New PHS Conflict of Interest

Regulations

David T. Wehrle, CPA, CIA, CFE/DirectorKhrys X. Myrddin, MPPM/Associate Director

Benjamin T. West, BA/Compliance Coordinator Conflict of Interest Office

October 23, 2012

Effective August 24, 2012 University Policy 11-01-03 Conflict of

Interest for Faculty, Researchers, Scholars, Research Staff/Coordinators reflects revised PHS regulations

Revised Public Health Service (PHS) Regulations

Administration for Children and Families (ACF)◦ Administration on Children, Youth and Families (ACYF)

Administration for Community Living (ACL) Agency for Healthcare Research and Quality (AHRQ) Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Indian Health Service (IHS) National Institutes of Health (NIH)

◦ National Cancer Institute Substance Abuse and Mental Health Services

Administration (SAMHSA)

Agencies of the Public Health Service (PHS)

The PI, project director, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, including collaborators and consultants. ◦ Definition is based on individual’s role in the

research. Can include undergraduate and graduate students and staff.

Definitions – Investigator

an Investigator’s professional responsibilities on behalf of the University of Pittsburgh, including activities such as research, teaching, professional practice, institutional committee memberships, service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards, and other administrative activities.

Definitions – Institutional Responsibilities

Significant Financial Interest (SFI): a financial interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities

Definitions – SFI (PHS)

Aggregated remuneration from and equity in any publicly traded entity exceeding $5,000 in value;

Remuneration from a non-publicly traded entity in the 12 months preceding the disclosure exceeding $5,000, or any equity interest in such an entity;

Being the inventor of a technology that has been patented, copyrighted or optioned/licensed to an external entity, and on which research is continuing;

Any reimbursed or sponsored travel related to Institutional Responsibilities, except travel that is reimbursed or sponsored by Exempt Institutions.

Definitions – SFI (PHS) cont’d

The term SFI does not include 1. salary or supplementary payments from the University

of Pittsburgh, University of Pittsburgh Medical Center (UPMC), University of Pittsburgh Physicians (UPP), or Veterans Administration Pittsburgh Healthcare System;

2. income from seminars, lectures, or non-promotional engagements sponsored by Exempt Institutions;

3. income from service on advisory committees or review panels for Exempt Institutions;

4. royalties, milestone payments, or licensing fees paid through the University of Pittsburgh;

5. income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.

Definitions – SFI exclusions

A federal, state, or local government agency;

A domestic Institution of Higher Education; An academic teaching hospital A medical center; or A research institute that is affiliated with an

Institution of higher education

Definitions – Exempt Institutions

A Significant Financial Interest determined to be related to a PHS-funded research project and that could directly and significantly affect the design, conduct, or reporting of the research.

Definitions – Financial Conflict of Interest (FCOI)

COI training (http://www.coi.pitt.edu/COItraining.htm)

◦ Investigators currently engaged, or who anticipate engaging, in PHS-supported research must complete the CITI (Collaborative Institutional Training Institute) PHS COI Training Module;

◦ The University will not submit a proposal to any PHS agency until the PI/PD and all Senior/Key Personnel complete the CITI PHS COI Training Module;

◦ PHS-funded researchers are required to complete the CITI COI Training Module every three years thereafter.

Investigator responsibilities-- Training (PHS-funded)

Investigators who do not work on any PHS-funded projects must complete the Internet-based Studies in Education and Research (ISER) Conflict of Interest Module if they:◦ submit a proposal through the Office of Research

for funding from a non-PHS source; or◦ disclosed outside financial interests on the

University’s Faculty/Researcher form; or ◦ have been directed by their supervisors to

complete COI training.

Investigator responsibilities-- Training (non-PHS funded)

Non-PHS funded Investigators may take the CITI module to meet their training requirement.

Investigator responsibilities--Training (non-PHS funded) cont’d

Individuals conducting research who do not receive any external funding and

Individuals who do not conduct any research

Do not need to complete either training module.

Investigator responsibilities-- Training cont’d

Investigators engaged in research funded by a PHS agency, or who plan to apply for funding from PHS, must complete the new PHS Faculty/Researcher form that reflects: new disclosure thresholds; disclosure of income from non-exempt not-for-profit organizations; and sponsored/reimbursed travel◦ New SFIs must be disclosed within 30 days

Investigator responsibilities-- Disclosure

Who must complete this form?◦ ALL PHS-funded Investigators (employees,

regardless of title, who participate in the design, conduct, and reporting of PHS-funded research)

◦ Students and trainees must complete this form and the PHS COI Training modules if their involvement with a research project is substantial enough that they fall under the PHS definition of an “Investigator.”

PHS Faculty/Researcher form

Value of equity and remuneration from publicly-traded companies combined (Q1)

Remuneration from nonprofit entities included (Q2)

Disclosure of reimbursed or sponsored travel (Q4)

PHS Faculty/Researcher form--Significant changes

Answer question 8 ONLY if the answer to questions 1, 2a, 2b, 4, or 6 is “yes”;

Include ALL grants that are funding ANY research project on which you serve as an investigator, regardless of whether or not you are listed on the grant;

Include ONLY protocols on which you are an Investigator;

Indicate if you believe you have an FCOI with the research; if not, explain why not.

