Research Matters - AdventHealth Research Institute · This research • Is well-designed, including...

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!