SSStudyParticipantsVulnerablePopulation object

Yes
No explicit provisions in national legislation

For all research other than clinical trials, a person must be over the age of 18 years in order to provide consent to participate in research. It is strongly recommended that expert advice is sought where the research study involves persons between the age of 16-18 years.

Further guidance on the specific provisions which apply to the types of research that can be performed in minors is provided in Section 3 of HSE National Consent Policy Part 3 Research. The guidance also provides further information on the matter of consent.

In accordance with S.I No. 252/1994, as amended by S.I No. 110 of 2009, all clinical investigations must be carried out in accordance with the Helsinki Declaration, including those measures relating to the protection of human subjects, such as informed consent.

Yes
No explicit provisions in national legislation

In accordance with S.I No. 252/1994, as amended by S.I No. 110 of 2009, all clinical investigations must be carried out in accordance with the Helsinki Declaration, including those measures relating to the protection of human subjects, such as informed consent. Outside of clinical trials, there is currently no specific legal provision(s) for the participation of an incapacitated person in research. The HSE National Consent Policy recommends that, in the absence of legislation, as a matter of best practice the same principles as those which apply to clinical trials should be applied. This means that consent for participation in any form of research on behalf of an incapacitated person must be obtained from the person's legal representative. However, this approach does not have a legislative/legal basis. Further guidance is available in Section 4 of HSE National Consent Policy Part 3 Research. The proposed approach should be clearly detailed in the ethics application.

Yes
No explicit provisions in national legislation

In accordance with S.I No. 252/1994 , as amended by S.I No. 110 of 2009 (www.irishstatutebook.ie), all clinical investigations must be carried out in accordance with the Helsinki Declaration, including those measures relating to the protection of human subjects, such as informed consent.

Outside of clinical trials, there is currently no specific legal provision(s) for subjects in emergency situations. However, guidance is given in Section 5.1.of HSE National Consent Policy Part 3 Research, regarding the handling of consent in such situations and the type of research that can be performed. Reference should also be made to the Helsinki Declaration, as required by national legislation. The proposed approach should be clearly detailed in the ethics application.

No explicit provisions in national legislation

No explicit provisions in national legislation

There is no specific legal provisions dealing with pregnant or lactating women. Ethics Committees should be informed if pregnant or lactating women are proposed to be recruited to a study.

Section 3-5 of HSE National Consent Policy Part 3 Research