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A consensus conference on the use of placebo in mood disorder studies consisted of expert presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work groups considered evidence and presented statements to the group. Although it was not possible to write a document for which there was complete agreement on all issues, the final document incorporated input from all authors. There was consensus that placebo has a definite role in mood disorder studies. Findings of equivalence between a new drug and standard treatment in active control studies is not evidence of efficacy unless the new drug is also significantly more effective than placebo. Add-on studies in which patients are randomized to standard therapy plus the investigational drug or standard therapy plus placebo are especially indicated for high-risk patients. Mood disorders in elderly and pediatric patients are understudied, and properly designed trials are urgently needed. Research is needed on the ethical conduct of studies to limit risks of medication-free intervals and facilitate poststudy treatment. Patients must fully understand the risks and lack of individualized treatment involved in research.

Pluripotent human stem cell research may offer new treatments for hundreds of diseases, but opponents of this research argue that such therapy comes attached to a Faustian bargain: cures at the cost of the destruction of many frozen embryos. The National Bioethics Advisory Commission (NBAC), government officials, and many scholars of bioethics, including, in these pages, John Robertson, have not offered an adequate response to ethical objections to stem cell research. Instead of examining the ethical issues involved in sacrificing human embryos for the goal of curing fatal and disabling diseases, they seek to either dismiss the moral concerns of those with objections or to find an "accomodation" with those opposed to stem cell research. An ethical argument can be made that it is justifiable to modify or destroy certain human embryos in the pursuit of cures for dread and lethal diseases. Until this argument is made, the case for stem cell research will rest on political foundations rather than on the ethical foundations that the funding of stem cell research requires.

The proportion of research misconduct cases among trainees in the biomedical sciences has risen, raising the question of why, and what are the responsibilities of research administrators and the research community to address this problem. Although there is no definitive research about causes, for trainees the relationship with a research mentor should play a major role in preventing actions that constitute research misconduct (fabrication, falsification and plagiarism). Examination of the limited literature and of the number of cases closed by the US Office of Research Integrity (ORI) between 2009 and 2013 raises questions about the mentor-student relationship and what it should be accomplishing. But many gaps in policy and its implementation inhibit this role. There is no acknowledgement of mentorship in federal regulations and research on how to teach research integrity is woefully underdeveloped, especially for international trainees. And some institutional research integrity officers may have had little preparation for the role.

Reviews factors involved in the rapid growth of medical ethics. Renal dialysis is discussed as an example of a problem in this applied field of ethics. (CS)

It is posited that varying uses of the words "values" and "ethics" signify important clashes of opinion about the proper subject matter, scope, and goals of teaching about normative prescriptive judgements and theories. (MJB)

• All adaptive platform trials assessing therapies on hospitalized COVID-19 patients have sought participants' informed consent before randomization. • I-SPY COVID adaptive platform trial is seeking participant's informed consent after randomization. • Modifications of the usual pre-randomization consent method are acceptable if, at least, three requirements are met. • It is argued that I-SPY does not fulfil the three requirements. • Designs of post-randomization consent approach are discussed in this piece. [ABSTRACT FROM AUTHOR]

Solid organ transplant (SOT) candidates and recipients were not included in the COVID‐19 vaccine trials that have justified vaccine administration to millions worldwide and will be critical to ending the pandemic. The risks of COVID‐19 for SOT candidates and recipients combined with data about this population's response to other vaccines has led to transplant centers recommending vaccination for their candidates and recipients in accordance with guidance from major transplant organizations. Relevant ethics considerations include: weighing the low risk of vaccination causing transplant complications against potentially limited antibody response of vaccines for transplant recipients; the equitable distribution of vaccines among vulnerable populations; the duty to steward and respect organs as limited resources; the duty to support vaccination; and patient autonomy. Vaccinated transplant patients and candidates should also consider participating in research studies to better understand the efficacy and potential long‐term risks in this patient population. There are difficult scenarios, like timing transplant after second vaccine dose, when to administer the second dose to a partially vaccinated candidate who gets an organ match, whether to vaccinate a recent transplant recipient with low exposure risk and which vaccine to use. Here we provide ethics considerations for vaccinating different groups within the transplant population. [ABSTRACT FROM AUTHOR]

