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Instructions: Sterling IRB (for Industry-sponsored multisite clinical trials)

UH investigators engaged in industry-sponsored multisite clinical trials are encouraged to utilize the services of Sterling IRB (a commercial IRB) with whom UH has signed an IRB reliance agreement. The UH IRB must review the PI’s Sterling submission before it is formally submitted to Sterling IRB. 

Here is the process required of UH investigators wishing to rely on Sterling IRB.

See here for the Sterling IRB Investigator handbook.

If the larger (“parent”) study has already been submitted to Sterling IRB by the Sponsor and UH is being added as a study site:

  1. Contact the UH IRB Office to advise that you wish to request to rely on Sterling IRB. The UH IRB office will confirm that UH is willing to rely on Sterling for the IRB review of the study.

  2. Start working on the ICON external study submission; however, you must wait to submit it until UH receives the approval docs from Sterling. The UH investigator is required to prepare and submit an external IRB submission in ICON.  Follow these instructions for completing this submission.

  3. You will need access to Sterling’s portal “SilverLink.” To request access to SilverLink for the first time, contact Sterling at 770-690-9491.

  4. You will need to add Kirstin Holzschuh from the UH Research Integrity and Oversight (RIO) Office (kmholzsc@central.uh.edu) as a collaborator. Select the Collaborator link located at the top of each form and fill out the requested information needed:headerimage

  5. The template consent form to be used at UH will require edits to meet the Texas Medical Records Privacy Act requirements. These edits, required by UH’s legal office, will require the PI to obtain Sponsor approval before submitting to Sterling IRB. These changes are:

    1. The document’s HIPAA/confidentiality language must clarify that the subject’s information may be released in electronic, paper or other format. For example:

      Your study information may be released to the groups listed above in electronic, paper, or other form. If your child's study information is reviewed by these people, they may need to see your 

    2. One of the following statements needs to be added into the HIPAA section of the form:

      Special permission is required to release drug, alcohol, and substance abuse records, HIV/AIDS-related information, genetic information and mental health information. These kinds of records will not be used or disclosed in this study.

      Or

      Special permission is required to release drug, alcohol, and substance abuse records, HIV/AIDS-related information, genetic information and mental health information. With the exception of ________________ (previously mentioned on page ___), these kinds of records will not be used or disclosed in this study.


  6. The following will need to be completed and/or attached in the SilverLink portal:

    • APP205 Submission Application for the Investigator-Site

    • Screening Script APP267 (if applicable)

    • Copies of letters resulting from recent FDA inspections (contact the IRB office for help)

    • UH site-specific recruitment tools/emails (if applicable)

    • The PI’s most recent CV (if not already on file with Sterling)

    • Information regarding the PI’s DEA certificate

    • Subject compensation schedule (either in the APP205 application or as a separate attachment)

    • A copy of the template consent document from the Sponsor with UH’s specific edits as described above in #3

    • Documentation of approval by the Sponsor of the changes to the template consent document

      The majority of the above documents can be located on the Sterling website

  7. Before you submit in the SilverLink, contact the UH IRB Office. The UH IRB office will review the application, consent form(s) and attachments for completeness, consistency and accuracy.

  8. The UH IRB office will notify you via email that the application is complete and can be submitted in SilverLink.

  9. Sterling IRB will conduct a pre-review and send back any administrative corrections needed.

  10. Sterling IRB routes the submission for IRB review.

  11. Sterling IRB notifies UH of approval through Silverlink. Once approved, you must attach the following Sterling-approved documents to your ICON external protocol submission:

    1. Approved protocol

    2. Approved consent form(s)

    3. Approved assent form(s) – if applicable

    4. Approved recruitment materials specific to UH

  12. Add the designated UH ancillary reviewers to your ICON external IRB protocol and submit.

  13. The UH IRB provides a final acknowledgment letter through the ICON system. Once received, UH engagement in the research may begin.

Note: If the larger study has not already been submitted to Sterling IRB by the Sponsor and Sterling is reviewing as a new study, contact the UH IRB office via email for instructions and guidance.