Fees subject to change at any time without notice
Current Fees:
|
Items |
Descriptions |
Cost |
|
Determination of Non-Human Subject Research |
Evaluation of protocol for non-human subject determination; if determined to be human subjects research, then the fee is applied toward the higher level of review |
$450.00 |
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US Research, Review of IRB Exemption |
Evaluation of protocol for exemption; if not exempt, the fee is applied toward the higher level of review. (Includes one informed consent and includes one iteration from 1 primary reviewer) |
$550.00 |
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Each Additional CO-PI |
$125.00 |
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Each Additional Consent Form |
$125.00 |
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Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$150.00 |
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Adverse Events |
$125.00 |
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Protocol Deviations |
$125.00 |
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COI Fee |
$250.00 |
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Additional COI Fee |
$125.00 |
|
Exempt Amendments/Modification |
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Review of Protocol Modifications |
$200.00 |
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Review of Consent Modifications/Each Form |
$125.00 |
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Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
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Review of each additional/modified study personnel |
$125.00 |
|
Exempt Annual Check-Ins |
Exempt studies do not require annual check-ins (If the study is determined to be more than exempt this fee depends on the level of review determined) |
If your study comes to a close it would be appreciated if you let us know. |
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US Research, Expedited Review |
Initial Review (If determined not expedited, the fee is applied toward the higher level of review. (Includes one informed consent and includes one iteration from 1 primary reviewer) |
$850.00 |
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Each Additional CO-PI |
$125.00 |
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Each Additional Consent Form |
$125.00 |
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|
Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$150.00 |
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Adverse Events |
$125.00 |
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Protocol Deviations |
$125.00 |
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COI Fee |
$250.00 |
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Additional COI Fee |
$125.00 |
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Expedited Amendments/Modification |
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Review of Protocol Modifications |
$200.00 |
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Review of Consent Modifications/Each Form |
$125.00 |
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Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
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Review of each additional/modified study personnel |
$125.00 |
|
Expedited |
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Annual Report study continuation |
$450.00 |
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If the study is allowed to expire |
$75.00 |
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Review of Study Closure |
$25.00 |
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US Research, Full Board Review (Non-Clinical) |
Initial Review + Convened Board Meeting (Includes one informed consent and includes one iteration from 2 primary reviewers) |
$1455.00 |
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Each Additional CO-PI |
$125.00 |
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Each Additional Consent Form |
$225.00 |
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Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$250.00 |
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Additional iterations of submission post full board review |
$350.00 |
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Adverse Events |
$125.00 |
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Protocol Deviations |
$125.00 |
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COI Fee |
$250.00 |
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Additional COI Fee |
$125.00 |
|
Initial Review of Additional Site (Full Board Multi-Site Studies) |
Review of Principle Investigator and 1 Location |
$650.00 |
|
Full Board (Non-Clinical) |
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Review of Protocol Modifications |
$500.00 |
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Review of Consent Modifications/Each Form |
$225.00 |
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Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
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Review of each additional/modified study personnel |
$125.00 |
|
Full Board (Non-Clinical) |
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Annual Report study continuation |
$750.00 |
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If the study is allowed to expire |
$75.00 |
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Review of Study Closure |
$25.00 |
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US Research, Full Board Review (Clinical) |
Initial Review + Convened Board Meeting (Includes one informed consent and includes one iteration from 2 primary reviewers) |
$1950.00 |
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Each Additional CO-PI |
$125.00 |
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Each Additional Consent Form |
$225.00 |
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Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$250.00 |
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Additional iterations of submission post full board review |
$350.00 |
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Adverse Events |
$125.00 |
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Protocol Deviations |
$125.00 |
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COI Fee |
$250.00 |
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Additional COI Fee |
$125.00 |
|
Full Board (Clinical) |
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Review of Protocol Modifications |
$500.00 |
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Review of Consent Modifications/Each Form |
$225.00 |
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Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
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|
Review of each additional/modified study personnel |
$125.00 |
|
Initial Review of Additional Site (Full Board Multi-Site Studies) |
Review of Principle Investigator and 1 Location |
$650.00 |
|
Full Board (Clinical) |
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Annual Report study continuation |
$750.00 |
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If the study is allowed to expire |
$75.00 |
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Review of Study Closure |
$25.00 |
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International Study Fees |
Initial Review and validation of international sites and requirements. |
$1750.00 |
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Full Board Review of International Study |
International fee + $450.00 |
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Each Additional CO-PI |
$125.00 |
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Each Additional Consent Form |
$225.00 |
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Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$250.00 |
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Additional iterations of submission post full board review |
$350.00 |
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Adverse Events |
$125.00 |
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Protocol Deviations |
$125.00 |
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International |
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Review of Protocol Modifications |
$500.00 |
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Review of Consent Modifications/Each Form |
$225.00 |
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Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
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Review of each additional/modified study personnel |
$125.00 |
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Adverse Events |
$125.00 |
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Protocol Deviations |
$125.00 |
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COI Fee |
$250.00 |
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Additional COI Fee |
$125.00 |
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International |
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Annual Report study continuation |
$750.00 |
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If the study is allowed to expire |
$75.00 |
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Review of Study Closure |
$25.00 |
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Consultation Services |
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Protocol consultation – minimal revisions |
$250.00 |
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Full protocol consultation – medium revisions |
$500.00 |
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Full protocol consultation – major revisions |
$750.00 |
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Other Service Fees |
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Study Pre-Review (prior to formal submission, IRB of record letter) |
$150.00 |
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Certified Translation Services |
Cost plus 20% |
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Administrative services as required FDA Studies |
Varies |
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Adverse Event Investigation |
$175.00/hour plus expenses |
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Device Determination of non-significant risk |
$500.00 |
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Determination of IND |
$500.00 |
Fees subject to change at any time without notice