TEMPLATE for an Informed Consent Form
for Genetic Research
(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 red is for guidance.
Please delete the latter when submitting the informed consent form.
Consent to participate in a genetic research study
Include Title of study
Investigator: Dr.
Address: American University Hospital
Hamra 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, 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, overview of participation and
procedures
Items 1-6, 10-12 and 22-26 of the checklist
2) Any risks as a result of participating in the study (Physical,
psychological, social, and economic)
Items 7-8 of the checklist
3) Any benefits as a result of participating in the study
Item 9 of the checklist
Include protocol number (if applicable), Version date and page #
4) Confidentiality (should include these 3 sections):
a. Include a statement regarding sample storage (identification and coding
of sample, location and length of storage, safeguards to protect privacy,
withdrawal of sample, unlinking/anonymization procedure and sample
destruction)
b. Include a statement regarding disclosure of results to the patient, family
members and third party
c. 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. (Items 19-20 of the
checklist)
5) Agreement for the use of samples for genetic testing (please note that these are
suggestions and that you can customize wording).
I permit coded use of my biological materials (specify: blood, fluids, tissue samples) for the
proposed study (“Coded” means identifiable, traceable. Biological materials that are unidentified
for research purposes but can be linked to their source through the use of codes; however, the
principal investigator or sponsor will be the only one to have the list linking patients to the codes
assigned.)
I specify the use of the samples in the following manner (please check only one of the following):
 I permit further contact to seek permission to do further studies on the samples.
OR
 I do not allow use of my biological samples for further studies.
OR
 I permit anonymized (samples cannot be linked to subject) use of my biological materials
for other studies without contact.
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 all the patient’s questions clearly. I will
inform the participant in case of any changes to the research
_______________________
Name of Investigator or designee
Include protocol number (if applicable), Version date and page #
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 felt that my questions have not been answered, I 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. I know that I will receive a copy of this signed
informed consent.
__________________________
Name of patient or Legal Representative
Signature
or Parent/Guardian
Date & Time
Witness’s Name
Signature
Date & Time
Include protocol number (if applicable), Version date and page #