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.)
Annex XVI (16) DL 145/2009 (pt) and Article 7 Law 21/2014 (pt)
Yes
Special provisions apply
Special provisions apply
No national legal framework available
Clinical investigations 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
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
Annex XVI (16) & (17) DL 145/2009 (pt) and Art 7 & 8 Law 21/2014 (pt)
