Research Matters · 2019-10-01 · ROC Charter & COI P&P ROC Charter states ROC will: • Review Financial Conflicts of Interests (FCOIs) deemed to be substantial • Determine FCOI

Research MattersDecember 6, 2018

WelcomeRob Herzog

VP Research Operations

DevotionStephanie Harris

Center for CREATION Health Research

Research Services Updates

RAS UpdatesMichelle Dolske, PhD

Research Services Phone Update

New phone numbers for Maitland offices!

407-200-2677 Institutional Review Board

407-200-1615 Office of Research Integrity

407-200-9262 Office of Sponsored Programs

407-200-2694 Research Advancement and Support

IRB UpdateJanice Turchin

AAHRPP Site VisitJanuary 11-12, 2019

Reminder• You may have been

invited to participate.

• THANK YOU, in advance for your contribution. It is important to all of us in research.

• Coaching sessions are being planned.

Questions?• Call Janice Turchin

• 407-200-2677 or 407-864-0386

Common Rule Changes

EFFECTIVE: January 21, 2019

• Current policies allow flexibility of applicability of the new rule.

• Starting 1/21/2019 - Will ONLY APPLY to new federally funded/conducted studies submitted on or after the effective date. E.g.: NIH, DOD, NIDKK, Etc….

• Working Sessions are being planned to prepare.

• Future State: Could apply to other studies where we see we can help release burden

• QUESTIONS? Call Janice Turchin 407-200-2677 or 407-864-0386

What Else is Changing?

EFFECTIVE: January 21, 2019

• New Protocol Template

• New Informed Consent Template

• Workshops being planned

• What else?

• Burden reducing

Office of Research Integrity UPDATE

Christina Jackson

ORI UpdatesCerner Patient Account (CPA)

NEW Go live date, April 1, 2019• Building PowerPlans-currently on hold

• Testing of new processes in CPA has begun

ORI UpdatesResearch Oversight Committee (ROC)

Added Vice-Chair:

• Ravi Shridhar, MD, PhD

• Vice Chair of the Department of Radiation Oncology

ORI quarterly reporting to ROC

• COI

• Serious & Continuing Noncompliance

• Auditing & Monitoring Activity

• Update on Annual Workplan progress

ORI UpdatesPolicy Development

• Conflicts of Interest (COI)• SOP revisions

• Research Billing Compliance• Currently in development

ROC Charter & COI P&P

ROC Charter states ROC will:

• Review Financial Conflicts of Interests (FCOIs) deemed to be substantial

• Determine FCOI management plan

COI Policy states:

• “COI Disclosures will be reviewed and acted upon within 60 days of submission to

FH Office of Research Integrity (ORI) in accordance with SOP 403.001.”

Involvement of ROC does not require a change to the policy.

SOP Revisions: Quarterly Reporting to ROC

• Aggregated summary of all COI and SFI disclosures

• Anonymized report of all SFIs > $40K including:• Amount

• Nature

• Entity

• # Projects with the entity

• Discloser’s role in the research

• Management plan implemented

ROC Charter & COI P&PQuarter 2: April 2018-June 2018Total Conflict of Interest Disclosures received: 231

Total Significant Financial Interest Disclosures received: 33

Total FCOI Management Plans deviced: 24

FCOI Management plan details: No recruitment (14), ICF consent (4), Other (2)

Amount dislcosed

Nature of SFI$5k-$9,999 $10k-$19,999 $20k-$39,999 $40k-$59,999 $60k-$79,999 80k-$99,999 100k-Higher

Total # of plans

Remuneration including salary and any payment for services not otherwise identified as salary, (e.g., consulting fees, speaking fees, payment for serving on a board/committee, honoraria, authorship, etc.).

13 5 2

Equity interest in a publicly traded entity, including stock, stock options, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

1 1 1 1

Remunerations from any non-publicly traded entity.

Proprietary and/or Intellectual Property rights and interests (e.g., patents, trademark, copyrights, or licensing

Any equity interest in any non-publicly traded entity, including but not limited to stock, stock option, or other ownership interest (no dollar threshold).

