[Federal Register: April 16, 2004 (Volume 69, Number 74)]
[Proposed Rules]
[Page 20777-20803]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap04-27]
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Part V
Department of Health and Human Services
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42 CFR Parts 50 and 93
Public Health Service Policies on Research Misconduct; Proposed Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Parts 50 and 93
RIN 0940-AA04
Public Health Service Policies on Research Misconduct
AGENCY: Department of Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Department proposes substantial revisions to the existing
regulation at 42 CFR part 50, subpart A, ``Responsibilities of Awardee
and Applicant Institutions for Dealing With and Reporting Possible
Misconduct in Science,'' 54 FR 32446 (Aug. 8, 1989) (final rule). We
propose to delete this regulation, which implemented section 493 of the
PHS Act, and add a new part 93, subparts A, B, C, D, and E. The purpose
of this proposed rule is to implement legislative and policy changes
that have occurred since the regulation was issued, including the
common Federal policies and procedures on research misconduct issued by
the Office of Science and Technology Policy. We have developed the
proposed changes based on over 12 years of experience with the existing
final rule. The proposed rule would help to ensure public confidence in
the integrity of scientific data and the Public Health Service (PHS)
supported research process.
DATES: Submit comments on or before June 15, 2004.
ADDRESSES: You may submit comments, identified by RIN 0940-
AA04, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: Research@osophs.dhhs.gov, attaching
either a WordPerfect file--version 9.1 or higher, a Microsoft Word 97
or 2000 file, or an ASCII file (avoiding special characters and any
form of encryption).
Mail: Chris B. Pascal, J.D., Director, Office of
Research Integrity, 1011 Wooten Parkway, Suite 750, Rockville MD 20852.
Address all comments concerning this proposal to: Chris B. Pascal,
J.D., Director, Office of Research Integrity, 1101 Wootton Parkway,
Suite 750, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Brenda Harrington, 301-443-3400 (this
is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
The National Institutes of Health Revitalization Act of 1993 (NIH
Act), Pub. L. 103-43, which amended the PHS Act, contains important
provisions that affect this proposed rule. Section 161 of the NIH Act
established the Office of Research Integrity (ORI) as an independent
entity reporting to the Secretary of the U.S. Department of Health and
Human Services (HHS). Section 162 of the NIH Act required the
establishment of a Commission on Research Integrity to review a broad
range of administrative and policy issues relating to research
integrity, including the definition of research misconduct, and to
provide a report to the Secretary and the Congress with recommendations
for PHS policies on research integrity. The Commission began its work
in 1994 and sent its final report to Congress and the HHS Secretary on
November 3, 1995. Section 163 of the NIH Act also requires the
Secretary to promulgate a regulation on the protection of
whistleblowers involved in cases of possible research misconduct. See
section 493 of the PHS Act, 42 U.S.C. 289b. We proposed separate
regulations to implement the whistleblower provisions and published a
Notice of Proposed Rulemaking, ``Public Health Service Standards for
the Protection of Research Misconduct Whistleblowers,'' 56 FR 70830
(Nov. 28, 2000); 65 FR 70830 (Dec. 29, 2000). We have postponed
finalizing that regulation to ensure that its provisions are consistent
with the proposed research misconduct rule.
In implementing the statutory provisions, the Secretary carefully
reviewed: (1) The report issued by the Commission on Research
Integrity; (2) the recommendations of an internal HHS review group
established to evaluate HHS procedures for handling allegations of
research misconduct; (3) the governmentwide policies on research
misconduct developed by the Office of Science and Technology Policy
(OSTP); and (4) other statutory and regulatory authorities such as 42
U.S.C. 216 and 241 and 42 CFR part 52 which confer broad authority upon
the Secretary to regulate the use of PHS funds and to operate and
manage PHS programs, including the authority to investigate and oversee
investigations of allegations concerning the integrity of researchers
who apply for or receive PHS funds and to take appropriate
administrative actions to protect Federal funds and the public health,
safety, and welfare. We developed this proposed rule to codify several
important changes described below.
Section 493 of the PHS Act directs the Secretary to promulgate
regulations requiring each entity that applies for or receives funds
under the PHS Act for the conduct of biomedical or behavioral research
to submit assurances that the entity: (1) Has established an
administrative process that conforms with the regulation to review
reports of research misconduct in PHS biomedical or behavioral
research; (2) will report to the Secretary any investigation of alleged
research misconduct; and (3) will comply with the regulations. The
statute also requires the Secretary to establish by regulation the
process by which the ORI reviews allegations and institutional reports
of research misconduct and takes appropriate actions in response to
findings of misconduct.
In response to the original section 493 of the PHS Act, and to
carry out its overall responsibilities in this area, the PHS
established two offices in 1989 for dealing with research misconduct
and published a Final Rule that contains requirements for extramural
institutions applying for or receiving PHS research funds. The two
offices were the Office of Scientific Integrity (OSI), located at the
National Institutes of Health (NIH), and the Office of Scientific
Integrity Review (OSIR), located in the Office of the Assistant
Secretary for Health. OSI had the primary responsibility for overseeing
investigations of research misconduct carried out by institutions and
for conducting investigations when necessary. OSIR provided a second
level of review for investigations and developed research integrity
policies for the PHS.
On August 8, 1989, HHS published its final regulation at 42 CFR
part 50, subpart A. 54 FR 32446. The rule assigns to applicant and
awardee institutions the primary responsibility for investigating
possible research misconduct. The regulation requires these
institutions to file an initial assurance that they have established
policies and procedures for investigations. Institutions also must
report annually on the numbers and types of allegations and inquiries
dealt with during the calendar year. The regulation codified the
existing PHS definition of research misconduct and established general
principles for the conduct of institutional inquiries and
investigations.
Based on our experience with the 1989 regulation and concerns
raised by Congress and the public about the effectiveness of the
existing office structure, we announced the reorganization of our
research misconduct operations in the Federal Register on June 8, 1992.
57 FR 24262. The reorganization abolished OSI and OSIR and transferred
their functions to the newly established ORI within the
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Office of the Assistant Secretary for Health. On November 6, 1992, we
announced the new PHS procedures for administrative hearing procedures
before a Research Integrity Adjudications Panel of the HHS Departmental
Appeals Board. 57 FR 53125 (1992), revised 59 FR 29809 (June 9, 1994).
Subsequently, a 1995 reorganization of the Office of the Assistant
Secretary for Health placed ORI within the Office of Public Health and
Science in the Office of the Secretary. 60 FR 56605 (Nov. 9, 1995).
In 1996, the Secretary created the HHS Review Group on Research
Misconduct and Research Integrity, consisting of senior HHS officials
representing the PHS and the Office of the Secretary, to review ORI's
policies and procedures. In July of 1999, the HHS Review Group made 14
recommendations to improve the quality, effectiveness, and efficiency
of the system for responding to allegations of research misconduct and
promoting research integrity. The Secretary approved these
recommendations in October of 1999, and we have implemented them
through policy changes. Some of the more significant changes are
included in this NPRM.
In March of 1999, NIH issued a report entitled ``NIH Initiative to
Reduce Regulatory Burden--Identification of Issues and Potential
Solutions.'' We have carefully reviewed the ``Research Integrity''
section of the report. We have already implemented a number of the
recommendations, such as assigning institutions primary responsibility
for investigating misconduct, promoting increased education programs in
research integrity, separating adjudication and appeals from the
inquiry and investigation stages, and providing some flexibility to
institutions in the assessment, inquiry, and investigation processes.
Where appropriate, we propose to codify them in this proposed
regulation.
In October of 1999, OSTP proposed a governmentwide definition of
research misconduct for adoption and implementation by Federal agencies
that conduct and support research. 64 FR 55722 (Oct. 14, 1999). After
receiving comments, OSTP published a final notice consisting of a
definition of research misconduct and policies and procedures for
handling misconduct allegations. 65 FR 76260 (Dec. 6, 2000). The OSTP
called upon all Federal agencies to adopt a common Federal framework
for responding to research misconduct. Although our current practices
are already substantially similar to the new OSTP policy, this proposed
rule would bring the PHS procedures into conformity in the few
divergent areas. Therefore, we propose to adopt and incorporate the
OSTP governmentwide definition and pertinent policy, procedures, and
guidelines in the proposed regulation.
On May 12, 2000, the Secretary approved organizational changes that
moved the responsibility for making proposed findings of research
misconduct and administrative actions from ORI to the Assistant
Secretary for Health. The reorganization also moved direct inquiries
and investigations previously conducted by ORI to components of the PHS
for intramural research and to the Office of the Inspector General for
extramural research. ORI continues, among other things, to direct PHS
research integrity activities on behalf of the Secretary, to coordinate
the development of research integrity policies regarding whistleblowers
and respondents, and to perform oversight review of research misconduct
inquiries and investigations. 65 FR 30600 (May 12, 2000). ORI also has
the responsibility of proposing findings of research misconduct to the
Assistant Secretary for Health and, if the Respondent challenges those
findings, supporting them before the HHS Departmental Appeals Board.
These changes are included in the proposed regulation.
As discussed above, the NIH Revitalization Act of 1993 amended
section 493 of the PHS Act to establish ORI by statute, and, among
other things, to change the term ``scientific misconduct'' to
``research misconduct.'' The proposed rule would implement these
statutory amendments and a number of policy changes that we believe are
necessary and appropriate, with the exception of the statutory
provision regarding whistleblowers which we are promulgating in a
separate regulation at 42 CFR part 94. The proposed rule incorporates
many of the features of the existing Final Rule concerning
responsibilities of awardee and applicant institutions, and it sets out
our procedures for responding to research misconduct.
We invite public comments on all aspects of this proposed
regulation and, in particular, on the following topics:
II. Proposed Changes
A. Applicability
1. Inclusion of PHS Intramural Programs: Based on the OSTP policy
and a recommendation from the internal HHS review groups, we propose to
codify a major difference between the existing Final Rule and current
practice. Under section 93.102 of the proposed rule, PHS intramural
programs would be treated similarly to extramural research
institutions. Because the procedures for conducting inquiries and
investigations are largely the same for both extramural and intramural
institutions, we have consolidated the procedures in the proposed
regulation.
Therefore, in addition to investigating allegations of misconduct
within their programs, the intramural programs would also submit
assurances to ORI that they have established administrative processes
to address allegations of misconduct in connection with research
conducted by the intramural institution. ORI would continue to provide
oversight of these intramural investigations just as it does for
extramural programs. Additional instructions for PHS officials on
intramural investigations may be issued via internal policies, as
needed.
2. Inclusion of Contracts: The existing Final Rule does not include
contracts involving PHS funds, but is limited to research grants,
training grants, and cooperative agreements. The proposed rule expands
the scope of coverage to include procurement contracts as required by
the PHS Act and consistent with the OSTP policy and current PHS
practice.
B. Definition of Research Misconduct
1. The Definition: The regulatory definition of ``scientific
misconduct'' in the existing Final Rule has been the subject of
considerable discussion over the years since its introduction, and we
have considered the comments and concerns expressed by Congress, the
research community, and other interested organizations. Now, as noted
above, OSTP has adopted a final new governmentwide Federal definition
and guidelines on research misconduct.
As an initial matter, the existing Final Rule refers to
``Misconduct or Misconduct in Science,'' 42 CFR 50.102, whereas, the
proposed regulation refers to ``Research Misconduct.'' This change
would be consistent with the statutory amendments and the OSTP
governmentwide definition.
In addition, the existing Final Rule defines ``scientific
misconduct'' as ``fabrication, falsification, plagiarism, or other
practices * * * for proposing, conducting, or reporting research.''
(Emphasis added.) In contrast, OSTP and section 93.103 of the proposed
regulation define ``research misconduct'' in relation to ``proposing,
performing, or reviewing research, or in reporting research results.''
(Emphasis added.) The proposed regulation would use the term
``performing'' instead of ``conducting'' research and would
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change the scope of the covered activity to include misconduct
occurring in connection with the ``reviewing'' of research. The
inclusion of ``reviewing'' in section 93.102 is consistent with the
addition of ``reviewing'' in the proposed definition. This is also
consistent with the intent of the HHS Review Group and the OSTP policy
to include the process of submitting an application for research
support (proposing), and the peer review of an application or a journal
article (reviewing). We propose to retain the definition of research
misconduct as ``fabrication, falsification or plagiarism'' (commonly
called FFP), but would augment it to include OSTP's description for
each of these terms. The ``other practices'' clause of the existing
final rule would be dropped.
We propose to interpret the phrase ``data or results'' in section
93.226 broadly to encompass all forms of scientific information about
the research at issue without regard to the type of recording or
storage media involved. The phrase would include, but not be limited
to, raw numbers, field notes, interviews, notebooks and folders,
laboratory observations, computers and other scientific equipment, CD-
ROMs, hard drives, floppy disks, Zip disks, back-up tapes, machine
counter tapes, research interpretations and analyses, tables, slides,
photographs, charts, gels, individual facts, statistics, tissue
samples, reagents, and statements by individuals. The phrase
``statements by individuals'' refers to documented oral representations
of research results made by scientists and, therefore, would also be
considered to be ``data.''
2. Burden of Proof: We propose to revise slightly the burden for
establishing research misconduct in three ways: First, in keeping with
the OSTP policy, the proposed regulation would require that the FFP be
a ``significant departure'' from accepted practices as opposed to ORI's
current standard of ``serious deviation.'' As discussed in the OSTP
policy statement, the phrase ``significant departure'' intends to make
clear that behavior alleged to invoke research misconduct should be
assessed in the context of practices generally accepted by the relevant
research community. As the current definition requires a serious
deviation from practices generally accepted in the particular
scientific community, we do not anticipate that this change in
phraseology would alter the burden of proving or disproving research
misconduct in any significant way. However, we specifically ask for
comments on this issue.
Second, the proposed regulation is consistent with the OSTP
position on who has the burden of proving honest error or a difference
of opinion. Proposed sections 93.106(a) and 93.516(c) provide that the
respondent bears the burden of proving any affirmative defenses raised,
including honest error and differences of opinion and any mitigating
factors that the respondent wants the institution or HHS to consider in
imposing administrative actions. Section 93.106(a) provides that once
the institution or HHS makes a prima facie showing of research
misconduct the burden of going forward to prove that the conduct was
the result of an honest error or difference of opinion shifts to the
respondent. Under section 93.106(a), the absence of, or a respondent's
failure to provide, research records adequately documenting the
questioned research establishes a rebuttable presumption of research
misconduct, specifically falsification. Credible evidence corroborating
the research or providing a reasonable explanation for the absence of,
or respondent's failure to provide, these research records may be used
by the respondent to rebut the presumption of research misconduct.
Third, consistent with the OSTP policy, the level of intent would be
expanded beyond an intentional and knowing standard to include
recklessness.
3. Plagiarism and the Definition of Research Misconduct: Section
93.102 of the proposed regulation would be applicable to PHS supported
research ``including any research proposed, performed, reviewed, or
reported * * * regardless of whether the user or reviewer receives PHS
support * * *.'' (Emphasis added.) Thus, the proposed regulation would
expressly cover research misconduct involving plagiarism of PHS
supported research. Neither the respondent nor the respondent's
research needs to be PHS supported for jurisdiction to attach. The
misconduct regulation would cover plagiarism where the respondent has
copied or appropriated ideas or data from another's PHS supported
research, for example, where the respondent is a reviewer in the PHS
grants review process or where the respondent is a reviewer for a
scientific journal.
The collective experience of the PHS and extramural institutions in
dealing with alleged research misconduct has revealed the use of
varying interpretations or definitions of the term ``plagiarism.'' For
purposes of the existing final rule and proposed regulation, we
consider plagiarism to include both the copying of words of another and
the appropriation of ideas, findings, or methods of another without
giving full and proper credit for those words, ideas, or methods. Under
the proposed regulation we would continue to limit our interpretation
of the term plagiarism to exclude those acts that involve limited use
of identical or nearly identical phrases (1) to describe a commonly
used method, (2) to describe previous research in a scientific article,
grant application, or contract proposal, and (3) where the use does not
materially inflate the contribution of the author as perceived by the
reader or reviewer in a manner which would be a significant departure
from accepted standards.
In keeping with the PHS and OSTP policies, we would also continue
to exclude disputes involving authorship or credit among collaborators
unless they involve plagiarism. Past allegations have often involved
disputes among former or current collaborators who participated jointly
in the development or conduct of a research project, but who
subsequently made independent use of the jointly developed concepts,
methods, descriptive language, or other products of the joint effort.
The ownership of the intellectual property in many of these situations
is seldom clear, and the collaborative history among the scientists may
support a presumption of implied consent for each of the collaborators
to use their joint efforts. Although these disputes involve very
important principles, we believe that these matters are best handled by
the researchers and their institutions. See ``ORI Provides Working
Definition of Plagiarism,'' ORI Newsletter, Vol. 3, No. 1 (Dec. 1994),
available at http://ori.dhhs.gov/html/publications/newsletters.asp.
Therefore, we propose to continue to consider them outside the PHS
regulatory definition of plagiarism. As these issues are of long-term
continuing interest, we invite comments on the PHS interpretation.
C. Institutional and Federal Responsibilities
1. Clarifying the Institutional and Federal Roles: In general, the
sections of the proposed regulation addressing the respective
responsibilities of institutions and HHS contain more detail than the
corresponding provisions of the existing final rule. Over the years,
institutions have often requested guidance in these matters, but the
existing final rule contained little in the way of explanation. In most
instances, the increased detail would require minor, if any, changes to
the current process used by the institutions and PHS for handling
research misconduct allegations. Rather, the proposed regulation would
memorialize current
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practices, as developed through experience and contact with
institutions, and recommendations already contained in ORI's guidance
documents and model policies.
Codifying these practices and policies should be helpful to
institutions and, in some instances, may provide them with legal
protection. First, setting out the steps to be taken in a research
misconduct proceeding would level the playing field by providing the
accused researcher with much needed notice of the required process to
be used and protections offered in addressing the allegations. Also as
noted, many institutions have requested a more specific road map to
follow in responding to allegations of research misconduct. Finally,
formalizing the specific process for institutional responses to
research misconduct allegations provides a mechanism by which all
players in the process, e.g., respondents, institutions, and
complainants, may be held accountable.
2. Institutions' Primary Responsibility: Research institutions'
responsibilities for handling allegations of research misconduct would
remain substantially the same under the proposed regulation, in keeping
with ORI's pre-existing conformity with the OSTP policy. Institutions
would continue to have primary responsibility for conducting inquiries
and investigations. In this regard, institutions have conducted over
95% of the PHS misconduct investigations since 1995 and all of them
since 2000. Furthermore, as recommended by the HHS Review Group, we
also propose at section 93.306 to increase institutional flexibility by
specifically providing that institutions which are too small, or
otherwise unable to respond adequately to allegations of research
misconduct, would be able to use the services of a consortium or other
entity to handle a research misconduct proceeding.
3. Providing a Clear Road Map: In conducting inquiries and
investigations of research misconduct, institutions assume an important
responsibility, made all the more important by the fact that the
Federal government relies largely on the institution's work in taking
action against an accused researcher. If an institution does not
conduct a thorough and fair investigation, the case may be forever
compromised, either failing to prove misconduct where it actually
exists or not properly considering evidence that would exonerate the
accused researcher. Therefore, we propose to modify the existing final
rule in certain areas where it would assist in clarifying institutional
responsibilities and PHS expectations. For example, the proposed rule
has several new definitions to aid in interpreting the regulation.
Perhaps most importantly, the proposed rule would clarify the steps
institutions should take to ensure a fair and thorough investigation,
such as securing the evidence and giving the respondent a reasonable
opportunity to comment on the investigational report. In addition, we
propose more explicit guidance regarding what information and evidence
institutions should provide to enable ORI to perform its oversight
function.
4. Institutional Standards: Section 93.319 of the proposed
regulation would formalize the current policy that institutions may,
and many do, have different definitions and standards for research
misconduct than those in the Federal regulation. For example, an
institution may treat certain authorship disputes as plagiarism under
its own internal standards for research misconduct while the PHS would
not. Although an institution must apply the PHS regulatory definition,
standards, and requirements in evaluating an allegation of research
misconduct reported to ORI, it may also apply its internal definition
or standards in determining whether research misconduct or other
misconduct occurred at the institutional level. Thus, an institution
may find misconduct under its internal standards and impose
administrative actions based on that finding, regardless of whether it
or PHS makes a finding of research misconduct under the PHS standards.
D. Retention of the Inquiry Stage
The existing final rule defines a two-stage process that takes
place when an institution receives allegations of research misconduct:
(1) An inquiry, or preliminary fact-finding, to determine if the
allegation involves PHS supported research and has sufficient substance
to warrant an investigation; and (2) an investigation, which is a
thorough review and analysis of all relevant facts to reach a
conclusion as to whether research misconduct has occurred, who was
responsible, and how serious any misconduct was.
Institutions treat the inquiry phase in a widely varying manner,
and the distinction between an inquiry and an investigation has caused
much confusion. Some inquiries conducted by institutions are largely
indistinguishable from investigations. As the OSTP policy adopts a two-
stage process, we have retained the current two-stage process but
propose to sharpen the distinction between inquiries and investigations
by clarifying that the inquiry is only an initial review of the
allegations to see if they warrant an investigation.
E. Safeguards
1. Confidentiality: Section 93.108 of the proposed regulation would
retain the goal of affording confidentiality, to the extent possible,
for respondents and complainants in research misconduct proceedings,
except for PHS administrative hearings, which must be open to the
public in accordance with section 93.517(g). Section 93.108 uses the
qualifying phrase, ``to the extent possible,'' because research
misconduct cases are often subject to unpredictable factors beyond
institutional or agency control, and it is not always possible to
ensure complete confidentiality for respondents and complainants in
these proceedings. Except as otherwise required by law, records or
evidence which could identify research subjects must be maintained
confidentially. Parties must limit disclosure of this data to those who
have a need to know to carry out a misconduct proceeding. Note that the
regulation, Standards for Privacy of Individually Identifiable Health
Information, 45 CFR parts 160 and 164, permits entities covered by that
regulation to disclose individually identifiable health information to
ORI for the oversight functions authorized by the Public Health Service
Act and the implementing regulation.
2. Access to Data: Following the OSTP policy, the proposed
regulation would provide an additional safeguard for respondents.
Specifically, and in conformance with ORI's current practice, section
93.305(b) of the proposed regulation would require institutions, where
appropriate, to give the respondent copies of or reasonable, supervised
access to, the research records.
F. Proposed Findings of Research Misconduct
1. Separation of Fact-finding and Decision Making: We propose to
adopt the current separation of the fact-finding and decision-making
processes in research misconduct cases within HHS. The proposed
regulation would codify the PHS practice since 1999, in which the
decision to find research misconduct is made by the Assistant Secretary
for Health (ASH) or the official designated by the ASH. OSTP policy
also supports this separation. ORI would continue to be responsible for
overseeing institutional inquiries and investigations and making
recommendations for proposed research misconduct findings, settlements,
and administrative actions to the ASH in cases where ORI believes
misconduct
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has occurred. Also, as under current practice, if ORI were to propose
debarment as an administrative action, that decision would be made by
the HHS Debarring Official, the Deputy Assistant Secretary for Grants
and Acquisition Management.
2. HHS Administrative Actions: As recommended by OSTP, we propose
in section 93.408 to include consideration of aggravating and
mitigating factors in determining which HHS administrative actions are
appropriate to protect the PHS and the research process. Historically,
PHS has incorporated an aggravating and mitigating factor analysis in
its assessment, but the proposed regulation would memorialize this
policy and provide guidance to all parties.
G. HHS Inquiries and Investigations
HHS would continue to have ultimate oversight authority for PHS
supported research. As part of this organizational scheme, PHS has
assigned to ORI the responsibility of conducting oversight reviews of
these investigations, recommending to the ASH findings and appropriate
administrative actions necessary to protect the interests of the PHS,
and supporting these findings before the HHS Departmental Appeals Board
(DAB). However, infrequent circumstances may arise where it becomes
necessary for HHS itself to investigate the allegations of research
misconduct at an extramural or intramural institution. Section
93.400(a)(4) would codify the HHS Review Group's recommendation that
the investigatory function for these cases be handled at the
Departmental level. The HHS Office of Inspector General (OIG) will
conduct such investigations.
H. Role of Complainants, Witnesses, and Others
1. Good Faith: The PHS Act requires the Secretary to establish
regulations for preventing and responding to institutional retaliation
against employees who raise good faith allegations that an individual
has committed research misconduct, or that an institution has failed to
respond adequately to an allegation of research misconduct. 42 U.S.C.
289b(e)(1). The existing final rule requires institutions to undertake
``diligent efforts to protect the positions and reputations of those
persons who, in good faith, make allegations.'' (Emphasis added.) 42
CFR 50.103(d)(13). Because the attachment of whistleblower protections
is contingent upon the making of good faith allegations, section 93.210
of the proposed regulation would define what it means to make an
allegation in ``good faith'' and, conversely, when an allegation is not
brought in good faith. With this provision, PHS seeks to clarify a
common misunderstanding about the nature of whistleblower protection.
Namely, even if an allegation is wrong, the person bringing that
allegation is still entitled to protection against retaliation as long
as the whistleblower made the allegation in good faith. However, if a
complainant does not make an allegation in good faith, (e.g. makes an
allegation with knowledge that the factual basis for the allegation is
untrue), an institution may take reasonable action to redress any harm
caused by the allegation. In the academic community, these are commonly
known as ``bad faith'' allegations, and some institutions currently
have policies and procedures for responding to them.
2. Complainants and Witnesses in Research Misconduct Proceedings:
We recognize the critical role of complainants and other witnesses in
research misconduct proceedings. The vast majority of cases that result
in misconduct inquiries or investigations result from a complaint
brought to the attention of appropriate institutional officials.
However, the responsibility for addressing allegations should not fall
on those who raise them. In conformance with the OSTP policy, the HHS
Review Group, and current agency practice, this proposed rule would
make clear that an institution has an obligation to pursue allegations
of misconduct independent of the complainant's role. Once the
complainant has made a formal allegation that research misconduct has
occurred, that person does not participate in the research misconduct
proceeding other than as a witness. A complainant is not the equivalent
of a ``party'' in a private dispute. Complainants are witnesses in that
they do not control or direct the process, do not have special access
to evidence except as determined by ORI or the investigative body, and
do not act as decision makers.
The proposed regulation would employ a new term, ``complainant,''
defined at section 93.203 as a person who in good faith makes an
allegation of research misconduct. The role of complainants is limited
by the proposed provisions governing the conduct of inquiries and
investigations. Under the proposed regulation, the institution may, but
would no longer be required, to give the complainant an opportunity to
comment on the inquiry and investigation reports.
I. Compliance
1. Assurances for Small Institutions: Since 1990, ORI has permitted
institutions determined to be too small to conduct research misconduct
proceedings effectively or without any appearance of a conflict of
interest to submit a ``Small Organization Statement'' under which they
agree to work with ORI to develop an alternative mechanism to handle
research misconduct allegations. Proposed section 93.303 would codify
this option. Because we want to retain the flexibility these small
institutions need, we have not explicitly defined the upward limit of
what is considered a small institution. In the past, this alternative
for small institutions has been applied to institutions with no more
than 10 employees.
2. Using a consortium or other entity to conduct research
misconduct proceedings. The HHS Review Group suggested that
institutions that were unable to conduct their own research misconduct
proceedings use the services of a consortium or other entity qualified
by practice and experience to conduct research misconduct proceedings.
Section 93.306 would allow institutions that are too small, have real
or apparent conflicts of interest, lack the capacity, or otherwise
prefer not to conduct misconduct proceedings to elect this alternative.
Our experience to date with this process has been positive, but we ask
for comments as to whether there should be any limitations on an
institution's ability to choose this option.
3. Noncompliance with the Regulation: The proposed regulation would
provide more information on institutional compliance obligations and
the potential actions we may take in response to compliance concerns.
The existing final rule provides that an institution's failure to
comply with its assurance and the applicable regulations may result in
an enforcement action against the institution. However, that rule does
not spell out what type of institutional action constitutes a failure
to comply. Nor does it explain what type of enforcement action an
institution may face for noncompliance other than revocation of its
assurance and the loss of PHS funding.
Over the past several years, ORI has needed to take a number of
compliance actions but has had to do so without any clear regulatory
guidance in place for either the institution or ORI. We propose to
rectify this problem and take some of the guesswork out of compliance
enforcement. First, section 93.412 of the proposed regulation would
[[Page 20783]]
establish the circumstances under which ORI could find an institution
out of compliance. These circumstances would include, among other
things, a failure to establish and comply with policies and procedures
required by the regulation or a failure to cooperate with review of
institutional research misconduct proceedings. As we already view all
of the factors listed in the proposed regulation as examples of
potential institutional noncompliance, the regulation would essentially
codify current policy and practice. To that end, like some of the other
changes in the proposed regulation, we believe it is helpful to spell
out existing practice.
A second way in which the proposed regulation would lend clarity to
the compliance process would be the addition in section 93.413 of a
more complete explanation of the potential enforcement actions that HHS
may impose in response to institutional noncompliance. This
clarification serves several functions. First, it introduces a
graduated scheme of actions that ORI could take itself or propose to
other PHS agencies or HHS, as appropriate, in response to a given
instance of noncompliance. These actions, most of which are already in
effect through other PHS regulations, range from issuance of a warning
letter (which could also require an institution to take corrective
actions) to revocation of an assurance. A graduated scheme of
compliance actions responds both to the needs of HHS and the
institutions. The proposed regulation would answer institutional
concerns that the current compliance system provides only for the
revocation of an assurance.
J. Maintenance and Custody of Records.
Responsibility for maintenance and custody of research records and
evidence: We propose to codify current policy regarding ongoing
institutional responsibilities for obtaining and maintaining custody of
the research records of the accused researcher and other evidence
relevant to the misconduct allegations. To protect respondents, the
OSTP policy recommends that institutions provide accused researchers
with reasonable access to the evidence supporting the allegations. It
cautions that misconduct policies should ensure that the mere filing of
an allegation does not bring research to a halt nor provide a basis for
other disciplinary or adverse action absent other compelling reasons.
Accordingly, section 93.305(b) of the proposed regulation would provide
that, where appropriate, institutions must ``give the respondent copies
of or reasonable, supervised access to the research record.'' However,
we do not propose to limit an institution's control over its employees
and the research conducted under its auspices. The proposed regulation
would not give a respondent any rights to continue research in the face
of reasonable institutional objections.
K. Hearing Process
We propose to add the HHS hearing process for reviewing PHS
findings of research misconduct, as the existing final rule did not
include provisions for a hearing. Since 1992, when we began to offer
hearings, we have not had clear-cut procedures for research misconduct
adjudications. Complainants, parties, witnesses, and others have
commented that the current informal hearing procedures, published at 59
FR 29809 (1994), lack the consistency and clarity provided by binding
rules of procedure for other types of cases. Accordingly, we believe
that adding a hearing regulation applicable only to research misconduct
cases is advisable to codify a fair, efficient, and timely process for
accused researchers.
We have modeled the proposed hearing regulation in subpart E
primarily on the current regulations, at 42 CFR part 1005, governing
the hearing process for the exclusion of health care providers used by
the OIG, while modifying them to reflect current practice, knowledge,
and experience in research misconduct proceedings. The proposed
regulation also retains several key features from the current informal
procedures.
The current ad hoc hearing process involves a trial-like
evidentiary hearing on the PHS findings of scientific misconduct and
proposed HHS administrative actions by a three-person panel of the DAB.
The panel, which may include one or two outside scientists, in addition
to the DAB Board Member(s), conducts a de novo review in which the
merits of the case are heard as if for the first time, without any
reference to or reliance on any previous decision making or review
process. In other words, both the PHS and the accused scientist have an
opportunity to present their side of the case to the DAB. The DAB
conducts this de novo hearing pursuant to the above noted informal
guidelines and determines whether the respondent committed scientific
misconduct and whether the proposed administrative actions should be
imposed. In reaching its decision, the panel does not rely on the
administrative record developed by the institution or ORI during its
oversight review but instead relies solely upon testimony and other
evidence presented by the parties at the hearing.
Because proposed subpart E is new, we have described it in greater
detail than the other subparts and request comment, especially on the
following issues.
1. Administrative Law Judges (ALJ): We believe that the proposal in
section 93.502 to change from the current system of using a panel of
three decision makers to using a single ALJ appointed from the DAB
Administrative Law Judges would substantially improve and simplify the
process for all parties. This change would provide a process similar to
program exclusion cases brought by the OIG, cases which have similar
impact on the subjects' reputations and livelihood. In fact, for many
other HHS programs, including those conducted under the OIG regulation,
a single decision maker conducts the hearings. Section 93. 506,
Authority of the Administrative Law Judge (ALJ) , closely follows the
OIG regulations at 42 CFR 1005.4. Under the OIG regulations, the ALJ
must follow all Federal laws, regulations, and Secretarial delegations
of authority. Proposed section 93.506(a) adds applicable HHS policies
to this list, because certain policies and guidelines apply to PHS
biomedical and behavioral research and research training grants.
2. Recommended decision: The ALJ's final ruling on the merits of
the PHS misconduct findings and the HHS administrative actions will now
constitute a recommended decision to the Assistant Secretary for
Health. Under current practice, the DAB's decision on the merits of PHS
findings of misconduct and HHS administrative actions, other than
debarment, constitutes final agency action as to these matters. In
2000, the Secretary redelegated the authority to propose findings of
research misconduct and administrative actions from the Director, ORI,
to the Assistant Secretary for Health. The Assistant Secretary for
Health will now take final agency action on PHS research misconduct
appeals, exercising the office's delegated authority to affirm,
reverse, or modify the ALJ's recommended decision. In accordance with
45 CFR part 76, the ALJ's final ruling constitutes proposed findings of
fact to the HHS Debarring Official. The respondent may continue to have
access to a final review in Federal court under the standards of the
Administrative Procedure Act.
3. Scientist Advisors and Experts: Substituting a single ALJ for
the current three-person panel would alter, to some extent, the role of
the scientist in the proceeding. Although the current
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system theoretically permits the panel to have up to two scientist
members, most panels to date have had either one or no scientist
member. However, to ensure that the necessary scientific expertise is
available, section 93.502(b) would authorize the ALJ to engage an
expert in the relevant area of science to advise the ALJ on scientific
or technical issues, and require the employment of such an expert, if
requested by either party. This is consistent with recent developments
in the Federal judicial system in which judges may select their own
outside experts to help them understand cases involving complex
scientific, medical, or technological issues. The proposed regulation
contemplates that the ALJ would consult informally with the scientific
expert, similar to the way experts are used by the Office of Special
Masters, United States Court of Federal Claims in the National Vaccine
Injury Compensation Program, rather than following the more formal
procedures in Federal Rules of Evidence 706. Thus, we do not
contemplate that the ALJ's expert advisor would provide testimony for
the record, but either party to the hearing (e.g., the accused
researcher and PHS) could offer its own experts as witnesses.
Therefore, the proposed new process should simplify the proceedings
while providing ample and necessary input from the scientific
community.
4. Real or Apparent Conflicts of Interest. Consistent with current
DAB and Federal court practice, section 93.502 (c) would prohibit the
appointment of any ALJs or outside science advisors with any real or
apparent conflict of interest that might reasonably impair their
objectivity in the proceeding. Section 93.502(d) would establish a
process for the disqualification of an ALJ or appointed scientist or
expert and, consistent with Federal court practice, would also permit
the ALJ to rule on a motion to disqualify. If the ALJ rules, either
party could appeal the decision directly to the Chief ALJ . This
process would permit the ALJ and Chief ALJ to address potential
conflicts of interest while maintaining a fair and objective hearing
process.
