Institutional Review Board
INFORMED CONSENT FORM CHECKLIST
(To assist in writing the informed consent document)
Instructions:
Kindly refer to this checklist while preparing an informed consent form for your study.
This checklist is used to assist you in writing an informed consent document in both English
and Arabic languages for any research that involves human subjects. Please make sure to
include all elements applicable to your study in the submitted informed consent form.
The elements of this checklist are derived from the ICH guidelines (section 4.8) and Code of Federal Regulations
(CFR 45, part 46.116).
Elements:
1. Statement that the study involves research and the medical condition that the drug (if any) is intended to treat
2. Explanation of the purposes of the research
3. The duration of the subjects participation
Length of study for a patient
Number of visits
Length/Duration of each visit
4. Approximate number of subjects to be recruited
5. Description of the procedures in the study in detail (including all invasive procedures)
6. Explanation of any experimental procedures (including all invasive procedures)
7. Description of any foreseeable risks or discomfort
8. Statement there may be unforeseeable risks
9. Description of any benefits to the subject or to others
10. Indicate if the subject will be paid for participating in the trial (amount paid)
11. Anticipated expenses, if any, to the subject for participating in the trial
12. Additional cost such as transportation, parking etc that will be reimbursed
13. Contact for questions about research subject's rights (Institutional Review Board)
14. Contact for injury to the subject due to research
15. Statement: participation is voluntary
16. Statement: refusal to participate will involve no loss in benefit
17. Statement: subject may stop at anytime without loss of benefits
18. Disclosure of alternative procedures or treatments that may be advantageous to subject
19. Statement: confidentiality of subjects records
20. Statement: records will be monitored & may be audited without violating confidentiality
21. Statement: compensation & treatment available if injury
Institutional Review Board
Informed Consent Content Checklist
Version March 2003
1
Elements:
22. Identification of the drug to be used in the study
23. Statement regarding the drugs therapeutic use/class
24. Statement: subject may receive placebo (probability of random assignment)
25. Statement: regarding subjects participation may be ended by investigator
26. Statement: significant new findings will be conveyed to subject
27. Statement: consent to participate
28. Statement that subject has had time to read and consider participation
29. Statement: for assent if subject is a child/minor or impaired and legally acceptable rep.
30. Date / Name and signature of Investigator or designee
31. Date / Name and signature of subject
32. Protocol Number on first page and on every subsequent page for IC more than 1 page. For Investigator
initiated studies, the protocol number will be assigned after submission of the protocol, in which case you will be
asked to add it to the approved IC form.
33. Version date on template to be used
34. Page numbers (preferably in the format: page x of y)
35. Consent form should have name, address and contact of Institution and name of PI
Institutional Review Board
Informed Consent Content Checklist
Version March 2003
2