Clinical Research Lifecycle

Submission & Review

From submission through approval by all applicable internal and external committees

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: 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, MS, Manager,  Pediatric Biorepository.  

 

Step 3: Activation

From receipt of protocol approval(s) through initiation of participant screening

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