Instructions for Submitting Applications to the IRB

All IRB applications must be submitted online.

The following changes to the Human Research Review Application (HRRA) will go into effect on 8/15/05.

The Principal Investigator’s Statement of Assurance will be deleted from the HRRA and will become a separate form. The following has been added to the Statement of Assurance:

“ I am responsible for all changes made to this study and for all reports submitted to the IRB by all members of my study team.”

By signing this statement, which is now a separate document within the application, the PI’s signature will no longer be required on IRB forms with two exceptions:
The Change in Personnel form and the Conflict of Interest form will require the Principal Investigator’s signature.

The signed Statement of Assurance (Signature Page) can be delivered or faxed to the IRB to complete the application process. When applicable, the signed Conflict of Interest form must accompany the signature page. If all material within the application has been entered electronically (typed in or uploaded), no additional hard copy information is required. Any items that are not submitted electronically must be delivered to the IRB in hard copy.

Informed Consent Guide - Use second person. The PI can either submit the standard paragraphs and signature lines, or the IRB staff will supply them. Note the sample consent for genetic studies.

Continuing Review Process - It is the responsibility of the PI to request renewal from the IRB. A reminder will be sent to the PI. Final notices will not be sent. If a study is not renewed by the IRB, it will out of compliance. Enrollment will be suspended and/or research will be stopped.

Amendments - All changes to approved studies must be reviewed and approved by the IRB.   Changes to approved studies that are greater than minimal risk will be reviewed by the Full Board at a convened meeting and must be submitted in accordance with deadlines. Some examples are:

*Increased risk

*Increased dose range or increased number of subjects

*Adding minors

*Changes to an IND/IDE study other than administrative in nature.

If changes are not highlighted on informed consents and/or protocols, they will be returned to the PI without review.

Adverse Event Reporting - The guidelines, reporting time frames and form for simultaneous reporting of external events are posted at research.musc.edu/ori/irb/unxadvev.htm

Conflict of Interest - Completion of this form is required for all corporate/industry sponsored studies, or if the investigator or any family member or other persons have any financial interest or relationship with sponsor or agency that would appear to be a conflict of interest.