Current through Reg. 49, No. 38; September 20, 2024
(a) For purposes of this chapter, a Conflict
of Interest exists when an individual subject to this rule has an interest in
the outcome of a Grant Application submitted by an entity receiving or applying
to receive money from the Institute such that the individual is in a position
to gain financially, professionally, or personally from either a positive or
negative evaluation of the Grant Application. Individuals subject to this rule
are:
(1) Oversight Committee
Members;
(2) Institute
employees;
(3) Scientific Research
and Prevention Programs Committee Members;
(4) Program Integration Committee Members;
and
(5) Independent Contractors
that perform services associated with the Grant Review Process on behalf of the
Institute, such as facilitating grant review activities, evaluating the
intellectual property held by or licensed to a Grant Applicant, or performing a
business management due diligence review.
(b) Except under exceptional circumstances as
provided in §
702.17
of this chapter (relating to Exceptional Circumstances Requiring
Participation), an individual who has a financial, professional, or personal
interest, as set forth herein, in an entity receiving or applying to receive
money from the Institute shall recuse himself or herself and may not
participate in the review, discussion, deliberation, or vote related to the
entity.
(c) A financial Conflict of
Interest exists if the individual subject to this rule or a Relative of the
individual subject to this rule:
(1) Owns or
controls, directly or indirectly, an ownership interest in an entity receiving
or applying to receive money from the Institute or in a foundation or similar
organization affiliated with the entity;
(A)
Interests subject to this provision include sharing in profits, proceeds, or
capital gains. Examples of ownership or control, include but are not limited to
owning shares, stock, or otherwise, and are not dependent on whether voting
rights are included;
(B) It is not
a financial Conflict of Interest if the ownership interest is limited to shares
owned via an investment in a publicly traded mutual fund or similar investment
vehicle so long as the individual subject to this rule does not exercise any
discretion or control regarding the investment of the assets of the fund or
other investment vehicle;
(2) Could reasonably foresee that an action
taken by the Scientific Research and Prevention Programs Committee, the Program
Integration Committee, the Institute, or its Oversight Committee related to an
entity receiving or applying to receive money from the Institute could result
in a financial benefit to the individual; or
(3) Has received a financial benefit from the
Grant Applicant unrelated to the Grant Application of more than $5,000 within
the past twelve months. This total includes fees, stock and other benefits. It
also includes current stock holdings, equity interest, intellectual property or
real property interest, but does not include diversified mutual funds or
similar investment vehicle in which the person does not exercise any discretion
or control regarding the investment of the assets of the fund or other
investment vehicle.
(d)
For purposes of this rule, a professional Conflict of Interest exists if the
individual subject to this rule or a Relative of the individual subject to this
rule:
(1) Is a member of the board of
directors, other governing board or any committee of an entity or of a
foundation or similar organization affiliated with an entity receiving or
applying to receive money from the Institute during the same Grant Review
Cycle;
(2) Serves as an elected or
appointed officer of an entity receiving or applying to receive money from the
Institute or of a foundation or similar organization affiliated with the
entity;
(3) Is an employee of or is
negotiating future employment with an entity receiving or applying to receive
money from the Institute or a foundation or similar organization affiliated
with the entity;
(4) Represents in
business or law, including actively seeking to represent, an entity receiving
or applying to receive money from the Institute or a foundation or similar
organization affiliated with the entity;
(A)
Representation that constitutes a professional Conflict of Interest includes
providing services as a consultant or contractor;
(B) "Actively seeking to represent" includes
activities such as responding to a request for proposals or qualifications
issued by the entity applying to receive money from the Institute, providing a
solicited or unsolicited proposal for work to the entity applying to receive
money from the Institute, and negotiating terms of service for representation
even if a final agreement has not yet been executed;
(C) For the purposes of this rule, an
individual is no longer considered to be actively seeking to represent an
entity if that entity has selected another provider or has notified the
individual that the individual's services are not needed;
(5) Is a colleague, scientific mentor, or
student of a Senior Member or Key Personnel of the research or prevention
program team listed on the Grant Application, or is conducting or has conducted
research or other significant professional activities with a Senior Member or
Key Personnel of the research or prevention program team listed on the Grant
Application within three years of the date of the review;
(6) Is a student, postdoctoral associate, or
part of a laboratory research group for a Senior Member or Key Personnel of the
research or prevention program team listed on the Grant Application or has been
within the past six years;
(7) Is
engaged or is actively planning to be engaged in collaboration with a Senior
Member or Key Personnel of the research or prevention program team listed on
the Grant Application; or
(8) Has
long-standing scientific differences or disagreements with a Senior Member or
Key Personnel of the research or prevention program team listed on the Grant
Application that are known to the professional community and could be perceived
as affecting objectivity.
(e) For purposes of this rule, a personal
Conflict of Interest exists if a Senior Member or Key Personnel of the research
or prevention program team listed on the Grant Application or an applicant is a
Relative or close personal friend of an individual subject to this
rule.
(f) Nothing herein shall
prevent the Oversight Committee from adopting more stringent standards with
regard to prohibited conflicts of interest.
(g) The General Counsel and Chief Compliance
Officer may provide guidance to individuals subject to this section on what
interests would constitute a Conflict of Interest or an appearance of a
Conflict of Interest.