SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Yes
Special provisions apply
Yes
Special provisions apply
Special provisions apply
Yes
Special provisions apply
Royal Decree 1090/2015 (Articles 4, 5, 6, 7)
Yes
Royal Decree 1090/2015 (Articles 4, 5, 6, 7)
ADDITIONAL PAEDIATRIC INFORMATION
LEGAL AGE OF CONSENT:
18 years
MANDATORY / SUGGESTED AGE RANGES DEFINED FOR ASSENT:
0-11 years
12-17 years with own signature
NUMBER OF REQUIRED SIGNATORIES:
One parent
OFFICIAL LANGUAGE OF INFORMED CONSENT:
Spanish
INFORMATION ON MATERIAL USED TO DESCRIBE THE CLINICAL TRIAL TO THE MINOR:
The child must also receive information adapted to their age and mental maturity according to the European regulation.
ADDITIONAL INFORMATION (INCLUDING REFERENCE FOR TEMPLATE):
• Prior informed consent of the parents who hold custody or of the legal representative of the minor must be obtained, and the minor, if under 12 years of age, must be heard if the minor has sufficient judgment. The informed consent form of the parents shall be valid provided it is signed by one of them with the express or tacit consent of the other, which should be adequately documented, as stipulated in article 156 of the Civil Code. When the subject's condition allows, or in any case when the minor is twelve years of age or older, the subject must also give his/her consent to participate in the trial.
• Reference legislation:
o Royal Decree 1090/2015 (Real Decreto 1090/2015, de 4 de diciembre, por el que se regulan los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos)
o Law 29/2006 on Medicinal Products and MD
o Law 14/2007 (Ley 14/2007, de 3 de julio, de Investigación biomédica - in Title V Chapters I-IV)
o Royal Decree 1716/2011 (Real Decreto 1716/2011, de 18 de noviembre)
• IC template(s) / guidelines / information sources:
o The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); A state agency within the Spanish Ministry of Health, Social Services and Equality -> Medicines for Human use - > Clinical Research with Medicines
o The Ministry of Health, section about regulation of clinical trials:
o Royal Decree 1090/2015, of 4 December, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry (English version)
SOURCE(S):
http://www.aemps.gob.es/en/investigacionClinica/medicamentos/home.htm
http://www.aemps.gob.es/en/legislacion/espana/investigacionClinica/ensayos.htm
https://www.aemps.gob.es/legislacion/espana/investigacionClinica/docs/Royal-Decree-1090-2015_4-December.pdf
