Information for Researchers | Human Subject Research Office | University of Miami

Studies that do not involve human subjects or do not meet definition of research are considered Not Human Subjects Research (NHSR) and do not require review in IBISResearch. If you think your study is NHSR, please follow instructions on this page.

Studies that are Human Subjects research must be submitted in IBISResearch for IRB review (exempt, expedited, or full board review). See below for instructions on submitting in IBISResearch.

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  • Logging into IBISResearch

    The eProst System (IRB8) is now an archived read-only site.

    The new IRB10 System is now part of the IBISResearch suite, click here to login: https://ibis-research.miami.edu/IRB

    For more information on the new system, including FAQs, please visit the IRB10 Project webpage

  • Submission Process

    Before opening a submission, be sure that the correct Forms & Templates are used.  Answer the questions and click Continue to save your information.  When you reach the end, click the Finish button. 

     

    Revising Research Documents

    • Save the last changes of the revised documents before you add any new changes. This allows only new changes appear as “tracked.”

    • It is unnecessary to provide a clean version of the revised documents AND a word track changes version.

    • For pdf protocols, please save the clean final version under the Protocol section using the update button to replace the old version and add a tracked changes version to the Other attachments section.

    • For updated Drug/Device documents, please upload the clean final version to the Drug/Device section and add a tracked changes version and summary of changes document to the Other attachments section.
    Note: If an updated Investigator Brochure contains revisions to risk profile or expected adverse reactions, please submit this within ten (10) business days via an RNI

  • Steps After Submitting

    • Your study may require specilized review by an Ancillary Committee which is conducted in parallel with the IRB review. You will need to contact the committee assigned to your study and submit the research to that Committee according to the Committee’s requirements.

    • If your study is cancer related, please submit all study related materials to the PRMC via the PRMC Electronic Submission (PES) Form at PES https://bbcapps.ad.med.miami.edu:8443/PES/login.htm

    • Principal Investigators are required ensure that all study team members hold current CITI certification

    • All team members must complete the Disclosure process

  • How to Access Letters & Documents

    To find initial determination letters:
    1. Log in to IBISResearch
    2. Navigate to an approved submission.
    3. View the initial determination letter from the IRB at the top right of the workspace.

    To find determination letters for other activities:
    1. Log in to IBISResearch
    2. Navigate to an approved submission (see Follow-On Submissions tab on the protocol landing page).
    3. Click the Follow-on Submissions tab and click the “Correspondence Letter” link to see any/all Modification or Continuing Review letters.  To view a letter, click on any Correspondence link and to save a letter, right-click and select ‘Save Link As.’

    To find currently approved study documents:
    1. Log in to IBISResearch
    2. Navigate to an approved study
    3. Click the Documents tab on the main study workspace.
    4. Click on the appropriate document link to view the version you’re looking for. To save a document, right-click and select ‘Save Link As.’

  • Expanded Use of Investigational Drugs and Devices

    The regulations allow clinicians to use an unapproved drug, biologic or device without prior IRB approval in limited circumstances; however, the clinician must comply with FDA requirements in these situations. 

    When seeking to use an unapproved product, it is critical that the patient and his/her licensed physician consider all possible risks because the FDA has not determined whether the products are safe. Such products may, or may not, be effective in the treatment of the condition.

     

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