Administrative Procedures for Allegations of Research Misconduct

1. It is the policy of Wright State University that the highest ethical standards in the conduct of research be maintained. Misconduct in research as defined in this policy shall be considered a major breach of the contract between the faculty, staff member, or student and the university. The goals of this statement relating to ethics in the conduct of research are to maintain the highest standards and to establish institutional policies that provide a conspicuous and understandable mechanism for dealing with instances of alleged misconduct.
2. The freedom traditionally accorded members of the university community carries with it the obligation of self-discipline. Dishonesty, a deliberate self-serving act to distort the truth, tarnishes the cause of truth, damages or destroys collegial relationships, and may cause irreparable harm to the relationship between the university and the public.
3. The increased competitiveness of modern university life may place additional stress on the scholar. Work carried out in collaboration, in particular, imposes a special responsibility upon the investigators. For this reason, each investigator must share in the assurance that data has been honestly gathered and reported and that appropriate credit is given for each individual’s contributions. While overall responsibility for the integrity of collaborative work always rests with a principal investigator, this statement of ethical standards in the conduct of research applies to all members of the university community who may be involved with a research project, whether or not supported by internal or external funds.
4. All scholars share the obligation to maintain the highest standard of conduct in their profession and to disclose what they perceive in good faith to be misconduct in research, secure in the knowledge that the university respects the honest exercise of their judgment. Such allegations must be made with caution, however, and the rights of the individual to a fair and careful hearing strenuously protected.
5. This policy and procedure are modeled on rules and guidelines promulgated by the Office of Research Integrity, with a view to protecting to the maximum extent possible the rights of both the respondent and the complainant. The basic outline of the procedures to be initiated once an allegation of research misconduct has been received includes:
   1. Assessment Phase (mandatory; see §6120.6.a.)
   2. Inquiry Phase (conditional upon certain findings in the Assessment Phase; see §6120.6.b. through §6120.7.c.)
   3. Investigation Phase (conditional upon a determination by Deciding Official; see §6120.8 and §6120.9)
6. Any allegation of misconduct in carrying out research procedures or handling research results is a serious matter requiring extreme care. The guiding principle in processing an initial allegation is to protect the rights and reputation of all parties involved, including the respondent and the individual or individuals who in good faith report perceived misconduct.

This policy is intended to carry out this institution’s responsibilities under applicable laws and regulations, commensurate with but not necessarily identical to the Public Health Services (PHS) Policies on Research Misconduct, 42 CFR Part 93; the National Sciences Foundation (NSF) regulations at 45 CFR Part 689; and any other sponsor requirements. This policy applies to allegations of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results), regardless of whether the research was supported by external funding, involving:

An institutional member; and

1. Research, research training, or activities related to that research or research training such as the operation of tissue and data banks and the dissemination of research information,
2. applications or proposals for external support of research, research training or activities related to that research or research training, or
3. research records produced in the course of externally-supported research, research training, or activities related to that research record generated from that research, regardless or whether an application or proposal for external funds resulted in a grant, contract, cooperative agreement, or other form of support.

This policy and associated procedures apply only to allegations of research misconduct that occurred within six years of the date the institution or a federal funding agency received the allegation, subject to the subsequent use, health or safety of the public, and, for awards from the Department of Health and Human Services (HHS), the grandfather exceptions in 42 CFR § 93.105(b).

The scope of this policy does not cover:

1. sexual harassment [see University Policy 1270, “Sex Gender-Based Harassment, Discrimination and Sexual Misconduct Policy”]
2. misappropriation of funds [see the Ohio Revised Code, Section 2921.41]
3. failure to comply with university policies governing the protection of human subjects and the welfare of laboratory animals [see Wright State University Policy and Procedures for Human Subjects and Animal Subjects; or,
4. failure to comply with other conditions or guidelines established by an external sponsor or by the university.

These problems should be referred to appropriate administrators or compliance committee chairs.

