University of Pittsburgh Conflict of Interest Office A Partner in Promoting Integrity in Research, Teaching, and Administration

COI RESPONSIBILITIES FACULTY/STAFF DEVELOPMENT PROGRAM: Annual COI Filing Process & Revised PHS COI Regulations COI Office: David Wehrle, Director Khrys Myrddin, Associate Director April 5, 2012

What is a Conflict of Interest? A potential Conflict of Interest may exist if an individual’s outside interests (especially financial) may affect, or perceive to affect, his/her research, teaching, or administrative activities at the University.

Examples of Potential Conflicts Example 1  Professor Maureen Belstein, faculty member/researcher  Serves on Scientific Advisory Board for National Tool Company (she earned $35,000 last year)  NTC wants to sponsor university research to evaluate new technologies  Professor Belstein wants to be PI on the study

Examples of Potential Conflicts (cont’d) Example 2  The University was awarded a federal grant on which Dr. Ari Samuel serves as PI.  He subcontracted a portion of the work to Scanware for installation of eye-movement analysis software.  Dr. Samuel has an equity interest in this vendor.

Examples of Potential Conflicts (cont’d) Example 3  Dr. Maryann Ruecken developed a back brace, which was patented by the University  The technology is licensed to Strait & Narrow, Inc., a non-publicly held company; she receives royalties for the device through Pitt  She holds equity in the company  Dr. Ruecken is conducting federally sponsored research to further evaluate the technology

Importance of COI Management If COI is not managed… protection of human subjects may be compromised; integrity of research may be at risk; the public may lose trust in the University and its research findings; the investigator/faculty member may lose the respect of the academic community; violation of scientific norms may result; University may lose public support and funding for research;

Importance of COI Management (cont’d) research results may be excessively delayed or not published; there may be a negative impact on students; University resources may be improperly used; increased government regulations; scandals or negative media attention may occur….

THE CHRONICLE of Higher Education Baylor College of Medicine Faces NIH Sanctions Over Financial Conflicts Paul Baskin  Tuesday, January 20, 2010 The NIH has ordered tougher financial disclosures on all grant applications from Baylor College of Medicine, [citing] ”serious concerns” about the college’s compliance with regulations governing conflicts of interest…. The doctors who spoke favorably of Vytorin ® included Christie M. Ballantyne…who collected $34,472 during a five-month period… The NIH informed the institution last month that the agency would impose ‘special award conditions” on all future grants.

Today’s topics Departmental responsibilities  Annual COI filing process  Using the Superform system  COI Oversight & Management

Today’s topics (cont’d) University-level COI Management  Research protocols  Entrepreneurial endeavors  Purchasing

Today’s topics (cont’d) PHS Final Rule

Annual COI Filing Process Annual COI memo from the provost & executive vice chancellor University Policies  

Annual COI Filing Process: Who? Faculty/Researcher Form  All full-time faculty members  Staff & students of any classification who “direct or can materially influence research, or who are responsible for the design, conduct, and reporting of research”  Part-time faculty members not conducting research are covered by this COI policy only to the extent that their outside financial interests would reasonably appear to be affected by their work for the University.  The policy does not apply to employees on unpaid leave from the University or to adjunct faculty.

Annual COI Filing Process: Who? (cont’d) Designated Administrator/Staff form  Deans, department chairs, division chiefs, and center directors with faculty appointments must complete both University forms.  Employees classified as Administrator IV or above;  Those of other classifications (including faculty) who are in a position to make, direct, or materially influence University business decisions (e.g., employees who have significant influence over the selection of outside vendors or providers of services);  P-card holders

Reporting Financial Relationships: When? Institutional Policies  Policies and require reporting of the outside interests of faculty, administrators, and investigators upon appointment by April 15 of each year whenever new outside interests are accrued using the Superform system

The Superform system COI disclosures must be filed electronically (there is no paper form). All forms filed become part of a secure COI database, accessible only to authorized individuals. The Superform system includes reporting forms for the University of Pittsburgh only.  For dually employed personnel, University forms can be generated through a combined form available through UPMC’s My Hub

Who Has Access to the COI Database? IRB/IACUC/CORID Purchasing Office of Research Internal Audit General Counsel COI Office COI Committee Chair Regional Campus Presidents/Deans/ Department Chairs Research administrators/coordinators

Who Has Access to the COI Database? (cont’d) Request access through the COI Office (requires name, HSConnect username, departmental affiliation, and level of access to be granted, i.e., basic or operational); operational access must be approved by department chair.  Send request for access to Research administrators with basic access can determine whether investigators have a current COI form on file.