5. Relation to HHS Debarment Regulations: The HHS Debarring
Official refers disputed material facts related to a proposed debarment
in PHS research misconduct proceedings to the DAB for determination.
See 45 CFR 76.314(b)(2). Subpart E of the proposed regulation would be
consistent with this practice and would not supersede or otherwise
alter the existing HHS Debarment regulations or procedures for
contesting proposed debarments.
6. Amendment to the PHS Charge Letter: Consistent with current DAB
practice, section 93.514 would permit the PHS to amend its findings of
research misconduct up to 30 days before the scheduled hearing. We
anticipate that this would occur only in rare circumstances where we
learned of additional acts of research misconduct after the DAB process
had begun (e.g., the acquisition of new information during the
discovery process). In addition, the Assistant Secretary for Health and
the HHS Debarring Official (if debarment were proposed) would have to
approve any amendments. In this instance, the respondent could request
a postponement of the hearing to prepare a response to the new charge.
7. De Novo Proceedings: Consistent with current policy, section
93.517(b) would codify the current practice of providing a de novo
hearing to consider challenges to any PHS findings of research
misconduct and proposed PHS administrative actions. We also propose in
section 93.503(d) to incorporate the current practice that permits a
respondent to waive an in-person hearing and have the case decided on
the basis of the administrative record.
8. Standardization of Requirements: We believe that the proposed
regulation would level the playing field by letting respondents know up
front how the hearing process works. For example, the regulation sets
up requirements for the content of the hearing request (sections
93.503-504), time frames for conducting preliminary conferences
(section 93.511), discovery (section 93.512), submission of witness
lists and exhibits (section 93.513), and the post-hearing process
(sections 93.520 through 523). Knowledge of these standards by the
accused researchers would help promote a fair, timely, efficient, and
less costly process for all parties.
9. Limited Discovery: Generally, discovery is not required to be
made available in administrative proceedings. Under the Administrative
Procedure Act, agencies may decide the extent of available discovery.
We propose to follow the standard Federal administrative practice of
limiting discovery to an exchange of documents. Thus, like other HHS
procedures, the proposed regulation would not permit other forms of
discovery available in Federal court litigation, such as requests for
admissions, written interrogatories, and deposition. See section
93.512(a). Limited discovery results in a faster and more efficient
process that reduces litigation costs for all parties. Following
discussion at a prehearing conference, the ALJ could order the parties
to develop stipulations and admissions of fact. See section
93.511(b)(2). In past hearings, however, these mechanisms have not
resulted in narrowing the issues or improving the efficiency of the
hearing, because the parties had to prepare, but failed to agree on,
any stipulations or admissions.
10. Written Direct Testimony and Use of Telephone and Audio-Visual
Communication: Section 93.518(b) of the proposed regulation would
permit the ALJ to admit written witness testimony, including prior
sworn testimony, if the person is available for cross-examination.
Section 93.518(c)) would permit testimony by telephonic or audio-visual
communication. Past experience has shown that these features help
foster an efficient and streamlined hearing process and reduce the risk
of unfair surprise and increased cost and inconvenience to the parties
and witnesses.
11. Evidentiary Standards: We also propose to clarify the standards
for admitting evidence at the hearing. Section 93.519(c) addresses the
standard Federal administrative practice of admitting relevant and
material evidence and excluding unreliable or unfairly prejudicial
evidence. To avoid ambiguity, the proposed regulation also incorporates
several provisions of the Federal Rules of Evidence. See sections
93.519(f)-(i). Similarly, section 93.519(e) would permit the ALJ to
take judicial notice of established scientific and technical facts,
which would reduce the need for expert testimony and, thereby, provide
a cost savings to the parties.
12. Other Federal Laws or Regulations: With respect to the hearing
process, the proposed regulation would not supersede or otherwise alter
existing Federal laws or regulations that may provide additional
procedures for Federal employees.
13. Recordkeeping for Inquiries and Research Misconduct
Proceedings: The OIG has raised concerns that the 3 year period for
retaining inquiry records in the current regulation, 42 CFR
50.103(d)(6), is too short to permit HHS or the Department of Justice
to investigate potential civil or criminal fraud cases. Accordingly,
the new NPRM proposes extending the period for retaining records on
inquiries and misconduct proceedings to 7 years. See proposed sections
93.309(c) and 93.317(a).
L. Other Features of the Proposed Rule
1. Coordination with Federal Agencies: Federal agencies try to
coordinate when allegations arise that affect more than one funding
agency. For example, NIH and the Department
[[Page 20785]]
of Energy might be jointly funding a particular project which is the
subject of research misconduct allegations. Failure to coordinate may
result in overlooking important government policies, adversely
impacting other agencies' missions and interests, and duplicating or
wasting resources. Therefore, the NPRM proposes to codify current
practice to recognize that, in these instances, the agencies may
coordinate responses with other Federal agencies. The PHS has
coordinated with other interested Federal agencies in a number of cases
and will continue to do so.
2. Limitations period: Because of the problems that may occur in
investigating older allegations and the potential unfairness to accused
researchers in defending against them, we propose to limit the scope of
the misconduct regulations to cases in which the alleged misconduct
occurred within 6 years before the allegation. The proposed rule models
this limitation period after the one used in the qui tam provision of
the False Claims Act, 31 U.S.C. 3731(b), and after the procedures used
by the OIG in its Medicare and Medicaid exclusion cases. Thus, with a
few exceptions, we would be barred from going forward with cases where
the alleged misconduct occurred outside this 6 year window.
3. Person: Section 93.219 of the proposed regulation would define
``person'' to include individuals as well as institutions and other
organizations. This approach to the definition of ``person'' is
consistent with many regulatory schemes including the governmentwide
nonprocurement debarment regulation which is cross-referenced with the
proposed misconduct regulation.
4. Investigation time limits: The OSTP policy recommends that the
Federal agencies establish reasonable time lines to balance expeditious
completion of an institutional research misconduct process against
fairness and thoroughness. Consistent with the existing final rule,
sections 93.307(g) and 93.311 would maintain the 60-day time limit for
institutional inquiries and the 120-day time limit for investigations,
subject to extensions. As experience has shown that institutions often
need extensions of time, we seek comments on whether these time limits
are realistic and provide sufficient time to conduct inquiries and
investigations.
5. Institutional Appeals: Although not required under the existing
Final Rule, some institutions provide respondents with an internal
process by which to appeal the institutional finding of misconduct. Our
experience has shown that often these appeals may result in substantial
delays in completing the institutional process and any subsequent
review. Therefore, in section 93.314, we have proposed a 120-day
deadline for completion of institutional appeals. This section would
provide that any appeals must be completed within 120 days of filing
the appeal, unless extended by ORI for good cause. The 120-day time
limit would apply only to a respondent's appeal of the merits of an
institutional finding of research misconduct, if such a process is
provided by an institution's research misconduct policy. The 120-day
time frame would not apply to any other procedures that an institution
may have, such as tenure proceedings, disciplinary proceedings, or
honor committee proceedings, that do not go to the merits of a research
misconduct finding. It also would not apply to any civil law suits
filed by a respondent challenging a finding of research misconduct. We
ask for comment on whether this proposed time limit is appropriate and
would ameliorate the problems caused by delays in completing
proceedings, and, if so, whether the proposed 120 day deadline is
sufficient.
6. Settlements: In making findings of research misconduct, ORI has
relied on settlement agreements with the accused scientist the great
majority of the time. These settlements can occur at any stage of the
investigative process, from the allegation to completion of the
investigation. Consistent with ORI's prior practice, ORI has expressly
provided in proposed section 93.409 that ORI may settle a research
misconduct proceeding at any time in the best interests of the Federal
government and the public health or welfare. ORI has also participated
in three-way agreements with the research institution, ORI, and the
accused scientist. We encourage institutions or respondents (or
counsel) to contact ORI directly when a settlement agreement appears
feasible. Finally, we caution institutions about entering into
settlement agreements with the respondent without consulting with ORI
in advance. In some cases, the institution has purported to enter into
a binding agreement with the respondent that seeks to restrict the
scope of an investigation or otherwise limits ORI's or the
institution's authority under the regulation. Any such attempt would
have no binding effect on ORI and would not abrogate the institution's
regulatory obligations. Accordingly, we request that any institution
considering such action consult with ORI staff and counsel before
agreeing to any settlement. However, no regulatory language requires
that institutions do so.
M. Structure and Format
We propose to adopt a different approach to the structure and
format from the existing final rule based on the Presidential
Memorandum on Plain Language issued on June 1, 1998. This memorandum
directed Federal agencies to ensure that all of their documents are
clear and easy to read. We organized the proposed rule so that matters
common to a particular subject appear together. We also grouped related
sections within subparts and placed them under unnumbered, centered
headings. This allows readers easy access to information of particular
importance to them. We have used fewer legal terms and more commonly
understood words along with shorter sentences and have tried to make
each section easy to understand by using clear and simple language
rather than jargon. We would like your comments on how effectively we
have used plain language, the organization and format of the proposed
rule, and whether the document is clear and easy to read.
III. Analysis of Impacts
As discussed in greater detail below, we have examined the
potential impact of this proposed rule as directed by Executive Orders
12866 and 13132, the Unfunded Mandates Act of 1995, the Regulatory
Flexibility Act, and the Paperwork Reduction Act of 1995.
We have also determined that this proposed rule would not: (1) Have
an impact on Family Well-Being under section 654 of the Treasury and
General Government Appropriations Act of 1999; nor (2) have a
significant adverse effect on the supply, distribution, or use of
energy sources under Executive Order 13211.
A. Executive Order 12866
These proposed regulations have been drafted and reviewed in
accordance with Executive Order 12866 (58 FR 51735), section 1(b),
Principles of Regulation. The Department has determined that this
proposed rule is a ``significant regulatory action'' under Executive
Order 12866, section 3(f), Regulatory Planning and Review because it
will materially alter the obligations of recipients of PHS biomedical
and behavioral research and research training grants. However, the
proposed regulation is not economically significant as defined in
section 3(f)(1), because it will not have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy,
[[Page 20786]]
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities.
Therefore, the information enumerated in section 6(a)(3)(C) of the
Executive Order is not required. The proposal has been reviewed by the
Office of Management and Budget (OMB) under the terms of the Executive
Order. Recipients of PHS biomedical and behavioral research grants will
have to comply with the reporting and record keeping requirements in
the proposed regulation. As shown below in the Paperwork Reduction Act
analysis, those burdens encompass essentially all of the activities of
the institutions that are required under the proposed regulation. The
total annual burden is 18,279.5 hours. The U.S Department of Labor,
Bureau of Labor Statistics, sets the mean hourly wage for Educational
Administrators, Postsecondary at $31.14. The mean hourly wage for
lawyers is $43.90. The average hourly cost of benefits for all civilian
workers would add $6.41 to these amounts. In order to ensure that all
possible costs are included and to account for potential higher rates
at some institutions, we estimated the cost per burden hour at $100.
This results in a total annual cost for all institutions of $1,827,950.
B. The Unfunded Mandates Reform Act of 1995
Sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (2
U.S.C. 1532 and 1535) require that agencies prepare several analytic
statements before proposing a rule that may result in annual
expenditures of State, local, and tribal governments, or by the private
sector, of $100 million or more in any one year. As any final rule
resulting from this proposal would not result in expenditures of this
magnitude, the Secretary certifies that such statements are not
necessary.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601, et seq.) requires
agencies to prepare a regulatory flexibility analysis describing the
impact of the proposed rule on small entities, but also permits agency
heads to certify that a proposed rule will not, if promulgated, have a
significant economic impact on a substantial number of small entities.
The primary effect of this rule would be to require covered
institutions to implement policies and procedures for responding to
research misconduct cases. The Department certifies that this proposed
rule would not have a significant impact on a substantial number of
small entities, as defined by the Regulatory Flexibility Act, based on
the following facts.
