[Human experiment study of Unit 731, Japan: take the report "The Research Report on Epidemic Prevention of Army Medical School â ¡: Vol.1, No.36 " as an example].

"The Research Report on Epidemic Prevention of Army Medical School Ⅱ: Vol.1, No.36" , the report named "various symptoms and serological responses of human body after receiving ultrasonic cholera vaccine" is one of the declassified materials of Japanese biological warfare. The author is M. D. Watanabe Be. Through detailed analysis of its contents, such as institute of report, test method, test results, and so forth, conclusion is reached that Unit 731 did conduct scientific research based on human-subject experiment to launch biological warfare on human beings. The report mentioned above is one of the most important evidence of crime that Japan conducts biological warfare which violates international convention and contempt bottom line of human basic morals and ethics.

Fevered Decisions: Race, Ethics, and Clinical Vulnerability in the Malarial Treatment of Neurosyphilis, 1922-1953.

Physicians deliberately inoculated marginalized patients with malaria, using them as reservoirs to facilitate malarial fever therapy for syphilitic patients. The history presents ethical questions in an evolving historical context.

The new military medical ethics: legacies of the Gulf Wars and the War on Terror.

United States military medical ethics evolved during its involvement in two recent wars, Gulf War I (1990-1991) and the War on Terror (2001-). Norms of conduct for military clinicians with regard to the treatment of prisoners of war and the administration of non-therapeutic bioactive agents to soldiers were set aside because of the sense of being in a 'new kind of war'. Concurrently, the use of radioactive metal in weaponry and the ability to measure the health consequences of trade embargos on vulnerable civilians occasioned new concerns about the health effects of war on soldiers, their offspring, and civilians living on battlefields. Civilian medical societies and medical ethicists fitfully engaged the evolving nature of the medical ethics issues and policy changes during these wars. Medical codes of professionalism have not been substantively updated and procedures for accountability for new kinds of abuses of medical ethics are not established. Looking to the future, medicine and medical ethics have not articulated a vision for an ongoing military-civilian dialogue to ensure that standards of medical ethics do not evolve simply in accord with military exigency.

Views of midwives about ethical aspects of participation in placental perfusion studies.

BACKGROUND: Little is known regarding the role of the midwife in recruiting mothers to participate in scientific research. OBJECTIVE: To describe ethical aspects of participation of midwives in placental perfusion studies. DESIGN: Qualitative study involving thematic interviews and thematic content analysis. SETTING: Two university hospitals in Finland in 2008-2009. PARTICIPANTS: Midwives (n=20) who had been involved in recruiting mothers for a placental perfusion study. FINDINGS: Midwives felt that the situation, when inviting the mothers to donate their placentas, was restless and hasty because of the considerable number of tasks required during a birth. For recruitment, they explained how they tried their best to find a quiet opportunity to provide information about the placental perfusion study, so that the mother could take her time reading the written information. During a birth, it was difficult to give information to the mother in such a way that she would truly understand. Information for the mother was planned to be provided in an equal, dialogic conversation, with the subject of research introduced by the midwife. Placental perfusion studies as carried out in this setting were not seen to have any risks for the mothers, and midwives were under less strain in this study than in other medical research projects. The midwives considered it normal to use placentas in scientific research, and did not see any associated ethical problems. In their opinion, the use of placentas was acceptable and even desirable, provided that the mother was informed about the research and gave voluntary informed consent. CONCLUSIONS AND IMPLICATIONS FOR PRACTISE: Recruitment must be taken into account in management of the ward, and should be planned so that no recruitment is undertaken during medical procedures. Midwives need more education about the research including the important aspects of the creation of general knowledge about substances which may harm the fetus. Dialogue is needed between the mother and the midwife to ensure genuine informed consent.

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

OBJECTIVE: To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. METHODS: A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). RESULTS: In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). CONCLUSION: Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers.

