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Research MattersFebruary 20, 2018
WelcomeRob Herzog, VP Research Operations
Devotion
Michelle Kilponen, MRAOffice of Sponsored Programs (OSP)
Research Operations Manager
Keep Me Safe
Psalm 4:8In peace I will lie down and sleep, for you alone, Lord, make me dwell in safety.
Psalm 16:1 Keep me safe, my God, for in you I take refuge.
Love MeJohn 13:34“A new command I give you: Love one another. As I have loved you, so you must love one another.”
1 Thessalonians 5:11Encourage one another and build each other up
Own ItGalatians 6:5For we are each responsible for our own conduct
Colossians 3:24Whatever you do, work at it with all your heart
Make it EasyMatthew 11:28Come to me, all who are weary and burdened, and I will give you rest.
Isaiah 40:11 He tends his flock like a shepherd. He gathers the lambs in his arms and carries them close to his heart
Live IntentionallyWork Intentionally
Study Review - Better Together
Dr. Ki Lee, MD, MBA Medical Director, FH Neuroscience Institute
Debbie SpielmanVP, COO, Florida Hospital for Children
Patricia Robinson, PhD, ARNP, Senior Director FHRI
Delores Barnes, BSN, RN, CCRC, Manager, CV Research
Scientific, Operational, & Academic Review (SOAR)
PURPOSE:To make sure that every study we support advances the strategic objectives of Florida Hospital Research Institute and our partners across Florida Hospital
Ki Lee, MD, MBA
How clinical team influences study selection and study design
• Investigator-initiated studies• Sponsored studies
Clinical & Academic ImpactCLINICAL IMPACT
This research• Has not already been answered in
peer-reviewed, published findings• Addresses an important problem
that fills a gap in scientific knowledge
• Improves safety or quality for our patients
• Aligns with patient preferences• Is likely to be scalable and
reproducible and positively impacts cost and quality of care
ACADEMIC IMPACTThis research• Is well-designed, including
statistical analysis• Builds stepwise toward
generalizability to a larger population
• Is likely to result in a peer-reviewed publication
• Is conducted by a team that is well-suited to recruit and complete the study
• Leads to academic partnerships and/or external funding
Deb Spielman, COO
Key considerations for supporting research
• Does the research align with our strategic imperatives?
• Is the research scientifically relevant?
• Is the research innovative?
• Does the research leverage something unique we have here at FHFC?o Program, people, technology
• Does the research lead to enhanced national recognition?o US News & World Report
Key considerations for supporting research
• Will the research ultimately translate to better clinical outcomes?o addressed untreatable conditionso less invasiveo lower cost (ie; lower LOS)o improved quality of life
The most important consideration:
•A well thought out vision articulated by the PI
•A commitment from the PI to do the work necessary upfront, during and at the end of a study
Me, Before and After
Feasibility & Financial Review - Operations
FEASIBILITYThis research• Other FH departments have staff to
support study conduct• Research unit has staff and skills to
support study conduct• Adequate patient population to
meet recruitment goals• PIs and study personnel commit to
all necessary training CITI/sponsor• Necessary space and equipment
exists to conduct study
FINANCIALThis research• Has cost-sharing agreements in
place with operational unit and FHRI senior leadership
• Medicare coverage analysis cleared• Is designed in a way that minimizes
expense to FHRI• Meets the financial goals of FHRI
and research unit• Aims to include solutions that are
scalable across AHS to improve quality or reduce cost
Delores Barnes, BSN, RN, CCRC
Cardiovascular Research Research Review Process
Our Challenge… Formulate a review process/committee to encompass eight different specialties Structural
Heart
Aortic and Vascular
Pulmonary Hypertension
(ALD)
Invasive Cardiology
Heart Failure
Preventive Cardiology
Electro-physiology
(EP)
Cardio-pulmonary
Surgery
CVR Research Review Forum
Physician Leader: Rohit Bhatheja, MD
Who’s Invited?• CV Investigators (PI’s and Sub-I’s)• Research Leadership (Rob – VP; Chris
– Sr. Director)• CVI Leadership (AVP)
How invited?• Calendar invite from CV Research
Schedule (Office Manager)• Reminders sent by Physician Leader
day before
Frequency• Monthly, with option to cancel if no
pertinent agenda items
Meeting Obstacles • Engagement
• Not appreciating the importance of the meeting.
