Compliance with National Ethics Requirements for Human-Subject Research in Non-biomedical Sciences in Brazil: A Changing Culture?

Ethics regulation for human-subject research (HSR) has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences (HSS), the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional documents (collected from June 2014 to May 2015) from 171 graduate programs at six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country.

Assisting the High Administrative Court in Restricting Too Broad a Concept of Academic Judgment.

I have received substantial monetary compensation and a formal apology from my first doctoral school, and a Ph.D. from another university. This essay describes my personal view on discussing the boundaries of academic judgment and research supervision with the ombudsman agency for higher education, and at the High Administrative Court of England and Wales. The Court's judicial doctrine addresses substantial research accountability matters. It clarifies that although the Court and ombudsman agency must not interfere with academic judgment, not everything done by an academic can be considered as academic judgment. A Ph.D. supervisor can seriously fail to perform his/her duties.

[Handling of misconduct in Swedish research must be improved. More strict investigative procedures, tougher punishments and withdrawals are required]. / Hantering av oredlighet i svensk forskning måste förbättras - Stramare utredningsrutiner, skärpta straff och tillbakadraganden krävs.

Scientific misconduct constitutes a severe threat to research. Procedures to handle misconduct must therefore be both efficient and precise. In Sweden, suspected cases of misconduct are handled by the universities themselves. Investigations are generally performed by appointed scientists, leading to unnecessary discussions of the validity of the conclusions made. Sweden has a Central Ethical Review Board but this is infrequently used by the universities. It is an absolute requirement for a university to withdraw incorrect publications from the literature but regulations in this area are lacking in Sweden. The extraordinarily strong legal status of graduate students at Swedish universities leads to slow and costly investigations. Even when found to be guilty of misconduct, students are allowed to defend their PhD theses. In conclusion, there is a large potential for improvement of the regulations and routines for handling scientific misconduct in Sweden.

[Soft tissue-cutting law, i.e. the career concept of an autopsy assistant]. / Lágyrészbe vágó jog, avagy egy boncmester-életpálya koncepciója.

Practical experience shows that the autopsy assistant society is fairly divided. There are some people who would have needed a thorough basic training, and there are those who - due to their diligence and the close cooperation with physician colleagues - would deserve an opportunity for further progress due to their extensive knowlegde. As regards the autopsy assistant profession the training, and the training system as well has changed significantly, and it requires further changes. Examining the issue in a wide spectrum, the aim of the authors is, as much as possible, to promote the formation of an "Autopsy assistant career," in which they want to create a predictable way for the members of the profession from the phase of becoming a student (competency, training, exams, vocational training, single note) to obtaining the master's degree. The authors would like to provide a summary about their experience and plans regarding this issue.

Desarrollo de la práctica de farmacia centrada en la atención del paciente y formación Universitaria (II) / Developing Pharmacy Practice on Patient-Centered Care and University Education (II

En esta segunda parte, y después de haber tratado una visión amplia de la formación universitaria, partiremos de un punto general de la formación del farmacéutico, no solo en el Grado sino en el postgrado, para continuar con algunos aspectos relacionados con la investigación

In this second part, and after having tried a broad view of university education, we start from a general point of the pharmacition, not only in the degree but also in postgraduate, to continue with some aspects related to research

[Professional Master's in Public Health: from legal precepts to experience in a research and education institution]. / Mestrado Profissional em Saúde Pública: do marco legal à experiência em uma instituição de pesquisa e ensino.

This study is about the discourses that prevailed over the course of time in Brazilian legislation for the Master's Course in Public Health, and how a Brazilian research and education institution in the area of Public Health appropriated these discourses in the creation of its course proposals. Discourse analysis techniques were applied to legal documents and to sixteen master's programs developed in the institution under scrutiny. The results revealed that with respect to legislation, analysis of the historical timeline makes it possible to say that the initial lack of definition progressively gave rise to the understanding that the identity of such post-graduate education presupposes pedagogical practices that promote the strengthening of ties between academia and the workplace. And, in relation to the master's course proposals for public health in the institutions under scrutiny, they still operate with traditionally consolidated training schemes and tend to standardize their proposals with those of the academic model. It was assumed in this study that the series of proposals would clearly mirror the intentions and, above all, the vision of the training institutions in the area of public health on this stricto sensu model, the identity of which also appears poorly defined.

