1. Office of Human Subjects Research
ACH: What you need to know to conduct research at All Children’s Hospital
Holly Pageau, CIP, Associate IRB Manager
Sue Ellie, Senior Research Subjects Specialist

2. Johns Hopkins All Children’s Hospital St. Petersburg, Florida

3. Johns Hopkins All Children’s 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

4. Background: Johns Hopkins All Children’s Hospital History and Facilities
Founded in 1926 as American Legion Hospital for Crippled Children
Non-profit
One of 3 free-standing children’s hospitals in FL
Direct catchment: 1.3M children

5. Background: Johns Hopkins All Children’s 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

6. 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 Children’s 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

7. Conducting Research at More than One Johns Hopkins Site
The Johns Hopkins Medicine All Children’s 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.

8. Johns Hopkins All Children’s Hospital Institutional Review Board
JHACH IRB meets monthly JHACH Research Review Committee Convenes, as needed, prior to the monthly IRB meeting

9. 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.

10. Bi-campus Participation
Ability to have study open in St. Petersburg and Baltimore
Avoids duplication of effort by 2 IRB’s
One JHM IRB committee serves as IRB of record

11. Bi-campus Participation
To start the process: New Application or Change in Research Submit in eIRB2 by Principal Investigator

12. Bi-campus Participation
For studies originating in Baltimore, application must reflect St. Petersburg’s participation:
Lead Site Investigator
Study team members
Locations where patients will be recruited
Recruitment plan
Informed consent also lists St. Petersburg’s Lead Site Investigator’s contact information

13. 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

14. Johns Hopkins All Children’s Hospital Research Cores & Offices  
Johns Hopkins All Children’s Hospital
Research Cores & Offices

15. 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

16. 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.)

17. 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

19. Johns Hopkins All Children’s Hospital  
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