IRB SUBMISSION REQUIREMENTS
& SCHEDULES
for Pre-Review and IRB Meetings

There are two deadlines that investigators need to be aware of when submitting IRB applications for Full Board review:

Pre-Review      

Pre-review of the CONSENT FORM: Make an appointment with the Research Subject Advocate who will examine your consent form to insure that it meets federal requirements and protects subjects adequately.

The RSA will sign one copy of the consent form once it meets the expectations to be understood by a lay person. This signed copy should be provided with the complete IRB documentation for review by the IRB.
 
Pre-review of the entire IRB protocol: Submit the Human Subjects Review Form electronically to the Human Subjects Administrator for pre-review. The Human Subjects administrator will return comments by Friday of the same week either by phone or e-mail to provide the PI with time to make corrections before the final submission on the same review timeline.

Final Submission - Due 2nd or 4th Monday of each month 

Provide 15 copies and one original signed original Human Subjects Review Form, two copies of protocol, 16 copies each of consent forms, last approved stamped consent forms, HIPAA authorization forms, recruitment material, etc. to the Human Subjects Administrator.

Exempt or Expedited reviews:  No deadline

Modifications: Provide a cover letter explaining the changes requested in the protocol, one  copy of amendment, and the appropriate number of documents based on Full Board or Expedited Review, as determined by the Human Protections Administrator.

Continuing reviews: Due 2nd or 4th Monday of each month 
Provide 15 copies + 1 original Continuing Review Form, 16 copies each of consent forms, last approved stamped consent forms, recruitment material (fliers, letters, etc.)

The Principal Investigator (and study nurse, if identified) receives a notification letter 6-8 weeks in advance of the expiration date. Receipt of this letter must be electronically acknowledged. If a continuing review has not been received and approved by that lapse date, a Hold Letter will be sent instructing the PI that no subjects may be recruited, until the required documents have been sent to the IRB for review.

Schedule of IRB Meetings

The IRB meets twice monthly on the 1st and 3rd Tuesday, at 12:00 – 1:30 p.m. in the CRC Conference Room, Room 416, Old Hospital, on the Dental side (See the exception for January 2008 )

2007-2008 SCHEDULE OF IRB MEETINGS:

2007

• December:  4, 18 

2008

• January:  15, 29   (this is the 2nd & 4th Tuesday, since Jan. 1 is a holiday);  
• February:  5, 19  
• March:  4, 18 
• April:  1, 15     
• May:  6, 20     
• June:  3, 17