Approximately 47 percent (1862) of the 4000 institutions that
currently have research misconduct assurances are small entities. The
primary impact of the NPRM on covered institutions results from the
reporting and record keeping provisions which are analyzed in detail
under the heading, ``The Paperwork Reduction Act.'' Significant annual
burdens apply only if an institution learns of possible research
misconduct and begins an inquiry, investigation, or both. In 2001, 86
inquiries and 46 investigations were conducted among all the
institutions. No investigations were conducted by a small entity and
only one conducted an inquiry. Small entities would be able to avoid
entirely the potential burden of conducting an inquiry or investigation
by filing a Small Organization Statement under proposed section 93.303.
The burden of filing this Statement is .5 hour. Thus, the significant
burden of conducting inquiries and investigations will not fall on a
substantial number of small entities.
A small organization that files the Small Organization Statement
must report allegations of research misconduct to ORI and comply with
all provisions of the proposed regulation other than those requiring
the conduct of inquiries and investigations. The total annual average
burden per response for creating written policies and procedures for
addressing research misconduct is approximately 16 hours. However,
approximately 99 percent of currently funded institutions already have
these policies and procedures in place and spend approximately .5 hour
updating them. The most significant of the burdens that might fall on
an entity filing a Small Organization Statement is taking custody of
research records and evidence when there is an allegation of research
misconduct. The average burden per response is 35 hours, but based on
reports of research misconduct over the last three years, less than 5
small entities would have to incur that burden in any year.
Based on the forgoing analysis, the Department concludes that the
regulations proposed in the NPRM will not impose a significant burden
on a substantial number of small entities. However, we will carefully
consider comments on the analysis and conclusion.
D. Executive Order 13132: Federalism
This proposed rule, if published as a final rule, would not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government. Therefore,
in accordance with section 6 of Executive Order 13132, we have
determined that this rule does not have sufficient federalism
implications to warrant the preparation of a federalism summary impact
statement.
E. The Paperwork Reduction Act
Sections 300-305, 307-311, 313-318, and 413 of the proposed rule
contain information collection requirements that are subject to review
by the OMB under the Paperwork Reduction Act of l995 (44 U.S.C. 3501,
et seq.). The title, description, and respondent description of the
information collection requirements are shown below with an estimate of
the annual reporting burdens. Included in the estimates is the time for
reviewing instructions, gathering and maintaining the data needed, and
completing and reviewing the collection of information. With respect to
the following information collection description, PHS invites comments
on: (1) Whether the proposed collection of information is necessary for
the proper performance of PHS functions, including whether the
information will have practical utility; (2) the accuracy of the PHS
estimate of the burden of the proposed collection of information
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of collection of
information on respondents, including the use of automatic collection
techniques or other forms of information technology.
Title: Public Health Service Policies on Research Misconduct.
Description: This proposed rule revises the current regulation, 42
CFR 50.101, et seq., in three significant ways and will supersede the
current regulation. First, the proposed rule integrates the White House
Office of Science and Technology Policy's (OSTP) December 6, 2000,
governmentwide Federal Policy on Research Misconduct. Second, the
proposed rule incorporates the recommendations of the HHS Review Group
on Research Misconduct and Research Integrity that were approved by the
Secretary of HHS on August 25, 1999. Third, the proposed rule
integrates a decade's worth of experience and understanding since the
agency's first regulations were promulgated.
[[Page 20787]]
Description of Respondents: The ``respondents'' for the collection
of information described in this regulation are institutions that apply
for or receive PHS support through grants, contracts, or cooperative
agreements for any project or program that involves the conduct of
biomedical or behavioral research, biomedical or behavioral research
training, or activities related to that research or training (see
definition of ``Institution'' at section 93.214).
Subpart C--Responsibilities of Institutions
Compliance and Assurances
Section 93.300(a)
See section 93.304 for burden statement.
Section 93.300(c)
See section 93.320 for burden statement.
Section 93.300(i)
See section 93.301(a) for burden statement.
Section 93.301(a)
Covered institutions must provide ORI with an assurance either by
submitting the initial certification (500 institutions) or by
submitting an annual report (3500 institutions).
Number of Respondents: 4000.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: .5 hour.
Total Annual Burden: 2000 hours.
Section 93.302(a)(1)
See section 93.301(a) for burden statement.
Section 93.302(a)(2)
See section 93.320 for burden statement.
Section 93.302(a)(3)
Each applicant institution must inform its scientific and
administrative staff of the institution's policies and procedures and
emphasize the importance of compliance with these policies and
procedures.
Number of Respondents: 4000.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: .5 hour.
Total Annual Burden: 2000 hours.
Section 93.302(b)
See section 93.301(a) for burden statement.
Section 93.302(c)
In addition to the annual report, covered institutions must submit
aggregated information to ORI on request regarding research misconduct
proceedings.
Number of Respondents: 100.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 1 hour.
Total Annual Burden: 100 hours.
Section 93.303
Covered institutions that, due to their small size, lack the
resources to develop their own research misconduct policies and
procedures may elect to file a ``Small Organization Statement'' with
ORI.
Number of Respondents: 75.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: .5 hour.
Total Annual Burden: 37.5 hours.
Section 93.304
Covered institutions with active assurances must have written
policies and procedures for addressing research misconduct.
Approximately 3500 institutions already have these policies and
procedures in place in any given year and spend minimal time (.5 hour)
updating them. Approximately 500 institutions each year spend an
average of two days creating these policies and procedures for the
first time.
Number of Respondents: 4000.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 2.5 hours.
Total Annual Burden: 10,000 hours.
Section 93.305(a), (b), (d), and (e)
When a covered institution learns of possible research misconduct,
it must promptly take custody of all research records and evidence and
then inventory and sequester them. Covered institutions must also take
custody of additional research records or evidence discovered during
the course of a research misconduct proceeding. Once the records are in
custody, the institutions must maintain them until ORI requests them,
HHS takes final action, or as required under section 93.317.
Number of Respondents: 53.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 35 hours.
Total Annual Burden: 1855 hours.
Section 93.305(c)
Where appropriate, covered institutions must give the respondent
copies of or reasonable, supervised access to the research record.
Number of Respondents: 53.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 5 hours.
Total Annual Burden: 265 hours.
The Institutional Inquiry
Section 93.307(b)
At the time of or before beginning an inquiry, covered institutions
must notify the presumed respondent in writing.
Number of Respondents: 53.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 1 hour.
Total Annual Burden: 53 hours.
Section 93.307(e)
See section 93.309 for burden statement.
Section 93.307(f)
Covered institutions must provide the respondent an opportunity to
review and comment on the inquiry report and attach any comments to the
report.
Number of Respondents: 53.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 1 hour.
Total Annual Burden: 53 hours.
Section 93.308(a)
Covered institutions must notify the respondent whether the inquiry
found that an investigation is warranted.
Number of Respondents: 53.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: .5 hour.
Total Annual Burden: 26.5 hours.
Section 93.309(a)
When a covered institution issues an inquiry report in which it
finds that an investigation is warranted, the institution must provide
ORI with a specified list of information within 30 days of the inquiry
report's issuance.
Number of Respondents: 16.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 16 hours.
Total Annual Burden: 256 hours.
Section 93.309(b)
Covered institutions must keep sufficiently detailed documentation
of
[[Page 20788]]
inquiries to permit a later assessment by ORI of reasons why decision
was made to forego an investigation.
Number of Respondents: 37.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 1 hour.
Total Annual Burden: 37 hours.
The Institutional Investigation
Section 93.310(b)
See section 309(a) for burden statement.
Section 93.310(c)
Covered institutions must notify the respondent of allegations of
research misconduct before beginning the investigation.
Number of Respondents: 16.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 1.
Total Annual Burden: 16 hours.
Section 93.310(d)
See section 93.305(a), (b), (d) and (e) for burden statement.
Section 93.310(g)
Covered institutions must record or transcribe all witness
interviews, provide the recording or transcript to the witness for
correction, and include the recording or transcript in the record of
the investigation.
Number of Respondents: 16.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 15 hours.
Total Annual Burden: 240 hours.
Section 93.311(b)
If unable to complete the investigation in 120 days, covered
institutions must submit a written request for an extension from ORI.
Number of Respondents: 16.
Number of Responses per Respondent: 1.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: .5 hour.
Total Annual Burden: 2.5 hours.
Section 93.315
At the conclusion of the institutional investigation process,
covered institutions must submit four items to ORI: The investigation
report (with attachments and appeals), final institutional actions, the
institutional finding, and any institutional administrative actions.
Number of Respondents: 16.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 80 hours.
Total Annual Burden: 1280 hours.
Section 93.316(a)
Covered institutions that plan to end an inquiry or investigation
before completion for any reason must contact ORI before closing the
case and submitting its final report.
Number of Respondents: 10.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 2 hours.
Total Annual Burden: 20 hours.
Other Institutional Responsibilities
Section 93.317(a) and (b)
See section 93.305(a), (b), (d), and (e) for burden statement.
Section 93.318
Covered institutions must notify ORI immediately in the event of
any of an enumerated list of exigent circumstances.
Number of Respondents: 2.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 1 hour.
Total Annual Burden: 2 hours.
Subpart D--Responsibilities of the U.S. Department of Health and
Human Services
Institutional Compliance Issues
Section 93.413(c)(6)
ORI may require noncompliant institutions to adopt institutional
integrity agreements.
Number of Respondents: 1.
Number of Responses per Respondent: 1.
Annual Average Burden per Response: 20 hours.
Total Annual Burden: 20 hours.
The Department will submit a copy of this proposed rule to OMB for
its review and approval of this information under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Send comments regarding
this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to the
agency official designated for this purpose whose name appears in this
preamble and to fax number (202) 395-6974, Attn: Fumie Yokota. Submit
written comments by June 15, 2004.
List of Subjects
42 CFR Part 50
Administrative practice and procedure, Science and technology,
Reporting and recordkeeping requirements, Research, Government
contracts, Grant programs.
42 CFR Part 93
Administrative practice and procedure, Science and technology,
Reporting and recordkeeping requirements, Research, Government
contracts, Grant programs.
Dated: December 29, 2003.
Cristina V. Beato,
Acting Assistant Secretary for Health.
Approved: December 31, 2003.
Tommy G. Thompson,
Secretary of Health and Human Services.
Editorial Note: This document was received in the Office of the
Federal Register on April 13, 2004.
Accordingly, under the authority of 42 U.S.C. 289b, HHS proposes to
amend 42 CFR parts 50 and 93 to read as follows:
PART 50--POLICIES OF GENERAL APPLICABILITY
1. The authority citation for 42 CFR part 50 continues to read as
follows:
Authority: Sec. 493, Public Health Service Act, as amended, 99
Stat. 874-875 (42 U.S.C. 289b); Sec. 501(f), Public Health Service
Act, as amended, 102 Stat. 4213 (42 U.S.C. 290aa(f)).
Subpart A [Removed]
2. Part 50, Subpart A is removed and reserved.
PART 93 [ADDED]
3. A new Part 93, with subparts A, B, C, D and E, is added to read
as follows:
PART 93--PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
Sec.
93.25 Organization of this part.
93.50 Special terms.
Subpart A--General
93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Research misconduct.
93.104 Requirements for findings of research misconduct.
93.105 Time limitations.
93.106 Evidentiary standards.
93.107 Rule of interpretation.
93.108 Confidentiality.
93.109 Coordination with other agencies.
[[Page 20789]]
Subpart B--Definitions
93.200 Administrative action.
93.201 Allegation.
93.202 Charge letter.
93.203 Complainant.
93.204 Contract.
93.205 Debarment or suspension.
93.206 Debarring official.
93.207 Deciding official.
93.208 Departmental Appeals Board or DAB.
93.209 Evidence.
93.210 Funding component.
93.211 Good faith.
93.212 Hearing.
93.213 Inquiry.
93.214 Institution.
93.215 Institutional member
93.216 Investigation.
93.217 Notice.
93.218 Office of Research Integrity or ORI.
93.219 Person.
93.220 Preponderance of the evidence.
93.221 Prima facie showing.
93.222 Public Health Service or PHS.
93.223 PHS support.
93.224 Research.
93.225 Research misconduct proceeding.
93.226 Research record.
93.227 Respondent.
93.228 Retaliation.
93.229 Secretary or HHS.
Subpart C--Responsibilities of Institutions
Compliance and Assurances
93.300 General responsibilities for compliance.
93.301 Institutional assurances.
93.302 Institutional compliance with assurances.
93.303 Assurances for small institutions.
93.304 Institutional policies and procedures.
93.305 Responsibility for maintenance and custody of research
records and evidence.
