LSU IRB CONSENT FORM CHECKLIST

(this list is also incorporated in the full application form)

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 granted.

CONSENT FORM CHECKLIST:

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 DEFIC-
IENCY 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, etc.)

___ (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 Form.

___ 6. Number of Subjects: Maximum number of subjects anticipated
including controls) if relevant.

___ 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 question-
naires 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 pro-
cedure which might hold risk for the
subject are explained. The number and
duration of sessions, and the overall
time commitment are stated.

A. If blood is to be withdrawn, the following is provided: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.

___ 8. Benefits: Study benefits to subjects or to
others (societal benefits)which may
reasonably be expected are stated.

___ 9. Risks/Discomforts: You must, at a minimum, state
there is no known risk! Any potential
for physical harm (e.g., risks asso-
ciated with having blood drawn);
potential for psychological harm (eg:
distress at being asked sensitive
questions of a very personal nature);
and potential for social harm (e.g.,
collection of information such as drug
or alcohol use or abuse, which if
inadvertently released, could be
damaging).
It is helpful to include measures to
reduce risk (e.g. use of trained
personnel, safety procedures, measures
to assure confidentiality).

___ 10. Right to Refuse: It is stated that participation in the
study is voluntary and that subjects
may change their mind and withdraw
from the study at any time without
penalty or loss of any benefit to
which they may otherwise be entitled.

___ 11. Privacy: It is specified whether the study is
Anonymous or Confidential (An
anonymous study is one in
which the data cannot be linked
to the identity of the subject
directly or indirectly - either
because the name/identity of the
subject is never obtained by the
investigator, or because there is no
code linking data to the subject's
identity.) If the study is not
anonymous, i.e., if there is a code
linking data to identity, describe the
extent, if any, to which confiden-
tiality of records identifying the
subject will be maintained. Confiden-
tiality cannot be absolute: always
state 'data will be kept confidential
unless release is legally compelled'.

____ 12. Financial Information: Any compensation for participating and
any uncompensated costs incurred by
subjects are specified. (State when
incentives will be delivered).


Nos 13-16 MUST BE INCLUDED IN A CONSENT FORM WHEN A SUBJECT
ENTERS AN EXPERIMENTAL MEDICAL OR BEHAVIORAL TREATMENT PROGRAM
TO EXPLORE THE POTENTIAL TO REMEDY A CONDITION FROM WHICH HE/SHE SUFFERS.

___ CHECK HERE IF NOT APPLICABLE AND SKIP TO #17. (OTHERWISE, ANSWER
EACH QUESTION WITH YES OR NO."NO" INDICATES A CONSENT FORM DEFICIENCY
WHICH MUST BE REMEDIED BEFORE THE IRB APPLICATION CAN BE APPROVED.)

___ 13. Alternatives: It is specified whether there are
proven, established treatment options
available that may be advantageous to
the subject (in lieu of the study
treatment).

___ 14. Unforeseeable Risks: It is specified that the treatment or
procedure may involve risks to the
subject (or the embryo or fetus, if
the subject is or may become pregnant)
which are currently unforeseeable.

15. Study-associated injury or illness:
___ A. Any compensation or medical care which will be arranged
for or provided by the investigators is described

___ B. Subjects are informed what to do and whom they are to
notify in the event of a study-related illness or injury.

___ 16. New Findings: Significant new findings developed
from the study data or independent
sources during the course of the
research which may relate to
the subjects' willingness to continue
participation (e.g., adverse response
to the treatment) will be explained to
the subjects.

=======================================================================
NOS. 17-18 MUST BE INCLUDED IN A CONSENT FORM WHEN A SUBJECT'S FAILURE TO
COMPLETE A STUDY WILL DEPRIVE THE SUBJECT OF BENEFIT (INCLUDING
COMPENSATION) OR EXPOSE THE SUBJECT TO RISK.

___ CHECK HERE IF NOT APPLICABLE AND SKIP TO #19. (OTHERWISE, ANSWER
EACH QUESTION WITH YES OR NO. "NO" INDICATES A CONSENT FORM DEFICIENCY
WHICH MUST BE REMEDIED BEFORE THE IRB APPLICATION CAN BE APPROVED.)

___ 17. Withdrawal: Specify the consequences of a
subject's unilateral decision to
withdraw from the research, and
explain the procedures for orderly
termination of participation.

___ 18. Removal: List/explain the conditions or
situations under which the
investigator will remove the
individual from the study without
his/her consent.


No. 19 IS REQUIRED FOR ALL STUDIES:

___ 19. Signatures: 'The study has been discussed with me
and all my questions have been
answered. I may direct additional
questions regarding study specifics to
the investigators. If I have questions
about subjects' rights or other
concerns, I can contact Robert C. Mathews,
Chairman, LSU Institutional
Review Board, (225)578-8692. I agree
to participate in the study described
above and acknowledge the researchers'
obligation to provide me with a copy
of this consent form if signed by me.'

Subject Signature Date

___ 20. Illiterate subjects (When ANY subjects are likely to be
illiterate, the "reader statement"
and signature line below are
included.)

'The study subject has indicated to me
that he/she is unable to read. I
certify that I have read this consent
form to the subject and explained that
by completing the signature line
above, the subject has agreed to
participate.'


Signature of Reader Date

=======================================================================
ANSWER #21-23 BELOW WITH YES or NO (or N/A when allowable)

___ 21. Is the consent form written for the 6th grade reading level in
nontechnical language which can be understood by the subjects?

___ 22. Is the consent form free of any exculpatory language through
which the participant is made to waive, or appears to be made
to waive any legal rights, including any release of the
investigator, sponsor, institution or its agents from liability
for negligence? (Note: the consent form is not a contract.)

___ 23. Are minors (individuals who have not reached the legal age of
consent, age 18 in LA) study subjects? If so, is provision made
for
___ (N/A) (a) securing and documenting the assent of the minors?

___ (N/A) (b) securing and documenting parental permission?
If N/A, Explain:

Note: Signature of the Investigator is not required, and leads to the
false impression the Consent Form is a contract.
The Consent Form Checklist which begins on the next page is designed to
ensure you have included all the required elements of informed consent,
using appropriate language. This should maximize the probability of
receiving approval promptly, since deficiencies must be addressed before
approval can be granted. chklst.txt 6/15/2001