Anne Ferris (Wicklow, Labour)
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Question 475: To ask the Minister for Health if standardised operating procedures are in place for all research ethics committees; the procedures in place for appointing members to these committees; and if he will make a statement on the matter. [24517/11]

Róisín Shortall (Dublin North West, Labour)
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Clinical trials of medicinal products for human use are currently regulated by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004. The operating procedures of clinical trials ethics committees are set out in Schedule 2 of these Regulations. These committees are required to be independent, consisting of healthcare professionals and lay members and to have responsibility to protect the rights, safety and wellbeing of human subjects involved in a trial. There are currently 13 research ethics committees approved under the regulations.

In addition, the Health Information Bill, which is currently being drafted, will facilitate a standardised approach in regard to research ethics committees dealing with research, other than clinical trials. The Bill will provide for the approval of committees by the Health Information and Quality Authority (HIQA) and for procedural matters, including the appointment of members.