Managing Conflicts of Interest

Slides:



Advertisements
Similar presentations
VCOM Conflict of Interest Policy Overview of Financial Conflict of Interest Related to Research December 4, 2013.
Advertisements

Financial Conflict of Interest July 2012 rev
Research Compliance NEW MEXICO THE UNIVERSITY of.
Conflict of Interest, Conflict of Commitment, and Outside Activities UTSA HOP 1.33 Non-covered UTSA staff 1.
Continuing Professional Development Conflict of Interest This presentation has been developed by the COI Working Group to assist in the implementation.
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.
Conflict of Interest Presented by Barbara L. Shiels Associate General Counsel February 2009.
Conflict of Interest: Dartmouth College. Why do we care about it ? Conflict of Interest in Research : Unbiased research: design, conduct, reporting Maintain.
1 FINANCIAL CONFLICTS OF INTEREST IN RESEARCH Avoiding Adverse Consequences by Disclosing, and then Reducing, Eliminating or Managing Conflicts Susan H.
 Why are you reading this? Both the Public Health Service and the National Science Foundation require WSU to provide all investigators training related.
University of Vermont Sponsored Project Administration New PHS Financial Conflict of Interest (FCOI) Regulations Effective August 24th, 2012 Ruth Farrell,
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 Recent Cases & Discussion Feb. 19, 2009 CTELS Tom Field, MSEd, MHSA Interim Associate Vice Chancellor for Compliance.
Dheeraj Agarwal Ethics Advisor Health Resources and Services Administration U.S. Dept. of Health and Human Services.
Sizewise Code of Ethics, Conflict of Interest and Disclosure HR-CECID.
1 Overview of Ethics Requirements for Employees of Montgomery County This is a summary to help identify issues; it is not the law. Please address ethics.
Congress and Contractor Personal Conflicts of Interest May 21, 2008 Jon Etherton Etherton and Associates, Inc.
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.
Reviewer Disclosure Guide 1) Ensure disclosed information is complete Reviewer Responsibilities 2) Assign a conflict of interest category 3) Develop management.
3 rd Party Entity A. Individual Financial Interests B. Spouse Financial Interests C. Dep. Children Financial Interests D. Collective (A+B+C) E. Significant.
Title Page Rozzie Gerstman May 15, Overview of Presentation.
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.
1 FERPA and Student Privacy in Records of University Research ECURE March 1, 2005 Richard Rainsberger, Ph.D. Consultant, Education Records Law and Privacy.
Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest UT HOP UT HOP The University of Texas at Austin.
Fraud, Waste & Abuse DEFICIT REDUCTION ACT OF 2005 Presented by: MARCH Vision Care, 2013.
Financial Conflict of Interest
COI Management Planning A guide and tutorial to assist with the development and drafting of a Conflict of Interest Management Plan.
Induction of New Board Members September 14 th, 2010 Trainer: Caroline Egan, Carmichael Centre for Voluntary Groups.
ECOI electronic Conflict of Interest User Guide 1 Emory University, Office of Research Administration.
Rice’s New Staff Conflict of Interest Policy and Procedures Administrators’ Forum Richard A. Zansitis General Counsel April 2008.
NEW SEC AUDITOR INDEPENDENCE REQUIREMENTS Financial Executives International Janet Luallen Director - Technical Activities.
Research Conflicts of Interest: Identifying and Minimizing COI from the Perspectives of Sponsors, Faculty and the IRB Research Conflicts of Interest: Identifying.
How to Prevent Findings Part 2 Michigan State Police Emergency Management and Homeland Security Division Ms. Jackie Reese, Audit Unit Manager Mr. Richard.
 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.
Financial Interests1995 Regulations 2011 Final Rule Significant Financial Interests (SFI) threshold De minimis $10,000 for disclosure generally applies.
Managing Your Grant Award August 23, 2012 Janet Stoeckert Director, Research Administration Sr. Administrator, Basic Sciences Keck School of Medicine 1.
1 Conflict of Interest: A Tricky Issue for Universities Karen Hersey, Professor Franklin Pierce University Nonprofit Technology Transfer Course November.
Family Educational Rights and Privacy Act (FERPA) UNION COLLEGE.
CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT Judith L. Curry Associate General Counsel NC State University February 27, 2014.
Fight On Training on NIH Conflict of Interest Rule and Introduction to diSClose Dan Shapiro Director, Research Compliance Ben Bell Manager, Research Compliance.
Managing Conflicts of Interest at the IRB and Institutional Level: INSTITUTIONAL CONFLICTS OF INTEREST Claudia R. Adkison, J.D., Ph.D. Executive Associate.
UMBC POLICY ON ESH MANAGEMENT & ENFORCEMENT UMBC Policy #VI
Faculty Council on Research April 11, 2012 Jeff Cheek, Ph.D. UW Associate Vice Provost for Research Compliance and Operations New PHS regulations on financial.
Partners Conflict of Interest Policy and Reporting October 11, 2012.
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.
Stanford Policy – Faculty ◦ Mission: Promote public good by transferring knowledge  Consulting  Technologies arising from research These activities can.
Office for Responsible Research Dr. Kerry Agnitsch IRB Co-Chair.
DRAFTING AN EFFECTIVE CONFLICT OF INTEREST POLICY William H. Jordan, Esq. Sowell, Gray, Stepp & Laffitte, LLC (803)
Michael Scian, MBA, JD Assistant Director of Compliance University of Florida.
To Disclose or Not to Disclose That is The Question
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
Kyle Conner, MA, CIP Associate Director, Office of Human Research
UCR PRO Reviewer Placemat
Conflict of Interest in Research
Sneak Preview: The Revised PHS FCOI Regulations
Contract Approvals & Signature Authority
Conflict of Interest (COI)
NEW YORK STATE ETHICS LAW
Conflicts of Interest and Management Plans
Managing Cases of Research Misconduct
University of Pittsburgh
Presentation transcript:

Managing Conflicts of Interest 10/16/2008 Managing Conflicts of Interest Presentation to Rensselaer’s Large Business Managers Group By Jeffrey Armstrong Whiteman Osterman & Hanna, LLP (Office of the General Counsel) & Frank J. DiSanto Research Administration & Finance 10/16/2008

Overview What is a Conflict of Interest? 10/16/2008 Overview What is a Conflict of Interest? What is a Conflict of Commitment? How does a college or university manage or eliminate these conflicts? 10/16/2008

What is a Conflict of Interest? 10/16/2008 What is a Conflict of Interest? A potential conflict exists when there is a possibility that an individual’s outside financial interests could directly and significantly affect the individual’s professional actions or decisions. 10/16/2008

Where can a Conflict of Interest occur? 10/16/2008 Where can a Conflict of Interest occur? Purchasing and other business relationships Gifts Employment Research Technology licensing Activities of family members 10/16/2008

What is a Conflict of Interest in Research? 10/16/2008 What is a Conflict of Interest in Research? In the sponsored research setting, a potential conflict exists when there is a possibility that an individual’s outside financial interests could directly and significantly affect the design, conduct, or reporting of the research. Under federal law, a financial interest is “significant” if: it amounts to more than $10,000 per year in outside income; or involves equity either worth more than $10,000 or equity representing more than 5% of the outstanding equity in a company. 10/16/2008

Sources of Law Federal: 10/16/2008 Sources of Law Federal: - National Science Foundation -“Investigator Financial Disclosure Policy” - National Institutes of Health “Objectivity in Research” - Other federal agencies – required FAR clauses imposing conflict of interest rules State: - Contractual clauses in grant and other awards 10/16/2008

Essential Requirement #1 10/16/2008 Essential Requirement #1 All conflict of interest laws require adoption of institutional procedures that require faculty and staff to disclose to the institution outside financial interests above specified thresholds when those interests would likely be affected by the research. 10/16/2008

Goals of a Conflict of Interest Policy 10/16/2008 Goals of a Conflict of Interest Policy Protect research participants Protect the integrity of the research Protect the institution, faculty, students Funding Status Litigation Reputation/Public Image Reconsideration & Noncompliance “Good Policy Practices” 10/16/2008

Conflict of Interest Policy 10/16/2008 Conflict of Interest Policy May be more than one policy Trustees Officers Employees Faculty Research policy Institutional Conflict of Interest Typical Scenario: Institution has a financial interest in a technology/company/invention and the research is conducted at that institution 10/16/2008

Conflict of Interest Policy – Basic terms 10/16/2008 Conflict of Interest Policy – Basic terms Definitions: including what is a Significant Financial Interest which must be reported Disclosures: periodic (usually annual) disclosures ad hoc disclosures when potential conflicts arise Responsible Individuals: Who are the responsible individuals who will (i) Receive and review the disclosures Create the conflict management plans Manage the plan Enforce the plan 10/16/2008

