Transcript Initial Applicability - UAH

Policy on Promoting
Objectivity in Research - Introduction
September 14, 2012
Michael Bryan, JD, CCEP – Compliance Officer
Initial Applicability
Initially, the Interim Policy on Promoting Objectivity in
Research is applicable only to sponsored research
projects funded by Public Health Service (PHS)
agencies, e.g. NIH, or the National Science Foundation
(NSF), and Human Subjects research.
However, definitions appearing in the Policy are referenced in the Conflict of
Interest Certifications submitted to OSP at the time of proposal submissions
for all externally funded research.
It is the intention in the very near future to transition the Policy to all
externally funded research projects.
9/14/2012
Michael B. Bryan, Compliance Officer
Learning Objectives
•
•
•
•
•
•
Understanding financial conflicts of interest
Definition of an Investigator
Responsibilities of an Investigator
Definition of a financial interest that must be disclosed
How to disclose financial interests
Determining if a financial conflict of interest (FCOI)
exists
• Managing a FCOI
• Consequences of noncompliance
• Things to Remember
9/14/2012
Michael B. Bryan, Compliance Officer
Conflict of Interest Regulations Revised
Full Implementation Deadline: Aug 24, 2012
• Investigators must disclose all Financial Interests (FIs) that
are related to their Institutional Responsibilities
• Threshold for Significant Financial Interests reduced from
10K to 5K, and $0 for certain interests
• Shift from investigator to institution to determine if SFI is
‘related’ to proposed research
• Conflict of interest training now required
• Additional information must be reported if PHS is funding
agency
• Requirement for retrospective reviews in PHS funded
research
• Public accessibility to certain information related to SFIs
(that are ultimately deemed to be Financial COIs)
9/14/2012
Michael B. Bryan, Compliance Officer
Who Must Disclose?
• All Investigators conducting research funded by the PHS or
NSF are required to disclose their financial interests and
those of family members to the University on an annual
and on an event basis.
• “Investigator” means the principal investigator, any coprincipal investigators and any senior/key personnel. For
PHS-funded research only, the term also includes University
faculty and staff who have independent responsibility for
designing, conducting, or reporting research, regardless of
title or position and may include, for example, postdoctorals paid on research grants, collaborators or
consultants.
9/14/2012
Michael B. Bryan, Compliance Officer
Design, Conduct, or Reporting of Research
• Oversight, decision-making, or participation in
research that includes creating the structure,
roles, and/or protocol of a research project;
• Participating in the execution of the research
roles and protocol;
• Participating in the publishing, presentation,
or discussion of the research results.
9/14/2012
Michael B. Bryan, Compliance Officer
Who Must Disclose?
• “Family Members” is defined to include spouse or
any dependent.
• “Dependent” is any person, regardless of his or
her legal residence or domicile, who receives 50
percent or more of his or her support from the
Investigator, or the Investigator’s spouse, or
anyone who resided with the Investigator for
more than 180 days during the reporting period.
9/14/2012
Michael B. Bryan, Compliance Officer
What Must Be Disclosed?
• Investigators must disclose all Financial Interests that
are related to their Institutional Responsibilities.
• “Financial Interest” is defined as anything of monetary
value, whether or not the value is readily ascertainable,
or serving in an executive position with an entity, i)
that reasonably appears to be related to the
Investigator’s institutional responsibilities or, (ii) in
entities whose financial interests would reasonably
appear to be affected by, or could affect, such
institutional responsibilities
9/14/2012
Michael B. Bryan, Compliance Officer
“Monetary Value”
“Monetary Value” is anything of value, whether or not
the value is readily ascertainable, including, but not
limited to: remuneration or salary (including payment
for services not otherwise identified as salary, e.g.,
consulting fees, honoraria, paid authorship, board
membership fees), commissions, equity interests
(includes any stock, stock option, or other ownership
interest), interests in real or personal property,
dividends, royalties, rent, capital gains, intellectual
property rights and interests (e.g., patents, copyrights,
trademarks and related income), any reimbursed or
sponsored travel and forgiveness of debt.
