Consent Form Checklist


Consent Form Checklist
The Consent Form Checklist is designed to ensure you have included all the required elements
of informed consent, using appropriate language. This should help maximize the probability of
receiving approval promptly, since deficiencies must be addressed before approval can be
For #1-12 below, indicate by yes or no whether each element is addressed in your
consent form. (a "no" answer indicates a consent form deficiency which must be
remedied before the IRB application can be approved.)
Y/N (Unless another appropriate response alternative is requested)
___ 1. Study Title: Name of the study.
___ 2. Performance Sites: Where the study will be conducted.
___ 3. Contacts: The names and telephone numbers of Investigators and hours available.
___ 4. Purpose of the Study: It is stated in lay language that the study is research and, what the
investigator wishes to accomplish.
5. Subjects:
___ A. Inclusion Criteria All criteria for participation in the study are specified.
(Examples: >18 years old, left or right-handed, diagnosed with a specified
condition; Subject pool, e.g. psychology undergraduate students, senior citizens,
___ (Or NA)B. Exclusion Criteria Specify any subset of those meeting the inclusion
criteria to be excluded from the study. (If none, indicate N/A & omit from Consent
___ 6. Number of Subjects: Maximum number of subjects anticipated including controls) if
___ 7. Study Procedures: A succinct, complete, specific nontechnical explanation (of what the
subject will experience or be required to do, is provided (e.g. 1 tsp. blood, rather than 5
cc. blood). If questionnaires are used, a description of types of questions - particularly if
of a personal or sensitive nature is provided. Procedures which are experimental, either
in the clinical sense, where a trial treatment is being studied; or any untried procedure
which might hold risk for the subject is explained. The number and duration of sessions,
and the overall time commitment are stated.
If blood is to be withdrawn, the following is provided:
___ (1) number of times, amount, period of time covered, minimal risk of bruising,
inflammation of vein and infection;
___ (2) qualifications of personnel collecting blood. (Comparable information for other
procedures, invasive or not)
___ B. If investigational drugs or devices are to be used, or if approved drugs or devices
are to be used in a manner for which they have not been approved, the consent
form identifies the drugs or devices as experimental.
LSU Institutional Review Board
Consent Form Checklist


00 votes

Related Articles

Related forms

Related Categories

Parent category: Education
Page of 4