Conflicts of Interest Brenda Seiton J D Assistant

Conflicts of Interest Brenda Seiton, J. D. Assistant Dean for Administration Department Administrators Course September 1, 2006

Presentation Overview • Individual Conflicts of Interest – Consulting Agreements – Start-up Companies • Use of Emory Resources • Institutional Conflicts of Interest

Individual Conflict of Interest • Definition: A situation that occurs when an individual has an outside interest (usually financial) that affects or appears to affect the individual’s professional judgment in carrying out university responsibilities – Interest may influence the university’s business and research decisions – Interest may influence the integrity of the employee’s decisions in teaching, research, and service – Interest may appear to influence individual’s decisions

Conflicts? Which Conflicts? • Physician/Researcher • Experiment/Therapy • Federal Funds/Private Funds • Consultant, Inventor, Equity Holder, Researcher/Teacher • Time Commitments • Resource Allocation • Hiring relatives • Accepting gifts

Why do we care? • Public Trust • Maintain integrity & credibility for our investigators & institution • Role models to our students & trainees • Protecting human subjects

A word about money. . . • In 2004, the median household income in the State of Georgia was $49, 475 • Average pharmaceutical company’s marketing budget was $120, 700, 000 – Of these budgets approximately $30, 000 was spent on “Thought Leaders” – These “Thought Leaders” include our faculty

Regulations & University Policies • Public Health Service • National Science Foundation • Food & Drug Administration • NIH Policies • Internal Revenue Service • Securities & Exchange Commission • University Bylaws Article IX • Research Conflict of Interest Policy • Policy on Use of Letterhead and Facilities for Private Purpose • Policy on Private Consulting by Faculty • Employment of Relatives (Nepotism) • Institutional Conflict of Interest Procedures • Guidelines for the Responsible Conduct of Scholarship and Research http: //www. or. emory. edu/share/policies/conflict_interest. cfm

Guidance Documents • AAMC –Individual Conflicts of Interest in Human Subjects Research - December 2001 • AAMC – Institutional Conflicts of Interest in Human Subjects Research – October 2002 • AAU – “Report on Individual and Institutional Financial Conflict of Interest” October 2001 • AMA – Code of Medical Ethics, Opinion 8. 031, March 1992 • Professional Societies and Peer Reviewed Journals

Consulting Agreement Basics • Faculty members may engage in outside consulting activities when the activities and the agreements have been approved by their Chairs and the Dean’s Office • Applicable policies from the University and School of Medicine may be found on the web • University Faculty Handbook Chapter 3: Policies, Reimbursement & Compensation: http: //www. emory. edu/PROVOST/ • School of Medicine Faculty Affairs Page: http: //www. emory. edu/WHSC/MED/DEAN/facultyaffairs. html

Consulting Agreement Basics • What activities are considered consulting? – Providing advice to an external company, person, or organization – Serving on an advisory committee – Serving on a review committee – Developing products owned by external group as long as Emory resources are NOT used and not within scope of academic duties – Speaking to the community or press about a company’s products, provided that the information has already been published

Consulting Agreement Requirements • Agreement must be between faculty member as a private individual, i. e. not representing Emory • Correspondence and payments made directly to the faculty member • Required language (see Consulting Agreement Reference Sheet) • Must be approved by Chair and Dean’s Office who take into consideration: – the academic and clinical needs of the Department, the School, Emory Healthcare, and the practice plans; and – the benefit of the consulting activity to the faculty member and the University

Which activities are not permitted in a Consulting Agreement? • Faculty may not use any Emory or Emory. Healthcare facilities, resources, or personnel for their private consulting activities – This means • no Emory laboratories or data • no reagents or equipment ordered by Emory • no Emory lab techs or assistants • no Emory conference rooms • no Emory. Healthcare operating rooms • no Emory trademarks, tradenames, or logos • no Emory intellectual property

Which activities are not permitted in a Consulting Agreement? • Faculty may not engage in the practice of medicine – Providing information or advice about an individual patient – Providing treatment to an individual patient – Prescribing treatments for individual patients – Recommending particular physicians in the patient’s geographical area • Faculty may not perform research or teach classes without written approval from Dean

Potential Conflicts of Interest Created Due to Consulting Relationships • Consulting activities & research or academic activities overlap • Inappropriate use of Emory facilities or resources • Most editors require disclosure of any consulting relationships • Consulting fees greater than $10 k may trigger COI Research policy and review is required by the COI Committee

Start-up Companies • Faculty owned companies • Purpose is to develop and/or commercialize intellectual property that faculty developed at Emory or other institution • Outcomes include commercial sales by start-up or sale to larger corporation

SOM Procedures for Start-up Companies • Faculty are required to submit to Chair and Dean a report outlining the business plan – Appropriate time for faculty member to start a company? – Time commitments? – Competitive with Emory? • Report must be reviewed by SOM Conflict of Interest Committee • Review by Office of Technology Transfer is required if plans include use of Emory Intellectual Property • If Emory technology is licensed to the start-up company, Emory may request an equity share in the company if cash is not available • http: //www. emory. edu/WHSC/MED/DEAN/facultyaffairs. html

Potential Conflicts with Start-up Companies • Use of Emory technology by business prior to license • Negotiating with Emory on behalf of company • Use of Emory resources • Co-mingling of assets with Emory • Inappropriate transfer of data/information/technology to company • Fiduciary duty to company

Conflict Management: University & Federal Requirements • Conflicts must be – Disclosed in writing (annually and as circumstances change) – Reviewed by designated officials – Properly managed, reduced, or eliminated – Consistent monitoring and oversight – Sanctions employed for non-compliance

Process for Disclosure & Review • Disclosures obtained annually from faculty – Annual Disclosure Form available on-line: http: //med. emory. edu/administration/faculty_affair s/profile_coi_links. cfm – Disclosure statements included on Sponsored Projects Approval Form, IRB forms, IACUC applications, Appointment & Promotions Committee • Disclosures reviewed to determine whether a conflict of interest or commitment exists • If a potential conflict is found, more information from individual is requested

Types of Information Requested for Review by COI Committee • • Faculty Status Research Proposal/Business Plan Equity Interest/Financial Interest Corporate Information Consulting/Advisory Agreements License Agreements Report from Individual(s)

What are the Goals? • To protect the integrity of data against bias, and thereby the reputation of the institution and the individual faculty member • To protect the safety of human subjects in research • To carry out the missions of the institution in accordance with the highest ethical standards

Considerations for Management Tools • • • Is the research clinical or non-clinical? Is this a pilot study? Does the investigator have unique expertise? What protections are built into the study design? Is the study design reviewed by peers through a grant review panel? How will data be used, i. e. is the pivotal study for approval by the FDA? From where does the investigator receive the majority of his/her funding? What would be the public’s perception of the conflict? Would this activity expose the University or the investigator to scrutiny by the IRS, SEC, or other federal agency?

Individual Conflicts That Are Not Permitted • Purchasing equipment/materials used in research from a private firm in which the investigator has a significant financial interest or other direct relationship (consultant) • Using SOM facilities/resources by an entity when the investigator is a consultant or has equity ownership • Using students/trainees on research projects directed by a conflicted investigator in a way that restricts – Freedom to discuss findings – Seeking training and advice from others – Conducting job searches freely – Publishing freely (confidentiality agreements)

Managing Conflicts – General Principles • Emory owns all the intellectual property generated by its employees and students (with some exceptions) • External activities cannot compromise the employee’s ability to perform his/her full-time Emory job • Emory business (scholarship, teaching service) is conducted in a manner that is above inferences that the activity could be compromised by the employee’s expectation of financial gain, direct or indirect • Students, trainees, and employees must be assigned duties consistent with their status and position. Their work should not be compromised by agreements with external sponsors or by a faculty member’s financial interests. • The University must authorize any use of Emory’s research facilities, personnel, and intellectual property for use by anyone other than Emory

Management Plans • • • Disclosure Re-design of research project Appointment of independent reviewer(s) Limitation of corporate responsibilities Leave of absence from faculty duties Prohibition of certain responsibilities associated with research or Emory activities • Divestment of corporate interest • Prohibition of corporate relationship • Annual reports on compliance with management plans

Questionable Uses of Emory Resources • Press releases or marketing campaigns by outside companies • Provision of facilities or resources to outside companies • Filming at Emory • “Training” Programs • Endorsements • Testimonials

Things to remember • All interactions with the press or public relations firm must be cleared with the Office of Communications • Emory facilities and resources cannot be used for commercial, political, or private financial gain or commercial advertising by third parties • Endorsements are not permitted and testimonials are rarely permitted (must be cleared through General Counsel and Communications)

Institutional Conflicts of Interest • When the financial or personal interests of the institution, or of an institutional official acting in his/her official capacity, might affect or appear to affect: – Any phase of its research mission -- conduct, review, oversight and compliance, outcome – Finances and economic status of the institution/school/department – Missions of the institution/school/department – Appropriate vendor relationships – Employment practices (oversight of faculty, staff, students)

