SSStudyParticipantsVulnerablePopulation object
Minors / Children - Studies allowed
Yes
Special provisions apply
Specific provision
A minor is defined as a person under the age of 16 years.
Incapacitated persons - Studies allowed
Yes
Special provisions apply
Legal framework / Reference (Incapacitated persons)
Schedule 1, Part 5 SI 190/2004
Emergency situations - Studies allowed
No explicit provisions in national legislation
Specific provisions
Studies including subjects in emergency situations are not explicitly mentioned in Irish legislation. However, clinical studies with incapacitated persons, who are unable by virtue of physical or mental incapacity to give informed consent, are possible under special provisions according to Schedule 1, Part 5 SI 190/2004.
Pregnant or breastfeeding women - Studies allowed
No explicit provisions in national legislation
Specific provisions
There are no specific provisions in national legislation. Ethics Committees should be clearly informed if pregnant or lactating women are proposed to be recruited to a study.