• CRC involvement.• Manager rounding with Physicians
critical
• Scheduling• Lack of Attendance (more of an
issue early-on)
Review ProcessSub-specialty Review (serves as first Scientific review)• Eight Sub-specialties: Structural Heart, Advanced Lung, Heart Failure, Aortic and
Vascular Disease, Arrhythmia, Cardiopulmonary/Thoracic Surgery, CV Prevention and Wellness,
• Frequent meetings (non-research)• Research projects are vetted
CVR Review (SOAR)Scientific: Physician Leader• Reviews project (form/slides) in preparation for meeting, consults with other Physician
InvestigatorsOperational: Manager• Reviews form, meets with PI, pre-site selection meetings, gather additional information from
clinical teams, etc.Administrative Review: Manager and Sr. Director• Review form/slides, operational specifics that are available, review budget (if available)
Research Review Forum• All studies are presented by PI followed by open discussion meeting
• our Sub-Specialties seem to enjoy learning about different areas and are providing input• Scientific/Operational hurdles discussed at time of presentation
Slides are Utilized by the PI Presenting the Study
• Study Overview• Target Population• Main Objectives• Research Device/Drug/Technique details for the team
(pictures may be included)• Inclusion/Exclusion
Senior Director/Manager• Operational Details as available on the review date
Presentation Concludes with Questions & Active Discussion amongst the team
Sample Meeting Minutes (Study Specific)
EVAS II
Decision – Proceed with study
See Slide Presentation Attached It is a prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. The polymer is the consistency of an eraser and seals the aneurysm. FH maximum enrollment is 14 subjects. Operationally – Pricing agreement for Device has been negotiated and approved by CVI, one scan with be non-standard of care at 6 months (radiology pricing requested). CVI leadership have reviewed this study for innovative design due to the polymer utilized for the endovascular repair. Research Nurse time/effort will be heavy for enrollment and procedure day. Follow-up for 5 years with minimum coordinator effort due to all visits, except for one being standard of care, for the patient population. Study execution time-line goals: IRB approval by December, sponsor to have CMS approval by Mid-December, enrollment to begin by End-December or 1st quarter 2018 (January)
Research Services Updates
• Classes• Common• Rule Changes• Policies• Forms
• New Team Member
• Coverage Analysis• Budget
Negotiation• SEFA Audit
OSPOffice of
Sponsored Programs
ORI/Compliance
RASResearchAdvancementand Support
ORI/Institutional
ReviewBoard
OSP: Coverage AnalysisGuidance on Coverage Analysis Requirements
Effective 2/1/2018, FH Research Services requires all new clinical research submissions that include billable patient care items and/or use of ancillary hospital services to have a full and comprehensive Coverage Analysis, regardless of the funding source.
Full text can be found on OSP website:https://drupal02.floridahospital.org/researchadmin/content/coverage-analysis
OSP: Budget Negotiation
Postponement of Budget Negotiation ServiceDue to other priorities, OSP is postponing the implementation of a centralized budget negotiation.
OSP: SEFA AuditSchedule of Expenditures of Federal Awards
As a recipient of Federal awards, including subawards, Florida Hospital is required to conduct a single audit annually under 2 CFR 200.
How does this affect me?Research Finance may need to reach out to you to obtain certain information and documentation to satisfy audit requirements.
