IRB #
PI:
The purpose of this checklist is to provide support for IRB members or the Consent Form Reviewer for review of consent forms.
The convened IRB uses this form to make its determinations. The minutes document the determinations required by the regulations along with protocol specific findings justifying those determinations, and this checklist is signed and dated and retained in ERSA.
Conflict of Interest
I do not have a conflict of interest in reviewing this protocol.
If you, or an immediate family member living with you, is an investigator in, subject in, or has an interest in the outcome of this study, please notify the IRB office at 504-842-3535 prior to review so reassignment can be made.
Federal regulations (46.116) specify general requirements for informed consent:
- Except as provided elsewhere in IRB policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
- The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.
- No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
For Review of Amended Consent Forms:
Review of amended consent forms should focus on the changes being requested. The reviewer should ensure the required elements (indicated on page 2) are included. However, the reviewer should only suggest further changes to the document if the changes requested with the amendment are not correctly identified in the amended consent.
Verify that the informed consent document contains each of the eight required elements (45 CFR 46.116)
Yes / No / Item # / ITEMS8 REQUIRED ELEMENTS
1a / a statement that the study involves research, and1b / an explanation of the purposes of the research, and
1c / the expected duration of the participant ‘s participation, and
1d / a description of the procedures to be followed, and
1e / identification of any procedures which are experimental;
2 / a description of any reasonably foreseeable risks or discomforts to the participant;
3 / a description of any benefits to the participant or to others which may reasonably be
expected from the research
4 / a disclosure of appropriate alternative procedures or courses of treatment, if any,
that might be advantageous to the participant;
5a / a statement describing the extent, if any, to which confidentiality of records
identifying the participant will be maintained; and
5b / if the research is subject to Food and Drug Administration (FDA) regulation, a statement that notes the possibility that FDA may inspect the records
6a / for research involving more than minimal risk, an explanation as to whether any
compensation is available if injury occurs, and
6b / an explanation as to whether any medical treatments are available if injury occurs and,
6c / if so, what they consist of, or where further information may be obtained;
7a / an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and
7b / whom to contact in the event of a research-related injury to the participant;
8a / a statement that participation is voluntary, and
8b / a statement that refusal to participate will involve no penalty or loss of benefits to
which the participant is otherwise entitled, and
8c / a statement that the participant may discontinue participation at any time without
penalty or loss of benefits to which the participant is otherwise entitled.
9 / if this is a clinical trial, Clinical trials.gov statement is included
When appropriate, which of the following additional elements of information are provided in the consent form?
Yes / NA / Item # / ITEMS7 ADDITIONAL ELEMENTS
1a / a statement that the particular treatment or procedure may involve risks to the participant which are currently unforeseeable; and1b / if the participant is or may become pregnant, a statement that the particular treatment or procedure may involve risks to the embryo or fetus which are currently unforeseeable;
2 / anticipated circumstances under which the participants participation may be terminated by the investigator without regard to the participant’s consent;
3 / any additional costs to the participant that may result from participation in the research;
4a / the consequences of a participants decision to withdraw from the research; and
4b / procedures for orderly termination of participation by the participant;
5 / a statement that significant new findings developed during the course of the research which may relate to the participants willingness to continue participation will be provided to the participant
6 / the approximate number of participants involved in the study.
7 / Does the protocol allow for use of a legally authorized representative (LAR)? If no, motion to remove LAR signature section of consent template.
For amended consent forms only:
Yes / No / ITEMSBased on the changes identified, should the existing study participants be re-consented with the revised consent?
Existing participants do not need re-consenting, but should be notified in writing of identified protocol changes?
MAKING MOTIONS after asking if anyone has questions or concerns or additional items to address make one of the following motions:
Approve as submitted
Approve with edits discussed at Board meeting
Table
Reviewer comments:
Reviewer Signature: ______Date: ______
1 G/Res/IRB/Forms/consent form version 2011.10.06, 2012.13.04, May 2012, April 2013, June 2013