North Shore – LIJ Health System

PREP Workshop #4:How to Report and Manage External Interests (COIs) Electronically

• The North Shore LIJ Health System adheres to the ACCME’s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations.

• Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH have nothing to disclose.

• Scott Beardsley and Gerry Kassoff are the speakers and have nothing to disclose.

CME Disclosure Statement

Course Objectives

• Discuss the External Interest Disclosure form submission and other requirements related to Conflict of Interest.

• Demonstrate how to submit an External Interest Disclosure form within the InfoEd eRA system.

• Provide an overview of the External Interest Disclosure form review process.

Content• Describe requirements for electronic

disclosure of external interests• Discuss the type of information required for

disclosure• Describe the process for submitting and

managing disclosures online and trouble shooting

• Discuss techniques and electronic applications that can assist in recording and reporting disclosures

Staff Introduction

For questions regarding your Research Disclosure:

• COI ORC Manager: Scott Beardsley

• ORC Analyst: Gerry Kassoff

For questions regarding your Corporate Compliance Disclosure

• North Shore LIJ & SIUH - Office of Corporate Compliance

516.465.8097 or corporatecompliance@nshs.edu

For technical issues involving the InfoEd eRA system

• eRA @nshs.edu

For password issues contact the IS HelpDesk

Detailed Contact Information available at Feinsteininstitute.org/coi

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GENERAL STATEMENT of PURPOSE

Conflict of Interest (COI) or the appearance of a conflict may arise in connection with a Health System employee’s involvement with outside entities.

The purpose of External Interest Disclosure review is to promote the identification, disclosure and, if required, resolution or management of such individual COI in an effort to promote objectivity and alleviate the potential for real or perceived bias in the context of an employee’s Health System related responsibilities.

Health System Policies:

•Conflict of Interest and Recusal (800.03) •Gifts and Interactions with Industry (800.04)•Code of Ethical Conduct

HS Research Policies:• Review and Management of Financial Conflict of Interest in Research (Individuals) (GR065).•Review of External Consulting Agreements with Industry (GR078)•Intellectual Property (GR017)

Reportable Interests for Researchers

“Significant Financial Interest” includes a financial interest of the reporting individual, and related parties such as spouse and dependent children, that reasonably appears to be related to the Investigator’s institutional responsibilities:

•Publicly Traded Entity –remuneration or equity exceeds $5,000.

•Non-publicly Traded Entity - remuneration exceeds $5,000 or any equity interest

•Intellectual Property -receipt of income related to such rights and interests.

•Reimbursed or Sponsored Travel

CITI Training in Conflicts of Interest is required for all clinical, animal, and basic science researchers conducting research on behalf of the health system. Conflict of Interest must be renewed every 4 years.

The Health System collects External Interest Disclosure Forms via the InfoEd eRA portal.

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LIVE DEMONSTRATION

CMS Mobile Apps

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Q&A