision-making, unlike other reproductive processes, which typically involve women's bodies much more asymmetrically. I address medical and reproductive decision-making by examining how a gamete donor's partner may be involved in the donation process. Some countries explicitly involve a donor's partner by legally requiring spousal consent for donation, but this is not the case for the U.S. In the absence of any formal regulation, what are the expectations for involving a donor's partner? Through a content analysis of materials from donation programs across the U.S., I examine how donation programs configure the partner's role. Overall, I find that there are quite different expectations for partner involvement in egg versus sperm donation. Such differences, I argue, both stem from and reinforce existing issues navigating boundaries between intimate relationships and women's medical and reproductive autonomy.

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission (MTCT). However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are infected perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.

The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves.

Physicians who care for critically ill people with opioid use disorder frequently face medical, legal, and ethical questions related to the provision of life-saving medical care. We examine a complex medical case that illustrates these challenges in a person with relapsing injection drug use. We focus on a specific question: Is futility an appropriate and useful standard by which to determine provision of life-saving care to such individuals? If so, how should such determinations be made? If not, what alternative decisionmaking framework exists? We determine that although futility has been historically utilized as a justification for withholding care in certain settings, it is not a useful standard to apply in cases involving people who use injection drugs for non-medical purposes. Instead, we are welladvised to explore each patient's situation in a holistic approach that includes the patient, family members, and care providers in the decision-making process. The scope of the problem illustrated demonstrates the urgent need to definitively improve outcomes in people who use injection drugs. Increasing access to high quality medication-assisted treatment and psychiatric care for individuals with opioid use disorder will help our patients achieve a sustained remission and allow us to reach this goal.

In most countries, the alcohol industry enjoys considerable freedom to market its products. Where government regulation is proposed or enacted, the alcohol industry has often deployed legal arguments and used legal forums to challenge regulation. Governments considering marketing regulation must be cognizant of relevant legal constraints and be prepared to defend their policies against industry legal challenges.

Accessing BRCA1/2 data facilitates the detection of disease-associated variants, which is critical to informing clinical management of risks. BRCA1/2 data sharing is complex and many practices exist. We describe current BRCA1/2 data-sharing practices, in the United States and globally, and discuss obstacles and incentives to sharing, based on 28 interviews with personnel at U.S. and non-U.S. clinical laboratories and databases. Our examination of the BRCA1/2 data-sharing landscape demonstrates strong support for and robust sharing of BRCA1/2 data around the world, increasing global accesses to diverse data sets.

Let us start with a conclusion that seems not to be in dispute: that in April of 1989 Samuel Linares had little or no interest in living. He had been competently diagnosed as being in a persistent vegetative state, by then eight months long. The cause was clearly prolonged asphyxiation, so that whatever uncertainty exists in cases of unknown etiology was not a factor. It could also be claimed that he had little interest in dying, in that he was probably incapable of suffering from prolonged treatment. But few advocate prolonged intensive care for preservation of mere vegetative functions. Nor is there serious argument that patients or surrogates who request discontinuation of treatment in such circumstances, when it serves no interest of the patient, are acting immorally. Even the vitalist federal Baby Doe regulations concede that life-sustaining treatment may be discontinued when the patient is permanently comatose.

Last April, 23 year-old Rudy Linares disconnected his 15-month-old comatose son, Sammy, from the mechanical ventilator that was maintaining the infant's life. He then used a gun to keep hospital staff from interfering while he withdrew the machine, allowing his son to die of acute respiratory failure. The death of this infant stirred great controversy among doctors, nurses, lawyers and ethicists. It also generated much discussion in the news media. The clearest common denominator of this discussion has been the willingness of commentators to advance opinions and interpretations without knowledge of the facts of the case. Some of the opinions have been critical of the hospital, the doctors, and/or the nurses. The present report is not intended to answer such criticism. The report will simply provide the facts and legal opinions as to the case. To the extent this information leads the reader to understand or agree with the management of the case the report will serve as a defense of these actions. To the extent it leads to rejection or criticism of the management, the report will support the detractors.

Virtually every state gives psychiatrists’ patients a broad statutory privilege to prevent the disclosure in legal proceedings of information about their diagnosis and treatment. Although the precise scope of the privilege varies from state to state, and a variety of exceptions are widely recognized, the contents of therapy sessions—and hence of psychiatrists’ written records of therapy sessions—are ordinarily protected by the privilege. Patients thus are gmerally entitled to prevent the courts and other government authorities from using their coercive evidencr-gathering powers to obtain psychiatric records or testimony about therapy. In conjunction with psychiatrists’ ethical and legal duties of confidentiality toward their patients outside legal proceedings, the privilege renders the privacy of the psychiatric relationship to a large degree sacrosanct.

