Changes to the Common Rule, the primary rule governing human subjects research, go into effect on January 19, 2019. Studies reviewed by the IRB after this date will fall under the new rule. More information on the changes can be found here.
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The Division of Research launched a new IRB protocol submission system called ICON in September 2016.
The University of Houston is committed to the pursuit of excellence in teaching, research and public service. Concomitantly, the university seeks to protect the welfare of every person who may become a participant in research projects undertaken by UH faculty, staff, and students.
Review and oversight of research involving human subjects or identifiable data derived from human subjects is the charge of a federally mandated committee called an Institutional Review Board, or IRB. The University of Houston has three IRBs. The IRB is responsible for safeguarding of the rights and welfare of all persons participating in University of Houston research projects in accordance with federal regulations and the ethical principles established by the Belmont Report.
Prior to proposing research to the IRB, please review the regulations applicable to your project. 45 Code of Federal Regulations (CFR) 46 (“The Common Rule”) specifically addresses the protection of human study subjects as promulgated by the Department of Health and Human Services (DHHS). Regardless of funding, all research at UH is held to the DHHS standard. 21 CFR 50 and 21 CFR 56 are the general regulations that govern U.S. Food and Drug Administration (FDA)-regulated research. FDA regulations 21 CFR 312 and 21 CFR 812 govern research involving drugs and devices, respectively.
All UH faculty, staff or students proposing to engage in any research activity involving the use of human subjects must have approval from the IRB prior to the recruitment of subjects or the initiation of research procedures. Any questions regarding the IRB or the Standard Operating Procedures and tools found in our online submission system should be directed to the IRB office at firstname.lastname@example.org. The submission of applications to the IRB is currently handled through ICON, the Integrated Compliance Oversight Network.
The University of Houston’s Federalwide Assurance number is FWA 00005994.
The main phone line for the IRB office is (713) 743-9204, and our email address is email@example.com.
Applications to the IRB
IRB applications must be submitted online through ICON (see button on top right). Detailed training materials and videos can be found here.
- IMPORTANT: Build your protocol prior to starting a submission in ICON. Use the Word protocol templates found on the IRB- Investigator Tools page of the IRB website to construct your protocol before logging into the online system. You will be asked to upload this on the first page of the ICON Smartform, and cannot proceed until the document is uploaded. These templates and others can also be found within the ICON Library. This is the biggest change from our previous submission system.
- Ensure time to obtain required ancillary reviews. Investigators must assign their own ancillary reviewers after entering their protocol into ICON, and prior to submission to the IRB. In most cases, the Dean of the College and Chair of the Department should be added as primary ancillary reviewers. A completed review from at least one of these parties is required (check with your college for specifics) prior to the submission of the protocol to the IRB. Student PIs must assign their faculty sponsor and obtain this review prior to submission. Other ancillary reviews may be required prior to protocol approval, such as Biosafety or Radiation Safety, if applicable. The IRB office will not place the protocol on an agenda until the primary ancillary reviews are complete.
- Assignment of review category and turnaround times. During the pre-review process, IRB staff will assign your protocol to the applicable regulatory category (exempt, expedited, full board), based on federally designated data. These criteria are found here.
Once the pre-review is complete, your protocol workspace in ICON will show your protocol as non-committee review (for exempt and expedited protocols) or committee review (for full committee review). Once assigned to a category, the expected turnaround time for non-committee reviews is 10 days. Full committee review meeting dates are listed under the tab for each committee; determination letter turnaround is approximately 5-8 business days following a convened meeting.
- Keep your protocol document updated with each submission. Each time additional information is required by the IRB for approval, or when a revision is made to approved research through the submission of a modification, ensure that the corresponding protocol document is updated into ICON with your submission. The protocol document should remain up to date with the current research procedures at all times. ICON will maintain a history of all approved versions of the protocol.
- Make sure the Smartform and protocol document is complete; answer all questions thoroughly and ensure appropriate attachments have been uploaded. All submissions to the IRB will undergo a preliminary administrative review to determine if the submission is complete and meets the basic requirements for compliance with IRB Standard Operating Procedures. Any submission that is incomplete will be returned for additional information and resubmission before being assigned to an IRB meeting.
- Allow time for feedback and resubmission. Most IRB submissions require at least minor modifications to be addressed prior to approval. When submitting your protocol, please budget time for addressing requested modifications and IRB office review of responses.
- Ensure that all human subjects procedures listed in a grant proposal are contained within the protocol reviewed by the IRB. The Research Integrity and Oversight (RIO) Office is tasked with performing a congruence review for all internal and external funded awards to ensure that research procedures described in the proposal are approved by the IRB. This review is conducted prior to the release of research funds. A delay in the release of funds may result if procedures outlined in the grant are not approved in the protocol.
IRB Committee 1
IRB Committee 1 is responsible for the full review of human subjects research protocols submitted by faculty/staff for all colleges except the C.T. Bauer School of Business and the College of Liberal Arts and Social Sciences (CLASS). Exceptions: The HHP Department of CLASS submits to IRB1; all FDA-regulated research is also reviewed by IRB 1, regardless of college.
IRB Committee 2
IRB Committee 2 is responsible for the full review of human subjects research protocols for the C.T. Bauer School of Business, the College of the Arts, and the College of Liberal Arts and Social Sciences (CLASS), with the exception of the Department of Health and Human Performance. IRB2 does not review FDA-regulated research.
IRB Committee 3
IRB Committee 3 reviews all student-led human subjects research. Student-led protocols require a faculty sponsor; the faculty sponsored must ensure that IRB review/approval is obtained prior to research initiation. Specified IRB office hours, assistance, and training are available for students and/or their faculty sponsors. IRB 3 does not review FDA-regulated research.