Submission and Review
From submission through approval by all applicable internal and external committees
![Research Lifecycle diagram with Submission (step two) highlighted](/-/media/migration/all-childrens-hospital/images/academics/research/clinical-research-lifecycle/02-submission/02-submission.png)
Protocols are internally reviewed by several committees to ensure they can be executed appropriately. The following committees may review your protocol:
- Data Trust Committee: studies meeting specified criteria may undergo review by this committee
- Institute / Department Research Council (if established): MFNI, Heart, IBPS, & Cancer are established
- Scientific Review Sub-council (SRS) : required if requesting use of Foundation funds
- Feasibility and Operational Needs Assessment (FONA): all prospective studies
- Imaging & Recording Oversight Committee (IROC): if research involves photographs or video of participants
- Clinical Radiation Research Committee (CRRC): when ionizing radiation is used for research-only purposes
- Institutional Biosafety Committee (IBC): refer to their website for qualifying studies
- Food & Drug Administration (FDA): if JHACH investigator serves as Sponsor for a study in which an IND/IDE may be required
- Institutional Review Board (IRB): all studies
During this stage the following centralized support groups / shared services may be engaged:
- Research Operations
- Health Sciences Research Informatics
- Database Design & Data Management Team
- Epidemiology & Biostatistics Team
- Clinical Research Unit (CRU)
- Investigational Drug Services (IDS)
- Biorepository
- Research & Grants Administration
- Office of Human Subjects Research (“IRB Office”)
- IND / IDE Support
Biospecimen Access Committee (BSAC): Study proposals that seek access to biospecimen banks are reviewed by BSAC for approval. Additional review of scientific merit is a prerequisite (performed by the corresponding Institute or Dept-based Research Council, if not already reviewed and awarded via an external peer-reviewed funding mechanism or by the Scientific Review Subcouncil for the internal Institutional Research Awards Program). In addition, assessment of prioritization and strategic alignment is a prerequisite (performed by the corresponding Institute or Dept-based Research Council). Pediatric Biorepository: Pediatric Biorepository leaders are available for consultation and/or navigation through the BSAC application process. Schedule an appointment with Billy Schlief, Ph.D., Manager, Pediatric Biorepository.
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- FONA Checklist
- 1572
- IBC Registration Procedures
- IND Initial Submission Checklist
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Phase 1: Development
From study conception through development of a completed protocol
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Phase 3: Activation
From receipt of protocol approval(s) through initiation of participant screening