91¿´Æ¬Íø

I. Scope

This policy applies to William & Mary as a whole university. 91¿´Æ¬Íø is committed to upholding the highest standards of scientific rigor in research. The university is committed to fostering an environment that promotes research integrity and the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.

All institutional members are expected to conduct research with honesty, rigor, and transparency. Each institutional member is responsible for contributing to an organizational culture that establishes, maintains, and promotes research integrity and the responsible conduct of research.

The university strives to reduce the risk of research misconduct, support all good-faith efforts to report suspected misconduct, promptly and thoroughly address all allegations of research misconduct, and seek to rectify the scientific record and/or restore researchers’ reputations, as appropriate.

Research misconduct is contrary to the interests of 91¿´Æ¬Íø, the health and safety of the public, the integrity of research, and the conservation of public funds. Both the university and its institutional members have an affirmative duty to protect those funds from misuse by ensuring the integrity of all research conducted on behalf of 91¿´Æ¬Íø.

The Research Integrity Officer is responsible for ensuring that these policies and procedures for addressing allegations of research misconduct meet the requirements of the (42 C.F.R. Part 93, “the PHS regulation”). This is required for the university to be eligible for Public Health Service (“PHS”), including National Institutes of Health, funding. The university will establish and maintain these policies and procedures, inform all institutional members about these policies and procedures, and make these policies and procedures publicly available. As set forth in the 91¿´Æ¬Íø Faculty Handbook, investigations of allegations of research misconduct involving research supported by or applications for PHS grants, contracts, or cooperative agreements shall comply with the requirements of the external funding agency, including the polices set out by PHS’s Office of Research Integrity ("ORI”). The university is committed to following these policies and procedures when responding to allegations of research misconduct and to the extent there are conflicts between the procedures set out here and the procedures set out in the Faculty Handbook, the procedures set out here shall control.

For definitions of terms used in this section and elsewhere, see the Definitions section.

To the extent there is any conflict between this policy and the Faculty Handbook regarding procedures for research misconduct, this policy shall control.

II. Applicability

These policies and procedures apply to allegations of research misconduct involving

1. Applications or proposals for PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training.
2. PHS-supported biomedical or behavioral research.
3. PHS-supported biomedical or behavioral research training programs.
4. PHS-supported activities that are related to biomedical or behavioral research or research training, such as, but not limited to, the operation of tissue and data banks or the dissemination of research information.
5. Research records produced during PHS-supported research, research training, or activities related to that research or research training.
6. Research proposed, performed, reviewed, or reported, as well as any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in an awarded grant, contract, cooperative agreement, subaward, or other form of PHS support.

These policies and procedures apply only to research misconduct occurring within six years of the date the U.S. Department of Health and Human Services (HHS) or the university receives an allegation of research misconduct, subject to the following exceptions:

• The six-year time limitation does not apply if the respondent continues or renews any incident of alleged research misconduct that occurred before the six-year period through the use of, republication of, or citation to the portion(s) of the research record alleged to have been fabricated, falsified, or plagiarized, for the potential benefit of the respondent (“subsequent use exception”). For alleged research misconduct that appears subject to this subsequent use exception, but that the Research Integrity Officer determines is not subject to the exception, the Research Integrity Officer will document the determination that the subsequent use exception does not apply and will retain this documentation for the later of seven years after completion of the institutional proceeding or the completion of any HHS proceeding.
• The six-year time limitation also does not apply if ORI or the Research Integrity Officer, following consultation with ORI, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

These policies and procedures do not supersede or establish an alternative to the PHS regulation or any existing regulations for handling research misconduct involving non-PHS-supported research. They do not replace the PHS regulation, and in case of any conflict between this document and 42 C.F.R. Part 93, the PHS regulation will prevail. They are intended to enable the university to comply with the requirements of the PHS regulation.

III. Definitions

Accepted practices of the relevant research community. This term means those practices established by 42 C.F.R. Part 93 and by PHS funding components, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive PHS awards.

Administrative record. The administrative record comprises: the institutional record; any information provided by the respondent to ORI, including but not limited to the transcript of any virtual or in-person meetings under 42 C.F.R. § 93.403(b) between the respondent and ORI, and correspondence between the respondent and ORI; any additional information provided to ORI while the case is pending before ORI; and any analysis or additional information generated or obtained by ORI. Any analysis or additional information generated or obtained by ORI will also be made available to the respondent.

Allegation. This term is a disclosure of possible research misconduct through any means of communication and brought directly to the attention of the Research Integrity Officer, another appropriate university administrator or HHS official.

