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Research MattersJanuary 10, 2017
WelcomeRob Herzog, VP Research Operations
DevotionJasmine Jones
Center for CREATION Health Research12 Just as a body, though one, has many parts, but all its many parts form one body, so it is with Christ. 13 For we were all baptized by one Spirit so as to form one body—whether OSP or ReSIS, Jews or Gentiles, Cancer or Orthopedic Research, slave or free, ORI or Research Finance—and we were all given the one Spirit to drink. 14 Even so the body is not made up of one part but of many.15
DevotionJasmine Jones
Center for CREATION Health Research15 Now if the foot should say, “Because I am not a hand, I do not belong to the body,” it would not for that reason stop being part of the body.16 And if the ear should say, “Because I am not an eye, I do not belong to the body,” it would not for that reason stop being part of the body.17 If the whole body were an eye, where would the sense of hearing be? If the whole body were an ear, where would the sense of smell be?18 But in fact God has placed the parts in the body, every one of them, just as he wanted them to be. 19 If they were all one part, where would the body be? 20 As it is, there are many parts, but one body.
DevotionJasmine Jones
Center for CREATION Health Research21 The eye cannot say to the hand, “I don’t need you!” And the head cannot say to the feet, “I don’t need you!” 22 On the contrary, those parts of the body that seem to be weaker are indispensable, 23 and the parts that we think are less honorable we treat with special honor. And the parts that are unpresentable are treated with special modesty,24 while our presentable parts need no special treatment. But God has put the body together, giving greater honor to the parts that lacked it,25 so that there should be no division in the body, but that its parts should have equal concern for each other. 26 If one part suffers, every part suffers with it; if one part is honored, every part rejoices with it.
27 Now you are the body of Christ, and each one of you is a part of it.
1 Corinthians 12:12-27
Leadership MessageState of the FHRI
Steven R. Smith, M.D. Chief Scientific Officer
Thank You!
Laying the Foundation
New StructureNew Leaders
1 Team
E2
Publ
icat
ions
Clin
ical
Impa
ct
Gran
ts &
con
trac
ts
Volu
ntee
r Exp
erie
nce
Q & A
About UsCardiovascular Research
• Partnered and aligned with the Cardiovascular Institute to provide state-of-the-art medical care and perform groundbreaking research in the Central Florida area
• As one of the top cardiac centers in the nation, the FH Cardiovascular Institute helps patients gain access to promising, new treatments and technologies before they are available to the general public
• CTMS “1st Wave”
57 Studies (Industry, Non-Industry, and FH Sponsored) • Interventional Cardiology• Cardiac and Vascular Surgery• Structural Heart Disease• Pulmonary Hypertension• Peripheral Vascular Disease• Heart Failure• Electrophysiology and Arrhythmia• Cardiac Imaging• Preventive Cardiology Staff• 11 Research Staff• 57 IRB Credentialed Investigators
About UsCenter for Interventional Endoscopy
CIE Quick Facts• CIE opened in 2011• #1 in Florida by volume• Tertiary Referral Center
• 39 states• 8 countries
• Providers• 5 Endoscopists• 1 Pathologist• 2 Mid-level
CIE Research • Goal: to innovate & attempt to
answer critical questions in the field of gastrointestinal endoscopy
• 43 Studies• 17 Investigator Initiated, Prospective,
Randomized Trials• 14 Retrospective studies• 7 Industry Sponsored• 2 Grant-funded (NIH & VA)• 3 Registries
• Research Staff• 3 FTEs
• Publications (Peer-reviewed journal articles)
• 24 in 2014• 42 in 2015
Research Services Updates
• ORI – Christina Jackson• ORI – Penny Carlson• IRB – Janice Turchin• OSP – Regina Tan• RAS – Michelle Dolske
Research Oversight Committee1st Meeting, January 12, 2017
Rob Herzog• VP Research Operations
Judith Fox• Corporate Responsibility
Fouad Hajjar, MD• IRB Chairman
Janice Turchin• IRB Manager
Troy Kishbaugh, JD• FH Legal
• Scott Silvestry, MD• Physician Investigator
• Jennifer Keehbauch, MD• Physician Investigator
• Esmond Chan• FH Finance Director A/R
Melissa Leonard• Clinical Operations & Nursing
RepresentativeJeff Carrico
• Investigational Drug Services (IDS )Penny Carlson
• ORI Compliance & EducationChristina Jackson
• ORI Compliance & EducationIvette Leka
• ORI Compliance & Education• TBD
• FHMG Representative
ClinicalTrials.govFinal Rule published September, 2016 - Effective, January 18, 2017• Applies to all Applicable Clinical Trials. ClinicalTrials.gov has developed a new
checklist to assist researchers in determining if their trial meets the criteria for an Applicable Clinical Trial (ACT)
https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
• Results must be submitted within 12 months after primary completion date• Potential Federal enforcement actions• Label as non-compliant in ClinicalTrials.gov• Civil monetary penalties of up to $10,000/day• NIH Clinical Trials registration policy also updated – Applies to all clinical trials with federal
funding• Includes phase 1, non-FDA regulated, and behavioral research• Potential enforcement actions related to CT.gov non-compliance includes:• Possible suspension or termination of grant or contract funding• Considered in future funding decisions• Label as non-compliant in CT.gov
Research Patientsand FHMG• AthenaHealth initiated 11/1/2016
• Need to differentiate between FHMG and independent PI and sub-I’s.
• How many active studies do you have that involves a PI or sub-I that is FHMG?
