Exploitation of the vulnerable in research: Responses to lessons learnt in history.

The Nuremberg Trials raised insightful issues on how and why doctors who were trained in the Hippocratic tradition were able to commit such egregious and heinous medical crimes. The vulnerable were considered to be subhuman, of decreased intelligence, of no moral status and lacking human dignity. The reputation of the medical profession had been undermined, professionalism questioned and the doctor-patient relationship damaged as a result of the Nazi medical experiments. The World Medical Association's Declaration of Helsinki has been hailed as one of the most successful efforts in rescuing medical research from the darkness of the scandals and tragedies in health research. The first Research Ethics Committee in South Africa was established in 1966 at the University of the Witwatersrand. From the mid-1970s other institutions followed suit. The promulgation of the National Health Act No. 61 of 2003, in 2004, resulted in strong protectionism for research participants in the country.

Research ethics on the agenda - the debates preceding the establishment of the ethics committees. / Forskningsetikk på dagsordenen ­ debattene bak de etiske komiteene.

BACKGROUND This article examines two factors that helped to trigger and drive forward the debate about research ethics committees (now the Regional Committees for Medical and Health Research Ethics) in Norway in the 1970s: the revision of the Declaration of Helsinki by a Scandinavian working group, and the unfolding of the so-called Gro case in the Norwegian national media.METHOD We have used existing literature in the form of books and articles on the history of research ethics from the University Library of the University of Oslo, the National Library of Norway, the History of Science, Technology and Medicine database, and Retriever. We have manually reviewed issues of the Dagbladet daily newspaper from 1974, and relevant volumes of the Journal of the Norwegian Medical Association from the 1960s and 1970s. Finally, we have used the archives of the Norwegian Association of Higher Education Institutions, and the Faculty of Social Sciences at the University of Oslo.RESULTS The World Medical Association's revision of the Declaration of Helsinki in 1975 stipulated the use of independent ethics committees for the assessment and supervision of research projects. The Gro case, which concerned the testing of behavioural therapeutic treatment on a young girl resident in an institution and the ensuing public debate, led to a demand from the public for closer monitoring and ethical regulation of research activity.INTERPRETATION Both of the events mentioned were used actively in the argumentation and preparatory work for the establishment of research ethics committees.

Declaración de Helsinki: cambios y exégesis / Helsinki Declaration: changes and interpretation

La Declaración de Helsinki es muy citada de en el ámbito de las ciencias médicas y de la salud. En Cuba se utiliza para valorar los aspectos éticos de las investigaciones, sin embargo, es escasa la literatura dedicada a la valoración crítica de la misma. Referir sus versiones presupone conocer su devenir histórico para interpretar sus aciertos y limitaciones. La intención del estudio es contribuir a actualizar los conocimientos de los profesionales de la salud sobre la Declaración de Helsinki. Se realizó revisión de la literatura publicada entre 2008 y 2014 (agosto) en las bases de datos bibliográficos Cumed, Lilacs, SciELO PubMed, MedLine, Clinical Key, Cochrane y el motor de búsqueda Google utilizando vocabulario controlado con los siguientes descriptores: Declaración de Helsinki, placebo, ensayo clínico, ética y bioética. Los temas más polémicos fueron: uso del placebo, doble estándar en las investigaciones clínicas y garantía de continuidad de tratamiento a los pacientes participantes. Se destacaron méritos en la versión de 2013 tales como la insistencia para aumentar la transparencia en la investigación, su nuevo diseño estructural y la consideración de la competencia ética como un requisito para los investigadores. Los comentarios sobre la Declaración de Helsinki oscilan desde el elogio hasta la sugerencia de su desaparición o sustitución. La polémica sobre la misma es considerada necesaria por algunos autores pero también estéril por otros. Los problemas más álgidos tratados en las últimas versiones emanan del enfrentamiento entre los intereses de la industria farmacéutica y los derechos de los participantes en las investigacione(AU)

In the fields of medical and health sciences, the Helsinki Declaration is quoted very often. The Helsinki Declaration is used to evaluate the ethical aspects of research studies; however, literature devoted to critical assessment of those studies is scanty. Making reference to the declaration versions presupposes the knowledge about its historical development in order to construe its good things and limitations. The intention of this study is to help to update the health professionals' knowledge about the Helsinki Declaration. A literature review published between 2008 and August 2014 was made and collected on the following databases: Cumed, Lilacs, SciELO PubMed, MedLine, Clinical Key, Cochrane and Google, using controlled vocabulary with the f subject headings Helsinki Declaration, placebo, clinical trial, ethics and bioethics. The most controversial topics were the use of placebo, application of the double standard possition in clinical research, and guaranteed continuous treatment for the participating patients. The following 2013 version's merits were highlighted: insistence on the research transparency its new structural design, and the concern for ethical competence as a requirement for researchers. Comments about the Helsinki Declaration range from praise to disappearance or replacement suggestions. Some authors deem the controversy necessary but others think it is a wasteful argument. The hottest problems in the most recent versions come from the confrontation between the pharmaceutical industry interests and the rights of participants in research studies(AU)