In the event that this policy or some portion thereof is found to be inconsistent with some provision of the Collective Bargaining Agreement (CBA), the CBA will prevail unless a duly constituted authority finds that said provision is in conflict with some applicable law or federal regulation in which case said law or federal regulation will prevail. In the latter event, Article 35 “Separability” of the CBA will apply.

1. AAUP-WSU means the Wright State University Chapter of the American Association of University Professors, as represented by a duly-authorized official with authority to receive confidential information.
2. Allegation means a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an institutional or federal funding agency official.
3. Assessment means a determination whether an allegation falls within the definition or research misconduct and warrants an inquiry.
4. Complainant means a person who in good faith makes an allegation of research misconduct.
5. Deciding Official (DO) means the institutional official who makes final determination on allegations of research misconduct and any institutional administrative actions. At Wright State the DO is the chief academic officer.
6. Evidence means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact.
7. Good faith, as applied to a complainant or witness, means having a belief in the truth of one’s allegation or testimony that a reasonable person in the complainant’s or witness’s position could have, based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith, if it is made with knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member means cooperating with the purpose of helping an institution meet its responsibilities under applicable federal regulations such as 42 CFR Part 93. A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
8. HHS means the United States Department of Health and Human Services.
9. Inquiry means preliminary information-gathering and preliminary fact-finding, following an assessment.
10. Institutional member means a person who is employed by, is an agent of, or is affiliated by contract or agreement with this institution. Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, clinical technicians, graduate assistants, postdoctoral and other fellows, students, volunteers, agents, and contractors, subcontractors, and subawardees, and their employees.
11. Investigation means the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct which may include aa recommendation for additional appropriate actions, including administrative actions.
12. Office of Research Integrity or ORI means the office to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS supported activities.
13. Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.
14. Public means any individual or group outside of the university or PHS who has a need to know about a particular misconduct allegation, inquiry, investigation, or outcome.
15. Public Health Service or PHS means the unit within HHS that includes the Office of Public Health and Science and the following Operating Divisions: Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.
16. PHS support or PHS funds means PHS funding, or applications or proposals therefore, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through: PHS grants, cooperative agreements, or contracts or sup-grants or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements or contracts.
17. Records of research misconduct proceedings means:

    1. the research records and evidence secured for the research misconduct proceeding pursuant to this policy, except to the extent the Research Integrity Officer determines and documentsthat those records are not relevant to the proceeding or that the records duplicate other records that have been retained;

    2. the documentation of the determination of irrelevant or duplicate records;

    3. the inquiry report and final documents (not drafts) produced in the course of preparing that report, including the documentation of any decision not to investigate; and

    4. the investigation report and all records (other than drafts of the report) in support of the report, including the recordings or transcripts of each interview conducted.

18. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

19. Research Integrity Officer (RIO) means the institutional official responsible for;

    1. assessing allegations of research misconduct to determine, with the concurrence of the DO, if they fall within the definition of research misconduct and warrant an inquiry on the basis that the allegation is sufficiently credible and specific so that potential evidence or research misconduct may be identified; and

    2. overseeing inquiries and investigations; and

    3. the other responsibilities described in this policy. At Wright State the RIO is the chief research officer.

20. Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.

21. Research record means the record of data or results (in either physical or electronic form) that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to the federal sponsoring agency (if any) or an institutional official by a respondent in the course of the research misconduct proceeding.

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

23. Retaliation means an adverse action taken against a complainant, witness, or committee member by this institution or one of its institutional members in response to

    1. a good faith allegation or research misconduct is directed or who is the subject of a research misconduct;

    2. good faith cooperation with a research misconduct proceeding.

24. Senate Advisory Committee on Research Misconduct is a standing committee of the Faculty Senate, whose members are appointed for two year terms and which consists of at least one Senator and two non-Senate faculty members, one of whom is the Bargaining Unit Faculty Member.

1. Research Integrity Officer (RIO)
   The RIO will have primary responsibility for implementation of the institution’s policies and procedures on research misconduct.
   
