Any appropriate consent taking for studies under HBRA must be taken in the presence of a Witness–
(a) who is 21 years of age or older;
(b) who has mental capacity; and
(c) who must not be the same individual taking the appropriate consent.
Note: The Witness may be a member of the team carrying out the research of which the individual giving the consent is a research subject, but the Witness should not be the same person who is taking the consent.
The Witness must take reasonable steps to ascertain –
(a) the identity of the individual giving the appropriate consent; and
(b) that the consent was given voluntarily without any coercion or intimidation.
Exemption from requirement for Witness where the research is –
(a) not invasive;
(b) not interventional; and
(c) not restricted human biomedical research (rHBR).
Note 1:Research that comprises solely of a survey or collection of information from research subjects is treated as not invasive and not interventional.
Note 2:Requirement for witness does not apply to any consent taken before 1 Nov 2017.
The latest Informed Consent Form template can be found on our forms page.