Research MattersDecember 14, 2017

Welcome

Rob Herzog

VP Research Operations

Who does a Delawarean cheer for when it comes to football?

Big Dilemma

Frank Olivo, the Santa Claus who, in 1968, was booed and pelted with snowballs by angry Philadelphia Eagles fans during a halftime Christmas game

Devotion

Alane WatersCenter for Thrombosis Research

Why are yougrateful?

© Zoran Vukmanov Simokov ID 3732239 | Dreamstime Stock Photos

Research Services UpdatesOSP – Regina Tan

• Budget Review Process

ORI – Christina Jackson• Research Billing Compliance Update

IRB – Janice Turchin• New and Revised Forms• Common Rule Revisions

RAS – Michelle Dolske• FHRI Metrics

Office of Sponsored Programs

Regina Tan

Budget Review Process -- Coverage Analysis-- Budget Negotiation

Budget Review Process

Budget Development The process of performing an internal cost analysis that identifies all individual costs associated with a research project, including evaluation of routine and non-routine care procedures (i.e. Coverage Analysis).

Budget Negotiation The process of engaging the sponsor by proposing and counter-proposing line item budgets to arrive at a mutually agreeable budget. The objective of the budget negotiation is to end up with an appropriately funded project.

Coverage Analysis

New Initiative:In an effort to increase research billing compliance, if a study requires billable patient care items and services, a full coverage analysis shall be required regardless of funding source.

How will this affect me:Coverage Analysis document will serve as a reference for Patient Financial Services to streamline the current billing notification process.

Coverage Analysis (continued)What to expect next:• OSP is currently engaging and working through workflow

with PFS Clinical for coverage analysis services for industry-sponsored or –funded studies.

• It will be required that the cost of coverage analysis be included in both internal and sponsor budget. *Fee schedule is currently being determined.*

• OSP will develop workflow for coverage analysis of all other studies.

Proposed Implementation:

1st Quarter 2018

Budget Negotiation

New Initiative:• FHRI Leadership has expressed the desire to move

towards a centralized budget negotiation process for some FHRI departments (TBD) with no dedicated resource or personnel for budget negotiation.

• Through an objective group performing the financial negotiation, we hope to streamline the process and to maximize our research revenue.

Budget Negotiation (continued)

What to expect next:Senior Directors will work with each Research Unit Leader for proposed standards/parameters (January 2018).

Phased Implementation:

1st Quarter 2018 (tentative)

Office of Research Integrity

Christina Jackson

Research Billing ComplianceInvestigator Forum

Investigator Forum

Keynote Speaker:Edward Livingston, MD, FACS, AGAF

Deputy Editor, JAMA

DatesJanuary 11th 6:00 pm – 7:30 pm evening session

January 12th 7:00 am – 8:30 am morning session

Institutional Review Board (IRB)

Michelle McKinneyJanice Turchin

New and Revised FormsCommon Rule Changes

IRB - New and Revised Forms

• New form• Determination of QI/QA vs. Research

• Revised forms• Determination of Human Subjects Research• HRP-204 Promptly Reportable Information

Available in IRBNet now!

Determination of QI/QA vs. Research Form

Why?• Resident, students, etc. - often do QI projects and need

written determination from IRB• Original determination form – intended to determine

whether a research project involved human subjects• QI projects often look like HSR so this form didn’t help!

What?• Simplified

• Removed HSR questions• Asks about intent/objectives and project plan

Always start with the HRP-820 QI/QA Guidance

Determination of Human Subjects Research Form

What?• Reformatted to match other forms

HRP-204 Promptly Reportable Information Form

Why?• Confusion about IRB section• Adding information to increase compliance

What?• Removed “For IRB Use Only” section

• The information on that page is built in to our SOPs• Added * to items that are reportable when

relying on external IRBsThis is not new!

Already on the HRP-801 guidance

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.

Common Rule ChangesEffective 1/19/2018

FH Current State• FH applies DHHS regs “across the board” regardless

of funding • FH applies FDA regs when applicable i.e. IND, IDE

DHHS and FDA rules mirror each other (with a few exceptions)

Common Rule ChangesEffective 1/19/2018

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

Common Rule ChangesEffective 1/19/2018

FAQsQUESTION:I have studies which are currently approved at FH and are DHHS funded/conducted. What can I expect will happen to those studies after 1/19/2018.

ANSWER:Most likely remain unaffected since they were approved prior to the effective date. No re-consenting, etc.

• Other factors / policies to consider • NIH – new Sirb policy• External IRB policies

Common Rule Changes - Effective 1/19/2018FAQs (continued)

QUESTIONI plan to submit DHHS funded studies after 1/19/2018? What can I expect to be different?

ANSWERConsent element(s) (next slide)Expedited / Exempt, Continuing Review

Common Rule Changes - Effective 1/19/2018FAQs (continued)

Consent Form Instructions: If your research is federally funded and is submitted on/after 1/19/2018, include at this point an initial summary.