   A detailed listing of the responsibilities of the RIO is set forth in §6120.13. These responsibilities include the following duties related to research misconduct proceedings:
    
   1. Consult confidentially with persons uncertain about whether to submit an allegation of research misconduct;
   2. Receive allegations of research misconduct;
   3. Assess each allegation of research misconduct in accordance with §6120.6.a . to determine, with the concurrence of the DO, whether it falls within the definition of research misconduct and warrants an inquiry;
   4. As necessary, take interim action and notify federal officials of special circumstances, in accordance with §6120.5.f.;
   5. Provide confidentiality to those involved in the research misconduct proceeding as required by applicable law or regulations, including 42 CFR §93.108, and institutional policy;
   6. Notify the respondent and provide opportunities for him/her to review/comment/respond to allegations, evidence, and committee reports in accordance with §6120.4.c.;
   7. Inform respondents, complainants, and witnesses of the procedural steps in the research misconduct proceeding;
   8. Appoint the chairs and members of the inquiry and investigation committees, ensure that those committees are properly staffed and that there is expertise appropriate to carry out a thorough and authoritative evaluation of the evidence;
   9. Determine whether each person involved in handling and allegation of research misconduct has an unresolved personal, professional, or financial conflict of interest and take appropriate action, including recusal of individuals with conflicts of interest, to ensure that no person with such conflict is involved in the research misconduct proceeding;
   10. In cooperation with other institutional officials, take all reasonable and practical steps to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members and counter potential or actual retaliation against them by respondents or other institutional members;
   11. Keep the Deciding Official and others who need to know apprised of the progress of the review of the allegation of research misconduct;
   12. Notify and make reports to ORI as required
   13. Ensure that administrative actions taken by the institution and ORI are enforced and take appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards of those actions; an
        
2. Complainant
   
   The complainant is responsible for making allegations in good faith, maintaining confidentiality and cooperating with the inquiry and investigation. As a matter of good practice, the complainant should be interviewed at the inquiry stage and during the investigation and given the transcript or recording of the interview for correction.
    
3. Respondent
   
   The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry and investigation. The respondent is entitled to:
   1. A good faith effort from the RIO to notify the respondent in writing at the time of or before beginning an inquiry;
   2. An opportunity to comment on the inquiry report ( see §6120.7) and have his/her comments attached to the report;
   3. Be notified of the outcome of the inquiry, and receive a copy of the inquiry report that includes a copy of, or refers to the institution’s policies and procedures on research misconduct;
   4. Be notified in writing of the allegations to be investigated within a reasonable time after the determination that an investigation is warranted, but before the investigation begins (within 15 calendar days after the institution decides to begin an investigation), and be notified in writing of any new allegations, not addressed in the inquiry or in the initial notice of investigation, within 15 calendar days after the determination to pursue those allegations;
   5. Be interviewed during the investigation (and to decline a request for an interview) by the RIO so as to present the respondent’s case, have the opportunity to correct the recording or transcript, and have the corrected recording or transcript included in the record of the investigation;
   6. Be accompanied and represented by either legal counsel (at the respondent’s own expense) or a personal representative at any stage of an assessment, inquiry, or investigation. In addition, a Bargaining Unit Faculty Member can be accompanied by and consult with a representative of the AAUP-WSU at any stage of an assessment, inquiry, or investigation. The respondent must be notified of the above rights before the first interview or meeting (at which the respondent will be present) that occurs as part of the processes delineated in this policy;
   7. Have interviewed during the investigation any witness who has been reasonably identified by the respondent as having information on relevant aspects of the investigation, have the recording or transcript provided to the witness for correction, and have the corrected recording or transcript included in the record of investigation; and
   8. Receive a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based, and be notified that any comments must be submitted within 30 days of the date on which the copy was received and that the comments will be considered by the institution and addressed in the final report

   The respondent should be given the opportunity to admit that research misconduct occurred and that he/she committed the research misconduct.  With the advice of the RIO and institutional legal counsel, the Deciding Official may terminate the institution's review of an allegation that has been admitted.  If PHS funds are involved, the institution's acceptance of the admission and any proposed settlement must be approved of ORI.

4. Deciding Official (DO)
   
   The DO will receive the assessment report from the RIO and make the final decision as to whether an allegation falls within the purview of this policy or is some other form of misconduct. If the allegation is considered research misconduct, and the assessment report finds sufficient grounds to proceed with an inquiry, the RIO will be so informed. If the allegation is considered some other form of misconduct, the DO will refer the allegation to other offices or officials with responsibility for resolving the problem.
   
   The DO will receive the inquiry report and, after consulting with the RIO, decide whether an investigation is warranted under this policy. Any finding that an investigation is warranted must be made in writing by the DO and, if PHS funds are involved, must be provided to ORI, together with a copy of the inquiry report meeting the requirements of 42 CFR §93.309, within 30 days of the finding. If it is found that an investigation is not warranted, the DO and the RIO will ensure that detailed documentation of the inquiry is retained for at least 7 years after the termination of the inquiry.
   
   The DO will receive the investigation report and, after consulting with the RIO and other appropriate officials, decide the extent to which the institution accepts the findings of the investigation and, if research misconduct is found, decide what, if any, institutional administrative actions are appropriate. If PHS funds are involved, the DO shall ensure that the final investigation report, the findings of the DO and a description of any pending or completed administrative action are provided to ORI, as required by 42 CFR §93.315.

1. Responsibility to Report Misconduct
   
   All institutional members will report observed, or suspected, or apparent misconduct-even if only indirectly related to research-to the RIO. Any official who receives an allegation of misconduct that might be research-related must report it immediately to the RIO. The RIO will then conduct an assessment pursuant to §6120.6.
    
2. Cooperation with Research Misconduct Proceedings
   
   Institutional members will cooperate with the RIO and other institutional officials in the review of allegations and the inquiries and investigations. Institutional members, including respondents, have an obligation to provide evidence relevant to research misconduct allegations to the RIO or other institutional officials.
    
3. Confidentiality
   
   The RIO shall:

   1. limit disclosure of the identity of respondents and complainants to those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding; and

   2. except as otherwise prescribed by law, limit the disclosure of any records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding. The RIO should use written confidentiality agreements or other mechanisms to ensure that the recipient of such disclosed records or evidence does not make any further disclosure of identifying information. If a confidentiality agreement is to be used with a Bargaining Unit Faculty Member, the AAUP-WSU will be given the opportunity to review such agreement before the Member is asked to sign it; also, the Member will have the right to consult legal counsel (at Member’s expense) after being given a copy of the proposed confidentiality agreement but before being asked to sign it. In asking any recipient of disclosed records or evidence to sign confidentiality agreements, the RIO shall notify the recipient that they may consult with legal counsel prior to signing.

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

5. Protecting the Respondent
   
   As appropriate, the RIO and other institutional officials shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.
   
   During the research misconduct proceeding, the RIO is responsible for ensuring that respondents receive all the notices and opportunities provided for in 42 CFR Part 93, as applicable, and the policies and procedures of the institution. Respondents may, at their own expense, consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal adviser to interviews or meetings on the case.

6. Interim Administrative Actions and Notifying Federal Officials of Special Circumstances 

   Throughout the research misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, federal funds and equipment, or, if applicable, the integrity of the PHS supported research process. To counter such a threat, the RIO will, in consultation with other institutional officials and (if PHS funds are involved) ORI, take appropriate interim action such as: additional monitoring of the research process and the handling of federal funds and equipment, reassignment of personnel or of the responsibility for the handling of federal funds and equipment, additional review of research data and results or delaying publication. If PHS funds are involved, the RIO shall, at any time during a research misconduct proceeding, notify ORI immediately if he/she has reason to believe that any of the following conditions exist:

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

   2. HHS resources or interests are threatened;

   3. Research activities should be suspended;

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

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

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

   7. To the extent consistent with applicable law, the research community or public should be informed.

   If other federal funds are involved, the RIO shall ensure compliance with any applicable regulations of the sponsoring agency (e.g., 45 CFR Part 689 for NSF).