Mestrado Profissional em Saúde Pública: do marco legal à experiência em uma instituição de pesquisa e ensino / Professional Master's in Public Health: from legal precepts to experience in a research and education institution

Trata-se de um estudo sobre os discursos que vigoraram ao longo do tempo na legislação brasileira sobre Mestrado Profissional (MP), e como uma instituição de pesquisa e ensino na área da Saúde Pública se apropriou deles na construção de suas propostas de cursos. Técnicas de análise de discurso foram utilizadas nos documentos legais e cotejadas com dezesseis propostas de cursos de MP da instituição-caso. Os resultados mostram que em relação à legislação, a análise da linha histórica permite dizer que as indefinições iniciais vêm progressivamente dando lugar ao entendimento de que a identidade dessa modalidade de formação pressupõe práticas pedagógicas que promovam o estreitamento das relações entre a academia e o mundo do trabalho. E, em relação às propostas de cursos de MP da instituição-caso, elas ainda operam com esquemas de formação tradicionalmente consolidados e tendem a conformar suas propostas à semelhança daquelas da modalidade acadêmica. Assumiu-se no presente estudo que o conjunto das propostas expressariam suficientemente as intencionalidades e, sobretudo, a visão das instituições formadoras na área de saúde pública sobre essa modalidade stricto sensu e cuja identidade ainda parece pouco determinada.

This study is about the discourses that prevailed over the course of time in Brazilian legislation for the Master's Course in Public Health, and how a Brazilian research and education institution in the area of Public Health appropriated these discourses in the creation of its course proposals. Discourse analysis techniques were applied to legal documents and to sixteen master's programs developed in the institution under scrutiny. The results revealed that with respect to legislation, analysis of the historical timeline makes it possible to say that the initial lack of definition progressively gave rise to the understanding that the identity of such post-graduate education presupposes pedagogical practices that promote the strengthening of ties between academia and the workplace. And, in relation to the master's course proposals for public health in the institutions under scrutiny, they still operate with traditionally consolidated training schemes and tend to standardize their proposals with those of the academic model. It was assumed in this study that the series of proposals would clearly mirror the intentions and, above all, the vision of the training institutions in the area of public health on this stricto sensu model, the identity of which also appears poorly defined.

Title IX and Pregnancy Discrimination in Higher Education: The New Frontier.

Pregnancy discrimination is a little known area covered by Title IX. According to the Title IX regulations, areas of prohibited discrimination include: admissions; hiring; coursework accommodations and completion; pregnancy leave policies and status protection upon return from leave; and health insurance coverage. These regulations will soon get more attention as the Obama Administration insists on Title IX dissemination and compliance in an effort to stop the leaky pipeline for women in the STEM fields. Research shows that pregnancy and childbirth are the major reasons why women drop out of research science in much greater numbers than men; this dropout is most likely to occur among graduate students and postdoctoral fellows who are in their peak childbearing years. A similar pattern of dropout can be seen in all fields, including related professional schools. Research also reveals that there are currently few established policies in higher education which adequately address pregnancy and childbirth in formal policies for students. This article will address new efforts by the United States Department of Education and the federal agencies to begin to seek compliance relating to Title IX and pregnancy discrimination in educational institutions. It will discuss the recent successful efforts of the U.S. Department of Education's Office for Civil Rights in investigating and settling pregnancy discrimination claims as well as the lessons learned in private action lawsuits under Title IX. Title IX private action suits have transformed athletics for women, and more recently Title IX has been applied in sexual harassment cases. Pregnancy discrimination is now the new frontier.

The regulation of clinical chemistry in Slovenia.