The cloak of secrecy around the psychiatrist-patient relationship, however, must inevitably be lifted to some extent when third parties pay for psychiatric diagnosis and treatment. Any third-party payer, be it a private insurer or a government agency (such as Medicaid or Medicare), must be able to obtain enough information about psychiatric services to determine the propriety of claims for payment for those services.

Active shooter incidents (ASI) have unfortunately become a common occurrence the world over. There is no country, city, or venue that is safe from these tragedies, and healthcare institutions are no exception. Healthcare facilities have been the targets of active shooters over the last several decades, with increasing incidents occurring over the last decade. People who work in healthcare have a professional and moral obligation to help patients. As concerns about the possibility of such incidents increase, how should healthcare institutions and healthcare professionals understand their responsibilities in preparation for and during ASI?

“Acceptability research” is a term first coined to describe inquiries into individuals’ responses to family planning and contraceptive technology. As defined by WHO, “acceptability” is a “quality which makes an object, person, event, or idea attractive, satisfactory, pleasing or welcome.” In fact, the word “acceptable” in English is distinct from other issues that are also encompassed within “acceptability research.” “Acceptable,” to many, connotes faint praise. It may mean that something is tolerable only to the point of not being protested. On the other hand, the attributes “desirable” and “preferable” are more positive. In fact, all of these qualities are examined within the meaning of “acceptability research” as currently used by the Population Council.

Acceptability of a product or a medical procedure is most commonly studied in terms of patients or clients. Do those who will undergo the procedure or be the subjects of the technology find its use acceptable? But, in fact, acceptability can also be tested in relation to the providers of the technologies (i.e., the medical professionals), to the program managers or to policymakers.

This article returns to a war waged for the better part of this century-between the theories of punishment and rehabilitation in impeding the drug epidemic. Today, the terms of the war are recast as supply-side policies based upon law enforcement, destroying crops in source countries, interdiction and increased sentencing, and demand reduction based upon prevention, education and treatment.

The war on drugs has reached a feverish pitch. New policies and statutes have tightened the grip of supply-side policies, with images of battle and hate-mongering which go beyond the vilified drug lords and governments which harbor them, to the middle men, the dealers, and even the users. The in-vogue policies of user accountability and zero tolerance make it acceptable to direct the state's formidable powers at drug dependent persons themselves. Drug dependent persons have profound physical and psychological problems, and are primarily concentrated in poor, minority urban areas.

In recent years, the competency of patients to refuse life-sustaining treatment has been widely discussed. Generally, competence has been recognized to be a legal concept, holding that the patient is presumed competent unless a court declares the person incompetent and designates a guardian. It has been noted, however, that clinical medical practice often diverges markedly from this standard. Some authors have suggested that in many cases the implicit medical presumption may be that many persons, particularly the aged, are presumed incompetent to refuse treatment until they demonstrate to their physician's satisfaction that they are competent. This gap between legal theory and medical practice presents numerous difficulties to both legal and medical professionals seeking to accommodate the competing values of patient self-determination and best interests.

This paper will present and discuss a case exemplifying a particular problem that can arise in the competency evaluation process.

There are a number of considerations, including ethical and clinical or diagnostic factors, in utilizing the diagnosis of posttraumatic stress disorder (PTSD) in criminal proceedings. The reliability and validity of the diagnosis may be questioned. Legal precedent may consider extant diagnostic criteria for PTSD and comorbid diagnoses. However, these diagnostic criteria are often in flux considering new research findings. For example, the introduction of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association, includes some changes in the PTSD diagnostic criteria. How will this affect interpretation of past legal judgments? Moreover, PTSD has significant psychiatric comorbidity, e.g., substance abuse, which in itself may influence violent behavior and its consequences. Some of these comorbid diagnoses also have changes in their diagnostic criteria. The introduction of biological tests in the assessment of PTSD will likely facilitate more objective diagnosis.

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.

The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Belmont Rept).

An inordinate number of low wage workers in essential industries are Black, Hispanic, or Latino, immigrants or refugees — groups beset by centuries of discrimination and burdened with disproportionate but preventable harms during the COVID-19 pandemic.

In her recent article, “Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial,” Deborah Hellman gives a new twist to an old objection against clinical equipoise. Roughly, clinical equipoise is the requirement that there exist credible uncertainty in the expert medical community regarding the preferred treatment for a particular condition. This uncertainty is widely regarded as a necessary condition for enrolling participants in a clinical trial. The old objection is that clinical equipoise represents an overly permissive, and therefore morally unacceptable, mechanism for resolving the fundamental tension in clinical research between fidelity to the interests of the individual research participant, and fidelity to the statistical and scientific methods that are necessary to produce generalizable data in a reliable manner. Hellman's new twist on this objection utilizes some of the rudimentary architecture of Bayesian statistical theory to argue that clinical equipoise focuses our moral attention on the wrong issue.