1. Assessment of Allegations
   
   Upon receiving an allegation of misconduct, the RIO will immediately assess the allegation to determine whether it is sufficiently credible and specific so that potential evidence of misconduct may be identified, whether it is within the jurisdictional criteria of §6120.2, and whether the allegation falls within the definition of research misconduct in §6120.3. The RIO will send a report of this assessment to the DO. An inquiry must be conducted if these criteria are met and the DO concurs with the RIO’s assessment.
   
   The assessment period should be brief, preferably concluded within a week. In conducting the assessment, the RIO will make every effort to interview the complainant, respondent, or other witnesses, or gather data beyond any that may have been submitted with the allegation, to the extent necessary to determine whether the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The RIO should consult with the DO, the institutional legal counsel, and others as appropriate, while strictly enforcing the confidentiality of the proceeding pursuant to 6120.5.c.
   
   If there is a danger of the respondent learning of the allegation from another source during the assessment phrase, the RIO may sequester data, records, or other materials in order to preserve their integrity (see 6120.6.c).
   
   If the RIO determines and the DO confirms that the criteria for an inquiry are not met, the RIO shall so notify the complainant and, if the respondent has been informed of the complaint, the respondent. The RIO shall also secure and maintain for 7 years after the termination of the assessment any documentation collected during the assessment phase.
    
2. Initiation and Purpose of the Inquiry
   
   If the RIO determines and the DO confirms that the criteria for an inquiry are met, the RIO will immediately initiate the inquiry process. The purpose of the inquiry is to conduct an initial review of the available evidence to determine whether to conduct an investigation. An inquiry does not require a full review of all the evidence related to the allegation.
    
3. Notice to Respondent: Sequestration of Research Records
   
   At the time of or before beginning an inquiry, the RIO must make a good faith effort to notify the respondent in writing, if the respondent is known. If the inquiry subsequently identifies additional respondents, they must be notified in writing. On or before the date on which the respondent is notified, or the inquiry begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence and sequester these materials in a secure manner. In order to minimize the respondent’s research disruption, a copy of the evidence either on paper or in electronic form is made and either are given to the respondent while the RIO or the inquiry committee (see §6120.6.d) keep the originals. Where the research records or evidence include scientific instruments shared by a number of users custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. The RIO may consult with ORI for advice and assistance in this regard.
    
4. Appointment of the Inquiry Committee
   
   The RIO, in consultation with other institutional members as appropriate, will appoint an inquiry committee and committee chair within 10 days of the initiation of the inquiry or as soon thereafter as practical. The inquiry committee must consist of an uneven number (at least three) of members of the academic community. The members must not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry and should include individuals with the appropriate scientific or other academic expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry.
    
5. Charge to the Committee and First Meeting

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

   1. Sets forth the time for completion of the inquiry;

   2. Describes allegations and any related issues indentified during the allegation assessment;

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

   4. States that an investigation is warranted if the committee determines:

      1. there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct and is within the jurisdictional criteria of §6120.2; and,
      2. the allegation may have substance, based on the committee’s review during the inquiry.

   5. Informs the inquiry committee that it is responsible for preparing or directing the preparation of a written report of the inquiry that meets the requirements of §6120.7.a.

   At the committee’s first meeting, the RIO will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The RIO will be present or available throughout the inquiry to advise the committee as needed.

