INTEREST – CPHS MEMBERS AND CONSULTANTS
CPHS members and consultants may not
participate in the review of any protocol in which they have a conflicting
interest, except to provide information requested by the CPHS.
- Significant financial interest in research is defined as the aggregate
interests of the investigator and his/her immediate family (spouse and
dependent children.). It also refers to anything of monetary value that would
reasonably appear to be affected by the outcome of the proposed research,
regardless of whether that entity is sponsoring the research.
include, but are not limited to:
§ Salary or other
payments for services (e.g. consulting fees or honoraria) expected to exceed
$5,000 in the next 12 months from a single entity. This does not include salary
or other remuneration from UTHSC-H or, as applicable, other academic
§ Equity interests
(e.g. stocks, stock options, or other ownership interests) that exceed $5,000
in value as determined through reference to public prices or other reasonable
measures of fair market value or represent more than a 5% ownership interest in
any single entity. This does not include interest in mutual funds where the
individual has no control over the selection of holdings.
property rights (e.g. patents, patents in which the investigator has a
financial interest, copyrights, and royalties from such rights.)
§ Payments or
entitlements paid by the sponsor in connection with the research, including
bonus or milestone payments, that are not directly related to the reasonable
costs of the research.
§ Service as an
officer, director, or fiduciary for a financially interested company.
§ Any other financial
interests if the CPHS Members have concerns that these interests would
reasonably appear to be affected by the proposed research (e.g. significant
financial interests of family members other than a spouse or dependent children)
significant financial interest in research does not include:
§ Income from
seminars, lectures, or teaching engagements sponsored by a federal, state, or
local government or an institution of higher education.
§ Income from service
on advisory committees or review panels for a federal, state, or local
government or an institution of higher education.
§ Salary, royalties,
or other remuneration paid by the institution to the covered individual, if the
covered individual is currently employed or otherwise appointed by the
– Non-financial conflicts of interest include a significant personal or
scientific interest, being member of the research team or administrative
involvement with the research.
Identifying Conflict of Interest - A CPHS Member
and/or consultant must declare any significant financial or non-financial COI. When
a Member / Consultant has a COI for a research proposal that was assigned to
them for review, they must notify the ORSC Staff. The ORSC Staff will reassign
the research proposal to another reviewer.
At the opening of all CPHS meetings, the Chairperson
will remind CPHS Members or Consultants in attendance at the meeting, to
declare any conflicting interests with items on the agenda.
Managing Conflict of Interest - A member or
consultant with COI must absent himself/herself from the meeting room prior to
any discussion, except to provide information requested by the CPHS. This
absence does affect the number of persons necessary for a quorum, which will be
noted in the minutes as not present for vote. Even when a member does not have
conflict of interest as defined in this policy, they may refrain from
discussion and vote to avoid any appearance of a conflicting interest.
Members with conflicting interests will not
be assigned as primary or secondary reviewers for review of the specific
research protocol for which conflict exists for initial review, continuing
review, expedited review, review of protocol amendments, review of SAE reports
and review of non compliance reports.
1. 45 CFR §46.107(e)
2. 21 CFR §56.107(e)
TO OTHER POLICIES
Interest – CPHS Members and Consultants
1 Aug 2008
1 Aug 2011