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Institutional Review Board Scope & Responsibilities

The UH Institutional Review Board (IRB) reviews all human subject research protocols that includes UH patients, PHI, or data. In addition, all studies involving human subjects carried out on the premises, or using the services, of any University Hospitals Health System facility must be submitted to the UH IRB.

IRB Policies 

The Investigator Manual for IRB Submissions is designed to guide you through policies and procedures related to the conduct of human subjects research specific to the UH IRB. Investigators are required to abide by procedures as described in the manual.

Meeting Dates and Submission Deadlines

The UH IRB consists of three boards, one of which specializes in the review of cancer research. The three committees are referred to as J Committee, M Committee and C Committee.

  • The J and M Committees meet every two weeks on Tuesdays (except holidays) at 3:30pm.
  • The C Committee meets the 2nd and 4th Thursdays of the month (except holidays) at 2:30pm.

The deadline for protocol submission is 10 days before the meeting date.

IRB Requirements & Process

The following must be completed prior to IRB submission:

  1. CREC Certification in Human Subjects Protections for all staff listed on the study personnel table
  2. Investigator Training for all Investigators and non-Investigator staff as part of Clinical Research Orientation
  3. UH Research Credentialing for all non-UH personnel that will have access to UH PHI, systems, or conducting research on UH facilities.
IRB Process Flow

Forms & Templates

New Protocol Submission review requests, including Human Research Determinations, Exemptions, HUDs and Emergency Use requests must be submitted for review in the SpartaIRB System.

In SpartaIRB, much of the information about your study will be submitted to the IRB in a protocol template document that is a Microsoft Word file. When submitting in SpartaIRB, the use of one of these templates is REQUIRED.

  • HRP-503BIO: Biomedical Protocol template
  • HRP-503DATA: Chart Review Data + Specimens Protocol template
  • HRP-503NHR: Non-Human or Non-Research Protocol template
  • HRP-503SUPP: Supplemental Form

In addition to the above templates there are several other templates and forms that are required and/or available for use. For example Recruitment Templates and a HIPAA Waiver Forms. All templates can be found in the SpartaIRB System.