All Children's Hospital Opening Conference The Joint Commission

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

Recently Viewed Presentations

  • Neuro-oncology core curriculum lecture series: End of Life ...

    Neuro-oncology core curriculum lecture series: End of Life ...

    Project ECHO-PACA: Communication about impending death. Daniel Epner, MD, FACP. Dept. of Palliative, Rehabilitation, and Integrative Medicine. October 27, 2016
  • Media Assets in Computer Games - WCS

    Media Assets in Computer Games - WCS

    Media Assets in Computer Games. Text. Graphics. Images - photos. ... (object) which makes up a graphic has its own set of properties also known as attributes. A full definition of the attributes of the shape is stored. ... 3D...
  • pradhanmantri-yogana.in

    pradhanmantri-yogana.in

    From table 2.1, it is observed that the proportion of subsidy to total cost is 25 per cent in the case of small farmers and 3314 per cent in the case of marginal farmers, agricultural labourers and rural artisans and...
  • Doing the LEQ - Kent School District

    Doing the LEQ - Kent School District

    A. The Thesis paragraph. While not required on the rubric, a good thesis paragraph will put the topic at hand into context- you should explain the broader historical events, developments, or processes immediately relevant to the question.. While not required...
  • Evo Psyc Lecture 1 Big Question: What are we?

    Evo Psyc Lecture 1 Big Question: What are we?

    EvoPsyc Lecture 1 Big Question: What are we?. Origin, nature, meaning or essence of being human? Creation myths offered answers. EnumaElish Babylonian creation myth. The father god, Apsu, intends to kill the younger, lesser gods, whom he finds bothersome.
  • Lane Dubin and Michael Boult

    Lane Dubin and Michael Boult

    2010 & Beyond - Seven Travel Trends * * * * * * * * Supply Chain Management Linking all stakeholders in the cycle of purchasing raw materials to delivering the end product to the customer Sourcing Buying components or...
  • Dewitt county Handbook

    Dewitt county Handbook

    Data Driven Output. Results & discussion. Project allowed us to provide 307 detailed maps showing, facility information, gate access and contact numbers for first responders. This will allow responders to set up road blocks and be able to warn surrounding...
  • SG Report

    SG Report

    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.