This may include, but is not limited to:• Time and Effort Reports• Study Tracking Logs• Vendor Quotes• EDC screenshots
Research Services Updates
• Classes• Common• Rule Changes• Policies• Forms
• New Team Member
• Coverage Analysis• Budget
Negotiation• SEFA Audit
OSPOffice of
Sponsored Programs
ORI/Compliance
RASResearchAdvancementand Support
ORI/Institutional
ReviewBoard
ORI
InstitutionalReview Board
Responsible Study Conduct
ResearchBilling
Office of Research Integrity
Compliance IRB
Melissa PalloneResearch Support Specialist
Christina JacksonIvette Leka
Vanessa LoweSarah Vulinec
Janice TurchinMichelle McKinneySamantha Bowling
Common Rule ChangesEffective 1/19/2018
Facts• DHHS (45 CFR 46) developed to regulate federally
funded/conducted research studiesNIH, NIDDK, DOD, VA, HRSA, AHRQ
• 1/2017 Long overdue changes implemented to meet the needs of the current research landscape.
• 10/2017 Further delay proposed. • 12/2017 No news to date. • 1/17/2018 - Official notice of delay
7/19/2018
Common Rule ChangesEffective .
What does this mean for FH? • More time to prepare • Policy Revisions remain underway• Revised Policies – AAHRPP re-Application/Benefit
Policies revised to
incorporate changes to
common rule
Revised Policies
submitted to AAHRPP
AAHRPP committed to
providing feedback on revised rule
7/19/2018
Common Rule ChangesEffective .
FH Future StateFH IRB Plans to Stage Implementation
• First stage - apply new rule to DHHS funded/conducted research submitted on/after Effective Date
• FH Portfolio• NIH funded studies - New sIRB Rule Effective 1/2018• Future other studies – IRB May Apply New Rule
• Policy revised and broad enough to allow staged approach • Release Burdens i.e. minimal risk studies• IRB review/considerations during Initial/Continuing Review
• FDA regs still apply as usual• Changes likely underway
7/19/2018
Revisions to IRB DocumentsGuidance Documents – Transition over to Policy HRP-800 – Investigator Obligations HRP-801-Prompt Reporting Requirements
-NOW-HRP-070 POLICY – Investigator ObligationsHRP-069 POLICY – Prompt Reporting
Revisions to IRB DocumentsRevised SOP: 400.071 – Revisions
Investigator GuidanceHRP-825 – HIPAA Privacy in Research
Purposes:• Training
• Workshops• 1:1
• Re-training• Yearly; CAPAs
Research Services Updates
• Classes• Common• Rule Changes• Policies• Forms
• New Team Member
• Billing Compliance Reminder
• Coverage Analysis• Budget
Negotiation• SEFA Audit
OSPOffice of
Sponsored Programs
ORI/Compliance
RASResearchAdvancementand Support
ORI/Institutional
ReviewBoard
ORI/Compliance Update
New Team Member• Sarah Vulinec, Research Compliance Specialist
Research Billing Compliance Reminder• Updates to your list of active research patients is
due every WEDNESDAY
ORI/Compliance Update
Consent with non-English Speaking Subjects
• Improvements to P&Ps and Guidance Documents are underway
• Updates coming soon!
FDA Audit• Congratulations to the Transplant Research
Institute for a successful FDA audit!
Research Services Updates
• Classes• Common• Rule Changes• Policies• Forms
• New Team Member
• Coverage Analysis• Budget
Negotiation• SEFA Audit
OSPOffice of
Sponsored Programs
ORI/Compliance
RASResearchAdvancementand Support
ORI/Institutional
ReviewBoard
Research Advancement & Support (RAS) Update
Classes
Big Data and StatisticsDr. Liqiang Ni, PhDUCF Department of StatisticsAn introductory talk on statistics, data mining and data scienceSAVE THE DATE:March 9th
2:30pm-3:30pmLocation TBD
About UsCenter for
Interventional EndoscopyRobin Barron
Clinical Research Ops ManagerRobin (Barron-Nelson) Kangas
Clinical Research CoordinatorsCristina CamposMillie LopezCallie Arnold
BiostatisticianXiang Zhu
PhysiciansShyam Varadarajulu, MDUdayakumar Navaneethan, MDMuhammad Hasan, MDJi Young Bang, MDRobert Hawes, MD
Specialized Endoscopy UnitNM – Mariel MadrideoANM – Heather Yount20 RNs & 5 Technicians
Research Team –Who are we?
