| Research
& Sponsored Programs |
Indiana University-Purdue University Indianapolis
Research and Sponsored Programs
IRB Review Fee
Dear Investigator:
As you know, research is one of our most important priorities at IUPUI and moreover, research with human subjects is extensively regulated. With new regulations and recent interpretations by the Office for Human Research Protections (OHRP) and others, we are all, investigators and Institutional Review Boards (IRBs) alike, faced with the challenge of complying with these rules. In order to ensure compliance for our University and Clarian to continue in our research endeavor, increased demands upon the IRB, staff, and investigators must be met.
In recent years, the institution has worked to develop and expand its human research protection program (HRPP) such that it will continue to operate in a highly principled way. However, costs have increased for the institution relative to ensuring the HRPP’s ethical and compliant functioning. The IRB plays an integral part in this program and the IRBs’ responsibilities continue to increase. For example, the number of study actions (including all new study submissions, continuing reviews, amendments, adverse event reports, etc.) requiring IRB review increased 18.5% between 2002 to 2003 and the number of adverse event reports requiring IRB review increased 4.7% during the same year.
As a result, additional IRB members have been recruited for service on the IRBs in response to an ever-increasing IRB workload, necessary additional support staff have been hired to facilitate the IRBs’ functioning, and new standard operating procedures (SOPs) for investigators are being continually implemented. An audit program (based upon these SOPs) has been instituted, as well. An electronic research application (ERA) submission system (which will allow for the electronic submission, processing, routing, and management of IRB protocols) is also being developed “in-house” and is anticipated for release in 2005.
Institutions around the nation are facing similar rising costs and have already established comparable IRB charges or are redefining them to ensure their appropriateness to adequately recover their institutional costs. Effective January 1, 2005, the fee schedule for IUPUI/Clarian IRB Review is as follows:
