IRB Information and Fee Schedule
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