8th Global Forum on Bioethics in Research Vilnius, Lithuania June 28, 2007 Student Perspectives on Training Programs Training program in research ethics in the Americas Dirce Guilhem University of Brasilia, Brazil Angelica Angeles-Llerenas National Institute of Public Health, Mexico

Training program in research ethics in the Americas Local: FLACSO; Buenos Aires – Argentina Tutorial training: 7 months (April-November 2003) Language: fluent in Spanish and excellent reading in English Professional background: Dirce, nurse and PhD in Bioethics, Angelica, medical doctor and epidemiologist,

Training methods 2 one-week intensive seminars in research ethics, with guest faculties from the US and Latin America 1 seminar about euthanasia Courses: FLACSO: Bioethics (basic course and social justice) UBA: Feminism, Medical Anthropology PINCLIFA: Clinical Research Methodology Attendance at 8 research ethics committees at public and private hospitals and clinics Preparation of a detailed plan for implementing practical results considering the activities developed in the training program Completion of a coached research project in research ethics

Strengths The experience, competence and engagement of the coordinators in the area of research ethics Opportunity to know and learn with the invited faculties (European, United States and Latin American experts) of the seminars To participate in different kinds of research ethics committees and to observe the process of decision making related to research protocols and to compare with each country and also with the colleagues To develop a scientific paper or a plan of research under coaching To share experiences with other trainees coming from different countries of Latin America

Weaknesses Focus on clinical research: Latin America has a great tradition in epidemiological and social research Proposed networking: it is necessary to improve the collaborative activities and knowledge about the advances Technical support after the training is finished

Dirces Activities Research Ethics Committees Member – College of Health Sciences – University of Brasilia (UnB) Assistant Chair – Institute of Humanities – UnB Professor Bioethics and Research Ethics – Graduate Program of Health Sciences (since 2004) Meeting Coordinator I Workshop related to Research Ethics in Graduate Programs of Health Sciences and Tropical Medicine of Central-West, Brazil (2005) II WorkshopStrengthening Research Ethics in Tropical Diseases and Public Health Academic Programmes (2006) 2 Extension Courses: Research Ethics

Dirces Activities Consultant of the Ministry of Health of Brazil Workgroup, elaboration of the Educational Material for Research Ethics Committees in Brazil, Accompaniment of the research project: Evaluation of the Brazilian Research Ethics System, Pedagogical Coordinator, Tutorial course for members of Research Ethics Committees, Research Coordinator The Nurses Role in the Clinical Research Team Bioethics and Health Public Policies for women

Dirces Activities Books Diniz D, Guilhem D. O que é ética em pesquisa. São Paulo: Loyola. In Press [What is research ethics?] Guilhem D, Zicker F, eds. Ética na pesquisa em saúde: avanços e desafios. 1st ed. Brasília: Editora LetraLivres / Editora UnB, p. [Ethics in health research: advances and challenges]. Diniz D, Guilhem D, Schuklenk U. Ética na pesquisa: a experiência de treinamento de países Sul Africanos. 1st ed. Brasília: Editora LetraLivres / Editora UnB, p. [Special Issue: Southern African research ethics training program]. Diniz D, Guilhem D. O que é Bioética. São Paulo: Brasiliense, 2002 and 2006 (2nd edition). 70p. [What is bioethics?].

Dirces Activities Chapter of Books Guilhem D, Zicker F. Introdução à pesquisa em saúde.. In: Guilhem D, Zicker F, eds. Ética na pesquisa em saúde: avanços e desafios. 1st ed. Brasília: Editora LetraLivres / Editora UnB, p [Introduction to health research]. Guilhem D, Diniz D. A ética na pesquisa no Brasil. In: Ética na Pesquisa: a experiência de treinamento de países Sul Africanos. 1st ed. Brasília: Editora LetraLivres / Editora UnB, p [Research ethics in Brazil]. Guilhem D, Sorokin, P. Ética de la investigación, vulnerabilidad y sida. In: Temas de enfermedad por VIH/SIDA. 1st ed. Buenos Aires: Sociedad Argentina de Sida, 2003, v p. (CD ROM). [Research ethics, vulnerability and aids].

Dirces Activities Papers Guilhem D, Azvedo AM. Brazilian public policies for womens in Brazil. Developing World Bioethics. In Press. Costa AM, Guilhem D, Silver L. Planejamento familiar: a autonomia das mulheres sob questão. Revista Brasileira de Saúde Materno Infantil. Recife, 2006; 6(1): [Family Planning: the womens authonomy in question]. Guilhem D, Oliveira MLC, Carneiro MH. Bioethics and research involving human subjects. Revista Brasileira de Ciência e Movimento, 2005; 13(1): Guilhem D. Ethical responsibility of institutions and researchers. Revista de Saúde do Distrito Federal, Brasilia, 2004; 15(1/2): Llerenas AA, Guilhem D, Bello MA, Salinas M. Argentina, Brasil y México. La investigación biomédica y la defensa de un único estándar de atención en países en desarrollo. Revista de Investigación Clinica, México – DF, 2004; 56(5): Guilhem D, Sorokin, P. Ética de la investigación, vulnerabilidad y sida. Revista Latinoamericana de Derecho Médico y Medicina Legal, Costa Rica, 2003; 8(2): Guilhem D. Pesquisas Biomédicas Multinacionales: ¿Es Posible Mantener un Unico Estándar Desde el Escenário de un País en Desarrollo? Perspectivas Bioeticas. Buenos Aires – Argentina, 2003; 8(15 Bis):44-66.

Dirces Activities Educational Material Zicker F, coord, Guilhem D, Diniz D, orgs. Bioética e pesquisa com seres humanos: programas acadêmicos e de extensão. Brasilia: Editora LetraLivres, (CD RomTutorial). [Bioethics and research involving human subjects: academic and extension programmes – with contents in Portuguese and Spanish]. Guilhem D, Prado MM, et al. Capacitação para comitês de ética em pesquisa. V. I. Brasília: Ministério da Saúde, [Strengthening research ethics capability for members of research ethics committees]. Available in: Guilhem D, Prado MM, et al. Capacitação para comitês de ética em pesquisa. V. II. Brasília: Ministério da Saúde, [Strengthening research ethics capability for members of research ethics committees]. Available in:

Angelica´s activities Research ethics committee: Assistant chair Reviewing protocols Developing and implementing the updated guidelines for the NIPH Teaching Research Ethics (2004) Master and Doctorate degree Meeting coordinator: 1 course (2005) 1 workshop (2006)

Angelica´s activities Book chapter: For an ethical practice, with Asuncion Alvarez & Alberto Lifshitz (As part of a project related to increase the professional competencies in undergraduate medical students). Articles (2007): Witnesses in the informed consent process – Legal or ethical requirement? With Veronika Wirtz & César Lara-Álvarez. Accepted in Developing world bioethics. (indexed to the current contents). Mexicos Agreement with the Tobacco Industry, with Ruth Macklin (sending for potential publication).

Angelica´s activities Articles: Nurses as part of the research team, with Dirce Guilhem, Mario Salinas & Alejandra Maglio, in process of sending to publication Argentina, Brazil & Mexico and the defense of a single standard of attention,with Dirce Guilhem, Alejandra Bello & Mario Salinas. Revista de Investigación Clínica, 2004 (indexed to the current contents).