IRB: Closure/Continued Review

My research is completed or I need more time - now what do I do?

It is a FDA requirement that all research must be “Closed out” or you must have an “Annual Continued Review” prior to the annual expiration approval date.

Continued review/Closure form.
• Find the form: (This form can be found on the Research website – www.Genesy.org - search “research” Select- Continued review/Closure form
• Indicate on the form - status of your research – Closed or needs a Continued Review – (more time – another year)
Research is completed!
• After turning in your research paper to your individual Program Director, the MERC – IRB committee will want the closure form and your results - “attach” a copy of your research paper with the closure form.
Need more time! - A Continued Review must be done.
• MERC must receive the continued review form prior to the annual expiration date
• Fill out the “Continued Review Form” –Give the reason why research is not completed.
• This will be placed on the next MERC agenda.
SUBMIT TO THE COMMITTEE -
Electronic submission via http://www.IRBnet.org –
• Click on "Study Manager" - Select “title” of your research –
• Click on Edit (top of page) click - “New Package” - and click - "Designer" “browse and attach” forms.
• Electronically sign and click submit this package
Contact: Candy Rainwater, IRB Administrative Coordinator, 606 7722 or crainwater@genesys.org - If you have any questions.

NOTICE REMINDER!
Seniors - EVERY RESIDENT, THAT CONDUCTS A RESEARCH STUDY AT GENESYS - MUST HAVE THE STUDY CLOSED OUT - OR TRANSFERRED TO ANOTHER GENESYS PRIMARY INVESTIGATOR (PI), PROIR TO LEAVING GENESYS.

A signature, from the Director of Research, Dr. Kim Barber verifying your research project has been completed; on the “MED ED check-out” form is mandatory for graduation requirements.

DO NOT WAIT - UNTIL THE LAST DAY AT GENESYS TO DO THIS.