ResearchMisconduct Policy

Versiti’s updated Research Misconduct Policy and Procedures (“Policy”) is adopted:

• To ensure that research activities conducted or supported by Versiti are performed in accordance with the highest ethical and scientific standards.¹
• To foster a research environment that promotes the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.
• To establish a consistent written process for addressing allegations of research misconduct in a thorough, competent, objective and fair manner.
• To protect a good faith complainant, respondent(s), witnesses and others who participate in the research misconduct review process from retaliation.
• To ensure compliance with applicable laws and regulations.

Versiti relies on all Institutional Members to establish and maintain the highest standards of ethical practices in research. Each Institutional Member is expected to:

• Support and contribute to the ongoing maintenance of a research environment that promotes the shared values described above, adheres to the highest standards of ethical practice, and inspires confidence and trust in research findings;
• Regularly attend sessions at which research data are presented and actively participate in the rigorous examination of research data and developments;
• Attend formal and informal training in ethical research practices provided by Versiti and other entities;
• Ensure that all research data are properly documented and retained in accordance with Versiti Record Retention Policy and Record Retention Guidelines;
• Encourage free and open exchange of research materials and new ideas;
• Maintain a high standard of personal and corporate accountability;
• Acknowledge and respect the intellectual contributions of others in the greater research community; and
• Remain in full compliance with all applicable statutes, regulations, and Versiti policies.

This Policy applies to allegations of research misconduct involving:

• Applications or proposals for Public Health Service (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 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.⁷

This Policy applies only to research misconduct occurring within six (6) years of the date8 Department of Health and Human Services (HHS) or Versiti receives an allegation of research misconduct, subject to the following exceptions:

• The six-year time limitation does not apply if a 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 (e.g., processed data, journal articles, funding proposals, data repositories, and the like) alleged to have been fabricated, falsified, or plagiarized, for the potential benefit of a respondent (“subsequent use exception”).⁹ For alleged research misconduct that appears subject to this subsequent use exception, but Versiti determines is not subject to the exception, Versiti will document its determination that the subsequent use exception does not apply and will retain this documentation for the later of seven years after completion of Versiti proceeding or the completion of any HHS proceeding.¹⁰
• The six-year time limitation also does not apply if the Office of Research Integrity (ORI) or Versiti, 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.¹¹

This Policy does not supersede or establish an alternative to the PHS regulation or any existing regulations for handling research misconduct involving non-PHS supported research.¹² This Policy does not replace the PHS regulation, and in case of any conflict between this document and 42 CFR Part 93, the PHS regulation will prevail. This Policy is intended to enable Versiti to comply with the requirements of the PHS regulation.

For funding that does not rely on PHS Research Misconduct regulations, such as NSF through https://www.ecfr.gov/current/title-45/subtitle-B/chapter-VI/part-689, Versiti will refer to and implement those specific funding research misconduct policies and procedures.

Versiti is committed to upholding the highest standards of scientific rigor in research. By fostering an environment that promotes research integrity and the responsible conduct of research, Versiti discourages research misconduct while enforcing this Policy to promptly and objectively handle allegations or evidence of possible research misconduct.¹³

Versiti Institutional Members are expected to conduct research with honesty, rigor, and transparency. Each Member is responsible for contributing to an organizational culture that establishes, maintains, and promotes research integrity and the responsible conduct of research.

Research misconduct is contrary to the interests of Versiti, the health and safety of the public, the integrity of research, and the conservation of the public trust. Both Versiti and its Institutional Members have an affirmative duty to protect public research funds from misuse by ensuring the integrity of all research conducted on behalf of Versiti.¹⁴

In the guide On Being a Scientist, The National Academy of Sciences states, “The scientific research enterprise, like other human activities, is built on a foundation of trust. Scientists trust that the results reported by others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe the world accurately and without bias. The level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct.”

The entirety of On Being a Scientist can be found online here: https://www.nationalacademies.org/our-work/on-being-a-scientist-an-updated-and-online-guide-to-the-responsible-and-ethical-conduct-of-research

Accepted practices for the responsible conduct of research can and do vary from discipline to discipline and even from laboratory to laboratory. Important shared values for the responsible conduct of research that bind all researchers together include:

HONESTY — conveying information truthfully and honoring commitments.
ACCURACY — reporting research findings precisely and taking care to avoid errors.
EFFICIENCY — using resources wisely and avoiding waste.
OBJECTIVITY — letting the facts speak for themselves and avoiding improper bias.

