Institutional Review Board

FAQ for Researchers

Q. What does the IRB consider research?

A. Research means a systematic investigation (including research development, testing and evaluation) designed to contribute to generalizable knowledge.

 

Q. What do I need to do to conduct a research project?

A. Please review the Investigator Reference Manual, on the IRB website?

  

Q. Do I need IRB approval to send study data to an outside site?

A. Yes, you do need IRB approval to send study data to an outside site.

 

Q. What types of IRB review are there?

A. Types of IRB review include convened full board, expedited, and exempt review.  All applications are submitted through CYBERIRB, the on-line electronic application submission system.

 

Q. What is the difference between Full Board, Expedited and Exempt Review?

A. Studies involving more than minimal risk*, including studies with vulnerable populations and/or sensitive questions, as well as studies with the possibility of physical risk and do not fit into any of the Exempt or Expedited categories (see below), will undergo convened Full Board review.

Expedited review is for minimal risk* studies that fall under one of the specified categories listed in the IRB Expedited Review Standard Operating Procedure (SOP), which are also listed on the Initial IRB submission form.  This review is conducted generally by one primary reviewer and typically is not does need to wait for review at the monthly convened Full Board IRB meeting.  Protocols approved under Expedited review are however, subject to ongoing continuing reviews.  That timeline is determined at the time of determination for approval.

Exempt review is for research studies that federal regulations have identified as those that can be exempt from IRB review.  Research studies must be minimal risk and must fall under one of the specified categories.  Most institutions, including Aspirus, require an IRB Administrative review to determine whether the claim for exemption is appropriate and whether exemption will be granted.  Once exemption is granted, protocols are exempt form continuing IRB review unless it changes and no longer qualifies.

*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

 

Q. Does Expedited review mean that my protocol application gets processed faster?

A. No, Expedited review doesn't mean your protocol application is processed faster; rather instead of two or more reviewers and the full board, only one primary reviewer is assigned to review your protocol.  However, most expedited protocol applications submitted are processed within a few weeks versus waiting for the full board IRB meeting, which meets once a month.

 

Q. How do I apply?

A. Contact the IRB Office at (715) 847-2569 or ext. 72569 to acquire access to the on-line IRB application and various other forms for submission through the CYBERIRB electronic submission system.

 

Q. Which form should I use when requesting my research project be reviewed by the IRB?

A.  Aspirus Wausau Hospital has transitioned into utilizing the internet to submit applications to the IRB through the use of a new program, "CYBERIRB".   This program is accessible from any computer at any site through the following website address link:   http://www.CyberIRB.net/Aspirus

If you are a new Investigator or an investigator who has previously submitted a paper IRB submission form please contact the IRB Office (715) 847-2569 to receive instructions, a USER ID and Password to access CYBERIRB.  

All requests to the IRB for review should be submitted electronically through the CYBERIRB program.  Within the CYBERIRB program you should choose the following forms depending on which type of review you are requesting:  For new research protocols that may qualify for full board or expedited review the form for Full Board or Expedited Application for Initial review 10-09.doc should be used.

Use the Exemption Request Form 3-08.doc when submitting a project that may qualify for exempt review status.

Use the Modification_Request Form_10-09.doc when submitting any change to the protocol such as amendments, revisions, consent form changes, enrollment closures any other miscellaneous changes.  Also use for submitting Data Safety Monitoring Committee reports, new findings, correspondence from sponsors, and study results. 

Use the Adverse Event Report Form111709.doc when submitting all Local adverse events or Off-Site Unanticipated/Unexpected and Related adverse events.

Use the Continuing Review (full or expedited) /Final Closure 10-09.doc when submitting a progress report for clinical studies or when requesting final closure/termination of IRB oversight. 

Use the Humanitarian Use Device (HUD) Continuing Review/Final Closure Report 10-08.doc when submitting a yearly progress report or closure of a HUD.

Use the Deviation Form 04-11.doc when notifying the IRB of a protocol deviation.

 

Q. When does the IRB meet?

A. The AWH IRB meets on the 3rd Tuesday of every month.  Please see meeting and submission due date timeline located on this website

 

Q. What if I still have questions after reading the Investigator’s Manual?

A. You may contact the IRB Office at 715-847-2569 with questions.