Making disclosures—Using the Superform system Returning users:  Login using existing HSConnect account  Retrieve forgotten password Do not create a new account!  Update HSConnect profile  Change address/password New users:  Create an HSConnect account If links to forms do not appear on Welcome screen, confirm correct affiliation in profile

Making disclosures—Using the Superform system (cont’d) Select the form you wish to complete  First-time users must answer every question  Returning users will be taken to the Form Summary page Edit responses as applicable Review the Form Summary Click “Submit this form” Click “View and Print” (next to the form you wish to print)

Making disclosures—Using the Superform system (cont’d) Print and sign Signature Page (SP); Forward Faculty/Researcher SP to department chair for review and signature; Forward Admin/Staff SP to the next higher administrator (who is at least at the level of director or department chair) for review and signature.

Combined Pitt/UPMC COI Form Individuals who have dual appointments at the University and UPMC may fulfill the University’s COI disclosure requirement by completing a combined Pitt/UPMC form, accessible through UPMC’s My HUB.  To access the combined form, go to Infonet and click on My HUB, select the Human Resources tab, then the COI link under My Profile.

Combined Pitt/UPMC COI Form (cont’d) Select “UPMC/Pitt combined form”  On the next screen, user has the option to also complete a Designated Administrator form User can “create a new disclosure”; “copy a disclosure”; or append an existing disclosure. After copying information from a previous form, user must confirm all answers and then “finalize disclosure.”

Combined Pitt/UPMC COI Form (cont’d) After user submits answers in the UPMC system, a Faculty/Researcher (and DesAdmin, if selected) form is generated in the University Superform system. User is prompted to login to HSConnect to print out form(s).

Combined Pitt/UPMC COI Form (cont’d) After login, users will see an “Import Successful” message, and the form will be highlighted in the Filing History. Print out, sign, and submit to  department chair (Faculty/Researcher form)  next higher administrator who is at least at the level of director or department chair (Designated Administrators/Staff form)

COI Oversight by Supervisors Faculty/Researcher—Department Level Ensure that all required individuals have signed and submitted a Signature Page by April 16 Department Chairs review Faculty/Researcher disclosures Prepare Management Reporting Forms (MRF) for individuals who disclosed outside interests

COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Management Reporting Form (MRF)  Used to document all actions that have been taken to manage identified conflicts of interest University level COI Committee Department level

COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d)  New: Instruction sheet for completing MRF  Identification of faculty member and supervisor  No need to re-enter detailed responses from disclosure, because this form is attached to the Signature Page  Conflict Disclosed – Enter the category of financial interest (e.g., ownership interests, offices & positions, remunerative activities, outside employment of students/staff, technology transfer activities)

COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Management actions taken – Briefly describe actions taken to mange conflicts of interest arising from the individual’s disclosed outside financial relationship(s)  If no management is needed, provide a justification (e.g., individual does not conduct research sponsored by, or of commercial interest to, this company; individual makes no purchasing decisions, etc.)

COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Prepare departmental Annual Data Summary report Submit Signature Pages disclosing outside interests, related MRFs, and department’s Annual Data Summary Report to dean or regional campus president for review  Signature Pages on which no outside interests were disclosed do not need to be submitted to the dean

COI Oversight by Supervisors Faculty/Researcher—Dean’s/Regional Campus President’s Level Dean/Regional campus president reviews forms received from chairs o Approves or modifies MRFs, as necessary Prepares School’s Annual Data Summary Report o Submit Signature Pages, related MRFs, and Departments’ and School’s Annual Data Summary Reports to the provost or senior vice chancellor for the health sciences by May 15.

COI Oversight by Supervisors Designated Administrators/Staff—Department Level Ensure all required employees have signed and submitted their Signature Pages by April 16 Supervisor reviews Designated Administrators/ Staff disclosures Supervisor should work with the employee to develop a plan to manage any potential COI and document it in the form of a memorandum (do not use the MRF) Prepares an Annual Data Summary Report and submits it to the next higher reporting authority within the responsibility center

COI Oversight by Supervisors Designated Administrators/Staff—Department Level (cont’d) Report unresolved conflicts to the provost, senior vice chancellor for the health sciences, or executive vice chancellor by May 15; o Hint: there should be no unresolved conflicts Signature Pages and management plans of resolved conflicts should not be forwarded, but should be filed in the department.

COI Oversight Signature Pages, Management Reporting Forms, and Annual Data Summary Reports are ultimately forwarded to the COI Office by the provost or senior vice chancellor for the health sciences Everything you need for the annual COI filing process can be found at

Departmental COI Management Prospective approval from department chair or dean is required for  All outside professional activities, consultancies, speaking engagements, scientific advisory boards;  Involvement of students in outside entities or in research of interest to a company in which a faculty member has a financial interest;  Purchasing from, or subcontracting work to, a company in which an individual has a financial interest. Cannot use University facilities or resources; Total time expenditures in all outside professional activities cannot exceed one day per week on the average. Note: staff members must conduct all outside activities on their own time.

