CASE REPORTS
Research nurse: new duties related to clinical trials. Experience of clinical research in oncovirology in Bahia/Brazil
Milena Bastos; Estela Luz
The clinical research can be defined as all investigation processes involving human beings to search new knowledge about drugs, procedures and methods solving problems to prevent, diagnose or cure diseases. This relates ultimately with human protection. Ethics in research field matured enormously in the last 50 years, mainly after the II World War with the landmark Nuremberg Code. After this, followed 7 declarations from 1964 to 2000 from the WMA Declaration of Helsinki - Recommendations guiding physicians in biomedical research involving human subjects; Belmont's Report (1979) and the Common Rule; Code of Federal Regulations / ICH Guidelines (2000). In Brazil, there are 3 main ethics declarations: MS/RDC/196/96, 251/97 and 292/99. All those follow the international principles in research ethics. After implementation of that rules, Brazil has received an increasing support on clinical research, which has required an insertion of different professionals in the different parts of the studies. As a result, the research nurse figure is growing mostly because of their vision of the subject with singular requirements moreover their high clinical and administrative skills. Legislation, however, is not following the pace of changing and no specific rules are found in Brazil for the research nurse, differently from the US allows to the research nurse a wide range of clinical activities, including prescriptions of specific drugs. The research nurse must have good knowledge of clinics, managerial vision, logistic skills and to be a clever trader. Besides that, they must have a profound knowledge on research ethics and the scientific methodology helping the researchers to improve the study design and documentation. Their present formal activities ranges from monitoring, manager, study coordinator, data / drug controller to clinical assistant. In Bahia, in the last 3 years, we began to study patients with virus related malignancies, involving teams from infectious diseases, hematology and pathology departments. We as research nurses have centralized our activities in link the national and international institutions involved; locate possible patients after medical suspicion; speed diagnosis and patients acceptance of their pathology, comforting them; compile data of clinical and laboratory history; speed treatment; and in the maintenance of data and specimen bank.
Publication Dates
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Publication in this collection
06 Jan 2006 -
Date of issue
Oct 2005
