Institutional Review Board

Columbus State University promotes and supports human research. Basic tenets of human research are voluntary participation and the ethical treatment of the subjects in the research process. The basic ethical principles are defined in the Belmont Report. The Code of Federal Regulations (CFR) defines the basic rules by which research should be evaluated (45 CFR 46). The purpose of the IRB is to ensure that the rights and welfare of all human subjects are protected.

Note: Older versions of the Application and Forms are not accepted for submission. Please always download copies of the current documents and forms from this website.

How to complete and submit an application:

1. Carefully read all CSU IRB Policies (PDF). Failure to follow policies and procedures may lead to significant delays in the processing of your application.
2. Complete the Human Research Application (Word). (If you are a student or you are not affiliated with CSU, then you must list a CSU faculty member as the Co-PI.)
3. Create the Addendum composed of all supporting materials. All supporting materials should be a merged into one PDF or Word file separate from the Application. The Addendum should include:
   1. Human subject research training certificates for every member of the research team. Expired certificates will not be accepted. ****The CSU IRB has transitioned to the CITI human subjects training. The IRB is NO LONGER ACCEPTING NIH CERTIFICATES. Click here for instructions on registering and completing CITI training. ****
   2. Copies of all recruitment materials (print and electronic).
   3. Completed Informed Consent template (Word). For internet surveys and other web-based projects, complete the Web-based Informed Consent template (Word). Research involving minor participants will require minor assent and parental consent. For additional IC templates see the Additional Forms section below.
   4. Letter of Cooperation on institutional letterhead from each off-campus site if applicable.
   5. Copies of all research measures, protocols, and instruments.
4. Complete the Application Checklist (Word) to verify all necessary elements are completed/included. Do not submit this checklist to the IRB.

5. Email the completed application as an attachment and the addendum as a second attachment to irb@columbusstate.edu from the researcher's CSU email account. Only PDF and Word documents will be accepted by the IRB. Students must copy (cc) their supervising faculty member on all correspondence with the IRB.

There are several steps in the IRB review process, which are detailed in the IRB Approval Process flowchart below. At each stage of review the application may be returned to the research team for revisions. Each time revisions are requested the research team will have one opportunity to completely address the submission issues. If the issues with the application are not resolved after one resubmission, then the researcher must wait 30 calendar days before resubmitting another revised application to the IRB.

IRB Approval Process Flowchart (PDF)

Visit the FAQ page for additional information related to successfully completing an application and addendum, and modifying approved research.

All correspondence or inquiries for the IRB should be sent to irb@columbusstate.edu

Additional Forms

Application:

• Lab Personnel Form (Word)- All lab/department personnel human subjects research training certificates must be included in a separate merged addendum.
• Alternate Informed Consent Templates
  • Multiple Investigators (Word)
  • Parental Guardian Signature (Word) (for High School Age Minors)
  • Participant Researcher Signature (Word)

Making Changes to Ongoing Research:

• Project Modification Form (Word) - If supporting materials are required for the modification request, all documents should be merged into one Addendum document and submitted with the modification form as a separate attachment.

Authorization of Outside IRB Reviewed Protocols:

• IRB Authorization Agreement (Word)- IRB Authorization Agreements allow two unaffiliated IRBs to establish an agreement under which one IRB agrees to rely on the other IRB to provide review and continuing oversight of a human subjects research project. Two common examples of how this form would be used:

1. A researcher from XYZ university, whose research protocol has been approved by XYZ IRB, wants permission to conduct human subjects research for the approved protocol at CSU. The researcher would request that the XYZ IRB submit the IRB Authorization Agreement form to the CSU IRB at irb@columbusstate.edu.
2. A researcher from Columbus State University, whose research protocol has been approved by CSU IRB, wants permission to conduct human subjects research for the approved protocol at XYZ University. The researcher would request that the CSU IRB submit the IRB Authorization Agreement form to the XYZ IRB. The researcher would need to provide the CSU IRB with the appropriate contact information for the outside IRB.

Average Processing Times (as of 1/15/19)

• Exempt Protocols are 12 days
• Expedited Protocols are 24 days

Processing times will be slower during the summer, and the IRB is closed during holidays and breaks. For a list of upcoming closures, visit the IRB Scheduled Meetings page.

The time frames listed refer to the average amount of time it takes the IRB faculty and staff to process applications. The total time frame to move through the review process may be significantly longer depending on the amount of time it takes the research team to respond to requests for additional information or revisions.

It is recommended that researchers submit applications for review at least one month prior to the desired start of research, and that they promptly respond to requests from the Board to avoid delays. The IRB is not able to accelerate review or give special considerations to accommodate a desired research start date.

Annual Reports

View annual reports for the IRB

If you have any questions, contact the CSU IRB at irb@columbusstate.edu