PHS Faculty/Researcher form –- PHS Funded Research

Review SFIs and indicate if any give rise to a conflict of interest with an individual’s University responsibilities.

Document all COI management actions taken by department, dean, COI Office, and/or COI Committee, as applicable.

Consider whether individual’s outside professional activities give rise to a conflict of commitment.

Supervisor Responsibilities-- PHS Management Reporting Form (MRF)

Previously: Investigators disclosed outside interests they determined to be related to research.

Now: Investigators disclose SFIs related to their institutional responsibilities, and the Institution (supervisors and/or the Conflict of Interest Committee) determines and documents whether they give rise to FCOIs with PHS-funded research requiring management--using the PHS Management Reporting Form (PHS MRF)

Supervisor Responsibilities–- PHS MRF cont’d

The supervisor reviews disclosed SFIs and must determine whether any SFI is related to PHS-funded research in which the Investigator is engaged.

Supervisor Responsibilities-- PHS MRF cont’d

Is the research project evaluating or developing any product or intellectual property (IP) owned by an entity in which the Investigator has an SFI?

Is the research project evaluating or developing any patented, copyrighted, or optioned/licensed IP invented by the Investigator?

Is an entity in which the Investigator has an SFI providing a drug, device, or additional funding to the project?

Is the research comparing treatment options that would affect the value of an Investigator’s SFI?

Supervisor Responsibilities--PHS MRF — Relatedness

Chair must review reimbursed or sponsored travel disclosed under Q4◦ If any seems inappropriate, s/he may request

more information;◦ If s/he has no concerns, answer “no” to Q4 on PHS

MRF Supervisor does not need to answer Q8 vis-à-vis

travel disclosure unless s/he believes the trip gives rise to an FCOI with a PHS-funded project.

Supervisor Responsibilities --PHS MRF — Travel

Supervisor must determine whether any related SFI constitutes an FCOI requiring management.◦ For FCOIs arising from SFIs

valued between $5,001 and $10,000 in public entities (Q1); and

remuneration between $5,001and $10,000 from privately-held entities (Q2a)

the supervisor develops a management plan. The review must be documented under Q8

of PHS MRF.

Supervisor Responsibilities — PHS MRF cont’d

After supervisor completes the PHS MRF, s/he should send a copy of only the PHS MRF to the COI Office◦ Send Signature Pages with outside interests

disclosed and the accompanying original PHS MRF to next higher level of authority.

Supervisor Responsibilities-- PHS MRF cont’d

For SFIs valued over $10,000 in public entities (Q1), and arising from remuneration over $10,000 from privately-held entities (Q2a), equity in non-public entities (Q2b), and IP (Q6)◦ the supervisor should indicate whether the SFI is

related to a PHS grant, but the COI Committee (COIC) will determine whether the SFI gives rise to an FCOI and indicate how it is to be managed.

COI Committee Responsibilities

Submissions: the Office of Research will check that PI/PD and all Senior/Key personnel have PHS Faculty/Researcher forms on file & have completed the CITI PHS COI Training module.

Awards: the Office of Research will refer to the COI Office awards on which Investigators have reported outside financial interests on PHS Faculty/Researcher forms.

Important changes in review of PHS-funded research

The COI Office will check whether we have a PHS MRF from the supervisor that includes the relevant review◦ If it does not, the COI Office write to Investigator

and request review from chair or chief; If disclosed SFIs require COIC review, the

COI Office will forward materials to the COIC Chair for final FCOI determination.

COI Office Review of PHS grants

Determine whether the subrecipient Institutions have PHS-compliant policies;

If not, those Institutions must agree to follow Pitt policy, and Investigators at the sub- Institutions must complete: ◦ CITI PHS Training◦ the Pitt “Subrecipient Disclosure of

Significant Financial Interests” paper form

Important changes –- Subrecipient Monitoring

If a contract provides for more than $5,000 in a 12 month period and the individual is engaged in PHS-funded research, the supervisor will be queried for FCOI review;

If a contract provides for more than $10,000, COIC FCOI review is required.

Additional implications –- Consulting Contract Review

COI Web site: http://www.coi.pitt.edu/◦ See section for PHS-Funded Researchers & Supervisors

Jerome L. Rosenberg: jrosenb@pitt.edu; 412-624-3007 David T. Wehrle: wehrledt@upmc.edu; 412-383-1774 Khrys X. Myrddin: myrddink@upmc.edu; 412-383-2828 Benjamin T. West: westbt@upmc.edu; 412-383-1735

For access to the COI database, contact Hannelore Rogers (Office Coordinator): rogershn@upmc.edu; 412-383-1968

To view completed ISER/CITI Training modules, contact Erin List (Center for Continuing Education/Health Sciences); listel@upmc.edu; 412- 647-8218)

For more information/assistance