Evaluation of the functionality of the reports of the Council for International Organizations of Medical Sciences (CIOMS) in ethics committees, in research in Mexico City

Authors

  • María De la Luz Casas
  • Diana Lammoglia Alatriste

DOI:

https://doi.org/10.18270/rcb.v10i1.680

Keywords:

bioethics, research, committees, ethics, adverse event, CIOMS

Abstract

Scientific and technological advances are key for the development of new medicines and technologies. Particu-larly in medicine, it is necessary to generate knowledge that will improve the probability of success. All proto-col should be authorized by the ethics research council, and its monitoring should be especially referred to the presentation of adverse and undesirable affects that should be valued, to guarantee an adequate risk/benefit for the patient. The most recognized instrument in this field is the Council for International Organizations of Medical Sciences’ (CIOMS) report used worldwide by the pharmaceutical industry. The general objective of this study consists in evaluating the functionality of the CIOMS report in committees in Mexico City, through a questionnaire validated by experts and applied to a sample of investigators and members of committees. The results show that this reports continue to be functional in some 80.5%, although 54.5% of the surveyed suggest the creation of a new instrument, with characteristics that the current one does not have. Nonetheless, it is evidenced that the CIOMS reports continues to be efficient, although with room for improvement.

Downloads

Download data is not yet available.

References

BANKOWSKI, Z. y HOWARD-JONES, N. (Edit).

Human Experimentation and Medical Ethics. Proceedings

of the XVth CIOMS Round Table Conference,

Manila, 13-16 September 1981. Geneva: Council for

International Organizations of Medical Sciences.

BRODY, Howard. Hooked: Ethics, the Medical Profesion,

and the Pharmaceutical Industry. Lanham

(MD): Rowman & Littlefield Plublishers, 2011.

BUERKI, Robert y VOTTERO, Louis. Pharmacy

Ethics: A Foundation for Professional Practice. Washington:

American Pharmacists Association, 2013.

CASAS M., María De la Luz. Bases bioéticas en la

toma de decisión. México: Trillas, 2008.

CIOMS. International Ethical Guidelines for Biomedical

Research Involving Human Subjects. [En línea].

[Fecha de consulta 15 de abril de 2013]. Disponible

en www.cioms.ch

CÓDIGO DE NÚREMBERG. [PDF]. [Fecha de consulta

de enero de 2014], Disponible en http://

www.conbioetica-mexico.salud.gob.mx/descargas/

pdf/normatividad/normatinter nacional /2.INTL._

Cod_Nuremberg.pdf

COFEPRIS. Comisión Federal para la protección

contra riesgos sanitarios. México, D. F. [En línea].

[Fecha de consulta 15 de enero de 2014]. Disponible

en http://www.cofepris.gob.mx/Paginas/Inicio.

aspx

COFEPRIS. Guía de Farmacovigilancia para el Reporte

de Eventos Adversos en Investigación Clínica.

México D.F. [PDF]. [Fecha de consulta 20 de mayo

. Disponible en www.cofepris.gob.mx

CONBIOÉTICA. Reuniones Nacionales. [En línea].

[Fecha de consulta 20 de noviembre de 2014]. Disponible

en http://www.conbioetica-mexico.salud.

gob.mx/interior/perfilesceb/reu nionesnacionales.

html

DECLARACIÓN DE HELSINKI DE LA ASOCIACIÓN

MÉDICA MUNDIAL. [PDF]. [Fecha de consulta

de enero de 2014]. Disponible en www.

wma.net/es/30publications/10po licies/b3/17c_

es.pdf

GOLDACRE, Ben. Bad Pharma: How Drug Companies

Mislead Doctors and Harm Patients. London:

HarperCollins, 2013.

KARLBERG, Johan y SPEERS, Marjorie A. (Edits).

Revisión de ensayos clínicos: una guía para el Comité

de ética. Hong Kong: Universidad de Hong Kong,

, p. 59. [PDF] [Fecha de consulta 12 de noviembre

de 2014]. Disponible en http://www.pfizer.com/

files/research /research_clinical_trials/ethics_committee

_guide_spanish.pdf

MÉXICO. CONGRESO GENERAL DE LOS ESTADOS

MEXICANOS. Ley General de Salud. Artículo

Bis. Diario Oficial de la Federación. [En

línea]. [Fecha de consulta 13 de mayo de 2013].

Disponible en http://dof.gob. mx/notadetalle.

php?codigo=5224260&fecha =14/12/2011

________. SECRETARÍA DE SALUD Guía nacional

para la integración y el funcionamiento de los Comités

de Ética en Investigación. [PDF]. [Fecha de consulta

de abril de 2014]. Disponible en http://www.

conbioetica-mexico.salud.gob.mx/descargas/pdf /

registrocomites/Guia_CEI.pdf

________. Norma Oficial Mexicana NOM-220-

SSA1-2002. Instalación y operación de la farmacovigilancia.

[En línea]. [Fecha de consulta 20 de mayo

de 2013]. Disponible en http://www.salud.gob.mx/

unidades/cdi/nom/220ssa102.html

NHS. HEALTH RESEARCH AUTHORITY. SUSAR.

[En línea]. [Fecha de consulta 13 de mayo de 2013].

Disponible en http://www.hra.nhs.uk/news/dictionary/

susar/

OMS. Operational Guidelines for ethical committees

that review biomedical research. [PDF]. [Fecha de

consulta 24 de agosto de 2013]. Disponible en

http://www.who.int/tdr/ publications/documents/

ethics.pdf

VEATCH, Robert y HADDAD, Amy. (Edit). Case

Studies in Pharmacy Ethics. New York: Oxford University

Press, 1999.

WHITE, Bruce. Drugs, ethics and quality of life.

Published

2015-10-22

How to Cite

Casas, M. D. la L., & Lammoglia Alatriste, D. (2015). Evaluation of the functionality of the reports of the Council for International Organizations of Medical Sciences (CIOMS) in ethics committees, in research in Mexico City. Revista Colombiana De Bioética, 10(1), 9–23. https://doi.org/10.18270/rcb.v10i1.680