Versiti 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 protect and restore researchers’ reputations, as appropriate.Versiti is responsible for ensuring that these policies and procedures for addressing allegations of research misconduct meet the requirements of the Public Health Service (PHS) Policies on Research Misconduct (42 CFR Part 93, “the PHS regulation”). Versiti is committed to following these policies and procedures, to sharing them publicly, and for training of Institutional Members.¹⁵

Institution

Versiti’s General Responsibilities

Versiti will make this Policy publicly available to all Versiti Institutional Members on its external-facing website. New Versiti Institutional Members will be required to review and acknowledge the policy at least every four (4) years. Thereafter, Versiti Institutional Members will review and acknowledge the policy at least every four (4) years; and if and when Versiti materially revises this Policy in accordance with federal regulations. A failure to comply with the provisions of this Policy and/or being a respondent with a finding of research misconduct may result in discipline, up to and including termination of employment.

To the extent possible, Versiti will protect the identity of respondents, complainants, and witnesses while conducting research misconduct proceedings to those who have a reasonable need to know.45 This limitation on disclosure no longer applies once Versiti has made a final determination of research misconduct findings.46 Versiti will respond to each allegation of research misconduct under 42 CFR Part 93 in a thorough, competent, objective, and fair manner.⁴⁷ Versiti will take 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.⁴⁸

Versiti will cooperate with ORI during any research misconduct proceeding or compliance review, including addressing deficiencies or additional allegations in the Versiti record if directed by ORI and to assist in administering and enforcing any HHS administrative actions imposed on institutional members.⁴⁹ Versiti may also take reasonable and practical steps to manage published data or acknowledge that data may be unreliable.⁵⁰ Versiti will take reasonable and practical steps to protect the positions and reputations of a good faith complainant, a respondent, a witness, and committee members who participate in the review process. All Versiti personnel are strictly prohibited from engaging in any form of retaliation against any individual (or entity) who: (i) communicates a good faith concern related to research misconduct (regardless of whether such concern reflects actual wrongdoing); or (ii) cooperates in any inquiry or investigation regarding such concern.

Prohibited retaliatory behavior includes any negative action that would deter a reasonable person in the same situation from communicating or participating in the investigation of a concern related to Versiti practices or conduct. Examples of retaliatory behavior include, but are not limited to, discharging, demoting, suspending, threatening, harassing, disciplining, changing a job or shift assignment, or in any other manner discriminating or retaliating against any person or entity involved in the good faith communication or Investigation of a concern. Versiti personnel who engage in retaliatory behavior in violation of this Policy will be subject to disciplinary action, up to and including termination.

Versiti’s Responsibilities During and After a Research Misconduct Proceeding

Except as may otherwise be prescribed by applicable law, Versiti 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.⁵¹ Those who need to know include, but are not limited to, Versiti’s Chief Human Resources Officer, Chief Research Officer, Chief Legal Officer, Chief Executive Officer, and Board of Directors (including committees thereof). Before or at the time of notifying a respondent of the allegation(s) and whenever additional items become known or relevant, Versiti will promptly take reasonable and practical steps to obtain all research records and other evidence and sequester them securely.⁵²

Versiti will ensure that the retained materials contain all required elements, i.e., research records that were compiled and considered during the proceedings, assessment documentation, and inquiry and/or investigation reports. Within 30 days of determining that an investigation is warranted, Versiti will provide ORI with the complete inquiry report and add it to Versiti record.⁵³ Versiti will maintain records and all sequestered materials and other evidence in a secure manner for seven years after completion of Versiti and/or HHS proceeding.⁵⁴

Versiti will provide information related to the alleged research misconduct and proceedings to ORI upon request and transfer custody or provide copies of Versiti record or any component of it and any sequestered evidence to HHS, regardless of whether the evidence is included in Versiti record.⁵⁵ Additionally, Versiti will promptly notify ORI of any special circumstances that may arise.⁵⁶

Disclosure of any respondent, complainant, and witness identity while Versiti is conducting the research misconduct proceedings is limited to those who need to know, which Versiti 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. Versiti, however, must disclose the identity of respondents, complainants, or other relevant persons to ORI pursuant to an ORI review of research misconduct proceedings under this part.⁵⁷

Versiti’s Responsibilities to a Complainant(s)

Versiti will provide confidentiality consistent with 42 CFR Part 93 for any complainant in a research misconduct proceeding. Versiti will also take precautions to ensure that an individual responsible for 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).⁵⁸ Versiti agrees to take reasonable and practical steps to protect the position and reputation of complainants and to protect these individuals from retaliation by respondents and/or other institutional members.⁵⁹ If Versiti chooses to notify one complainant of the inquiry results in a case, all complainants will be similarly notified by Versiti, to the extent possible.⁶⁰

Versiti’s Responsibilities to a Respondent(s)

As with a complainant, Versiti will provide confidentiality consistent with 42 CFR Part 93 to any respondent in a research misconduct proceeding. Versiti will make a good faith effort to notify a respondent(s) in writing of the allegations being made against them.⁶¹ Versiti will take precautions to ensure that an individual responsible for any part of the research misconduct proceeding does not have unresolved personal, professional, and/or financial conflicts of interest with a respondent.⁶² Versiti is responsible for giving a respondent(s) copies of or supervised access to the sequestered research records.⁶³

Versiti will notify a respondent whether the inquiry found that an investigation is warranted, provide a respondent an opportunity to review and comment on the inquiry report, and attach their comments to the inquiry report.⁶⁴ If an investigation is warranted, Versiti must notify a respondent, give written notice of any additional allegations raised against them not previously addressed by the inquiry report, and allow a respondent(s) an opportunity to review the witness transcripts.⁶⁵ Versiti however may decide on a case-by-case basis whether redactions or anonymizing of the transcripts may be appropriate to protect a witness. Versiti will give a respondent(s) an opportunity to read and comment on the draft investigation report and any information or allegations added to the Versiti record.⁶⁶ At the inquiry stage as well as the investigation stage of a research misconduct proceeding, Versiti will give due consideration to admissible credible evidence of honest error or difference of opinion presented by a respondent.⁶⁷

Versiti will bear the burden of proof, by a preponderance of the evidence, for making a finding of research misconduct.⁶⁸ Versiti will make reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of a respondent against whom no finding of research misconduct is made.⁶⁹

Versiti’s Responsibilities to Committee Members

Versiti will ensure that a committee, consortium, or person acting on Versiti’s behalf conducts research misconduct proceedings in compliance with the PHS regulation. Versiti will take reasonable and practical steps to protect the positions and reputations of good faith committee members and to protect these individuals from retaliation.⁷⁰

Versiti’s Responsibilities to Witness[es]

Versiti will provide confidentiality consistent with 42 CFR Part 93 for any witness. Versiti will take precautions to ensure that any individual responsible for any part of the proceedings does not have unresolved personal, professional, or financial conflicts of interest with a witness.⁷¹ Versiti will also take reasonable and practical steps to protect the positions and reputations of a witness without retaliation.⁷²

Research Integrity Officer

The Versiti RIO is responsible for administering this Policy and procedures in compliance with the PHS regulation.⁷³ The same individual will not serve as both Versiti Deciding Official and the RIO.⁷⁴ Versiti may choose to have the RIO 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.⁷⁵

Upon receiving an allegation of research misconduct, the RIO will promptly assess the allegation to determine whether the allegation is within the definition of research misconduct under the PHS regulation, is within the applicability criteria of the regulation at § 93.102, and is sufficiently credible and specific so that potential evidence of research misconduct may be identified.⁷⁶ If the RIO determines that the requirements for an inquiry are met, they will document the assessment, promptly sequester all research records and other evidence per the PHS regulation, and promptly initiate the inquiry.⁷⁷ If the RIO determines that requirements for an inquiry are not met, they will keep sufficiently detailed documentation of the assessment to permit a later review by ORI of the reasons why Versiti did not conduct an inquiry.⁷⁸ Versiti will keep this documentation and related records in a secure manner for seven years and provide them to ORI upon request.⁷⁹

Complainant

A complainant is a person who in good faith makes an allegation of research misconduct.⁸⁰ A complainant brings research misconduct allegations directly to the attention of the RIO or other Versiti official, or HHS official through any means of communication. A complainant may also report concerns to Versiti’s third-party compliance hotline provider (refer to Versiti’s Whistleblower Policy for contact information). A complainant is encouraged to provide as much information and documentation as possible, including any presentations, publications, or other documents that may be affected by the alleged misconduct.

