IRB Fees
- Institutional Review of Privately Funded Research on Human Subjects
- Administrative Review of Commercial IRB Approved Research on Human Subjects
- IRB Archived File Request
INSTITUTIONAL REVIEW BOARD REVIEW OF PRIVATELY FUNDED RESEARCH ON HUMAN SUBJECTS
Institutional Review Board charges for review of human subject research funded by private industry sponsors (predominantly pharmaceutical or device manufacturing companies) will be as follows:
Full Board | New Protocol Submission | Non-Network and Network | $2500 |
---|---|---|---|
Continuing Review | Non-Network and Network | $650 | |
Amendment | Non-Network and Network | $650 | |
Expedited Review | New Protocol Submission | Non-Network and Network | $650 |
Continuing Review | Non-Network and Network | $500 | |
Amendment* | Non-Network and Network | $500 | |
Closure Fee | Non-Network and Network | $200 |
Note: At present, there will be no charge for:
- Emergency Use of an Investigational Drug or Biologic (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126491.htm)
- Treatment Use of Investigational Drugs (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126495.htm)
- Humanitarian Use Device (A HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year)
- Studies in followup, data analysis
*IRB fees apply only to non-administrative changes of study documents requiring IRB review.
Administrative Review of Commercial IRB Approved Research on Human Subjects
Initial Review | $2000 |
Continuing Review | $500 |
Close Out | $200 |
For Cause Audit | $1000 |
IRB Archived File Request
Study teams are expected to maintain their own documents according to federal, institutional and departmental guidelines. In the event that a study team needs to access inactive, archived regulatory files maintained by the IRB, an IRB Archived File Request form must be submitted.