F S D P W o r k s h o p

F S D P W o r k s h o pF S D P W o r k s h o p

University of Pittsburgh

Conflict of Interest OfficeA Partner in Promoting Integrity in Research, Teaching, and

Administration

INTRODUCTION TO THE SUPERFORM SYSTEM &

FINANCIAL CONFLICT OF INTEREST MANAGEMENT

COI OfficeDavid Wehrle, Director

Khrys Myrddin, Associate Director

April 2, 2010

What is a Conflict of Interest?

A potential Conflict of Interest (COI) 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

Consultant/speaker 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 Dr. William Monardo, faculty member/

researcherPresident/owner of Laboratory

Solutions, Inc. (LSI)Dr. Monardo’s research group

purchases scientific supplies and equipment from LSI.

Examples of Potential Conflicts (cont’d)

Example 3 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 4

Dr. Maryann Ruecken developed a back brace, which was patented by the University; she receives royalties for the device through Pitt

The technology is licensed to Strait & Narrow, Inc., a non-publicly held company

She holds equity in the company Dr. Ruecken is conducting federally

sponsored research to further evaluate the technology.

Examples of Potential Conflicts (cont’d)

Example 5 Dr. Argus Hawkeye invented forceps for

micro surgery of the eye; This device was licensed to Rod & Cone

Corp by the University; Dr. Hawkeye has a right to licensing

income (royalties) for the device through Pitt;

Dr. Hawkeye wishes to be PI on a clinical trial to further develop the forceps.

Importance of COI Management

Why is it important to identify and manage conflicts of interests?

Importance of COI Management (cont’d)

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 academic science;

Importance of COI Management (cont’d)

product or service may be inferior; price may be too high; may give actual or perceived improper

preferential treatment to vendors; may violate terms of research grants and

contracts (including failure to disclose COI) and federal regulations.

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 may result;

scandals or negative media attention may occur….

Today’s topics

Departmental responsibilities Annual COI filing processUsing the Superform systemCOI Oversight & Management

Today’s topics (cont’d)

University-level COI ManagementResearch protocols Entrepreneurial endeavorsPurchasing Office of Research

Additional Help with COI/Resources

Annual COI Filing Process

University Policies 11-01-03 (COI – Research/Teaching) 07-05-02 (COI – Designated Administrators

and Staff) Annual COI memo from the provost & executive

vice chancellor

Note: A new University COI policy has just been signed by the Chancellor.

Annual COI Filing Process: Who? Faculty/Researcher Form

All individuals with regular faculty appointments

Employees who direct or can materially influence research, or who are responsible for the design, conduct, and reporting of research

Annual COI Filing Process: Who? (cont’d)

Designated Administrator/Staff form Employees classified as Administrator IV or

above, and 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)

• Deans, department chairs, division chiefs, and center directors with faculty appointments must complete both University forms.

Reporting Financial Relationships: When? Institutional Policies

Policies 11-01-03 and 07-05-02 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

https://coi.hs.pitt.edu

What is the Superform system?

The electronic Superform system must be used to file COI disclosures (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 only the University of Pittsburgh. UPMC uses a separate system accessible through

Infonet http://compliance.infonet.upmc.com/COI.htm

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)

Research administrators can determine whether investigators have a current COI form on file

Request access through the COI Office (requires name, HSConnect username, departmental affiliation, and level of access to be granted. i.e., basic or operational Send request to rogershn@upmc.edu

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 e-mail address/password

New users: Create an HSConnect account

If no links to forms appear on Welcome screen, add University affiliation to 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 Print and sign Signature Page (SP)

Making disclosures—Using the Superform system (cont’d)

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

COI Oversight by Supervisors Faculty/Researcher—Department Level

Department Chairs review Faculty/Researcher disclosures Ensure that all required employees

have signed and submitted the Signature Page by April 15

COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Prepare Management Reporting Forms

(MRF) for individuals who disclosed outside interestsSection E: Is disclosure alone of the

individual’s potential conflict in abstracts, publications, presentations, press releases, and in proposals and applications for research funding sufficient to manage the conflict?

