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Loyola University Chicago

Institutional Review Board

Section Three

How to Respond to the IRB After your Protocol has been Reviewed

[NOTE: Where this document refers to contacting the IRB, such contacts should usually be done via the CAP system unless an urgent situation requires immediate attention by the IRB Chair or the Assistant Director for Research Compliance.]

There are three possible outcomes of an Exempt Review: Approved, Conditionally Approved, and Denied. Once the IRB has reviewed your application the IRB will send you an email notifying you of the outcome of your Exempt review.

  • Approved: If the IRB determines that the proposed research qualifies for Exempt Review and satisfies the Criteria for IRB Approval then Exempt Approval is granted to proceed with the project as outlined in the Exempt Application.
  • Deferred: If the IRB determines that the research might qualify for Exempt Review but changes or clarifications are required in order for the research to satisfy the IRB’s Criteria for Approval then the protocol will be deferred. The notification to the Investigator will contain a list of conditions that must be met in order for the Protocol to be confirmed Exempt.
  • Denied: If the IRB determines that the proposed research does not qualify for Exempt review, the Exempt application will be denied and the Investigator will need to re-submit the research for Expedited or Full Board review.

Please Note: If an Exempt application is denied, it does not mean that the research cannot be approved at all. The denial of an Exempt application only means that the research does not qualify for Exemption, and the research must be reviewed by the IRB.

There are four possible outcomes of an IRB Review: Approved, Conditionally Approved, Tabled for Re-review, and Disapproval. Once the IRB has reviewed your application the IRB will send you an email notifying you of the outcome of your review.

  • Approved: If all of the Criteria for IRB Approval have been met, then approval is granted to proceed with the project as outlined in the IRB application.
  • Conditionally Approved:If the IRB determines that risks to participants are minimal but minor changes or clarifications are required in order for the research to satisfy the IRB’s criteria for Approval, then the project will be conditionally approved. The notification email will contain a list of conditions that must be met in order for the protocol to be Approved. The Investigator must respond in writing to the conditions. If the Investigator is a student, the Faculty Sponsor must sign the letter of response to indicate their review and approval of the student's revisions. This response is reviewed by the IRB Chair and/or other designated members to determine if conditions have been met. The research may not proceed until all conditions have been met and full approval is secured. Once it is determined that each specified condition has been met, the Investigator is sent a letter of approval and the research may then proceed as outlined.
  • Tabled for Re-Review:If the IRB determines that it does not have sufficient information to determine if the project satisfies the IRB’s Criteria for Approval or if significant changes would be required to satisfy the IRB's Criteria for Approval, then the IRB may table a protocol. The notification email will contain feedback regarding the reasons for the tabling, a list of concerns/conditions, and the review mechanism through which the Investigator should resubmit the application. The Investigator must respond in writing to the concerns of the Board. If the Investigator is a student, the Faculty Sponsor must sign the letter of response to indicate their review and approval of the student's revisions.

    Because tabled protocols must be reviewed again the Investigator must submit a revised application for review along with the letter of response to the Board's concerns. The response and original materials are reviewed again by the IRB and the Investigator is notified in writing of the outcome of the review.

    Often when the IRB Tables a Protocol for Re-Review the IRB will determine that the Investigator will be required to meet with representatives from the IRB before the Protocol may be re-reviewed. If the IRB determines that a meeting is required, the Tabled for Re-Review letter will indicate who the Investigator is required to meet with before the Protocol will be re-reviewed.

  • Disapproval:If the IRB determines that a project does not meet the criteria for approval and there are serious concerns related to one or more criteria, the IRB may disapprove a project. The notification email will indicate the disapproval decision and detail the IRB's reasons for disapproval. Protocols that are reviewed via Expedited Review will not be disapproved by an Expedited Reviewer. If an Expedited Reviewer believes that a Protocol should be disapproved, the Expedited Reviewer will Table the Protocol for Re-Review by the Full Board. Only the Full Board has the authority to disapprove a Protocol.

First, read the letter of Conditional Approval carefully.

If you do not understand any of the conditions in the letter or are not sure what the IRB is asking you to do, please contact the IRB to request clarification before you draft your response.

If after you have read the conditions you believe the IRB has misunderstood your research, please describe what you believe was misunderstood in your letter of response.

If you disagree with the IRB's conditions, you are welcome to request the IRB to remove or modify the conditions. If you would like to request a change to the conditions, you should indicate your request in your letter of response and provide a justification for your request.

If you are a student:

  • Review the letter of Conditional Approval with your Faculty Sponsor and discuss how you should respond to each condition.
  • Write a detailed letter of response to the IRB.
    Your letter of response to the IRB should respond point-by-point to each of the conditions the IRB specified. Your response to each point should follow the same outline style and numbers used by the IRB in the letter of Conditional Approval. You should write your letter of response either in an email or as a Word document.

    Do NOT submit a revised application. The IRB will not review revised Applications that are submitted in response to the IRB's letter of Conditional Approval. Reviewing revised applications requires more time of the IRB staff and makes the review process lengthier for all Investigators.

  • Revise any research materials the IRB requested changes to.
    Remember the IRB wants to see marked copies indicating the changes you have made to your research documents. Reviewing marked copies of revised documents helps the IRB to review your response more quickly.

    If you are revising documents in Microsoft Word, turn on Word's Track Changes feature before you make changes to your documents.

