The Colorado Multiple Institutional Review Board (COMIRB) administration provides office support for the five institutional review board (IRB) panels and processes protocols submitted for review under the expedited or exempt process.
COMIRB administration is made up of 25 individuals whose responsibility is to ensure that all research activities involving human participants are conducted in a way that promotes the rights and welfare of the subjects. The COMIRB administration is made up of the following people: Director, Assistant Director, Senior IRB Analyst, Senior IRB Manager, Senior IRB Specialist, coordinators, regulatory analysts and administrative assistants. All of these staff play key roles in processing new protocols, continuing reviews, amendments and addressing unanticipated problems. There are six teams (one for each panel including five full board panels and the expedited/exempt panel), each is made up of an administrative assistant, regulatory analyst and coordinator(s) that work for a specific panel.
- 1991
- COMIRB established with four affiliates (UCHSC, VA, TCH, DHHA)
- CPC joined as an affiliate
- 09/1999
- FDA (then OHRR) shut down COMIRB operations
- 1999-2000
- Utilized WIRB while COMIRB was re-structured
- 01/2000
- COMIRB re-opened with three Review Panels (2 general adult and 1 pediatric)
- 2000
- COMIRB made quarterly reports to OHRR
- 02/2000
- FDA audit of COMIRB
- 07/2002
- Panel D established as a review panel for high risk protocols
- 12/2004
- OHRP audit of COMIRB
- 05/2004
- NCQA audit for Denver VAMC
- 08/2005
- FDA audit of COMIRB
- 07/2005
- Contracted with WIRB for certain pharmaceutically sponsored research
- 04/2006
- Re-reviewed Expedited/Exempt protocols previously reviewed due to internal audit findings
- 11/2006
- FDA audit of COMIRB
- 09/2007
- Took on administrative responsibility for HSRC (Downtown Campus IRB)
- 11/2007
- Audited all open studies at HSRC (Downtown Campus IRB)
- 02/2008
- Submitted application to AAHRPP
- 08/2008
- Denver VA AAHRPP accredited
- 12/2009
- Converted database to InfoEd
- 06/2009
- UCD AAHRPP accredited
- 05/2010
- Began electronic submission for request for exemptions
09/2010
Began electronic submission for request for Expedited (All Campuses)
Began electronic submission for request for Full Board (Downtown CampusOnly)