Essential Requirement #2 10/16/2008 Essential Requirement #2 The institution must review the disclosures, determine whether there is a conflict, and, if so, manage, reduce, or eliminate it, before funds are expended. 10/16/2008

How are Conflicts Disclosed at Rensselaer? 10/16/2008 How are Conflicts Disclosed at Rensselaer? Annual Survey from HR Project Information Form (PIF) Human Subjects Protocols Intellectual Property Processes (disclosure, patenting, licensing) 10/16/2008

10/16/2008

Essential Requirement #3 10/16/2008 Essential Requirement #3 The institution must disclose and/or otherwise notify the sponsoring agency of the nature of the conflict or the action taken to manage, reduce, or eliminate it. 10/16/2008

Emory U. Psychiatrist Failed to Report Income From Drug Makers October 4, 2008 Emory U. Psychiatrist Failed to Report Income From Drug Makers A prominent psychiatrist at Emory University is the latest researcher to come under fire in Congress for violating federal and university rules against financial conflicts of interest. The New York Times reports that Charles B. Nemeroff, chairman of the psychiatry department at Emory and former editor in chief of the journal Neuropsychopharmacology, earned more than $2.8-million for consulting with drug companies from 2000 to 2007 and hid much of that income from his university. October 14, 2008 NIH Halts Study at Emory Over Concerns About Drug Company's Payments The National Institutes of Health has halted a $9.3-million five-year research project at Emory University, pending an investigation into potential conflicts of interest by the project’s former leader, according to Ron Sauder, vice president for communications and marketing at Emory. 10/16/2008

Basics of Conflict Management 10/16/2008 Basics of Conflict Management Adopt an Institution-wide Conflict of Interest Policy Establish training Establish a disclosure procedure When the Institution learns of a conflict, adopt specific plans to manage or eliminate it Establish processes to ensure that the management plans are enforced 10/16/2008

Individual Conflict Management Plans – Basic Terms 10/16/2008 Individual Conflict Management Plans – Basic Terms Summary of Conflict Set forth facts which describe the conflict Address management of primary conflict Is a particular business contract or project allowed or prohibited If allowed, appoint a disinterested person to directly oversee the relationship or the project Make sure that the conduct of the project is reported to supervisors Establish rules for use of resources, such as facilities, students or staff (e.g. prohibit dual employment of students or staff, use of university facilities by outside companies without permission, etc.) 10/16/2008

Individual Conflict Management Plans – Basic Terms (cont.) 10/16/2008 Individual Conflict Management Plans – Basic Terms (cont.) Consider and manage effects on other projects Aside from primary transaction in which conflict exists, manage other projects that the conflict could affect (e.g. technology license to a professor’s start up company might affect other research projects involving similar work, etc.) Responsible Individuals Establish persons who will be responsible to supervise the conflict management Establish an appeal process to resolve disputes - Transparency - Set forth procedures to ensure that change in facts will always be reported Require fact that potential conflict exists to be disclosed to all who might otherwise be misled (e.g. in publications, etc.) 10/16/2008

Individual Conflict Management Plans – Basic Terms (cont.) 10/16/2008 Individual Conflict Management Plans – Basic Terms (cont.) Follow-Up Establish a regular process of ensuring that the conflict management plan is being adhered to Consequences Be clear in the plan about the possible penalties for noncompliance 10/16/2008

What is a Conflict of Commitment? 10/16/2008 What is a Conflict of Commitment? A conflict of commitment exists when the commitment to external activities of a faculty or staff member adversely affects his or her capacity to meet their job responsibilities. 10/16/2008

What can cause a Conflict of Commitment? 10/16/2008 What can cause a Conflict of Commitment? External consulting by faculty or staff Being over committed on sponsored projects Outside teaching Officer or Director in outside organizations, including churches and nonprofit organizations Start Up or other entrepreneurial businesses Note: A conflict of commitment often exists alongside of a conflict of interest and both may need to be addressed at the same time. 10/16/2008

What can we expect? Greater focus by government 10/16/2008 What can we expect? Greater focus by government Continued focus by the press Audits OIG involvement Legal action? 10/16/2008

Significant conflict of interest? 10/16/2008