F S D P W o r k s h o pF S D P W o r k s h o pUniversity of Pittsburgh

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

Administration

The WHYs & HOWs of Financial Conflict of Interest Management

Khrys Myrddin Associate Director, COI Office

March 25, 2008

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/

researcher President/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.

Importance of COI ManagementWhy 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….

FDA Halts Gene Experimentsat University of Pennsylvania

By Rick Weiss and Deborah NelsonWashington Post Staff WritersSaturday, January 22, 2000; Page A1

The federal government yesterday halted all human gene therapy experiments involving a prominent researcher at the University of Pennsylvania, saying an investigation into the September death of a teenager there found the school's prestigious program in serious disarray.

                                                                      

THE CHRONICLE OF HIGHER EDUCATION

Thursday, April 14, 2005Former Professor Pleads Guilty to Embezzling Nearly $1-Million in Federal Grants

Thursday, April 21, 2005George Washington U. to Pay $1.8-Million to Avoid Prosecution in Embezzlement Case

December 4, 2006 NIH Scientist Charged in

Connection with Pfizer Consulting

Disclosure: Why? University Policies

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

COI Committee Working COI Policies IRB IACUC CORID ESCRO

Industry Relationship Policy (SOHS/UPMC) Annual COI memo from the provost & executive

vice chancellor (Directive to Disclose)

Disclosure: Who? Faculty/Researchers Employees classified as staff, who

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

Disclosure: Who? (cont’d)

Employees classified as Administrator IV or above, and those of other classifications 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)

Reporting Financial Relationships 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 Superform system contains

reporting forms for the University of Pittsburgh, the UPMC, and the University of Pittsburgh Physicians.

All forms filed become part of a secure COI database, accessible only to authorized individuals.

Who Uses 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 Uses the COI Database?(cont’d)

Research administrators can determine whether investigators have a current COI form on file by using the Administrative Access Gateway Administrative access may be requested

through the COI Office (requires name, HS Connect e mail address & departmental affiliation of individuals eligible to have access)

Using the Superform system Create an HSConnect account/use

an existing account Retrieve forgotten password

Create/update your profile Describe University affiliation Indicate which COI forms must be filed

Change e-mail address/password

Using the Superform system (cont’d) Answer Part I Questions Answer Part II Questions (as appropriate) Review and file disclosure 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

Faculty/Researcher formPart I Question 1 Ownership Interests

During the past calendar year, did you or members of your immediate family, own or control an equity interest in any organization in your field of academic interest or specialization that when aggregated for you, your spouse and dependent children exceeded a 5% ownership interest or is greater than $10,000?

Faculty/Researcher formPart I Question 2 Offices and Positions

During the past calendar year, were you or a member of your immediate family, a director, officer, partner, employee, or agent, or in any managerial position in any organization outside the University of Pittsburgh that might be affected by your research or administrative activities? (does not apply to governmental committees, community, political, academic, charitable, religious, social or professional nonprofit organizations.)

Faculty/Researcher formPart I Question 3 Remunerative Activities

Does income (cash or in-kind, other than reimbursement of reasonable expenses) related to your teaching, research, or administrative activities received by you during the past year or expected over the coming year from any one organization outside the University exceed 1% of your University salary, or does income aggregated for you, your spouse, and dependent children received from such an organization during the past year or expected over the coming year exceed $10,000?

Faculty/Researcher formPart I Question 4 Outside Employment of

Students or Staff Do you now, or did you during the past

calendar year, employ any of your students or staff in a company or organization outside the University?

Faculty/Researcher formPart I Question 5 Technology Transfer

Activities Are you or a member of your immediate

family the inventor of any technology for which an invention disclosure has been filed or which is being developed or evaluated in connection with your research activities?

Faculty/Researcher formPart I Question 6 Other Transactions or

Facts During the past calendar year, did you or

any member of your immediate family have an interest in any contract, sale, or other transaction to which the University of Pittsburgh or one of its affiliates was a party, or are there other situations, not listed above, that you believe may create an actual or perceived conflict of interest?

Faculty/Researcher form Part II

Part II Details must be provided to explain

any positive responses provided in Part I by describing the nature of the outside interest.

Faculty/Researcher form Part II Question 7 Federally supported

research If you answered Yes to Question 1 or,

under certain circumstances, to Question 3 , answer the following:

Do you have, or have you had within the past twelve months, federally supported research that might reasonably appear to affect a company in which you have an interest?

Faculty/Researcher form Part II Question 8 Industry supported

research If you answered Yes to Questions 1, 2, or

3, answer the following question. Do you have, or have you had within the

past twelve months, industry supported research that might reasonably appear to affect a company in which you have an interest?

