III. THE ROLE OF THE RESEARCH ETHICS COMMITTEES IN THE REGULATION OF PHARMA-SPONSORED STUDIES.
Rev Invest Clin
; 71(5): 297-305, 2019.
Article
en En
| MEDLINE
| ID: mdl-31599878
ABSTRACT
Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos como Asunto
/
Comités de Ética en Investigación
/
Industria Farmacéutica
Límite:
Humans
Idioma:
En
Revista:
Rev Invest Clin
Asunto de la revista:
MEDICINA
Año:
2019
Tipo del documento:
Article
País de afiliación:
México