Giving Children a Say without Giving Them a Choice: Obtaining Affirmation of a child's Non-dissent to Participation in Nonbeneficial Research.

To what extent, if any, should minors have a say about whether they participate in research that offers them no prospect of direct benefit? This article addresses this question as it pertains to minors who cannot understand enough about what their participation would involve to make an autonomous choice, but can comprehend enough to have and express opinions about participating. The first aim is to defend David Wendler and Seema Shah's claim that minors who meet this description should not be offered a choice about whether they participate. The second aim is to show, contra Wendler and Shah, that the principle of nonmaleficence requires more with respect to giving these minors a say than merely respecting their dissent. Additionally, it requires that investigators obtain affirmation of their non-dissent. This addresses intuitive concerns about denying children a choice, while steering clear of the problems that arise with allowing them one.

[Proposal of a deontological framework for spanish biologists]. / Propuesta de un marco deontológico para los biólogos españoles.

Deontology is the set of duties and obligations in which the correct act is specified in the exercise of a profession. The Deontological Codes (CD), in addition to respecting the legal framework in which they are inserted, must go beyond the laws insofar as they are a reflection of the ethical commitment of each profession; commitment to deontological principles, which also helps to shape your identity. The aim of this project is to provide, based on the bibliography and current legal and deontological regulations, a proposal to serve as a guide for the accomplishment of Ethic Codes for Biologists (CDB), which currently does not exist in Spain, taking as a basis the revision of the ethics codes of other professions related to Biology. Under this purpose, a systematic and comparative review has been carried out of other health professions ethics codes, of the ethical guidelines emanating from scientific societies (above all, from the Anglo-Saxon area) and of the regulations applicable to those professions. The result is the proposal of the most important sections that we believe this Code should contain.

Bioethics in the Oversight of Clinical Research: Institutional Review Boards and Data and Safety Monitoring Boards.

This article describes oversight mechanisms for clinical research that have developed substantially over the last few decades, including institutional review boards and data safety and monitoring boards. LeRoy Walters and others in the 1970s in the US thoughtfully described the importance of fundamental ethical principles and the application of bioethics to clinical research. Dr. Walters's important essay and work with the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research helped identify and explain ethical principles that guide research. These principles, subsequently enunciated by the Commission in the Belmont Report, remain central to our understanding of the ethics of clinical research and are the foundation of our regulations. In this article, I review some history, successes, and challenges of IRBs and DSMBs to exemplify the significance of understanding and applying ethical principles to the design and conduct of clinical research, and to honor Dr. Walters's contributions.

U.S. Public Health Service STD Experiments in Guatemala (1946-1948) and Their Aftermath.

The U.S. Public Health Service's sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the source of biological specimens-all without informed consent and often with active deceit. It also explores and evaluates governmental and professional responses that followed the public revelation of these experiments, including by academic institutions, professional organizations, and the U.S. federal government, pushing us to reconsider both how we prevent such lapses in the future and how we respond when they are first revealed.

Biospecimens, Research Consent, and Distinguishing Cell Line Research.

Newly revised regulations for human research affecting translational oncology will become effective in January 2019. A substantial component of the debate leading to this revision was how to regulate biospecimen research; specifically, whether all biospecimens should be considered inherently "identifiable," thereby necessitating informed consent for use in research. The famous cases seminal to this discussion involve cancer cell lines, but the unique features of this kind of biospecimen research were largely missing from the regulatory deliberation. However, special aspects of cell line research-at the stages of procurement, generation, evolution, and sharing-alter how society should balance participant interests against the goals of research. Recommendations are offered to cancer researchers and policymakers going forward to enable ethically appropriate regulation of biospecimen research across its diverse spectrum.

Exploring Ethical Concerns About Human Challenge Studies: A Qualitative Study of Controlled Human Malaria Infection Study Participants' Motivations and Attitudes.

Controlled human malaria infection (CHMI) studies deliberately infect healthy participants with malaria to test interventions faster and more efficiently. Some argue the study design and high payments offered raise ethical concerns about participants' understanding of risks and undue inducement. We conducted baseline and exit interviews with 16 CHMI study participants to explore these concerns. Participants described themes including decision-making tension with friends and family, mixed motivations for participating, low study risks but high burdens, fair compensation, sacrificing values, deceiving researchers, and perceived benefits. Our findings do not support concerns that high payments limit understanding of study risks, but suggest participants may lack appreciation of study burdens, withhold information or engage in deception, and experience conflict with others regarding study participation.

Burdensome Research Procedures in Trials: Why Less Is More.

A large volume of trials involve invasive, nontherapeutic research procedures, like organ biopsy or sham surgeries, that can pose risks comparable with the experimental treatment itself but that have no direct benefit for volunteers. Though such procedures can enhance the value of clinical investigations, recent studies suggest that many studies involving invasive, nontherapeutic research procedures are not well planned and reported; some studies suggest that their results are often not utilized in the planning of new investigations. This commentary offers recommendations for how investigators, sponsors, and ethics committees might improve evaluation and implementation of studies involving invasive nontherapeutic procedures. We conclude by urging more demanding scientific standards for the rationale, design, and reporting of burdensome, nontherapeutic research procedures-particularly where they involve risk of serious complications.

Ethical Challenges in Infant Feeding Research.