Assessment. Assessment means a consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct; appears to involve PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training; and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The assessment only involves the review of readily accessible information relevant to the allegation.

Complainant. Complainant means an individual who in good faith makes an allegation of research misconduct.

Evidence. Evidence means anything offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact. Evidence includes documents, whether in hard copy or electronic form, information, tangible items, and testimony.

Fabrication. Fabrication means making up data or results and recording or reporting them.

Falsification. Falsification means 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.

Good faith. (a) Good faith as applied to a complainant or witness means having a reasonable belief in the truth of one’s allegation or testimony, 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 knowledge of or reckless disregard for information that would negate the allegation or testimony. (b) Good faith, as applied to an institutional or committee member, means cooperating with the research misconduct proceeding by impartially carrying out the duties assigned for the purpose of helping an institution meet its responsibilities under 42 C.F.R. Part 93. An institutional or committee member does not act in good faith if their acts or omissions during the research misconduct proceedings are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.

Inquiry. Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of 42 C.F.R. § 93.307 through § 93.309.

Inquiry Committee. Inquiry Committee means a case-specific committee appointed by the Research Integrity Officer to conduct the inquiry stage of a research misconduct proceeding. The Inquiry Committee is responsible for preliminary information-gathering and preliminary fact-finding to determine whether an investigation is warranted, consistent with 42 C.F.R. § 93.307 through § 93.309. The Inquiry Committee does not make a final determination as to whether research misconduct occurred.

 Institutional Deciding Official. Institutional Deciding Official (IDO) means the institutional official who makes final determinations on allegations of research misconduct and any institutional actions. The same individual cannot serve as the Institutional Deciding Official and the Research Integrity Officer.[xxvi] At 91¿´Æ¬Íø, the IDO is the Provost or their designee.

Institutional member. Institutional member and members means an individual (or individuals) 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, technicians, postdoctoral and other fellows, students, volunteers, subject matter experts, consultants, or attorneys, or employees or agents of contractors, subcontractors, or sub-awardees.

Institutional record. The institutional record comprises: (a) The records that the Research Integrity Officer, on behalf of 91¿´Æ¬Íø, compiled or generated during the research misconduct proceeding, except records that were not considered or relied on. These records include but are not limited to (1) documentation of the assessment as required by 42 C.F.R. § 93.306(c); (2) if an inquiry is conducted, the inquiry report and all records (other than drafts of the report) considered or relied on during the inquiry, including, but not limited to, research records and the transcripts of any transcribed interviews conducted during the inquiry, information the respondent provided to the institution, and the documentation of any decision not to investigate as required by 42 C.F.R. § 93.309(c); (3) if an investigation is conducted, the investigation report and all records (other than drafts of the report) considered or relied on during the investigation, including, but not limited to, research records, the transcripts of each interview conducted pursuant to 42 C.F.R. § 93.310(g), and information the respondent provided to the institution; (4) decision(s) by the Institutional Deciding Official, such as the written decision from the Institutional Deciding Official under 42 C.F.R. § 93.314; (5) the complete record of any institutional appeal consistent with 42 C.F.R. § 93.315; (b) a single index listing all the research records and evidence that the university compiled during the research misconduct proceeding, except records the university did not consider or rely on; and (c) a general description of the records that were sequestered but not considered or relied on.

Intentionally. To act intentionally means to act with the aim of carrying out the act.

Investigation. Investigation means the formal development of a factual record and the examination of that record that meets the criteria and follows the procedures of 42 C.F.R. §§ 93.310 through 93.317.

Investigation Committee. Investigation Committee means a case-specific committee appointed by the Research Integrity Officer to conduct the investigation stage of a research misconduct proceeding. The Investigation Committee is responsible for developing the factual record, conducting interviews, reviewing research records and other evidence, and preparing the investigation report, including recommended findings for consideration by the Institutional Deciding Official, consistent with 42 C.F.R. §§ 93.310 through 93.317.

Knowingly. To act knowingly means to act with awareness of the act.

Plagiarism. Plagiarism means the appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit. (a) Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another’s work that materially misleads the reader regarding the contributions of the author. It does not include the limited use of identical or nearly identical phrases that describe a commonly used methodology. (b) Plagiarism does not include self-plagiarism or authorship or credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project. Self-plagiarism and authorship disputes do not meet the definition of research misconduct.

Preponderance of the evidence. Preponderance of the evidence means proof by evidence that, compared with evidence opposing it, leads to the conclusion that the alleged misconduct is more likely than not to have occurred.

PHS support. PHS support means PHS funding, or applications or proposals for PHS funding, 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; PHS grants, cooperative agreements, or contracts; subawards, contracts, or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements, or contracts.

