Consent arrangements: Adults unable to give consent

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Three pieces of legislation in the UK cover the involvement of adults unable to consent for themselves in research.

  1. UK Clinical Trials Regulations 2004, and Amendment Regulations 2006 – for more information on the Clinical Trials Regulations please visit the Clinical Trials Toolkit
  2. Adults With Incapacity (Scotland) Act 2000
  3. Mental Capacity Act 2005

The Human Tissue Act 2004, refers to these pieces of legislation to make provision for appropriate consent from adults unable to consent for themselves.

The MRC has developed guidance on the requirements of these pieces of legislation and how they relate to each other (see 1st resource below).

The HRA and the MRC Regulatory Support Centre have worked in partnership to develop online consent and participant information sheet preparation guidance (see resource 2). Including guidance on adults who are not able to consent for themselves.  The HRA have also produced guidance on the Mental Capacity Act and involving adults unable to consent for themselves in research. (3rd resource below).

It's worth noting that there are specific Research Ethics Committees that review these projects, the NHS Research Ethics Committee Central Booking Service should be used when the project involves adults unable to consent for themselves.