Policies and Procedures

IRB Submissions
All research protocol submissions must be submitted within the following three categories. Only completed research protocols will be reviewed. Definitions for each research category are provided by the United States Department of Health and Human Services (45 CFR 46).

  • Exempt
  • Expedited
  • Full Review

Protocol forms are available on the IRB website and are periodically updated. The Principle Investigator (PI) is responsible to ensure that current versions of protocol forms are being used. Prior versions will not be accepted.

Research Protocol Process Overview
1. The Principle Investigator (PI) should submit a completed, original submission form to the Office of Institutional Effectiveness, IRB Administration, President’s Hall or irb@CCUniversity.edu. Email submissions are strongly encouraged.
2. Only completed submissions will be reviewed. Submissions requiring a full board review will be placed on the meeting agenda according to published meeting deadlines. Other submissions not requiring a full board review will be processed as they are received.
3. The IRB Chair will review (or designate reviewers for) exempt and expedited submissions.
4. The IRB Chair will provide written communication with the PI regarding the status of the
protocol submission and review.
5. The PI responds to all comments, requests, and requirements from the reviewer until the submission is approved. Any items not resolved between the reviewer and PI will be referred to the full IRB for review and final resolution.

Exempt Protocols may be approved for up to three years. To continue the project beyond the approval period requires the PI to submit a renewal request form, as well receive approval by the IRB prior to theexpiration of the initial approval period. Any changes to the protocol that may affect the “Exempt” status requires the submission of a modification request form to the IRB, which must be reviewed and approved prior to any implementation of the change(s).

Per federal regulations, Expedited and Full Board protocols may not be approved for more than one year. To continue the project beyond the approval period requires the PI to submit a renewal request form, as well as receive approval by the IRB prior to the expiration of the initial approval period. Any changes to the protocol requires the submission of a modification request form to the IRB, which must be reviewed and approved prior to any implementation of the change(s). A Final Report form is required to close out all Full Board and Expedited research protocols.

Exempt Overview
To request an Exempt Determination, the PI must submit a completed Exempt Research Protocol Form, which will be reviewed by the IRB. For research proposals to be classified as “Exempt,” the research project must meet the exempt categories of the United States Department of Health and Human Services (45 CFR 46.101(b)) and be approved as such by the IRB. If determined to be “Exempt,” the research project is reviewed by the IRB Chair or a designated reviewer. There is no deadline to submit an Exempt Research Protocol Form; exempt submissions are reviewed on a continuous basis. The IRB may approve exempt research projects for up to three years. To continue a research project past the initial approval period, the PI must submit a Request for Project Renewal Form at least one month prior to the expiration date of the initial approval period. Any project modifications that may affect the “Exempt” determination must be submitted to the IRB for review and approval using a Modification Request Form. No modifications may be implemented until approval has been given by the IRB. Reporting requirements for non-compliance or other events are completed using the appropriate forms located on the IRB website.

Expedited Overview
To request an Expedited Review, the PI must submit a completed Research Protocol Form, which will be reviewed by the IRB. For research proposals to be classified as “Expedited” (covered by Federal Regulations, but not requiring Full Board Review), the research project must meet the expedited categories of the United States Department of Health and Human Services (45 CFR 46.110) and be approved as such by the IRB. If determined to be “Expedited,” the research project is reviewed by the IRB Chair or a designated reviewer. The reviewer may not reject an expedited protocol; instead, the protocol is referred to the full IRB for discussion at the next board meeting, according to posted due dates. There is no deadline to submit a Research Protocol Form; expedited submissions are reviewed on a continuous
basis. The IRB may approve expedited research projects for up to one year. To continue a research project past the initial approval period, the PI must submit a Request for Project Renewal Form at least one month prior to the expiration date of the initial approval period. Any project modifications that may affect the “Expedited” determination must be submitted to the IRB for review and approval using a Modification Request Form. No modifications may be implemented until approval has been given by the IRB. When the research project is completed, the PI must submit a Final Report Form to close out the expedited protocol. Reporting requirements for non-compliance or other events are completed using the appropriate forms located on the IRB website.

Full Board Review Overview
To request a Full Board Review, the PI must submit a completed Research Protocol Form, which will be reviewed by the IRB. Any research project that is not classified as “Exempt” or “Expedited” must be reviewed by the full IRB and can only be approved at an IRB meeting where a quorum of voting members are present. The IRB will determine if theproposed research project should be classified as “Minimum Risk” (MR) or “At Risk” (AR). The PI must submit a completed Research Protocol Form within the posted deadlines to be reviewed by the IRB. The full IRB may approve a full board review research project for up to one year. To continue a research project past the initial approval period, the PI must submit a Request for Project Renewal Form at least one month prior to the expiration date of the initial approval period. Any project modifications must be submitted to the full IRB for review and approval using a Modification Request Form. No modifications may be implemented until approval has been given by the full IRB. When the research project is completed, the PI must submit a Final Report Form to close out the full board review protocol. Reporting requirements for non- compliance or other events are completed using the appropriate forms located on the IRB website.

Required Research Ethics Training

Cincinnati Christian University contracts with the Collaborative Institutional Training Initiative (CITI) at the University of Miami to provide online Human Subjects Research (HSR) training. All IRB members must complete CITI training to serve on the IRB. CITI training must be completed every three years. All new research protocol requests, renewals, and modifications will only be approved if the research team, including faculty advisors, has completed CITI training in accordance with current requirements (e.g., completed within the past three years, etc.).