Ethical aspects in placental perfusion studies: views of the researchers.

Within the EU-project NewGeneris human placental perfusion has been used for predicting fetal exposure to food carcinogens. Within the work package of ethical aspects of the research, we studied opinions of the researchers (n = 23) who carried out perfusions of human placenta. Data were collected by focus group interviews (n = 12) and an open-ended questionnaire (n =19 of which 8 were also attending the group session) from scientists representing 9 different nationalities. Both types of data were analysed together thematically and with data triangulation. Studied researchers considered communication between all stakeholders extremely important. Good communication was considered a prerequisite for the recruitment of mothers to donate the placenta, as well as for the process of getting the informed consent. Voluntariness, confidentiality and societal meaning were mentioned as important by all studied researchers. Educating the hospital personnel was regarded as essential in order to provide the best possible information to the mothers. The researchers also pointed out that cultural aspects should be respected, and that in Western thinking placenta is mostly considered as waste. Some researchers suggested that current guidelines and processes for obtaining informed consent should be reviewed also from a cultural perspective. With the development of biobanks, the use of human tissues, including placenta will most probably increase in the future, and the awareness of ethical considerations both in legislation and in practice need support. Thus, continuous effort for better research ethics is essential and requires research on research ethics.

Prisoners' bodies: methods and advances in convict medicine in the transportation era.

Recent historical research looks upon the plight of Australian convicts not as victims of a harsh penal system, but as workers whose health had to be judiciously maintained. What then can be said for the medical treatments provided for convict patients during this chapter in Australia's past? Did convicts receive medical treatments with the same measure of importance and urgency as the free populace, or were prisoners' bodies considered with such a measure of insignificance that they provided veritable opportunities for advances in medicine? This article will provide general insight into prison medicine in Australia during the transportation era and how some convicts were subjected to experimental medical practices. It will also place these techniques into a wider global context by considering experimental practices involving convict patients in establishments in other places, such as Wakefield and Bermuda.

Bioética: visão multidimensional / Bioethics: multidimensional

O livro integra múltiplos assuntos específicos e atuais das mais diversas disciplinas, oferecendo posicionamento humano e adequado à realidade. Aborda a estrutura científica da Bioética, alteridade nas questões ambientais, a relação quanto às origens das políticas públicas de saúde, reflexão sobre a relação médico-paciente, a bioestatística frente aos resultados da investigação, a importância dos cuidados paliativos às pessoas sem possibilidades terapêuticas e os significados e interpretações da dignidade da morte. Trata do suicídio e suas implicações bioéticas, a espiritualidade como necessidade de atendimento humano e de saúde, os significados emergentes e os motivos de iatrogenia.

The role of an independent and interdisciplinary assessment of research studies with human subjects in Europe and worldwide.

The author reviews the history of human experimentation beginning as documented by holes in human sculls 6000 years before, addressing the first controlled experiments by James Lind and Edward Jenner in the 18th century and ending with the inhuman experiments in Nazi Camps and the Tuskegee case in Alabama in the 20th century. Resting on the Declaration of Helsinki, quite a number of declarations, scientific, national and international guidelines was issued since aiming at enhancing medical research as well as protecting the subjects from harm. Now a dense ethical, legal, scientific and social network exists for investigator initiated and commercial trials for a rich market of the Pharmaceutical Industry. However, pitfalls still occur (e.g., the cases of thalidomide, VIOXX and TGN 1412) as examples that can only be prevented by even more stringent rules and well informed, conscientious, compassionate and responsible performance of all parties involved.

Committees for Ethics in Research involving human subjects.

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Conflicts of interest in research involving human beings.