93.306 Using a consortium or other entity for research misconduct
proceedings.
The Institutional Inquiry
93.307 Institutional inquiry.
93.308 Notice of the results of the inquiry.
93.309 Reporting to ORI on the decision to initiate an investigation
.
The Institutional Investigation
93.310 Institutional investigation.
93.311 Investigation time limits.
93.312 Opportunity to comment on the investigation report.
93.313 Institutional investigation report.
93.314 Institutional appeals.
93.315 Notice to ORI of institutional findings and actions.
93.316 Completing the research misconduct process.
Other Institutional Responsibilities
93.317 Retention and custody of the research misconduct proceeding
record.
93.318 Notifying ORI of special circumstances.
93.319 Institutional standards.
Subpart D--Responsibilities of the U.S. Department of Health and Human
Services
General Information
93.400 General statement of ORI authority.
93.401 Communications with other offices and interim actions.
Research Misconduct Issues
93.402 ORI allegation assessments.
93.403 ORI review of research misconduct proceedings.
93.404 HHS findings on research misconduct proceedings.
93.405 Notifying the respondent of findings of research misconduct
and HHS administrative actions.
93.406 Final HHS actions.
93.407 HHS administrative actions.
93.408 Mitigating and aggravating factors in HHS administrative
actions.
93.409 Settlement of research misconduct proceedings.
93.410 Final HHS action with no settlement or finding of research
misconduct.
93.411 Final HHS action with a settlement or finding of research
misconduct.
Institutional Compliance Issues
93.412 Making decisions on institutional noncompliance.
93.413 HHS compliance actions.
Disclosure of Information
93.414 Notice.
Subpart E--Opportunity To Contest PHS Findings of Research Misconduct
and HHS Administrative Actions
General Information
93.500 General policy.
93.501 Opportunity to contest PHS findings of research misconduct
and HHS administrative actions.
Hearing Process
93.502 Appointment of the Administrative Law Judge and scientific
expert.
93.503 Grounds for granting a hearing request.
93.504 Grounds for dismissal of a hearing request.
93.505 Rights of the parties.
93.506 Authority of the Administrative Law Judge .
93.507 Ex parte communications.
93.508 Filing, forms, and service.
93.509 Computation of time.
93.510 Filing motions.
93.511 Prehearing conferences.
93.512 Discovery.
93.513 Submission of witness lists, witness statements, and
exhibits.
93.514 Amendment to the charge letter.
93.515 Actions for violating an order or for disruptive conduct.
93.516 Standard and burden of proof.
93.517 The hearing.
93.518 Witnesses.
93.519 Admissibility of evidence.
93.520 The record.
93.521 Correction of the transcript.
93.522 Filing post-hearing briefs.
93.523 The Administrative Law Judge's ruling.
Authority: 42 U.S.C. 216, 241, and 289b.
Sec. 93.25 Organization of this part.
This part is subdivided into five subparts. Each subpart contains
information related to a broad topic or specific audience with special
responsibilities as shown in the following table.
------------------------------------------------------------------------
You will find provisions
In subpart . . . related to . . .
------------------------------------------------------------------------
A General information about this
rule.
B Definitions of terms used in
this part.
C Responsibilities of
institutions with PHS support.
D Responsibilities of the U.S.
Department of Health and Human
Services and the Office of
Research Integrity.
E Information on how to contest
PHS research misconduct
findings and HHS
administrative actions.
------------------------------------------------------------------------
Sec. 93.50 Special terms.
This part uses terms throughout the text that have special meaning.
Those terms are defined in subpart B of this part.
Subpart A--General
Sec. 93.100 General policy.
(a) The U.S. Department of Health and Human Services (HHS) and
institutions, including individual researchers who apply for or receive
Public Health Service (PHS) support for biomedical or behavioral
research, biomedical or behavioral research training, or activities
related to that research or training share responsibility for the
integrity of the research process. HHS has ultimate oversight authority
for PHS supported research, and for taking other actions as appropriate
or necessary, including the right to assess allegations and perform
inquiries or investigations at any time. Institutions have primary
responsibility for reporting and responding to allegations of research
misconduct.
(b) Under this regulation and Section 493 of the PHS Act, 42 U.S.C.
289b, each institution that applies for or receives PHS support for any
biomedical or behavioral research or research training activity must
comply with this part in responding to allegations of research
misconduct occurring at or involving research or research training
projects or staff of the institution.
(c) Research misconduct involving PHS support is contrary to the
interests of the PHS and the Federal government and to the health and
safety of the
[[Page 20790]]
public, to the integrity of research, and to the conservation of the
public fisc.
(d) Institutions that apply for or receive PHS support and persons
who work on PHS supported biomedical or behavioral research, biomedical
or behavioral research training or activities related to that research
or research training have an affirmative duty to protect those funds
from misuse by ensuring the integrity of any research or research
training activities related to the PHS support and by responding to
allegations of research misconduct as provided in this part.
Sec. 93.101 Purpose.
The purpose of this part is to--
(a) Establish the responsibilities of HHS, PHS, the Office of
Research Integrity (ORI), and institutions in responding to research
misconduct issues;
(b) Define what constitutes misconduct in PHS supported research;
(c) Define the general types of administrative actions HHS and the
PHS may take in response to research misconduct; and
(d) Require institutions to develop and implement policies and
procedures for--
(1) Reporting and responding to allegations of research misconduct
in connection with PHS supported research;
(2) Providing ORI with the assurances necessary to permit the
institutions to participate in PHS supported research.
(e) Protect the health and safety of the public, promote the
integrity of PHS supported research and the research process, and
conserve the public fisc.
Sec. 93.102 Applicability.
(a) This part applies to allegations of research misconduct and
research misconduct involving PHS supported biomedical or behavioral
extramural and intramural research, biomedical or behavioral research
training programs, or activities related to that research or research
training. This includes any research proposed, performed, reviewed, or
reported, or any research record generated from that research,
regardless of whether the user or reviewer receives PHS support or
whether an application or proposal for PHS funds resulted in a grant,
contract, cooperative agreement, or other form of PHS support.
(b) This part does not supersede or establish an alternative to any
existing regulations or procedures for handling fiscal improprieties,
the ethical treatment of human or animal subjects, criminal matters,
personnel actions against Federal employees, or actions taken under the
HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR
subparts 9.4 and 309.4.
(c) This part does not prohibit or otherwise limit how institutions
handle allegations of misconduct that do not fall within this part's
definition of research misconduct or that do not involve PHS support.
Sec. 93.103 Research misconduct.
Research misconduct means fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting
research results.
(a) Fabrication is making up data or results and recording or
reporting them.
(b) Falsification is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.
(c) Plagiarism is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.
(d) Research misconduct does not include honest error or
differences of opinion.
Sec. 93.104 Requirements for findings of research misconduct.
A finding of research misconduct made under this part requires
that--
(a) There be a significant departure from accepted practices of the
relevant research community; and
(b) The misconduct be committed intentionally, knowingly, or
recklessly; and
(c) The allegation be proven by a preponderance of the evidence.
Sec. 93.105 Time limitations.
(a) Six year limitation. This part applies only to research
misconduct occurring within six years before the date HHS or an
institution receives an allegation of research misconduct.
(b) Exceptions to the six year limitation. Paragraph (a) of this
section does not apply in the following instances:
(1) Subsequent use exception. The respondent continues or renews
any incident of alleged research misconduct that occurred before the
six year limitation through the use or republication of the fabricated,
falsified, or plagiarized research record.
(2) Health or safety of the public exception. If ORI, or the
institution following consultation with ORI, determines that the
alleged misconduct, if it occurred, would possibly have a substantial
adverse effect on the health or safety of the public.
(3) ``Grandfather'' exception. If HHS or an institution had the
allegation of research misconduct under review or investigation on the
effective date of this regulation.
Sec. 93.106 Evidentiary standards.
The following evidentiary standards apply to findings made under
this part.
(a) Burden of proof. (1) The institution or HHS has the burden of
proof for making a finding of research misconduct. The absence of, or
respondent's failure to provide, research records adequately
documenting the questioned research establishes a rebuttable
presumption of research misconduct that may be relied upon by the
institution or HHS in proving research misconduct. Credible evidence
corroborating the research or providing a reasonable explanation for
the absence of, or respondent's failure to provide, the research
records may be used by the respondent to rebut this presumption.
(2) Once the institution or HHS makes a prima facie showing of
research misconduct, the respondent has the burden of proving any
affirmative defenses raised, including any honest error or differences
of opinion and of proving any mitigating factors that the respondent
wants the institution or HHS to consider in imposing administrative
actions following research misconduct proceedings.
(b) Standard of proof. An institutional or HHS finding of research
misconduct must be established by a preponderance of the evidence.
Sec. 93.107 Rule of interpretation.
Any interpretation of this part must further the policy and purpose
of the PHS and the Federal government to protect the health and safety
of the public, to promote the integrity of research, and to conserve
the public fisc.
Sec. 93.108 Confidentiality.
(a) Disclosure of the identity of respondents and complainants in
research misconduct proceedings is limited, to the extent possible, to
those who need to know, consistent with a thorough, competent,
objective and fair research misconduct proceeding, and as allowed by
law. Provided, however, under section 93.517(g), PHS administrative
hearings must be open to the public.
(b) Except as may otherwise be prescribed by applicable law,
confidentiality must be maintained for any records or evidence from
which research subjects might be identified. Disclosure is limited to
those who have
[[Page 20791]]
a need to know to carry out a research misconduct proceeding.
Sec. 93.109 Coordination with other agencies.
(a) When more than one agency of the federal government has
jurisdiction of the subject misconduct allegation, the agencies may
coordinate responses to the allegation.
(b) In cases involving more than one agency, HHS may refer to
evidence or reports developed by that agency if HHS determines that the
evidence or reports will assist in resolving HHS issues. In appropriate
cases, HHS will seek to resolve allegations jointly with the other
agency or agencies.
Subpart B--Definitions
Sec. 93.200 Administrative action.
Administrative action means--
(a) An HHS action in response to a research misconduct proceeding
taken to protect the health and safety of the public, to promote the
integrity of PHS supported research or research training, and to
conserve the public fisc; or
(b) An HHS action in response either to a breach of a material
provision of a settlement agreement in a research misconduct proceeding
or to a breach of any HHS debarment or suspension.
Sec. 93.201 Allegation.
Allegation means a disclosure of possible research misconduct
through any means of communication. The disclosure may be by written or
oral statement or other communication to an institutional or HHS
official.
Sec. 93.202 Charge letter.
Charge letter means the written notice, as well as any amendments
to the notice, that are sent to the respondent stating the PHS deciding
official's findings of research misconduct and any HHS administrative
actions. If the charge letter includes a debarment or suspension
action, it may be issued jointly by the deciding and debarring
officials.
Sec. 93.203 Complainant.
Complainant means a person who in good faith makes an allegation of
research misconduct.
Sec. 93.204 Contract.
Contract means an acquisition instrument awarded under the HHS
Federal Acquisition Regulation (FAR), 48 CFR Chapter 1, excluding any
small purchases awarded pursuant to FAR Part 13.
Sec. 93.205 Debarment or suspension.
Debarment or suspension means the Governmentwide exclusion, whether
temporary or for a set term, of a person from eligibility for Federal
grants, contracts, and cooperative agreements under the HHS regulations
at 45 CFR Part 76 (nonprocurement) and 48 CFR Subparts 9.4 and 309.4
(procurement).
