Consent Form Checklist (Page 3 of 4) in pdf

___ 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.

Numbers 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.

Number 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,

irb@lsu.edu, 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:_______________

Check #21-23 below to be sure your consent form is correct:

___ 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.)

LSU Institutional Review Board

Consent Form Checklist

Consent Form Checklist Page 3