Infants have a complex set of nutrient requirements to meet the demands of their high metabolic rate, growth, and immunological and cognitive development. Infant nutrition lays the foundation for health throughout life. While infant feeding research is essential, it must be conducted to the highest ethical standards. The objective of this paper is to discuss the implications of developments in infant nutrition for the ethics of infant feeding research and the implications for obtaining informed consent. A search was undertaken of the papers in the medical literature using the PubMed, Science Direct, Web of Knowledge, Proquest, and CINAHL databases. From a total of 9303 papers identified, the full text of 87 articles that contained discussion of issues in consent in infant feeding trials were obtained and read and after further screening 42 papers were included in the results and discussion. Recent developments in infant nutrition of significance to ethics assessment include the improved survival of low birth weight infants, increasing evidence of the value of breastfeeding and evidence of the lifelong importance of infant feeding and development in the first 1000 days of life in chronic disease epidemiology. Informed consent is a difficult issue, but should always include information on the value of preserving breastfeeding options. Project monitoring should be cognisant of the long term implications of growth rates and early life nutrition.

Unit 731 and moral repair.

Unit 731, a biological warfare research organisation that operated under the authority of the Imperial Japanese Army in the 1930s and 1940s, conducted brutal experiments on thousands of unconsenting subjects. Because of the US interest in the data from these experiments, the perpetrators were not prosecuted and the atrocities are still relatively undiscussed. What counts as meaningful moral repair in this case-what should perpetrators and collaborator communities do decades later? We argue for three non-ideal but realistic forms of moral repair: (1) a national policy in Japan against human experimentation without appropriate informed and voluntary consent; (2) the establishment of a memorial to the victims of Unit 731; and (3) US disclosure about its use of Unit 731 data and an apology for failing to hold the perpetrators accountable.

Historical Origins of the Tuskegee Experiment: The Dilemma of Public Health in the United States.

The Tuskegee Study of Untreated Syphilis in the Negro Male was an observational study on African-American males in Tuskegee, Alabama between 1932 and 1972. The U. S. Public Health Service ran this study on more than 300 people without notifying the participants about their disease nor treating them even after the introduction of penicillin. The study included recording the progress of disease and performing an autopsy on the deaths. This paper explores historical backgrounds enabled this infamous study, and discusses three driving forces behind the Tuskegee Study. First, it is important to understand that the Public Health Service was established in the U. S. Surgeon General's office and was operated as a military organization. Amidst the development of an imperial agenda of the U.S. in the late 19th and early 20th centuries, the PHS was responsible for protecting hygiene and the superiority of "the American race" against infectious foreign elements from the borders. The U.S. Army's experience of medical experiments in colonies and abroad was imported back to the country and formed a crucial part of the attitude and philosophy on public health. Secondly, the growing influence of eugenics and racial pathology at the time reinforced discriminative views on minorities. Progressivism was realized in the form of domestic reform and imperial pursuit at the same time. Major medical journals argued that blacks were inclined to have certain defects, especially sexually transmitted diseases like syphilis, because of their prodigal behavior and lack of hygiene. This kind of racial ideas were shared by the PHS officials who were in charge of the Tuskegee Study. Lastly, the PHS officials believed in continuing the experiment regardless of various social changes. They considered that black participants were not only poor but also ignorant of and even unwilling to undergo the treatment. When the exposure of the experiment led to the Senate investigation in 1973, the participating doctors of the PHS maintained that their study offered valuable contribution to the medical research. This paper argues that the combination of the efficiency of military medicine, progressive and imperial racial ideology, and discrimination on African-Americans resulted in the Tuskegee Syphilis Experiment.

La investigación clínica sin beneficio directo en niños y el estándar del mejor interés / Clinical research without direct profit in children and the best interest standard

La experimentación clínica tiene un carácter ambivalente por los beneficios que promete y los riesgos que inevitablemente se contraen. Cuando los sujetos implicados son menores, las cuestiones éticas se complican. El calado ético de la cuestión se pone de manifiesto especialmente cuando se valoran ensayos clínicos en los que se expone a los niños a riesgos elevados (que pueden implicar incluso la vida del sujeto), dado que los niños que no tienen la capacidad legal para decidir sobre la cuestión, y cuando las grandes instituciones (empresas farmacéuticas, universidades o instituciones públicas) anteponen el ‘progreso’ de la investigación al bienestar de los menores. En estas páginas vamos a analizar sobre qué criterios se sustenta la investigación en niños, así como cuáles son los estándares que se deben aplicar en dicha actividad, y nos detendremos particularmente en la valoración del uso de placebo, especialmente cuando los niños implicados en un estudio no reciben un beneficio directo del mismo

Clinical research has an ambivalent nature for the benefits it promises and the risks we inevitably incur. When the subjects involved are minors, ethical issues become more complicated. The ethical importance of the matter is revealed especially when assessing clinical trials in which children are exposed to high risk (it can involve even the subject’s live), because those children have no legal skill to decide about the question, and when the big institutions (pharmaceutical companies, universities or public institutions) give preference to research ‘progress’, over the welfare of the minors. In this paper we analyze on which criteria research involving children is uphold, as well as the standards that should be applied in this activity, and we will detain particularly in the valuation of the use of placebo, especially when the children involved in a trial do not receive a direct profit from it