All Children's Hospital Opening Conference The Joint Commission
Office of Human Subjects Research ACH: What you need to know to conduct research at All Childrens Hospital Holly Pageau, CIP, Associate IRB Manager Sue Ellie, Senior Research Subjects Specialist Johns Hopkins All Childrens Hospital St. Petersburg, Florida
2 Johns Hopkins All Childrens Hospital JHM ACH IRB Staff E. Verena Jorgensen, MD, IRB Chair Holly Pageau, CIP, Associate IRB Manager Sue Ellie, Senior Research Subject Specialist Dawn Bruton, RN, BSN, CCRP, Consent Form Specialist
3 Background: Johns Hopkins All Childrens Hospital History and Facilities Founded in 1926 as American Legion Hospital for Crippled Children Non-profit One of 3 free-standing childrens hospitals in FL Direct catchment: 1.3M children
4 Background: Johns Hopkins All Childrens Hospital History and Facilities Moved to new facility (Hospital and Outpatient Care Center) in 2010 Hospital: 10 floors, 738K sq ft
OCC: 7 floors BabyPlace (owned by Bayfront): 4,000 deliveries per year Integration into JHM in 2011 ACH IRB became JHM ACH IRB in 2013 Re-branded as JHACH in 2016 5
Conducting Research at More than One Johns Hopkins Site Researchers who are interested in conducting research at both JHACH and another JHM site (e.g., Johns Hopkins Childrens Center) will have their studies undergo a primary IRB review at one JHM site and a local review at the non-primary JHM site by a Research Review
Committee 6 Conducting Research at More than One Johns Hopkins Site The Johns Hopkins Medicine All Childrens Hospital Institutional Review Board (JHACH IRB) has been
constituted as the JHACH Research Review Committee (ACH RRC). Upon approval by a Johns Hopkins Medicine IRB based in Baltimore of an eIRB study in which JHACH is indicated as a site of the research, approval of the JHACH RRC shall be required prior to implementation of the research at ACH. 7
Johns Hopkins All Childrens Hospital Institutional Review Board JHACH IRB meets monthly JHACH Research Review Committee Convenes, as needed, prior to the monthly IRB meeting 8 JHACH IRB Research Review Committee Activity May
2018 The JHACH Research Review Committee has reviewed and approved approximately 40 Baltimore studies for implementation in St. Petersburg. 9 Bi-campus Participation
Ability to have study open in St. Petersburg and Baltimore Avoids duplication of effort by 2 IRBs One JHM IRB committee serves as IRB of record 10 Bi-campus Participation
To start the process: New Application or Change in Research Submit in eIRB2 by Principal Investigator 11 Bi-campus Participation For studies originating in Baltimore, application must reflect St. Petersburgs participation:
Lead Site Investigator Study team members Locations where patients will be recruited Recruitment plan Informed consent also lists St. Petersburgs Lead Site Investigators contact information 12
Bi-campus Participation Process is similar for opening St. Petersburg IRB approved study in Baltimore Research Review Committee (RRC) in Baltimore will review study for local context 13
Johns Hopkins All Childrens Hospital Research Cores & Offices 14 JHACH Research Cores & Offices: Overview Pediatric Biorepository: CAP-accredited; LIMS-driven sample access management system (PHI-free; 2D barcode scanner)
Molecular Determinants Core: Metabolomics, lipidomics, peptidomics (planned) Clinical Research Unit: opened Spring 2017; 4 bed; emphasis on early-phase trials 15 JHACH Research Cores & Offices: Overview Health Informatics Core: Epi/Biostats; database design; data
mgmt. Research Administration: Grants/contracts OHSR/IRB: Fully integrated into JHM IRB system (including policies, training & ed.) 16 JHACH Research Cores & Offices: Overview Clinical and Translational Research Organization
Investigational Drug Services Unit: Invest. pharmacy; PharmD IND/IDE Support Unit: FDA submissions & pre-IND/IDE telecons Regulatory Affairs Unit: Internal monitoring program; SOP training Research Operations Unit: Study coordinators, research nurses, research assistants
17 Johns Hopkins All Childrens Hospital Questions? 19
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Bi-annual safeguarding newsletters are sent to all staff to ensure they remain updated with key national and local developments. The Safeguarding Children and Young people Policy has been completely revised and was launched in January 2018.
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