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IRB Information and Fee Schedule

IRB MEMBERSHIP FWA LETTER

2017 DEADLINE AND MEETING SCHEDULE

IRB Fee Schedule

Pharmaceutical/Industry Sponsored Trials (pass through invoicing)
Initial Review
•Initial Review of Protocol and Investigator ................................................................. $2500.00
Protocol/grant, principal investigator, first consent form, recruitment materials

Initial Review/Expedited
•Initial Review of Protocol and Investigator ............................................................... $1000.00
Protocol/grant, principal investigator, first consent form, recruitment materials

Continuing Review
•Study Renewal Review (at least annually) .................................................................. $750.00

Changes in Research/Amendments/Full Board
Protocol amendments/revisions increased subject enrollment level, new or updated recruitment/retention materials, other changes to research

•Changes to Research Involving Consent Form Review................................................ $500.00
Changes to Research not Involving Consent Form Review........................………......…$275.00

Changes in Research/Amendments/Expedited Review
Protocol amendments/revisions increased subject enrollment level, new or updated recruitment/retention materials, other changes to research

•Changes to Research Involving Consent Form Review................................................. $275.00
•Changes to Research not Involving Consent Form Review............................................ $75.00

Misc IRB Review/Full Board
Includes changes to research staff, IND reports, protocol deviations, subject diaries, assessment tools, advertisements, telephone scripts, etc.

Misc Expedited Review....................................................................................................... $150.00

Misc IRB Review/Expedited

Includes changes to research staff, IND reports, protocol deviations, subject diaries, assessment tools, advertisements, telephone scripts, etc.

•Misc Expedited Review........................................................................................................ $50.00

Termination of Study/ Close Out

File Storage Fees……........................................................................................................ $200.00

Non-Pharmaceutical/Industry Sponsored Trials
Resident, Student, Tenet employed physicians initiated study, Tenet employee initiated study (i.e. Nursing, Bariatrics).

Includes Full Board and/or exempt Review and new ICF if applicable,....................no charge

Initial and Continuing Review- Non-Tenet employed physicians acting as Principal Investigator.

Initial Review of Protocol and Investigator ................................................................ $250.00
Protocol/grant, principal investigator, first consent form, recruitment materials
Includes approval letters, creating new study in IRB plus software and subsequent oversight.

Other Regulatory Fees
For-Cause Audit

•Per Day On Site Audit Team…............ $1250.00 Plus travel expense—Two member audit team review issues related to potential non-compliance

GCP and/or HSP Training                

•Review of Good Clinical Practice elements and/or Human Subject Protection Training via teleconferencing............. $100.00/hr