A 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 a complainant at the time.⁸¹

This Policy is also intended to protect an individual against false allegations of research misconduct. Any communication that proves to be both unsubstantiated and made with malice or with knowledge of its falsity is not protected by this Policy. Versiti personnel who (i) knowingly or with reckless disregard for the truth give false information, (ii) knowingly make a false report of wrongful conduct, or (iii) knowingly submit a false report of retaliation, will be subject to disciplinary action, up to and including termination. An allegation that is not substantiated, yet made in good faith, is not subject to corrective action.

Respondent

A respondent is the individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.⁸² A respondent has the burden of going forward with and proving, by a preponderance of the evidence, any raised affirmative defense.⁸³ A respondent’s destruction of research records documenting the questioned research is evidence of research misconduct where a preponderance of the evidence establishes that a respondent intentionally or knowingly destroyed records after being informed of the research misconduct allegations.⁸⁴ A respondent’s failure to provide research records documenting the questioned research is evidence of research misconduct where a respondent claims to possess the records but refuses to provide them upon request.⁸⁵ Potential examples of an affirmative defense include 1) lack of data retention; 2) data destruction 3) lack of training and/or knowledge of Versiti Policies relevant to research, such as data retention.

A respondent will not be present during any witness interview but will be provided a transcript of the interview within a reasonable time after it takes place.⁸⁶ However, Versiti may decide on a case-by-case basis whether redactions or anonymizing of the transcripts may be appropriate to protect a witness. A respondent will have opportunities to view and comment on the inquiry report, view and comment on the investigation report, and submit any comments on the draft investigation report to Versiti within 30 days of receiving it.⁸⁷

If admitting to research misconduct, a respondent will sign a written statement specifying the affected research records and confirming the misconduct was: 1) falsification, fabrication, and/or plagiarism; 2) committed intentionally, knowingly, or recklessly; and 3) a significant departure from accepted practices of the relevant research community.⁸⁸

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 Versiti meet its responsibilities under 42 CFR Part 93.⁸⁹ Committee and consortium members will be assessed for conflicts of interest with any of the involved parties, and investigation committee members will have appropriate scientific expertise to evaluate the allegation and evidence.⁹⁰ Versiti must address any potential, perceived, or actual personal, professional, or financial conflicts of interest between members of the committee or consortium, or other person, and the complainant, respondent, or witnesses. Versiti may use an outside member for an inquiry but must have at least one outside member for an investigation, who is subject to the same selection criteria described in this Policy.

Committee or consortium members or anyone acting on behalf of Versiti will conduct research misconduct proceedings consistent with the PHS regulation. They will determine whether an investigation is warranted, documenting the decision in an inquiry report.⁹¹ During an 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 a respondent(s).⁹² They will also determine whether or not a respondent(s) engaged in research misconduct and document the decision in the investigation report.⁹³ They consider respondent and/or complainant comments on the inquiry/investigation report(s) and document that consideration in the investigation report.⁹⁴

An investigation into multiple respondents may convene with the same investigation committee or consortium members or anyone acting on behalf of Versiti, but there will be separate investigation reports and separate research misconduct determinations for each respondent.⁹⁵ Committee or consortium members may serve for more than one investigation, in cases with multiple respondents.⁹⁶ Committee members may also serve for both the inquiry and the investigation.

