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 study team carrying out the research; but the Witness should not be the same person who is also 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 the requirement for Witness is allowed where the research study –
(a) is not invasive; is not interventional; and is not restricted human biomedical research (rHBR).
(b) is interventional, but is no more than minimal risk; and subject is able to read/sign the consent form; and is not rHBR. [Item (b) is applicable for TB protocols under HTF.]
Note:Research that comprises solely of a survey or collection of information from research subjects is treated as not invasive and not interventional.
The latest Informed Consent Form template can be found on our Forms page.