Legacy WIRB Studies

Studies approved by WIRB and ongoing at UW as of February 17, 2018 are “grandfathered in” to the legacy WIRB process. All new studies must be submitted per the initial review process.

The UW HS IRBs Office point of contact for studies approved by WIRB and ongoing as of 2/17/18 is the submitwirb@medicine.wisc.edu email address.

The following applies for studies approved by WIRB and ongoing at UW as of 2/17/18:

Changes in Research

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 do not need to be submitted.

  • 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 to Key Personnel

  • Please email an updated delegation of authority log to submitwirb@medicine.wisc.edu. The Reliance Team reviews human subjects training for all staff.  Since WIRB does not require updated study team information, it is not necessary to submit personnel updates to WIRB. Submitting removal of personnel is not required.

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 form 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.

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Continuing Reviews

WIRB will notify the Principal Investigator, via email, about the need to obtain continuing review of a WIRB approved protocol. This notice is sent three weeks prior to the due date, which is approximately 50 days before the study's expiration date. It is the responsibility of UW study personnel to submit the required documents by the due date listed on the Continuing Review Report Form (CRRF). The CRRF and applicable study documents should be sent directly to WIRB. WIRB may take action to suspend or terminate approval of the research if a report is not accurately completed and returned promptly. Please contact WIRB if you have any questions.

WIRB Contacts: http://www.wirb.com/Pages/default.aspx

Client Services:
clientservices@wirb.com
1-800-562-4789

Christopher Gennai
Account Manager, Institutions
Direct Phone: 360-252-2460
cgennai@wirb.com

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Reportable Events

Due to the nature of these events, research teams submit unanticipated problem reports (promptly reportable information) directly to WIRB via the WIRB Connexus portal. WIRB will provide notice to the UW WIRB Gateway Team of any significant reports.

Submitting Promptly Reportable Information to WIRB:

The Promptly Reportable Information is uploaded directly by the study team to WIRB through WIRB Connexus.

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HIPAA Authorization

UW-Madison is responsible for the review of HIPAA authorization forms. The Reliance Team, rather than WIRB, reviews and accepts all HIPAA forms on behalf of the UW. The HIPAA authorizations are required to be separate from consent documents to facilitate their review by the UW. For more information about UW HIPAA requirements, see the HIPAA website.

Requirements for UW HIPAA Authorization Forms

  1. Institutional templates must be used.
  2. All HIPAA language must be removed from the consent documents.

If authorization forms are used to obtain permission for the use of protected health information for multiple components of a study, such as optional sub-studies, they must include corresponding opt in/out check boxes for each component. These check boxes may be located either in section A or the authorization signature section of the document. For guidance and tools to help with drafting HIPAA authorization forms, please see HIPAA Privacy Rule: Forms and HIPAA Wizard.


Special Populations Additional Requirements

  • Limited or Non-readers

    When selecting to include limited or non-readers in the study, please add a witness signature line in the HIPAA Authorization signature section.

    Example:

    ______________________________________________________             _________________

    Signature of Witness Observing the Authorization Process                             Date

  • Impaired Decision-Making Capacity

    When selecting to include subjects with impaired decision-making capacity in the study, please add a legally authorized representative signature line in the HIPAA authorization signature section.

    Example:

    ______________________________________________________             _________________

    Signature of Individual or Personal Representative                                         Date

    If this Authorization Form is signed by a personal representative, please print his or her name and relationship to the individual:

    Name (print): _______________________________

  • Minors

    When choosing to include minors in the study, please prepare a HIPAA authorization form addressed to the "Parent or Guardian."

  • Pregnant Partner

    A HIPAA authorization form to match a pregnant partner consent is not necessary at the time of initial review submission. In the event that the study team needs to use the pregnant partner consent document, please contact the UW-Madison HIPAA Privacy Officer for direction.


Adding a Sponsor Statement to the HIPAA Authorization Form

If the sponsor would like to add their own language to the UW HIPAA templates, a new section called "Sponsor Additional Information" should be added just prior to the signature section, such as:

    H. Sponsor Additional Information

    The following information is from the sponsor of this study about how the sponsor will use and protect your health information from this research. Federal privacy laws do not generally apply to the sponsor's use of your health information. UW-Madison and its researchers cannot guarantee that the sponsor's statement is correct, complete, or current. The sponsor's use and protection of your health information from this study is the responsibility of the sponsor, not UW-Madison and its researchers.

      [Add the sponsor statement(s) here as indented text.]

      [End of sponsor statement.]


Shared Meriter/UW WIRB Deferral HIPAA Authorization Template

If UW personnel will use Meriter Hospital resources for the research study or enroll Meriter patients and Meriter has also agreed to defer the study to WIRB, use the joint Meriter/UW HIPAA Authorization Template.


Tissue Banking HIPAA Authorization

For guidance about when and how to draft a HIPAA Authorization for tissue banking, please contact submitwirb@medicine.wisc.edu.

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Study Closure

Study teams are required to close their studies with WIRB when the sponsor directs them to do so or they will no longer be actively involved in the study (e.g., no subjects will be enrolled). Follow the steps below to close a study with WIRB:

  1. Log into WIRB Connexus "Workspace Sites" to locate the approved WIRB study.
  2. Select "Add New Submission" within the "IRB Submissions Site Workspace" and scroll down to and select SmartForm for "Study Closure."
  3. When prompted to enter the "Submission Name", include the UW tracking number first, followed by date of the action request.
  4. Upload any applicable associated documents.
  5. Allow PI and sponsor document review time.
  6. Click Submit.

NOTE: Do not email submitwirb@medicine.wisc.edu when study closures are being submitted.

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Email Communication

Please use the following to determine the best person to contact:


Send Email to submitwirb@medicine.wisc.edu Send Email to clientservices@wirb.com
Question or discussion with CRO or Sponsor that does not require a response from UW Reliance Team No No
Questions study teams cannot resolve with sponsor or CRO, requiring Reliance Team assistance Yes No
General Inquiry/Questions about UW requirements for WIRB studies and submission process Yes No
General Inquiry/Questions directed to WIRB Client Services No Yes

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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.

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Keywords:grandfather, change, continuing review, WIRB, Western IRB, legacy   Doc ID:78327
Owner:Tesha Z.Group:Central IRB Gateway
Created:2017-11-20 10:53 CSTUpdated:2018-02-19 11:00 CST
Sites:Central IRB Gateway, Health Sciences IRBs
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