SUBJECT: Conflict of
Interest
PURPOSE: To establish the guideline for
managing conflict of interest involving the IRB members.
POLICY: To manage, reduce, or eliminate
potential or real conflicts of interest (e.g. financial, relational,
or institutional) in approved research.
To ensure that no IRB member participates in the initial or
continuing review of any protocol in which the member has a conflicting
interest, except to provide information requested by the IRB. The IRB members, including the
Chairperson, who have conflicting interests are
required to disclose such interests and to recuse themselves from deliberations,
quorum counts, and votes on the relevant protocol. This policy also covers the
investigators and their staff to ensure that they report any conflict of
interest and ensure that
financial or other incentives do not negatively impact the collection,
analysis and interpretation of data, scientific objectivity and integrity, and
ultimately the public trust in the research.
SCOPE:
This policy covers all IRB members, including the Chairperson and
alternate members, the Institutional Official, Director of the Office of
Research Compliance (ORI) investigators, research staff, and research sponsors.
DEFINITION: Conflict of Interest is defined as any situation in which financial or personal obligations may compromise or present the appearance of compromising an individual’s or group’s professional judgment in conducting, reviewing, or reporting research. Conflict of interest is defined as any situation in which financial or personal obligations may compromise or present the appearance of compromising an individual’s or group’s professional judgment in conducting, reviewing, or reporting research. Conflict of interest may arise because the intellectual property involved in many research discoveries, industry academic partnerships and pharmaceutical or biotech companies may offer researchers or staff incentives for conducting trials or enrolling subjects.
RESPONSIBILITY:
The IRB Chairman and
members have the responsibility to report any situation in which
financial or personal obligations may compromise or present the appearance of
compromising his/her professional judgment in conducting, reviewing, or
reporting research.
Even though the
Principle Investigator
(PI) is responsible for ensuring
that financial or other incentives do not negatively impact the
collection, analysis and interpretation of data, scientific objectivity and
integrity, and ultimately the public trust in the research all such potential
conflicts of interest must be reported to the IRB. In addition, if the investigator is also
the treating physician, he/she must not unwittingly exert coercion or undue
influence on subjects to participate in research.
PROCEDURE:
To avoid possible conflict of interest among institutional
officials, the Vice President for Research and the Director of the Office of
Research Integrity, do not serve on the IRB as voting members because those who
administer the research programs have access to wider knowledge, have the
ability to influence programmatic and budgetary decisions, and are in a position
to possibly exert undue influence on the IRB.
The IRB members,
including the Chairperson, who have conflicting interests are required to disclose such interests and to
recuse themselves from deliberations, quorum counts, and votes on the relevant
protocol. Such absences are
recorded in the meeting’s minutes as recused and not as
abstentions. The IRB is careful to
keep a quorum if votes are taken during absences.
IRB chairperson and members may find themselves in any of
the following conflicts of interest when reviewing research:
(1) Where
the IRB Chairperson or member is listed as an investigator on the
research.
(2) Where
any investigator must report to or is under the supervision of an IRB
chairperson or member.
(3) Where
the IRB Chairperson or member competes for research grants or contracts in the
same or similar field as an investigator whose research is scheduled for
review.
The IRB chairperson and members are
prohibited from participating in the IRB’s initial or continuing review of
research when he/she has a conflicting interest.
(1) Such
conflicts must be disclosed, and the IRB member, chairperson, or staff
member must not take part in the discussion or voting of such research,
except to answer questions from the IRB.
(2) The IRB
may consider any matter that raises the possibility of coercion or undue
influence in the consent process.
The existence of an investigator conflict of interest would fall within
this category.
(3) The IRB
requires disclosure of any potential conflicts of interest to the
Chairperson or the Director, ORI prior to voting on the research
activity.
FDA requires a
sponsor in a marketing application of any drug, device, or biologic to submit
certain information on financial interests and arrangements of clinical
investigators conducting studies to FDA. The following financial arrangements
must be disclosed:
(1) Any
relationship between the study outcome and the value of the compensation made to
the investigator.
(2) The
investigator’s proprietary interest in the studied product, including but not
limited to a patent, trademark, copyright or licensing agreement.
(3) Any
equity interest in the study sponsor, ownership interest, stock options, or
other financial interest.