Declaración de Helsinki: cambios y exégesis / Helsinki Declaration: changes and interpretation

La Declaración de Helsinki es muy citada de en el ámbito de las ciencias médicas y de la salud. En Cuba se utiliza para valorar los aspectos éticos de las investigaciones, sin embargo es escasa la literatura dedicada a la valoración crítica de la misma. Referir sus versiones presupone conocer su devenir histórico para interpretar sus aciertos y limitaciones. La intención del estudio es contribuir a actualizar los conocimientos de los profesionales de la salud sobre la Declaración de Helsinki. Se realizó revisión de la literatura publicada entre 2008 y 2014 (agosto) en las bases de datos bibliográficos Cumed, Lilacs, SciELO PubMed, MedLine, Clinical Key, Cochrane y el motor de búsqueda Google utilizando vocabulario controlado con los siguientes descriptores: Declaración de Helsinki, placebo, ensayo clínico, ética y bioética. Los temas más polémicos fueron: uso del placebo, doble estándar en las investigaciones clínicas y garantía de continuidad de tratamiento a los pacientes participantes. Se destacaron méritos en la versión de 2013 tales como la insistencia para aumentar la transparencia en la investigación, su nuevo diseño estructural y la consideración de la competencia ética como un requisito para los investigadores. Los comentarios sobre la Declaración de Helsinki oscilan desde el elogio hasta la sugerencia de su desaparición o sustitución. La polémica sobre la misma es considerada necesaria por algunos autores pero también estéril por otros. Los problemas más álgidos tratados en las últimas versiones emanan del enfrentamiento entre los intereses de la industria farmacéutica y los derechos de los participantes en las investigaciones(AU)

In the fields of medical and health sciences, the Helsinki Declaration is quoted very often. The Helsinki Declaration is used to evaluate the ethical aspects of research studies; however, literature devoted to critical assessment of those studies is scanty. Making reference to the declaration versions presupposes the knowledge about its historical development in order to construe its good things and limitations. The intention of this study is to help to update the health professionals' knowledge about the Helsinki Declaration. A literature review published between 2008 and August 2014 was made and collected on the following databases: Cumed, Lilacs, SciELO PubMed, MedLine, Clinical Key, Cochrane and Google, using controlled vocabulary with the f subject headings Helsinki Declaration, placebo, clinical trial, ethics and bioethics. The most controversial topics were the use of placebo, application of the double standard possition in clinical research, and guaranteed continuous treatment for the participating patients. The following 2013 version's merits were highlighted: insistence on the research transparency its new structural design, and the concern for ethical competence as a requirement for researchers. Comments about the Helsinki Declaration range from praise to disappearance or replacement suggestions. Some authors deem the controversy necessary but others think it is a wasteful argument. The hottest problems in the most recent versions come from the confrontation between the pharmaceutical industry interests and the rights of participants in research studies(AU)

[Wisdom of the World Medical Association (to one forgotten anniversary)]. / Moudrost Svetové lékarské asociace (k pozapomenutému výrocí).

BACKGROUND: The idea to found an international medical organization was born in July 1945 at the informal conference of doctors from several countries which was held in London. This date represents the very beginning of The World Medical Association. We can therefore celebrate its 70th anniversary and above all to congratulate WMA for keeping the true wisdom of medical ethics and therefore also the integrity of the medical profession to this day. In any medical decision the best interest of individual patient should be considered first.

Evaluación de la satisfacción del paciente diabético con la utilización del glucómetro portátil BGSTAR(c) mediante el cuestionario SATIGLU / Assessment of satisfaction of diabetic patients with the use of the portable glucometer BGSTAR© using the SATIGLU questionnaire

OBJETIVOS: Evaluar la satisfacción con el glucómetro portátil BGStar(c) del paciente diagnosticado de diabetes mellitus (DM) tipo 1 (DM1) y 2 (DM2), mediante el cuestionario SATIGLU, previamente validado, y analizar la asociación de la satisfacción con la adherencia a la monitorización y al tratamiento insulínico y con el grado de control de la glucemia (%HbA1c). MATERIAL Y MÉTODO: Estudio epidemiológico, multicéntrico y transversal. Participaron 221 pacientes con DM, mayores de edad, insulinizados y usuarios del BGStar(c). Se recogieron datos socio-demográficos, clínicos, de tratamiento y adherencia. Los pacientes cumplimentaron el SATIGLU y el Morisky-Green (M-G). Se realizó un análisis descriptivo de las puntuaciones del cuestionario SATIGLU y del resto de las variables. Se evaluó la asociación de la satisfacción con el número de inyecciones de insulina/número de controles de glucemia (rho de Spearman), con la clasificación de adherencia al tratamiento según M-G y con la clasificación de control de glucemia según la cifra de %HbA1c (U de Mann-Whitney). Se ajustó un modelo de regresión lineal múltiple para identificar las variables asociadas a la puntuación del SATIGLU. RESULTADOS: Edad media ± DE 57,96 (15,60) años; 56,60% varones; 80,82% DM2; 65,30% bien controlados (%HbA1c≤ 7). Media ± DE de inyecciones de insulina/día, 2,35 ± 1,34, y de controles glucemia/día 2,56 ± 1,29. Un 75,57% de los pacientes fueron adherentes al tratamiento (M-G). Se encontró correlación positiva del SATIGLU con los controles realizados (rho = 0,251; p = 0,001), y con las inyecciones de insulina (rho = 0,235; p = 0,001). Las puntuaciones del SATIGLU fueron mayores en los pacientes adherentes y con mejor control (p < 0,0001). El modelo de regresión mostró que las variables asociadas a la satisfacción fueron: adherencia (B = 7,006; p < 0,0001), y número de controles de glucemia (B = 3,214; p = 0,014). CONCLUSIONES: Los pacientes analizados muestran elevada satisfacción con el BGStar(c) son adherentes al tratamiento, realizan mayor número de inyecciones de insulina, más controles de glucemia y tienen un mejor control de la DM

