IRB Fees
A review fee will be assessed by the Prisma Health Institutional Review Board (IRB) at the time of the Initial Submission, Continuing review (full board) and Amendment review (full board). IRB fees are charged for sponsored studies that require Full IRB Committee Review. This fee will cover the expenses for IRB operations and administration related to the submission and review of a research project. This fee is retained by the IRB and is not available to the Principal Investigator or clinical department. This fee is not intended to compensate the PI or regulatory staff time related to IRB preparation, submission, and maintenance.
The fee structure will be applied to studies that are submitted to the IRB after September 30, 2019
| IRB Fee Schedule | |
|---|---|
| Initial IRB Review ( Full Board Review ) | $2500 |
| Annual Review* ( Full Board Review) | $1000 |
| Amendment Review (Full Board Review) | $1000 |
| Facilitation of Central IRB Review ( one – time fee) | $1000 |
*Annual review fee – (continuing review fee) will only be assessed annually. Some IRB determinations may require review more frequently, however only one fee will be assessed based on the initial review date every 12 months.
Fee Payment
IRB review fees are charged for IRB administration and review considerations for sponsored studies that require Full IRB Committee review.
- IRB review/administrative fees are due in full once the protocol is reviewed by a convened IRB Committee. The fees are applied whether or not the IRB approves the study, participants are never enrolled, or the study is withdrawn/terminated before enrollment begins or research objectives met.
- Fees are not refundable.
- Decisions about how to address non-payment of IRB review fees that are not granted a waiver will be made on a case-by-case basis by the IRB/ OHRP office, in consultation with the Prisma Health Clinical Trials Office.
Fee Waiver Criteria
- Unfunded research conducted to fulfill specific or general academic or accreditation requirements of students or training programs affiliated with Prisma Health (e.g., residents, fellows, nursing students, medical students, and allied health students).
- Investigator – initiated research led by a HSC team member that is not funded by an external organization
- Research funded by a federal, state or local government entity that does not allow inclusion of IRB fees or the amount of funds granted is so limited that paying the IRB review fee would not allow the research to go forward
- An activity requiring IRB review but conducted for clinical , non-research purposes (i.e., Emergency Use, Compassionate Use, HUDs)
- An activity funded solely by a not-for-profit group/ entity and the group/entity either does not allow the charging of IRB fees or the amount of funds granted is so limited that paying for the IRB review services would not allow the research to go forward.
- Determination of request for waiver will be made by the Institutional Official or their designee.
Waiver of IRB Fees
If a study does not meet any of the above criteria, a waiver of or reduction in the amount of the established IRB review fee may occur under other extenuating circumstances. A request to waive or reduce the established IRB fee must be submitted in writing to the Director, Office of Human Research Protection prior to the submission of the actual IRB application. Please do not include this form in your IRB submission unless instructed to by the IRB.