Total 24

ROC Charter & COI P&P

Reporting: COI/SFI Details1st-3rd Quarter:

Cases greater or equal to $40k

Researcher Amount Nature Entity Name# of projects

w/reported SFIRole on Project

Management plan implemented

Individual 5 $40k-$59,999

Remuneration including salary and any payment for services not otherwise identified as salary, (e.g., consulting fees, speaking fees, payment for services on board/committee, honoria, authorship, etc).

Genentech 1 of 6 Principal Investigator

--This individual will not participate in the recruitment of subjects, nor obtain informed consent for the related research project(s). This individual may answer questions the research candidate may have. --The SFI will be disclosed directly to the participating subjects through the informed consent form or letter of invitation, and by statement of public disclosure if presenting or publishing.

SOP Revisions: Management Plans

• FCOI’s >$40K

• Ongoing

ROC Chair

• FCOI’s deemed substantial

• Suggested management plan (MP)

ROC• Review/approve

suggested MP

• May add to, or revise suggested MP

ROC Input

OSP UpdatesRegina Tan

OSP UPDATES

Study Submission Process Update

Coverage Analysis Fees▪ 2018 Fee True Up

▪ 2019 Fee Schedule

New OSP Member

Study Submission Process Update

▪ For “CTMS-Implemented Departments,” effective February 1, 2019, OSP study-related submissions should be routed through Clinical Conductor.

▪ Clinical Conductor Training – January 2019

Coverage Analysis Fees

▪ 2018 Coverage Analysis Fee True Up

▪ 2019 Coverage Analysis Fee Schedule

Service Frequency Fee1

New Coverage Analysis Request

Single-Arm $1,250

Multi-Arm $1,500

Coverage Analysis Amendment Per Amendment $200 / hour

1 Fees are inclusive of overhead.

New OSP Staff Member

Camary (Cami) Knoblock – Sponsored Programs Analyst I

2018TheYear in Review

Rob Herzog

Cancer Research

Departmental Accomplishments

• Accolades received from the Children’s Oncology Group

(COG) Audit for the Patient and Regulatory components

• Lynn Penyak - Health Coach Champion

• BMT moves forward with CAR T-cell therapy and on a new

Stem Cell Lab.

Personal Accomplishments

• Lauren Clise - 2 week missionary trip to the Philippines

Protocol Review Committee (PRC) – Adult Oncology

2018 Overview – Our inaugural year completed!

• 27 Committee Members – Oncology Physicians and Surgeons.

• 40 Peer Reviews Completed (2 reviews for each trial).

• 3 Campuses (Orlando, Celebration & Altamonte) now allow web conferencing to accommodate more committee members.

Visit our SharePoint for more info on the PRC!

https://ahsonline.sharepoint.com/Central-Florida/prc/ Pro

toco

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evie

wed

26

Trials came to the PRC

6

Expedited Review

20

Full Committee Review

https://ahsonline.sharepoint.com/Central-Florida/prc/

Cardiovascular Research

Degrees & Certifications• Deanna Allen - Certification as a Research Coordinator (CCRC)

• Tracey Purvis - Completion of Masters Program (MSN)

Service Milestones• Deanna Allen – 5 years

• Joy Meyer – 15 Years

• Leann Goodwin – 30 Years

Personal Accomplishments• Kimberly Cawthon (STARK) got married

Cardiovascular Research continued

Study Highlights• DELIVERY

• PI: James Tarver, Primary Coordinator: Kimberly Cawthon• Received FDA Approval in 2018• Implantable pump for medication administration• Florida Hospital – 5 Active Subjects throughout study• CV’s 1st Pulmonary Hypertension Study

• FH will have first access to the implantable pump for commercial use.

