Requirements for obtaining ethical approval
According to chapter III of the Royal Decree 223/2004, each institution planning to carry out clinical trials must have approval from an Ethics Committee (EC). The ECs of each institution are accredited by the health authority of each of Spain’s 17 autonomous regions, and have to be notified to the Spanish Agency of Medicine and the Coordination Centre of Ethics Committees (Privireal 2005).
According to article 10 of the Royal Decree 223/2004, the ethics committees shall examine the methodological, ethical and legal aspects of the clinical research projects they receive for review (Romeo-Casabona and Nicolas 2005: 238). Hence, ethical committees’ approval is necessary for both the legal and ethical authorisation of the clinical research conducted. The legal sustainability of the research is the first criterion to be considered within the examination, but the committees may also choose to reject lawful activities on the basis of a breach of ethical principles. On this basis, Romeo-Casabona and Nicolas concludes that the linkage of the decisions of the ethics committees to the law is total (2005: 239).
Serious administrative infractions to the research review system will result in sanctions and financial penalties (cf. Article 8 and 9 of the Royal Decree 223/2004).
There are no established system for obtaining ethical review of research conducted in other scientific fields of research than medicine, but the established criteria in the health legislation must be followed in other disciplines as well (Romeo-Casabona and Nicolas 2005: 233).
Conditions for ethical approval of health research
According to the LOPD, the Royal Decree 223/2004 and Law 41/2002 on Respect for the Patient’s Autonomy, these main principles should be respected in medical research:
- The necessity to obtain the expressed consent of the data subject for the use of health data;
- Provide information on the conditions of data treatment;
- The obligation of confidentiality;
- Fulfillment of security requirements in relation to the processing of personal data;
- The recognition of the right of the data subject to access their data at any moment and the right to cancel them (Romeo-Casabona and Nicolas 2005: 243).
The ethics committees oversee the compliance with these rules in order to approve research projects, and may reject a project if respect to these principles is not guaranteed (ibid.).
Research ethics committees
The Clinical Research Ethics Committees (Comités de Ética en Investigación Clínica, CEIC) are independent bodies, consisting of health professionals and non-medical members whose responsibility to protect the rights, safety and welfare of human subjects involved in clinical research projects. Currently there are over 140 CEICs in Spain (Lanzerat).
There are also ethics committees in Universities and public research organisations in Spain. The ethics committees of the Universities gather around a network called “Network of Ethics Committees in Universities and Public Research Centres in Spain” (Red de Comités de Ética de Universidades y Organismos Públicos de Investigación de España, RCE), consisting of 45 committees that hold regular meetings since 2002 (RCE website).
There must be at least 9 members of an ethics committee, including a doctor, a clinical pharmacologist and a pharmacist from the hospital where the committee is based. Two of the members must not belong to the medical professions, and one of these two must be a lawyer (Privireal 2005b).
Case 1: University of Barcelona:
University of Barcelona has four specific ethics committees that ensure that the experimental design of the research is in line with current legislation and ethical standards:
1. University of Barcelona Bioethics Committee (CBUB)
2. Animal Experimentation Ethics Committee (CEEA)
3. Clinical Research Ethics Committee of the Hospital Clinic de Barcelona (CEIC Hospital Clinic)
4. Clinical Research Ethics Committee of the Ciutat Sanitària de Bellvitge (CEIC Bellvitge) (University of Barcelona website).
The Royal Decree 223/2004 clinical trials (in Spanish):
Network of Ethics Committees in Universities and Public Research Centres in Spain” (Red de Comités de Ética de Universidades y Organismos Públicos de Investigación de España, RCE):
Spanish Agency of Medicine (AEMPS, Agencia Estatal adscrita al Ministerio de Sanidad)):
The Coordination Centre of Ethics Committees (El Centro Coordinador de los Comités Éticos de Investigación Clínica):
LOPD. Organic Law 15/1999 of 13 December on the Protection of Personal Data (LOPD). Agencia Española de Protección de Datos (AEPD). [Online]. Unofficial English translation available at: http://www.agpd.es/portalwebAGPD/english_resources/regulations/common/pdfs/Ley_Orgaica_15-99_ingles.pdf, [accessed 17.07.2014].
Privireal 2005. “Spain: RECs and medical research”. Privireal: Privacy in Research Ethics and Law. [Online]. Available at: http://www.privireal.org/content/rec/spain.php, [accessed 17.07.2014].
Lanzerat, Dirk. “Clinical Research Ethics Committees in Spain”. European Network of Research Ethics Committees (EUREC). [Online]. Available at: http://www.eurecnet.org/information/spain.html, [accessed 17.07.2014].
RCE website. “Introduction”. Red de Comités de Ética de Universidades y Organismos Públicos de Investigación de España, (RCE). [Online]. Available at: http://www.ub.edu/rceue/index2.htm, [accessed 17.07.2014].
University of Barcelona website. “Ethics and Research”. University of Barcelona. [Online]. Available at: http://www.ub.edu/web/ub/en/recerca_innovacio/recerca_a_la_UB/etica_recerca/etica_recerca.html, [accessed 17.07.2014].
Romeo-Casabona, Carlos Maria and Nicolas, Pilar, 2005. “Research Ethics Committees in Spain”, in Research Ethics Committees, Data protection and medical Research in European Countries, D. Beyleveld, D. Townend and J. Wright (eds.). Aldershot, Burlington: Ashgate. Pp. 233-244.