Conflicts of interest are inherent to the majority of relationships among individuals and of these with companies and institutions and, certainly, research involving human beings is no exception. In relation to clinical research, the main focus of this manuscript, conflicts of interest occur at different levels and usually permeate among them: In the pharmaceutical industry in their decisions to invest to develop new products, especially vaccines and drugs, and also in relation to marketing of these products; Among the investigators the conflicts may be related to the financial gains to participate in pharma sponsored trials, or to the expected academic career boost attained with the publication of the results of the trials and also to personal interests such as the financial support for trips to international conferences. Often the participation of host country investigators is restricted to performing phase III or IV protocols developed abroad, many times with low scientific relevance, and even lower relevance to public health; Universities or research institutes themselves also have conflicts of interest, as the sponsored projects may help increase their budgets, both directly (taxes) and indirectly (e.g., improvement of physical infrastructure of laboratories or out patient clinics); For the trial volunteers in developing countries, and Brazil is no exception despite free and universal access to its health system, participation in clinical trials is many times seen as, and can really be, an unique opportunity of receiving better health care, better treatment by the health professionals, easier access to costly lab exams and also to receiving certain medications which would otherwise be difficult to have access to. In order to handle these conflicts of interest, Brazil has a well-established and respected legal support and ethical normatization. The latter is represented by Resolution 196/96 of the Brazilian National Research Ethics Committee (CONEP). This national system was established in 1996 providing guidance to all research involving human beings and currently there are approximately 500 local research ethical committees certified by CONEP in all States of Brazil. However, there is intense international pressure mainly from the pharmaceutical industry especially to the ethical requirements emanated from the Declaration of Helsinki (DH), aiming to lower the level of ethical requirements in research to be carried out with volunteers from developing countries. Fallacious reasoning includes that the equity stated at the DH, especially the access to the best proven medical care and to the developed products to all volunteers independently of where the trial is being held, would inflate the costs of research and drive the sponsors away from the developing countries. In this line of thought, if the volunteers have not the same rights that would constitute an unacceptable double standard, or in other words, the best for the volunteers from developed countries and whatever is possible for those in developing countries. This manuscript will focus on the various levels where conflict of interest issues are more prone to happen, such as in the actions of pharmaceutical industries, their relation to health professionals, the participation of universities and research institutes, the ethical research committees and their members, including the possible pressures exerted on them by researchers, sponsors and even their institutions. Emphasis will be given to the interrelation between conflicts of interest and vulnerability, and also the causes and possible solutions to lower the risks of exploitation of volunteers in research. It will also emphasize the need to guarantee access to products that are proven efficacious to all individuals who may need them. Possible ways of empowering these volunteers will be evaluated, so that they become aware of their rights and demand for them. It will discuss the need of separating economic interests from the real needs of public health and of demystifying economic arguments used in order to justify the lowering of ethical requirements. And finally it will address the search for or the establishment of real and effective involvement of all stakeholders in an international organism really representing everyone (e.g., WHO) in order to evaluate, debate, and decrease the risks of several conflicts of interest, aiming at the establishment of research projects that can truly contribute to lower the obscene disparities of health between developed and developing countries.

[AIDS: ethics and scientific investigation on human beings]. / Sida: éthique et investigation scientifique sur l'être humain.

The experimentation on human beings of one or several therapeutic molecules discovered in laboratory is necessary and important because it helps to find new treatments or new diagnostic methods. But, it presents serious ethical problems. In this article we are analysing the example of the HIV infection. We are succinctly describing the research methods in laboratory for therapeutic molecules, first the experimentation on animals and then on human being in clinical trials. We will then try to show, with several examples, how during these last 25 years of HIV infection, the research of new molecules has not always respected the ethical rules set out in Helsinki declaration, "Code de la santé publique" or "Guide de bonnes pratiques cliniques-ICH" etc. We are discussing here the way to avoid these irregularities.

Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

Bioethics: a search for moral diversity.

The concept of global, Asian and Chinese bioethics are discussed in this paper and the difficulty in applying universal bioethics within different cultures and countries is addressed. The traditional beliefs and values in China are described with particular reference to medicine, and the implications for bioethics and research ethics within the country are considered.