Witness

A witness is any individual who Versiti has reasonably identified as having information regarding any relevant aspects of the investigation. A witness provides information for review during research misconduct proceedings. A witness cooperates with the research misconduct proceedings in good faith and has a reasonable belief in the truth of their testimony, based on the information known to them at the time.⁹⁷

Institutional Deciding Official

The Versiti IDO makes the final determination of research misconduct findings.⁹⁸ The IDO cannot serve as the RIO.⁹⁹ The IDO 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 Versiti has taken or will take.¹⁰⁰ The IDO’s written decision becomes part of Versiti record.¹⁰¹

Assessment

An assessment’s purpose is to determine whether an allegation warrants an inquiry.¹⁰² An assessment is intended to be a review of readily accessible information relevant to the allegation.¹⁰³

Upon receiving an allegation of research misconduct, the RIO will promptly determine whether the allegation falls within the definition of research misconduct, is within the applicability criteria of 42 CFR Part 93 § 93.102 and is credible and specific enough to identify and sequester potential evidence.¹⁰⁴

If the RIO determines that the allegation meets these three criteria, they will promptly document the assessment and initiate an inquiry along with sequestering and inventorying research records and other evidence.¹⁰⁵ For research records or other evidence that involve 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 original data. The RIO must document the assessment and retain the assessment documentation securely for seven years after completion of the misconduct proceedings.¹⁰⁶ If the RIO determines that the alleged misconduct does not meet the criteria to proceed to an inquiry, the RIO will write sufficiently detailed documentation to permit a later review by ORI of why Versiti did not proceed to an inquiry and securely retain this documentation for seven years.¹⁰⁷

Inquiry

An inquiry is warranted if the allegation falls within the definition of research misconduct under 42 CFR Part 93, is within the applicability criteria of § 93.102, and is sufficiently credible and specific so that potential evidence of research misconduct may be identified.¹⁰⁸ An inquiry’s purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation.¹⁰⁹ An inquiry does not require a full review of all related evidence.¹¹⁰ Versiti will complete the inquiry within 90 days of initiating it unless circumstances warrant a longer period, in which case it will sufficiently document the reasons for exceeding the time limit in the inquiry report.¹¹¹

Sequestering Evidence and Notifying a Respondent

Before or at the time of notifying a respondent(s), Versiti will obtain the original or substantially equivalent copies of all research records and other evidence that are pertinent to the proceeding, inventory these materials, sequester the materials in a secure manner, and retain them for seven years.¹¹² Versiti 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.¹¹³

At the time of or before beginning the inquiry, Versiti will make a good faith effort to notify the presumed respondent(s), in writing, that an allegation(s) of research misconduct has been raised against them, the relevant research records have been sequestered, and an inquiry will be conducted to decide whether to proceed with an investigation.¹¹⁴ The written notice will include: (1) the nature of the allegations; (2) the composition of the inquiry committee or RIO; (3) a copy of this Policy; and (4) a copy of the applicable federal regulations (42 CFR Part 93).

If additional allegations are raised, Versiti will notify a respondent(s) in writing.¹¹⁵ When appropriate, Versiti will give a respondent(s) copies of, or reasonable supervised access to, the sequestered materials.¹¹⁶ See the section above on respondents for evidence of research misconduct related to research records.

If additional respondents are identified, Versiti will provide written notification to the new respondent(s).¹¹⁷ Any additional respondent will be given the same rights and opportunities as the initial respondent.¹¹⁸ Only allegations specific to a particular respondent will be included in the notification to that respondent.¹¹⁹

Convening the Committee and Ensuring Neutrality

Versiti will appoint an inquiry committee if the RIO is not conducting the inquiry (see below). The inquiry committee will include at least three (3) members who have been assessed for conflicts of interest in the case as described above, are unbiased, and have the breadth of knowledge to evaluate the available evidence and issues related to the allegations, conduct any interviews if necessary and complete the inquiry. Inquiry committee members may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside Versiti. Non-Versiti inquiry committee members will be required to sign conflict of interest and confidentiality statements prior to serving. The inquiry committee may consult with legal counsel as necessary.

Versiti will ensure that all inquiry committee members understand their role and responsibilities, keep the identities of a respondent, complainant, and any witness as confidential as described above, and conduct the research misconduct proceedings in compliance with the PHS regulation. In lieu of a committee, Versiti may task the RIO to conduct the inquiry, provided this person involves subject matter experts as needed to assist in the inquiry.¹²⁰

Determining Whether an Investigation Is Warranted

The inquiry committee or RIO will conduct a preliminary review of the evidence.¹²¹ In the process of information-gathering and fact-finding, the inquiry committee may interview a respondent and/or one or more witnesses, and will preliminarily review the available evidence.¹²² An investigation is warranted if a reasonable basis exists for concluding that the allegation falls within the definition of research misconduct under 42 CFR 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 § 93.102; and preliminary information-gathering and fact-finding from the inquiry indicates that the allegation may have substance.¹²³

The inquiry committee will not determine if research misconduct occurred, or assess whether the alleged misconduct was intentional, knowing, or reckless; such a determination is not made until the case proceeds to the investigation, if necessary.¹²⁴

Documenting the Inquiry

At the conclusion of the inquiry, regardless of whether an investigation is warranted, the inquiry committee, RIO, or other designated institutional official will prepare a written inquiry report. The contents of a complete inquiry report will include:

• The names, professional aliases, and positions of 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 used, including name(s), position(s), and subject matter expertise.
• An inventory of sequestered research records and other evidence and 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.
• The basis on which any allegation(s) do not merit further investigation.
• Any comments on the inquiry report by a respondent or the complainant(s).
• Any Versiti actions implemented, including internal communications or external communications with journals or funding agencies.¹²⁵
• Documentation of potential evidence of honest error or difference of opinion.126

Completing the Inquiry

Versiti will give a respondent a copy of the draft inquiry report for review and comment, and attach any comments received from the respondent to the inquiry report.¹²⁷ Versiti may, but is not required to, provide relevant portions of the report to a complainant for comment.¹²⁸ Any review must be completed within five (5) business days of receipt by the respondent and complainant (if any).

Versiti will notify a respondent of the inquiry’s final outcome and provide a respondent with copies of the final inquiry report, the PHS regulation, and these policies and procedures.¹²⁹ Versiti may, but is not required to, notify a complainant whether the inquiry found that an investigation is warranted.¹³⁰ If Versiti provides notice to one complainant in a case, it must provide notice, to the extent possible, to all complainants in the case.¹³¹

If an Investigation Is Not Warranted:

If the inquiry committee or RIO determines that an investigation is not warranted, Versiti will keep sufficiently detailed documentation to permit a later review by ORI of why Versiti 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.¹³²

If an Investigation is Warranted:

If the inquiry committee or RIO determines that an investigation is warranted, Versiti must, within a reasonable amount of time after this decision, provide written notice to a respondent(s) of the decision to conduct an investigation of the alleged misconduct, including any allegations of research misconduct not addressed during the inquiry;¹³³ and within 30 days of determining that an investigation is warranted, provide ORI with a copy of the inquiry report.¹³⁴

On a case-by-case basis, Versiti may choose to notify the complainant that an investigation of the alleged misconduct has been warranted but is required to take the same notification action for all complainants in cases where there is more than one complainant.¹³⁵ The inquiry committee or RIO will provide notification of the inquiry report and whether an investigation is warranted to Versiti management.

Investigation

The purpose of an investigation is to formally develop a factual record, pursue leads, examine the record, and recommend finding(s) to the IDO, who will make the final decision, based on a preponderance of the evidence, on each allegation and any institutional actions.¹³⁶ As part of its investigation, Versiti 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.¹³⁷ Within 30 days after deciding an investigation is warranted, Versiti will begin the investigation and notify ORI of the decision to investigate. The notification to ORI will include a copy of the final inquiry report.¹³⁸

Notifying a Respondent and Sequestering Evidence

Versiti will notify a respondent(s) of the allegation(s) within 30 days of determining that an investigation is warranted and before the investigation begins.¹³⁹ If any additional respondent(s) are identified during the investigation, Versiti will notify them of the allegation(s) and provide them an opportunity to respond consistent with the PHS regulation.¹⁴⁰ If Versiti 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.¹⁴¹ Versiti 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.¹⁴²

Convening an Investigation Committee

If an inquiry committee was initially convened, Versiti can opt to use the same members or appoint new ones. With the latter option, after vetting investigation committee members for conflicts of interest and appropriate scientific expertise, Versiti will convene the committee. Investigation committee members will be required to sign conflict of interest and confidentiality statements prior to serving. Versiti will ensure that the members understand their responsibility to conduct the research misconduct proceedings to ensure a fair objective investigation in compliance with the PHS regulation.¹⁴³ The investigation committee will conduct interviews, diligently pursue all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and examine all research records and other evidence relevant to reaching a decision on the merits of the allegation(s).¹⁴⁴ Versiti will use diligent efforts to ensure that the investigation is thorough, sufficiently documented, and impartial and unbiased to the maximum extent practicable.¹⁴⁵ Versiti will notify a respondent in writing of any additional allegations raised against them during the investigation.¹⁴⁶ 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.

