Draft of 19.048: Policy for Addressing Allegations of Research Misconduct

Status:

Draft

Effective:

January 1, 1900

Initiated by:

Eric Muth, Vice President for Research and Creative Activity Research

Signatures and dates on archival copy
  1. Purpose

    Ohio university is committed to upholding the highest standards of scientific rigor in research. Each institutional 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 Ohio university, the health and safety of the public, the integrity of research, and the conservation of public funds. Both the institution 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 Ohio university.

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

    Ohio university is responsible for ensuring that this policy for addressing allegations of research misconduct meets the requirements of the Public Health Service (PHS) policies on research misconduct pursuant to 42 CFR Part 93, as from time to time amended, ("the PHS Regulation”).

    To the fullest extent applicable, Ohio university is committed to following the policies and processes set forth in the PHS regulation when responding to allegations of research misconduct.

  2. Scope

    This policy applies to research proposed, performed, reviewed, or reported, as well as any record generated from that research, inclusive, regardless of whether the research was supported by a PHS grant, contract, cooperative agreement, subaward, or other form of PHS support. As used herein, the term PHS regulation is intended to encompass the policies and regulations of other funding agencies except to the extent in deviation from the procedures of this policy are required by funding agencies, law or grant requirements.

    This policy applies to all persons involved in research activities.

    This policy is intended to address allegations of research misconduct defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research proposals, or in reporting research results. 

    Research misconduct, as used herein, does not include honest, good faith error or differences of opinion that arise out of proposing, performing, reviewing or reporting research. Moreover, this policy is not intended to apply to authorship or collaboration disputes.

    This policy applies to research misconduct occurring within six years of the date Ohio university receives an allegation of research misconduct, subject to the following exceptions: 

    1. 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 Ohio university determines is not subject to the exception, the institution 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 the institutional proceeding or the completion of any U.S. Department of Health and Human Services (HHS) proceeding.
    2. The six-year time limit also does not apply if Ohio university, following consultation with the HHS Office of Research Integrity (ORI) or other granting authority as may be the case, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

      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. It does not replace the PHS regulation, and in case of any conflict between this policy and the PHS regulation or other controlling regulation, the PHS regulation or other controlling regulation will prevail. This policy is intended to ensure compliance with the requirements of the PHS regulation.

  3. Definitions

    As used herein, the following terms have the indicated meaning:

    1. Accepted practices of the relevant research community. This term means those practices established by the PHS regulation and by PHS funding components or other applicable regulations or 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.
    2. Administrative record. The administrative record consists of: the institutional record; any information provided by the respondent to the U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI), including but not limited to the transcript of any virtual or in-person meetings under 42 CFR § 93.403(b) between the respondent and ORI, and correspondence between the respondent and 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.
    3. Allegation. Disclosure of possible research misconduct through any means of communication and brought directly to the attention of an institutional or HHS official.
    4. Assessment. A consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct; appears to involve activities related to research or research training or PHS-supported biomedical or behavioral research, biomedical or behavioral 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.
    5. Complainant. Individual(s) who in good faith make(s) an allegation of research misconduct.
    6. Evidence. Anything of relevance 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 electric form, demonstration(s), information, tangible items, and testimony.
    7. Fabrication. Making up or otherwise creating unsupported data or results and recording or reporting them.
    8. Falsification. Manipulation of research materials, equipment, conclusions, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
    9. Good faith.
      1. 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.
      2. 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 the PHS Regulation. 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.
    10. Inquiry. Preliminary information gathering and preliminary fact-finding that meets the criteria and follows the procedures of 42 CFR § 93.307 through § 93.309.
    11. Institution. Ohio university, its component entities, and personnel who apply for, and receive, grant funding.
    12. Institutional deciding official (IDO). The institutional official who makes final determinations on allegations of research misconduct and any institutional actions. At Ohio university the IDO is the vice president for research and creative activity, or, in the case of conflict or unavailability, their designee. The person who serves as the IDO may not also serve as the research integrity officer.
    13. Institutional member. Institutional member and members mean an individual(s) 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, attorneys, or employees or agents of contractors, subcontractors, or sub-awardees.
    14. Institutional record. The institutional record is comprised of:
      1. The records that the Institution compiled or generated during the research misconduct proceeding, except records the institution did not consider or rely on. These records include but are not limited to:
        1. Documentation of the assessment as required by 42 CFR § 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 CFR § 93.309(c);
      2. 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 43 CFR § 93.310(g), and information the respondent provided to the institution;
      3. Decision(s) by the institutional deciding official, such as the written decision from the institutional deciding official under 42 CFR§ 93.314;
      4. The complete record of any institutional appeal consistent with 42 CFR § 93.315;
      5. A single index listing all the research records and evidence that the institution compiled during the research misconduct proceeding, except records the institution did not consider or rely on; and
      6. A general description of the records that were sequestered but not considered or relied on.
    15. Intentionally. Act with the aim of carrying out the act.
    16. Investigation. Formal development of a factual record and the examination of that record that meets the criteria and follows the procedures of 42 CFR § 93.310 through 93.317.
    17. Knowingly. To act with awareness of the act.
    18. Plagiarism. The appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit.
      1. 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.
      2. 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.
    19. Preponderance of the evidence. Proof by evidence that, compared with evidence opposing it, leads to the conclusion that the fact at issue is more likely true than not.
    20. PHS Support. 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.
    21. Recklessly. To propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.
    22. Research. Any systematic investigation, including research development, testing, and reporting, designed to develop or contribute to the body of knowledge in any field. The term encompasses basic research, applied research, and research training activities in areas such as, but not limited to, biomedical and life sciences, natural sciences, engineering, humanities and arts, and social and behavioral sciences.
    23. 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 the PHS regulation or other applicable regulation. At Ohio university the RIO is the director of research compliance, or in the case of conflict or unavailability, their designee.
    24. Research misconduct. 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.
    25. Research misconduct proceeding. Any actions related to alleged research misconduct taken under the PHS Regulation, including allegation assessments, inquiries, investigations, ORI oversight reviews, and appeals under subpart E of the PHS regulation.
    26. Research record. 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.
    27. Respondent. The individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.
    28. Retaliation. An adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to
      1. A good faith allegation of research misconduct or
      2. Good faith cooperation with a research misconduct proceeding.
    29. Witnesses. People who Ohio university has reasonably identified as having information regarding any relevant aspects of the investigation.
  4. Responsibilities and rights