• Answer Yes, if an individual's outside activities create no conflict with his/her University work, i.e., s/he is not conducting research of commercial interest to any company or making purchases from any company with which s/he has a relationship

COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d)

Answer No if any relationship requires COI management; describe actions taken; e.g., SMP has been invoked for a clinical trial; a data monitoring committee was established for the individual’s research program; entrepreneurial activities are being overseen by the COI Committee, etc.

COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d)

Prepare departmental Annual Data Summary report

Submit Signature Pages, related MRFs, and department’s Annual Data Summary Report to dean for review

• SPs on which no outside interests were disclosed do not need to be submitted to the dean

COI Oversight by Supervisors Faculty/Researcher—Dean’s Level Dean reviews forms received from

chairs• Approves or modifies any MRFs, as

necessary Prepares School’s Annual Data

Summary Report• 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 Monday, May 17, 2010

COI Oversight by Supervisors Designated Administrators/Staff—Department Level

Supervisor reviews Designated Administrators/Staff disclosures Ensures that all required employees have

signed and submitted the SP by April 15 The 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 a brief memo summarizing disclosures made, and submits it to the next higher reporting authority within the responsibility center

COI Oversight by Supervisors Designated Administrators/Staff—Department Level

Report unresolved conflicts to the provost, senior vice chancellor for the health sciences, or executive vice chancellor by Monday, May 17;

SPs and management plans of resolved conflicts need not be forwarded, and should be filed in 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 http://www.coi.pitt.edu/directive.htm

Departmental COI Management Prospective approval from department chair or

dean is required for Consultancies, speaking engagements, and

membership on scientific advisory boards• cannot use University facilities or resources • total time expenditures in all outside professional

activities cannot exceed one day per week• Note: staff members must conduct all outside activities on

their own time 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

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

Establishment of an oversight committee Dilution of investigator’s role in study, i.e.,

cannot be PI, but may be co-investigator

Proper use of students/staff by faculty members with outside interests

Prospective review and approval of activities by department chair or dean

Formal notification of faculty members’ interest in an outside company Faculty members should distribute

Student/Staff Notification Form for signature by students/staff

Students/staff should discuss any concerns with faculty members’ non-conflicted supervisor and/or COI Committee

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 (e.g., no overtime) 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’ inventions remain

property of University Employment of students at faculty member’s

company Salary must be commensurate with tasks

performed Students/staff cannot perform work on University

time or use University resources related to a faculty member’s outside professional activities (e.g., providing administrative assistance with faculty’s outside consulting activities)

Proper use of students/staff by faculty members with outside interests (cont’d) Reporting of troublesome COI issues by

students/staff to department chair, dean, school’s

representative in the Graduate and Professional Student Assembly and/or the Conflict of Interest Committee, or

AlertLine, 1-866-858-4456: anonymous, 24 hours a day, accessible from any North American telephone.

SOHS/UPMC Industry Relationship Policy Covers interactions between faculty/

staff in the Schools of the Health Sciences and representatives of the pharmaceutical, biotechnology, medical device, and hospital equipment supply industry (“Industry”)

Bans gifts & meals Prohibits participation in “Speakers

Bureaus” Defines criteria for participation at off-site

meetings

Imposes certain requirements on consulting contractsCompensation must be tied to specific

deliverables (i.e., no flat rate per month)

Contracts for more than $10K/12 months must be approved by office of Senior Vice Chancellor for the Health Sciences, Dr. Arthur Levine

SOHS/UPMC Industry Relationship Policy (cont’d)

University-level COI Management—Research Protocols

The COIC is responsible for managing potential conflicts involving the following: Human subject research overseen by the

IRB Animal research overseen by the IACUC Research on the clinically brain-dead

(CORID) Recombinant DNA research (rDNA/IBC) Human stem cell research (hSCRO)

COI questions appear on protocol applications; apply to PI, Co-Is, and research coordinators

PI is responsible for ensuring that all Co-Is and research coordinators answer these questions

Reporting must be kept current Whenever new outside interests are

accrued, faculty members should notify the COI Office and the appropriate regulatory committee (e.g., IRB, IACUC, etc), and update their Faculty/Researcher forms.

