Reviewer Disclosure Guide 1) Ensure disclosed information is complete Reviewer Responsibilities 2) Assign a conflict of interest category 3) Develop management.

Slides:



Advertisements
Similar presentations
UCSF School of Medicine OCME Program Frequently Asked Questions Faculty Disclosure and Resolution of Conflict of Interest.
Advertisements

AS-18 Related Party Disclosures
VCOM Conflict of Interest Policy Overview of Financial Conflict of Interest Related to Research December 4, 2013.
Financial Conflict of Interest July 2012 rev
Research Compliance NEW MEXICO THE UNIVERSITY of.
Disclosure Reporting for Conflicts of Interest and Commitment Conflict of Interest Program UTMB Research Services.
Conflict of Interest, Conflict of Commitment, and Outside Activities UTSA HOP 1.33 Non-covered UTSA staff 1.
Welcome to the IAQG Supplier Forum Montreal, Canada 10/10/13 1.
Conflict of Interest (COI) Objectives: Provide an overview of financial conflict of interest (FCOI) related to research activities at Gillette Describe.
Responsible Conduct in Research Conflict of Interest and Commitment.
1 UMass Dartmouth Conflicts of Interest Policies UMass Dartmouth Liz Rodriguez February 17, 2011.
IRB Member Conflict of Interest Presentation for IRB Members.
Managing Conflicts of Interest © ACCME.
Financial Conflict of Interest (FCOI) Updates Office of Sponsored Programs April 2014.
NIH FINANCIAL CONFLICT OF INTEREST REGULATIONS – 2012 Office of Sponsored Programs Research & Graduate Studies.
Presented by: David E. Broome, Jr. Vice Chancellor and General Counsel Carl P.B. Mahler, II Executive Director, Office of Technology Transfer October 30,
Conflicts of Interest in Public Health Service-Funded Research.
This tutorial reviews the main requirements of and the responsibilities for compliance with the 2011 revised Federal regulation on Financial Conflict of.
An Overview of the Student Loan Practices Code of Conduct Richard W. Buck Associate General Counsel University of North Florida Office of the General Counsel.
Conflicts of Interest in Research: Policies and Regulations Marie Barron, M.A., COI Program Specialist Rick Lyons, M.D., Ph.D., COI Committee C Chair.
Member Overview Conflict of Interest Policy & Disclosure Process.
3 rd Party Entity A. Individual Financial Interests B. Spouse Financial Interests C. Dep. Children Financial Interests D. Collective (A+B+C) E. Significant.
Conflict of Interest and Technology Transfer Sherrie Settle Assistant Director, Research Compliance Program Institutional Conflict of Interest Officer.
Conflict of Interest Faculty & Staff of Instruction or Research Human Resources 2011.
Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest UT HOP UT HOP The University of Texas at Austin.
Financial Conflict of Interest
Board Accreditation Education. Anti-Discrimination Policy: Four Villages is committed to ensuring that all staff, students, Board members and volunteers.
ECOI electronic Conflict of Interest User Guide 1 Emory University, Office of Research Administration.
Put your organisation’s logo here. Conflicts of Interest A conflict occurs when the interests of one role/ position/ relationship are not aligned with.
Conflict of Interest Michelle Stickler, DEd Office for Research Protections
Research Conflicts of Interest: Identifying and Minimizing COI from the Perspectives of Sponsors, Faculty and the IRB Research Conflicts of Interest: Identifying.
North Shore – LIJ Health System PREP Workshop #4: How to Report and Manage External Interests (COIs) Electronically.
 Tracy L. LeGrow, Psy.D. Associate Professor Department of Psychiatry and Behavioral Medicine.
CONFLICTS OF INTEREST PRESENTED BY THE UMMC OFFICE OF INTEGRITY AND COMPLIANCE.
1 Conflict of Interest: A Tricky Issue for Universities Karen Hersey, Professor Franklin Pierce University Nonprofit Technology Transfer Course November.
ACCREDITATION CRITERIA CONFLICT OF INTEREST CONTENT INTEGRITY.
Need of AS on Related Party Transactions  There is general presumption that transaction reflected in the financial statements are executed on arm’s-length.
Fight On Training on NIH Conflict of Interest Rule and Introduction to diSClose Dan Shapiro Director, Research Compliance Ben Bell Manager, Research Compliance.
New Federal Policy on Financial Conflicts of Interest Matt Richter, MA, JD anticipated 2012 COI Program Specialist Office of Research Policy
Partners Conflict of Interest Policy and Reporting October 11, 2012.
Connolly – International Financial Accounting and Reporting – 4 th Edition CHAPTER 22 RELATED PARTY DISCLOSURES.
CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT Judith L. Curry Associate General Counsel NC State University March 5, 2007.
Copyright © Harvard Medical School. All Rights Reserved. Outside Activity Report: What Do I Need to Report?
Conflicts of Interest in the Academy: Recognition and Management Dave Broome Senior Associate General Counsel NC State University 20 March 2002.
“Commercial Interest” ● ‘exempt’ entities (per ACCME) ● ‘exempt’ entities (per ACCME) – 501-C non-profit organizations – Government organizations – Non-health.
VA Connecticut Research and Education Foundation
1 Ethics CLARK COUNTY M-PLAN TRAINING. 2 Sources of Ethical Standards Ethics standards for management staff are derived from the following sources. They.
COI 101: What is Conflict of Interest and How Can it Affect You? Jennifer Morales Research Compliance Specialist Office of Research Integrity & Compliance.
Financial Conflict of Interest January  Financial Conflict of Interest regulation 42 CFR 50 Subpart F promotes objectivity in research by establishing.
ARVO Disclosure Guidelines Presenting Authors must fully disclose to ARVO and the session participants all commercial relationships relevant to the subject.
Legislative Origins Federal Ethics in Government Act enacted following the Nixon Watergate scandal States also enacted laws applying to state and.
Michael Scian, MBA, JD Assistant Director of Compliance University of Florida.
eCOI electronic Conflict of Interest
Kyle Conner, MA, CIP Associate Director, Office of Human Research
IRB Open House Conflicts of Interest and Financial Conflicts of Interest in Research May 19, 2017 Office of Policy Coordination, Division of Outside.
Conflict of Interest Policy 4:35
Colorado State University Conflict of Interest Committee (COIC)
Kyle Conner, MA, CIP Associate Director, Office of Human Research
UW Conflict of Interest Program Manager Office of Research Policy
UCR PRO Reviewer Placemat
2018 Canadian Transplant Summit - DISCLOSURE FORM
Conduct Speak slowly and use simple language
Conflict of Interest Shilene Johnson- Research Compliance Specialist
NEW YORK STATE ETHICS LAW
Balancing Outside Interests & Activities with
NEW SBA Form 159 Notice (a) & 504
Financial Conflict of Interest in Research SEMINAR
Conflicts of Interest and Management Plans
Financial Conflict of Interest in Research SEMINAR
ARVO Disclosure Guidelines
Presentation transcript:

Reviewer Disclosure Guide 1) Ensure disclosed information is complete Reviewer Responsibilities 2) Assign a conflict of interest category 3) Develop management plan where required 1. Financial Interests in a Third Party Entity Do you, your spouse and/or dependent children, individually or collectively, have any of the following significant financial interests that are, or could reasonably appear to be, related to your work at the University: ● Equity or similar financial interest in a third party entity that exceeds $10,000 in value or that represents more than a 5% ownership interest in any privately held enterprise or entity or at least a 0.5% ownership interest in a publicly traded company? ● Salary, royalties, or similar compensation that exceed, or are expected to exceed, $10,000 in a twelve month period that are paid by or originate from a third party entity? ● Ownership interest in any intellectual property rights? Ensure complete information is disclosed: □ Is the amount of the financial interest clearly identified? □ Is it clear who has the financial interest? (member, spouse, etc.) □ Is complete information provided regarding the third party entity? □ Is the relationship of the third party entity clearly identified to the member’s work at the University? Assign category: Category A: It is possible, though not required, that a member may report financial information regarding an entity which is not related to his or her work at the University. In this case, the interest is not significant as long a it could not appear to others to be connected to the member’s role at the University. Category B: In some cases a member may report financial interests that are currently below the definitions for a significant financial interest, however, consider whether or not there may be a potential that these interests could become significant in the near future. Management Plan requiredManagement Plan required Category C: If there is a “yes” response to any of the federally-defined threshold criteria in the question, then a Significant Financial Interest exists and would create an actual conflict of interest. Management Plan requiredManagement Plan required 2. Positions Held in a Third Party Entity Do you hold a management position such as a board member, director, partner or trustee in any third party entity relating to your work at the University? Ensure complete information is disclosed: □ Is the management position clearly identified? □ Is complete information provided regarding the third party entity? □ Is the connection of the third party entity and the member’s role at the University clear? Assign category: Category A: If the member does not have any influence over University decisions regarding the company or the entity does not do business with the University, then no safeguards or oversight are required for this activity. Category B: If the organization in which the member holds a management position does business with the University or may do business in the future, then the potential or perception of a conflict may exist. Management Plan requiredManagement Plan required Category C: If the member is in a role at the University to influence or commit resources to the entity in which he or she also hold a management position, then an actual conflict exists. Management Plan requiredManagement Plan required