Conducting Interviews

Versiti 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 a respondent.¹⁴⁷ Versiti will number all relevant exhibits and refer to any exhibits shown to the interviewee during the interview by that number.¹⁴⁸ Versiti will record and transcribe interviews during the investigation and make the transcripts available to the interviewee for correction.¹⁴⁹ Versiti will include the transcript(s) with any corrections and exhibits in Versiti record of the investigation.¹⁵⁰ During the witnesses’ interviews, a respondent must not be present, but Versiti will provide them with a transcript of each interview, with redactions as appropriate to maintain confidentiality.¹⁵¹

Documenting the Investigation

Versiti will provide the entire report to the IDO for review and a final determination of research misconduct findings. Versiti will complete all aspects of the investigation within 180 days of its start to its completion with the decision by the IDO.¹⁵² Versiti will conduct the investigation, prepare the draft investigation report for each respondent, and provide the opportunity for each respondent to comment.¹⁵³ The investigation committee will use diligent efforts to ensure that the investigation is thorough, sufficiently documented, and includes examination of all research records and evidence relevant to reaching a decision on the merits of the allegations. A finding of research misconduct is based on a preponderance of the evidence standard of proof. Versiti has the burden of proof for making a finding of research misconduct. The respondent has the burden of going forward with and proving, by a preponderance of the evidence, any and all affirmative defenses raised. In determining whether Versiti has carried the burden of proof, the finder of fact will consider admissible credible evidence of honest error or differences of opinion presented by the respondent.

Versiti will document the IDO’s final decision and transmit the Versiti record (including the final investigation report and IDO’s decision) to ORI.¹⁵⁴ If this process takes more than 180 days to complete, Versiti will ask ORI in writing for an extension and document the reasons for exceeding the 180-day period in the investigation report.¹⁵⁵

The investigation report for each respondent will include:

• Description of the nature of the allegation(s) of research misconduct, including any additional allegation(s) addressed during the research misconduct proceeding.
• Description and documentation of PHS support, including any grant numbers, grant applications, contracts, and publications listing PHS support. This documentation includes known applications or proposals for support that a respondent has pending with PHS and non-PHS Federal agencies.
• Description of the specific allegation(s) of research misconduct for consideration in the investigation of a respondent.
• Composition of investigation committee, including name(s), position(s), and subject matter expertise.
• Inventory of sequestered research records and other evidence, except records Versiti did not consider or rely on.¹⁵⁶ 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.
• Transcripts of all interviews conducted.
• 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.
• Any scientific or forensic analyses conducted.
• A copy of this Policy.
• Any comments made by a respondent and complainant(s) on the draft investigation report and the committee’s consideration of those comments.
• A statement for each separate allegation of whether the committee recommends a finding of research misconduct.¹⁵⁷

If the committee recommends a finding of research misconduct for an allegation, the investigation report will present a finding for each separate allegation. These findings will comprise the following required elements: identify the individual(s) who committed the research misconduct; indicate whether the misconduct was falsification, fabrication, and/or plagiarism; indicate whether the misconduct was committed intentionally, knowingly, or recklessly; identify any significant departure from the accepted practices of the relevant research community and state that the allegation was proven by a preponderance of the evidence; summarize the facts and analysis supporting the conclusion and consider the merits of any explanation by a respondent; identify the specific PHS support; and state whether any publications need correction or retraction.¹⁵⁸

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.¹⁵⁹

The investigation report must also provide a list of any current support or known applications or proposals for support that a respondent has pending with PHS and non-PHS Federal agencies.¹⁶⁰

Completing the Investigation

Versiti will give a respondent a copy of the draft 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.¹⁶¹ A respondent will submit any comments on the draft report to Versiti within 30 days of receiving the draft investigation report.¹⁶² If Versiti 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 within 30 days of the date on which they received the report.¹⁶³ Versiti will add any comments received to the investigation report.¹⁶⁴

IDO Review of the Investigation Report

Versiti’s IDO will review the investigation report and make a final written determination of whether Versiti found research misconduct and, if so, who committed the misconduct.¹⁶⁵ In this statement, the IDO will include a description of relevant institutional actions taken or to be taken.¹⁶⁶

Creating and Transmitting Versiti’s Investigation Record

After the IDO has made a final determination of research misconduct findings, Versiti will add the IDO’s written decision to the investigation report and organize Versiti’s record in a logical manner for transmitting to ORI.¹⁶⁷ Versiti will also submit a copy of the final investigation report to Versiti’s Quality and Compliance Committee of the Board, along with Versiti’s Chief Compliance Officer.

