Standard Application Form For The Ethical Review Of Health-Related Research Studies, Which Are Not Clinical Trials Of Medicinal Products For Human Use As Defined In S.i. 190/2004 Page 7
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24Version 5.5
May 2011
Office Use:
-
REC Reference No:__________
SECTION C3
ADULT PARTICIPANTS - CAPACITY
C3.1 (a) Will all adult research participants have the capacity to give
informed consent?
Yes / No / Non-Applicable
C3.1 (b) If no, please elaborate.
Answer
C3.1 (c) If no, is this research of such a nature that it can only be
carried out on adults without capacity?
Yes / No
C3.1 (d) What arrangements are in place for research participants
who may regain their capacity?
Answer
SECTION C4
PARTICIPANTS UNDER THE AGE OF 18
C4.1
(a) Will any research participants be under the age of 18 i.e.
Children?
Yes / No
C4.1 (b) If yes, please specify:
Persons < 16
Yes / No
Persons aged 16 – 18
Yes / No
Children in care
Yes / No
C4.2 Is this research of such a nature that it can only be carried out
on children?
Yes / No
C4.3 Please comment on what will occur if the researcher discovers
that a child is at risk during the course of this study?
Answer
C4.4 Will each child receive information according to his/her capacity
of understanding regarding the risks and benefits of the study?
Please elaborate and provide copies.
Answer
C4.5 Will the explicit wish of the child who is capable of forming an
opinion and assessing information to refuse to participate or to be
withdrawn from the study be considered by the lead investigators, co-
investigators and principal investigator?
Please elaborate.
Answer
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