9/14/2012
Michael B. Bryan, Compliance Officer
Exclusions from Financial Interests:
• compensation from the University or income from the University
related to intellectual property rights and interests;
• income from seminars, lectures, or other educational activities or
reimbursed travel sponsored by a federal, state, or local government
agency, an Institution of higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital, a medical center, or a research
institute that is affiliated with an Institution of higher education;
• income from service on advisory committees, or review panels for a
federal, state, or local government agency, an Institution of higher
education as defined at 20 U.S.C. 1001(a), an academic teaching
hospital, a medical center, or a research institute that is affiliated with
an Institution of higher education; or
• an interest arising solely by means of investment in a mutual, pension,
or other institutional investment fund where the Investigator does not
exercise control over the management and investments of such fund.
9/14/2012
Michael B. Bryan, Compliance Officer
To Be Clear…
• You are NOT being asked to divulge all your
financial holdings, or those of your family
members.
• You ARE being asked to reveal on COI
disclosure forms any financial interests that
intersect in some way with UAHuntsville or
your UAHuntsville activities.
9/14/2012
Michael B. Bryan, Compliance Officer
Example Definitions
• “Institutional Responsibilities” are defined as
the professional responsibilities (e.g.,
academic or research area of interest or
expertise) of an Investigator on behalf of the
University to perform duties and/or activities
that are undertaken to fulfill one’s research,
teaching, or service responsibilities within the
University.
9/14/2012
Michael B. Bryan, Compliance Officer
Example Definitions
• What is meant by “Related to your
Institutional Responsibilities”?
• An interest or relationship that relies upon the
same expertise as does your ability to carry
out your University responsibilities; as well as
any interest or relationship that has the
potential to influence the duties that the
University considers to be a part of your work.
9/14/2012
Michael B. Bryan, Compliance Officer
When Must Disclosures be Made?
• Annual Disclosures. Investigators must disclose their
financial interests to the University by March 1 for the
previous calendar year. (Transitioning Disclosures now.)
• Event-based Disclosures.
1. Material Change in Circumstances: W/I 30 days of any
changes to responses.
2. Proposal-Specific: Prior to commencing a research or
sponsored program.
3. Protocol-Specific: At the time of submission of an IRB
reviewed protocol.
4. Initiating License Activity: At the time OTC begins to
negotiate a license for technologies for which the
Investigator is names as inventor.
9/14/2012
Michael B. Bryan, Compliance Officer
When Must Disclosures be Made?
5. During a research project, (i) when an existing
Investigator discloses a new FI, or (ii) a FI is
identified that was not disclosed, or (iii) for
whatever reason a FI was not previously
reviewed, the designated officials shall within 60
days review the FI.
• If a COI is determined to exist, a Mgt Plan shall be
implemented at least on an interim basis.
• Additional interim measures may be necessary
such as suspending the Investigator’s
participation until the completion of the review.
9/14/2012
Michael B. Bryan, Compliance Officer
How are Disclosures Processed?
• Review to determine whether any disclosed
Financial Interests are Significant Financial
Interests (SFIs).
• SFIs threshold reduced from $10k to $5k, and
$0 for certain interests.
9/14/2012
Michael B. Bryan, Compliance Officer
Review
9/14/2012
Michael B. Bryan, Compliance Officer
Significant Financial Interests
•
•
•
•
Means one or more of the following financial interests of the Investigator (alone or
in combination with the Investigator’s family members):
With regard to any publicly traded entity, it is the value of any remuneration
received from the entity in the twelve months preceding the disclosure and the
value of any equity interest in the entity as of the date of disclosure, when
aggregated, the value of which exceeds $5,000 from one enterprise or entity, or
serving in an executive position with such entity; or
With regard to any non-publicly traded entity, it is the value of remuneration
received from the entity in the twelve months preceding the disclosure, when
aggregated, exceeds $5,000, or when the Investigator holds any equity interest or
serves in an executive position with such entity;
Intellectual property rights and interests, upon receipt of income related to such
rights and interests that exceeds $5,000 in the twelve months preceding the
disclosure paid by an entity other than the University or a University affiliated
entity; or
Any reimbursed or sponsored travel, related to an Investigator’s institutional
responsibilities. (See Policy for exceptions)
9/14/2012
Michael B. Bryan, Compliance Officer
How are Disclosures Processed?
Shift from Investigator to University to determine if SFI
is ‘related’ to proposed research.
• “An investigator’s SFI is related to research when the
Institution, through its designated official(s),
reasonably determines that the SFI: could be affected
by the research; or is in an entity whose financial
interest could be affected by the research.”
