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PHS Policies on Research Misconduct
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42 U.S.C. § 289b
Establishment of Office
§ 289b. Office of Research Integrity
- (a) In general
- (1) Establishment of Office
Not later than 90 days after June 10, 1993, the Secretary
shall establish an office to be known as the Office of Research
Integrity (referred to in this section as the "Office"),
which shall be established as an independent entity in the
Department of Health and Human Services.
- (2) Appointment of Director
The Office shall be headed by a Director, who shall be appointed
by the Secretary, be experienced and specially trained in
the conduct of research, and have experience in the conduct
of investigations of research misconduct. The Secretary shall
carry out this section acting through the Director of the
Office. The Director shall report to the Secretary.
- (3) Definitions
- (A) The Secretary shall by regulation establish a definition
for the term "research misconduct" for purposes
of this section.
- (B) For purposes of this section, the term "financial
assistance" means a grant, contract, or cooperative
agreement.
- (b) Existence of administrative processes as condition of funding
for research
The Secretary shall by regulation require that each entity that
applies for financial assistance under this chapter for any project
or program that involves the conduct of biomedical or behavioral
research submit in or with its application for such assistance
-
- (1) assurances satisfactory to the Secretary that such entity
has established and has in effect (in accordance with regulations
which the Secretary shall prescribe) an administrative process
to review reports of research misconduct in connection with
biomedical and behavioral research conducted at or sponsored
by such entity;
- (2) an agreement that the entity will report to the Director
any investigation of alleged research misconduct in connection
with projects for which funds have been made available under
this chapter that appears substantial; and
- (3) an agreement that the entity will comply with regulations
issued under this section.
- (c) Process for response of Director
The Secretary shall by regulation establish a process to be followed
by the Director for the prompt and appropriate -
- (1) response to information provided to the Director respecting
research misconduct in connection with projects for which funds
have been made available under this chapter;
- (2) receipt of reports by the Director of such information
from recipients of funds under this chapter;
- (3) conduct of investigations, when appropriate; and
- (4) taking of other actions, including appropriate remedies,
with respect to such misconduct.
- (d) Monitoring by Director
The Secretary shall by regulation establish procedures for the
Director to monitor administrative processes and investigations
that have been established or carried out under this section.
- (e) Protection of whistleblowers
- (1) In general
In the case of any entity required to establish administrative
processes under subsection (b) of this section, the Secretary
shall by regulation establish standards for preventing, and
for responding to the occurrence of retaliation by such entity,
its officials or agents, against an employee in the terms
and conditions of employment in response to the employee having
in good faith -
- (A) made an allegation that the entity, its officials
or agents, has engaged in or failed to adequately respond
to an allegation of research misconduct; or
- (B) cooperated with an investigation of such an allegation.
- (2) Monitoring by Secretary
The Secretary shall by regulation establish procedures for
the Director to monitor the implementation of the standards
established by an entity under paragraph (1) for the purpose
of determining whether the procedures have been established,
and are being utilized, in accordance with the standards established
under such paragraph.
- (3) Noncompliance
The Secretary shall by regulation establish remedies for
noncompliance by an entity, its officials or agents, which
has engaged in retaliation in violation of the standards established
under paragraph (1). Such remedies may include termination
of funding provided by the Secretary for such project or recovery
of funding being provided by the Secretary for such project,
or other actions as appropriate.
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