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Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research...

Date post: 08-Jan-2018
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Policy Revisions  Nine HOP policies related to COI will be re-aligned into five  Most are outdated with current federal and state policies and guidance  Revisions do not include any new requirements  Attempt to streamline and clarify existing policy  Used UT System policy and model HOP & other UT HSC policies
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Update: Conflict of Interest
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Page 1: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,

Update:Conflict of Interest

Page 2: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,

Complex Regulatory EnvironmentDisclose, Manage and Report

Research related Conflict of Interest◦ Federal regulations (DHHS, FDA, DoD, DVA, etc.)◦ UT System – Systemwide Policy UTS175◦ HSC HOP 10.1.6

Outside Activities UTS180 (not involving research COI)◦ Prior approval of outside employment, compensation or board service◦ Non-research related Conflict of Interest◦ Annual reporting to UT System◦ HSC HOP 10.1.9 & 10.1.10

Conflict of Commitment Faculty & A&P (exempt) Staff◦ HSC HOP 10.1.8

Page 3: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,

Policy Revisions Nine HOP policies related to COI will be re-aligned into fiveMost are outdated with current federal and state policies and guidanceRevisions do not include any new requirements Attempt to streamline and clarify existing policyUsed UT System policy and model HOP & other UT HSC policies

Page 4: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,
Page 5: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,

New guidance tools

Page 6: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,

Complex Regulatory Environment Simple Disclosure System

VPR/IT developed “iDisclose” for the CY2012 annual reporting season◦ Used by the Departments and Schools to identify faculty and exempt staff

outside activities ◦ Used by the Conflict of Interest Committee to identify possible conflicts of

interest◦ Used by the VPR to report outside activities to UT System as required by

UTS180

Page 7: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,
Page 8: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,

New Approval for Employment, Consulting or Board Membership

◦ Integrate the Request for Approval of External Employment, Consulting, Board Membership or Related Activities

◦ Will replace the PDF form and allow for electronic review & approval – record retention

◦ Captures these activities for UTS reporting & consideration by COIC, as needed

Page 9: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,
Page 10: Update: Conflict of Interest. Complex Regulatory Environment Disclose, Manage and Report Research related Conflict of Interest ◦Federal regulations (DHHS,

Melanie Zuñiga Rapp, BA – Manager, COI & Research Integrity

email: [email protected]: 562-6838


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