Designated Administrator/Staff form Part I (cont’d) Question 1 Offices and Positions

Are you, your spouse, your registered domestic partner or a dependent child an officer, director, trustee, partner (general or limited), employee or regularly retained agent of any organization with which (a) the University has had business dealings during the past year, or (b) there is a reasonable possibility the University may in the next year have business dealings?

Designated Administrator/Staff form Part I (cont’d) Question 2 Ownership Interests

Do you, your spouse, your registered domestic partner or a dependent child, individually or in the aggregate, have the actual or beneficial ownership of stock, equity, debt or any other financial interest (other than a Permitted Interest as defined in the policy) in any organization with which (a) the University has had business dealings during the past year, or (b) there is a reasonable possibility the University may in the next year have business dealings?

Designated Administrator/Staff form Part I (cont’d) Question 3 Remunerative Activities

Does remuneration for services (other than salary as an employee) received during the past year or expected over the coming year aggregated for you, your spouse, and dependent children exceed $500 from any one organization with which (a) the University has had business dealings during the past year, or (b) there is a reasonable possibility that the University may in the next year have business dealings?

Designated Administrator/Staff form Part I (cont’d) Question 4 Other Transactions

Do you have any other interest, relationship or transaction that has in the past year created, or reasonably could in the next year create, a real, apparent or potential conflict of interest contrary to the spirit or general principles set forth in the University’s Conflict of Interest Policy for Designated University of Pittsburgh Administrators and Staff (e.g., a proposed University transaction with a nephew, even though a nephew is not included in the definition of “Related Person”)?

Designated Administrator/Staff form Part I (cont’d) Part II

Details must be provided to explain any positive responses provided in Part I by describing the nature of the outside interest.

COI Oversight by SupervisorsFaculty/Researcher—Department Level

Department Level Review of Faculty/Researcher

disclosures Ensure that all required employees have

submitted and signed the Signature Page (SP) by April 15

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

Prepare a Management Reporting Form (MRF) or electronic MRF (eMRF) for those individuals who disclosed outside interests

Prepare departmental Annual Data Summary report on disclosures submitted

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’s level Review forms received from chairs

Approve or modify any MRFs, as necessary Prepare School’s Annual Data Summary

report Submit Signature Pages, Management

Reporting Forms, 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—Dept. Level

Review of Designated Administrators/Staff disclosures Ensure that all required employees have

submitted and signed a 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)

Prepare a brief annual summary of disclosures made, and submit it to the next higher reporting authority within the responsibility center

COI Oversight by Supervisors Designated Administrators/Staff—Dept. Level

Report unresolved conflicts to the provost, senior vice chancellor for health sciences, or executive vice chancellor by May 15;

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

COI Management Strategies

Required prospective approval from dean or department chair for Consultancies, participation in speakers bureaus, 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

COI Management Strategies 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

COI Management involving Start-up Companies The Entrepreneurial Oversight Committee

is responsible for managing potential conflicts involving start-up companies (i.e., they are 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

Transactional Reporting 4 COI questions appear on protocol

applications 4 COI questions 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 (i.e.,

whenever new outside interests are accrued, a revised disclosure must be made)

4 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? [ ] Yes [ ] No

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?

[ ] Yes [ ] No …….

4 COI Questions on Protocols (cont’d)

c. have an agreement with the University or an external entity that would entitle sharing current or future commercial proceeds related to the technology being evaluated (e.g., royalties through a license agreement)?

[ ] Yes [ ] Nod. have a financial relationship with a start-up

company (which is being monitored by the Entrepreneurial Oversight Committee) that has an option or license to utilize the technology being evaluated?

[ ] Yes [ ] No

COI Management Involving Specifically Regulated Research The COIC is responsible for managing potential

conflicts involving the following: Human subject research overseen by the IRB

Invocation of the COI Committee’s Standard COI Management Plan, as appropriate

http://www.coi.pitt.edu/forms/StandardCOIMgmtPlan-HSR.doc

Animal research overseen by the IACUC Research on the clinically brain-dead (CORID) Recombinant DNA research Embryonic stem cell research

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, links to relevant policies, and annual COI memo from the provost and the executive vice chancellor (aka: Directive to Disclose)

Resources: Learning about COI

COI management presentations tailored to specific departments, upon request

ISER Conflict of Interest Module…

ISER Conflict of Interest Module: Who must complete it? Those who completed Part II of the

University’s Faculty/Researcher form and/or those involved in industry-sponsored research are required to complete the ISER COI module (Internet-based Studies in Education and Research, formerly known as RPF modules)

Completing the ISER 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 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