6. Inquiry Process
   
   The inquiry committee will normally interview the complainant, the respondent, and key witnesses as well as examine relevant research records and materials. Then the inquiry committee will evaluate the evidence, including the testimony obtained during the inquiry. After consultation with the RIO, the committee members will decide by majority vote of the full committee whether an investigation is warranted based on the criteria in §6120.6.e.4. The scope of the inquiry is not required to and does not normally include deciding whether misconduct definitely occurred, determining definitely who committed the research misconduct or conducting exhaustive interviews and analyses. However, if a legally sufficient admission of research misconduct is made by the respondent and all relevant issues are resolved, misconduct may be determined at the inquiry stage. In that case, and if PHS funds are involved, the institution shall promptly consult with ORI to determine the next steps that should be taken.
    
7. Time for Completion
   
   The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, must be completed within 60 calendar days of initiation of the inquiry, unless the RIO determines that circumstances clearly warrant a longer period. If the RIO approves an extension, the inquiry record must include documentation of the reasons for exceeding the 60-day period.

1. Elements of the Inquiry Report

   A written inquiry report must be prepared that includes the following information:

   1. the name and position of the respondent;

   2. a description of the allegations of research misconduct;

   3. the PHS support, if any, including, for example, grant numbers, grant applications, contracts and publications listing PHS support;

   4. the basis for recommending or not recommending that the allegations warrant an investigation;

   5. any comments on the draft report by the respondent or complainant; and

   6. minority report(s), if any.

   Institutional counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the inquiry committee.

2. Notification to the Respondent and Opportunity to Comment

   The RIO shall notify the respondent of the inquiry outcome and whether the inquiry found an investigation to be warranted, include a copy of the draft inquiry report for comment, and include the copy of or refer to the institution’s policies and procedures on research misconduct. The respondent shall be given 15 calendar days within which to submit comments to the RIO on the draft report.

   Any respondent comments that are submitted will be attached to the final inquiry report. Based on the comments, the inquiry committee may revise the draft report as appropriate and prepare it in final form. The committee will deliver the final report to the RIO.

3. Institutional Decision and Notification

   Decision by Deciding Official: The RIO will transmit the final inquiry report and any
   comments to the DO, who will determine in writing whether an investigation is warranted. The
   inquiry is completed when the DO makes this determination.
   
   Notification to ORI: If PHS funds are involved, then within 30 calendar days of the DO’s decision that an investigation is warranted the RIO will provide ORI with the DO’s written decision and a copy of the inquiry report. The RIO must provide the following information to ORI upon request:

   1. the institutional policies and procedures under which the inquiry was conducted;
   2. the research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and
   3. the charges to be considered in the investigation.

   Documentation of Decision Not to Investigate: If the DO decides that an investigation is not warranted, the RIO shall secure and maintain for 7 years after the termination of the inquiry sufficiently detailed documentation of the inquiry. If PHS funds were involved, these documents must be provided to ORI or other authorized HHS personnel upon request. It is not otherwise necessary to notify ORI of a decision not to investigate, unless warranted by the special circumstances enumerated in §6120.5.f.

1. Initiation and Purpose
   
   The investigation must begin within 30 calendar days after the determination by the DO that an investigation is warranted. The purpose of the investigation is to develop a factual record by exploring the allegations in detail and examining the evidence in depth, leading to recommended findings on whether research misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations. This determination is particularly important where the alleged research misconduct involves clinical trials or potential harm to human subjects or the general public or if the possible misconduct affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.
    
2. Notifying Federal Officials and Respondent; Sequestration of Research Records
   
   On or before the date on which the investigation begins:
   1. If federal funds are involved, the RIO must notify the appropriate federal office of the decision to begin the investigation at least 3 days before the investigation begins, and, if required, provide a copy of the inquiry report to that federal office, and
   2. within 15 calendar days of the decision to begin the investigation, the RIO must notify the respondent and the AAUP-WSU (if the respondent is a member of the bargaining unit) in writing of the allegations to be investigated and the respondent's right to counsel and/or personal representative. The RIO must also give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.