3.Relationships with any Sponsor, Vendor, Contractor Do you, any family member, or close friend, have a relationship with any sponsor, vendor, contractor, or business entity with which the University does, or is likely to do business, where you have an opportunity to influence the University’s decision-making related to that entity? Ensure complete information is disclosed: □ Is the member’s relationship to the sponsor, vendor or contractor clearly identified? □ Is the nature of the entity’s business with the University provided? □ Is the connection to the member’s work at the University described? Assign category: Category A: The member may report a relationship when he or she is uncertain as to whether or not the University does business with that entity. If the entity does conduct business with the University and the member has no opportunity to influence decision-making regarding the entity, then no safeguards or oversight are required. Category B: A member’s relationship to an entity with which the University conducts business may create the appearance of or potential for a conflict of interest. Consider whether or not there is any potential in the future that the member could influence decision-making regarding that entity. If it could appear to others that the member’s relationship is relevant, safeguards and oversight may be warranted. Management Plan requiredManagement Plan required Category C: If a member’s relationship is to an entity that conducts business with the University and the member has the opportunity to influence decisions involving the entity, then an actual conflict exists. Management Plan requiredManagement Plan required 4. Activities Involving Students and staff Do you receive non-University income from any activities that involve students, staff, or the use of ND property? Ensure complete information is disclosed: □ Is the member’s activity identified? □ Is the involvement of students, staff or the use of ND property clear? □ Is the connection to the member’s role at the University indicated? □ Is the member using any ND resources without an agreement to pay for such resources? Assign category: Category A: A member may disclose an activity that involves students or staff where the member does not directly teach or supervise them in any way. As long as University resources are not used this would be permissible and not require oversight. Category B: If the member’s activity involves students or staff in which the member has the potential to teach or supervise, then the appearance of or potential for a conflict of interest may exist when the member is carrying out their responsibilities to the University. Management Plan requiredManagement Plan required Category C: If a member requires any non-University use of laboratory space, classroom, or other resources on campus, an actual conflict may exist if the member does not have a contract to pay for the use of such resources. An actual conflict also exists If a member’s activity involves students or staff where the member has a current role of evaluating or assigning a grade as part of his or her University responsibilities. Management Plan requiredManagement Plan required 5. Any Other Activity Are you involved in any other activity that could result in a financial, personal, or professional benefit for you, a family member or close friend that: ● relates to any personal influence you may have in University operations or business decisions, or ● could appear to others to affect your decision-making and judgment in carrying out your work responsibilities? Ensure complete information is disclosed: □ Is the activity clearly identified? □ Is the connection to the member’s role at the University indicated? Assign category: If the situation does not fall under any of the previous disclosure guidelines, please contact: Policy Specialist, Office of General Counsel or