Current Portfolio –15 Prospective Physician Initiated Studies
• 9 Randomized• Partnered with TRI, ISA, and Cleveland Clinic
3 Physician Initiated Registries6 Retrospective Physician Initiated Studies2 VA Partnership Studies3 Industry Sponsored Pharma Studies2 Industry Sponsored Observational Studies2 NIH Funded Studies
• Partnered with MUSC and the NIDDK
Research Focus
GASTROINTESTINAL
Crohn’s DiseaseUlcerative ColitisColon PolypsColon Cancer
PANCREAS
PancreatitisChronic & Acute
Pancreatic CancerPancreatic CystsPancreatic Necrosis
LIVER
Liver BiopsyBiliary Obstruction
2017Statistics
• 3rd in the world for the number of Endoscopic Ultrasounds performed globally.
• Screened 1,707 subjects and enrolled 644 into studies or registries
• 21 journal publications
• 2nd highest enrolling site for NIH funded study
About UsCenter for Pediatric Research
Tere Richard
CPR TEAM
WILLIAM OH, MDSCIENTIFIC MEDICAL
DIRECTOR
TERE RICHARD, MHSA, CCRP, CAHIMSUNIT LEADER
DEBBIE OTT,BSN, RNC-NIC LEAD NICU CRC
COMING SOON
VICKI FLYNN, BSN, RNC-NICNICU CRC
HEIDI ANDERSEN, RNLAKE MARY PEDIATRIC
OUTPATIENT CRC
KATHLEEN EWING, MHA, RN
NEURO CRC
ARIANA FRANCO MORA, BS, CCRPNICU F/U, PEDIATRIC OP PM
SANDRA BENT, BS, CCRPCOMPLIANCE MANAGER
PAMELA HEDRICK, BA, RNPEDIATRIC OP CRC
Research PortfolioCenter for Pediatric Research
SERVICE LINE STUDIESAnesthesia 1Bariatric 1Cardiology 4Critical Care 4Endocrinology 1Gastro/Hepatology 1Hematology/Oncology 4Neonatology 15Nephrology 1Neurology 7Orthopedics 1Pediatric OP 1Urology 1Women's 1
Grand Total 43
SERVICE LINE STUDIESAnesthesia 1Cardiology 1Critical Care 1Endocrinology 1Gastro/Hepatology 6Hematology/Oncology 1Neonatology 6Neurology 6Orthopedics 1Pediatric OP 2
Grand Total 26
Active Studies In Development
31 Primary InvestigatorsCenter for Pediatric Research
INVESTIGATOR STUDIESAbraham-Pratt 1Allewelt 1Boardman 1Gireesh 2Godshall 1Gomez 1Gonzalez-Peralta 7Hajjar 2Hellner 1Kirby 3Korostenskaja 3Landis 2Lee 6Looke 2Mavroudis 3Mayor 1
INVESTIGATOR STUDIESMikulencak 1Mirza 4Oh 1Ott 1Pena 1Pulickal 2Reddy 2Sensakovic 1Shook 2Skinner 1Trivedi 2Vega 1Wadhawan 9Westerveld 2Woo 2
Grand Total 69
Research Impact of theCenter for Pediatric Research
PENUT
TOLSURF
ECHO DINE
Leadership Message
Steven R. Smith, M.D.Chief Scientific Officer
Closing RemarksRob Herzog
Thank You for Attending!
Our next Research Matters meeting will be in April or May…
Details will be released soon!