OBJECTIVES: To assess satisfaction of patients diagnosed with Diabetes Mellitus (DM), type 1 and 2, with use of the portable glucometer BGStar(c) using the previously validated SATIGLU questionnaire. The relationships between satisfaction level and adherence to continuous glucose monitoring, insulin therapy, and with the level of glycemic control (% HbA1c), were also studied. MATERIAL AND METHOD: Epidemiological, multicenter, cross-sectional study that included 221 diabetic patients aged over 18 years, receiving treatment with insulin and using the BGStar(c) glucometer. Socio-demographic and clinical data were collected, as well as treatment and adherence data. Patients self-completed the SATIGLU questionnaire and Morisky-Green (M-G). A descriptive analysis was carried out on the SATIGLU scores and other study variables. An analysis was performed to calculate the association between satisfaction scores and the number of insulin injections and the number of glucose controls (Spearman rho), and with the adherence to treatment classification according to M-G, and with the glycemic control classification according to % HbA1c. Multiple Linear Regression analysis was conducted to identify the variables associated with SATIGLU scores. RESULTS: Mean age (SD) 57.96 (15.60) years; 56.60% male; 80.82% T2DM; good glycemic control (% HbA1c≤7), 65.30%. Mean (SD) insulin injections/day, 2.35 (1.34), and blood glucose/day controls 2.56 (1.29), with 75.57% showing adherence to therapy (M-G). A positive correlation was found between the SATIGLU and the number of glycemic controls (rho = 0.251; P=.001) and of insulin injections (rho = 0.235; P=.001). SATIGLU scores were higher in adherent patients and in those with better glycemic control (P<.0001). The regression model showed that the variables associated with satisfaction were: adherence (B= 7.006;P<.0001), and the number of glycemic controls (B= 3,214; P=.014). CONCLUSIONS: The patients studied showed high satisfaction with the BGStar(c) glucometer, with a high level of adherence to insulin therapy. They also had more insulin injections, a higher number of glycemic controls, and a better DM control

50th anniversary of the Declaration of Helsinki: the double standard was introduced.

The Declaration of Helsinki (DoH), adopted by the World Medical Association (WMA), is one of the most influential international documents in research ethics, is turning 50 in 2014. Its regular updates, seven versions (1975, 1983, 1989, 1996, 2000, 2008, 2013) and two notes of clarification (2002, 2004), characterize it as a 'live' document. The seventh version of the DoH was amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. The new version was reorganized and restructured, with paragraphs subdivided and regrouped. However, the DoH remains controversial and some ethical issues are still uncovered. The major problem was the insertion of the phrase 'less effective than the best proven' on placebo paragraph in order to allow double standard in medical research in low-resource countries. The DoH is a 'live' document, which will continually have to deal with new topics and challenges. Health equity needs to be a priority, and with that, a single ethical standard for medical research.

[About the genesis of the first Polish local research ethics committee]. / Wokól utworzenia pierwszej polskiej komisji bioetycznej.

From the moment in which the development of medicine became necessary experimental research involving human subjects, the question arose about the ethical limits and limitations of the experiment. The turning point was the year 1947. The Nuremberg Code was formulated after the disclosure of pseudo-medical experiments involving human subjects during the Second World War. In 1964, the medical world accepted the Declaration of Helsinki, which, however, did not prevent abuses and it became necessary to appoint independent ethics committees supervising and enforcing the application of ethics in biomedical experiments. In Poland in the 60's and 70's started a discussion on the ethical rules related to conduct of research involving humans. The initiators of the appointment of bioethics committees were professors of medicine, inspiring experiences of their Western colleagues. It was difficult for reasons of political ideologies to convince the authorities to use the best of western solutions. This paper attempts to describe the circumstances connected with the appointment in 1979 at the Medical University of Gdansk, the first Polish bioethics committee.