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Research MattersJune 30th 2015

ORAMichelle Dolske, Administrative Director

Bianca Maldonado, Administrative Assistant

Michelle Kilponen, Operations Specialist

Ivette Leka, Operations Specialist

Amy Hinton, Research Support Specialist

Christina Jackson, Compliance and Education Manager for Responsible Study Conduct

Penny Carlson, Compliance and Education Manager for Research Billing/Finance

Julie Pepe, Biostatistician

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New Contract Language

PROMISES TO STUDY SUBJECTS ON BEHALF OF SPONSOR

Each of INSTITUTION and INVESTIGATOR shall not make any◦ written or oral promises, ◦ statements or other representations

to Study subjects (whether or not formally documented in the informed consent forms) that SPONSOR or CRO will (i) provide any form of

◦ compensation, ◦ reimbursement or payment, ◦ medical treatment (including post-Study provisioning of any additional Study

Drug) and/or ◦ any other support or thing of value,

except to the extent expressly provided within this Agreement or the Protocol; or (ii) provide any greater reimbursement for Study-related injuries than that which is set forth in an agreement as discussed in Article 8 <Study Budget>.

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Any member of research team

Make sure this is in Contract before talking about it…

Look before you leap…

If consent is wrong and

promises more than the

contract, you are still

prohibited from talking about it.

ORA - Onboard Education Update

Currently Under Development

◦ Overview of Research at Florida Hospital

◦ Research Resources

◦ Responsible Conduct of Research

◦ Case Studies

Next in the Queue for Development

◦ Data Collection/Management and Ownership

◦ History and Ethics

◦ PI Responsibilities

If you are interested in working with the ORA to develop these modules, we would welcome your help. Please contact the ORA to be included.

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ORA - Contract & Budget Submissions

FH Research Legal Announcement

◦ Attorney Viki Prescott’s last day July 7th

◦ ORA has transition plan in place (started 2 weeks ago)

Contracts

◦ Submit as early as possible

◦ Look for consistency between contract language and informed consent (RE: subject injury)

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ORA Contract & Budget Submissions

Budget Submissions

◦ Submit as early as possible

◦ If you have questions during preparation, please contact us

◦ Submit to ORA mailbox and cc: Penny Carlson and Ivette Leka

Budget Review

◦ Version control - label all budgets with version and/or dates of edits

◦ Once submitted, all work should be done to the submitted budget in sequential order

◦ No additional changes should be made to a submitted budget until after it is reviewed by ORA and returned to the research department

◦ Make requested changes only to the budget version returned to you (version control)

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Budget Process: Step-by-Step

Complete FH Budget

(use fresh template from ORA website)

Compare to Sponsor’s Budget

(usually excel worksheet)

Negotiate with Sponsor – Get what you need!

(finalize all changes, and make updates, etc.)

Submit Budget and Associated Documents to the ORA (IRBnet # in subject line)

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FH Budget

Template

Sponsor’sFinal

Template (excel)

Final CTA Budget Exhibit (word)

Support Letters

Protocol Informed Consent

Budget & Associated Documents

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FH Budget

Template

Sponsor’sFinal

Template (excel)

Final CTA Budget Exhibit (word)

Support Letters

Protocol Informed Consent

attach the file

Physician Services,

Pharmacy, etc.

Budget Review Efficient and Effective Communication

•Develop and implement foolproof system of version control

•Manage sponsor expectations via effective communication - Explain how the budget review process works and how it fits into the CTA being finalized

1. Research Department negotiates budget with sponsor and comes to an agreement with sponsor/CRO

2. Budget and associated documents are submitted to ORA for internal review3. Internal (ORA) compliance review and approval occurs4. Documents are reviewed to make sure each is consistent with the other (IC,

contract, budget)5. CTA and Budget Exhibits are finalized (ready for signature)6. Contract is executed by all parties

•Never hesitate to ask questions!

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IRBJanice Turchin, IRB Administrator

Michelle McKinney, IRB Operations Specialist

Samantha Carter, IRB Office Coordinator

Melissa Pallone, IRB Administrative Specialist

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HRPP Policies/ProceduresInvestigator Guidance's/Manual

IRB Forms

July 15, 2015 Roll Out Date

Grace Period for Forms 7/15 - 8/2

August 3, 2015 and forwardMust Use New Forms

HRPP Policies/ProceduresInvestigator Guidances/Manual

IRB Forms, Cont.

Where to find what:

Policies – IRB Website / FH Site

SOPs – IRB Website

Forms – IRBNet

Investigator Guidances – IRB Website

Investigator Manual – IRB Website

HRPP Policies/ProceduresInvestigator Guidances/Manual

IRB Forms, Cont.

NOTABLE CHANGES

• Shorter Application

• Protocol Supplement - required when external sponsor protocol is submitted

• Revised Consent Form Templates

• Clearer Policy for LAR, Children, Guardians

• Investigator Guidances / Manual

HRPP Policies/ProceduresInvestigator Guidances/Manual

IRB Forms, Cont. WHAT ABOUT EXISTING APPROVED STUDIES

AT THE TIME OF CHANGE?

• Use of new FORMS wi l l be mandatoryContinuing Review FormChange Request Form

• New Research Personnel log – Your Choice

• Consent Forms - Certain language wi l l be mandatory to meet regulat ions i .e. e lements of consent

IRB Documents Published in IRBNet

• Stamped Docs – IRB ALWAYS s tamps consents and invi tat ion to part ic ipate le t ters• Other documents that do not receive a stamp are expected to be used and/or

distributed as submitted, i.e. letters to subjects, advertisements, etc.

• Protocols• ONLY IRB protected and published if using the FH protocol template• NEVER stamped

NOTE:

Alert IRB i f you f ind errors / inaccurac ies in publ ished documents . Reviewed on a case -by-case bas is

Case Studies: New ProcessPRIMARY DIFFERENCE

Old Way

Submit to ORA for HIPAA De-identification review

New Way

Self-certify HIPAA De-identification

NEW DIFFERENCE

ORA will no longer give Institutional Acknowledgement

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ORA/IRB AnnouncementsORA Classes

July 7 9-10am IRBNet Training

July 14 3-4:30pm Protocol Development

July 24 9-10am Biostatistics and Epidemiology

July 29 4-5pm Statistical Basics

July 30 3-4:30pm Study Initiation 101

Email or call the ORA to register!

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Closing

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Research Enterprise Update from Leadership

Steven SmithChief Scientific Officer

Rob HerzogVice President

THANK YOU FOR YOUR ATTENDANCE AT

RESEARCH MATTERS!