Change in Research Guidance for WIRB Submission

Investigators should submit most changes of protocol directly to WIRB.

Only the following changes in research should be reviewed by the UW Reliance Team before submission to WIRB:

  • Changes in PI, addition of Co-Investigator(s), addition of other key personnel.
    • NOTE: Changes involving the removal of key personnel should still be sent directly to WIRB.

  • Changes in research that include changes to/additions of UW-Madison's required institutional language in consent documents.
  • Changes in research that include changes to/additions of HIPAA authorization documents.

Any changes not described above should be submitted directly to WIRB via Connexus.

Type of Change Institutional Sign-Off Required
Changes of PI, addition of Co-Investigator(s), addition of other key personnel Yes
Changes to HIPAA Authorization documents Yes
Changes to institutionally required consent language Yes
All other changes No


Instructions for Submitting Changes Directly to WIRB

  1. Log into WIRB Connexus and select "Submit for Active Investigator Site" to locate your approved WIRB study.
  2. Select the appropriate Study and Investigator Site from the drop-down choices.
  3. You will be prompted to provide a name for the new submission. For the "Submission Name," please include the UW tracking number first, followed by the date of the Change in Research (e.g., "2015-5089 - 11/1/2015").
  4. Place any additional comments or notes for the submission the comments field.
  5. Select "Change in Research" in the Submission Types field.
  6. Select “Save and Continue to Submission."
  7. Complete the smart form and upload any associated documents, if applicable.
  8. When the change is ready for submission, click "Submit."

Instructions for Submitting Changes that Require UW Reliance Team Review

  1. Log into WIRB Connexus and select “Submit for Active Investigator Site” to locate your approved WIRB study.
  2. Select the appropriate Study and Investigator Site.
  3. You will be prompted to provide a name for the new submission. For the “Submission Name,” please include the UW tracking number first, followed by the date of the Change (e.g., "2015-5089 - 10/15/2015).
  4. Place any additional comments or notes for the submission in the comments section.
  5. Select "Change in Research" in the Submission Types field.
  6. Select “Save and Continue to Submission."
  7. Complete the smartform and upload any associated documents.
  8. Click “Save and Submit Later.”
  9. After the PI and sponsor (if needed) have completed their review of the revised documents, email submitwirb@medicine.wisc.edu The email subject line should be in the following format: [UW Tracking number], Date CIR available for review.
    • Please also include within your email text the date associated with your Connexus upload. The UW Reliance Team will use this date to verify review of the correct CIR submission.


WIRB Errors (Reconsideration Requests)

A study team has 5 business days to correct WIRB errors to newly approved documents without charge. WIRB may not give an extension beyond the 5-day window and errors identified after the 5 days will require a change in research and will incur a fee for that review.

The following can be considered WIRB errors:

  • Incorrect institutional language
  • Obtuse word smithing
  • Scientific errors with editing

The following are not considered WIRB errors:

  • Post approval editing missed during the initial submission of the document
  • Disagreements with WIRB-inserted stylistic language and/or grammar

To submit the error correction request, follow the steps below:

  1. Prepare an email to clientservices@wirb.com.
  2. In the subject line, place the wording "Reconsideration request" and include the UW Tracking Number.
  3. Create a tracked change word document using the approved document provided by WIRB.
  4. Insert comment boxes to identify WIRB errors. Failure to do so could result in a CIR fee.
  5. Attach applicable documents to the email.

Institutional sign-off is not required for identification of WIRB errors and there is no fee for reconsideration if requested within the 5 day timeframe.

Tips:

  • Most errors occur between WIRB red-lined document and the clean copy.
  • Check for changes to UW required template language or the absence of required language.
  • To avoid being charged for a change, please ensure a comment box was placed with the text of "WIRB error" adjacent to each error you find.



Keywords:WIRB, administrative change, PI change, IND, IDB, key personnel, contact information, addendum, name change, cover sheet, personnel, personnel change, cover, 5 day, post review, errors, reconsideration, letter, editing, disagreement, inserted language, grammar, coversheet   Doc ID:18817
Owner:Mike B.Group:Western Institutional Review Boards
Created:2011-06-13 18:00 CSTUpdated:2017-11-20 10:43 CST
Sites:Western Institutional Review Boards
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