    Note:

    - Submit your letter of response and revised research materials to your faculty sponsor for him/her to review.
    - After your faculty sponsor approves of your response, ask him/her to submit your response to the IRB by email.

Responses to Conditional Approval must be submitted to the IRB by email.

Note on Responding by Email: Email responses should be sent to the IRB staff member that emailed you the letter of Conditional Approval.

The IRB reviews responses to Conditional Approval on a rolling basis. A response to Conditional Approval will be reviewed by the IRB as soon as it is received.

Once you have submitted a response to the IRB's conditions, it generally takes the IRB 2-3 business days to review your response. However, please remember that the IRB may identify additional questions or concerns after reviewing your response. Often Investigators must complete several rounds of correspondence with the IRB before a Protocol is ready to be approved.

Responses to Conditional Approval are reviewed by the IRB Chair or Vice-Chair. Once the review of your response has been completed, you will be sent an email notifying you of the outcome of the review.

  • If the IRB determines that your response satisfied all of the IRB's concerns and that your project satisfies all of the IRB's Criteria for Approval, your project will be approved.
  • If the IRB determines that additional revisions or clarification is required, you will be sent an email detailing the conditions that you must satisfy in order for your project to be approved. You must submit another response to the IRB's list of remaining conditions before your project will be approved.

Read the Tabled for Re-Review letter carefully. Be sure to note the review mechanism the IRB indicates that you should use for your re-submission.

If you do not understand any of the conditions in the letter or are not sure what the IRB is asking you to do, please contact the IRB to request clarification before you revise your application and write your letter of response.

If after you have read the conditions you believe the IRB has misunderstood your research, please describe what you believe was misunderstood in your letter of response and clarify the misunderstood information in your application.

If you disagree with the IRB's conditions, you are welcome to request the IRB to remove or modify the conditions. If you would like to request a change to the conditions, you should indicate your request in your letter of response and provide a justification for your request. If you are a student:

  • Review the Tabled for Re-Review letter with your Faculty Sponsor and discuss how you should respond to each condition.
  • Schedule a meeting with the IRB representative(s) indicated if the Tabled for Re-Review letter indicated that a meeting was required. Investigators for whom a meeting was not required are welcome to request a meeting with a representative of the IRB as well.

The IRB has found that when Investigators meet with representatives from the IRB before re-submitting their application Investigators are better able to revise their application and respond to the IRB's concerns.

  • Revise your research materials in accordance with the IRB's conditions.
    Remember the IRB wants to see marked copies indicating the changes you have made to your research documents. Reviewing marked copies of revised documents helps the IRB to review your response more quickly.
    If you are revising documents in Microsoft Word, turn on Word's Track Changes feature before you make changes to your documents.
  • Revise your Application in accordance with the IRB's conditions.
    Generally protocols are Tabled for Re-Review primarily because the IRB does not have enough information to clearly understand what the research will involve. When you make revisions to your application you should be careful to write clearly and provide sufficient details.

    Be sure to revise your application in accordance with each of the conditions from the Tabled for Re-Review letter.

  • Write a detailed letter of response to the IRB.
    Your letter of response to the IRB should respond point-by-point to each of the conditions the IRB specified. Your response to each point should follow the same outline style and numbers used by the IRB in the Tabled for Re-Review letter.

    Your letter of response should describe in detail the changes you have made to your application and research materials. It is not sufficient to only write that you have revised your application. Your letter of response should be written as a Word document.

If you are a Student:

  • Submit your letter of response, your revised application, and revised research materials to your Faculty Sponsor for him/her to review.
  • After your Faculty Sponsor approves of your response, ask them to submit your response and Revised Application to the IRB by email.

Applications for Re-Review must be submitted to the IRB by email.

Notes on Submitting for Re-Review by Email:

Before making any changes to materials saved in Microsoft Word, turn on Tracked Changes so the IRB can easily see what you have changed.

Ideally, you should submit all of your appendixes in one Word document. If you have hard copies of materials (such as questionnaires, letters of cooperation, etc.) these should be scanned and submitted as one PDF document. The IRB will NOT accept submissions where each appendix is saved as a separate file.

Note: All Consent Forms must be submitted as Word documents.

The IRB reviews Applications that were tabled for re-review through Expedited or Full Board review. The Tabled for Re-Review letter from the IRB will detail the review mechanism that the application will be re-reviewed through.

Re-Submitted Applications for Expedited Review

Applications that are re-submitted for Expedited Review are reviewed on a rolling basis. The IRB will begin the review of your application as soon as you submit it for review.

The IRB is generally able to notify Investigators of the outcome of their re-review within 15 business days of receiving the revised application. Investigators are notified of the outcome of their re-review by email.

Re-Submitted Applications for Full Board Review

Applications that are submitted for Full Board Review are re-reviewed at IRB Full Board Meetings that are held once every month. Applications for Full Board Review must generally be received by the Office of Research Services two weeks before the Full Board Meeting Date. Please review the IRB's current Full Board Meeting and Submission Schedule for the submission deadlines and meeting dates for the current term.

The IRB is generally able to notify Investigators of the outcome of their Full Board review within one week of the Full Board meeting the Protocol was reviewed at.

Loyola

Institutional Review Board
Loyola University Chicago · 6439 N. Sheridan Road, Suite 400 · Chicago, IL 60626-5309
Phone: 773.508.2471 · Fax: 773.508.8942 · E-mail: irb@luc.edu

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