• “Reasonably” means that the determination is a
“reasoned decision” made as the result of a regular
process and not done in a capricious or arbitrary
manner.
9/14/2012
Michael B. Bryan, Compliance Officer
Involving Investigators re: ‘Relatedness’
• Per the regulations, “…the institution may
involve the investigator in the designated
official(s)’s determination of whether a SFI is
related to the funded research.”
• Is the investigator’s input sufficient?
Necessary, but not sufficient in and of itself.
• Post‐disclosure follow‐up consultation, and
additional information in writing.
9/14/2012
Michael B. Bryan, Compliance Officer
Assessing Relatedness
•
Entity in which the investigator has an SFI is a sub‐recipient under the proposed
research
•
The investigator will be involved in research under a sub-award from an entity in
which he/she has a SFI
•
The investigator has a SFI in an entity that is part of a consortium or will otherwise
participate in the research
•
The investigator is a founder, holds a management or executive position, serves on
a Board, is a consultant (with or without compensation) and/or has received travel
income/reimbursement from an entity whose products or services will be used in,
are the subject of and/or are closely aligned with the research
•
IP developed by the investigator is being used, tested or further developed in the
research
9/14/2012
Michael B. Bryan, Compliance Officer
Conflict of Interest Determination
A Conflict of Interest exists when the
institutional designated officials determine:
• that a significant financial interest is related to
research or sponsored programs activities,
and
• could directly and significantly affect the
design, conduct, or reporting of research or a
sponsored program activity.
9/14/2012
Michael B. Bryan, Compliance Officer
Conflict of Interest = Management Plan
• If a conflict of interest is determined to exist, the
VPR, through the Department Chair, College Dean
and/or Research Center Director and Chief
Compliance Officer, is required to reduce,
eliminate or manage the conflict through the
development and implementation of a written
management plan.
• Investigator must develop and initially propose a
plan for approval.
9/14/2012
Michael B. Bryan, Compliance Officer
Management Plan Conditions
•
•
•
•
public disclosure of the conflict,
modification of the research design,
monitoring of the research by independent reviewers,
disqualifying participation in all or a portion of the
research,
• divesting significant financial interests, or
• severing relationships that create actual or potential
conflicts of interest.
Plans shall prescribe monitoring and shall continue until
conclusion of the research project.
9/14/2012
Michael B. Bryan, Compliance Officer
Conflict of Interest in Research Committee
• Advisory Only
• Appointed by the Vice President of Research
• At least five members selected from full time, tenured
faculty and senior research staff members who are
experienced with the administration of Federal
contracts/grants and sponsored programs
• Others as deemed appropriate by the Vice President for
Research
• Associate Vice President, ex officio and Chair
• Office of Counsel representative and Chief Compliance
Officer, ex officio members
• Other ex officio members as determined by VPR
9/14/2012
Michael B. Bryan, Compliance Officer
Investigator Non-Compliance
• Sanctions. Enforcement of this policy resides with the
VPR. VPR may report instances of non-compliance to
the Investigator’s applicable supervisor who may
initiate disciplinary action in accordance with
University policies and procedures.
• Additionally. VPR may: deny submission of research
proposals; not allow expenditures of research funds;
not execute award documents; terminate sponsored
agreements; or, retrospective review and submission of
a mitigation report to the sponsor of research.
9/14/2012
Michael B. Bryan, Compliance Officer
Training
Each Investigator is required to complete conflict
of interest training prior to engaging in research
at the University, and at least every four years,
and immediately when any of the following
circumstances apply:
1. An Investigator is not in compliance with the
University’s Policy on Promoting Objectivity in
Research or a management plan.
2. The University revises its financial conflict of
interest policies or procedures in any manner
that affects the requirements of Investigators.
9/14/2012
Michael B. Bryan, Compliance Officer
Things to Remember
• You – and UAHuntsville – are responsible for
promoting and maintaining objectivity in
research.
• You are responsible for:
– being familiar with disclosure processes,
– making sure you have disclosed the required financial
information on time, and
– adhering to the conditions of the management plan if
one is required.
9/14/2012
Michael B. Bryan, Compliance Officer
Policy on Promoting Objectivity in Research
QUESTIONS?
9/14/2012
Michael B. Bryan, Compliance Officer
Policy on Promoting
Objectivity in Research - Introduction
September 14, 2012
Michael Bryan, JD, CCEP – Compliance Officer