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Schulman IRB Reliance

Schulman IRB Reliance

 

What is Schulman?

Schulman Associates Institutional Review Board (IRB) is an independent IRB located out of Cincinnati, Ohio that provides services for academic and non-academic institutions.  Schulman has been accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP) since 2008.  Schulman has built a reputation as one of the nation’s leading independent IRBs. For decades, the Ohio-based company was known primarily as a reviewer of multicenter phase 2 and phase 3 clinical trials. In 2009, Schulman decided to branch out and capture a larger share of the single-site phase 1 market.

 

What Type of Studies Qualify for Schulman Review?

Studies that meet all of the following criteria are eligible for Schulman review: 

  • Phase IIb, III or IV clinical trials
  • Industry authored
  • Industry funded
  • Sponsor/CRO has contracted with Schulman or with an affiliated IRB (i.e., Copernicus Group IRB, Aspire IRB, MidLands IRB and New England IRB) to provide IRB services for the study (documentation required)

Exceptions

Studies involving the following procedures or populations do not qualify for Schulman review:

  • Surgical techniques or procedures
  • Transplant techniques, procedures or other interventions
  • Stem cell therapies
  • Gene therapy or gene transfer
  • Investigational radiologic procedures
  • FDA-approved or investigational radiological agents
  • Neonates

UCI IRB reserves the right to make additional exceptions and has final say on whether UCI IRB review is required. 

 

How do I obtain clearance from UCI to submit to Schulman?

Schulman IRB will not review research on behalf of UCI without a formal ‘Clearance Notice’ issued by UCI IRB.  

A.   Pre-Submission

The UCI Lead Researcher (LR):

  • Determines that study meets eligibility criteria for Schulman review. If there are any questions, contact the UCI IRB staff via email at IRBReliance@uci.edu for guidance.
  • Confirms that Sponsor/CRO has contracted with Schulman or its affiliates to provide IRB services for this study and that sponsor will cover cost of Schulman review.  Documentation required.
  • Includes the UCI IRB fees (expedited IRB fee rate) in the clinical trial budget for administrative review and oversight.
  • Initiates process, if not already started or completed, to obtain other UCI regulatory committee/ institutional approvals (i.e., Radiation Safety Committee (RSC), Conflict of Interest Oversight Committee (COIOC)), as needed.

B.  Submission to UCI

The UCI LR must submit the following documents, as applicable:

    • Master Protocol (MP) and any applicable Amendments not included in MP
    • Investigator Brochure
    • Sponsor Template Consent
    • Draft of UCI Schulman Consent using UCI template language
    • UC/UCI HIPAA Research Authorization Form
    • Recruitment Materials
      • Appendix T (HIPAA) if a partial waiver of HIPAA for recruitment purposes only is requested to review UCI Medical Records to screen for eligibility
    • Self-Certification of Surrogate Decision Makers for Potential Subject’s Participation, as applicable
    • FDA Investigational New Drug (IND) Letter indicating Sponsor’s IND filing date
    • FDA Investigational Device Exemption (IDE) Letter or Non-Significant Risk (NSR) Determination Letter
    • Other UCI regulatory and institutional approvals/acknowledgements (e.g., PRMC, COIOC, RSC)

C.  Review Process

1.  UCI IRB confirms that study is eligible for reliance on Schulman, the paperwork is complete, and all other required UCI regulatory committee approvals are obtained.

  • If study is eligible, paperwork complete and all required approvals in place, UCI IRB will send an email (ie, ‘Clearance Notice’) to the UCI LR indicating that the study is eligible for Schulman review. 
  • If study is not eligible and/or the paperwork is incomplete, or other regulatory committee approvals are not provided, UCI IRB will notify UCI LR in writing of the determination or additional requirements.

2.  Once eligibility is confirmed, a formal ‘Clearance Notice’ is sent to the UCI LR that the study may be submitted for Schulman review through eTools.

3.  Schulman reviews LR's documentation and communicates directly with UCI LR with respect to any required revisions or additional information needed.

4.  Schulman sends the UCI IRB notification that study has been approved. 

  • Schulman provides an approval notice, a stamped version of the approved recruitment and consent documents, which includes the UCI IRB previously-approved and agreed upon consent template language.
  • UCI IRB Staff releases the approval notice and other relevant study documents through the IRB Doc Depot.

D.  Post Schulman Approval

The UCI LR submits all other transactions to Schulman:

  • Amendments, Continuing Approval, Unanticipated Problems are reported directly to Schulman.
  • UCI IRB is notified of all Schulman approved transactions by Schulman.
  • Exceptions
  • All changes in study team personnel must be submitted to UCI through a modification request.
  • Request to access Personal Health Information (PHI) covered under HIPAA, as UCI serves as its own Privacy Board.

 

Schulman Submission and Review Process

  • If PI/Sub-I is working with Schulman for the first time, please submit a CV signed and dated within the last two years.
  • During the IRB review process, you may receive emails from different Schulman staff members who are working on your submission.
  • Schulman can insert your TJU-specific ICF language, which has been approved by OHR and is already on file with Schulman. You may also submit the ICF with TJU-specific language already inserted.
  • You can develop a template in eSubmission to use with multiple Schulman submissions.
  • You can share documents with other users via eSubmission.
  • SiteAccess is Schulman’s tracking and approval document access system. Please contact Maria or Ashley if you have any questions about using SiteAccess.
  • You may receive an automated email indicating there are study-related documents to review and revise on SiteAccess.
  • Once your submission has been approved by the IRB, you will receive an email notification informing you of the approval. The email will include a direct link to access the approval documents. You can also access your approval documents by signing in to Schulman’s eTools and choosing “SiteAccess.”   

Resources:

Schulman Templates for Use at UCI:

 

Contact:

Maria Stivers, Manager
(Institutional Services)
W: 513-794-5743
mstivers@sairb.com

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