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Office of Research

Application Review Process

Except as noted, all communications described below are via e-mail.  IRB correspondence is sent to the Principal Investigator (PI). If additional research team members will be coordinating research activities and should be copied on correspondence, please let the IRB staff know.

Exempt Review Process
Exempt Protocol Extension Request
Expedited Review Process
Full Board Review Process
Developmental Approval Review Process
Continuing Review Process
Amendment Review Process
Addition/Removal of Research Team Members Review Process 
Review Process for International Research
Review Process for Collaborative Research

Exempt Review Process: 

1. There is no deadline for submitting Exempt Applications for review.

2. All requests for an exemption must include a completion date.  The initial expiration date will be determined by the completion date on the application form. The exemption is only valid until that date. If the research extends beyond the assigned expiration date, the PI has to request an extension. The PI must provide written documentation to the IRB that the project is ongoing or that the protocol should be closed (see FAQs for more information).

3. Upon receipt, Exempt Applications are pre-screened by an IRB staff. If anything is needed to complete the application packet, an IRB staff will contact the PI and request additional materials/revisions.

4. Once the application is complete, it is forwarded to the IRB Chair or designated reviewer. The reviewer will contact the PI if there are any questions or suggestions.

5. Once the review is complete and the study is approved, the IRB staff communicates the exemption approval to the PI.

6. Exemption approval is usually granted within 14 days of receipt of an Exempt Application. It is recommended that you submit your IRB application at least a month before your desired start date.

Exempt Protocol Extension Request:

1. The PI should submit the Exempt Protocol Extension Request form at least three weeks before the protocol expiration date.

2. The IRB Chair or designated reviewer will review the extension request and contact the PI if anything is needed to complete the request.

3. Once the review is complete, the IRB staff will communicate the extension approval to the PI.

4. Exemption approval is usually granted within 14 days of receipt of the extension request.

Expedited Review Process: 

1. There is no deadline for submitting Expedited Applications for review.

2. Upon receipt, Expedited Applications are pre-screened by IRB staff. If anything is needed to complete an application, IRB staff will contact the PI and request additional materials/revisions.

3. Once the application is complete, it is forwarded to a member of the IRB for review. If the reviewer has questions or suggestions, he or she will contact the PI directly.

4. Once the review is complete and the study is approved, the IRB staff communicates the approval to the PI, and attaches the approved date-stamped informed consent documents to the approval email.

5. Upon approval, a formal approval letter and the orginals of the date-stamped informed consent documents are mailed to the PI via interoffice mail.

6. Approval is usually granted within four weeks of receipt of an Expedited Application.

Full Board Review Process: 

1.  All required documents must be submitted to the Office of Research Compliance, 223 Brackett Hall, no later than 4:30 p.m. on the specified deadline date ( IRB Meeting Schedule and Full Board Review Submission Deadlines).  The IRB usually meets on the first Wednesday of each month.

2.  Upon receipt, Full Board Review Applications are pre-screened by IRB staff. If anything is needed to complete an application, IRB staff will contact the PI and request additional materials/revisions.

3.  Once the application is complete, it is assigned to primary and secondary reviewers on the IRB and made available to all IRB members for review. If the reviewers have questions or suggestions, the primary reviewer will contact the PI directly.

4.  The PI and Co-Investigators are invited to attend the IRB meeting where the protocol will be reviewed. This allows the PI to summarize the research protocol for the Board and allows board members to ask questions to the researchers directly.

5.  Once the Board has its questions answered and has sufficient discussion of any concerns or questions raised, a vote is held on whether or not the protocol should be approved.

6.  There are four possible outcomes to Board consideration of a protocol.

  • The protocol may be approved as is.
  • The protocol may be approved with revisions. These changes would be non-substantive and would be verified by the IRB/ORC. The approval would go into effect once the revisions were verified.
  • The Board may table its review of the protocol and request substantive revisions to be completed before the next board meeting.
  • The Board, in extremely rare cases, may disapprove the protocol if the Board and the PI have reached an impasse with regard to ethical issues or regulatory requirements.

7.  After the Board's vote, the IRB will inform the researchers of its decision. The PI will also receive a detailed e-mail explaining the reasons for the Board's decision and any required revisions.

8.  Once the review of any required non-substantive revisions is complete and the study is approved, the IRB staff communicates the approval to the PI, and attaches the approved date-stamped informed consent documents to the approval email

9.  Upon approval, a formal approval letter and the originals of the date-stamped informed consent documents are mailed to the PI via interoffice mail.

10.  Approval is usually granted within one month of the IRB meeting at which the protocol is first considered.

Developmental Approval Review Process:

1.  There is no deadline for submitting Developmental Approval Applications for review.

2.  Upon receipt, Developmental Approval Applications are reviewed by a designated IRB staff member. If anything is needed to complete an application, IRB staff will contact the PI and request additional materials/revisions.

3.  Once the review is complete and the application is approved, the IRB staff communicates the approval to the PI and the Office of Sponsored Programs.