Sec. 93.206 Debarring official.
Debarring official means an official authorized to impose debarment
or suspension. The HHS debarring official is either--
(a) The Secretary; or
(b) An official designated by the Secretary.
Sec. 93.207 Deciding official.
Deciding official means an official authorized to make PHS findings
of research misconduct and to impose HHS administrative actions. The
deciding official is either--
(a) The Secretary; or
(b) An official designated by the Secretary.
Sec. 93.208 Departmental Appeals Board or DAB.
Departmental Appeals Board or DAB means, depending on the context--
(a) The organization, within the Office of the Secretary,
established to conduct hearings and provide impartial review of
disputed decisions made by HHS operating components; or
(b) An Administrative Law Judge (ALJ) at the DAB.
Sec. 93.209 Evidence.
Evidence means any document, tangible item, or testimony offered or
obtained during a research misconduct proceeding that tends to prove or
disprove the existence of an alleged fact.
Sec. 93.210 Funding component.
Funding component means any organizational unit of the PHS
authorized to award grants, contracts, or cooperative agreements for
any activity that involves the conduct of biomedical or behavioral
research or research training, e.g., agencies, bureaus, centers,
institutes, divisions, or offices and other awarding units within the
PHS.
Sec. 93.211 Good faith.
Good faith means having a belief in the truth of one's allegation
or testimony that a reasonable person in the complainant's or witness's
position could have based on the information known to the complainant
or witness at the time. An allegation or cooperation with a research
misconduct proceeding is not in good faith if made with knowing or
reckless disregard for information that would negate the allegation or
testimony.
Sec. 93.212 Hearing.
Hearing means that part of the research misconduct proceeding from
the time a respondent files a request for an administrative hearing to
contest PHS findings of research misconduct and HHS administrative
actions until the time the hearing officer issues a recommended
decision.
Sec. 93.213 Inquiry.
Inquiry means preliminary information-gathering and preliminary
fact-finding to determine whether an allegation or apparent instance of
research misconduct has substance and if an investigation is warranted.
Sec. 93.214 Institution.
Institution means any individual or entity that applies for or
receives PHS support for any activity or program that involves the
conduct of biomedical or behavioral research, biomedical or behavioral
research training, or activities related to that research or training.
This includes, but is not limited to, colleges and universities, PHS
intramural biomedical or behavioral research laboratories, research and
development centers, national user facilities, industrial laboratories
or other research institutes, small research institutions, and
independent researchers.
Sec. 93.215 Institutional member.
Institutional member or members means a person who is employed by,
is an agent of, or is affiliated by contract or agreement with an
institution. Institutional members may include, but are not limited to,
officials, teaching and support staff, researchers, clinical
technicians, fellows, students, volunteers, agents, and contractors,
subcontractors, and subawardees, and their employees.
Sec. 93.216 Investigation.
Investigation means the formal development of a factual record and
the examination of that record leading to a decision not to make a
finding of research misconduct or to a recommendation for a finding of
research misconduct or other appropriate remedies, including
administrative actions.
Sec. 93.217 Notice.
Notice means a written communication served in person, sent by mail
or its equivalent to the last known street address, facsimile number or
e-mail address of the addressee. Several sections of Subpart E have
special notice requirements.
[[Page 20792]]
Sec. 93.218 Office of Research Integrity or ORI.
Office of Research Integrity or ORI means the office to which the
HHS Secretary has delegated responsibility for addressing research
integrity and misconduct issues related to PHS activities.
Sec. 93.219 Person.
Person means any individual, corporation, partnership, institution,
association, unit of government, or legal entity, however organized.
Sec. 93.220 Preponderance of the evidence.
Preponderance of the evidence means proof by information that,
compared with that opposing it, leads to the conclusion that the fact
at issue is more probably true than not.
Sec. 93.221 Prima facie showing.
Prima facie showing means evidence that on its face is sufficient
to establish research misconduct in the absence of respondent's
presentation of substantial contradictory evidence.
Sec. 93.222 Public Health Service or PHS.
Public Health Service or PHS means the unit within the Department
of Health and Human Services that includes the Office of Public Health
and Science and the following Operating Divisions: Agency for
Healthcare Research and Quality, Agency for Toxic Substances and
Disease Registry, Centers for Disease Control and Prevention, Food and
Drug Administration, Health Resources and Services Administration,
Indian Health Service, National Institutes of Health, and the Substance
Abuse and Mental Health Services Administration, and the offices of the
Regional Health Administrators.
Sec. 93.223 PHS support.
PHS support means PHS funding, or applications or proposals
therefor, for biomedical or behavioral research, biomedical or
behavioral research training, or activities related to that research or
training, that may be provided through: Funding for PHS intramural
research; grants, cooperative agreements, or contracts; or subgrants,
subcontracts, or other payments under grants, cooperative agreements,
or contracts.
Sec. 93.224 Research.
Research means a systematic experiment, study, evaluation,
demonstration or survey designed to develop or contribute to general
knowledge (basic research) or specific knowledge (applied research)
relating broadly to public health by establishing, discovering,
developing, elucidating or confirming information about, or the
underlying mechanism relating to, biological causes, functions or
effects, diseases, treatments, or related matters to be studied.
Sec. 93.225 Research misconduct proceeding.
Research misconduct proceeding means any actions related to alleged
research misconduct taken under this part, including but not limited
to, allegation assessments, inquiries, investigations, ORI oversight
reviews, hearings, and administrative appeals.
Sec. 93.226 Research record.
Research record means the record of data or results that embody the
facts resulting from scientific inquiry, including but not limited to,
research proposals, laboratory records, both physical and electronic,
progress reports, abstracts, theses, oral presentations, internal
reports, journal articles, and any documents and materials provided to
HHS or an institutional official by a respondent in response to
questions about the research at issue.
Sec. 93.227 Respondent.
Respondent means the person against whom an allegation of research
misconduct is directed or who is the subject of a research misconduct
proceeding.
Sec. 93.228 Retaliation.
Retaliation for the purpose of this part means an adverse action
taken against a complainant, witness, or committee member by an
institution or one of its members in response to--
(a) A good faith allegation of research misconduct; or
(b) Good faith cooperation with a research misconduct proceeding.
Sec. 93.229 Secretary or HHS.
Secretary or HHS means the Secretary of HHS or any other officer or
employee of the HHS to whom the Secretary delegates authority.
Subpart C--Responsibilities of Institutions
Compliance and Assurances
Sec. 93.300 General responsibilities for compliance.
Institutions under this part must--
(a) Have written policies and procedures for conducting and
reporting inquiries and investigations of alleged research misconduct
in compliance with this part;
(b) Respond to each allegation of research misconduct at the
institution involving PHS supported research in compliance with this
part;
(c) Foster a research environment that promotes the responsible
conduct of research and research training, discourages research
misconduct, and deals promptly with allegations or evidence of possible
research misconduct;
(d) Take all reasonable and practical steps to protect the
positions and reputations of good faith complainants, witnesses and
committee members and protect them from retaliation by respondents and
other institutional members;
(e) Provide confidentiality to the extent required by Sec. 93.108
to all respondents, complainants, and research subjects identifiable
from research records or evidence;
(f) Take all reasonable and practical steps to ensure the
cooperation of respondents and other institutional members with
research misconduct proceedings, including, but not limited to, their
providing information, research records, and evidence;
(g) Cooperate with HHS during any research misconduct proceeding or
compliance review;
(h) Assist in administering and enforcing any HHS administrative
actions imposed on its institutional members; and
(i) Have an active assurance of compliance.
Sec. 93.301 Institutional assurances.
(a) General policy. An institution with PHS supported biomedical or
behavioral research, biomedical or behavioral research training or
activities related to that research or training must provide PHS with
an assurance of compliance with this part, satisfactory to the
Secretary. PHS funding components may authorize funds for biomedical
and behavioral research, research training, and related activities only
to institutions that have approved assurances and required renewals on
file with ORI.
(b) Institutional Assurance. The responsible institutional official
must assure on behalf of the institution that the institution--
(1) Has written policies and procedures in compliance with this
part for inquiring into and investigating allegations of research
misconduct; and
(2) Complies with its own policies and procedures and the
requirements of this part.
Sec. 93.302 Institutional compliance with assurances.
(a) Compliance with assurance. ORI considers an institution in
compliance with its assurance if the institution--
[[Page 20793]]
(1) Establishes policies and procedures according to this part,
keeps them in compliance with this part, and upon request, provides
them to ORI and to other authorized HHS personnel;
(2) Takes all reasonable and practical specific steps to foster
research integrity consistent with Sec. 93.300, including--
(i) Informs the institution's research members participating in or
otherwise involved with PHS supported biomedical or behavioral
research, research training or related activities, including those
applying for support from any PHS funding component, about its policies
and procedures for responding to allegations of research misconduct,
and the institution's commitment to compliance with the policies and
procedures; and
(ii) Complies with its policies and procedures and each specific
provision of this part.
(b) Annual report. An institution must file an annual report with
ORI which contains information specified by ORI on the institution's
compliance with this part.
(c) Additional information. Along with its assurance or annual
report, an institution must send ORI other aggregated information on
research misconduct proceedings and compliance with the requirements of
this part that ORI may request.
Sec. 93.303 Assurances for small institutions.
(a) If an institution is too small to handle research misconduct
proceedings, it may file a ``Small Organization Statement'' with ORI in
place of the formal institutional policies and procedures required by
Sec. 93.301.
(b) By submitting a Small Organization Statement, the institution
agrees to report all allegations of research misconduct to ORI. ORI or
another appropriate HHS office will work with the institution to
develop and implement a process for handling allegations of research
misconduct consistent with this part.
(c) The Small Organization Statement does not relieve the
institution from complying with any other provision of this part.
Sec. 93.304 Institutional policies and procedures.
Institutions seeking an approved assurance must have written
policies and procedures for addressing research misconduct that include
the following--
(a) Consistent with Sec. 93.108, protection of the confidentiality
of respondents, complainants, and research subjects identifiable from
research records or evidence;
(b) A thorough, competent, objective, and fair response to
allegations of research misconduct consistent with and within the time
limits of this part;
(c) Notice to the respondent, consistent with and within the time
limits of this part;
(d) Written notice to ORI of any decision to open an investigation
either within 30 days of the decision or before the date the
investigation begins, whichever happens first;
(e) Opportunity for the respondent to provide written comments on
the institution's inquiry report;
(f) Opportunity for the respondent to provide written comments on
the draft report of the investigation, and provisions for the
institutional investigation committee to consider and address the
comments before issuing the final report;
(g) Protocols for handling the research record and evidence,
including the requirements of Sec. 93.305;
(h) Appropriate interim institutional actions to protect public
health, Federal funds and equipment, and the integrity of the PHS
supported research process;
(i) Notice to ORI under `` 93.318 and notice of any facts that may
be relevant to protect public health, Federal funds and equipment, and
the integrity of the PHS supported research process;
(j) Institutional actions in response to final findings of research
misconduct;
(k) All reasonable and practical efforts, if requested and as
appropriate, to protect or restore the reputation of persons alleged to
have engaged in research misconduct but against whom no finding of
research misconduct is made;
(l) All reasonable and practical efforts to protect or restore the
position and reputation of any complainant, witness, or committee
member and to counter potential or actual retaliation against these
complainants, witnesses, and committee members; and
(m) Full and continuing cooperation with ORI during its oversight
review under Subpart D of this part or any subsequent administrative
hearings or appeals under Subpart E of this part. This includes
providing all research records and evidence under the institution's
control, custody, or possession and access to all persons within its
authority necessary to develop a complete record of relevant and
material evidence.
Sec. 93.305 Responsibility for maintenance and custody of research
records and evidence.
An institution, as the responsible legal entity for the PHS
supported research, has a continuing obligation under this part to
ensure that it maintains adequate records for a research misconduct
proceeding. The institution must--
(a) Either before or when the institution notifies the respondent
of the allegation, inquiry or investigation, promptly take all
reasonable and practical efforts to obtain custody of all the research
records and evidence needed to conduct the research misconduct
proceeding, inventory the records and evidence, and sequester them in a
secure manner;
(b) Where appropriate, give the respondent copies of or reasonable,
supervised access to the research records;
(c) Undertake all reasonable and practical efforts to take custody
of additional research records or evidence that are discovered during
the course of a research misconduct proceeding; and
(d) Maintain the research records and evidence until ORI requests
them, HHS takes final action, or as required by Sec. 93.317, as
applicable.
Sec. 93.306 Using a consortium or other entity for research
misconduct proceedings.
(a) If an institution is too small, is otherwise unable to respond
to allegations of research misconduct because of real or apparent
conflicts of interest, lacks the capacity, or otherwise prefers not to
conduct its own research misconduct proceeding, it may use the services
of a consortium or other entity qualified by practice and experience to
conduct research misconduct proceedings.
(b) A consortium may be a group of institutions, professional
organizations, or mixed groups which will conduct research misconduct
proceedings for other institutions.
(c) A consortium or entity acting on behalf of an institution must
follow the requirements of this part in conducting research misconduct
proceedings.
The Institutional Inquiry
Sec. 93.307 Institutional inquiry.
(a) Criteria warranting an inquiry. An inquiry is warranted if the
allegation--
(1) Falls within the definition of research misconduct under this
part;
(2) Involves PHS supported research; and
(3) Is sufficiently credible and specific so that potential
evidence of research misconduct may be identified.
(b) Notice. At the time of or before beginning an inquiry, an
institution must make a good faith effort to notify in writing the
presumed respondent, if any. If the inquiry subsequently identifies
additional respondents, the institution must notify them.
[[Page 20794]]
(c) Review of evidence. The purpose of an inquiry is to conduct an
initial review of the evidence to determine whether to conduct an
investigation. Therefore, an inquiry does not require a full review of
all the evidence related to the allegation.
(d) Criteria warranting an investigation. An inquiry's purpose is
to decide if an allegation warrants an investigation. An investigation
is warranted if there is--
(1) A reasonable basis for concluding that the allegation involves
PHS supported research and falls within the PHS definition of research
misconduct; and
(2) Preliminary information-gathering and preliminary fact-finding
from the inquiry indicates that the allegation may have substance.
(e) Inquiry report. The institution must prepare a written report
that meets the requirements of Sec. 93.309.
(f) Opportunity to comment. The institution must provide the
respondent an opportunity to review and comment on the inquiry report
and attach any comments received to the report.
(g) Time for completion. The institution must complete the inquiry
within 60 calendar days of its initiation unless circumstances clearly
warrant a longer period. If the inquiry takes longer than 60 days to
complete, the inquiry record must include documentation of the reasons
for exceeding the 60-day period.
Sec. 93.308 Notice of the results of the inquiry.
(a) Notice to respondent. The institution must notify the
respondent whether the inquiry found that an investigation is
warranted. The notice must include a copy of the inquiry report and
include or refer to a copy of this part and the institution's policies
and procedures adopted under its assurance.
(b) Notice to complainants. The institution may notify the
complainant who made the allegation whether the inquiry found that an
investigation is warranted. The institution may provide relevant
portions of the report to any complainant for comment.
Sec. 93.309 Reporting to ORI on the decision to initiate an
investigation.
(a) Within 30 days of finding that an investigation is warranted,
the institution must provide ORI with the written finding by the
responsible institutional official and a copy of the inquiry report
which includes the following information--
(1) The name and position of the respondent;
(2) A description of the allegations of research misconduct;
(3) The PHS support, including, for example, grant numbers, grant
applications, contracts, and publications listing PHS support;
(4) The basis for recommending that the alleged actions warrant an
investigation; and
(5) Any comments on the report by the respondent, complainant, or a
witness.
(b) The institution must provide the following information to ORI
on request--
(1) The institutional policies and procedures under which the
inquiry was conducted;
(2) The research records and evidence reviewed, transcripts or
recordings of any interviews, and copies of all relevant documents; and
(3) The charges for the investigation to consider.
(c) Documentation of decision not to investigate. Institutions must
keep sufficiently detailed documentation of inquiries to permit a later
assessment by ORI of the reasons why the institution decided not to
conduct an investigation. Consistent with section 93.317, institutions
must keep these records in a secure manner for at least 7 years after
the termination of the inquiry, and upon request, provide them to ORI
or other authorized HHS personnel.
(d) Notification of special circumstances. In accordance with Sec.
93.318, institutions must notify ORI and other PHS agencies, as
relevant, of any special circumstances that may exist.
The Institutional Investigation
Sec. 93.310 Institutional investigation.
Institutions conducting research misconduct investigations must:
(a) Time. Begin the investigation within 30 days after determining
that an investigation is warranted.
(b) Notice to ORI. Notify the ORI Director of the decision to begin
an investigation on or before the date the investigation begins and
provide an inquiry report that meets the requirements of Sec. 93.309.
(c) Notice to the respondent. Notify the respondent in writing of
the allegations within a reasonable amount of time after determining
that an investigation is warranted, but before the investigation
begins. The institution must give the respondent written notice of any
new allegations of research misconduct within a reasonable amount of
time of deciding to pursue allegations not addressed during the inquiry
or in the initial notice of investigation.
(d) Custody of the records. Take custody of and sequester any
relevant research records and evidence needed to conduct the
investigation not taken into custody at the allegation or inquiry
stage. Whenever possible, the institution must take custody of the
records--
(1) Before or at the time the institution notifies the respondent;
and
(2) Whenever additional items become known or relevant to the
investigation.
(e) Documentation. Use diligent efforts to ensure that the
investigation is thorough and sufficiently documented and includes
examination of all research records and evidence relevant to reaching a
decision on the merits of the allegations.
(f) Ensuring a fair investigation. Take reasonable steps to ensure
an impartial and unbiased investigation to the maximum extent
practicable, including participation of persons with appropriate
scientific expertise who do not have unresolved personal, professional,
or financial conflicts of interest with those involved with the inquiry
or investigation.
(g) Interviews. Interview each respondent, complainant, and any
other available person who may have substantive information regarding
any relevant aspects of the investigation, including witnesses
identified by the respondent, and maintain detailed records. Record or
transcribe each interview, provide the recording or transcript to the
interviewee for correction, and include the recording or transcript in
the record of the investigation.
(h) Pursue leads. Pursue diligently all significant issues and
leads discovered, including any evidence of additional instances of
possible research misconduct, and continue the investigation to
completion.
Sec. 93.311 Investigation time limits.
(a) Time limit for completing an investigation. An institution must
complete all aspects of an investigation within 120 days of beginning
it, including conducting the investigation, preparing the report of
findings, giving the draft report to the respondent for comment, and
sending the final report to ORI under Sec. 93.315.
(b) Extension of time limit. If unable to complete the
investigation in 120 days, the institution must ask ORI for an
extension in writing.
(c) If ORI grants an extension, it may direct the institution to
file periodic progress reports.
[[Page 20795]]
Sec. 93.312 Opportunity to comment on the investigation report.
(a) The institution must give the respondent a copy of the draft
investigation report for review and comment within 30 days of the
respondent's receipt of the draft report; and
(b) The institution may provide relevant portions of the report to
complainants for comment within 30 days of their receipt of the
relevant portions of the report.
Sec. 93.313 Institutional investigation report.
The final institutional investigation report must be in writing and
include:
(a) Allegations. Describe the nature of the allegations of research
misconduct.
(b) PHS support. Describe and document the PHS support, including,
for example, any grant numbers, grant applications, contracts, and
publications listing PHS support.
(c) Institutional charge. Describe the specific allegations of
research misconduct for consideration in the investigation.
(d) Policies and procedures. If not already provided to ORI with
the inquiry report, include the institutional policies and procedures
under which the investigation was conducted.
(e) Research records and evidence. Identify and summarize the
research records and evidence reviewed, and identify any evidence taken
into custody but not reviewed.
(f) Statement of findings. For each separate allegation of research
misconduct identified during the investigation, provide a finding as to
whether research misconduct did or did not occur, and if so--
(1) Identify whether the research misconduct was falsification,
fabrication, or plagiarism, and if it was intentional, knowing, or in
reckless disregard;
(2) Summarize the facts and the analysis which support the
conclusion and consider the merits of any reasonable explanation by the
respondent;
(3) Identify the specific PHS support;
(4) Identify whether any publications need correction or
retraction;
(5) Identify the person(s) responsible for the misconduct; and
(6) List any current support or known applications or proposals for
support that the respondent has pending with non-PHS Federal agencies.
(g) Comments. Include and consider any comments made by the
respondent and complainant on the draft investigation report.
(h) Maintain and provide records. Maintain and provide to ORI upon
request all relevant research records, including results of all
interviews and the transcripts or recordings of such interviews.
Sec. 93.314 Institutional appeals.
(a) While not required by this part, if the institution's
procedures provide for appeal by the respondent, the institution must
complete any appeals within 120 days of filing the appeal.
(b) If unable to complete any appeals within 120 days, the
institution must ask ORI for an extension in writing and provide an
explanation for the request.
(c) ORI may grant requests for extension for good cause. If ORI
grants an extension, it may direct the institution to file periodic
progress reports.
Sec. 93.315 Notice to ORI of institutional findings and actions.
The institution must give ORI the following:
(a) Investigation Report. Include a copy of the report, all
attachments, and any appeals.
(b) Final institutional action. State whether the institution found
research misconduct, and if so, who committed the misconduct.
(c) Findings. State whether the institution accepts the
investigation's findings.
(d) Institutional administrative actions. Describe any pending or
completed administrative actions against the respondent.
Sec. 93.316 Completing the research misconduct process.
(a) ORI expects institutions to carry inquiries and investigations
through to completion and to pursue diligently all significant issues.
If an institution plans to end an inquiry or investigation before
completion for any reason, including an admission of misconduct by the
respondent, it must contact ORI before closing the case and submitting
its final report.
(b) After review of an institution's decision to end an inquiry or
investigation before completion, ORI may direct the institution to
complete its process or refer the matter for further investigation by
HHS.
Other Institutional Responsibilities
Sec. 93.317 Retention and custody of the research misconduct
proceeding record.
(a) Maintenance of record. Institutions must maintain records of
research misconduct proceedings in a secure manner for 7 years after
their completion or the completion of any PHS proceeding involving the
research misconduct allegation under subparts D and E of this part,
whichever is later.
(b) Provision for HHS custody. On request, institutions must
transfer custody of or provide copies to HHS, of any institutional
record relevant to a research misconduct allegation covered by this
part, including the research records and evidence, to perform forensic
or other analyses or as otherwise needed to conduct an HHS inquiry or
investigation or for ORI to conduct its review or to present evidence
in any PHS proceeding under subparts D and E of this part.
Sec. 93.318 Notifying ORI of special circumstances.
At any time during a research misconduct proceeding, as defined in
section 93.225, an institution must notify ORI immediately if it has
reason to believe that any of the following conditions exist:
(a) Health or safety of the public is at risk, including an
immediate need to protect human or animal subjects.
(b) HHS resources or interests are threatened.
(c) Research activities should be suspended.
(d) There is reasonable indication of possible violations of civil
or criminal law.
(e) Federal action is required to protect the interests of those
involved in the research misconduct proceeding.
(f) The research institution believes the research misconduct
proceeding may be made public prematurely so that HHS may take
appropriate steps to safeguard evidence and protect the rights of those
involved.
(g) The research community or public should be informed.
Sec. 93.319 Institutional standards.
(a) Institutions may have internal standards of conduct different
from the PHS standards for research misconduct under this part.
Therefore, an institution may find conduct to be actionable under its
standards even if the action does not meet this part's definition of
research misconduct.
(b) An HHS finding or settlement does not affect institutional
findings or administrative actions based on an institution's internal
standards of conduct.
Subpart D--Responsibilities of the U.S. Department of Health an