Recklessly. To act recklessly means to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.

Research Integrity Officer. The Research Integrity Officer (RIO) refers to the institutional official responsible for administering the institution’s written policies and procedures for addressing allegations of research misconduct in compliance with 42 C.F.R. Part 93.At 91¿´Æ¬Íø, the RIO is the Vice Provost for Research or their designee.

Research misconduct. Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.

Research misconduct proceeding. Research misconduct proceeding means any actions related to alleged research misconduct taken under 42 C.F.R. Part 93, including allegation assessments, inquiries, investigations, ORI oversight reviews, and appeals under subpart E of 42 C.F.R. Part 93.

Research record. Research record means the record of data or results that embody the facts resulting from scientific inquiry. Data or results may be in physical or electronic form. Examples of items, materials, or information that may be considered part of the research record include, but are not limited to, research proposals, raw data, processed data, clinical research records, laboratory records, study records, laboratory notebooks, progress reports, manuscripts, abstracts, theses, records of oral presentations, online content, lab meeting reports, and journal articles.

Respondent. Respondent means the individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.

Retaliation. Retaliation means an adverse action taken against a complainant, witness, or committee member by the university or one of its institutional members because of to (a) a good faith allegation of research misconduct or (b) good faith cooperation with a research misconduct proceeding.

University. University means any person who 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, the university and other colleges and universities, PHS intramural biomedical or behavioral research laboratories, research and development centers, national user facilities, industrial laboratories or other research institutes, research institutions, and independent researchers.

IV. Roles, Rights & Responsibilities

A.     The University

 

91¿´Æ¬Íø’s General Responsibilities

To the extent possible, the university will limit disclosure of the identity of respondents, complainants, and witnesses while conducting the research misconduct proceedings to those who need to know, inform all institutional members about these policies and procedures, and make these policies and procedures publicly available.This limitation on disclosure no longer applies once the university has made a final determination of research misconduct findings. The Research Integrity Officer will respond to each allegation of research misconduct under 42 C.F.R. Part 93 in a thorough, competent, objective, and fair manner. The Research Integrity Officer, with the authority of the Provost where necessary, will 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 other evidence. The Research Integrity Officer will cooperate with ORI and, where required, coordinate submissions with the Institutional Deciding Official during any research misconduct proceeding or compliance review, including addressing deficiencies or additional allegations in the institutional record if directed by ORI and will assist in administering and enforcing any HHS administrative actions imposed on institutional members. The Provost, upon recommendation of the Research Integrity Officer, may also take steps to manage published data or acknowledge that data may be unreliable.

91¿´Æ¬Íø’s Responsibilities During and After a Research Misconduct Proceeding

Except as may otherwise be prescribed by applicable law, the university will maintain confidentiality for any records or evidence from which research subjects might be identified and will limit disclosure to those who need to know to carry out a research misconduct proceeding. Before or at the time of notifying the respondent of the allegation(s) and whenever additional items become known or relevant, the Research Integrity Officer will promptly take all reasonable and practical steps to obtain all research records and other evidence and sequester them securely. The Research Integrity Officer will ensure that the institutional record contains all required elements, i.e., research records that were compiled and considered during the proceedings, assessment documentation, and inquiry and/or investigation reports. Upon completion of the inquiry, the Research Integrity Officer will provide ORI with the complete inquiry report and add it to the institutional record. The university will maintain the institutional record and all sequestered research records and other evidence in a secure manner for seven years after completion of the institutional and/or HHS proceeding.

The Research Integrity Officer will provide information related to the alleged research misconduct and proceedings to ORI upon request and transfer custody or provide copies of the institutional record or any component of it and any sequestered evidence to HHS, regardless of whether the evidence is included in the institutional record. Additionally, the Research Integrity Officer will promptly notify ORI of any special circumstances listed in § 93.305(g) that may arise.

Disclosure of the identity of respondents, complainants, and witnesses while the Research Integrity Officer is conducting the research misconduct proceedings is limited to those who need to know, which the Research Integrity Officer will determine consistent with a thorough, competent, objective, and fair research misconduct proceeding, and as allowed by law. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions.

91¿´Æ¬Íø’s Responsibilities to the Complainant(s)

The university will provide confidentiality consistent with 42 C.F.R. Part 93 for all complainants in a research misconduct proceeding. The Provost, upon recommendation of the Research Integrity Officer, will take precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have potential, perceived, or actual personal, professional, or financial conflicts of interest with the complainant(s). The university agrees to take all reasonable and practical steps to protect the positions and reputations of complainants and to protect these individuals from retaliation by respondents and/or other institutional members. If the university chooses to notify one complainant of the inquiry results in a case, all complainants will be notified by the institution, to the extent possible.

