Conditions

1. "The Committee would like written clarification in a cover letter on
headed paper as to whether research staff will be members of the
clinical team or not."
==> for cover letter

2. "The Committee would like written confirmation in the aforementioned
cover letter on headed paper, that the use of deferred consent in
Scotland will be removed and that any reference to deferred consent
will also be removed from the paperwork for Adults With Incapacity
(AWI)."
==> amended in protocol

3. "The Committee would like written confirmation in the aforementioned
cover letter on headed paper, that the PIS & Consent Form for
Parent/Guardians of 16-18 year olds will not be used in Scotland and
that the Guardian/Welfare Attorney/Closest Relative PIS will be used
for this age group."
==> not mentioned directly in protocol; for cover letter

4. "The Committee would like written confirmation in the aforementioned
cover letter on headed paper, that there will be no use of
Professional Legal Representatives in Scotland and that any
reference to a Professional Legal Representative, will be removed
from the AWI paperwork."
==> not mentioned in protocol/PIS; for cover letter

5. "As per the AWI (Scotland) Act 2000, those seeking consent must
ensure that they put aside their own feelings and wishes and
consider what the past and present, feelings and wishes of the
person they are consenting on behalf of, would have been, had they
been able to consent for themselves."
==> amended in relevant PIS

6. "The PIS refers to patients being re-consented should they regain
capacity whilst in the study, but no Recovered Capacity PIS or
Consent Form were submitted for review."
==> new PIS and consent form created (regainedcapacity_consent and regainedcapacity_pis)

Recommendations

1. "It is the opinion of the Committee that it is always beneficial and
reassuring for participants, to know that they can contact someone to
talk to, who is not connected to the study should they wish to do so.
At present there are no details provided of an Independent Person
(someone who is independent from the study)."
==> included field for this in PIS/consent forms - to be populated.

2. "In Scotland, Children over the age of 12 who are deemed to have
capacity can consent on their own behalf, but the Committee noted
that there is a Signature line on the Assent form for under 12’s. The
Committee would like to suggest that the researchers consider
changing this to a name line, for the child to write their name rather
than have a signature line."
==> amended in 12to16_assent_2.0.docx