[Code of Federal Regulations]
[Title 42, Volume 1, Parts 1 to 399]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR50]
[Page 180-183]
TITLE 42--PUBLIC HEALTH
CHAPTER I--PUBLIC HEALTH SERVICE,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 50--POLICIES OF GENERAL APPLICABILITY--Table of Contents
Subpart F--Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
Authority: 42 U.S.C. 216, 289b-1, 299c-3.
Source: 60 FR 35815, July 11, 1995; 60 FR 39076, July 31, 1995,
unless otherwise noted.
Sec. 50.601 Purpose.
This subpart promotes objectivity in research by establishing
standards to ensure there is no reasonable expectation that the design,
conduct, or reporting of research funded under PHS grants or cooperative
agreements will be biased by any conflicting financial interest of an
Investigator.
Sec. 50.602 Applicability.
This subpart is applicable to each Institution that applies for PHS
grants or cooperative agreements for research and, through the
implementation of
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this subpart by each Institution, to each Investigator participating in
such research (see Sec. 50.604(a)); provided, that this subpart does not
apply to SBIR Program Phase I applications. In those few cases where an
individual, rather than an institution, is an applicant for PHS grants
or cooperative agreements for research, PHS Awarding Components will
make case-by-case determinations on the steps to be taken to ensure that
the design, conduct, and reporting of the research will not be biased by
any conflicting financial interest of the individual.
Sec. 50.603 Definitions.
As used in this subpart:
HHS means the United States Department of Health and Human Services,
and any components of the Department to which the authority involved may
be delegated.
Institution means any domestic or foreign, public or private, entity
or organization (excluding a Federal agency).
Investigator means the principal investigator and any other person
who is responsible for the design, conduct, or reporting of research
funded by PHS, or proposed for such funding. For purposes of the
requirements of this subpart relating to financial interests,
``Investigator'' includes the Investigator's spouse and dependent
children.
PHS means the Public Health Service, an operating division of the
U.S. Department of Health and Human Services, and any components of the
PHS to which the authority involved may be delegated.
PHS Awarding Component means the organizational unit of the PHS that
funds the research that is subject to this subpart.
Public Health Service Act or PHS Act means the statute codified at
42 U.S.C. 201 et seq.
Research means a systematic investigation designed to develop or
contribute to generalizable knowledge relating broadly to public health,
including behavioral and social-sciences research. The term encompasses
basic and applied research and product development. As used in this
subpart, the term includes any such activity for which research funding
is available from a PHS Awarding Component through a grant or
cooperative agreement, whether authorized under the PHS Act or other
statutory authority.
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). The
term 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 SBIR 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: Does not exceed $10,000 in value as determined through
reference to public prices or other reasonable measures of fair market
value, and does not represent more than a five percent ownership
interest in any single entity; or
(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.
Small Business Innovation Research (SBIR) Program means the
extramural research program for small business that is established by
the Awarding Components of the Public Health Service and certain other
Federal agencies under Pub. L. 97-219, the Small Business Innovation
Development Act, as amended. For purposes of this subpart, the term SBIR
Program includes the Small Business Technology Transfer (STTR) Program,
which was established by Pub. L. 102-564.
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Sec. 50.604 Institutional responsibility regarding conflicting
interests of investigators.
Each Institution must:
(a) Maintain an appropriate written, enforced policy on conflict of
interest that complies with this subpart and inform each Investigator of
that policy, the Investigator's reporting responsibilities, and of these
regulations. If the Institution carries out the PHS-funded research
through subgrantees, contractors, or collaborators, the Institution must
take reasonable steps to ensure that Investigators working for such
entities comply with this subpart, either by requiring those
Investigators to comply with the Institution's policy or by requiring
the entities to provide assurances to the Institution that will enable
the Institution to comply with this subpart.
(b) Designate an institutional official(s) to solicit and review
financial disclosure statements from each Investigator who is planning
to participate in PHS-funded research.
(c)(1) Require that by the time an application is submitted to PHS
each Investigator who is planning to participate in the PHS-funded
research has submitted to the designated official(s) a listing of his/
her known Significant Financial Interests (and those of his/her spouse
and dependent children):
(i) That would reasonably appear to be affected by the research for
which PHS funding is sought; and
(ii) In entities whose financial interests would reasonably appear
to be affected by the research.
(2) All financial disclosures must be updated during the period of
the award, either on an annual basis or as new reportable Significant
Financial Interests are obtained.
