Summary
Biomedical research: guidance on how to take the first research steps
Riba i García N, Gómez Pérez B
Affiliation of the authors
Servicio de Farmacología Clínica- UASP, Hospital Clínic, Barcelona, Spain. Servicio de Farmacia, Hospital Clínic, Barcelona, Spain.
DOI
Quote
Riba i García N, Gómez Pérez B. Biomedical research: guidance on how to take the first research steps. Emergencias. 2015;27:55-61
Summary
The expanding body of regulations that affect biomedical research both in Spain and the rest of Europe have led to an increasing amount administrative work for obtaining approvals before a study can start. The complexity of the requirements will depend on the study design: clinical trials with medicines or other health care products are subject to the most highly developed regulations, whereas those affecting studies of noninvasive procedures are
less complex. Between the 2 extremes, a range of requirements can complicate the clinical researcher’s task. In this article we seek to provide instructions according to the type of study being planned and to explain relevant legislation.