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Mental Capacity Act 2005 – transitional arrangements

Under the Mental Capacity Act 2005, where “intrusive research” is to be carried out in England or Wales involving participants who are unable to consent for themselves, the research requires the approval of an “appropriate body” under Section 30 of the Act.   This approval must be sought from a NHS Research Ethics Committee.
Where a research project started with ethics committee approval before the Act came into force, i.e. prior to 1 October 2007, the research has until 1 October 2008 to obtain approval under Section 30.

Researchers to whom this applies are encouraged to submit their applications to NHS RECs as soon as possible, and no later than 1 June 2008, in order to ensure that final approval can be given before 1 October 2008.  Any intrusive research continuing after 1 October 2008 without Section 30 approval will be unlawful.

Guidance on applying for Section 30 approval. (For information this links to NRES guidance on research involving adults unable to consent for themselves (incorporating guidance on the Mental Capacity Act 2005) (pdf) at the research ethics website.

Ethical review of research tissue banks – transitional arrangements
New arrangements for ethical review of research tissue banks (RTB) were introduced on 1 October 2006. These arrangements allow a NHS Research Ethics Committee to give “generic ethical approval” for the activities of a bank, extending to individual research projects using samples from the bank within agreed terms and conditions.

Under the new arrangements, any ethical approval issued to a RTB by a NHS Research Ethics Committee prior to 1 October 2006 will expire on 30 September 2008. 

Managers of RTBs who wish to have continuing NHS REC approval for their activities and research programmes should therefore consider making a fresh application as soon as possible and by no later than 1 June 2008 to allow for approval to be in place by 1 October 2008

Applications for ethical review of RTBs are voluntary.  In England, Wales and Northern Ireland, any tissue bank holding “relevant material” under the Human Tissue Act must hold a storage licence for research from the Human Tissue Authority. Ethical review for the bank is not a legal requirement and is complementary to the licensing scheme. However, where a bank is not ethically approved, researchers receiving samples from the bank and storing them on unlicensed premises would legally require separate ethical approval.

Applications may be made either in the new Integrated Research Application System or using the existing NRES application form system.

Detailed guidance on completion of the application form is available by clicking on the information buttons next to each question.

More information

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