91¿´Æ¬Íø’s Responsibilities to the Respondent(s)

As with complainants, the university will provide confidentiality consistent with 42 C.F.R. Part 93 to all respondents in a research misconduct proceeding. The Research Integrity Officer will make a good-faith effort to notify the respondent(s) in writing of the allegations being made against them. The Research Integrity Officer will take precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the respondent. The Research Integrity Officer is responsible for giving the respondent(s) copies of or supervised access to the sequestered research records. The Research Integrity Officer will notify the respondent whether the inquiry found that an investigation is warranted, provide the respondent an opportunity to review and comment on the inquiry report, and attach their comments to the inquiry report. If an investigation is commenced, the Research Integrity Officer must notify the respondent, give written notice of any additional allegations raised against them not previously addressed by the inquiry report, and allow the respondent(s) an opportunity to review the witness transcripts. The Research Integrity Officer will give the respondent(s) an opportunity to read and comment on the draft investigation report and any information or allegations added to the institutional record.The Research Integrity Officer will give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.

The university will bear the burden of proof, by a preponderance of the evidence, for making a finding of research misconduct. The university will make all reasonable, practical efforts, if requested and as appropriate, to protect or restore the reputation of respondents against whom no finding of research misconduct is made.

91¿´Æ¬Íø’s Responsibilities to Committee Members

The Research Integrity Officer will ensure that a committee, consortium, or person acting on the institution’s behalf conducts research misconduct proceedings in compliance with the PHS regulation. The Provost, upon recommendation of the Research Integrity Officer, will take all reasonable and practical steps to protect the positions and reputations of good-faith committee members and to protect these individuals from retaliation.

91¿´Æ¬Íø’s Responsibilities to the Witness[es]

The university will provide confidentiality consistent with 42 C.F.R. Part 93 for all witnesses. The Research Integrity Officer will take precautions to ensure that individuals responsible for carrying out any part of the proceedings do not have unresolved personal, professional, or financial conflicts of interest with the witnesses. The Provost, upon recommendation of the Research Integrity Officer, will also take all reasonable and practical steps to protect the positions and reputations of witnesses and to protect these individuals from retaliation.

B.     Research Integrity Officer

The Research Integrity Officer (RIO) is the institutional official responsible for administering 91¿´Æ¬Íø’s written policies and procedures for addressing allegations of research misconduct in compliance with the PHS regulation. The same individual will not serve as both the Institutional Deciding Official and the Research Integrity Officer. The institution may choose to have the Research Integrity Officer or another designated institutional official conduct the inquiry in lieu of a committee, and, if needed, this individual may utilize one or more subject matter experts to assist them in the inquiry.

Upon receiving an allegation of research misconduct, the Research Integrity Officer will promptly assess the allegation to determine whether the allegation (a) is within the definition of research misconduct under the PHS regulation, (b) is within the applicability criteria of the regulation at 42 C.F.R. § 93.102, and (c) is sufficiently credible and specific so that potential evidence of research misconduct may be identified. If the Research Integrity Officer determines that the requirements for an inquiry are met, they shall document the assessment, promptly sequester all research records and other evidence per the PHS regulation, and promptly initiate the inquiry. If the Research Integrity Officer determines that requirements for an inquiry are not met, they will keep sufficiently detailed documentation of the assessment to permit a later review by the Research Integrity Officer of the reasons why the university did not conduct an inquiry. The university will keep this documentation and related records in a secure manner for seven years and provide them to ORI upon request.

C.    Dean, Department Chair, or Program Director

If an allegation is initially received by a Department Chair, Program Director, or Dean, that administrator shall promptly forward the allegation to the Research Integrity Officer. No inquiry or investigation shall proceed without oversight by the Research Integrity Officer.

D. Complainant

The complainant is the person who in good faith makes an allegation of research misconduct. The complainant brings research misconduct allegations directly to the attention of an institutional or HHS official through any means of communication.

The complainant will make allegations in good faith, as it is defined in the PHS regulation, as having a reasonable belief in the truth of one’s allegation or testimony, based on the information known to the complainant at the time.

E.     Respondent

The respondent is the individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding. The respondent has the burden of going forward with and proving, by a preponderance of evidence, any affirmative defenses raised. The respondent’s destruction of research records documenting the questioned research is evidence of research misconduct, where a preponderance of evidence establishes that the respondent intentionally or knowingly destroyed records after being informed of the research misconduct allegations. The respondent’s failure to provide research records documenting the questioned research is evidence of research misconduct where the respondent claims to possess the records but refuses to provide them upon request.

