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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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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.

Presents a lecture on cloning presented at the symposium on international arbitrage of controversial medical technologies sponsored by the Cox center and the "Journal of International Law" at Case Western Reserve Law School. Technologies used in cloning; Cloning benefits and risks; Limitations and forseeble consequences of cloning; Ethical issues on cloning; Lecturer's rejection of reproductive cloning and acceptance of therapeutic cloning.

Discusses therapeutic cloning, or cell replacement by means of nuclear transfer, a biomedical technology that has the potential to transform medicine. Scientific background on the procedure; Ethical objections; Legal issues.

The article discusses the policy of requiring health care personnel to be vaccinated against influenza as an employment mandate in the U.S. and states that at presents, there are more than 200 health care centers that have mandated influenza vaccine for its employees. It discusses the failure of voluntary vaccination strategies in the country and code of ethics for employment mandates for health care workers. It states that health workers should understand moral issues behind the requirement.

The author discusses the meeting of the Pontifical Academy of Culture to see the ethical ways to do an embryo research in the Vatican City. He mentions that the stance of Roman Catholic Church from opposing on embryo research leaves the church in a tough ethical situation. He states that the Roman Catholic Church is attempting to lead an emerging area of science in a direction with the use of its resistance to embryo research as an as an ethical rudder.

Life expectancy statistics predict that in a couple of decades women will enjoy a mean life of 90 years. Assuming a median age for the onset of menopause of 51, women will spend about 40 years in menopause. Harvesting and freezing ovarian cortical tissue at a younger age to permit future transplantation for postponing menopause and its sequelae could become a possible option. However, both medical and ethical issues need to be addressed before this can be offered as a treatment for menopause. [ABSTRACT FROM AUTHOR]

The author discusses issues related to legalization of physician-assisted suicide in the U.S. He says that the thought that only God can decide when one's time is over is not a good reason for outlawing physician-assisted suicide. It rests firmly on a foundation of religious belief, and it runs roughshod over the right to individual self-determination.

The article provides information on the advantages and dangers of medical screening tests. It informs that screening tests are helpful in detecting diseases like cancer at an early stage and detecting the work of defensive medicine. It further states that it is the duty of physicians to inform patients about the harmful effects of radiations and false positive results to patients.

Years ago, one of us had the opportunity to talk with a starting guard in the National Basketball Association about his health care. The player, then a rookie, did not have his own personal doctor. Instead, he received his health care from the team doctor. This athlete was very well paid and could have received care anywhere he wished in the area. But he came from a very poor neighborhood. Growing up, he said, he had no health care other than hearing and eye tests done at his school and maybe (he was not sure) vaccinations given by the school nurse. The player said he now felt fine and trusted his team to look out for his health since they were paying him a lot of money and obviously wanted him on the court. While it might seem obvious that conflicts of role could arise for doctors working simultaneously for a team and for an athlete-wanting to please coaches, owners, and maybe fans while looking out for the athletes on the team-that is not how this young player saw things. He trusted his team and those who worked for them, and he figured that their interest in keeping him healthy overlapped nicely with his interest in staying healthy. As someone who did not get much access to health care as a child and had little need for it, he did not have concerns about conflicts of interest and second opinions foremost in his mind. But as is clear from a recent scandal involving the National Football League and concussion research, there are reasons for concern when athletes deal with health care workers paid by their teams. [ABSTRACT FROM AUTHOR]

The author discusses the contentious nature and continuous debate over the moral status of the human embryo. It is stressed that empirical information is having a perspicuous effect on key elements of the moral debate. He comments of the decision made by U.S. President Barack Obama to allow public funding of embryonic stem cell research. The Roman Catholic Church's stance on stem cell research is assessed. How embryo loss as a natural component of human reproduction has affected opinion is discussed.

A response by Arthur L. Caplan, Carolyn Plunkett and Bruce Levin to the letters to the editor about their article "Selecting the Right Tool for the Job" about the treatments for Ebola virus disease (EVD) in a 2015 issue is presented.

A letter to the editor is presented in response to commentary about the article "All Gifts Large and Small," by Dana Katz, Arthur L. Caplan, and Jon F. Merz.

The authors offer views on the medical and legal issues surrounding brain death in the U.S. They discuss the two controversial cases of brain death in the U.S., the effect of technology on the U.S. approach to determining death, criticisms of the concept of brain death in the U.S., the implications of rejecting brain death for organ donation, and the determination of death as a social boundary.