    1. Institution
      1. Ohio university's general responsibilities

        To the extent permissible under law, the institution 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 Institution has made a final determination of research misconduct findings. The institution will respond to each allegation of research misconduct under the PHS Regulation in a thorough, competent, objective, and fair manner. The institution 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 institution agrees to cooperate with ORI during any research misconduct proceeding or compliance review, including addressing deficiencies or additional allegations in the institutional record if directed by ORI and to assist in administering and enforcing any HHS administrative actions imposed on institutional members. The Institution may also take steps to manage published data or acknowledge that data may be unreliable.

      2. Ohio university's responsibilities during and after a research misconduct proceeding

        Except as may be required by applicable law, the institution 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 institution will promptly take all reasonable and practical steps to obtain all research records and other evidence and sequester them securely. The institution 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 institution will provide ORI with the complete inquiry report and add it to the institutional record. The institution 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 institution will provide information related to the alleged research misconduct and proceedings to ORI upon request and 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 institution will promptly notify ORI of any special circumstances that may arise.

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

      3. Ohio university's responsibilities to the complainant(s)

        Ohio university will provide confidentiality consistent with the PHS regulation for all complainants in a research misconduct proceeding. The institution will also 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) or respondent(s). The institution 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 Ohio 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.

      4. Ohio university's responsibilities to the respondent(s)

        As with complainants, and to the extent permitted by law, the institution will provide confidentiality consistent with the PHS regulation to all respondents in a research misconduct proceeding. The institution will make a good-faith effort to notify the respondent(s) in writing of the allegations being made against them.  The institution 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 institution is responsible for giving the respondent(s) copies of, or supervised access to, the sequestered research records. The institution 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 institution 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 institution 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 institution will give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.

        The institution will bear the burden of proof, by a preponderance of the evidence, for making a finding of research misconduct. The institution 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.

      5. Ohio university's responsibilities to committee members

        The institution 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 institution 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.

      6. Ohio university's responsibilities to the witness(es)

        The institution will provide confidentiality consistent with the PHS regulation for all witnesses. The institutions 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 institutions will also take reasonable and practical steps to protect the positions and reputations of witnesses and to protect these individuals from retaliation.

    2. Research integrity officer (RIO)

      Upon receiving an allegation of research misconduct, the RIO or another designated institutional official will promptly assess the allegation to determine whether the allegation is:

      1. Within the definition of research misconduct under the PHS regulation,
      2. Withing the applicability criteria of the regulation at 42 CFR§ 93.102, and
      3. Sufficiently credible and specific so that potential evidence of research misconduct may be identified. If the RIO or another designated institutional official 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 RIO or another designated institutional official 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 Ohio university did not conduct an inquiry. The institution will keep this documentation and related records in a secure manner for seven years and provide them to ORI upon request.
    3. Complainant

      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.

    4. Respondent

      The respondent has the burden of going forward with and proving, by a preponderance of evidence, 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. 

    5. 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:
      1. View and comment on the inquiry report,
      2. View and comment on the investigation report, and
      3. Submit any comments on the draft investigation report to Ohio university within 30 days of receiving it.

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

    6. 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 Ohio university meet its responsibilities under 42 CFR 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 parties involved. At Ohio university a committee will be formed in consultation with the professional relations committee of the faculty senate.

      Committee or consortium members or anyone acting on behalf of Ohio university 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. 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 the respondent(s). They will also determine whether the respondent(s) engaged in research misconduct and document the decision in the investigation report. They consider respondent and/or complainant comments on the inquiry/investigation report(s) and document that consideration in the investigation report.

      An investigation into multiple respondents may convene with the same investigation committee or consortium members or anyone acting on behalf of Ohio university, 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.

    7. Witnesses

      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.

    8. Institutional deciding official

      The institutional deciding official (IDO) may choose to have the RIO, or another designated institutional official, conduct the assessment and inquiry and investigation (if relevant) in lieu of a committee, and, if needed, this individual may utilize one or more subject matter experts to assist them. The IDO shall make the final determination of research misconduct findings. 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 Ohio university has taken or will take. The IDO’s written decision will become part of the institutional record.