The practice of medical biochemistry in Slovenia includes clinical biochemistry (including toxicology, therapeutic drug monitoring, endocrinology, molecular diagnostics, immunology), hematology and coagulation. To start the vocational medical biochemistry training programme it's necessary to have a completed university degree (second cycle) in pharmacy, chemistry, biochemistry, medicine or other relevant university study and 1 year supervised practical training in medical laboratories, completed with mandatory state exam at Ministry of Health. The duration of vocational training programme is 4 years and is completed with final exam. The title after passed final examination is Medical biochemistry specialist. In October 2005 EC4 (Communities Confederation of Clinical Chemistry and Laboratory Medicine) approved Equivalence of standards of Slovenian national standards for medical biochemistry specialists. Since 2006 it is mandatory to be registered and to have valid license for medical biochemistry specialists and other professionals in laboratory medicine with at least university degree (second cycle) of education. Laboratory medicine in Slovenia is regulated globally through the Law of health-care activity and particularly through the Bylaw of laboratory medicine. The latter is based on standard ISO 15189, ratified in 2004. The Bylaw envisages granting working license to laboratories, valid for 5 years period. Granting of working licenses is ongoing process and first licenses have been granted in 2009. Important improvement toward the quality requirements for medical laboratories can be observed in the last 5 years. Parallel with the Bylaw of medical laboratories, Slovenian Accreditation (SA), the legal national accreditation body, started the initiative for accreditation of medical laboratories according to ISO 15189. It is in the implementation phase.

Clinical chemistry and laboratory medicine in Croatia: regulation of the profession.

Heterogeneity exists across Europe in the definition of the profession of clinical chemistry and laboratory medicine and also in academic background of specialists in this discipline. This article provides an overview of the standards of education and training of laboratory professionals and quality regulations in Croatia. Clinical chemistry in Croatia is almost exclusively practiced by medical biochemists. Although term Medical biochemist often relates to medical doctors in other European countries, in Croatia medical biochemists are not medical doctors, but university degree professionals who are qualified scientifically. Practicing the medical biochemistry is regulated by The Health Care Law, The Law of the Medical Biochemistry Profession and The Law of the State and Private Health Insurance. According to the law, only medical biochemists are entitled to run and work in the medical biochemistry laboratory. University degree is earned after the 5 years of the studies. Register for medical biochemists is kept by the Croatian Chamber of Medical Biochemists. Licensing is mandatory, valid for 6 years and regulated by the government (Law on the Health Care, 1993). Vocational training for medical biochemists lasts 44 months and is regulated by the national regulatory document issued by the Ministry of Health. Accreditation is not mandatory and is provided by an independent, non-commercial national accreditation body. The profession has interdisciplinary character and a level of required competence and skills comparable to other European countries.

Graduate and postgraduate state university education of laboratory specialists in Hungary: medical doctors, pharmacists and laboratory analysts.

The authors focus on the description of graduate and postgraduate training of specialists working in clinical laboratories in Hungary. All training schemes are regulated by government decrees and, after obtaining an MSc degree, medical doctors and pharmacists may enter a specialty program for Medical Laboratory Diagnostics. For biologists, chemists and medical research laboratory analysts with an MSc degree a clinical biochemistry specialty training program is open. Regulated by law, the trainings are uniform in Hungary and are assigned to accredited medical universities. The candidates should complete a 26-month core program followed by 36 months' specific education. After a successful final examination including both practical skills and theoretical questions, specialists get a full license which will enable them to supervise laboratory work and validate test results. Laboratory specialists should join a continuous (lifelong) learning program and collect scores by attending special training courses. To receive a scientific degree, specialists may join PhD programs at any of the accredited universities.

[On the training of specialists for forensic biological departments of forensic medical bureaus].

The author analyses the main activities of the departments of forensic medicine in the Russian Medical Academy of Post-Diploma Education and the Sankt-Peterburg Medical Academy of Post-Diploma Education in the sphere of training and education of biologist experts. Information about the participants of these educational and training programs is presented. Taken together, these data give an idea of the character of post-diploma training of biologist experts and its dynamics during the period from 1950 and 2010. Results of the analysis may be of value for the long-term planning of advanced professional training and upgrading of qualification of the experts for forensic biological departments.

