National Research Ethics Service

Consent guidance

Informed consent

DH consent home page
(External link)
Informed consent in CTIMPs
NRES information paper on informed consent in clinical trials of investigational medicinal products
Language and ExclusionHow should RECs consider and decide about the inclusion or exclusion of participants in research who may have difficulties in adequate understanding of English?
Making written information easier to understand for people with learning disabilitiesGuidance for people who commission or produce Easy Read information – Revised Edition 2010.

Patient information sheets and consent forms

Information sheet and consent form guidance
NRES guidance on information sheets and consent forms
Making written information easier to understand for people with learning disabilitiesGuidance for people who commission or produce Easy Read information – Revised Edition 2010.

Adults unable to consent for themselves

Adults lacking capacity – on-line toolkit An on-line toolkit on research involving adults lacking capacity to consent for themselves. The toolkit covers the provisions of the Mental Capacity Act 2005 and the separate provisions for medicinal trials under the Medicines for Human Use (Clinical Trials) Regulations 2004. It includes a specific module on research in emergency medicine.
Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002
(Pdf - external link) Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002.
Adults with Incapacity (Scotland) Act 2000
(External link) Adults with Incapacity (Scotland) Act 2000
DH Mental Capacity Act 2005 guidance page
(External link) Department of Health Mental Capacity Act 2005 guidance page
Guidance on nominating a consultee for research
Guidance on nominating a consultee for research involving adults who lack capacity to consent. (External link to DH)
Informed consent in CTIMPs
NRES information paper on informed consent in clinical trials of investigational medicinal products
MCA1 - Supplementary Information Form
MCA1 - Supplementary Information Form for approval under Section 30 of the Mental Capacity Act
MCA2 - Supplementary Information Form for approval
MCA2 - Supplementary Information Form for approval under Section 34 of the Mental Capacity Act
Mental Capacity Act 2005
Mental Capacity Act (MCA) 2005
Mental Capacity Act 2005 (Loss of Capacity during Research Project) (Wales) Regulations 2007
(External link) Mental Capacity Act 2005 (Loss of Capacity during Research Project) (Wales) Regulations 2007
Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007 (External link) The Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007
Mental Capacity Act 2005 Questions and Answers
Questions and answers on the Mental Capacity Act 2005, including principles, scope of the research provisions, applying for approval under the Act, approval criteria, consultees, loss of / regaining capacity during research.
Mental Capacity Act Code of Practice
(External link) Mental Capacity Act Code of Practice
Mental Capacity Act Factsheet for Social ScientistsMental Capacity Act Factsheet for Social Scientists
Section 30 approval criteria
Criteria for approving research under sections 30-33 of the Mental Capacity Act 2005
Section 34 approval criteria
Criteria for approving research under section 34 of the Mental Capacity Act 2005