4.  Approval is usually granted within three to seven days of receipt of the Developmental Approval Application.

Continuing Review Process:

1.  Requests for continuing review (CR requests) should be submitted at least three weeks prior to the expiration of the approval period. CR requests for full board review studies must be submitted to the Office of Research Compliance, 223 Brackett Hall, no later than 4:30 p.m. on the specified deadline date ( IRB Meeting Schedule and Full Board Review Submission Deadlines).

2.  Upon receipt, CR requests are pre-screened by IRB staff. If anything is needed to complete a CR request, IRB staff will contact the PI and request additional materials/revisions.

3.  Once the CR request is complete, it is forwarded to a member of the IRB for review. If the reviewer has questions or suggestions, he or she will contact the PI directly.

4.  For full board review studies, the CR request is discussed and voted on at the next IRB meeting.

5.  Once the review is complete and the study receives continuing approval, the IRB staff communicates the approval to the PI, and attaches the approved date-stamped informed consent documents to the approval email.

6.  Upon approval, a formal approval letter and the originals of the date-stamped informed consent documents are mailed to the PI via interoffice mail.

7.  Approval is usually granted within three weeks of receipt of the CR request.

Amendment Review Process:

1.  There is no deadline for submitting requests for amendment of exempt or expedited studies. Requests for amendment of full board review studies must be submitted to the Office of Research Compliance, 223 Brackett Hall, no later than 4:30 p.m. on the specified deadline date ( IRB Meeting Schedule and Full Board Review Submission Deadlines).

2.  Upon receipt, amendment requests are pre-screened by IRB staff. If anything is needed to complete an application, IRB staff will contact the PI and request additional materials/revisions.

3.  Once the amendment is complete, it is forwarded to a member of the IRB for review. If the reviewer has questions or suggestions, he or she will contact the PI directly.

4.  For full board review studies, the amendment is discussed and voted on at the next IRB meeting. The PI and Co-Investigators are invited to attend the IRB meeting where the amendment will be reviewed to summarize the amendment and answer questions for the Board.

5.  Once the review is complete and the amendment is approved, the IRB staff communicates the approval to the PI, and attaches the approved date-stamped informed consent documents, if appropriate, to the approval email.

6.  For amendments to expedited or full board review studies, a formal approval letter and the originals of the date-stamped informed consent documents are mailed to the PI via interoffice mail unless the researchers request to pick up the date-stamped documents.

7.  Approval of amendments to exempt studies is usually granted within 14 business days while approval of amendments to expedited or full board review studies is usually granted within three weeks of receipt of the amendment.

Addition/Removal of Research Team Members Review Process:

1.  There is no deadline for submitting requests to add or remove research team members.

2.  Requests to remove team members are recorded by IRB staff and are approved upon receipt. This is true except in the rare circumstance that one of the team members to be removed holds responsibility for a research function that can only be carried out by certain qualified people. In this case, IRB staff will verify that the function is still being covered by an appropriately qualified research team member before approving the removal of that particular team member.

3.  Upon receipt of requests to add team members, IRB staff verify completion of required training by personnel to be added to the team.  Addition to the team is approved for those who have completed training.

4.  Once the addition of team members is approved, the IRB staff communicates the approval to the PI.

5.  Approval is usually granted within seven to ten days of receipt.

Review Process for International Research

1. There is no deadline for submitting international research applications for exempt or expedited review. International research requiring full board review must be submitted to the Office of Research Compliance, 223 Brackett Hall, no later than 4:30 p.m. on the specified deadline date ( IRB Meeting Schedule and Full Board Review Submission Deadlines).

2. Review of applications follows the procedures outlined above for each level of review, with a few additional review requirements:

  • IRB staff investigates laws / regulations for the protection of human subjects in research in the country in which the research will be conducted. These laws / regulations will be strictly followed by the CU IRB.
  • We will make every reasonable effort (in proportion to the level of review) to identify laws / regulations which might affect human subjects research in particular countries. However, these laws / regulations differ significantly across countries, and can be difficult to research. When conducting research in countries other than the United States, it is always in your best interest to become familiar with all pertinent information about local human subjects protection regulations and requirements. We encourage you to discuss with your local contacts any possible human subjects research requirements that are specific to your research site, to comply with those requirements, and to inform this office of those requirements so we can better help other researchers prepare for international research in the future.
  • If a research protocol requires expedited or full board review, and study materials will be presented to participants in a language other than English (either verbally or in writing), the study materials must be submitted to the CU IRB in both English and the other language(s) being used. More information about translation requirements can be found here.

3. Once the application is complete, it is forwarded to the IRB Chair or designated reviewer. If the reviewer has questions or suggestions, he or she will contact the PI directly.

4. Once the review is complete and the study is approved, the IRB staff communicates the approval to the PI.

** Please note that the approval of international research may require additional time due to requirements in other countries, arranging appropriate local context reviews, negotiation of Individual Investigator Agreements, and geographical and communication constraints. It is recommended you plan to submit your IRB application at least three months prior to your desired study start date.

Review Process for Collaborative Research

Collaborative work involving researchers at other organizations, especially other organizations that have their own IRBs, may require additional time due to negotiating Individual Investigator Agreements, IRB Authorization Agreements (deferral agreements), and communications with additional parties. Please contact Laura Moll, IRB Administrator, at 864-656-6460 to discuss how to best manage the IRB review of collaborative research studies.

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