   The RIO will, prior to notifying the respondent of the allegations, take all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct proceedings that were not previously sequestered during the inquiry. Where appropriate, the respondent will be given copies of, or reasonable supervised access to, the research records. Where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. The need for additional sequestration of records for the investigation may occur for any number of reasons, including the institution's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.

3. Appointment of the Investigation Committee
   
   The RIO, in consultation with the Senate Advisory Committee on Research Misconduct and other institutional members as appropriate, will appoint an investigation committee and its chair within 10 calendar days of the beginning of the investigation, or as soon thereafter as practical. The investigation committee must consist of an uneven number (at least five) of members of the academic community. The members must not have unresolved personal, professional, or financial conflicts of interest with those involved in the investigation. Committee members should include individuals with the appropriate scientific or other academic expertise to evaluate the evidence and issues related to the allegation, interview the respondent and complainant, and conduct the investigation. Individuals appointed as members of the investigation committee may also have served on the inquiry committee.

4. Charge to the Committee and the First Meeting

   The RIO will define the subject matter of the investigation in a written charge to the committee that:

   1. Describes the allegations and related issues identified during the inquiry:
   2. Identifies the respondent;
   3. Informs the committee that it must conduct the investigation as prescribed in paragraph E of this section;
   4. Defines research misconduct;
   5. Informs the committee that it must evaluate the evidence and testimony to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, the type and extent of research misconduct and who was responsible;
   6. Informs the committee that in order to determine that the respondent committed research misconduct, it must find that a preponderance of the evidence establishes that:
      1. research misconduct, as defined in this policy, occurred;
      2. the research misconduct is a significant departure from accepted practices of the relevant academic research community; and
      3. the respondent committed the research misconduct intentionally, knowingly, or recklessly;
   7. Informs the committee that the respondent has the burden of proving by a preponderance of the evidence any defense that counters the allegation, including honest error or a difference of opinion; and
   8. Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy and any applicable federal regulations.

   The RIO will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of this policy. The RIO will be present or available throughout the investigation to advise the committee as needed.

5. Investigation Process
   
   The investigation committee and the RIO must:
   1. Be diligent in ensuring that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of each allegation;
   2. Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical;
   3. Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent;
   4. Record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of the investigation; and
   5. Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continue the investigation to completion.
       
6. Time for Completion
   
   The investigation is to be completed within 120 calendar days of its beginning, including conducting the investigation, preparing the report of findings, and, if PHS funds are involved, providing the draft report for comment, and sending the final report to ORI. However, if the RIO determines that the investigation will not be completed within this 120-day period, he/she will submit to ORI, if required, a written request for an extension, setting forth the reasons for the delay. The RIO will ensure that any required periodic progress reports are filed with ORI, if ORI grants the request for an extension and directs the filing of such reports.

1. Elements of the Investigation Report
   
   The investigation committee and the RIO are responsible for preparing a written draft report of the investigation that:

   1. Describes the nature of the allegation of research misconduct, including identification of the respondent;

   2. Describes and documents any federal support, including, for example, the grant numbers of any grants that are involved in the research misconduct investigation, grant applications, contracts, and publications in which the federal support is noted;

   3. Describes the specific allegations of research misconduct considered in the investigation;

   4. Includes or references the institutional policies and procedures under which the investigation was conducted;

   5. Indentifies and summarizes the research records and evidence reviewed and identifies any evidence taken into custody but not reviewed; and

   6. Includes a statement of findings for each allegation of research misconduct identified during the investigation, along with minority report(s), if any. Each statement of findings must:

      1. identify whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly;
      2. summarize the facts and the analysis that support the conclusion,
      3. consider the merits of any reasonable explanation by the respondent, including any effort by the respondent to establish by a preponderance of the evidence that he or she did not engage in research misconduct because of honest error or a difference of opinion;
      4. identify whether any publications should be corrected or withdrawn;
      5. identify the person(s) responsible for the misconduct; and
      6. list any current support of known applications or proposals for support that the respondent has currently or pending with non-PHS federal agencies.