F.      Committee and Consortium Members

Committee members (and consortium members where applicable) are experts who act in good faith to cooperate with the research misconduct proceedings by impartially carrying out their assigned duties for the purpose of helping the university meet its responsibilities under 42 C.F.R. Part 93. Committee and consortium members will have relevant scientific expertise and be free of real or perceived conflicts of interest with any of the involved parties. In appointing inquiry or investigation committee members, the Research Integrity Officer shall consult with the relevant Dean regarding appropriate subject matter expertise and potential conflicts of interest. The Dean’s role is consultative only.

Committee or consortium members or anyone acting on behalf of the university will conduct research misconduct proceedings in accordance with the PHS regulations. The inquiry committee or consortium members will determine whether an investigation is warranted, documenting the decision in an inquiry report. The investigation committee or consortium members participate in recorded interviews of 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(s). They will also determine whether or not the respondent(s) engaged in research misconduct and document their decision in the investigation report. They consider respondent and/or complainant comments on the investigation report and document those considerations in the report.

An investigation into multiple respondents may convene with the same investigation committee or consortium members or anyone acting on behalf of 91¿´Æ¬Íø, but there will be separate investigation reports and separate research misconduct determinations for each respondent. Committee or consortium members may serve for more than one investigation, in cases with multiple respondents. Committee members may also serve for both the inquiry and the investigation.

G.    Witnesses

Witnesses are people whom the university has reasonably identified as having information regarding any relevant aspects of the investigation. Witnesses provide information for review during research misconduct proceedings. Witnesses will cooperate with the research misconduct proceedings in good faith and have a reasonable belief in the truth of their testimony, based on the information known to them at the time.

H.    Institutional Deciding Official

The Institutional Deciding Official (IDO) makes the final determination of research misconduct findings. The same individual will not serve as both the Institutional Deciding Official and the Research Integrity Officer. The Institutional Deciding Official documents their determination in a written decision that includes whether research misconduct occurred, and if so, what kind and who committed it, and a description of the relevant actions the university has taken or will take. The Institutional Deciding Official’s written decision becomes part of the institutional record.

Where research misconduct is found, the Institutional Deciding Official shall determine appropriate institutional sanctions in accordance with the Faculty Handbook. The Provost retains authority to impose major sanctions, subject to applicable appeal rights under Section III.F.5 of the Faculty Handbook.

V. Procedures for Addressing Allegations of Research Misconduct

A.     Assessment

An assessment’s purpose is to determine whether an allegation warrants an inquiry. An assessment is intended to be a review of readily accessible information relevant to the allegation.

Upon receiving an allegation of research misconduct, the Research Integrity Officer will promptly and no later than ten business days, determine whether the allegation (a) falls within the definition of research misconduct, (b) is within the applicability criteria of 42 C.F.R. Part 93 § 93.102, and (c) is credible and specific enough to identify and sequester potential evidence.

If the Research Integrity Officer determines that the allegation meets these three criteria, they will : (a) document the assessment (b) initiate an inquiry per Section V.B of this policy and (c) sequester all research records and other evidence. The Research Integrity Officer must document the assessment, including the determination and rationale that the alleged misconduct does or does not meeting the criteria to proceed to an inquiry, and retain the assessment documentation securely for seven years after completion of the misconduct proceedings. If the Research Integrity Officer determines that the alleged misconduct does not meet the criteria to proceed to an inquiry, they will write sufficiently detailed documentation to permit a later review by ORI of why the university did not proceed to an inquiry and securely retain this documentation for seven years. 

B.     Inquiry

An inquiry is warranted if the allegation (a) falls within the definition of research misconduct under 42 C.F.R. Part 93, (b) is within the applicability criteria of 42 C.F.R. § 93.102, and (c) is sufficiently credible and specific so that potential evidence of research misconduct may be identified. An inquiry’s purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation. An inquiry does not require a full review of all related evidence.The inquiry shall be completed within 90 days of initiating it unless circumstances warrant a longer period, in which case the Research Integrity Officer or the Inquiry Committee will sufficiently document the reasons for exceeding the time limit in the inquiry report and inform the respondent of reason and duration of the extension.

Sequestering Evidence and Notifying the Respondent

Before or at the time of notifying the respondent(s), the Research Integrity Officer will obtain the original or substantially equivalent copies of all research records and other evidence that are pertinent to the proceeding, inventory these materials, , and retain them for seven years. The Research Integrity Officer has a duty to obtain, inventory, and securely sequester evidence that extends to whenever additional items become known or relevant to the inquiry or investigation and, where appropriate, give the respondent copies of, or reasonable supervised access to, the research records that are sequestered.