(4) Any
equity interest in a publicly held company that exceeds $50,000 in
value.
(5)
Significant payment of another type, which has a
cumulative monetary value of $25,000 or more, made by the sponsors to the
investigator(s).
The Director, ORI is responsible for reviewing all
financial disclosures, and determining if a conflict of interest exists. If one exists, the Director must
determine what actions should be taken to manage, reduce, or eliminate the
conflicting interest. At this
institution, the Director, ORI is designated as the institutional conflict of
interest official.
Under FDA regulations, an “Investigator” means the principal
investigator and any other person who is responsible for the design, conduct, or
reporting of the research. For
purposes of determining financial interests, the Investigator's interests
include those of his/her spouse and dependent children.
“Significant financial interest” means anything of monetary
value, including but not limited to, salary or other payments for services
(e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock
options or other ownership interests); and intellectual property rights (e.g.,
patents, copyrights and royalties from such rights). Financial interests which are subject to
reporting for any given research proposal include those which would reasonably
appear to be affected by the specific research proposed; or are interests in
entities whose financial interests would reasonably appear to be affected by the
research.
"Significant financial interest" does not include:
(1) Salary,
royalties, or other remuneration from the applicant institution.
(2) Any
ownership interests in the institution, if the institution is an applicant under
the Public Health System (PHS) Small Business Innovation Research
Program.
(3) Income
from seminars, lectures, or teaching engagements sponsored by public or
nonprofit entities.
(4) Income
from service on advisory committees or review panels for public or nonprofit
entities.
(5) An
equity interest that when aggregated for the Investigator and the Investigator's
spouse and dependent children, meets both of the following tests: (a) Does not exceed $10,000 in value as
determined through reference to public prices or other reasonable measures of
fair market value, and (b) does not represent more than a five percent ownership
interest in any single entity.
(6) Salary,
royalties or other payments that when aggregated for the Investigator and the
Investigator's spouse and dependent children over the next twelve months, are
not expected to exceed $10,000.
Examples of conditions or restrictions that
might be imposed to manage conflicts of interest include, but are not limited
to:
(1) Public
disclosure of significant financial interests;
(2)
Monitoring of research by independent
reviewers;
(3)
Modification of the research plan;
(4)
Disqualification from participation in all or a portion
of the research funded;
(5)
Divestiture of significant financial interests;
and
(6)
Severance of relationships that create actual or
potential conflicts.
This facility requires
that all investigators submit conflict of interest disclosure forms to the
Director, Office of Research Integrity.
As one method of preventing, monitoring, managing, and
resolving conflicts of interest, the IRB requires full disclosure of conflicts
of interest by investigators. Full
disclosure of conflicting information demonstrates good faith and protects the
integrity of the research and the reputation of the institution. Disclosure is
made to this institution’s conflict of interest official, and where deemed
appropriate by that official to the IRB.
Financial certification/disclosure with appropriate forms (e.g. Form FDA
3454/3455) shall be used as deemed appropriate. If necessary, the IRB may require the
information be included in the Informed Consent Form to inform prospective
subjects about any conflict of interest.
Role conflicts (investigator/caregiver) may require particular attention
for studies involving more than minimal risks. Investigators who are also a subject’s
caregiver should not perform the recruitment action, but rather should enlist
the services of other personnel to approach potential subjects for subject
recruitment to avoid undue influence on subjects to consent. The IRB will also review proposals to
ensure the absence of an institutional conflict of interest (e.g., funding
arrangements of institution with protocol sponsor).
Procedures for Removal of Members. Any IRB member may be removed for not acknowledging conflict of
interest. In the event a member is
charged with not disclosing a conflict of interest, the IRB will review the
charges and a majority vote, not including the accused, may result in the
recommendation to remove the member from the Board. The Director, Office of Research
Integrity will make the final decision as to the removal and notify the member
and the IRB, in writing.
Investigator Conflict
of Interest Checklist
IRB Member Conflict
of Interest Checklist
FOLLOW-UP
RESPONSIBILITY: Director,
Office of Research Integrity
REFERENCES: 38 CFR 16
21
CFR 50
21 CFR 812
21 CFR 312
REVIEW DATE: February 2008