HCA - HealthONE IRB
Getting Started
The HCA-HealthONE IRB requires that all investigators submit their IRB submissions through an electronic submission program called IRBManager©. Additional documentation is also required in order for the submission application to be considered complete for the convened IRB to review.
Submission Requirement Checklist:
□ Access to IRBManager© - complete the IRBManager© Access form
□ Individual Investigator Agreement (IIA) Form – must be signed by the PI and all co-PI/sub-PI’s involved in the study
□ Financial Disclosure Form - must be signed by the PI and all co-PI/sub-PI's involved in the study
□ Human Subject Protections Certification verification – all study personnel involved and listed on the study application ( i.e. PI, co-PIs/sub-PIs, study coordinators) must have completed or renewed their certification within the last two years from the time of the protocol submission. To complete certification requirements refer to one of the following sites: Citiprogram.org or phrp.nihtraining.com
□ IRBManager© Application completed through electronic submission process (this includes all documents that are required for completing the application, i.e. consent documents, IND/IDE forms, surveys/questionnaires and recruitment materials. http://irbmanager.becirb.com
□ IRB Fee - required for new submissions PRIOR to review unless an exempt from fee is granted
□ Additional Documents (as applicable)
Statement of Investigator form (Form FDA 1572)
Investigator’s Brochure
Letters of Agreement
Submission Deadlines/Meeting Dates
The HCA-HealthONE IRB meets the third Wednesday of each month to review protocol submissions that require full board review.
SUBMISSION DEADLINE REQUIREMENTS
New Protocols (to be reviewed by the full committee) must be submitted to IRBManager© by the 24th of each month in order to placed on the following month’s agenda. This deadline allows for preliminary reviews, a time allowance for revisions to be made and re-submitted and have the agenda items distributed to the board members at least 7 days prior to the board meeting date.
Amendments (reviewed by the full committee) must be submitted to IRBManager© by the 24th of each month in order to be placed on the following month’s agenda.
Expedited/Exempt Requests—no submission deadline requirement. All qualifying expedited and exempt submissions, which may include new protocols, amendments, and personnel changes may be submitted at any time. If an expedited request does not qualify for expedited review, it will be automatically referred to the next full committee agenda for review and the PI/study coordinator will be notified. Please Note: All expedited new protocol submission requests must complete a New Protocol Application and be submitted through IRBManager©.
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