As the field of vascularized composite allotransplantation (VCA) continues to evolve and technological approaches improve, VCA programs must focus on promoting greater consistency in psychosocial assessment across programs to support the equitable selection of patients. Based on a summary of published reports of VCA, we address the ethical considerations raised by the present heterogeneity of approaches to psychosocial assessment, including weighing risks and benefits, informed consent and the role of decisional capacity, and potential or perceived bias in the assessment process. We propose transparency of process across the field and encourage VCA programs to work collaboratively to share approaches to psychosocial assessment both pre- and posttransplant to promote health equity. [ABSTRACT FROM AUTHOR]

In critically ill patients, it is frequently challenging to identify who will benefit from admission to the intensive care unit and life-sustaining interventions when the chances of a meaningful outcome are unclear. In addition, the acute illness not only affects the patients but also family members or surrogates who often are overwhelmed and unable to make thoughtful decisions. In these circumstances, a time-limited trial (TLT) of intensive care treatment can be helpful. A TLT is an agreement to initiate all necessary treatments or treatments with clearly delineated limitations for a certain period of time to gain a more realistic understanding of the patient's chances of a meaningful recovery or to ascertain the patient's wishes and values. In this article, we discuss current research on different aspects of TLTs in the intensive care unit. We propose how and when to use TLTs, discuss how much time should be taken for a TLT, give an overview of the potential impact of TLTs on healthcare resources, describe ethical challenges concerning TLTs, and discuss how to evaluate a TLT. [ABSTRACT FROM AUTHOR]

Objective: We sought to determine the characteristics of "expanded access" and "compassionate use" programs registered in ClinicalTrials.gov and to determine the percentage of drugs provided through these programs that ultimately received FDA marketing approval. Results: We identified 398 expanded access and compassionate use programs (hereafter referred to as expanded access programs) registered on ClinicalTrials.gov. Industry funded 61% (n = 241) of programs individually or collaboratively, while NIH and the US Federal Government rarely funded programs (3% [n = 11] and 2% [n = 6], respectively). Most programs provided access to drugs (71% [n = 282]), 11% to biologics (n = 43), and 10% to medical devices (n = 40). These programs covered 460 unique conditions, the most common being HIV (n = 26), leukemia (22), and multiple myeloma (n = 14). Only 2% of programs reported results in ClinicalTrials.gov. Most programs (82%) were open to enrolling adults and seniors (n = 326). These programs provided access to 210 unique experimental drugs, of which 76% have received FDA approval. [ABSTRACT FROM AUTHOR]

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Bioethics has become a common course of study in medical schools, other health professional schools, and graduate and undergraduate programs. An analysis of past ethical scandals, as well as the bioethics apparatus that emerged in response to them, is often central to the discussion of bioethical questions. This historical perspective on bioethics is invaluable and demonstrates how, for example, the infamous Tuskegee syphilis study was inherently racist and how other experiments exploited mentally disabled and other disadvantaged persons. However, such instruction can resemble so-called Whig history, in which a supposedly more enlightened mindset is seen as having replaced the "bad old days" of physicians behaving immorally. Bioethical discourse-both in the classroom and in practice-should be accompanied by efforts to historicize but not minimize past ethical transgressions. That is, bioethics needs to emphasize why and how such events occurred rather than merely condemning them with an air of moral superiority. Such instruction can reveal the complicated historical circumstances that led physician-researchers (some of whom were actually quite progressive in their thinking) to embark on projects that seem so unethical in hindsight. Such an approach is not meant to exonerate past transgressions but rather to explain them. In this manner, students and practitioners of bioethics can better appreciate how modern health professionals may be susceptible to the same types of pressures, misguided thinking, and conflicts of interest that sometimes led their predecessors astray. [ABSTRACT FROM AUTHOR]

