IRB Fee Structure
The costs associated with the University of Rochester’s Institutional Review Board (IRB) review must be factored into study budgets during the budget development process. IRB fees are dependent on funding sources and whether URochester IRB will act as the Reviewing IRB or Relying Institution.
On rare occasions, the IRB may waive these fees, but this is considered on a study-by-study basis. To request a waiver, the PI must submit a written request to the IRB Director with justification for waiving the fees.
When the URochester IRB acts as the Reviewing IRB
Study teams requesting the URochester IRB to act as the Reviewing IRB for a multi-site funding proposal are required to meet with the Research Reliance Director and Reliance Coordinator to ensure adequate budgeting and monitoring, well in advance of submission. This includes federal, foundation, and industry-funded proposals.
All funded studies that wish to use the University of Rochester IRB as the Single IRB (SIRB) are required to pay SIRB review fees. This includes studies with federal funding, industry funding, foundation funding, etc.聽 All review fees are a 糖心传媒渇ee-for-service糖心传媒�, meaning charges will be assessed based upon the actual number of IRB reviews required.
The IRB will provide an SIRB Fee Quote to assist researchers with budget planning during the pre-award process.聽 To obtain a quote, the researcher should submit an .聽 An IRB Specialist will then work with the study team to create the quote based upon specific details about the individual project.
For federally funded projects, the cost of the Rochester site review is not included in the SIRB review fees, as it is covered by indirect costs.聽 However, review of all external sites relying on the IRB will be billed to the URochester study team as a direct cost.
SIRB review fees are based upon several factors:
- Number of years the study will be open
- Number of participating research sites requiring SIRB review
- Number of consent documents used by each site
- Number of modifications required throughout the life of the study
- Complexity of each modification
Remember, the SIRB Fee Quote is an estimate based upon information provided by the study team.聽 Under the fee-for-service model, the study is responsible for all costs based upon the services provided. For example, if you budget for one protocol modification per year but require two protocol modifications, you will be responsible for costs associated with two protocol modifications.
As part of the SIRB Fee Quote, the IRB Specialist will provide a breakdown of all fees.聽 If the IRB review fee schedule changes after the quote has been provided, the study will be billed at the amount from the quote ONLY if the quote was an IRB authorized quote.聽 To obtain an authorized quote, researchers must utilize the .聽 SIRB fees budgeted by the study team without consultation of the IRB may not be accepted and the IRB may decide not to act as the reviewing IRB.
All funded studies that wish to use the University of Rochester IRB as the Single IRB (SIRB) are required to pay SIRB review fees.聽 This includes studies with federal funding, industry funding, foundation funding, etc.聽 All review fees are a 糖心传媒渇ee-for-service糖心传媒�, meaning charges will be assessed based upon the actual number of IRB reviews required.
The IRB will provide an SIRB Fee Quote to assist researchers with budget planning during the pre-award process.聽 To obtain a quote, the researcher should submit an .聽 An IRB Specialist will then work with the study team to create the quote based upon specific details about the individual project.
For industry or foundation-funded projects, the SIRB cost will include the Rochester site and all external sites relying on the IRB.聽 These costs will be billed to the URochester study team.
SIRB review fees are based upon several factors:
- Number of years the study will be open
- Number of participating research sites requiring SIRB review
- Number of consent documents used by each site
- Number of modifications required throughout the life of the study
- Complexity of each modification
Remember, the SIRB Fee Quote is an estimate based upon information provided by the study team.聽 Under the fee-for-service model, the study is responsible for all costs based upon the services provided. For example, if you budget for one protocol modification per year but require two protocol modifications, you will be responsible for costs associated with two protocol modifications.
As part of the SIRB Fee Quote, the RSRB Specialist will provide a breakdown of all fees.聽 If the IRB review fee schedule changes after the quote has been provided, the study will be billed at the amount from the quote ONLY if the quote was an IRB authorized quote.聽 To obtain an authorized quote, researchers must utilize the .聽 SIRB fees budgeted by the study team without consultation of the IRB may not be accepted and the URochester IRB may decide not to act as the reviewing IRB.
Fees are not charged for single-site research that is federally funded; review is included in indirect costs.
- Initial Review: $1,100
- Continuing Review: $725
- Modification: Protocol Only: $725
- Modification: Recruitment Only: $362.50
- Modification: Consent Form Only: $725
- Modification: Protocol & Consent Form: $1,000
- Close Out: $362.50
When the URochester IRB is a Relying Institution
Fees are not charged for IRB administrative review of 糖心传媒 sites participating in multi-site, federally funded research; review is included in indirect costs.
- A one-time $1000 fee for initial institutional/administrative review is charged for all 糖心传媒 sites participating in multi-site research that is industry or foundation funded. This fee covers costs associated with the institutional review that is required to ensure compliance with University and OHSP policies (e.g., conflict of interest, compensation for injury, etc.); the fee must be factored into the budgets appropriately.
- Fees are not applied to follow-on submissions (e.g., modifications and continuing reviews following initial approval of the research).
Additional no-charge reviews
The IRB does not charge for:
- Unfunded research
- Submissions involving expanded access or emergency use
- Research deemed exempt (regardless of funding)
- Proposals that do not meet the definition of ‘human subject research’ (regardless of funding)
- Modifications to update study personnel only
- Modifications for editorial/administrative revisions to study documents
- Reports of new information
- Withdrawn or discarded submissions