Suggested formats of Patient / Participant Information Leaflet & Informed Consent
Document; Parent/Guardian Information Leaflet & Informed Consent Document / Assent
Form & Permission to access files/data base at hospital/clinic/schools etc.
PIC 1(a) Patient / Participant’s Information Leaflet & Informed Consent Form For Clinical
Medication Trial
PIC 1(b) Parent/Guardian Information Leaflet & Informed Consent Form For Clinical
Medication Trial
PIC 1(c) Assent Form For 7-18 Years For Clinical Trial / Intervention Research
PIC 2 Patient / Participant’s Information Leaflet & Informed Consent Form For A NonIntervention Study
PIC 3 Information Leaflet And Informed Consent For Educational, Health Systems Or NonClinical Operational Research
PIC 4 Patient / Participant’s Information Leaflet & Informed Consent For Anonymous
Questionnaires
PIC 5 Retrospective Records Research Information For Non-Clinical Trial / Non-Intervention /
Study Clinical Trial / Intervention Research (Permission to access files/data base at
hospital/clinic/ school etc)
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PICD = Patient / Participant Informed Consent Document
1.
The following PICD’s are presented to researchers as examples of suitable paragraphs for
inclusion in the specific study’s PICD. Researchers should closely examine the ambit of their
proposed research and with this in mind are invited to make appropriate alterations to the
examples where necessary.
2.
Note:
2.1
All of the instructions above the title on the proposed documents should be deleted
from the final submitted PICD.
2.2
Number pages to indicate the page number as follows: Page 1 of XXX, Page 2 of XXX,
etc.
2.3
Make the name and all contact details of the researcher and our Research Ethics
Committee clear and easy to find.
2.4
For genetic sub-studies, a separate PICD should be submitted:
 Explain what genetic testing means
 State explicitly that that only the relevant genetic testing regarding the
specific study disease will be done.
 State that bloods will be kept for no longer than 15 years.
 Explain how the blood samples will be destroyed.
2.5
Where emotional discomfort is caused by the specific research related intervention,
explain what counselling will be available for the participant.
2.6
For lab based studies:
Participants must be informed about all the tests to be done on their blood/urine
…..samples.
If unused samples are to be stored, state where and for how long it will be stored.
State that no genetic testing will be done on the samples.
Reassure confidentiality e.g. “All samples will be identified by a study number and
not your name.”
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2.7
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HIV Testing: A separate PICD should be submitted:
Pre and post counselling should be available
Results and further treatment to be discussed with patient….
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