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Minors’ consent to clinical trials discussed

The consultation was referenced at the April meeting of the HPRA Management Committee, minutes of which were seen by the Medical Independent (MI) following a Freedom of Information request.

A spokesperson for the HPRA confirmed to MI that the talks are ongoing and taking place against the backdrop of new clinical trials legislation to be introduced across the EU in the coming time period.

“The revised HSE national consent policy was published in 2017, and it refers to consent for the participation of minors in research,” the spokesperson said.

“The approval of clinical trials, and their subsequent monitoring for good clinical practice, falls within the remit of the HPRA. The HPRA is consulting with the Department on the interpretation of the clinical trials legislation in relation to consent for minors’ participation in clinical trials.   

“Policy in this area is a matter for the Department of Health and HSE.  New clinical trials legislation will be introduced across the EU and will require national implementation via legislation. This legislation is likely to address consent.”

A Department of Health spokesperson referred MI’s queries regarding these discussions to the HPRA.

According to the HSE national consent policy, “for the purposes of participation in clinical trials, anyone over the age of 16 years can consent on his/her own behalf. For all other research, the person must be over the age of 18 years in order to provide consent.

“Children should not be denied the possible benefits of research participation but instead should be afforded the opportunity to participate in research on matters that might affect them. 

“Neither should children be exploited or inappropriately enrolled in research because they lack the capacity to consent to participation.”

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