Fees for "single site" are posted above the fee for "multi-center sites" and the multi-center site fee is "per site." For example, a multi-center study with 8 sites has 8 separate invoiced fees.
| Service | Fee |
| New Study Review Fee , Including up to 10 Subject Materials, regular review fee will be applied thereafter - Single Center: | $1,225.00 |
| New Study Review Fee, Including up to 10 Subject Materials, regular review fee will be applied thereafter - per site - Multicenter: | $1,225.00 |
| New Study Review Fee - Investigator-Initiated - For Formal Fellowship Only (Discounted): | $350.00 |
| New Study Review Fee (Third Party Oversight Premium) - Single Center: | $1,750.00 |
| Emergency Review Surcharge Fee- (Surcharge is separate from submission item fee): | $1,950.00 |
| Multicenter Discounted for CRO/Sponsor submitted Site Addition/Review of each of the Following Investigators: | $450.00 |
| Multicenter Site Addition/Review of the Following Investigators: | $500.00 |
| MA or International Site Additions/Review of the Following Investigators (Site visit and travel cost fee applied separately): | $600.00 |
| Site Continual Review Fee - Single Center: | $350.00 |
| Site Continual Review Fee - Multicenter: | $350.00 |
| Site Continual Review Fee (Third Party Oversight Premium) - Single Center: | $700.00 |
| Sponsor-Elected Study Level Continual Review - Multicenter: | $350.00 |
| Suspension/Reinstatement Fee: | $250.00 |
| Review of Protocol Related Submittal including, but not limited to, Amendments, Administrative Letters, Administrative Changes, Errata, and Memos (Including Revision of One Concurrent Informed Consent Document): | $250.00 |
| Review of Protocol Related Submittal including, but not limited to, Amendments, Administrative Letters, Administrative Changes, Errata, and Memos (Including Revision of One Concurrent Informed Consent Document) - For each of the Following Investigators: | $250.00 |
| Revised Informed Consent Document or Addendum [Due to revised 1572s, safety information (including, but not limited to, Investigator Brochure, safety letters, SAE's, package inserts, or IRB, sponsor, or site-requested changes), or informed consent changes due to Amendments, administrative letters or administrative changes to the protocol] - Per Copy: | $250.00 |
| Revised Informed Consent Document or Addendum [Due to revised 1572s, safety information (including, but not limited to, Investigator Brochure, safety letters, SAE's, package inserts, or IRB, sponsor, or site-requested changes), or informed consent changes due to Amendments, administrative letters or administrative changes to the protocol] - Per Copy - For each of the Following Investigators: | $250.00 |
| Review of Protocol Extension Amendment (Including Revision of One Informed Consent Document): | $500.00 |
| Review of Protocol Extension Amendment (Including Revision of One Informed Consent Document) - For each of the Following Investigators: | $500.00 |
| BioMed IRB Administrative Review Letter: | $100.00 |
| Review of Invesigator Brochure including but not limited to, Package Inserts and Annual Reports (NOT including revisions to the Informed Consent): | $100.00 |
| Review of Invesigator Brochure including but not limited to, Package Inserts and Annual Reports (NOT including revisions to the Informed Consent)- For each of the Following Investigators: | $100.00 |
| Review of Study-Related Material (including, but not limited to, recruitment materials, advertisements, websites, brochures, or questionnaires): | $100.00 |
| Review of Study-Related Material (including, but not limited to, recruitment materials, advertisements, websites, brochures, or questionnaires) - For the Following Investigators: | $100.00 |
| Review of Addition/Deletion of Site Facilities or Sub-Investigators (Reported via FDA Form 1572 or IRB Equivalent): | $100.00 |
| Review of Addition/Deletion of Site Facilities or Sub-Investigators (Reported via FDA Form 1572 or IRB Equivalent) - For each of the Following Investigators: | $100.00 |
| Review of Change in Principal Investigator (Including up to 10 subject materials): | $500.00 |
| Review of Change in Principal Investigator (Including up to 10 subject materials): | $500.00 |
| Compassionate Use Exemption (Drug or Device that has been reviewed by the IRB previously) - Per Patient: | $150.00 |
| Compassionate Use Exemption (Drug or Device that has NOT been reviewed by the IRB previously) - Per Patient: | $250.00 |
| Consent/Assent Development Flat Fee ( For development that does NOT require research by the IRB): | $350.00 |
| Vendor Translation of Study Documents (Vendor Cost plus 10%): | variable |
| Generation of Additional Copies (Per copy): | $150.00 |
| Shipping Charges: | variable |
| Archive/Destroy Fee (For any study; 6 months after closure date) files will be kept for up to 3 years. To arrange for files to be stored longer, please contact the IRB office: | $100.00 |
| Archive Retrieval Fee (For IRB Files/Documents that have been archived) Per document: | $50.00 |
| Consulting/Researching Fee (COTS for Indirect Overhead) for 100 hours or less within an accounting year for client (including, but not limited to, RDRC panel review, ESCRO panel review, PSO panel review, and Consent/Assent Development that require research by the IRB) - Per Hour: | $350.00 |
| Consulting/Researching Fee (COTS for Indirect Overhead) for more than 100 hours within an accounting year for client (including, but not limited to, RDRC panel review, ESCRO panel review, PSO panel review, and Consent/Assent Development that require research by the IRB) - Per Hour: | $80.00 |
| IRB Training and Education | variable |
| IRB For Cause Site Visit/Audit - $750 fee plus travel costs (Required as additional service to MA Site Additions/Review): | variable |
| Multicenter Random Site Visit/Audit - $750 fee plus travel costs: | variable |
| Data hosting | $700 per month |
| User authentication support | $100 per user perhour |
| Password Generator | $100 per person per year |
| Late Submittal Accommodation Fee- Submittals AFTER 7:30AM Friday until Tuesday 12:00PM. ANY SUBMITTAL TURNED IN AFTER TUESDAY NOON FOR FULL BOARD REVIEW WILL BE PROCESSED FOR THE FOLLOWING MEETING. *For any late submittal that requires full board review AFTER Tuesday, please refer to the Emergency Review Surcharge Fee. |
$250.00 |
| * These prices are subject to change with thirty (30) days prior written notice. | |