At the time of or before beginning the inquiry, the Research Integrity Officer will  notify the presumed respondent(s), in writing, that an allegation(s) of research misconduct has been raised against them, that  relevant research records have been sequestered, and that an inquiry will be conducted to decide whether to proceed with an investigation. If additional allegations are raised, the Research Integrity Officer will notify the respondent(s) in writing. When appropriate, the Research Integrity Officer will give the respondent(s) copies of, or reasonable supervised access to, the sequestered materials.

If additional respondents are identified, the Research Integrity Officer will provide written notification to the new respondent(s). All additional respondents will be given the same rights and opportunities as the initial respondent. Only allegations specific to a particular respondent will be included in the notification to that respondent.

Convening the Committee and Ensuring Neutrality

The Research Integrity Officer shall appoint the Inquiry Committee and shall ensure that members possess appropriate disciplinary expertise and have no unresolved conflicts of interest.

The Research Integrity Officer will ensure that all inquiry committee members understand their commission, keep the identities of respondents, complainants, and witnesses confidential, and conduct the research misconduct proceedings in compliance with the PHS regulation.

Determining Whether an Investigation Is Warranted

In coordination with the Research Integrity Officer, the Inquiry Committee will conduct a preliminary review of the evidence. During the fact-finding process, the Inquiry Committee may interview the respondent and/or witnesses. An investigation is warranted if (a) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct under 42 C.F.R. Part 93 and involves PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, as provided in 42 C.F.R. § 93.102; and (b) preliminary information-gathering and fact-finding from the inquiry indicates that the allegation may have substance.

The Inquiry Committee will not determine if research misconduct occurred, nor assess whether the alleged misconduct was intentional, knowing, or reckless; such a determination is not made until the case proceeds to an investigation.

Documenting the Inquiry

At the conclusion of the inquiry,  the Inquiry Committee or the Research Integrity Officer will prepare a written inquiry report. The contents of a complete inquiry report will include:

• The names, professional aliases, and positions of the respondent and complainant(s).
• A description of the allegation(s) of research misconduct.
• Details about the PHS funding, including any grant numbers, grant applications, contracts, and publications listing PHS support.
• The composition of the inquiry committee, if u..sed, including name(s), position(s), and subject matter expertise.
• An inventory of sequestered research records and other evidence and a description of how sequestration was conducted.
• Transcripts of interviews, if transcribed.
• Inquiry timeline and procedural history.
• Any scientific or forensic analyses conducted.
• The basis for recommending that the allegation(s) warrant an investigation or the basis on which any allegation(s) do not merit further investigation.
• Any comments on the inquiry report by the respondent or the complainant(s).
• Any institutional actions implemented, including internal communications or external communications with journals or funding agencies.
• Documentation of potential evidence of honest error or difference of opinion.

Completing the Inquiry

The Research Integrity Officer will give the respondent a copy of the draft inquiry report for review and comment.

The Research Integrity Officer will notify the respondent of the inquiry’s final outcome and provide the respondent with copies of the final inquiry report, the PHS regulation, and these policies and procedures. If the Research Integrity Officer provides notice to one complainant in a case, it must provide notice, to the extent possible, to all complainants in the case.

If an Investigation Is Not Warranted:

If the Inquiry Committee or the Research Integrity Officer determines that an investigation is not warranted, the Research Integrity Officer will keep sufficiently detailed documentation to permit a later review by ORI of why the university did not proceed to an investigation, store these records in a secure manner for at least seven years after the termination of the inquiry, and provide them to ORI upon request.  

If an Investigation is Warranted:

If the Inquiry Committee or the Research Integrity Officer determines that an investigation is warranted, the Research Integrity Officer must: (a) within a reasonable amount of time after this decision, provide written notice to the respondent(s) of the decision to conduct an investigation of the alleged misconduct, including any allegations of research misconduct not addressed during the inquiry;and (b) within 30 days of determining that an investigation is warranted, provide ORI with a copy of the inquiry report.

On a case-by-case basis, the Research Integrity Officer may choose to notify the complainant that there will be an investigation of the alleged misconduct but is required to take the same notification action for all complainants in cases where there is more than one complainant.

C.    Investigation

The purpose of an investigation is to formally develop a factual record, pursue leads, examine the record, and recommend finding(s) to the Institutional Deciding Official, who will make the final decision, based on a preponderance of evidence, on each allegation and any institutional actions. As part of its investigation, the Research Integrity Officer will pursue diligently all significant issues and relevant leads, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion. Within 30 days after deciding an investigation is warranted, the Research Integrity Officer will notify ORI of the decision to investigate and begin the investigation.

