Transcript New PHS COI Regulations & changes to University Policy 11

NEW PHS COI
REGULATIONS
CRITICAL CARE MEDICINE
DECEMBER 4, 2012
University of Pittsburgh Conflict of Interest Office
David T. Wehrle, CPA, CFE, CIA
Director
Khrys X. Myrddin, MPPM
Associate Director
Benjamin T. West
Compliance Coordinator
New PHS COI Regulations
• Effective August 24, 2012
• University policy 11-01-03 Conflict of Interest Policy for
Faculty, Researchers, Scholars, Research
Staff/Coordinators revised to reflect the changed
regulations
• Summary of changes available on COI website:
http://www.coi.pitt.edu/Policies/index.htm
Agencies of the Public Health Service
(PHS)
• 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)
Definitions – Investigator
• 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 – Institutional Responsibilities
• 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 – SFI (PHS)
• Significant Financial Interest (SFI): a financial interest
that reasonably appears to be related to the Investigator’s
Institutional Responsibilities
Definitions – SFI (PHS) cont’d
• 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 exclusions
• The term SFI does not include
•
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;
•
income from seminars, lectures, or non-promotional
engagements sponsored by Exempt Institutions;
•
income from service on advisory committees or review panels
for Exempt Institutions;
•
royalties, milestone payments, or licensing fees paid through
the University of Pittsburgh;
•
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 – Exempt Institutions
• 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 – Financial Conflict of Interest
(FCOI)
• 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.
Investigator responsibilities – Training
(PHS-funded)
• 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) 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
(non-PHS funded)
• Investigators who do not work on any PHS-funded
projects should complete the Internet-based Studies in
Education and Research (ISER) Conflict of Interest
Module if they:
• Plan to submit a proposal through the Office of Research for
funding from a non-PHS funding source; or
• Disclosed outside financial interests on the University’s
Faculty/Researcher form; or
• Have been directed by their supervisors to complete COI training.
• Completion of the CITI Training module will also fulfill the
COI training requirement for non-PHS investigators.
Investigator responsibilities – Training
(others)
• Individuals conducting research without any external
funding, and
• Individuals who do not conduct any research
do not need to complete either training module.
Investigator responsibilities – Disclosure
• 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.
• Applies to all Investigators engaged in the funded research; not
limited to only PI/PD and Senior/Key personnel on the grant.
• New SFIs must be disclosed within 30 days.
PHS Faculty/Researcher form
• Who must complete this form?
• ALL 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 CITI COI
Training module if their involvement with a research project is
substantial enough that they fall under the PHS definition of an
“Investigator.”
• If you complete the PHS form, you do NOT have to additionally
complete a “regular” Faculty/Researcher form.
PHS Faculty/Researcher form –Significant changes
• 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 –Question 8 PHS Funded Research
• Answer this question 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.
• Is the research evaluating or developing any IP of which you are an
inventor or that is owned by an entity in which you disclose an SFI?
• Is any entity in which you disclose an SFI providing funding or
materials (e.g., drugs, devices) for the study?
Supervisor responsibilities
• Review PHS-specific Faculty/Researcher COI form;
• Complete a PHS-specific Management Reporting Form
(MRF):
• determine whether an SFI in the $5,001-$10,000 range
gives rise to an FCOI (i.e., the SFI is related to the PHSfunded research and could directly and significantly affect
the design, conduct, or reporting of such research);
• if it does not, explain why; or
• state that there is an FCOI, indicate how it will be managed,
and send a copy of the COI form and the MRF to the COI
Office .
Supervisor responsibilities cont’d
• If an FCOI has been identified, the conflict management plan
(CMP) must include at least the following elements:
• Investigator must disclose SFI in relevant abstracts, presentations, press
releases, publications, and in proposals/applications for research funding;
• Other students, staff, faculty engaged in the research must be notified of
the Investigator’s SFI through the use of a standard notification form;
• Students must have approval of their department chairs or deans to be
engaged in the research project.
• Other optional management techniques: data steward or
oversight committee; prohibiting individual from serving as
PI, or other limits on his/her role in the research project.
COI Committee (COIC) responsibilities
• The COIC, in consultation with department chairs and
investigators, will review SFIs greater than $10,000,
ownership interests in nonpublic companies, and
technology transfer activities to determine whether they
constitute FCOIs with PHS-funded research.
• If they do, the COIC will manage the FCOIs.
Investigator responsibilities – Disclosure
• NEW – COI Declaration Form for research protocol
applications
• IRB (OSIRIS), IACUC (ARO), IBC/rDNA, hSCRO, CORID
• Two versions: one for protocols funded by PHS agencies and
another for all others.
• PI is responsible for ensuring that the relevant SFIs of ALL
Investigators on the study are reported on the form.
• ALL Investigators on studies supported by PHS agencies
must complete CITI COI training module and have a
current PHS Faculty/Researcher COI form on file.
Important changes in Office of Research
review of PHS-funded research
• Submissions: the Office of Research will verify 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
those awards on which Investigators have reported
outside financial interests on their PHS
Faculty/Researcher forms.
COI Office Review of PHS grants
• The COI Office will determine whether it has a PHS MRF
from the supervisor that includes the relevant award
• If it does not, the COI Office will write to Investigator and request
review from department chair or division chief;
• If disclosed SFIs require COIC review, the COI Office will
forward materials to the COIC Chair for final FCOI
determination.
Important changes –Subrecipient Monitoring
• Office of Research will determine whether the
subrecipient Institutions have PHS-compliant policies;
• If not, those Institutions will rely on Pitt’s policy, and
Investigators at the subrecipient Institutions must
complete:
• CITI COI Training module
• Pitt’s “Subrecipient Disclosure of Significant Financial
Interests” paper form
Additional implications –Consulting Contract Review
• If a contract provides for more than $5,000 annually or
stock/stock options in a nonpublic company and the
individual is engaged in PHS-funded research, the
supervisor will be asked to conduct an FCOI review;
• If a contract provides for more than $10,000 annually or
stock/stock options in a nonpublic company, an FCOI
review by the COI Committee is required.
Public disclosure of FCOIs
• To comply with PHS regulations, the following information
concerning FCOIs held by an Investigator on a PHSfunded project will be posted on the COI website:
• Name, title, and role of investigator on the research project
• Name of entity in which interest is held
• Nature of the SFI
• Approximate dollar value of SFI within a defined set of ranges,
where possible
• Applies to grants with a Notice of Award after August 24,
2012.
PHS FCOI Retrospective Reviews
• If identification or management of an FCOI was delayed,
or the Investigator failed to comply with a plan to manage
his or her FCOI, the COIC must complete a retrospective
review to determine whether any PHS-funded research
was biased in the design, conduct, or reporting of such
research performed during the period of non-compliance.
For more information/assistance
• COI Web site: http://www.coi.pitt.edu/
• See section for PHS-Funded Researchers & Supervisors
• Jerome L. Rosenberg, PhD (Chair, COIC): [email protected];
412-624-3007
• David T. Wehrle: [email protected]; 412-383-1774
• Khrys X. Myrddin: [email protected]; 412-383-2828
• Benjamin T. West: [email protected]; 412-383-1735
• For access to the COI database, contact Hannelore Rogers
(Office Coordinator): [email protected]; 412-383-1968
• To view completed ISER/CITI Training modules, contact Erin
List (Center for Continuing Education/Health Sciences);
[email protected]; 412- 647-8218)