Versiti’s record consists of the records that were compiled or generated during the research misconduct proceeding, except records Versiti did not rely on.¹⁶⁸ These records include documentation of the assessment, a single index listing all research records and evidence, the inquiry report and investigation report including any transcripts of interviews, and all records considered or relied on during the investigation.¹⁶⁹ Versiti’s record also includes the IDO’s final decision and any information a respondent provided to Versiti.¹⁷⁰ Versiti’s record must also include a general description of the records that were sequestered but not considered or relied on.¹⁷¹

If a respondent filed an appeal, the complete record of any institutional appeal alsobecomes part of Versiti’s record.¹⁷² For such situations, Versiti will wait until the appeal is concluded to transmit Versiti’s record containing the appeal record to ORI.¹⁷³ After the IDO has made a final written determination, and any institutional appeal is complete, Versiti must transmit its record to ORI.¹⁷⁴

Other Procedures and Special Circumstances

Multiple Institutions and Multiple Respondents

If the alleged research misconduct involves multiple institutions, Versiti may work closely with the other affected institutions to determine whether a joint research misconduct proceeding needs to be conducted.¹⁷⁵ If so, the cooperating institutions will decide which institution will 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.¹⁷⁶ By mutual agreement, the joint research misconduct proceeding may include committee members from Versiti.¹⁷⁷ The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and Versiti actions to be taken may be made by the institutions jointly or tasked to the lead institution.¹⁷⁸

If the alleged research misconduct involves multiple respondents, Versiti may either conduct a separate inquiry for each new respondent or add them to the ongoing proceedings.¹⁷⁹ Versiti must give additional respondent(s) notice of and an opportunity to respond to the allegations.¹⁸⁰

Respondent Admissions

Versiti will promptly notify ORI in advance if at any point during the proceedings (including the assessment, inquiry, investigation, or appeal stage) it plans to close a research misconduct case because a respondent has admitted to committing research misconduct or a settlement with a respondent has been reached.¹⁸¹ If a respondent admits to research misconduct, Versiti will not close the case until after providing ORI with a respondent’s signed written admission.¹⁸² The admission must meet all elements required for a research misconduct finding, specifically stating the specific fabrication, falsification, and/or plagiarism that occurred, which research records were affected, and that the misconduct constituted a significant departure from accepted practices of the relevant research community.¹⁸³ Versiti is not allowed to close the case until giving ORI a written statement confirming a respondent’s culpability and explaining how Versiti determined that a respondent’s admission fully addresses the scope of the misconduct.¹⁸⁴ After consulting with Versiti on its basis for closing a case, ORI may conduct an oversight review of Versiti’s handling of the case and take appropriate action including: approving or conditionally approving closure of the case; directing Versiti to complete its process; directing Versiti to address deficiencies in the institutional record; referring the matter for further investigation by HHS; or taking a compliance action.

Other Special Circumstances

At any time during the misconduct proceedings, Versiti 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 protect human or animal subjects.
• 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.
• HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.¹⁸⁵

Records Retention

In accordance with Versiti’s Record Retention Policy and applicable regulations, Versiti will maintain its record of any research misconduct activity and all sequestered evidence, including physical objects (regardless of whether the evidence is part of Versiti 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.¹⁸⁶

The Chief Research Officer and Chief Legal Officer will review and make any needed changes to this Policy at least every two years.

Questions regarding the implementation of this Policy should be directed to Versiti’s Chief Research Officer or Chief Compliance Officer.

REVIEW PERIOD: As needed, and at least every two (2) years.

APPROVALS: 2025: December 9, 2025 Approved by the Interim Co-Chief Research Officers and Chief Legal Officers and effective for research misconduct allegations first reported on and after December 9, 2025.