Trends in health research ethics in the Philippines during the American Colonial Period (1898-1946).

Research involving human participants has been conducted in the Philippines since the beginning of the Spanish colonial period. Such studies are expected to adhere to internationally accepted ethical guidelines. This paper discusses trends in clinical research ethics in the Philippines during the American colonial period (1898-1946). Specifically, studies were assessed on: 1) their observance of ethical protocols, including review; 2) identification of inclusion and exclusion criteria in the selection of participants; 3) use of vulnerable subjects; and 4) practice of the informed consent process. Only the informed consent process had a significant logistic correlation with progression of years. Recruitment of vulnerable groups was common during this period; children and prisoners were the most common participants. Trends in medical ethics in the Philippines reflected those in the United States prior to the publication of the Nuremberg Code, which served as a milestone in the protection of human welfare in clinical research.

Beyond Nazi War Crimes Experiments: The Voluntary Consent Requirement of the Nuremberg Code at 70.

The year 2017 marks both the 70th anniversary of the Nuremberg Code and the first major revisions of federal research regulations in almost 3 decades. I suggest that the informed consent provisions of the federal research regulations continue to follow the requirements of the Nuremberg Code. However, modifications are needed to the informed consent (and institutional review board) provisions to make the revised federal regulations more effective in promoting a genuine conversation between the researcher and the research subject. This conversation must take seriously both the therapeutic illusion and the desire of both the researcher and the research subject not to engage in sharing uncertainty.

The Nazi Physicians as Leaders in Eugenics and "Euthanasia": Lessons for Today.

This article, in commemoration of the 70th anniversary of the Doctors' Trial at Nuremberg, reflects on the Nazi eugenics and "euthanasia" programs and their relevance for today. The Nazi doctors used eugenic ideals to justify sterilizations, child and adult "euthanasia," and, ultimately, genocide. Contemporary euthanasia has experienced a progression from voluntary to nonvoluntary and from passive to active killing. Modern eugenics has included both positive and negative selective activities. The 70th anniversary of the Doctors' Trial at Nuremberg provides an important opportunity to reflect on the implications of the Nazi eugenics and "euthanasia" programs for contemporary health law, bioethics, and human rights. In this article, we will examine the role that health practitioners played in the promotion and implementation of State-sponsored eugenics and "euthanasia" in Nazi Germany, followed by an exploration of contemporary parallels and debates in modern bioethics. 1.

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.

Prisoners as research participants: current practice and attitudes in the UK.

The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them as participants. Hence, prisoners are routinely denied the opportunity to participate in research. In the absence of comprehensive information regarding prisoners' current involvement in research, we examined UK prisoners' involvement through review of research applications to the UK National Research Ethics Service. We found that prisoners have extremely limited access to research participation. This analysis was augmented by a survey of those involved in research and research governance (UK researchers and Research Ethics Committee members). Our results suggest that pragmatic concerns regarding the perceived burden of including prisoners are far more prominent in motivating their exclusion than ethical concerns or knowledge of regulations. While prisoners may remain a vulnerable research population due to constraints upon their liberty and autonomy and the coercive nature of the prison environment, routine exclusion from participation may be disadvantageous. Rigorous ethical oversight and the shift in the prevailing attitude towards the risks and benefits of participation suggest that it may be time for research to be more accessible to prisoners in line with the principle of equivalence in prison healthcare. We suggest the necessary first step in this process is a re-examination of current guidance in the UK and other countries with exclusions.

The ethical challenges of animal research.

In 1966, Henry K. Beecher published an article entitled "Ethics and Clinical Research" in the New England Journal of Medicine, which cited examples of ethically problematic human research. His influential paper drew attention to common moral problems such as inadequate attention to informed consent, risks, and efforts to provide ethical justification. Beecher's paper provoked significant advancements in human research policies and practices. In this paper, we use an approach modeled after Beecher's 1966 paper to show that moral problems with animal research are similar to the problems Beecher described for human research. We describe cases that illustrate ethical deficiencies in the conduct of animal research, including inattention to the issue of consent or assent, incomplete surveys of the harms caused by specific protocols, inequitable burdens on research subjects in the absence of benefits to them, and insufficient efforts to provide ethical justification. We provide a set of recommendations to begin to address these deficits.

Los experimentos de Sífilis y otras infecciones de transmisión Sexual en Guatemala, 1946-1948, ¿un dilema ético y político para Guatemala y el mundo? / The experiments of Syphilis and other sexually transmitted infections in Guatemala, 1946-1948, an ethical and political dilemma for Guatemala and the world?

En Guatemala se llevaron a cabo experimentos por entidades de salud de Estados Unidos de Norte América, inoculando infecciones de transmisión sexual (gonorrea, sífilis y cancroide) a poblaciones vulnerables con el objetivo de generar un modelo humano para estudio de este tipo de enfermedades. Estos experimentos permanecieron ocultos durante 64 años, cuando la Dra. Susan Reverby los descubrió al revisar los archivos de quien fuera el investigador de los mismos, Dr. John C. Cutler. Fueron inoculados 1308 personas y reportadas fallecidas 83. Al hacerse pública esta nefasta noticia, se condenaron los hechos acontecidos entre 1946-1948 por múltiples organizaciones y el gobierno, nombrándose una Comisión Presidencial en Guatemala y por su parte el gobierno de Estados Unidos también conformó una Comisión Presidencial. Los informes y dictámenes de ambas Comisiones coinciden en que se violaron los principios éticos y morales, que la desigualdad social y racismo existente en esa época fueron condicionantes muy importantes, que lo acontecido puede ser catalogado como crímenes de lesa humanidad y que las personas que planificaron, aprobaron, condujeron, facilitaron y financiaron estos experimentos son moralmente culpables. A la fecha no se ha otorgado ningún resarcimiento a los afectados o familiares, ni compensación alguna a Guatemala...(AU)

In Guatemala, experiments were carried out by health entities in the United States of America, inoculating sexually transmitted infections (gonorrhea, syphilis and canker) into vulnerable populations with the aim of generating a human model for the study of this type of disease. These experiments remained hidden for 64 years, when Dr. Susan Reverby discovered them by reviewing the files of whoever was their researcher, Dr. John C. Cutler. 1308 people were inoculated and 83 were reported deceased. When this ominous news was made public, the events occurred between 1946-1948 by multiple organizations and the government were condemned, a Presidential Commission was appointed in Guatemala and for its part the government of the United States also formed a Presidential Commission. The reports and opinions of both Commissions agree that ethical and moral principles were violated, that the social inequality and racism that existed at that time were very important conditions, that what happened can be classified as crimes against humanity and that the people who planned , approved, conducted, facilitated and financed these experiments are morally culpable. To date no compensation has been granted to those affected or relatives, nor any compensation to Guatemala ... (AU)

"Case Neisser": experimental design, the beginnings of immunology, and informed consent.

In 1892, Albert L. Neisser (1855-1916), the professor of dermatology and venereology at the University of Breslau (Prussia), undertook two series of clinical experiments: one to test whether serum from syphilitic patients had a prophylactic value against contracting syphilis, and the other to test whether such serum had a therapeutic value for syphilitic patients. The first experiment was based on the erroneous scientific hypothesis called "Colles's law," which posited that a fetus that was syphilitic due to the father's disease could in utero immunize its mother against syphilis. Neisser acknowledged that neither experiment achieved its goal. However, when his work was published, Neisser was criticized not for the various errors of experimental design that should have been recognizable to him, but because of his failure to obtain the consent of his non-syphilitic subjects. The political furor that followed led to the first governmental edict to require informed consent of participants in clinical research. This essay examines how Neisser's generally forgotten investigation into therapies for syphilis led to some of the first regulations about informed consent.

Hermannsburg, 1929: turning aboriginal "primitives" into modern psychological subjects.

In 1929, the Lutheran mission at Hermannsburg (Ntaria), central Australia, became an extraordinary investigatory site, attracting an array of leading psychologists wishing to define the "primitive" mentality of the Arrernte, who became perhaps the most studied people in the British Empire and dominions. This is a story of how scientific knowledge derived from close encounters and fraught entanglements on the borderlands of the settler state. The investigators-Stanley D. Porteus, H. K. Fry, and Géza Róheim-represent the major styles of psychological inquiry in the early-twentieth century, and count among the vanguard of those dismantling rigid racial typologies and fixed hierarchies of human mentality. They wanted to evaluate "how natives think," yet inescapably they found themselves reflecting on white mentality too. They came to recognise the primitive as an influential and disturbing motif within the civilised mind-their own minds. These intense interactions in the central deserts show us how Aboriginal thinking could make whites think again about themselves-and forget, for a moment, that many of their research subjects were starving.

CPCJ 50th Anniversary Editorial Board Commentary: Ethics and Health Policy-Then and Now.

To celebrate the 50th year of the Cleft Palate-Craniofacial Journal we look back to where we started in 1964, where we are now, and speculate about directions for the future in a Then and Now editorial series. This editorial examines 50 years of social, policy, and regulatory changes that broaden the responsibility for research integrity to include the investigator, the journal editorial review process, and institutional oversight. Internationally recognized standards for authorship, publication of recognizable cases and images, and confidentiality of peer-review are addressed in the context of the history of the CPCJ. As we look to the future, the core principles will continue to guide the endeavor of research involving human subjects while adhering to our obligations to protect the interests of the people we serve.