Frequently Asked Questions

Am I conducting human subjects research?

What is required for inclusion or exclusion of subject who do not speak English?

When do I need IRB review?

Any activity that either:

  1. meets the DHHS definition of “research” and involves “human subjects” as defined by DHHS OR
  2. meets the FDA definition of “research” and involves “human subjects” as defined by FDA.

requires IRB review and approval prior to engaging in the activity or any such procedure. Investigators meeting either of these criteria must submit the project/activity to the IRB for review and approval (either as “Exempt” or review via “Expedited” or “Full Board’).

Investigators engaging in activities who believe that the activity either is not research or does not involve human subjects should submit a formal request for determination to the UH Clinical Research Center (UHCRC). The Office of Research Compliance (ORC), in consultation with the Vice President for Research and Technology, in UHCRC will affirm if an activity qualifies as “human subjects research.”

Where is the IRB office located?

The IRB Administration office is part of the UH Clinical Research Center which is located in Lakeside 1400. This is toward the front of the Lakeside Building across from the elevators, near the Chaplain’s office. The IRB office mail stop is LKS 7061. The IRB phone number is 216-844-1529.

What is the IRB’s Federal Wide Assurance number?

An FWA is an institution or organization's assurance to the federal government that human subject research conducted at that site is in compliance with federal regulations pertaining to the protection of human subjects. The UH IRB’s FWA is 00003937.

How often does the IRB meet?

A Full Board meeting, or a fully convened meeting of the IRB, occurs every Tuesday at 3:30 p.m. (unless otherwise noted on the IRB meeting date calendar). Research considered “greater than minimal risk” or research that does not otherwise meet OHRP and/or FDA requirements for “expedited review” per 45 CFR 46.110 and 21 CFR 56.110 are scheduled for Full Board review.

What is the IRB’s Registration number?

An FWA is an institution or organization's assurance to the federal government that human subject research conducted at that site is in compliance with federal regulations pertaining to the protection of human subjects. The registration numbers for the UH IRB committees are 00001691 (M) and 00000684 (J).

How do I submit something to the IRB for review?

All submission forms can be found on the Internet. View “Forms and Templates” to obtain all the necessary forms for any type of submission to the IRB (new protocol, amendment, continuing review, problem/adverse event reporting, etc…).

For additional assistance regarding what should be included with each type of submission please review the UH IRB policy specific to the type of submission and/or the “reminder checklist” (also found on the forms and templates page).

Please be sure to provide the original and one copy of the submission (for a total of 2 copies) to the IRB Administration office in Lakeside 1400.

Do I submit my project to UH IRB or the Case Behavioral Sciences IRB?

The UH IRB will conduct the review of all research undertaken by all members of the UHCMC staff. As the UHCMC is constituted to review biomedical research, the UH IRB also reviews projects for the following: Case clinical and academic departments housed within the Case School of Medicine; The Case Frances Payne Bolton School of Nursing, Case School of Dentistry, Case School of Engineering, and any other Case School if the protocols involve patients personnel, or resources of UHCMC; All projects involving patients or personnel of UHCMC; Other selected proposals as requested by the Case Behavioral Sciences IRB; Other selected proposals as outline under a fully executed IRB authorization agreement.

Projects that are non-biomedical and that do not involve UH patients, staff, or faculty may be reviewed by the Case Behavioral Sciences IRB. Projects that involve animal use should be reviewed by Case’s Institutional Animal Care and Use Committee (IACUC).

How long will it take for expedited review of a protocol?

The length of review time for any protocol varies by the complexity of the submission and the number of IRB submissions currently being processed by the IRB office. NOTE: The term “expedited” does not mean “fast” or “quick”. The term “expedited” refers to the type of review that the submission qualifies for according to the requirements outlined in 45 CFR 46.110 and 21 CFR 56.110. Expedited is different than Full Board review in that the submission does not need to be triaged to review at a fully convened meeting of the IRB (which occurs every Tuesday of the month). These Federal Regulations pertaining to human subject protections allow for certain kinds of research involving no more than minimal risk, and for minor changes in approved research to be reviewed by the IRB Chair, Vice Chair or by one or more experienced reviewers designated by the Chair from among IRB members outside of a fully convened meeting.

Please note that regardless of the type of review an investigator requests, the IRB Chair, Vice Chair or the Vice President for Research and Technology has the right to request a different type of review based on the type and nature of the submission (e.g., a submission that was submitted for expedited review may be forwarded to the Full Board and vice versa).

Can you tell me the status of my protocol?

Yes, in order for the IRB to provide a status report of the protocol, you must provide us with the IRB number (the six digit number xx-xx-xx). If the submission is a new protocol submission, please provide the IRB with the name of the Principal Investigator and the study title. The IRB will search the database and provide you with the IRB number for your records.

The following are possible status dispositions:

Administrative Review: The protocol has been received by the IRB office and is being looked at by a member of the IRB administrative staff to assist in determining the method of review (full board or expedited), and affirming that all information is present to appropriately assess the submission.

Full Board review: The submission has been triaged to the next available full Board meeting for review by a fully convened meeting of the IRB. These meetings take place every Tuesday afternoon.

Expedited review: The submission has been triaged for review by the IRB Chair, a Vice Chair of the IRB or by one or more experienced reviewers designated by the Chair from among IRB members outside of a fully convened meeting.

Approved: The submission was reviewed at either a fully convened meeting of the IRB or via Expedited review and found to meet criteria outlined in 45 CFR 46, 21 CFR 50, 56, 312, and 812 and the UH IRB policies. Once a submission is “approved”, investigators will receive a copy of the submission and a letter from the IRB indicating that the submission was approved.

Modifications required to secure approval: The submission was reviewed at a fully convened meeting. The Board determined that the submission could be approved pending receipt and administrative review of specific changes and/or receipt of clarifications. Typically, the Investigator’s Response to this type of request does not need to return to the full Board for re-review unless the changes are not made, the investigator disputes the Board’s findings or new information is added to the submission that was not included during the previous review.

Deferred: The submission was reviewed at a fully convened meeting of the IRB and the review was “deferred” pending receipt of additional information. A deferral typically occurs when the Board does not have sufficient information in the protocol and/or consent form to make a determination with respect to the risk to benefit ratio to subjects.

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