Investigação em Humanos: Assuntos Metodológicos, Éticos, e Legais Fundamentais para Ensaios Clínicos
Código
21244
Unidade Orgânica
Faculdade de Ciências Médicas
Créditos
4,5
Professor responsável
Michael E. Drues
Língua de ensino
Inglês
Objectivos
By the end of this course, the student will be able to describe the scope, breath and depth of the clinical trials field and gain an appreciation of where we are today and what the future may hold.
Pré-requisitos
Os exigidos para a frequência de um programa de mestrado da Faculdade de Ciências Médicas.
Conteúdo
Issues related to human experimentation are explored, including both methodological issues and the ethical, clinical, and financial repercussions. The limitations and problems of clinical trials with a discussion of particular effects and results that may occur in certain study designs and the lack of studies on the treatment of symptoms and the need to consider endpoints other than cure will be presented. Ethical issues, such as selective reporting of clinical research and informed consent and protection of research participants in domestic and international clinical trials, will also be considered.
Bibliografia
Due to the timeliness of the information presented in this course, no textbook per se will be used. However, there is a course manual available which contains much of the information, supplemental handouts and articles which will be used throughout this course. The course manual is not required but it is strongly recommended. For NEU students, the course manual is available only thru the NEU bookstore.
Método de ensino
Ensino a distancia (E-learning) e workshops.
Método de avaliação
Apresentação de projectos e testes de avaliação