Notifying the Respondent and Sequestering Evidence

The Research Integrity Officer will notify the respondent(s) of the allegation(s) within 30 calendar days of determining that an investigation is warranted and before the investigation begins. If any additional respondent(s) are identified during the investigation, the Research Integrity Officer will notify them of the allegation(s) and provide them an opportunity to respond consistent with the PHS regulation. If the Research Integrity Officer identifies additional respondents during the investigation, it may choose to either conduct a separate inquiry or add the new respondent(s) to the ongoing investigation. The Research Integrity Officer will obtain the original or substantially equivalent copies of all research records and other evidence, inventory these materials, sequester them in a secure manner, and retain them for seven years after its proceeding or any HHS proceeding, whichever is later.

Convening an Investigation Committee

After vetting investigation committee members for conflicts of interest and appropriate scientific expertise, the Research Integrity Officer will convene the committee and ensure that the members understand their responsibility to conduct the research misconduct proceedings in compliance with the PHS regulation. Appointment of the Investigation Committee shall be made in accordance with the consultation requirements set forth in Section V.B.2 (Convening the Committee and Ensuring Neutrality).

The Investigation Committee will conduct interviews, pursue leads, and examine all research records and other evidence relevant to reaching a decision on the merits of the allegation(s). The Research Integrity Officer will use diligent efforts to ensure that the investigation is thorough, sufficiently documented, and impartial and unbiased to the maximum extent practicable. The Research Integrity Officer will notify the respondent in writing of any additional allegations raised against them during the investigation.

Conducting Interviews

The Investigation Committee will interview each respondent, complainant(s), 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. The Investigation Committee will number all relevant exhibits and refer to any exhibits shown to the interviewee during the interview by that number. The Investigation Committee will record and transcribe interviews during the investigation and make the transcripts available to the interviewee for correction. The Investigation Committee will include the transcript(s) with any corrections and exhibits in the institutional record of the investigation. The respondent will not be present during the witnesses’ interviews, but the Research Integrity Officer will provide the respondent with a transcript of each interview, with redactions as appropriate to maintain confidentiality.

The respondent will not be present during the witnesses’ interviews but will be provided a transcript of the interview after it takes place. The respondent will have opportunities to (a) view and comment on the inquiry report, (b) view and comment on the investigation report, and (c) submit any comments on the draft investigation report to The university within 30 days of receiving it.

Documenting the Investigation

The Research Integrity Officer will ensure that all aspects of the investigation are completed within 180 days of beginning of the investigation.[cxlix] The Investigation Committee will conduct the investigation, prepare the draft investigation report for each respondent, and provide the opportunity for respondents to comment.[cl] If the investigation takes more than 180 days to complete, the Research Integrity Officer will ask ORI in writing for an extension and document the reasons for exceeding the 180-day period in the investigation report.

The investigation report for each respondent will include:

1. Description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.
2. Description and documentation of the PHS support, including any grant numbers, grant applications, contracts, and publications listing PHS support. This documentation includes known applications or proposals for support that the respondent has pending with PHS and non-PHS Federal agencies.
3. Description of the specific allegation(s) of research misconduct for consideration in the investigation of the respondent.
4. Composition of Investigation Committee, including name(s), position(s), and subject matter expertise.
5. Inventory of sequestered research records and other evidence, except records that the Investigation Committee did not consider or rely on. This inventory will include manuscripts and funding proposals that were considered or relied on during the investigation. The inventory will also include a description of how any sequestration was conducted during the investigation.
6. Transcripts of all interviews conducted.
7. Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other research records that contain the allegedly falsified, fabricated, or plagiarized material.
8. Any scientific or forensic analyses conducted.
9. A copy of these policies and procedures.
10. Any comments made by the respondent andon the draft investigation report and the committee’s consideration of those comments.
11. A statement for each separate allegation of whether the committee recommends a finding of research misconduct.

If the Investigation Committee recommends a finding of research misconduct for an allegation, the investigation report will present a finding for each allegation. These findings will (a) identify the individual(s) who committed the research misconduct; (b) indicate whether the misconduct was falsification, fabrication, and/or plagiarism; (c) indicate whether the misconduct was committed intentionally, knowingly, or recklessly; (d) identify any significant departure from the accepted practices of the relevant research community and that the allegation was proven by a preponderance of the evidence; (e) summarize the facts and analysis supporting the conclusion and consider the merits of any explanation by the respondent; (f) identify the specific PHS support; and (g) state whether any publications need correction or retraction.

If the Investigation Committee does not recommend a finding of research misconduct for an allegation, the investigation report will provide a detailed rationale for its conclusion.

