TEMPLATE for an Informed Consent Form
(To be customized to each research project. Kindly refer to the checklist
for elements required in an informed consent form)
Wording in black can be used as is and wording in blue is for guidance.
Please delete the latter when submitting the informed consent form.
Consent to participate in a research study
Include Title of study
Investigator: Dr.
Address: American University Hospital
Cairo Street
Beirut, Lebanon
Phone:
(01) 350 000 ext
Site where the study will be conducted:
The informed consent should be written in a language understandable by
a layperson preferable at the level of 8th grade, should not contain
scientific jargon and if it does this should be explained, should be written
in the second person singular (addressed to the patient), and should
include the following sections:
You are being asked to participate in a clinical research study conducted
at the American University of Beirut. Please take time to read the following
information carefully before you decide whether you want to take part in
this study or not. Feel free to ask your doctor if you need more
information or clarification about what is stated in this form and the study
as a whole.
1) Purpose of the research study and overview of participation
Items 1-6, 10-12 and 22-26 of the checklist
2) Any risks as a result of participating in the study
Items 7-8 of the checklist
3) Any benefits as a result of participating in the study
Item 9 of the checklist
4) Any alternative treatment
Item 18 of the checklist
Include protocol number (if applicable), Version date and page #
If you agree to participate in this research study, the information will be
kept confidential. Unless required by law, only the study doctor and
designee, the ethics committee and inspectors from governmental
agencies will have direct access to your medical records.
Item 19-20 of the checklist
6) In case of any adverse event as a result of the study, there will be no
compensation to cover such expenses in case it is not covered by a third party or
governmental insurance. (This phrase may be modified according to each study /
Item 21 of the checklist)
Signature section (as listed in items 13-17, 25-31 and 35 of the checklist);
Investigator’s Statement:
I have reviewed, in detail, the informed consent document for this
research study with
(name of patient, legal
representative, or parent/guardian) the purpose of the study and its risks
and benefits. I have answered to all the patient’s questions clearly. I will
inform the participant in case of any changes to the research study.
_______________________
Name of Investigator or designee
Signature
Date & Time
Patient’s Participation:
please add the name of the PI and the contact number in the highlighted
section below.
I have read and understood all aspects of the research study and all my
questions have been answered. I voluntarily agree to be a part of this
research study and I know that I can contact Dr.
at
or any of his/her designee involved in the study in case of any
questions. If I feel that my questions have not been answered, I can
contact the Institutional Review Board for human rights at
. I
understand that I am free to withdraw this consent and discontinue
participation in this project at any time, even after signing this form, and it
will not affect my care or benefits. I know that I will receive a copy of this
signed informed consent.
__________________________
Name of Patient or Legal Representative
or Parent/Guardian
Signature
Include protocol number (if applicable), Version date and page #
Date & Time
Witness’s Name
(if patient, representative or parent do not read)
Witness’s Signature
Date & Time
Include protocol number (if applicable), Version date and page #