El Jefe de Estudios y la Comisión de Docencia ante los cambios en la Formación Especializada introducidos por el Real Decreto 183/2008 / The Head of Studies and the Education Committee face the changes in Specialised Training introduced in the Royal Decree 183/2008

El Real Decreto 183/2008 sobre Formación Médica Especializada en Ciencias de la Salud ha supuesto un cambio sustancial de esta formación en nuestro país. Desde su publicación las Unidades Docentes (UU DD) han comenzado un proceso de adaptación a este decreto, proceso que es complejo y que por los múltiples e importantes cambios que introduce requiere mucho esfuerzo por parte de los docentes. Este viaje presenta dificultades añadidas por el incumplimiento de casi todas las instituciones competentes de elaborar la normativa que desarrolle la mayoría de sus contenidos, y por lo tanto las UU DD carecen de las guías y orientaciones al respecto. Como iniciativa de la Comisión de Docencia de Formación Especializada del Hospital Universitario Virgen de la Arrixaca, se presenta el resultado del trabajo en grupo de los asistentes (informadores clave) al taller de Actualización en la Normativa sobre las Figuras Docentes en la Formación Sanitaria Especializada celebrado en Murcia, febrero de 2010. En este caso se centra en las propuestas elaboradas sobre las figura del Jefe de Estudios de las Unidades Docentes y la Comisión de Docencia, con la intención de aportar ayuda para los jefes de estudios y los docentes en esta adaptación(AU)

The Spanish Royal Decree 183/2008 on Specialised Medical Training in Health Sciences has meant a substantial change to this kind of training in Spain. Since its publication, the Teaching Units (TUs) have started a process of adaptation to this decree, a process that is complex and that requires much effort in view of the many significant changes. The process is complicated even more because the competent institutions have failed to develop regulation on most of the Decree’s contents, leaving the TUs with no guidelines. As an initiative of the Education Committee on Specialised Training of the Teaching Hospital ‘Virgen de la Arrixaca’ we present the results of the teamwork (key informers) in a workshop on the Update of the Regulation on Educators in Specialised Health Training that took place in Murcia in February 2010. We focus on the proposals developed for the Head of Studies of the Teaching Units and the Education Committee, with the aim of providing support to the directors of studies and teachers in this adaptation(AU)

[Problems of postdiploma training of specialists for forensic chemical departments of bureaus of forensic medical examination and approaches to their solution].

This paper is focused on selected problems of postdiploma training of experts for forensic chemical departments of bureaus of forensic medical examination. The main drawbacks of the existing system of advanced education for such specialists are the narrow spectrum of pharmaceutical disciplines and the lack of internship training for future experts for forensic chemical departments. Other interfering factors are conflicting situations arising in the course of forensic chemical examination at bureaus of forensic medical examination and chemical-toxicological investigations carried out in clinical and diagnostic laboratories by specialists having diploma of higher education in pharmacia. It is proposed that a new speciality (forensic toxicology) should be listed in the nomenclature of specialities of workers having higher and postdiploma education in medicine and pharmaceutics, in analogy with the universally accepted world practice.

La enseñanza de la Toxicología en los estudios de pregrado y postgrado en la Universidad de Extremadura / Toxicology teaching in the undergrade and postgrade studies at the University of Extremadura

En la Universidad de Extremadura se ha iniciado en el curso 2009-10 la adaptación gradual de la mayoría de los estudios que en ella se imparten al Espacio Europeo de Educación Superior, de manera que durante los próximos años coexistirán las antiguas titulaciones (licenciaturas, diplomaturas, ingenierías) con los nuevos títulos de Grado. Según esto la enseñanza de la Toxicología en la actualidad se lleva a cabo en las Licenciaturas de Veterinaria y de Ciencias Ambientales bajo la tutela del área de Toxicología y en la Licenciatura de Medicina bajo la de Medicina Legal y Forense. Con la adaptación a sus respectivos títulos de Grado las distintas asignaturas relacionadas con la toxicología se han adaptado, transformado o extinguido, expandiéndose por otro lado en la enseñanza de postgrado con la ampliación de oferta de nuevos Másteres en los que el área de Toxicología interviene de forma activa (AU)

The gradual adaptation of the majority of the studies in the University of Extremadura to the European Higher Education Area has started in 2009-10, so that the old qualifications co-exist with the new degrees for the next few years. According to this, at present the teaching of toxicology takes place in the Bachelors of Veterinary and Environmental Sciences under the supervision of the area of T oxicology and the Bachelor of Medicine under the Legal Medicine one. With the changes to their respective titles of degree, the different toxicology-related subjects have adapted, transformed or extinguished. On the other hand postgraduate education is expanding with the increasing supply of new masters in which the area of Toxicology is actively involved (AU)