This section is meant to provide potential participants with an overview of the most important facts for the study.

Add the following information in a brief format.

Detailed information will be provided in the body of the document.

The recommendation is to limit to one page only. If the body of your consent form is three pages or shorter, (exclusive of face page and signature blocks), a summary is not required.

You are being invited to take part in a research study. Your participation is voluntary. It’s your choice whether or not to participate. Cover the following item in the initial summary, but limit the description to the key information that are relevant to why one might or might not want to take part in the research, and defer the greater detail to the body of the consent form following the initial summary: 1. The purposes of the research 2. The procedures to be followed in the research 3. The reasonably foreseeable risks or discomforts to the prospective subject 4. The benefits to the prospective subject or to others that may reasonably be expected from the research 5. Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject For example, with a cancer trial the initial summary should identify the most important risks, like the information that a doctor might deliver in the clinical context in telling a patient how sick the chemotherapy drugs will make them. The initial summary should emphasize how those risks are changed by taking part in the study. Include the complete list of reasonably foreseeable risks in the main body of the consent form following the initial summary. Organize the remaining consent information in sufficient detail relating to the research in a way that facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate. Do not merely provide lists of isolated facts.

Common Rule Changes - Effective 1/19/2018FAQs (continued)

QUESTIONMy research does/will not include DHHS funded/conducted projects. What can I expect?

ANSWERMost likely remain unaffected • Consent elements and other updates unrelated to common rule

revisions• Continuing Review

Research Advancement and Support (RAS)

Michelle Dolske

FHRI Metrics

Snapshot of Studies by Sponsorn=565

as of 9/30/17

122

194

37

212

0

50

100

150

200

250

Cancer Coop Grp Industry Non-Industry Florida Hospital

Industry Sponsored Studies by Typen=194

as of 9/30/17

91

56

2312 10

0102030405060708090

100

Drug Device Other CUD/HUD Registry

Florida Hospital SponsoredStudies by Type

n=212as of 9/30/17

88

71

9

34

16 3

0102030405060708090

100

Studies by Research Department

Cancer209

TRI-MD55

Cardiovascular54

Children's46

Endoscopy31

Radiology29

Neuroscience26

GME18

ISA22

Celebration16

Transplant…

Nursing11

Independent10

Thrombosis8

Pharmacy6

CREATION4

Global Robotics4

Ortho2

n=565as of 9/30/17

Ashley Kohrt | Center for CREATION Health Research Karin Donaldson | Neuroscience Research

Better Together

Better Together

CREATION Health Readmission Risk Assessment Tool

• Goal: Identify modifiable social determinants that contribute to readmissions.

• Focus: CMS 6 + stroke• Tool: Survey focusing on whole-person wellness;

mind, body, spirit.

Better Together

Enrollment Criteria• CMS 6 + stroke• Cognitively capable• Reside in Central Florida area• Discharge to home

Better Together

Initial Barriers• Enrollment• Approaching clinical staff• Approaching patients• Length of stay initiatives

Better Together

Collaboration• Cerner knowledge• Diagnosis codes • Flexed labor• Relationship with nurses

Better TogetherParticipants

ScreenedParticipants Approached

Participants Not Visited

Weekly Enrollment

First Week 367/week 24/week 154/week 12/week

Weeks Prior to Collaboration

184/week 24/week 32/week 9/week

First Week of Collaboration

213/week 39/week 0 28/week

Weeks Since Collaboration

220/week 47/week 0 23/week

Better Together

Questions?

Leadership

Steven R. SmithSenior VP

Chief Scientific Officer

Leadership MessageRob Herzog

Vice President Research Operations

Our VisionTransform healthcare through world-class research

Our MissionTo expedite groundbreaking and globally-recognized whole –person healthcare research that leverages the scale and diversity of our population.

Our Pillars

Clinical Impact

Academic Impact

Economic Impact (G & C)

Participant Experience

2018 FHRIBusiness Plan

Solidify partnership opportunities

o Academic

o Industry Pharma

Device

o Precision Medicine and NGS

Leadership Message

Complete on-boarding of CTMS

Invest in tools that help us tell our story

Become a major source of value for our PHSO through CREATION Health and Research Analytics Institute (RAI)

Solidify metrics for Clinical Impact and Participant Experience

Leadership Message

Strengthen portfolio management through SOAR

ScientificOperationalAdministrativeReview Babe Ruth holds the MLB

record in Slugging Percentage

LeadershipMessage

Research Serviceso Sustain and further improve process

improvements that started with IRB and Budget review efficiencies

o Achieve AAHRPP Re-Accreditation

o Maintain focus on Billing Compliance

o Working 'smarter‘ Ex. Centralized budget negotiation

Leadership Message

Closing RemarksRob Herzog

Thank You for Attending!

Our next Research Matters meeting will be in February or March

Details will be released soon!