University-level COI Management—Research Protocols (cont’d)

COI Questions on Protocols Does the principal investigator or any co-investigator

or research coordinator involved in this study (or in aggregate with his/her spouse, dependents or other members of his/her household):

a. possess an equity interest in the entity that either sponsors this research or owns the technology being evaluated that exceeds 5% ownership interest or a current value of $10,000?

b. receive salary, royalty or other payments from the entity that either sponsors this research or owns the technology being evaluated that is expected to exceed $10,000 per year?

…….

COI Questions on Protocols (cont’d)

c. have rights to the intellectual property (IP) being evaluated as either the inventor of the IP for which a patent has been issued, or as the inventor of the IP that has been optioned or licensed to a company?

d. have a financial relationship with a Licensed Start-up

Company that has an option or license to utilize the technology being evaluated?

IRB onlye. Receive compensation of any amount when the

value of the compensation would be affected by the outcome of the research, such as compensation that is explicitly greater for a favorable outcome than for an unfavorable outcome or compensation in the form of an equity interest in the entity that either sponsors this research or owns the technology being evaluated.

COI Questions on Protocols (cont’d)

Answering Yes to any of the questions on the IRB protocol requires use of the Standard COI Management Plan (SMP) for Human Subject ResearchAvailable w/in OSIRIS and from the

COI Office Web site: http://www.coi.pitt.edu/Forms/StandardCOIMgmtPlan-HSR.htm

University COI Management—Research Protocols

For IACUC, CORID, and hSCRO, investigator cannot be PI if s/he answers Yes to the questions asking about equity, remuneration, or a relationships with a start-up company.Management plan similar to SMP, less the

items specific to HSR IBC did not adopt the PI-exclusion rule;

reviewed on a case-by-case basis Financial relationships only in the IP being

evaluated are reviewed on a case-by-case basis.

University COI Management—Research Protocols

University-level COI Management—Licensed Start-up Companies The COI Committee is responsible for

managing potential conflicts involving start-up companies (i.e., not publicly traded) that have an option or a license for University

intellectual property in which equity (including stock options) is

held by University employees or students, members of their immediate families, or by the University

Special restrictions on individual relationships with these companies

University-level COI Management—Purchasing University Purchasing Services refers

issues to the COI Office for review; e.g., if the requestor or approver of 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 COIC on purchases made from licensed start up companies

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

Contracts officers query the database to see whether PI or other investigators have disclosed a relationship with an industry sponsor Refer to COI Office for review & management

Additional Help with COI Management Conflict of Interest Office COI Office Web site www.coi.pitt.edu

includes sample management plans, case studies, oversight checklist for

supervisors, COI-related forms, links to relevant policies and the Superform system, and the annual COI memo from the provost and the executive vice chancellor

Resources: Learning about COI

COI management presentations tailored to specific departments, upon request

ISER (Internet-based Studies in Education and Research) Conflict of Interest Module…

ISER COI Module: Who must complete it? Those who have disclosed outside

interests on the University’s Faculty/Researcher form and/or those involved in industry-sponsored research are required to complete the ISER COI module (formerly RPF module 4).

Completing the ISER COI Module Go to https://cme.hs.pitt.edu/ 

click "All Modules"select "COI Module" from list

Test out of module Take chapter quizzes Receive certification

Completing the ISER COI Module (cont’d)

at this time, re-certification is not required (despite the “expired” note that may appear in system)

access to the ISER database for appropriate individuals (to determine whether the COI module was completed) may be requested through Kathy Sidorovich (ksidorovich@hs.pitt.edu)

Questions?

Contacts/Assistance

Jerome L. Rosenberg, PhD/Chair, COI Committee 412-624-3007 jrosenb@pitt.edu

David T. Wehrle, CPA, CIA, CFE/Director, COI Office412-383-1774 wehrledt@upmc.edu

Khrys X. Myrddin/Associate Director, COI Office412-383-2828 myrddink@upmc.edu

Hannelore Rogers, MA/Coordinator, COI Office412-383-1968 rogershn@upmc.edu

COI Web site: www.coi.pitt.edu

iTarget Team: 412-648-2222 for technical assistance with Superform system