IRB Fees
It is the policy of Louisiana State University Health Sciences Center-Shreveport to assess a review fee for all industry sponsored research protocols. Industry sponsored clinical trial protocols often represent some of the most complex and resource demanding research reviewed by the IRB. This practice is consistent with the policies and fees incurred at other academic medical centers throughout the country. The fees will be used to support the administrative costs associated with the review of research.
All initial study submissions to the LSUHSC-S IRB must identify the funding sources supporting the proposed research, including whether there is current or planned support from an industry sponsor. When an IRB submission is received and is not designated as industry-supported, but is later determined by the IRB to be industry-supported, appropriate IRB fees will be assessed.
It is expected that investigators or their staff incorporate and negotiate applicable IRB fees into the study budget. This fee is often included in the start-up funds requested from the sponsor. Industry sponsors are accustomed to paying a fee for review services.
The fees are due in full from the sponsor for the costs of the specific review services rendered even if the IRB does not approve the study, subjects are never enrolled, or the study is terminated before objectives are reached.
IRB applications for projects funded by other sources such as Federal, State, non-profit or internal funds are not subject to IRB fees. The costs for reviewing non-industry supported studies are included in the Facilities and Administrative rate, which is applied to those research projects.
Applicability
All industry sponsored research submitted for review during or after January, 2008 will be assessed fees as described in the table below.
All industry sponsored contracts or grants that are currently being negotiated or renegotiated with the sponsor or funding agency are also subject to the fees as described in the table below.
|
IRB Submission Type
|
Amount per
Submission
|
|
Initial Application
|
|
|
Full Committee Review
|
$2,500
|
|
Expedited Review
|
$500
|
|
Exemption Determination
|
$250
|
|
Continuing Review
|
|
|
Annual
|
$500
|
|
More often than Annual
|
$250
|
|
Modification Request
|
|
|
Full Committee Review
|
$500
|
|
|
Expedited Review
|
$250
|
|
|
Safety Information
|
$100
|
|
|
|
Study Closure
|
$500
|
|
|
|
Reopening of Closed Study
|
$500
|
*Note: Recruitment materials submitted after initial review of a protocol are considered modification requests and are subject to applicable fees.
Exclusions
IRB submissions for research protocols that are fully funded by the following sources are not subject to IRB review fees:
- Federal Government
- State of Louisiana and its parish or local governments;
- Internal grants
- Non-profit Foundations and similar organizations that prohibit such fees;
Additionally, the following submissions will not be assessed an IRB review fee;
- Reporting of noncompliance
- Reporting of unanticipated problems
- Applications for emergency or one-time use of an investigational drug or device;
- Modification of an approved protocol, when the only noted change in a proposed modification is the study personnel change
Contacts
For questions regarding IRB review fees please contact:
Rhonda Feldt, RN, CCRC-Project Manager/Contracts and Agreements
Office of Legal Affairs
rfeldt@lsuhsc.edu or 318.675.8324
Aliese Seawright, MS, C.I.P– HRPP Staff Director
Human Research Protections Program
jseawr@lsuhsc.edu or 318.813.1363
Kathleen Bloomingdale, BS
Administrative Coordinator
Institutional Review Board
kbloom@lsuhsc.edu or 318.813.1351