Scientific Reviewer Presentation Notes

Ochsner Institutional Review Board SCIENTIFIC REVIEWER CHECKLIST: Convened_New Study IRB #

The purpose of this checklist is to provide support for IRB members or the Scientific/Primary Reviewer for convened new studies.

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.

Presentation of a new protocol begins with a description of the research study. In reviewing the protocol, the following criteria require consideration, and should shape the presentation to the committee. The presentation should include information necessary for the committee to make an informed decision regarding approval of the protocol.

Basic Regulatory Requirements for IRB Approval

The criteria for IRB approval are itemized below: (1) – (7). The bulleted list following each criterion contains factors for consideration when evaluating whether or not the criterion is met.

Federal regulations (45 CFR 46.111, 21 CFR 56.111) require the following criteria for IRB approval of research: (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

Revision Date: G:/Res/Forms/Reviewers/ February 2012, April 2012, May 2012, April 2013

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(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

(4) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Not applicable (these subject populations are not being enrolled) Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

(5) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45CFR 46.116, and, if applicable, 21 CFR 50.20 and 21 CFR 50.25

Not applicable, a waiver of informed consent will be granted for all subjects Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

(6) Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117, and, if applicable, 21 CFR 50.27

Not applicable, a waiver of documentation of informed consent will be granted for all subjects Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

(7) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

Not applicable- the risk level or nature of the study does not require data monitoring Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

(8) There are adequate provisions for protecting the privacy of subjects. Privacy means freedom from unauthorized intrusion or the state of being left alone and able to keep certain personal information to oneself.

Not applicable (use textbox below) Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

(9) There are adequate provisions for protecting the confidentiality of subject information. Confidentiality means the ethical or legal right that information is considered private and will be held secret unless consent is provided permitting disclosure.

Not applicable (use textbox below) Yes Revisions or clarifications are needed (use textbox below) Unable to judge at this time (use textbox below) Other (use textbox below)

Reviewer comments:

MAKING MOTIONS after asking if anyone has questions or concerns:

1. If children or pregnant women are included in the research, you must use the appropriate checklist. NOTE: Employees and other populations vulnerable to coercion are presumed to be possible in any study, and are handled by default in the IRB SOPs by a standard safeguard statement in EVERY approval letter. If you think this particular study requires safeguards beyond the default ones, then please include the details in your motion so it can be discussed by the IRB and voted on.

2. If federally funded with Ochsner being the primary grant recipient (e.g., CCOP study or other study where the box is checked on application) , than make a motion that the study purpose is concordant with the grant purpose (if that is true).

3. Motion to approve, table or disapprove the study + investigators listed + supplemental materials that will be given to subjects (list questionnaires, brochures, etc.) + advertisements (if submitted) for a period of 1 year [or specify a shorter time if high risk warrants it].

Provide comments/justification below:

Reviewer Signature: ______Date:______