Los ensayos clínicos en colectivos vulnerables en el Reglamento 536/2014 Clinical trials on vulnerable groups in Regulation 536/2014

Authors

  • Miguel Vieito Villar Máster en Derecho – Doctorando en Derecho Grupo de análisis jurídico-económico Universidad de Santiago de Compostela

DOI:

https://doi.org/10.14195/1647-6336_14_9

Keywords:

Clinical trials, vulnerable groups, persons with disabilities, minors

Abstract

The new Regulation (EU) No 536/2014 will define, after it enters into force, the new legal framework for biomedical research in Europe. One of its main features is to develop a harmonized system of protection in respect of vulnerable groups, beyond articles 4 and 5 of the current Directive. In this new scenario, chaired by non-discrimination and individualization of care, we will witness a greater detail in the safeguards and protections for the elderly, persons with disabilities, minors, pregnant or nursing women, and people in confinement.

http://dx.doi.org/10.14195/1647-6336_14_9

Downloads

Download data is not yet available.

Downloads

Published

2015-02-01

How to Cite

Vieito Villar, M. (2015). Los ensayos clínicos en colectivos vulnerables en el Reglamento 536/2014 Clinical trials on vulnerable groups in Regulation 536/2014. Debater a Europa, (14), 223-242. https://doi.org/10.14195/1647-6336_14_9

Issue

No. 14 (2016): Europe, Pharmacy, Medicine

Section

Articles

License

Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows sharing the work with recognition of authorship and initial publication in Antropologia Portuguesa journal.