Change in Research Guidance for WIRB Submission

Guidance for change in research (CIR) submissions to WIRB

Changes in Research Guidance for WIRB Submissions


Effective immediately, investigators should submit most changes of protocol directly to WIRB. These changes no longer require institutional sign-off. In the past, only administrative changes (removal of key personnel, non-regulatory document changes, such as CRO contact information changes) have been able to be submitted directly to WIRB.


Only the following changes in research should be reviewed by the UW WIRB 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. Please see WIRB Consent Template and "Consent Form Checklist for Changes to WIRB Studies" to determine if your consent changes require review by the WIRB Gateway Team.
  • 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.


Instructions for Submitting Changes Directly to WIRB:

  • Log into WIRB Connexus and select "Submit for Active Investigator Site" to locate your approved WIRB study.
  • Select the appropriate Study and Investigator Site from the drop-down choices.
  • 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. For example. "2015-5089 - 11/1/2015"
  • Place any additional comments or notes for the submission the comments field.
  • Select "Change in Research" in the Submission Types field.
  • Select “Save and Continue to Submission."
  • Complete the smart form and upload any associated documents, if applicable.
  • When the change is ready for submission, click "submit."

 

Instructions for submitting changes that require WIRB Gateway Team review:

  • Log into WIRB Connexus and select “Submit for Active Investigator Site” to locate your approved WIRB study.
  • Select the appropriate Study and Investigator Site.

  • 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. For example, 2015-5089 10/15/2015

  • Place any additional comments or notes for the submission in the comments section.

  • Select "Change in Research" in the Submission Types field. 
  • Select “Save and Continue to Submission."

  • Complete the smart form and upload any associated documents.

  • Click “Save and Submit Later.”

  • Email submitwirb@medicine.wisc.edu after the PI and sponsor (if needed) have completed their review of the revised documents. The email subject line should be in the following format: [UW Tracking number] Connexus CIR available for review.

  • Please also include within your email text the date associated with your Connexus upload. The UW WIRB Reliance Team will use this date to verify review of the correct CIR submission.


Types of Changes

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

 


WIRB Errors (Reconsideration Requests)


The following can be considered WIRB errors:

  • Incorrect institutional language
  • Obtuse work 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

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. 

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

  • Prepare an email to clientservices@wirb.com
  • In the subject line, place the wording "Reconsideration request" and include the UW Tracking Number.
  • Create a tracked change word document using the approved document provided by WIRB.
  • Insert comment boxed to identify WIRB errors. Failure to do so could result in a CIR fee.
  • 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, investigator initiated, on behalf, administrative change, PI change, IND safety report, IDB, key personnel, contact information, addendum, name change, wirb cover sheet, cover sheet, submission cover sheet, personnel, personnel change, adding personnel, cover letter, cover, submission cover sheet, 5 day, post review, errors, reconsideration, letter, administrative letter, safety letter, editing, grammatical error, disagreement, inserted language, grammar, initiated change, coversheet   Doc ID:18817
Owner:Mike B.Group:Western Institutional Review Boards
Created:2011-06-13 19:00 CDTUpdated:2016-06-01 08:37 CDT
Sites:Western Institutional Review Boards
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