SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Minors aged above 16 years: Informed consent must be obtained from the minor and his his legal representative.
Minors aged less than 16 years: the representative is the sole responsible for grating informed consent, although it must reflect the presumed will of the minor.
(The concerned EC is given the right, under exceptional circumstances, to waive the requirements of informed consent and informing the minor patients in clinical studies without intervention. The assigned ethic committee is given the same right for adults unable to provide informed consent).
Yes
Special provisions apply
Special provisions apply
No national legal framework available
Clinical trials involving subjects in emergency situations are not explicitly mentioned in Portuguese law.
However, the same standards apply as for investigations with minors and incapacitated persons.
Any provisions on the protection of human subjects must conform to the spirit of the Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, and all phases of clinical investigations must be conducted in that spirit, from first consideration of the need and justification of the study to publication of results.
No national legal framework available
Special provisions apply
No national legal framework available
Clinical trials involving pregnant or lactating women are not explicitly mentioned in Portuguese law.
However, the same standards apply as for investigations with minors and incapacitated persons.
Any provisions on the protection of human subjects must conform to the spirit of the Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, and all phases of clinical investigations must be conducted in that spirit, from first consideration of the need and justification of the study to publication of results.
Yes
ADDITIONAL PAEDIATRIC INFORMATION
LEGAL AGE OF CONSENT:
18 years
MANDATORY / SUGGESTED AGE RANGES DEFINED FOR ASSENT:
Case 1: <5 years; Case 2: 16< years>=5; Case 3: >=16 years
Specifications regarding assent: >12, but the investigator decides about the maturity of the child
NUMBER OF REQUIRED SIGNATORIES:
Case 1: both parents/legal tutor (1 document); Case 2: assent from child and consent from both parents/legal tutor (2 documents); Case 3: consent from child and both parents/legal tutor (1 document)
OFFICIAL LANGUAGE OF INFORMED CONSENT:
Portuguese and adapted to the age of the child
INFORMATION ON MATERIAL USED TO DESCRIBE THE CLINICAL TRIAL TO THE MINOR:
Different models should be used for child assent in the different age groups: 5-11 and 12-15.
ADDITIONAL INFORMATION (INCLUDING REFERENCE FOR TEMPLATE):
• From 12-15 years: when the assent from the child is required and the investigator decides about their maturity, a signed declaration from the investigator should be added assuring that clear and adapted information was provided and understood by the child about the clinical trial and all the procedures and risks.
• Reference legislation:
Recommendation from National Ethical Committee (CEIC) entitled: "Documento Orientador CEIC sobre Consentimento Informado (CI) para participação em ensaios clínicos em pediatria ", written in Portuguese and accessible on CEIC website
• IC template(s) / guidelines / information sources
Recommendations by National Ethical Committee for Clinical research (CEIC); Clinical research national Law 21/2014, 14 April 2014; Ethical considerations for clinical trials on medicinal products conducted with minors (18 September 2017); ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population (28 Feb 2018); Regulation (EC) No 1901/2006 of the European Parliament and of the Council (12 December 2006)
SOURCE(S):
https://www.ceic.pt/documentos-orientadores
https://www.ceic.pt/web/ceic/legislacao-especifica