Departmental COI Management (cont’d) Department chairs are responsible for the development of COI management plans for research not overseen by a regulatory committee.  Chairs may contact the COI Office for assistance;  COI Office appreciates receiving a copy of the management plans for our records.

Departmental COI Management (cont’d) Management Options  Divestment or reduction of financial interest;  Disclosure of COI in publications, presentations, press releases, abstracts, and in proposals and applications for research funding;  Disclosure of potential COI to others involved in the research;  Dilution of investigator’s role in study, i.e., cannot be PI, but may be co-investigator;  Addition of a data steward to a particular research project;  Establishment of an oversight committee.

Proper use of students/staff by faculty members with outside interests Prospective review and approval of activities by students’ department chairs or deans Formal notification of faculty members’ interest in an outside company  Faculty members should distribute Student/Staff Notification Form (available on COI web site) for signature by students/staff;  Students/staff should discuss any concerns with faculty members’ non-conflicted supervisor and/or COI Office;

Proper use of students/staff by faculty members with outside interests (cont’d) Work under approved Corporate Research Agreement (CRA) should correspond to effort provided for in the CRA  Cannot be compelled to perform work that will benefit the company;  Compatibility with academic interests of students;  Timely ability to publish research results for academic credit without hindrance by the company’s commercial interests;

Proper use of students/staff by faculty members with outside interests (cont’d) Assurance that students’ intellectual property is protected; Employment of students at faculty member’s company  Salary must be commensurate with tasks performed;

University Level COI Management: Research Protocols The COIC is responsible for managing potential conflicts involving the following:  Human subject research (IRB)  Animal research (IACUC)  Research and Clinical Training on Decedents (CORID)  Recombinant DNA research (IBC)  Human stem cell research (hSCRO)

University Level COI Management: Research Protocols (cont’d) COI questions appear on all research protocol applications and apply to all individuals listed on protocol Referred to COI Office for review & management

University-level COI Management— Licensed Start-up Companies The COI Committee is responsible for managing potential conflicts involving Licensed Start-up Companies (i.e.,  Are not publicly-traded  Have an option or license to University intellectual property  University and/or University employees or students, or members of their immediate families hold equity, (including stock options) Special restrictions on relationships with these companies

University-level COI Management —Purchasing University Purchasing Services refers issues to the COI Office for review; e.g., if the individual completing a Directed/Sole Source form has a financial relationship with the company from which a purchase is being requested. Purchasing Services reports quarterly to the COI Committee on purchases made from companies in which University employees have a financial interest.

University-level COI Management —Office of Research University must attest that the PI of a grant has a current COI disclosure on file; grants administrators query COI database to verify compliance; Contract officers also query the database to determine whether PI or other investigators have disclosed a relationship with an Industry sponsor  If yes, matter is referred to COI Office for review & management

Revised Public Health Service Regulations: Major Changes Definitions  SFI/Significant Financial Interest: a financial interest exceeding established thresholds that reasonably appears to be related to the Investigator’s institutional responsibilities  FCOI/Financial Conflict of Interest: an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research

Revised Public Health Service Regulations: Major Changes (cont’d) Reporting thresholds have been decreased Sponsored & reimbursed travel must now be reported and evaluated Publicly accessible website disclosing FCOIs COI training at least every 3 years

Revised Public Health Service Regulations: Major Changes (cont’d) “Relatedness” assessment  Department chairs will need to review SFIs between $5, ,000 to determine whether they constitute an FCOI with PHS-funded research.  COIC will review and make relatedness determination for SFIs greater than $10,000.

Revised Public Health Service Regulations: Major Changes (cont’d) Management of FCOIs  For FCOIs in the $5-10K range, department chairs will determine level of COI management;  For FCOIs over $10K, centralized management proceeds as normal.

Additional Help with COI Management Conflict of Interest Office COI Web site  includes oversight checklist for supervisors, COI-related forms, and links to relevant policies, the Superform system, and the annual COI memo from the provost and the executive vice chancellor  SOHS Industry Relationship Policy Specially tailored COI presentations for your department can be requested free of charge

Questions?

Contacts/Info/Assistance Jerome L. Rosenberg, PhD Chair/COI Committee David T. Wehrle, CPA, CFE, CIA Director/COI Office Khrys X. Myrddin, MPPM Associate Director/COI Office Hannelore N. Rogers, MA Coordinator/COI Office COI Web site: