REGULATIONS
[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.
§ 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.
§ 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 this subpart by each Institution, to each Investigator participating
in such research (see § 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.
§ 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.
§ 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.
§ 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-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.
§ 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.
§ 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
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