IRBs began in 1974 when the National Research Act was signed into law, the Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was charged with identifying the basic ethical principles that underlie the conduct of Biomedical and Behavioral research and to develop guidelines for research involving human subjects. Human subject research provides many societal benefits, but it also brings some troubling ethical questions due to reported abuses of human subjects. These abuses were most egregious during the Second World War, but other cases occurred such as the U.S. Tuskegee Syphilis trial in which rural black men with syphilis were not told they were participating in research and were subsequently denied treatment for their disease when penicillin became a known cure.
The Nuremberg Code was drafted from the Nuremberg War Crimes trials of Nazi physicians and scientist who had conducted atrocious biomedical experimentation on concentration camp prisoners. The Code comprises certain basic principles that must be observed in order to satisfy the moral, ethical and legal requirements for the conduct of human research, and has become the prototype of many later codes. Another set of guidelines is the Declaration of Helsinki, authored by the World Medical Association, which allows for research on subjects with the diminished capacity to participate in research provided consent is obtained from their legal guardian.
COMIRB Historic Timeline
- 1991 - COMIRB established with 4 affiliates (UCHSC, VA, TCH, DHHA) and CPC joined as an affiliate
- 1999 - FDA then OHRR shut down COMIRB operations
- 1999 – 2000 - Utilized WIRB while COMIRB was re-structured
- 2000 - COMIRB re-opened with 3 Review Panels (2 General Adult and 1 Pediatric)
- 2002 - Panel D established as a Review Panel for high risk protocols
- 2004 - NCQA audit for VA
- 2005 - Contracted with WIRB for certain pharmaceutically sponsored research
- 2007 - Took on administrative responsibility for the Downtown Campus
- 2008 - Submitted application to AAHRPP
- 2008 - Denver VA AAHRPP accredited
- 2009 - Converted database to eRA(InfoEd)
- 2009 - UCD AAHRPP accredited
- 2012 - Re-accreditation by AAHRPP