Research Ethics Committee for Medicinal Products (CEIm)

• Well-designed and properly conducted Clinical Trials (CTs) involving medicines are considered the best scientific tool available to us for demonstrating the efficacy of a new prophylactic, diagnostic or therapeutic measure.

• However, research involving human subjects must be reconciled with the protection and safeguarding of the rights of research subjects. For this reason, and following public awareness of the experiments carried out by Nazi doctors in concentration camps during the Second World War, a series of documents were drawn up (first the Nuremberg Code -1947-, followed by the Declaration of Helsinki -1964- and the Belmont Report -1978-) which were accepted as recommendations, but whose principles were subsequently incorporated into legally binding regulations by the various Health Authorities.

• Decree 39/1994 of 28 April, issued by the Governing Council, regulating the powers of the Community of Madrid in the field of Clinical Trials involving medicines, establishes, in Title III, the conditions for the accreditation of Research Ethics Committees for Medicines in the Community of Madrid, as well as their operating rules and other standard operating procedures, in accordance with the provisions established. The entry into force of Royal Decree 1090/2015 of 4 December, regulating Clinical Trials involving medicines, which incorporates into national legislation the provisions contained in Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014, entails the necessary updating and modification of the standard operating procedures of the CEICs.

• Law 14/2007 of 3 July on biomedical research provides a new legislative framework for all research processes involving humans, the authorisation and monitoring of which are entrusted to Research Ethics Committees. Their functions are assumed by the existing Research Ethics Committees for Medicines until those provided for in the Law are established. Both of the aforementioned legal texts expressly establish the need to comply with the rules of Good Clinical Practice.

Composition and structure

• Members were selected from among the professionals who voluntarily submitted their applications, in accordance with the Standard Operating Procedures established by the Committee. The Chair, Vice-Chair and Secretary were elected by majority vote.

• Committee re-accredited on 24 July 2024 by the Subdirectorate-General for Pharmaceutical Inspection and Regulation of the Ministry of Health of the Community of Madrid.

CURRENT COMPOSITION OF THE CEIm

Calendar and Report