To Maintain the Public Trust. . . Institutional officials must • Make decisions and policies for the institution that are free from improper bias or conflict of interest • Be able to document that they have done so

The Institution has Competing Interests in. . . • Its financial gain from external entities – donors, research sponsors, companies, investments • Its own academic and clinical missions and the policies that support them – Allocations of space, money, people – Review and approval processes – Monitoring, auditing, compliance – Discipline – Purchasing for Departments, School, Hospitals, Clinic, Grady • Its reputation • Its research integrity • The safety and welfare of its human subjects Decisions are made by Chairs & Deans at SOM level

Potential ICOI in Research Exist when the institution or institutional officials who manage or oversee research also: – Might get royalties from the sale of the product that is to be investigated – Hold any equity through licensing its technology to a non-publicly traded research sponsor (e. g. , startup company) – Hold ownership interests through licensing its technology to a publicly-traded research sponsor (>$100 K ? ) – Receives a significant gift from a potential research sponsor

Potential ICOI in Research When an institutional official who has research responsibility has a: • Significant financial interest in the research sponsor or the product to be investigated – – Equity interest Consulting relationship Honoraria, gifts Service as officer, board member • Purchasing relationship with the research sponsor (vendor)

Rules and Regulations on ICOI • Various regulations and statutes govern ICOI in finance, employment, Board duties, etc. (IRS, SEC, corporate law. . . ) • No federal regulations on ICOI in research • Excellent guidance for institutions engaged in human subject research, adaptable to broader application: – Protecting Subjects, Preserving Trust, Promoting Progress II: Principles & Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research AAMC Task Force on Financial Conflicts of Interest in Clinical Research, October 2002

A Few SIMPLE Rules For Chairs & Administrators • Carefully weigh the competing interests: – Need for money, but does the end justify the means? • Think about how the arrangement would be seen in view of an adverse event involving a patient • Think about your own and the institution’s reputation (with colleagues and the public) if the arrangement is published in the newspaper • Ask yourself whether the arrangement passes the smell test • Think about ways to manage the potential COI – disclose or modify the arrangement for better management of the COI

A Few SIMPLE Rules for The Institution • Separate the roles of administrators who oversee and make institutional decisions about research and administration from those who oversee investments and technology transfer • Have established policies and procedures for the identification, disclosure, review, and management or elimination of potential ICOI • Have an ICOI Committee with some external members, and high-ranking independent internal members (not COI Committee) • Make use of external committees, ad hoc or standing, routinely or in certain cases, if feasible

A Few SIMPLE Rules. . . • Have good communication among the ICOI Committee, COI Committee(s), Tech Transfer Office, and IRB • Disclose, disclose • Require IRB members to disclose potential conflicts of interest and recuse or divest if appropriate

School of Medicine Conflict of Interest Committee Members: Tristram Parslow, M. D. , Ph. D. , Chair Pathology & Laboratory Medicine Edmund E. Waller, M. D. , Ph. D. , Vice-Chair Hematology/Oncology, WCI Greg Berns, M. D. , Ph. D. Psychiatry & Behavioral Sciences Victoria Greene, J. D. , M. D. Gynecology/Obstetrics Jay Justice, Ph. D. Chemistry, Emory College Ex-Officio Members: Claudia R. Adkison, J. D, Ph. D. , Exec. Assoc. Dean/Faculty Affairs & Administration Todd Sherer, Ph. D. Director, OTT Brenda J. Seiton, J. D. Dean for Administration Tanya Sudia-Robinson, Ph. D. IRB/IACUC Office Jeff Lessesne, M. D. Geriatric Medicine Shawn Akkerman, Pharm. D. OSP Rebecca Pentz, Ph. D. Winship Cancer Institute Arri Eisen, Ph. D. Center for Ethics & Biology James Ramsay, M. D. Anesthesiology Asst.

Questions/More Information • Brenda J. Seiton, JD, Assistant Dean for Administration, bseiton@emory. edu 727 -3413 • Claudia R. Adkison, JD, Ph. D. , Executive Associate Dean/Administration & Faculty Affairs, cadkison@emory. edu 727 -5673 • Kris West, JD, Chief Compliance Officer, Emory University Research Office kwest 02@emory. edu 727 -2237 • Emory Healthcare – Anne Adams, MHA, JD, Chief Compliance Officer, EHC anne_adams@emoryhealthcare. org 778 -2186