Background: In December 2014, China announced that only voluntarily donated organs from citizens would be used for transplantation after January 1, 2015. Many medical professionals worldwide believe that China has stopped using organs from death-row prisoners.Discussion: In the present article, we briefly review the historical development of organ procurement from death-row prisoners in China and comprehensively analyze the social-political background and the legal basis of the announcement. The announcement was not accompanied by any change in organ sourcing legislations or regulations. As a fact, the use of prisoner organs remains legal in China. Even after January 2015, key Chinese transplant officials have repeatedly stated that death-row prisoners have the same right as regular citizens to "voluntarily donate" organs. This perpetuates an unethical organ procurement system in ongoing violation of international standards.Conclusions: Organ sourcing from death-row prisoners has not stopped in China. The 2014 announcement refers to the intention to stop the use of organs illegally harvested without the consent of the prisoners. Prisoner organs procured with "consent" are now simply labelled as "voluntarily donations from citizens". The semantic switch may whitewash sourcing from both death-row prisoners and prisoners of conscience. China can gain credibility only by enacting new legislation prohibiting use of prisoner organs and by making its organ sourcing system open to international inspections. Until international ethical standards are transparently met, sanctions should remain. [ABSTRACT FROM AUTHOR]

The article discusses the ethics of provider risk factor modification in total joint arthroplasty. Topics include the studies which showed improved outcomes in terms of mortality and reoperations following surgical procedure to treat intertrochanteric hip fracture and spinal fusion to treat scoliosis, ethical consideration for and against regionalization in total joint arthroplasty, and the benefit of implant restriction.

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with prevailing norms governing human subjects research. Some maintain that only randomized controlled trials (RCTs) with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs. [ABSTRACT FROM PUBLISHER]

The article discusses the authors' views on the ethics of prescribing placebos as medical therapeutics in pediatrics. Topics covered include the advantages and disadvantages of using placebos in clinical interventions and stand-alone treatments, the concept of open-label placebos, and the negative impact of placebo use on general medicine and health care.

Background: The emerging field of stem cell-based aesthetics has raised ethical concerns related to advertising campaigns and standards for safety and efficacy.Objectives: The authors sought to characterize the attitudes of plastic surgeons regarding the ethics of stem cell-based aesthetics.Methods: A cross-sectional electronic survey was distributed to 4592 members of the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons. Statements addressed ethical concerns about informed consent, conflicts of interest, advertising, regulation, and stem cell tourism. An agreement score (AS) from 0 to 100 was calculated for each statement. Majority agreement was designated as ≥60 and majority disagreement as ≤40.Results: A total of 770 questionnaires were received (16.7%). The majority of respondents indicated that knowledge regarding the risks and benefits of stem cell procedures is insufficient to obtain valid informed consent (AS, 29) and that direct-to-consumer advertising for these technologies is inappropriate and unethical (AS, 23). Most respondents reported that patients should be actively warned against traveling abroad to receive aesthetic cell therapies (AS, 86) and that registries and evaluations of these clinics should be made publicly available (AS, 71). Even more respondents noted that financial conflicts of interest should be disclosed to patients (AS, 96) and that professional societies should participate in establishing regulatory standards (AS, 93).Conclusions: The plastic surgeons surveyed in this study support a well-regulated, evidence-based approach to aesthetic procedures involving stem cells. [ABSTRACT FROM AUTHOR]

Lung transplantation is a potentially life-saving procedure for patients with irreversible lung failure. Five-year survival rates after lung transplantation are >50% for children and young adults. But there are not enough lungs to save everyone who could benefit. In 2005, the United Network for Organ Sharing developed a scoring system to prioritize patients for transplantation. That system considered transplant urgency as well as time on the waiting list and the likelihood that the patient would benefit from the transplant. At the time, there were so few pediatric lung transplants that the data that were used to develop the Lung Allocation Score were inadequate to analyze and prioritize children, so they were left out of the Lung Allocation Score system. In 2013, the family of a 10-year-old challenged this system, claiming that it was unjust to children. In the article, we asked experts in health policy, bioethics, and transplantation to discuss the issues in the Murnaghan case. [ABSTRACT FROM AUTHOR]

The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess "noise" and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/ SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well- tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD- affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of and rote response to AEs and SAEs. [ABSTRACT FROM AUTHOR]