(d) Provide guidelines consistent with this subpart for the
designated official(s) to identify conflicting interests and take such
actions as necessary to ensure that such conflicting interests will be
managed, reduced, or eliminated.
(e) Maintain records of all financial disclosures and all actions
taken by the Institution with respect to each conflicting interest for
at least three years from the date of submission of the final
expenditures report or, where applicable, from other dates specified in
45 CFR 74.53(b) for different situations.
(f) Establish adequate enforcement mechanisms and provide for
sanctions where appropriate.
(g) Certify, in each application for the funding to which this
subpart applies, that:
(1) There is an effect at that Institution a written and enforced
administrative process to identify and manage, reduce or eliminate
conflicting interests with respect to all research projects for which
funding is sought from the PHS,
(2) Prior to the Institution's expenditure of any funds under the
award, the Institution will report to the PHS Awarding Component the
existence of a conflicting interest (but not the nature of the interest
or other details) found by the institution and assure that the interest
has been managed, reduced or eliminated in accordance with this subpart;
and, for any interest that the Institution identifies as conflicting
subsequent to the Institution's initial report under the award, the
report will be made and the conflicting interest managed, reduced, or
eliminated, at least on an interim basis, within sixty days of that
identification;
(3) The Institution agrees to make information available, upon
request, to the HHS regarding all conflicting interests identified by
the Institution and how those interests have been managed, reduced, or
eliminated to protect the research from bias; and
(4) The Institution will otherwise comply with this subpart.
Sec. 50.605 Management of conflicting interests.
(a) The designated official(s) must: Review all financial
disclosures; and determine whether a conflict of interest exists and, if
so, determine what actions should be taken by the institution to manage,
reduce or eliminate such conflict of interest. A conflict of interest
exists when the designated official(s) reasonably determines that a
Significant Financial Interest could directly and significantly affect
the design, conduct, or reporting of the PHS-
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funded research. 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 by the PHS;
(5) Divestiture of significant financial interests; or
(6) Severance of relationships that create actual or potential
conflicts.
(b) In addition to the types of conflicting financial interests
described in this paragraph that must be managed, reduced, or
eliminated, an Institution may require the management of other
conflicting financial interests, as the Institution deems appropriate.
Sec. 50.606 Remedies.
(a) If the failure of an Investigator to comply with the conflict of
interest policy of the Institution has biased the design, conduct, or
reporting of the PHS-funded research, the Institution must promptly
notify the PHS Awarding Component of the corrective action taken or to
be taken. The PHS Awarding Component will consider the situation and, as
necessary, take appropriate action, or refer the matter to the
Institution for further action, which may include directions to the
Institution on how to maintain appropriate objectivity in the funded
project.
(b) The HHS may at any time inquire into the Institutional
procedures and actions regarding conflicting financial interests in PHS-
funded research, including a requirement for submission of, or review on
site, all records pertinent to compliance with this subpart. To the
extent permitted by law, HHS will maintain the confidentiality of all
records of financial interests. On the basis of its review of records
and/or other information that may be available, the PHS Awarding
Component may decide that a particular conflict of interest will bias
the objectivity of the PHS-funded research to such an extent that
further corrective action is needed or that the Institution has not
managed, reduced, or eliminated the conflict of interest in accordance
with this subpart. The PHS Awarding Component may determine that
suspension of funding under 45 CFR 74.62 is necessary until the matter
is resolved.
(c) In any case in which the HHS determines that a PHS-funded
project of clinical research whose purpose is to evaluate the safety or
effectiveness of a drug, medical device, or treatment has been designed,
conducted, or reported by an Investigator with a conflicting interest
that was not disclosed or managed as required by this subpart, the
Institution must require the Investigator(s) involved to disclose the
conflicting interest in each public presentation of the results of the
research.
Sec. 50.607 Other HHS regulations that apply.
Several other regulations and policies apply to this subpart.
They include, but are not necessarily limited to:
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Uniform Administrative Requirements for Awards and
Subawards to Institutions of Higher Education, Hospitals, Other Non-
Profit Organizations, and Commercial Organizations; and Certain Grants
and Agreements with States, Local Governments and Indian Tribal
Governments
45 CFR part 76--Government-wide debarment and suspension (non-
procurement)
45 CFR part 79--Program Fraud Civil Remedies
45 CFR part 92--Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments