Model Policy

for Responding to Allegations

of Research Misconduct

Table of Contents

[**I.** **Introduction** 1](#__RefHeading___Toc148145291)

[A. General Policy 1](#__RefHeading___Toc148145292)

[B. Scope 1](#__RefHeading___Toc148145293)

[**II.** **Definitions** 2](#__RefHeading___Toc148145294)

[A. *Allegation* 2](#__RefHeading___Toc148145295)

[B. *Complainant* 2](#__RefHeading___Toc148145296)

[C. *Deciding Official* 2](#__RefHeading___Toc148145297)

[D. *Evidence* 2](#__RefHeading___Toc148145298)

[E. *Good faith* 2](#__RefHeading___Toc148145299)

[F. *HHS* 3](#__RefHeading___Toc148145300)

[G. *Inquiry* 3](#__RefHeading___Toc148145301)

[H. *Institutional member* 3](#__RefHeading___Toc148145302)

[I. *Investigation* 3](#__RefHeading___Toc148145303)

[J. *Office of Research Integrity* 3](#__RefHeading___Toc148145304)

[K. *Preponderance of the evidence* 3](#__RefHeading___Toc148145305)

[L. *Public Health Service* or *PHS* 3](#__RefHeading___Toc148145306)

[M. *PHS support* 4](#__RefHeading___Toc148145307)

[N. *Records of research misconduct proceedings*
4](#__RefHeading___Toc148145308)

[O. *Research Integrity Officer* 4](#__RefHeading___Toc148145309)

[P. *Research misconduct* 4](#__RefHeading___Toc148145310)

[Q. *Research misconduct proceeding* 4](#__RefHeading___Toc148145311)

[R *Research* *record* 5](#__RefHeading___Toc148145312)

[S. *Respondent* 5](#__RefHeading___Toc148145313)

T[*. Retaliation* 5](#__RefHeading___Toc148145314)

[**III.** **Rights and Responsibilities**
5](#__RefHeading___Toc148145315)

[A. Research Integrity Officer 5](#__RefHeading___Toc148145316)

[B. Complainant 7](#__RefHeading___Toc148145317)

[C. Respondent 7](#__RefHeading___Toc148145318)

[D. Deciding Official 8](#__RefHeading___Toc148145319)

[**IV.** **General Policies and Principles**
9](#__RefHeading___Toc148145320)

[A. Responsibility to Report Misconduct 9](#__RefHeading___Toc148145321)

[B. Cooperation with Research Misconduct Proceedings
9](#__RefHeading___Toc148145322)

[C. Confidentiality 9](#__RefHeading___Toc148145323)

[D. Protecting complainants, witnesses, and committee members
10](#__RefHeading___Toc148145324)

[E. Protecting the Respondent 10](#__RefHeading___Toc148145325)

[F. Interim Administrative Actions and Notifying ORI of Special
Circumstances 10](#__RefHeading___Toc148145326)

[**V.** **Conducting the Assessment and Inquiry**
11](#__RefHeading___Toc148145327)

[A. Assessment of Allegations 11](#__RefHeading___Toc148145328)

[B. Initiation and Purpose of the Inquiry
11](#__RefHeading___Toc148145329)

[C. Notice to Respondent; Sequestration of Research Records
12](#__RefHeading___Toc148145330)

[D. Appointment of the Inquiry Committee
12](#__RefHeading___Toc148145331)

[E. Charge to the Committee and First Meeting
12](#__RefHeading___Toc148145332)

[F. Inquiry Process 13](#__RefHeading___Toc148145333)

[G. Time for Completion 13](#__RefHeading___Toc148145334)

[**VI.** **The Inquiry Report** 14](#__RefHeading___Toc148145335)

[A. Elements of the Inquiry Report 14](#__RefHeading___Toc148145336)

[B. Notification to the Respondent and Opportunity to Comment
14](#__RefHeading___Toc148145337)

[C. Institutional Decision and Notification
14](#__RefHeading___Toc148145338)

[1. Decision by Deciding Official 14](#__RefHeading___Toc148145339)

[2. Notification to ORI 15](#__RefHeading___Toc148145340)

[3. Documentation of Decision Not to Investigate
15](#__RefHeading___Toc148145341)

[**VII.** **Conducting the Investigation**
15](#__RefHeading___Toc148145342)

[A. Initiation and Purpose 15](#__RefHeading___Toc148145343)

[B. Notifying ORI and Respondent; Sequestration of Research Records
15](#__RefHeading___Toc148145344)

[C. Appointment of the Investigation Committee
16](#__RefHeading___Toc148145345)

[D. Charge to the Committee and the First Meeting
17](#__RefHeading___Toc148145346)

[1. Charge to the Committee 17](#__RefHeading___Toc148145347)

[2. First Meeting 17](#__RefHeading___Toc148145348)

[E. Investigation Process 18](#__RefHeading___Toc148145349)

[F. Time for Completion 18](#__RefHeading___Toc148145350)

[**VIII.** **The Investigation Report**
18](#__RefHeading___Toc148145351)

[A. Elements of the Investigation Report
18](#__RefHeading___Toc148145352)

[B. Comments on the Draft Report and Access to Evidence
19](#__RefHeading___Toc148145353)

[1. Respondent 19](#__RefHeading___Toc148145354)

[2. Complainant 20](#__RefHeading___Toc148145355)

[3. Confidentiality 20](#__RefHeading___Toc148145356)

[C. Decision by Deciding Official 20](#__RefHeading___Toc148145357)

[D. Appeals 20](#__RefHeading___Toc148145358)

[E. Notice to ORI of Institutional Findings and Actions
21](#__RefHeading___Toc148145359)

[**IX.** **Completion of Cases; Reporting Premature Closures to ORI**
21](#__RefHeading___Toc148145360)

[**X.** **Institutional Administrative Actions \[Optional\]**
21](#__RefHeading___Toc148145361)

[**XI.** **Other Considerations** 22](#__RefHeading___Toc148145362)

[A. Termination or Resignation Prior to Completing Inquiry or
Investigation 22](#__RefHeading___Toc148145363)

[B. Restoration of the Respondent\'s Reputation
22](#__RefHeading___Toc148145364)

[C. Protection of the Complainant, Witnesses and Committee Members
23](#__RefHeading___Toc148145365)

[D. Allegations Not Made in Good Faith 23](#__RefHeading___Toc148145366)

**Appendix A---Research Integrity Officer Responsibilities**

**MODEL POLICY FOR RESPONDING**

**TO ALLEGATIONS OF RESEARCH MISCONDUCT**

[]{.mark}

**This Model Policy is non-binding and is not intended to create any
right or benefit, substantive or procedural, enforceable at law by a
party against the United States, its agents, officers, or employees. It
has been developed to provide suggestions to institutions for their
research misconduct policies consistent with 42 CFR Part 93. In case of
any conflict between the Model Policy and 42 CFR Part 93, the regulation
shall prevail.**

**I. Introduction**[]{#__RefHeading___Toc148145291 .anchor}

> A. General Policy[]{#__RefHeading___Toc148145292 .anchor}

**\[NOTE: Institutions may wish to insert in this section general
statements about their philosophy and that of the scientific community
related to research integrity. These might include institutional values
related to the responsible conduct of research, a statement of
principles, and the institution\'s position on preventing misconduct in
research and protecting the positions and reputations of good faith
complainants, witnesses and committee members.\]**

> B. Scope[]{#__RefHeading___Toc148145293 .anchor}
>
> This policy is intended to carry out this institution's
> responsibilities under the Public Health Service (PHS) Policies on
> Research Misconduct, 42 CFR Part 93.[^1] This policy applies to
> allegations of research misconduct (fabrication, falsification, or
> plagiarism in proposing, performing, or reviewing research, or in
> reporting research results) involving:

-   A person who, at the time of the alleged research misconduct, was
    employed by, was an agent of, or was affiliated by contract or
    agreement with this institution;[^2] and

-   \(1\) PHS support biomedical or behavioral research, research
    training or activities related to that research or research
    training, such as the operation of tissue and data banks and the
    dissemination of research information, (2) applications or proposals
    for PHS support for biomedical or behavioral research, research
    training or activities related to that research or research
    training, or (3) plagiarism of research records produced in the
    course of PHS supported research, research training 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 an
    application or proposal for PHS funds resulted in a grant, contract,
    cooperative agreement, or other form of PHS support.[^3]

> This policy and the associated procedures do not apply to authorship
> or collaboration disputes and apply only to allegations of research
> misconduct that occurred within six years of the date the institution
> or HHS received the allegation, subject to the subsequent use, health
> or safety of the public, and grandfather exceptions in 42 CFR §
> 93.105(b).
>
> **\[Option: Under 42 CFR § 93.319 institutions may adopt additional
> standards of conduct that go beyond the PHS standards in 42 CFR Part
> 93. These additional standards may be included in the same policy
> document as the PHS standards, but if an institution chooses that
> option, it should make certain that the two sets of standards and
> actions under them are easily distinguishable. These additional
> institutional standards will apply only to the internal decisions at
> the institution. They must not apply to decisions made under 42 CFR
> Part 93.\]**

**II. Definitions**[]{#__RefHeading___Toc148145294 .anchor}

> A. *Allegation*[]{#__RefHeading___Toc148145295 .anchor} 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.[^4]
>
> B. *Complainant*[]{#__RefHeading___Toc148145296 .anchor} means a
> person who in good faith makes an allegation of research
> misconduct.[^5]
>
> C. *Deciding Official*[]{#__RefHeading___Toc148145297 .anchor} (DO)
> means the institutional official who makes final determinations on
> allegations of research misconduct and any institutional
> administrative actions. **\[[Optional addition]{.underline}: The
> Deciding Official will not be the same individual as the Research
> Integrity Officer and should have no direct prior involvement in the
> institution\'s inquiry, investigation, or allegation assessment. A
> Deciding Official's appointment of an individual to assess allegations
> of research misconduct, or to serve on an inquiry or investigation
> committee, is not considered to be direct prior involvement.\]**
>
> D. *Evidence*[]{#__RefHeading___Toc148145298 .anchor} 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.[^6]
>
> E. *Good faith*[]{#__RefHeading___Toc148145299 .anchor} as applied to
> a complainant or witness, 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 it is made
> with knowing or reckless disregard for information that would negate
> the allegation or testimony. Good faith as applied to a committee
> member means cooperating with the purpose of helping an institution
> meet its responsibilities under 42 CFR Part 93. A committee member
> does not act in good faith if his/her acts or omissions on the
> committee are dishonest or influenced by personal, professional, or
> financial conflicts of interest with those involved in the research
> misconduct proceeding.[^7]
>
> F. *HHS*[]{#__RefHeading___Toc148145300 .anchor} means the United
> States Department of Health and Human Services.
>
> G. *Inquiry*[]{#__RefHeading___Toc148145301 .anchor} means preliminary
> information-gathering and preliminary fact-finding that meets the
> criteria and follows the procedures of 42 CFR §§ 93.307-93.309.[^8]
>
> H. *Institutional member*[]{#__RefHeading___Toc148145302 .anchor}
> 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, tenured and untenured
> faculty, teaching and support staff, researchers, research
> coordinators, clinical technicians, postdoctoral and other fellows,
> students, volunteers, agents, and contractors, subcontractors, and
> subawardees, and their employees.[^9]
>
> I. *Investigation*[]{#__RefHeading___Toc148145303 .anchor} 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
> which may include a recommendation for other appropriate actions,
> including administrative actions.[^10]
>
> J. *Office of Research Integrity*[]{#__RefHeading___Toc148145304
> .anchor} or *ORI* means the office to which the HHS Secretary has
> delegated responsibility for addressing research integrity and
> misconduct issues related to PHS supported activities.[^11]

K. *Preponderance of the evidence*[]{#__RefHeading___Toc148145305
.anchor} 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.[^12]

> L. *Public Health Service* or *PHS*[]{#__RefHeading___Toc148145306
> .anchor} means the unit within HHS 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.[^13]
>
> M. *PHS support*[]{#__RefHeading___Toc148145307 .anchor} 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: PHS grants, cooperative agreements, or contracts or subgrants
> or subcontracts under those PHS funding instruments; or salary or
> other payments under PHS grants, cooperative agreements or
> contracts.[^14]
>
> N. *Records of research misconduct
> proceedings*[]{#__RefHeading___Toc148145308 .anchor} means: (1) the
> research records and evidence secured for the research misconduct
> proceeding pursuant to this policy and 42 CFR §§ 93.305, 93.307(b),
> and 93.310(d), except to the extent the Research Integrity Officer
> determines and documents that those records are not relevant to the
> proceeding or that the records duplicate other records that have been
> retained; (2) the documentation of the determination of irrelevant or
> duplicate records; (3) the inquiry report and final documents (not
> drafts) produced in the course of preparing that report, including the
> documentation of any decision not to investigate, as required by 42
> CFR § 93.309(c); (4) the investigation report and all records (other
> than drafts of the report) in support of the report, including the
> recordings or transcripts of each interview conducted; and (5) the
> complete record of any appeal within the institution from the finding
> of research misconduct.[^15]
>
> O. *Research Integrity Officer*[]{#__RefHeading___Toc148145309
> .anchor} (RIO) means the institutional official responsible for: (1)
> assessing allegations of research misconduct to determine if they fall
> within the definition of research misconduct, are covered by 42 CFR
> Part 93, and warrant an inquiry on the basis that the allegation is
> sufficiently credible and specific so that potential evidence of
> research misconduct may be identified; and (2) overseeing inquiries
> and investigations; and (3) the other responsibilities described in
> this policy. **\[[Option]{.underline}: A multi-campus institution or
> an institution with several large research components may wish to
> delegate these functions to more than one individual.\]**
>
> P. *Research misconduct*[]{#__RefHeading___Toc148145310 .anchor} means
> fabrication, falsification, or plagiarism in proposing, performing, or
> reviewing research, or in reporting research results. *Fabrication* is
> making up data or results and recording or reporting them.
> *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.
> Plagiarism is the appropriation of another person's ideas, processes,
> results, or words without giving appropriate credit. Research
> misconduct does not include honest error or differences of
> opinion.[^16]
>
> Q. *Research misconduct proceeding*[]{#__RefHeading___Toc148145311
> .anchor} means any actions related to alleged research misconduct that
> is within 42 CFR Part 93, including but not limited to, allegation
> assessments, inquiries, investigations, ORI oversight reviews,
> hearings and administrative appeals.[^17]

R. *Research* *record*[]{#__RefHeading___Toc148145312 .anchor} 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 the course of the research misconduct proceeding.[^18]
>
> S. *Respondent*[]{#__RefHeading___Toc148145313 .anchor} means the
> person against whom an allegation of research misconduct is directed
> or who is the subject of a research misconduct proceeding.[^19]
>
> T. *Retaliation*[]{#__RefHeading___Toc148145314 .anchor} means an
> adverse action taken against a complainant, witness, or committee
> member by this institution or one of its institutional members in
> response to (1) a good faith allegation of research misconduct; or (2)
> good faith cooperation with a research misconduct proceeding.[^20]

**III. Rights and Responsibilities**[]{#__RefHeading___Toc148145315
.anchor}

> A. Research Integrity Officer[]{#__RefHeading___Toc148145316 .anchor}
>
> The \[[designated institutional official]{.underline}\] will appoint
> \[**[Option]{.underline}: will serve as**\] the RIO who will have
> primary responsibility for implementation of the institution's
> policies and procedures on research misconduct. The RIO will be an
> institutional official who is well qualified to administer the
> procedures and is sensitive to the varied demands made on those who
> conduct research, those who are accused of research misconduct, those
> who make good faith allegations of research misconduct, and those who
> may serve on inquiry and investigation committees.
>
> A detailed listing of the responsibilities of the RIO is set forth in
> Appendix A. These responsibilities include the following duties
> related to research misconduct proceedings:

-   Consult confidentially with persons uncertain about whether to
    submit an allegation of research misconduct;

-   Receive allegations of research misconduct;

-   Assess each allegation of research misconduct in accordance with
    Section V.A. of this policy to determine whether it falls within the
    definition of research misconduct and warrants an inquiry;

-   As necessary, take interim action and notify ORI of special
    circumstances, in accordance with Section IV.F. of this policy;

-   Sequester research data and evidence pertinent to the allegation of
    research misconduct in accordance with Section V.C. of this policy
    and maintain it securely in accordance with this policy and
    applicable law and regulation;

[]{.mark}

-   Provide confidentiality to those involved in the research misconduct
    proceeding as required by 42 CFR § 93.108, other applicable law, and
    institutional policy;

-   Notify the respondent and provide opportunities for him/her to
    review/ comment/respond to allegations, evidence, and committee
    reports in accordance with Section III.C. of this policy;

[]{.mark}

-   Inform respondents, complainants, and witnesses of the procedural
    steps in the research misconduct proceeding;

-   Appoint the chair and members of the inquiry and investigation
    committees, ensure that those committees are properly staffed and
    that there is expertise appropriate to carry out a thorough and
    authoritative evaluation of the evidence;

[]{.mark}

-   Determine whether each person involved in handling an allegation of
    research misconduct has an unresolved personal, professional, or
    financial conflict of interest and take appropriate action,
    including recusal, to ensure that no person with such conflict is
    involved in the research misconduct proceeding;

-   In cooperation with other institutional officials, take all
    reasonable and practical steps to protect or restore the positions
    and reputations of good faith complainants, witnesses, and committee
    members and counter potential or actual retaliation against them by
    respondents or other institutional members;

-   Keep the Deciding Official and others who need to know apprised of
    the progress of the review of the allegation of research misconduct;

-   Notify and make reports to ORI as required by 42 CFR Part 93;

-   Ensure that administrative actions taken by the institution and ORI
    are enforced and take appropriate action to notify other involved
    parties, such as sponsors, law enforcement agencies, professional
    societies, and licensing boards of those actions; and

-   Maintain records of the research misconduct proceeding and make them
    available to ORI in accordance with Section VIII.F. of this policy.

> B. Complainant[]{#__RefHeading___Toc148145317 .anchor}
>
> The complainant is responsible for making allegations in good faith,
> maintaining confidentiality, and cooperating with the inquiry and
> investigation. As a matter of good practice, the complainant should be
> interviewed at the inquiry stage and given the transcript or recording
> of the interview for correction. The complainant must be interviewed
> during an investigation, and be given the transcript or recording of
> the interview for correction.[^21] **\[[Option]{.underline}: As a
> matter of policy or on the basis of case-by-case determinations, the
> institution may provide to the complainant for comment: (1) relevant
> portions of the inquiry report (within a timeframe that permits the
> inquiry to be completed within 60 days of its initiation); and (2) the
> draft investigation report or relevant portions of it. The institution
> must require that comments on the draft investigation report be
> submitted within 30 days of the date on which the complainant received
> the draft report. The institution must consider any comments made by
> the complainant on the draft investigation report and include those
> comments in the final investigation report.\]**
>
> C. Respondent[]{#__RefHeading___Toc148145318 .anchor}
>
> The respondent is responsible for maintaining confidentiality and
> cooperating with the conduct of an inquiry and investigation. The
> respondent is entitled to:

-   A good faith effort from the RIO to notify the respondent in writing
    at the time of or before beginning an inquiry;[^22]

-   An opportunity to comment on the inquiry report and have his/her
    comments attached to the report;[^23]

-   Be notified of the outcome of the inquiry, and receive a copy of the
    inquiry report that includes a copy of, or refers to 42 CFR Part 93
    and the institution's policies and procedures on research
    misconduct;[^24]

-   Be notified in writing of the allegations to be investigated within
    a reasonable time after the determination that an investigation is
    warranted, but before the investigation begins (within 30 days after
    the institution decides to begin an investigation), and be notified
    in writing of any new allegations, not addressed in the inquiry or
    in the initial notice of investigation, within a reasonable time
    after the determination to pursue those allegations;[^25]

-   Be interviewed during the investigation, have the opportunity to
    correct the recording or transcript, and have the corrected
    recording or transcript included in the record of the
    investigation;[^26]

[]{.mark}

-   Have interviewed during the investigation any witness who has been
    reasonably identified by the respondent as having information on
    relevant aspects of the investigation, have the recording or
    transcript provided to the witness for correction, and have the
    corrected recording or transcript included in the record of
    investigation;[^27] and

-   Receive a copy of the draft investigation report and, concurrently,
    a copy of, or supervised access to the evidence on which the report
    is based, and be notified that any comments must be submitted within
    30 days of the date on which the copy was received and that the
    comments will be considered by the institution and addressed in the
    final report.[^28]

> The respondent should be given the opportunity to admit that research
> misconduct occurred and that he/she committed the research misconduct.
> With the advice of the RIO and institutional legal counsel, the
> Deciding Official may terminate the institution's review of an
> allegation that has been admitted if the institution's acceptance of
> the admission and any proposed settlement is approved by ORI.[^29]
>
> **\[[Optional Addition]{.underline}: As provided in 42 CFR §
> 93.314(a), the respondent will have the opportunity to request an
> institutional appeal if the institution's procedures provide for an
> appeal.\]**
>
> D. Deciding Official[]{#__RefHeading___Toc148145319 .anchor}
>
> The DO will receive the inquiry report and after consulting with the
> RIO, decide whether an investigation is warranted under the criteria
> in 42 CFR § 93.307(d). Any finding that an investigation is warranted
> must be made in writing by the DO and must be provided to ORI,
> together with a copy of the inquiry report meeting the requirements of
> 42 CFR § 93.309, within 30 days of the finding. If it is found that an
> investigation is not warranted, the DO and the RIO will ensure that
> detailed documentation of the inquiry is retained for at least 7 years
> after termination of the inquiry, so that ORI may assess the reasons
> why the institution decided not to conduct an investigation.[^30]
>
> The DO will receive the investigation report and, after consulting
> with the RIO and other appropriate officials, decide the extent to
> which this institution accepts the findings of the investigation and,
> if research misconduct is found, decide what, if any, institutional
> administrative actions are appropriate. The DO shall ensure that the
> final investigation report, the findings of the DO and a description
> of the any pending or completed administrative action are provided to
> ORI, as required by 42 CFR § 93.315.

**IV. General Policies and Principles**[]{#__RefHeading___Toc148145320
.anchor}

> A. Responsibility to Report Misconduct[]{#__RefHeading___Toc148145321
> .anchor}
>
> All institutional members will report observed, suspected, or apparent
> research misconduct to the RIO **\[[Option]{.underline}: also list
> other officials\]**. Any official who receives an allegation of
> research misconduct must report it immediately to the RIO. If an
> individual is unsure whether a suspected incident falls within the
> definition of research misconduct, he or she may meet with or contact
> the RIO at [\[contact information\]]{.underline} to discuss the
> suspected research misconduct informally, which may include discussing
> it anonymously and/or hypothetically. If the circumstances described
> by the individual do not meet the definition of research misconduct,
> the RIO will refer the individual or allegation to other offices or
> officials with responsibility for resolving the problem.
>
> At any time, an institutional member may have confidential discussions
> and consultations about concerns of possible misconduct with the RIO
> **\[[Option]{.underline}: list other officials\]** and will be
> counseled about appropriate procedures for reporting allegations.

B. Cooperation with Research Misconduct
Proceedings[]{#__RefHeading___Toc148145322 .anchor}

> Institutional members will cooperate with the RIO and other
> institutional officials in the review of allegations and the conduct
> of inquiries and investigations. Institutional members, including
> respondents, have an obligation to provide evidence relevant to
> research misconduct allegations to the RIO or other institutional
> officials.
>
> C. Confidentiality[]{#__RefHeading___Toc148145323 .anchor}
>
> The RIO shall, as required by 42 CFR § 93.108 : (1) limit disclosure
> of the identity of respondents and complainants to those who need to
> know in order to carry out a thorough, competent, objective and fair
> research misconduct proceeding; and (2) except as otherwise prescribed
> by law, limit the disclosure of any records or evidence from which
> research subjects might be identified to those who need to know in
> order to carry out a research misconduct proceeding. The RIO should
> use written confidentiality agreements or other mechanisms to ensure
> that the recipient does not make any further disclosure of identifying
> information. **\[Option: The institution may want to provide
> confidentiality for witnesses when the circumstances indicate that the
> witnesses may be harassed or otherwise need protection.\]**
>
> D. Protecting complainants, witnesses, and committee
> members[]{#__RefHeading___Toc148145324 .anchor}

Institutional members may not retaliate in any way against complainants,
witnesses, or committee members. Institutional members should
immediately report any alleged or apparent retaliation against
complainants, witnesses or committee members to the RIO, who shall
review the matter and, as necessary, make all reasonable and practical
efforts to counter any potential or actual retaliation and protect and
restore the position and reputation of the person against whom the
retaliation is directed.

> E. Protecting the Respondent[]{#__RefHeading___Toc148145325 .anchor}
>
> As requested and as appropriate, the RIO and other institutional
> officials shall make all reasonable and practical efforts 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.[^31]
>
> During the research misconduct proceeding, the RIO is responsible for
> ensuring that respondents receive all the notices and opportunities
> provided for in 42 CFR Part 93 and the policies and procedures of the
> institution. Respondents may consult with legal counsel or a
> non-lawyer personal adviser (who is not a principal or witness in the
> case) to seek advice and may bring the counsel or personal adviser to
> interviews or meetings on the case. **\[[Option]{.underline}: Some
> institutions may decide not to permit the presence of lawyers at
> interviews or meetings with institutional officials. Some institutions
> that permit lawyers to be present at interviews and meetings restrict
> the lawyer's role to advising (as opposed to representing) the
> respondent.\]**

F. Interim Administrative Actions and Notifying ORI of Special
Circumstances[]{#__RefHeading___Toc148145326 .anchor}

> Throughout the research misconduct proceeding, the RIO will review the
> situation to determine if there is any threat of harm to public
> health, federal funds and equipment, or the integrity of the PHS
> supported research process. In the event of such a threat, the RIO
> will, in consultation with other institutional officials and ORI, take
> appropriate interim action to protect against any such threat.[^32]
> Interim action might include additional monitoring of the research
> process and the handling of federal funds and equipment, reassignment
> of personnel or of the responsibility for the handling of federal
> funds and equipment, additional review of research data and results or
> delaying publication. The RIO shall, at any time during a research
> misconduct proceeding, notify ORI immediately if he/she has reason to
> believe that any of the following conditions exist:

-   Health or safety of the public is at risk, including an immediate
    need to protect human or animal subjects;

-   HHS resources or interests are threatened;

-   Research activities should be suspended;

-   There is a reasonable indication of possible violations of civil or
    criminal law;

-   Federal action is required to protect the interests of those
    involved in the research misconduct proceeding;

-   The research misconduct proceeding may be made public prematurely
    and HHS action may be necessary to safeguard evidence and protect
    the rights of those involved; or

-   The research community or public should be informed.[^33]

**V. Conducting the Assessment and
Inquiry**[]{#__RefHeading___Toc148145327 .anchor}

> A. Assessment of Allegations[]{#__RefHeading___Toc148145328 .anchor}
>
> Upon receiving an allegation of research misconduct, the RIO will
> immediately assess the allegation to determine whether it is
> sufficiently credible and specific so that potential evidence of
> research misconduct may be identified, whether it is within the
> jurisdictional criteria of 42 CFR § 93.102(b), and whether the
> allegation falls within the definition of research misconduct in this
> policy and 42 CFR § 93.103.[^34] An inquiry must be conducted if these
> criteria are met.
>
> The assessment period should be brief, preferably concluded within a
> week. In conducting the assessment, the RIO need not interview the
> complainant, respondent, or other witnesses, or gather data beyond any
> that may have been submitted with the allegation, except as necessary
> to determine whether the allegation is sufficiently credible and
> specific so that potential evidence of research misconduct may be
> identified. The RIO shall, on or before the date on which the
> respondent is notified of the allegation, obtain custody of,
> inventory, and sequester all research records and evidence needed to
> conduct the research misconduct proceeding, as provided in paragraph
> C. of this section.

B. Initiation and Purpose of the Inquiry[]{#__RefHeading___Toc148145329
.anchor}

> If the RIO determines that the criteria for an inquiry are met, he or
> she will immediately initiate the inquiry process. The purpose of the
> inquiry is to conduct an initial review of the available evidence to
> determine whether to conduct an investigation. An inquiry does not
> require a full review of all the evidence related to the
> allegation.[^35]
>
> C. Notice to Respondent; Sequestration of Research
> Records[]{#__RefHeading___Toc148145330 .anchor}
>
> At the time of or before beginning an inquiry, the RIO must make a
> good faith effort to notify the respondent in writing, if the
> respondent is known. If the inquiry subsequently identifies additional
> respondents, they must be notified in writing. On or before the date
> on which the respondent is notified, or the inquiry begins, whichever
> is earlier, the RIO must take all reasonable and practical steps 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, except that where the
> research records or evidence encompass scientific instruments shared
> by a number of users, custody may be limited to copies of the data or
> evidence on such instruments, so long as those copies are
> substantially equivalent to the evidentiary value of the
> instruments.[^36] The RIO may consult with ORI for advice and
> assistance in this regard.
>
> D. Appointment of the Inquiry Committee[]{#__RefHeading___Toc148145331
> .anchor}
>
> The RIO, in consultation with other institutional officials as
> appropriate, will appoint an inquiry committee and committee chair
> within **\[suggested: 10 days\]** of the initiation of the inquiry or
> as soon thereafter as practical. The inquiry committee must consist of
> individuals who do not have unresolved personal, professional, or
> financial conflicts of interest with those involved with the inquiry
> and should include individuals with the appropriate scientific
> expertise to evaluate the evidence and issues related to the
> allegation, interview the principals and key witnesses, and conduct
> the inquiry.[^37] **\[Option: As an alternative, the institution may
> appoint a standing committee authorized to add or reuse members and
> use experts when necessary to evaluate specific allegations.\]
> \[Option: An institution may establish a procedure for notifying the
> respondent of the proposed committee membership to give the respondent
> an opportunity to object to a proposed member based upon a personal,
> professional, or financial conflict of interest. If so, the
> institution should limit the period for submitting objections to no
> more than 10 calendar days. The institution would make the final
> determination of whether a conflict exists.\]**

E. Charge to the Committee and First
Meeting[]{#__RefHeading___Toc148145332 .anchor}

> The RIO will prepare a charge for the inquiry committee that:

[]{.mark}

-   Sets forth the time for completion of the inquiry;

-   Describes the allegations and any related issues identified during
    the allegation assessment;

-   States that the purpose of the inquiry is to conduct an initial
    review of the evidence, including the testimony of the respondent,
    complainant and key witnesses, to determine whether an investigation
    is warranted, not to determine whether research misconduct
    definitely occurred or who was responsible;

-   States that an investigation is warranted if the committee
    determines: (1) there is a reasonable basis for concluding that the
    allegation falls within the definition of research misconduct and is
    within the jurisdictional criteria of 42 CFR § 93.102(b); and, (2)
    the allegation may have substance, based on the committee's review
    during the inquiry.

-   Informs the inquiry committee that they are responsible for
    preparing or directing the preparation of a written report of the
    inquiry that meets the requirements of this policy and 42 CFR §
    93.309(a).

> At the committee\'s first meeting, the RIO will review the charge with
> the committee, discuss the allegations, any related issues, and the
> appropriate procedures for conducting the inquiry, assist the
> committee with organizing plans for the inquiry, and answer any
> questions raised by the committee. The RIO will be present or
> available throughout the inquiry to advise the committee as needed.
>
> F. Inquiry Process[]{#__RefHeading___Toc148145333 .anchor}
>
> The inquiry committee will normally interview the complainant, the
> respondent, and key witnesses as well as examining relevant research
> records and materials. Then the inquiry committee will evaluate the
> evidence, including the testimony
>
> obtained during the inquiry. After consultation with the RIO, the
> committee members will decide whether an investigation is warranted
> based on the criteria in this policy and 42 CFR § 93.307(d). The scope
> of the inquiry is not required to and does not normally include
> deciding whether
>
> misconduct definitely occurred, determining definitely who committed
> the research misconduct or conducting exhaustive interviews and
> analyses. However, if a legally sufficient admission of research
> misconduct is made by the respondent, misconduct may be determined at
> the inquiry stage if all relevant issues are resolved. In that case,
> the institution shall promptly consult with ORI to determine the next
> steps that should be taken. See Section III.C.
>
> G. Time for Completion[]{#__RefHeading___Toc148145334 .anchor}
>
> The inquiry, including preparation of the final inquiry report and the
> decision of the DO on whether an investigation is warranted, must be
> completed within 60 calendar days of initiation of the inquiry, unless
> the RIO determines that circumstances clearly warrant a longer period.
> If the RIO approves an extension, the inquiry record must include
> documentation of the reasons for exceeding the 60-day period.[^38]
> **\[Option: The respondent will be notified of the extension.\]**

**VI. The Inquiry Report**[]{#__RefHeading___Toc148145335 .anchor}

> A. Elements of the Inquiry Report[]{#__RefHeading___Toc148145336
> .anchor}
>
> A written inquiry report must be prepared that 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 or not recommending that the allegations warrant an
> investigation; (5) any comments on the draft report by the respondent
> or complainant.[^39]
>
> Institutional counsel should review the report for legal sufficiency.
> Modifications should be made as appropriate in consultation with the
> RIO and the inquiry committee. **\[Option: The inquiry report should
> include:** **the names and titles of the committee members and experts
> who conducted the inquiry; a summary of the inquiry process used; a
> list of the research records reviewed; summaries of any interviews;
> and whether any other actions should be taken if an investigation is
> not recommended.\]**
>
> B. Notification to the Respondent and Opportunity to
> Comment[]{#__RefHeading___Toc148145337 .anchor}
>
> The RIO shall notify the respondent whether the inquiry found an
> investigation to be warranted, include a copy of the draft inquiry
> report for comment within **\[suggested: 10 days\]**, and include a
> copy of or refer to 42 CFR Part 93 and the institution's policies and
> procedures on research misconduct.[^40] **\[Option: The institution
> may notify the complainant whether the inquiry found an investigation
> to be warranted and provide relevant portions of the inquiry report to
> the complainant for comment \[suggested: within 10 days\]. A
> confidentiality agreement should be a condition for access to the
> report.\]**
>
> Any comments that are submitted will be attached to the final inquiry
> report. Based on the comments, the inquiry committee may revise the
> draft report as appropriate and prepare it in final form. The
> committee will deliver the final report to the RIO.
>
> C. Institutional Decision and
> Notification[]{#__RefHeading___Toc148145338 .anchor}
>
> 1\. Decision by Deciding Official[]{#__RefHeading___Toc148145339
> .anchor}

The RIO will transmit the final inquiry report and any comments to the
DO, who will determine in writing whether an investigation is warranted.
The inquiry is completed when the DO makes this determination.

> 2\. Notification to ORI[]{#__RefHeading___Toc148145340 .anchor}
>
> Within 30 calendar days of the DO's decision that an investigation is
> warranted, the RIO will provide ORI with the DO's written decision and
> a copy of the inquiry report. The RIO will also notify those
> institutional officials who need to know of the DO\'s decision. The
> RIO must provide the following information to ORI upon 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 to be considered in the investigation.[^41]
>
> 3\. Documentation of Decision Not to
> Investigate[]{#__RefHeading___Toc148145341 .anchor}
>
> If the DO decides that an investigation is not warranted, the RIO
> shall secure and maintain for 7 years after the termination of the
> inquiry sufficiently detailed documentation of the inquiry to permit a
> later assessment by ORI of the reasons why an investigation was not
> conducted. These documents must be provided to ORI or other authorized
> HHS personnel upon request.

**VII. Conducting the Investigation**[]{#__RefHeading___Toc148145342
.anchor}

> A. Initiation and Purpose[]{#__RefHeading___Toc148145343 .anchor}
>
> The investigation must begin within 30 calendar days after the
> determination by the DO that an investigation is warranted.[^42] The
> purpose of the investigation is to develop a factual record by
> exploring the allegations in detail and examining the evidence in
> depth, leading to recommended findings on whether research misconduct
> has been committed, by whom, and to what extent. The investigation
> will also determine whether there are additional instances of possible
> research misconduct that would justify broadening the scope beyond the
> initial allegations. This is particularly important where the alleged
> research misconduct involves clinical trials or potential harm to
> human subjects or the general public or if it affects research that
> forms the basis for public policy, clinical practice, or public health
> practice. The findings of the investigation will be set forth in an
> investigation report.
>
> B. Notifying ORI and Respondent; Sequestration of Research
> Records[]{#__RefHeading___Toc148145344 .anchor}
>
> On or before the date on which the investigation begins, the RIO must:
> (1) notify the ORI Director of the decision to begin the investigation
> and provide ORI a copy of the inquiry report; and (2) notify the
> respondent in writing of the allegations to be investigated. The RIO
> must also 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 the investigation.[^43]
>
> The RIO will, prior to notifying respondent of the allegations, take
> all reasonable and practical steps to obtain custody of and sequester
> in a secure manner all research records and evidence needed to conduct
> the research misconduct proceeding that were not previously
> sequestered during the inquiry. Where the research records or evidence
> encompass scientific instruments shared by a number of users, custody
> may be limited to copies of the data or evidence on such instruments,
> so long as those copies are substantially equivalent to the
> evidentiary value of the instruments. The need for additional
> sequestration of records for the investigation may occur for any
> number of reasons, including the institution\'s decision to
> investigate additional allegations not considered during the inquiry
> stage or the identification of records during the inquiry process that
> had not been previously secured. The procedures to be followed for
> sequestration during the investigation are the same procedures that
> apply during the inquiry.[^44]
>
> C. Appointment of the Investigation
> Committee[]{#__RefHeading___Toc148145345 .anchor}
>
> The RIO, in consultation with other institutional officials as
> appropriate, will appoint an investigation committee and the committee
> chair within **\[suggested: 10 days\]** of the beginning of the
> investigation or as soon thereafter as practical. The investigation
> committee must consist of individuals who do not have unresolved
> personal, professional, or financial conflicts of interest with those
> involved with the investigation and should include individuals with
> the appropriate scientific expertise to evaluate the evidence and
> issues related to the allegation, interview the respondent and
> complainant and conduct the investigation. Individuals appointed to
> the investigation committee may also have served on the inquiry
> committee. **\[Option: When necessary to secure the necessary
> expertise or to avoid conflicts of interest, the RIO may select
> committee members from outside the institution.** **\[Option: As an
> alternative, the institution may appoint a standing committee
> authorized to add or reuse members or use consultants when necessary
> to evaluate specific allegations.\] \[Option: An institution may
> establish a procedure for notifying the respondent of the proposed
> committee membership to give the respondent an opportunity to object
> to a proposed member based upon a personal, professional, or financial
> conflict of interest. If so, the institution should limit the period
> for submitting objections to no more than 10 calendar days. The
> institution will make the final determination of whether a conflict
> exists.\]**
>
> D. Charge to the Committee and the First
> Meeting[]{#__RefHeading___Toc148145346 .anchor}
>
> 1\. Charge to the Committee[]{#__RefHeading___Toc148145347 .anchor}
>
> The RIO will define the subject matter of the investigation in a
> written charge to the committee that:

-   Describes the allegations and related issues identified during the
    inquiry;

-   Identifies the respondent;

-   Informs the committee that it must conduct the investigation as
    prescribed in paragraph E. of this section;

-   Defines research misconduct;

-   Informs the committee that it must evaluate the evidence and
    testimony to determine whether, based on a preponderance of the
    evidence, research misconduct occurred and, if so, the type and
    extent of it and who was responsible;

-   Informs the committee that in order to determine that the respondent
    committed research misconduct it must find that a preponderance of
    the evidence establishes that: (1) research misconduct, as defined
    in this policy, occurred (respondent has the burden of proving by a
    preponderance of the evidence any affirmative defenses raised,
    including honest error or a difference of opinion); (2) the research
    misconduct is a significant departure from accepted practices of the
    relevant research community; and (3) the respondent committed the
    research misconduct intentionally, knowingly, or recklessly; and

[]{.mark}

-   Informs the committee that it must prepare or direct the preparation
    of a written investigation report that meets the requirements of
    this policy and 42 CFR § 93.313.

> 2\. First Meeting[]{#__RefHeading___Toc148145348 .anchor}
>
> The RIO will convene the first meeting of the investigation committee
> to review the charge, the inquiry report, and the prescribed
> procedures and standards for the conduct of the investigation,
> including the necessity for confidentiality and for developing a
> specific investigation plan. The investigation committee will be
> provided with a copy of this policy and 42 CFR Part 93. The RIO will
> be present or available throughout the investigation to advise the
> committee as needed.
>
> E. Investigation Process[]{#__RefHeading___Toc148145349 .anchor}
>
> The investigation committee and the RIO must:

-   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 each allegation;[^45]

-   Take reasonable steps to ensure an impartial and unbiased
    investigation to the maximum extent practical;[^46]

-   Interview each respondent, complainant, and any other available
    person who has been reasonably identified as having information
    regarding any relevant aspects of the investigation, including
    witnesses identified by the respondent, and 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;[^47] and

-   Pursue diligently all significant issues and leads discovered that
    are determined relevant to the investigation, including any evidence
    of any additional instances of possible research misconduct, and
    continue the investigation to completion.[^48]

F. Time for Completion[]{#__RefHeading___Toc148145350 .anchor}

> The investigation is to be completed within 120 days of beginning it,
> including conducting the investigation, preparing the report of
> findings, providing the draft report for comment and sending the final
> report to ORI. However, if the RIO determines that the investigation
> will not be completed within this 120-day period, he/she will submit
> to ORI a written request for an extension, setting forth the reasons
> for the delay. The RIO will ensure that periodic progress reports are
> filed with ORI, if ORI grants the request for an extension and directs
> the filing of such reports.[^49]

**VIII. The Investigation Report**[]{#__RefHeading___Toc148145351
.anchor}

> A. Elements of the Investigation Report[]{#__RefHeading___Toc148145352
> .anchor}
>
> The investigation committee and the RIO are responsible for preparing
> a written draft report of the investigation that:

-   Describes the nature of the allegation of research misconduct,
    including identification of the respondent; **\[Option: The
    respondent's c.v. or resume may be included as part of the
    identification.\]**

-   Describes and documents the PHS support, including, for example, the
    numbers of any grants that are involved, grant applications,
    contracts, and publications listing PHS support;

-   Describes the specific allegations of research misconduct considered
    in the investigation;

-   Includes the institutional policies and procedures under which the
    investigation was conducted, unless those policies and procedures
    were provided to ORI previously;

-   Identifies and summarizes the research records and evidence reviewed
    and identifies any evidence taken into custody but not reviewed; and

-   Includes a statement of findings for each allegation of research
    misconduct identified during the investigation.[^50] Each statement
    of findings must: (1) identify whether the research misconduct was
    falsification, fabrication, or plagiarism, and whether it was
    committed intentionally, knowingly, or recklessly; (2) summarize the
    facts and the analysis that support the conclusion and consider the
    merits of any reasonable explanation by the respondent, including
    any effort by respondent to establish by a preponderance of the
    evidence that he or she did not engage in research misconduct
    because of honest error or a difference of opinion; (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.[^51]

> B. Comments on the Draft Report and Access to
> Evidence[]{#__RefHeading___Toc148145353 .anchor}
>
> 1\. Respondent[]{#__RefHeading___Toc148145354 .anchor}
>
> The RIO must give the respondent a copy of the draft investigation
> report for comment and, concurrently, a copy of, or supervised access
> to the evidence on which the report is based. The respondent will be
> allowed 30 days from the date he/she received the draft report to
> submit comments to the RIO. The respondent\'s comments must be
> included and considered in the final report.[^52]
>
> 2\. Complainant[]{#__RefHeading___Toc148145355 .anchor}
>
> **\[Option: As a policy applicable to all cases or on a case-by-case
> []{.mark}basis, the institution may provide the complainant a copy of
> the draft investigation report, or relevant portions of it, for
> comment. If the institution chooses this option, the complainant's
> comments must be submitted within 30 days of the date on which he/she
> received the draft report and the comments must be included and
> considered in the final report. See §§ 93.312(b) and 93.313(g).\]**
>
> 3\. Confidentiality[]{#__RefHeading___Toc148145356 .anchor}
>
> In distributing the draft report, or portions thereof, to the
> respondent, **\[Option: and complainant\]** the RIO will inform the
> recipient of the confidentiality under which the draft report is made
> available and may establish reasonable conditions to ensure such
> confidentiality. For example, the RIO may require that the recipient
> sign a confidentiality agreement.

C. Decision by Deciding Official[]{#__RefHeading___Toc148145357 .anchor}

> The RIO will assist the investigation committee in finalizing the
> draft investigation report, including ensuring that the respondent's
> **\[Option: and complainant's\]** comments are included and
> considered, and transmit the final investigation report to the DO, who
> will determine in writing: (1) whether the institution accepts the
> investigation report, its findings, and the recommended institutional
> actions; and (2) the appropriate institutional actions in response to
> the accepted findings of research misconduct. If this determination
> varies from the findings of the investigation committee, the DO will,
> as part of his/her written determination, explain in detail the basis
> for rendering a decision different from the findings of the
> investigation committee. Alternatively, the DO may return the report
> to the investigation committee with a request for further fact-finding
> or analysis.
>
> When a final decision on the case has been reached, the RIO will
> normally notify both the respondent and the complainant in writing.
> After informing ORI, the DO will determine whether law enforcement
> agencies, professional societies, professional licensing boards,
> editors of journals in which falsified reports may have been
> published, collaborators of the respondent in the work, or other
> relevant parties should be notified of the outcome of the case. The
> RIO is responsible for ensuring compliance with all notification
> requirements of funding or sponsoring agencies.

D. Appeals[]{#__RefHeading___Toc148145358 .anchor}

> **\[Option: An institution's procedures may provide for an appeal by
> the respondent that could result in a reversal or modification of the
> institution's findings of research misconduct. If such an appeal is
> provided for, it must be completed within 120 days of its filing,
> unless ORI finds good cause for an extension, based upon the
> institution's written request for an extension that explains the need
> for the extension. If ORI grants an extension, it may direct the
> filing of periodic progress reports. 42 CFR 93.314.\]**
>
> E. Notice to ORI of Institutional Findings and
> Actions[]{#__RefHeading___Toc148145359 .anchor}
>
> Unless an extension has been granted, the RIO must, within the 120-day
> period for completing the investigation **\[Option: or the 120-day
> period for completion of any appeal\]**, submit the following to ORI:
> (1) a copy of the final investigation report with all attachments
> **\[Option: and any appeal\]**; (2) a statement of whether the
> institution accepts the findings of the investigation report
> **\[Option: or the outcome of the appeal\]**; (3) a statement of
> whether the institution found misconduct and, if so, who committed the
> misconduct; and (4) a description of any pending or completed
> administrative actions against the respondent.[^53]
>
> F. Maintaining Records for Review by ORI
>
> The RIO must maintain and provide to ORI upon request "records of
> research misconduct proceedings" as that term is defined by 42 CFR §
> 93.317. Unless custody has been transferred to HHS or ORI has advised
> in writing that the records no longer need to be retained, records of
> research misconduct proceedings must be maintained in a secure manner
> for 7 years after completion of the proceeding or the completion of
> any PHS proceeding involving the research misconduct allegation.[^54]
> The RIO is also responsible for providing any information,
> documentation, research records, evidence or clarification requested
> by ORI to carry out its review of an allegation of research misconduct
> or of the institution's handling of such an allegation.[^55]

**IX. Completion of Cases; Reporting Premature Closures to
ORI**[]{#__RefHeading___Toc148145360 .anchor}

Generally, all inquiries and investigations will be carried through to
completion and all significant issues will be pursued diligently. The
RIO must notify ORI in advance if there are plans to close a case at the
inquiry, investigation, or appeal stage on the basis that respondent has
admitted guilt, a settlement with the respondent has been reached, or
for any other reason, except: (1) closing of a case at the inquiry stage
on the basis that an investigation is not warranted; or (2) a finding of
no misconduct at the investigation stage, which must be reported to ORI,
as prescribed in this policy and 42 CFR § 93.315.[^56]

**X. Institutional Administrative Actions
\[Optional\]**[]{#__RefHeading___Toc148145361 .anchor}

> If the DO determines that research misconduct is substantiated by the
> findings, he or she will decide on the appropriate actions to be
> taken, after consultation with the RIO. The administrative actions may
> include:

-   Withdrawal or correction of all pending or published abstracts and
    papers emanating from the research where research misconduct was
    found;

-   Removal of the responsible person from the particular project,
    letter of reprimand, special monitoring of future work, probation,
    suspension, salary reduction, or initiation of steps leading to
    possible rank reduction or termination of employment;

-   Restitution of funds to the grantor agency as appropriate; and

-   Other action appropriate to the misconduct.

**XI. Other Considerations**[]{#__RefHeading___Toc148145362 .anchor}

> A. Termination or Resignation Prior to Completing Inquiry or
> Investigation[]{#__RefHeading___Toc148145363 .anchor}
>
> The termination of the respondent\'s institutional employment, by
> resignation or otherwise, before or after an allegation of possible
> research misconduct has been reported, will not preclude or terminate
> the research misconduct proceeding or otherwise limit any of the
> institution's responsibilities under 42 CFR Part 93 .
>
> If the respondent, without admitting to the misconduct, elects to
> resign his or her position after the institution receives an
> allegation of research misconduct, the assessment of the allegation
> will proceed, as well as the inquiry and investigation, as appropriate
> based on the outcome of the preceding steps. If the respondent refuses
> to participate in the process after resignation, the RIO and any
> inquiry or investigation committee will use their best efforts to
> reach a conclusion concerning the allegations, noting in the report
> the respondent\'s failure to cooperate and its effect on the evidence.
>
> B. Restoration of the Respondent\'s
> Reputation[]{#__RefHeading___Toc148145364 .anchor}
>
> Following a final finding of no research misconduct, including ORI
> concurrence where required by 42 CFR Part 93, the RIO will, at the
> request of the respondent, undertake all reasonable and practical
> efforts to restore the respondent\'s reputation.[^57] Depending on the
> particular circumstances and the views of the respondent, the RIO
> should consider notifying those individuals aware of or involved in
> the investigation of the final outcome, publicizing the final outcome
> in any forum in which the allegation of research misconduct was
> previously publicized, and expunging all reference to the research
> misconduct allegation from the respondent\'s personnel file. Any
> institutional actions to restore the respondent\'s reputation should
> first be approved by the DO.
>
> C. Protection of the Complainant, Witnesses and Committee
> Members[]{#__RefHeading___Toc148145365 .anchor}
>
> During the research misconduct proceeding and upon its completion,
> regardless of whether the institution or ORI determines that research
> misconduct occurred, the RIO will undertake all reasonable and
> practical efforts to protect the position and reputation of, or to
> counter potential or actual retaliation against, any complainant who
> made allegations of research misconduct in good faith and of any
> witnesses and committee members who cooperate in good faith with the
> research misconduct proceeding.[^58] The DO will determine, after
> consulting with the RIO, and with the complainant, witnesses, or
> committee members, respectively, what steps, if any, are needed to
> restore their respective positions or reputations or to counter
> potential or actual retaliation against them. The RIO is responsible
> for implementing any steps the DO approves.
>
> D. Allegations Not Made in Good Faith[]{#__RefHeading___Toc148145366
> .anchor}
>
> If relevant, the DO will determine whether the complainant's
> allegations of research misconduct were made in good faith, or whether
> a witness or committee member acted in good faith. If the DO
> determines that there was an absence of good faith he/she will
> determine whether any administrative action should be taken against
> the person who failed to act in good faith.
>
> Appendix A

Research Integrity Officer Responsibilities

# I. General

The Research Integrity Officer (RIO) has lead responsibility for
ensuring that the institution:

-   Takes all reasonable and practical steps to foster a research
    environment that promotes the responsible conduct of research,
    research training, and activities related to that research or
    research training, discourages research misconduct, and deals
    promptly with allegations or evidence of possible research
    misconduct.

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-   Has written policies and procedures for responding to allegations of
    research misconduct and reporting information about that response to
    ORI, as required by 42 CFR Part 93.

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-   Complies with its written policies and procedures and the
    requirements of 42 CFR Part 93.

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-   Informs its institutional members who are subject to 42 CFR Part 93
    about its research misconduct policies and procedures and its
    commitment to compliance with those policies and procedures.

-   Takes appropriate interim action during a research misconduct
    proceeding to protect public health, federal funds and equipment,
    and the integrity of the PHS supported research process.

# 

# II. Notice and Reporting to ORI and Cooperation with ORI

The RIO has lead responsibility for ensuring that the institution:

-   Files an annual report with ORI containing the information
    prescribed by ORI.

-   Sends to ORI with the annual report such other aggregated
    information as ORI may prescribe on the institution's research
    misconduct proceedings and the institution's compliance with 42 CFR
    Part 93.

-   Notifies ORI immediately if, at any time during the research
    misconduct proceeding, it has reason to believe that health or
    safety of the public is at risk, HHS resources or interests are
    threatened, research activities should be suspended, there is
    reasonable indication of possible violations of civil or criminal
    law, federal action is required to protect the interests of those
    involved in the research misconduct proceeding, the institution
    believes that the research misconduct proceeding may be made public
    prematurely, or the research community or the public should be
    informed.

-   Provides ORI with the written finding by the responsible
    institutional official that an investigation is warranted and a copy
    of the inquiry report, within 30 days of the date on which the
    finding is made.

-   Notifies ORI of the decision to begin an investigation on or before
    the date the investigation begins.

-   Within 120 days of beginning an investigation, or such additional
    days as may be granted by ORI, (or upon completion of any appeal
    made available by the institution) provides ORI with the
    investigation report, a statement of whether the institution accepts
    the investigation's findings, a statement of whether the institution
    found research misconduct and, if so, who committed it, and a
    description of any pending or completed administrative actions
    against the respondent.

-   Seeks advance ORI approval if the institution plans to close a case
    at the inquiry, investigation, or appeal stage on the basis that the
    respondent has admitted guilt, a settlement with the respondent has
    been reached, or for any other reason, except the closing of a case
    at the inquiry stage on the basis that an investigation is not
    warranted or a finding of no misconduct at the investigation stage.

-   Cooperates fully with ORI during its oversight review and any
    subsequent administrative hearings or appeals, including 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
    evidence.

# III. Research Misconduct Proceeding

#  A. General

The RIO is responsible for:

-   Promptly taking all reasonable and practical steps to obtain custody
    of all research records and evidence needed to conduct the research
    misconduct proceeding, inventory the records and evidence, and
    sequester them in a secure manner.

-   Taking 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.

-   Providing confidentiality to those involved in the research
    misconduct proceeding as required by 42 CFR 93.108, other applicable
    law, and institutional policy.

-   Determining whether each person involved in handling an allegation
    of research misconduct has an unresolved personal, professional or
    financial conflict of interest and taking appropriate action,
    including recusal, to ensure that no person with such a conflict is
    involved in the research misconduct proceeding.

-   Keeping the Deciding Official (DO) and others who need to know
    apprised of the progress of the review of the allegation of research
    misconduct.

-   In cooperation with other institutional officials, taking all
    reasonable and practical steps to protect or restore the positions
    and reputations of good faith complainants, witnesses, and committee
    members and to counter potential or actual retaliation against them
    by respondents or other institutional members.

-   Making 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.

-   Assisting the DO in implementing his/her decision to take
    administrative action against any complainant, witness, or committee
    member determined by the DO not to have acted in good faith.

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-   Maintaining records of the research misconduct proceeding, as
    defined in 42 CFR 93.317, in a secure manner for 7 years after
    completion of the proceeding, or the completion of any ORI
    proceeding involving the allegation of research misconduct,
    whichever is later, unless custody of the records has been
    transferred to ORI or ORI has advised that the records no longer
    need to be retained.

-   Ensuring that administrative actions taken by the institution and
    ORI are enforced and taking appropriate action to notify other
    involved parties, such as sponsors, law enforcement agencies,
    professional societies, and licensing boards, of those actions.

B.  **Allegation Receipt and Assessment**

> The RIO is responsible for:

-   Consulting confidentially with persons uncertain about whether to
    submit an allegation of research misconduct.

-   Receiving allegations of research misconduct.

-   Assessing each allegation of research misconduct to determine if an
    inquiry is warranted because the allegation falls within the
    definition of research misconduct, is within the jurisdictional
    criteria of 42 CFR 93.102 (b), and is sufficiently credible and
    specific so that potential evidence of research misconduct may be
    identified.

C.  **Inquiry**

> The RIO is responsible for:

-   Initiating the inquiry process if it is determined that an inquiry
    is warranted.

-   At the time of, or before beginning the inquiry, making a good faith
    effort to notify the respondent in writing, if the respondent is
    known.

-   On or before the date on which the respondent is notified, or the
    inquiry begins, whichever is earlier, taking all reasonable and
    practical steps to obtain custody of all research records and
    evidence needed to conduct the research misconduct proceeding,
    inventorying the records and evidence and sequestering them in a
    secure manner, except that where the research records or evidence
    encompass scientific instruments shared by a number of users,
    custody may be limited to copies of the data or evidence on the
    instruments, so long as those copies are substantially equivalent to
    the evidentiary value of the instruments.

-   Appointing an inquiry committee and committee chair as soon after
    the initiation of the inquiry as is practical.

-   Preparing a charge for the inquiry committee in accordance with the
    institution's policies and procedures.

-   Convening the first meeting of the inquiry committee and at that
    meeting briefing the committee on the allegations, the charge to the
    committee, and the appropriate procedures for conducting the
    inquiry, including the need for confidentiality and for developing a
    plan for the inquiry, and assisting the committee with
    organizational and other issues that may arise.

-   Providing the inquiry committee with needed logistical support,
    e.g., expert advice, including forensic analysis of evidence, and
    clerical support, including arranging witness interviews and
    recording or transcribing those interviews.

-   Being available or present throughout the inquiry to advise the
    committee as needed and consulting with the committee prior to its
    decision on whether to recommend that an investigation is warranted
    on the basis of the criteria in the institution's policies and
    procedures and 42 CFR 93.307 (d).

-   Determining whether circumstances clearly warrant a period longer
    than 60 days to complete the inquiry (including preparation of the
    final inquiry report and the decision of the DO on whether an
    investigation is warranted), approving an extension if warranted,
    and documenting the reasons for exceeding the 60-day period in the
    record of the research misconduct proceeding.

-   Assisting the inquiry committee in preparing a draft inquiry report,
    sending the respondent a copy of the draft report for comment (and
    the complainant if the institution's policies provide that option)
    within a time period that permits the inquiry to be completed within
    the allotted time, taking appropriate action to protect the
    confidentiality of the draft report, receiving any comments from the
    respondent (and the complainant if the institution's policies
    provide that option), and ensuring that the comments are attached to
    the final inquiry report.

-   Receiving the final inquiry report from the inquiry committee and
    forwarding it, together with any comments the RIO may wish to make,
    to the DO who will determine in writing whether an investigation is
    warranted.

-   Within 30 days of a DO decision that an investigation is warranted,
    providing ORI with the written finding and a copy of the inquiry
    report and notifying those institutional officials who need to know
    of the decision.

-   Notifying the respondent (and the complainant if the institution's
    policies provide that option) whether the inquiry found an
    investigation to be warranted and including in the notice copies of
    or a reference to 42 CFR Part 93 and the institution's research
    misconduct policies and procedures.

-   Providing to ORI, upon request, the institutional policies and
    procedures under which the inquiry was conducted, the research
    records and evidence reviewed, transcripts or recordings of any
    interviews, copies of all relevant documents , and the charges to be
    considered in the investigation.

-   If the DO decides that an investigation is not warranted, securing
    and maintaining for 7 years after the termination of the inquiry
    sufficiently detailed documentation of the inquiry to permit a later
    assessment by ORI of the reasons why an investigation was not
    conducted.

**D. Investigation**

The RIO is responsible for:

-   Initiating the investigation within 30 calendar days after the
    determination by the DO that an investigation is warranted.

-   On or before the date on which the investigation begins: (1)
    notifying ORI of the decision to begin the investigation and
    providing ORI a copy of the inquiry report; and (2) notifying the
    respondent in writing of the allegations to be investigated.

-   Prior to notifying respondent of the allegations, taking all
    reasonable and practical steps to obtain custody of and sequester in
    a secure manner all research records and evidence needed to conduct
    the research misconduct proceeding that were not previously
    sequestered during the inquiry.

-   In consultation with other institutional officials as appropriate,
    appointing an investigation committee and committee chair as soon
    after the initiation of the investigation as is practical.

-   Preparing a charge for the investigation committee in accordance
    with the institution's policies and procedures.

-   Convening the first meeting of the investigation committee and at
    that meeting: (1) briefing the committee on the charge, the inquiry
    report and the procedures and standards for the conduct of the
    investigation, including the need for confidentiality and developing
    a specific plan for the investigation; and (2) providing committee
    members a copy of the institution's policies and procedures and 42
    CFR Part 93.

-   Providing the investigation committee with needed logistical
    support, e.g., expert advice, including forensic analysis of
    evidence, and clerical support, including arranging interviews with
    witnesses and recording or transcribing those interviews.

-   Being available or present throughout the investigation to advise
    the committee as needed.

-   On behalf of the institution, the RIO is responsible for each of the
    following steps and for ensuring that the investigation
    committee: (1) uses diligent efforts to conduct an investigation
    that includes an examination of all research records and evidence
    relevant to reaching a decision on the merits of the allegations and
    that is otherwise thorough and sufficiently documented; (2) takes
    reasonable steps to ensure an impartial and unbiased investigation
    to the maximum extent practical; (3) interviews each respondent,
    complainant, and any other available person who has been reasonably
    identified as having information regarding any relevant aspects of
    the investigation, including witnesses identified by the respondent,
    and records or transcribes each interview, provides the recording or
    transcript to the interviewee for correction, and includes the
    recording or transcript in the record of the research misconduct
    proceeding; and (4) pursues diligently all significant issues and
    leads discovered that are determined relevant to the investigation,
    including any evidence of any additional instances of possible
    research misconduct, and continues the investigation to completion.

-   Upon determining that the investigation cannot be completed within
    120 days of its initiation (including providing the draft report for
    comment and sending the final report with any comments to ORI),
    submitting a request to ORI for an extension of the 120-day period
    that includes a statement of the reasons for the extension. If the
    extension is granted, the RIO will file periodic progress reports
    with ORI.

-   Assisting the investigation committee in preparing a draft
    investigation report that meets the requirements of 42 CFR Part 93
    and the institution's policies and procedures, sending the
    respondent (and complainant at the institution's option) a copy of
    the draft report for his/her comment within 30 days of receipt,
    taking appropriate action to protect the confidentiality of the
    draft report, receiving any comments from the respondent (and
    complainant at the institution's option) and ensuring that the
    comments are included and considered in the final investigation
    report.

-   Transmitting the draft investigation report to institutional counsel
    for a review of its legal sufficiency.

-   Assisting the investigation committee in finalizing the draft
    investigation report and receiving the final report from the
    committee.

-   Transmitting the final investigation report to the DO and: (1) if
    the DO determines that further fact-finding or analysis is needed,
    receiving the report back from the DO for that purpose; (2) if the
    DO determines whether or not to accept the report, its findings and
    the recommended institutional actions, transmitting to ORI within
    the time period for completing the investigation, a copy of the
    final investigation report with all attachments, a statement of
    whether the institution accepts the findings of the report, a
    statement of whether the institution found research misconduct, and
    if so, who committed it, and a description of any pending or
    completed administrative actions against the respondent; or (3) if
    the institution provides for an appeal by the respondent that could
    result in a modification or reversal of the DO's finding of research
    misconduct, ensuring that the appeal is completed within 120 days of
    its filing, or seeking an extension from ORI in writing (with an
    explanation of the need for the extension) and, upon completion of
    the appeal, transmitting to ORI a copy of the investigation report
    with all attachments, a copy of the appeal proceedings, a statement
    of whether the institution accepts the findings of the appeal
    proceeding, a statement of whether the institution found research
    misconduct, and if so, who committed it, and a description of any
    pending or completed administrative actions against the respondent.

-   When a final decision on the case is reached, the RIO will normally
    notify both the respondent and the complainant in writing and will
    determine whether law enforcement agencies, professional societies,
    professional licensing boards, editors of involved journals,
    collaborators of the respondent, or other relevant parties should be
    notified of the outcome of the case.

-   Maintaining and providing to ORI upon request all relevant research
    records and records of the institution's research misconduct
    proceeding, including the results of all interviews and the
    transcripts or recordings of those interviews.

[^1]: ^^ Sections based on 42 CFR Part 93 have endnotes indicating the
    applicable section.

[^2]: 42 CFR § 93.214

[^3]: 42 CFR § 93.102

[^4]: 42 CFR § 93.201

[^5]: 42 CFR § 93.203

[^6]: 42 CFR § 93.208

[^7]: 42 CFR § 93.210

[^8]: 42 CFR § 93.212

[^9]: 42 CFR § 93.214

[^10]: 42 CFR § 93.215

[^11]: 42 CFR § 93.217

[^12]: 42 CFR § 93.219

[^13]: 42 CFR § 93.220

[^14]: 42 CFR § 93.221

[^15]: 42 CFR § 93.224

[^16]: 42 CFR § 93.103

[^17]: 42 CFR § 93.223

[^18]: 42 CFR § 93.224

[^19]: 42 CFR § 93.225

[^20]: 42 CFR § 93.226

[^21]: 42 CFR § 93.310(g)

[^22]: 42 CFR §§ 93.304(c), 93.307(b)

[^23]: 42 CFR §§ 93.304(e), 93.307(f)

[^24]: 42 CFR § 308(a)

[^25]: 42 CFR § 310(c)

[^26]: 42 CFR § 310(g)

[^27]: 42 CFR § 310(g)

[^28]: 42 CFR §§ 93.304(f), 93.312(a)

[^29]: 42 CFR § 93.316

[^30]: 42 CFR § 93.309(c)

[^31]: 42 CFR § 93.304(k)

[^32]: 42 CFR § 93.304(h)

[^33]: 42 CFR § 93.318

[^34]: 42 CFR § 93.307(a)

[^35]: 42 CFR § 93.307(c)

[^36]: 42 CFR §§ 93.305, 93.307(b)

[^37]: 42 CFR § 93.304(b)

[^38]: 42 CFR § 93.307(g)

[^39]: 42 CFR § 93.309(a)

[^40]: 42 CFR § 93.308(a)

[^41]: 42 CFR § 93.309(a) and (b)

[^42]: 42 CFR § 93.310(a)

[^43]: 42 CFR § 93.310(b) and (c)

[^44]: 42 CFR § 93.310(d)

[^45]: 42 CFR § 93.310(e)

[^46]: 42 CFR § 93.310(f)

[^47]: 42 CFR § 93.310(g)

[^48]: 42 CFR § 93.310(h)

[^49]: 42 CFR § 93.311

[^50]: 42 CFR § 93.313

[^51]: 42 CFR § 93.313(f)

[^52]: 42 CFR §§ 93.312(a), 313(g)

[^53]: 42 CFR § 93.315

[^54]: 42 CFR § 93.317(b)

[^55]: 42 CFR §§ 93.300(g), 93.403(b) and (d)

[^56]: 42 CFR § 93.316(a)

[^57]: 42 CFR § 93.304(k)

[^58]: 42 CFR § 93.304(l)