• EVAS II Confirmatory Study • PI: Dr. Manuel Perez, Primary Coordinator: Sandra Houser• New Technology for Endovascular Abdominal Aortic Aneurysm Repair• First Enrollment in the State of Florida

Cardiovascular Research continuedStudy Highlights

• DIAMOND AF • PI: Dr. Usman Siddiqui, Primary Coordinator: Leann Goodwin, RN

• World Record for Most Ablation Enrollments in 24 Hours

• Total of 4

• ADAPTABLE• PI: Dr. Hani Seifein, Primary Coordinator: Margaret Warrington, RN

• First Collaborative Clinical Study with UF and PCORI Network

• First E-Consent

• REDUCE-IT (Investigational Drug: Vascepa icosapent ethyl)• PI: Dr. Hector Lozano

• Primary Study Team: Kimberly Cawthon, RN (Research Nurse); Robin Michaels (Research Assistant);

Carol Stastny, RN (Retired-Primary Coordinator)

• Enrollment at FH – 18 Subjects

• Presented at AHA 2018 in the Main Arena

Celebration Health


• Completed their first FDA audit at FH with flying colors

• Opened the Celebration Infusion Center

• Radiation Center - building underway

• Accruing oncology patients with Premier Hematology

• Moved into a new Research Office where the team is now back

together again!


• France Deronvil – 5 years

CIE: Center for Interventional Endoscopy


• Dr. Navaneethan’s Lipidomics study will be the largest

Biorepository at TRI-MD

• 20+ publications for 2018

Grant News

• 2nd Highest Enrolling Site for NIH study

Study Highlights• Opened 10 Industry Sponsored studies in the last 4 months

Center for CREATION Health Research

Departmental Accomplishments• CreationHealthResearch.org website

• 2 Studies Completed

Study Highlights• Lake Nona Life Study

• Compassion Rounds

• Performing Arts Intervention for Caregivers of Patients with Memory Loss –Partnership with Dr. Phillips Center for Performing Arts

• Nurse Resilience RCT Study plus intensive program for critical care nurses

• Whole-Person Wellness Assessment – Outpatients

• Whole-Person Wellness Assessment– College Students

CREATION continued

Degrees & Certifications

• Ashley Kohrt, MBA

• Petronio Martins, MHA


• Amanda: 2-Time 1st Place Trail Runner; Publication in Journal of School Health

• Stephanie: Publication in Journal of the Medical Library Association

• Pam: Completed FL Master Naturalist Program Freshwater & Uplands Module

• Hong: Rescued a cat that led to a successful adoption

Global Robotics Institute


• Tadzia Harvey - CCRC through the ACRP exam on October 1, 2018

ISA – Institute for Surgical Advancement


• First cases in USA using the Senhance/Transenterix Robot

NSI: Neuroscience Institute Research

Departmental Accomplishments• Red Skirt Run and American Heart Walk

• 2 Conference Presentations

• Sambursky J, Padalia A, Gandhi R, et alO-029 Self-expanding stent versus drug-

eluting balloon-expandable stent for intracranial arterial stenosis Journal of

NeuroInterventional Surgery 2018;10:A19-A20.

• Self-Expanding versus Drug-Eluting Balloon-Expandable Stenting for Intracranial

Arterial Stenosis- 2018 Society of NeuroInterventional Surgery (SNIS)

Grant News• $2,400 from Fraternal Order of Eagles for the ENHANCE trial- collaborative study

with TRI

Center for Pediatric Research

Departmental Accomplishments• 3 publications• 2 conference presentations

Grant News• Children’s Research, in collaboration with TRI, received a $2,400 grant from Fraternal Order of

Eagles for the ENHANCE trial- collaborative study.• Hussnain Mirza received funding award from Thrasher for his original 3 year study: Treatment of

delayed pulmonary transition in extremely preterm infants & bronchopulmonary dysplasia. He also received donation of IP and placebo for the study from Mallinckrodt.

• Regino Gonzalez-Peralta received a subaward through Yale for the Wilson Disease Association funded 4 year project: Wilson Disease Registry.

