Fees subject to change at any time without notice
Current Fees:
|
Items |
Descriptions |
Cost |
|
|
|
|
| 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 |
| Each Additional CO-PI |
$125.00 |
|
| Each Additional Consent Form |
$125.00 |
|
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$150.00 |
|
| Adverse Events |
$125.00 |
|
| Protocol Deviations |
$125.00 |
|
| Minor Mitigated COI |
$250.00 |
|
| COI Fee (If reviewed with other FB studies/reviewed by already convened board) |
$550.00 |
|
| Additional COI Fee (Multiple COI) |
$125.00 |
|
| Exempt Amendments/Modification |
|
|
| Review of Protocol Modifications |
$200.00 |
|
| Review of Consent Modifications/Each Form |
$125.00 |
|
| Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
|
| 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. |
|
|
||
| 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 |
| Each Additional CO-PI |
$125.00 |
|
| Each Additional Consent Form |
$125.00 |
|
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$150.00 |
|
| Adverse Events |
$125.00 |
|
| Protocol Deviations |
$125.00 |
|
| Minor Mitigated COI |
$250.00 |
|
| COI Fee (If reviewed with other FB studies/reviewed by already convened board) |
$550.00 |
|
| Additional COI Fee (Multiple COI) |
$125.00 |
|
| Expedited Amendments/Modification |
|
|
| Review of Protocol Modifications |
$200.00 |
|
| Review of Consent Modifications/Each Form |
$125.00 |
|
| Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
|
| Review of each additional/modified study personnel |
$125.00 |
|
| Expedited Annual Check-Ins |
|
|
| Annual Report study continuation |
$450.00 |
|
| If the study is allowed to expire |
$75.00 |
|
| Review of Study Closure |
$25.00 |
|
|
|
||
| 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 |
| Each Additional CO-PI |
$125.00 |
|
| Each Additional Consent Form |
$225.00 |
|
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$250.00 |
|
| Additional iterations of submission post full board review |
$350.00 |
|
| Adverse Events |
$125.00 |
|
| Protocol Deviations |
$125.00 |
|
| COI Fee |
$250.00 |
|
| 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) Amendments/Modification |
|
|
| Review of Protocol Modifications |
$500.00 |
|
| Review of Consent Modifications/Each Form |
$225.00 |
|
| Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
|
| Review of each additional/modified study personnel |
$125.00 |
|
| Full Board (Non-Clinical) Annual Check-Ins |
|
|
| Annual Report study continuation |
$750.00 |
|
| If the study is allowed to expire |
$75.00 |
|
| Review of Study Closure |
$25.00 |
|
|
|
||
| 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 |
| Each Additional CO-PI |
$125.00 |
|
| Each Additional Consent Form |
$225.00 |
|
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$250.00 |
|
| Additional iterations of submission post full board review |
$350.00 |
|
| Adverse Events |
$125.00 |
|
| Protocol Deviations |
$125.00 |
|
| COI Fee |
$250.00 |
|
| Additional COI Fee |
$125.00 |
|
| Full Board (Clinical) Amendments/Modification |
|
|
| Review of Protocol Modifications |
$500.00 |
|
| Review of Consent Modifications/Each Form |
$225.00 |
|
| Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
|
| 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) Annual Check-Ins |
|
|
| Annual Report study continuation |
$750.00 |
|
| If the study is allowed to expire |
$75.00 |
|
| Review of Study Closure |
$25.00 |
|
|
|
||
| International Study Fees | Initial Review and validation of international sites and requirements. |
$1750.00 |
| Full Board Review of International Study |
International fee + $450.00 |
|
| Each Additional CO-PI |
$125.00 |
|
| Each Additional Consent Form |
$225.00 |
|
| Additional iterations (2nd, 3rd, 4th iterations, if required after initial review) |
$250.00 |
|
| Additional iterations of submission post full board review |
$350.00 |
|
| Adverse Events |
$125.00 |
|
| Protocol Deviations |
$125.00 |
|
| Minor Mitigated COI |
$250.00 |
|
| COI Fee (If reviewed with other FB studies/reviewed by already convened board) |
$550.00 |
|
| Additional COI Fee (Multiple COI) |
$125.00 |
|
| International Amendments/Modification |
|
|
| Review of Protocol Modifications |
$500.00 |
|
| Review of Consent Modifications/Each Form |
$225.00 |
|
| Review of Advertisements or other documents post-approval/Each Form |
$125.00 |
|
| Review of each additional/modified study personnel |
$125.00 |
|
| Adverse Events |
$125.00 |
|
| Protocol Deviations |
$125.00 |
|
| International Annual Check-Ins |
|
|
| Annual Report study continuation |
$750.00 |
|
| If the study is allowed to expire |
$75.00 |
|
| Review of Study Closure |
$25.00 |
|
|
|
||
| Consultation Services |
|
|
| Protocol consultation – minimal revisions |
$250.00 |
|
| Full protocol consultation – medium revisions |
$500.00 |
|
| Full protocol consultation – major revisions |
$750.00 |
|
|
|
||
| Other Service Fees |
|
|
| Study Pre-Review (prior to formal submission, IRB of record letter) |
$250.00 |
|
| Certified Translation Services |
Cost plus 20% |
|
| Administrative services as required FDA Studies |
Varies |
|
| Adverse Event Investigation |
$175.00/hour plus expenses |
|
| Device Determination of non-significant risk |
$850.00 |
|
| Determination of IND |
$850.00 |
Fees subject to change at any time without notice