The Investigation Committee should also provide a list of any current support or known applications or proposals for support that the respondent has pending with PHS and non-PHS Federal agencies.

Completing the Investigation

The Research Integrity Officer will give the respondent a copy of the investigation report and, concurrently, a copy of, or supervised access to, the research records and other evidence that the investigation committee considered or relied on. The respondent will submit any comments on the draft report to the Research Integrity Officer within 30 days of receiving the draft investigation report. If the Research Integrity Officer chooses to share a copy of the draft investigation report or relevant portions of it with the complainant(s) for comment, the complainant’s comments will be submitted to the Research Integrity Officer within 30 days of the date on which they received the report. The Research Integrity Officer will add any comments received to the investigation report.

Institutional Deciding Official Review of the Investigation Report

The Institutional Deciding Official will review and make a final written determination of whether research misconduct occurred and, if so, who committed the misconduct. In this statement, the Institutional Deciding Official will include a description of relevant institutional actions taken or to be taken. The Research Integrity Officer will document the Institutional Deciding Official’s final decision and transmit the institutional record (including the final investigation report and the Institutional Deciding Official’s decision) to ORI.

Creating and Transmitting the Institutional Record

After the Institutional Deciding Official has made a final determination of research misconduct findings, the Research Integrity Officer will add the Institutional Deciding Official’s written decision to the investigation report and organize the institutional record in a logical manner.

The institutional record consists of records that the Research Integrity Officer, on behalf of 91¿´Æ¬Íø, compiled or generated during the research misconduct proceeding, except for records that were not considered or relied on. These records include documentation of the assessment, a single index listing all research records and evidence, the inquiry report and investigation report, and all records considered or relied on during the inquiry and the investigation. The institutional record also includes the Institutional Deciding Official’s final decision and any information the respondent provided to the Research Integrity Officer. The institutional record must also include a general description of the records that were sequestered but not considered or relied on.

If the respondent filed an appeal, the complete record of any institutional appeal also becomes part of the institutional record. For institutions with an internal appeals process, the Research Integrity Officer will wait until the appeal is concluded to transmit the institutional record to ORI. After the Institutional Deciding Official has made a final written determination, and any institutional appeal is complete, the Research Integrity Officer must transmit the institutional record to ORI.

D. Other Procedures and Special Circumstances

 

Multiple Institutions and Multiple Respondents

If the alleged research misconduct involves multiple institutions, the university may work closely with the other affected institutions to determine whether a joint research misconduct proceeding will be conducted. If so, the cooperating institutions will choose an institution to serve as the lead institution. In a joint research misconduct proceeding, the lead institution will obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institutions. By mutual agreement, the joint research misconduct proceeding may include committee members from the institutions involved. The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.

If the alleged research misconduct involves multiple respondents, the university may either conduct a separate inquiry for each new respondent or add them to the ongoing proceedings. The institution must give additional respondent(s) notice of and an opportunity to respond to the allegations.

Respondent Admissions

The Research Integrity Officer will promptly notify ORI if at any point during the proceedings (including the assessment, inquiry, investigation, or appeal stage) it plans to close a research misconduct case because the respondent has admitted to committing research misconduct or has been reached.

If the respondent admits to research misconduct, the Research Integrity Officer will not close the case until providing ORI with the respondent’s signed, written admission. The admission must state the specific fabrication, falsification, or plagiarism that occurred, which research records were affected, and that it constituted a significant departure from accepted practices of the relevant research community. The respondent’s signed, written admission must also confirm that the misconduct was committed intentionally, knowingly, or recklessly.

The Research Integrity Officer must not close the case until giving ORI a written statement confirming the respondent’s culpability and explaining how the Institutional Deciding Official determined that the respondent’s admission fully addresses the scope of the misconduct.

Other Special Circumstances

At any time during the misconduct proceedings, the Research Integrity Officer will immediately notify ORI if any of the following circumstances arise:

• Health or safety of the public is at risk, including an immediate need to 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.
• HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.

E.     Records Retention

The Research Integrity Officer will maintain the institutional record and all sequestered evidence, including physical objects (regardless of whether the evidence is part of the institutional record), in a secure manner for seven years after the completion of the proceeding or the completion of any HHS proceeding, whichever is later, unless custody has been transferred to HHS.

VI. Authority and Amendment

This interim policy was approved by the Provost on March 30, 2026.

The Office of the Provost is responsible for the interpretation and enforcement of this policy and the Vice Provost of Research is permitted to make minor and technical amendments.

VII. Related Policies and Documents

Full Policy with Table of Contents and Footnotes (pdf)