• Draeger funded first of 5 projects -- a NICU nursing study titled: Automated servo-control system facilitates the weaning of preterm very low birth weight infants from incubator to open crib. PI: Debbie Ott

Pharmacy

Departmental Accomplishments• Annual Children’s Oncology Group (COG) audit

• Auditor praised the IDS Pharmacy staff stating “You are the most organized

Pharmacy I have seen”

• Rebecca Prevost, PharmD, presented at the Hematology-Oncology

Pharmacists Association (HOPA) Practice Management meeting in Chicago on

September 14th, 2018. 23 and Pharmacy: Gearing pharmacy operations for

preparation of vaccine and viral vector therapies.

Service Milestones• Kevin Kilmer – 40 years (12 years with Investigational Drug Services)

TRI-MD

Departmental Accomplishments• Paul Coen and team – On 11/15/18 muscle cells were sent to the International

Space Station from a TRI study to study the effects of microgravity on muscles.

This may provide insight on sarcopenia (age-related muscle loss).

Grant News• 5 new grants totaling (over the differing project periods) an estimated $5.41

million total costs in federal and foundation grant awards (direct and

subawards)

• Additional funding in non-competing continuation awards.

Transplant

Departmental Accomplishments• Recognized by Abbott for our top ten enrollments in the HeartMate 3 CAP study,

contributing to the successful approval of the device this year

• Recommended by NuPulseCV as an “excellent site” for a Research Coordinator

to visit in order to help her struggling research department up north.

Study Highlights• Invited to contribute data to Stanford university regarding liver transplant patients

over the age of 65 “Outcomes in Liver Transplant Recipients of Advanced Age”

• Invited to contribute data to Medical University of Vienna, “Cardiac Surgery after

Heart Transplantation-an exploratory, retrospective, multi-center study”

Grant News• Received their first NIH grant sub-award, Sustain-It with Northwestern.

• Collaborating with UCF and Miami on two more sub-awards

IRB – Institutional Review Board


• Survived the postponements of the updated Common Rule

• Preparing for AAHRPP re-accreditation visit

ORI – Office of Research Integrity

Departmental Accomplishments• Development of Research Oversight Committee

• Partnering with IRB to improve processes & guidance (non-Eng Speaking

project)

• Adding Internal Monitoring to our services offered

• Improving communication and aligning research compliance efforts with FHMG

• Improving standardization of research billing processes

• Began research billing compliance rounding with FH Rev Cycle, FHMG Rev

Cycle, and Research Depts.

• Participated in teambuilding volunteer event at Sunbelt Nursing Home

ORI - continued

Degrees & Certifications• Ivette Leka sitting for CHRC exam today!

Personal Accomplishments• Sarah- bought a new car!

• Ivette- Began teaching classes in the onboarding workshops and presented at

Research Matters, currently attending HCCA Basic Research Academy and sitting

for CHRC this afternoon, improving her acrylic painting skills• Vanessa Lowe -Completed FH “New Day, New Weigh” Program, presented at

Research Matters, tutored 3 people to sit for the AAPC Certified Professional

Coding exam

• Christina Jackson - Presented workshop at The 12th Annual Clinical Trial Billing &

Research Compliance Conference, March 2018 & currently sitting on the Program Committee for the AAMC Forum on Conflict of Interest in Academe, exploring new

recipes

OSP: Office of Sponsored Programs


• Leerin Shields recertified her Certified Research

Administrator (CRA) with almost 4x the required

continuing education


• Meghan Brodie brought Dillan into the world

RAS: Research Advancement & Support


• Shelley Watson received her Masters of Public Health from USF on May 3rd

RF: Research Finance

Departmental Accomplishments• Successful SEFA Audit

• Rolled out CTMS for Finance for Oncology, TRC, Celebration, CIE, Pediatrics, CV,

and Transplant Research

• Successful 2019 budget planning season

• Published RF Industry Sponsored Documentation Manual

• Standardized processes across the multiple research units supported by RF

• Improved month end close process to include accruing for patient activity

revenue as well as stipends and physician payments expense

• Made significant progress in:

• New participant stipend payment mechanism

• Non-standard of care research payments

Closing RemarksRob Herzog

Research Matters · 2019-10-01 · ROC Charter & COI P&P ROC Charter states ROC will: • Review Financial Conflicts of Interests (FCOIs) deemed to be substantial • Determine FCOI

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