• Standardizing pneumonic: Shortname|IRBNet#|PI name
• Contact: Kate MacNaughton [email protected]• Notify:
• when initiating a new study• new patient enrollment
OSP: Office of Sponsored Programs
TBA
Regina Tan
Bianca Maldonado
Leerin Shields
Michelle Kilponen
QuilinMars
Jessica Hyacinthe
OSP
Team A
IIT/IIS Grants and Contracts -Funded Studies
Team B
Industry-Sponsored
Studies
IIT/IIS Internally - Funded Studies
Meghan Brodie
TBA
Research Services Updates
Research Advancement and Support
• Class Schedules posted on Intranet Research Services Website
• Email class RSVPs to [email protected]• New FHRI website expected to be released
by end of January www.FHResearch.com
Better TogetherHighlighting a Best Practice,
Collaboration, or Process Improvement
Use of Biospecimens in Research*TRI-MD
• Paul Coen, PhD*• Mandy Jones, BSN, CCRC• Josh Smith• Anna Zago• Chris Davis, PhD
Research Services• Michelle Dolske, PhD, CRCH• Michelle Kilponen, MRA• Janice Turchin, CIP• Michelle McKinney, MS, CIP• Fouad Hajjar, MD
DilemmaAs an institution, we have been on a learning curve. Approved protocols and ICFs have not always been detailed or sophisticated with regard to what could be done with residual or archived biospecimens.
Here is our Story
Scope of Biospecimen Research at FHCancer
Transplant
TRI-MD
Pharmacy Nursing Research
Neuroscience
GME
Global Robotics Institute
CelebrationHealth
Cardiovascular
Ortho
Children’s
InterventionalEndoscopy
Surgery
Winter ParkMemorial Hospital
Radiology
Creation Health
Thrombosis
FH Research Enterprise
TRI-MD Current State (July 2016)
After a study is completed, there are often requests for archived tissue from the study. Three specific problem’s were identified:1. Protocol and Informed
Consent are not always specific about how archived tissue will be handled
2. Protocol and Informed Consent may have conflicting information about how archived tissue will be handled
3. Protocol and Informed Consent may not reflect the PI’s intent of how archived tissue will be handled
We developed a Guidance Document to ensure:
• Delineation of Scientist/Investigator intent for the use of biospecimen in research
• Accurate depiction of this intent in the Protocol and Informed Consent as well as other study documents
Problem & Solution
1. Talked to scientists/investigators to define common “intents”
2. Defined the different intents both graphically and in the written document
3. Mapped the different “intents” to sections of the protocol and Informed Consent to yield “Synchronization”
4. Reviewed Guidance Document with ORA and IRB to insure institutional alignment – multiple iterations to achieve consensus.
Steps We Took to Develop the Guidance Document
• Provided a common language, common ground to discuss Scientist and Investigator intent regarding biospecimen use
• Reduced questions and ambiguities related to use of leftover and archived biospecimens in the protocol and informed consent
• More efficient IRB review and approval of studies• More efficient OSP review of MTA requests
Result
Impact StoryHow We Make a Difference
Anne Epley, BSN, RN, CCRPClinical Research Manager
FH Transplant Institute
Jarvik 2000Ventricular Device SystemPost Auricular Connection
Ventricular Assist Device
• Pulls blood from the left ventricle through a pump
• The pump sends the blood to the aorta and out to the rest of the body
• Battery operated• Power connection
exits out the abdomen
• Destination or bridge
Jarvik 2000
• Implanted directly into the left ventricle
• Battery operated• Power Connection is
post auricular• Can implant via
sternotomy or thoracotomy
• Destination only via clinical trial
Mr. S.
• 71 years old
• Retired auto service supervisor
• Married 49 years
• 2 daughters
• 2 grandchildren
• Referred to FHTI Advance Heart Failure clinic in
September 2013
Mr. S.Initial Presentation• On multiple medications• Using oxygen at night• Increased fatigue• SOB with minimal activity• Decreased functional
status – NYHA class IV• Frequent napping
Medical History• CAD• Ischemic Cardiomyopathy• Atrial Fib• H/O Vtach, • s/p multiple ablations• ICD implanted• HTN• Dyslipidemia• Obstructive Sleep Apnea• Cancer survivor
Mr. S.Current Status• Stable, NYHA class I• Enjoying walking and
water activities• Able to move to West
Coast to be near daughters
• Quality of Life greatly improved
VAD Implant• VAD evaluation completed• Consented for RELIVE trial,
randomized to the Jarvik 2000 device
• Implanted 11/2013• LOS 30 days (non-device related
complications)• Only 2 admissions since, both
related to his defibrillator and rhythm issues
• Recently completed his final 3 year study visit
Mr. S.’s Thoughts on Being a Study Participant
• Grateful for the
option
Ease of use
Shower, swim
No infections
• No regrets
TeamworkRob Herzog
• Assignment• Re-group• Discussion• Re-cap
Small Group DiscussionHow is research making care at FH
•more affordable? (eyes, ears, nose)
•more connected ? (mouth, hands, arms)
•more exceptional? (trunk, leg, feet)
Wrap-UpRecognition
Team Members• Promotions
• Tere Richards (Pediatric)• Jasmine Jones (CREATION
• Graduations• Diane Thomas (BHCA)
Teams• ResIS
• CTMS “Go Live!”• Cardiovascular
• 1st Wave of CTMS• TRI-MD
• Grant Awards• Microbiome• Epigenetics of adipose
tissue• Molecular Transducers of
Physical Activity in Humans (MoTrPAC)
• Industry Partnerships• Sanofi• Pfizer
New Team• Research Analytics
Institute
Closing Remarks
Thank You for Attending!
Our next Research Matters meeting will be in March…
Details will be released soon!