Saybrook IRB

Starting an IRB Application

To create a new application (or to edit an application in progress or to check on the status of an application), log into Mentor IRB from the Saybrook website and select My Applications tab on the left navigation menu.  

For detailed step-by-step guidance on the application process, including signing and submitting applications, see the Researcher Guide to the Application Process in Mentor IRB.   This guidance document is primarily intended for students, yet faculty may find it helpful as well as an orientation.  

For students, please be aware that there is a Pre-Application Survey before you start your new IRB application.  The Pre-Application Survey is a diagnostic survey designed to help you determine whether your project meets the definition of human subjects research, and if it qualifies for an exempt determination, or an expedited review or will require a full board committee review.  For Faculty submitting an IRB application, the Pre-Application Survey is an optional item, and not required.  

Dissertation Faculty Co-PIs

For students submitting an IRB application, the Faculty Advisor role in Mentor is a type of Co-PI.   All student applications require the identification of a Faculty Advisor and for dissertation work, two committee members, who also act as Co-PIs.  Faculty Co-PIs are responsible for mentoring student researchers through the IRB process.  They are responsible for ensuring the project plans submitted to the IRB represent the faculty-approved proposed research project and that the project is implemented in accordance with the IRB approval.  Faculty Co-PIs sign student IRB applications verifying that they have reviewed the application and will provide oversight, as well as divulging any financial conflicts of interest associated with the research.  Faculty Co-PIs also help student PIs understand when the IRB must be contacted for a modification, or to report an adverse or unanticipated event.

Full Board Review
A full board review is required when a proposed research project is “greater than minimal risk” (in other words, the project does not meet certain criteria for an expedited review or exempt determination) and is reviewed by a duly-convened meeting with a quorum of voting members present. 

Expedited Review
According to Merriam-Webster, “expedited” means fast. But in the IRB world, “expedited” means that the research project presents no more than minimal risk and does not have to be reviewed by a Full IRB Committee. The IRB Chairperson or designee can review the submission and has the full authority of the duly-convened IRB with the exception that the Expedited Reviewer cannot disapprove a project. When a reviewer cannot approve a submission under the expedited process, the item is referred to the full board for discussion.  A list of categories of research that are eligible for an Expedited review can be found on the OHRP Website.

Exempt Determination
The Code of Federal Regulations identifies several different categories of minimal risk research as being exempt from the regulatory requirements and IRB oversight. This does not mean that they are exempt from IRB review, simply that the research project is exempt from ongoing, periodic IRB oversight.

Non-Human Subjects Research Determination (NHSR)
45 CFR 46.102 lists very specific definitions about what constitutes “research” and what is meant by a “human subject.” Although the federal regulations do not require official IRB review of studies that do not involve human subjects research, investigators may be required to obtain documentation that their project either is not research and/or does not involve human subjects.   If it is determined that the submission does constitute research involving human subjects, the project will be referred to an Expedited reviewer for further consideration.

When an IRB application is submitted in Mentor, a member of our team will conduct a pre-review, essentially to determine if the content in various application sections are in alignment, all materials are clear, articulate, and professionally formatted (e.g., Informed Consent, recruitment materials/flyers, site permissions, data management and security procedures), verification of CITI training credentials, committee signatures are present, and if needed, process a Revisions Requested.  Please know that we in the IRB consider Revisions Requested to be a dialogue with you as we confirm the application is complete.  During a pre-review the IRB team may encourage you to attend Office Hours to faciliate the process.   During the pre-review the Type of Review is confirmed for next steps.  Following the pre-review revisions and determination of review type (minimal risk or greater than minimal risk) an application is sent to an IRB member for review and determination, or placed on a Full Board agenda.  

How Long Does it Take to Obtain IRB Approval? 

The answer to this question varies and is dependent upon the type of review, the IRB queue (we review as applications are submitted), how quickly responses to Revisions Required are re-submitted, and the calendar schedule (recognizing term breaks and holidays).   

All doctoral dissertation studies and faculty or staff research must pass through the IRB and the IRB makes a determination about on-going oversight (or not if exempt or NHSR).  It is important to note that reviews and determinations by the IRB must take place before any element of the study can begin.  

During the pre-review should the Principal Investigator (PI) not respond to the revisions requested or there are extenuating circumstances which prevent responses, the IRB Office may process an Administrative Withdrawal after six months of inactivity.   This is not a suspension or termination, yet an administrative action removing the application from active review allowing investigators to ascertain what appropriate next steps may be taken.  The administrative withdrawal also ensures that IRB materials are timely and site approvals and permissions don't expire during an extended review process, necessitating PI's reconnecting with outside entities.   

When in doubt, always contact the IRB Office.