IRB Initial Reviewer Form

IRB Expedited / Full Board Data Set Analysis Review – Reviewer Form Clemson University (CU) Institutional Review Board (IRB) (Version 10.28.2011) Clemson University IRB Website

Primary Reviewer: Secondary Reviewer: Date Assigned:

Title of Study: IRB Protocol Number: Review Status: PI Name: Department: Phone:

Acceptable category for EXPEDITED REVIEW (If applicable): 5

Instructions: Please complete the form and expand your review in narrative form. To check (uncheck) box electronically, place cursor on box and left click mouse.

NA = Not Applicable Y = Yes N = No NI/D = Needs More Information or Discussion

Conflict of Interest I do not have a conflict of interest in reviewing this protocol. If you do have a conflict of interest in reviewing this protocol, please contact the Office of Research Compliance at 656-6460 so a different reviewer can be assigned.

Research Design 1. Are study objectives clearly stated? Y N NI/D

2. Has a grant application for this protocol been submitted to a funding agency? Y N NI/D

If yes, is it consistent with the IRB research protocol submitted? Y N NI/D

Comments:

Privacy and Confidentiality 1. Are methods identified to protect the confidentiality of research data? Y N NI/D

Comments:

Risk/Benefit Analysis 1. Are reasonably foreseeable risks described (e.g., psychological, social, economic, legal)? NA Y N NI/D

of 2 2. Are risks to subjects minimized through one of the following (a) sound research design and/or (b) procedures to protect the subject from unnecessary risks? Y N NI/D

3. Have probable benefits of research to subjects or others been identified? Y N NI/D

4. Are risks to subjects reasonable in relation to the benefits to subjects, if any; and the importance of knowledge to be gained? Y N NI/D

Comments:

RECOMMENDATION(S)

1. Approval / Disapproval Category: Check one.

The application should be approved “as is”.

The application should be approved pending receipt and review of minor changes by the Chair of IRB or designee. (Identify changes below in Comments section.)

The application should be approved pending receipt and review of substantive changes by the reviewer(s) (or the full IRB if the protocol requires full board review). (Identify changes below in Comments section.)

The application should be disapproved. (The protocol must go to the full IRB for disapproval.)

Comments:

2. Level of Review

No more than minimal risk (expedited) More than minimal risk (full board)

3. Interval for Continuing Review

One year Less than 1 year, (specify):

4. Signature

Reviewer Signature Date