Abstract

JARAMILLO-JIMENEZ, Miriam; DELGADO-TARAZONA, Paola  and  CAMPOS DE ALDANA, María Stella. Ethical Considerations of the Nursing Role in the Coordination of Clinical Studies. Rev Cuid [online]. 2011, vol.2, n.1, pp.230-235. ISSN 2216-0973.  https://doi.org/10.15649/cuidarte.v2i1.62.

Introduction: Worldwide, the research phenomenon on health areas is increasing, with the emergence of new clinical trial protocols, the society is being forced to ensure in a stricter way the safety of their patients who participate, comply with the legal, ethical and actual fundamental rights. This ensures compliance with the ethical principles throughout the development of a research study. This is where the Nurse clinical research coordinator, takes great importance by the nature of your profession, which is the care and your active participation in all processes that lead to the improvement and maintenance of health, recovery and rehabilitation of the disease. Materials and Methods: Through a search of the literature using the key words: bioethics, research and clinical studies, is presented an analysis of the major ethical foundations that are involved in the development of research, with emphasis on the discipline of nursing and coordination of clinical studies. Results: It was possible to observe that globally there are several tools that protect the integrity of the individuals who participate in clinical trials, the most important in our view are: The Nuremberg Code, the Declaration of Helsinki, Good Clinical Practice Guides, Nursing ethics codes and national regulation.It was found that there is worldwide controversy about the use of placebo; however there are specific recommendations that justify its use. Discussion and Conclusions: During the development of clinical studies, the nurse may be confronted with ethical dilemmas; it realizes the importance of the formation of competencies and skills that ensure assertive decision to established patient comfort and compliance with regulations. Hence it is recommended to conduct courses for the new knowledge of current regulations and Good Clinical Practice Guidelines.

Keywords : Ethics; Nursing; Research; Clinical Studies.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )