IRB Review for Federal or State Grant

Many grant management officers will not issue a Notice of Award until IRB approval has been obtained. Hence, the IRB advises investigators to plan ahead and prepare a submission to the IRB as soon as possible.

Some grant management officers may accept an IRB review date or a preliminary administrative review determination from the IRB.

It is important to understand the requirements set forth by the sponsor and the grant management officer to ensure a smooth process. Please discuss your IRB review requirements with your grant management officer and/or the Office of Research Services (ORS) Pre-Award to confirm what is required.

Approval in Concept or Delayed Onset of Human Research

The following describes preliminary administrative review determinations. These determinations do not serve as authorization to begin human research activities. A full protocol application (including consent forms and supplemental documents) must first be submitted through HS ERA for assessment and approval by the IRB prior to engagement in human research activities.

1. Approval in Concept

   Some grant management officers allow for documentation of IRB Approval in Concept to be submitted after the proposal has received a certain impact score.

2. Delayed Onset of Human Research

   Some NIH funding proposals fund development work that is necessary in order to finalize the phase(s) of the research that involve human participants. In these cases, some funding grant management officers may accept a determination notice that establishes a limited time period under which the PI may conduct preliminary or conceptual work that does not involve human subjects.

   
   IMPORTANT: Please note that “delayed onset” is not the same as “delayed start.” You must have approval from the funding sponsor’s grants management officer in order to apply for a delayed onset award.

Request Approval in Concept or Confirmation of Delayed Onset

A preliminary administrative review determination from the IRB can be requested by submitting the following documentation. These determinations will be granted for a period of one year.

1. Copy of the grant, minus appendices.

2. Name of the Principal Investigator

3. Study Title (exactly as it should appear on the letter)

4. Funding Source

5. Notice / communication from the grants management officer that specifies IRB requirements and associated deadline

6. If applicable: Any additional information that the IRB may need to confirm in the determination letter (e.g. proposal number)

7.  

Request an IRB Review Date or Rush Approval

The IRB advises investigators to plan ahead and prepare a submission to the IRB as soon as possible.

A member of the IRB staff will respond with the anticipated review timeline and any additional items that may be required to complete the review.

Due to the high volume of submissions, the IRB will not honor rush requests without confirmation of the necessity of the rush request and specific deadlines for review/approval.

If you are required to provide an IRB approval date or require a rush approval, please do the following:

1. Consult with Office of Research Services (ORS) Pre-Award to confirm your IRB requirements

2. Prepare your IRB submission and submit it through HSERA

3. Contact your Department Chair for rush department review, if needed.

4. Email the IRB PO Box with your request (for an IRB Review Date or Rush Approval), your HSERA confirmation code, and notice / communication from the grants management officer that specifies IRB requirements and associated deadline.