Abstract: Deep brain stimulation (DBS) is an efficacious surgical treatment for many conditions, including obsessive-compulsive disorder and treatment-resistant depression. DBS provides a unique opportunity to not only ameliorate disease but also to study mood, cognition, and behavioral effects in the brain. However, there are many ethical questions that must be fully addressed in designing clinical research trials. It is crucial to maintain sound ethical boundaries in this new era so as to permit the proper testing of the potential therapeutic role DBS may play in ameliorating these devastating and frequently treatment-refractory psychiatric disorders. In this review, we focus on the selection of patients for study, informed consent, clinical trial design, DBS in the pediatric population, concerns about intentionally or inadvertently altering an individual’s personal identity, potential use of DBS for brain enhancement, direct modification of behavior through neuromodulation, and resource allocation. [Copyright &y& Elsevier]

The success of deep brain stimulation (DBS) for movement disorders and the improved understanding of the neurobiologic and neuroanatomic bases of psychiatric diseases have led to proposals to expand current DBS applications. Recent preclinical and clinical work with Alzheimer's disease and obsessive-compulsive disorder, for example, supports the safety of stimulating regions in the hypothalamus and nucleus accumbens in humans. These regions are known to be involved in addiction and overeating associated with obesity. However, the use of DBS targeting these areas as a treatment modality raises common ethical considerations, which include informed consent, coercion, enhancement, threat to personhood, and manipulation of the reward center. Pilot studies for both of these conditions are currently investigational. If these studies show promise, then there is a need to address the ethical concerns related to the initiation of clinical trials including the reliability of preclinical evidence, patient selection, study design, compensation for participation and injury, cost-effectiveness, and the need for long-term follow-up. Multidisciplinary teams are necessary for the ethical execution of such studies. In addition to establishing safety and efficacy, the consideration of these ethical issues is vital to the adoption of DBS as a treatment for these conditions. We offer suggestions about the pursuit of future clinical trials of DBS for the treatment of addiction and overeating associated with obesity and provide a framework for addressing ethical concerns related to treatment. [ABSTRACT FROM AUTHOR]

Researchers are developing a fertility preservation technique—testicular tissue cryopreservation (TTCP)—for prepubescent boys who may become infertile as a result of their cancer treatment. Although this technique is still in development, some researchers are calling for its widespread use. They argue that if boys do not bank their tissue now, they will be unable to benefit from any therapies that might be developed in the future. There are, however, risks involved with increasing access to an investigational procedure. This article examines four methods of expanding access to TTCP: (1) expansion of institutional review board (IRB)-approved research trials; (2) offering TTCP as an innovative procedure in hospitals; (3) offering TTCP as a standard practice in hospitals; and (4) commercialization of TTCP. The ethical and practical implications of each are evaluated through a comparison with umbilical cord blood banking (UCBB), a technology that has achieved widespread use based on similar claims of future benefit. [ABSTRACT FROM PUBLISHER]

In this text, we present and elaborate ethical challenges in transplant medicine related to organ procurement and organ distribution, together with measures to solve such challenges. Based on internationally acknowledged ethical standards, we looked at cases of organ procurement and distribution practices that deviated from such ethical standards. One form of organ procurement is known as commercial organ trafficking, while in China the organ procurement is mostly based on executing prisoners, including killing of detained Falun Gong practitioners for their organs. Efforts from within the medical community as well as from governments have contributed to provide solutions to uphold ethical standards in medicine. The medical profession has the responsibility to actively promote ethical guidelines in medicine to prevent a decay of ethical standards and to ensure best medical practices. [ABSTRACT FROM AUTHOR]

The article reports on the emergence of advances in the field of synthetic biology. Developments in synthetic biology have reportedly resulted in additional regulatory challenges, particularly in relation to ethics and governance risks. Europe is considered the most challenging area in terms of regulating biosynthetic technologies, given its diverse culture and varying ethical stands taken by each member state. Countries in Europe use either hazard or risk-based approach in risk regulation.

Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice. [ABSTRACT FROM AUTHOR]

Abstract: Evidence-based decision making (EBDM) is a tool to assess the value of medical interventions by weighing costs and health outcomes that has increasingly been applied to vaccines. However, many of the ethical considerations that support EBDM when used to evaluate therapeutic care do not readily translate to prevention. This mismatch can result in policy decisions that produce unanticipated negative consequences, including public resistance. In its emphasis on quantifiable outcomes, EBDM invokes the ethical principle of rule-utilitarianism, which values the optimal long-run balance of benefit over harm. Vaccines raise a number of competing ethical concerns in ways that individual medical treatments do not. They rely on widespread compliance for effectiveness, which can limit individual autonomy, emphasize population over individual effects, which can obscure the imperative of beneficence to help the vulnerable, require a just allocation process within populations, and sometimes challenge strong social norms. For EBDM to effectively guide vaccine policy makers, such as the Advisory Committee on Immunization Practices (ACIP) in the United States, an ethical foundation is needed that systematically considers all relevant values and transparently places vaccination recommendations in the context of social norms and individual concerns. [Copyright &y& Elsevier]

The movement to try to close the ever-widening gap between demand and supply of organs has recently arrived at the prison gate. While there is enthusiasm for using executed prisoners as sources of organs, there are both practical barriers and moral concerns that make it unlikely that proposals to use prisoners will or should gain traction. Prisoners are generally not healthy enough to be a safe source of organs, execution makes the procurement of viable organs difficult, and organ donation post-execution ties the medical profession too closely to the act of execution. [ABSTRACT FROM AUTHOR]

This article discusses a study which reviewed the informed consent and the risk-benefit analysis of offering experimental fertility preservation procedures for patients undergoing chemotherapy. All available options to preserve fertility, except for embryo and semen freezing, are considered experimental and thus, raise ethical issues. The study suggested that there should be no ethical objections to such services as they are offered with the scope of preserving future fertility.

The article offers information on limited reproducibility of research findings and implications for the welfare of research participants and considerations for institutional review boards. Topics discussed include lack of reproducibility of research results has caused alarm about wasted human and financial resources; and inability to replicate findings has significant implications for reliability of science and for research subjects.

The latest Centers for Disease Control and Prevention (CDC) guidelines recommend routine HIV screening for a large segment of the population, given that the individual understands that an HIV test will be performed unless he or she declines testing (opt-out testing). The CDC recommendation calls for the elimination of formalized requirements for written consent and pretest counseling to encourage more Americans to voluntarily accept testing. Knowledge of HIV infection can increase early access to care and treatment and reduce further transmission. A rapid non-invasive test for HIV infection (OraQuick Advance) from oral fluid has recently become available. It offers two distinct advantages: 1) results are available within twenty minutes, thereby eliminating a long waiting period; and 2) it has high sensitivity and specificity comparable to blood testing. A preliminary positive test result must be confirmed with a Western Blot by an outside laboratory or physician. Important ethical and legal issues must be resolved before the successful implementation of HIV testing in the dental setting. An educational emphasis on broader coverage of HIV testing is also needed within the dental school curriculum. The integration of HIV testing into dental practice is discussed as well. A policy of screening patients in dental offices will contribute to a major advance in public health. [ABSTRACT FROM AUTHOR]

This article examines the actions and testimonies of 14 nurses who killed psychiatric patients at the state hospital of Meseritz-Obrawalde in the Nazi 'euthanasia' program. The nurses provided various reasons for their decisions to participate in the killings. An ethical analysis of the testimonies demonstrates that a belief in the relief of suffering, the notion that the patients would 'benefit' from death, their selection by physicians for the 'treatment' of 'euthanasia', and a perceived duty to obey unquestioningly the orders of physicians were the primary ethical reasons that were stated for their behavior. However, 20 years had elapsed between the killings and the trial, thus giving ample opportunity for the defendants to develop comfortable rationales for their actions and for their attorneys to have observed successful defenses of others accused of euthanasia. [ABSTRACT FROM AUTHOR]

Pediatric patients are excluded from most coronavirus disease 2019 (COVID-19) therapeutic trials. We outline a rationale for the inclusion of children in COVID-19 therapeutic trials, which enabled us to include children of all ages in a therapeutic COVID-19 trial at our institution. [ABSTRACT FROM AUTHOR]

Focuses on the need to criminalize some forms of scientific misconduct. Public policy governing scientific misconduct; Administrative structures to regulate misconduct in research funded by the Public Health Services; Development of investigative processes from informal ones traditional to the scientific community.