This is a template Consent Form and is intended as a guide to help you draft your own Consent
Form. Please check all sentences and tailor each sentence carefully to match your own study.
Watch out for words such as ‘Patient’ and ‘Medical Record.’ Your study may not involve
patients!
CONSENT FORM
Protocol Title:
Please tick the appropriate answer.
I confirm that I have read and understood the Patient Information Leaflet dated ____________
attached, and that I have had ample opportunity to ask questions all of which have been
satisfactorily answered.
Yes No
I understand that my (my child) participation in this study is entirely voluntary and that I may
withdraw at any time, without giving reason, and without this decision affecting my future
treatment or medical care.
Yes No
I understand that my records may be viewed by individuals with delegated authority from
___________________
Yes No
(Be careful: your study may not involve viewing medical records!)
I understand that my (my child) identity will remain confidential at all times.
Yes No
While I (my child) is a subject of this study, I agree to follow the instructions of the
doctor/researcher and to call the doctor/researcher immediately if I (my child) become(s) ill or
experience(s) any side effects.
Yes No
I give my informed consent for the doctor/researcher to have access to my medical notes in the National
Rehabilitation Hospital. I understand that the contents of my medical notes will not be disclosed to a
third party.
Yes No
I have been given sufficient time to consider my (my child’s) participation in this study.
Yes
No
I understand that my (my child) records will be viewed by (NAME)
Yes
No
I understand that my name and address will be given (NAME) at the ………………. in order to be
included in the study.
Yes No
I am aware of the potential risks of this research study.
Yes No
(Be careful: you may have stated in your Information Leaflet that there are no risks!)
I have been given a copy of the Patient Information Leaflet and this (my child) Consent form for
my records.
Yes No
FUTURE USE OF ANONYMOUS DATA:
I agree that I will not restrict the use to which the results of this study may be put. I give my
approval that unidentifiable data concerning my person may be stored or electronically processed
for the purpose of scientific research and may be used in related or other studies in the future.
(This would be subject to approval by an independent body, which safeguards the welfare and
rights of people in biomedical research studies - the National Rehabilitation Hospital Ethics
Committee.)
Yes No
(Be careful to check if this sentence applies to your research study. Do not blindly copy this
sentence to your own Consent Form.)
Patient ________________
Signature and dated
___________________
Name in block capitals
To be completed by the Principal Investigator or his nominee.
I the undersigned, have taken the time to fully explained to the above patient the nature and
purpose of this study in a manner that he/she could understand. I have explained the risks
involved, the experimental nature of the treatment, as well as the possible benefits and have
invited him/her to ask questions on any aspect of the study that concerned them.
I have obtained written consent from the subject (subject’s legally authorised
representative) prior to the subject’s participation in this study.
________________
Signature:
_____________________
Name in Block Capitals:
_____________
Qualification:
________
Date:
In accordance with Good Clinical Practice if there is a dependent relationship between the Physician and
the Subject then another Physician should obtain consent. Likewise the person obtaining consent should
be fully conversant with the study and be suitably trained and qualified.
3 copies to be made: 1 for patient, 1 for PI and 1 for hospital records.
Don’t forget to put the Version Number and date of this Consent Form at the bottom of
this form!