2. Comments on the Draft Report and Access to Evidence

   The RIO must give the respondent a copy of the draft investigation report for comment and, concurrently, a copy of, or supervised access to, the evidence on which the report is based. If the respondent is a Bargaining Unit Faculty Member, the draft investigation report will also be transmitted to the AAUP-WSU. The respondent will be allowed 30 days from the date he/she received the draft report to submit comments to the RIO. The respondent’s comments must be included and considered in the final report. In distributing the draft report, or portions thereof, to the respondent, the RIO will inform the respondent of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality.

3. Decision by Deciding Official

   The RIO will assist the investigation committee in finalizing the draft investigation report, including ensuring that the respondent’s comments are included and considered, and transmit the final investigation report to the DO, with a copy to the respondent and, if the respondent is a Bargaining Unit Faculty Member, to the AAUP-WSU.
   
   Prior to any final determination that research misconduct on the part of the respondent is substantiated by the findings,

   1. if the respondent is a Bargaining Unit Faculty Member, the DO will hold a disciplinary meeting with the respondent pursuant to Article 14, “Discipline,” of the collective bargaining agreement, and in the event that the DO contemplates sanctions covered by Article 15 “Suspension and Tenure Removal”, the DO and university will abide by the provisions of that Article as well;
   2. if the respondent is a faculty member who is not represented by collective bargaining, he/she, pursuant to the Faculty Handbook, will be given an opportunity to meet with the DO in order to present his/her case and to be accompanied by another faculty member at this meeting; or
   3. the DO will follow disciplinary procedures appropriate for non-faculty.

   After such disciplinary meetings and/or procedures, the DO will determine in writing

   1. whether the institution accepts the investigation report, its findings and the recommended institutional actions; and
   2. the appropriate institutional actions in response to the accepted findings of research misconduct. If the DO’s determination varies from the findings of the investigation committee, the DO will, as part of his/her written determination, explain in detail the basis for rendering a decision different from the findings of the investigation committee. Alternatively, the DO may return the report to the investigation committee with a request for further fact-finding or analysis.

   When a final decision on the case has been reached, the RIO will normally notify both the respondent and the complainant in writing. The DO will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

4. Notice to ORI of Institutional Findings and Actions

   If PHS funds are involved, then, unless an extension has been granted, the RIO must, within the 120 calendar day period for completing the investigation, submit the following to ORI:

   1. a copy of the final investigation report with all attachments;
   2. a statement of whether the institution accepts the findings of the investigation report;
   3. a statement of whether the institution found misconduct and, if so who committed the misconduct; and
   4. a description of any pending or completed administrative actions against the respondent.

5. Maintaining Records for Review by ORI

   If PHS funds are involved, the RIO must maintain and provide to ORI, upon request, “records of research misconduct proceedings” as that term is defined by 42 CFR § 93.317. Unless custody has been transferred to HHS or ORI has advised in writing that the records no longer need to be retained, records of research misconduct proceedings must be maintained in a secure manner for 7 years after completion of the proceedings or the completion of any PHS proceeding involving the research misconduct allegation. The RIO is also responsible for providing any information, documentation, research records, evidence, or clarification requested by ORI to carry out its review of an allegation of research misconduct or of the institution’s handling of such an allegation.

Generally, all inquiries and investigations will be carried through to completion, and all significant issues will be pursued diligently. If PHS funds are involved, the RIO must notify ORI in advance if there are plans to close a case at the inquiry or investigation stage on the basis that the respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except:

1. closing of a case at the inquiry stage on the basis that an investigation is not warranted; or

2. a finding of no misconduct at the investigation stage, which must be reported to ORI, as prescribed in this policy and 42 CFR § 93.315.

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

1. Withdrawl or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;
2. Removal of the responsible person from the tainted project, letter of reprimand, special monitoring of future work, or a revocation, for a specified period, of the responsible person’s ability to be involved in sponsored research;
3. Restitution of funds to the grantor agency as appropriate; and Other action appropriate to the misconduct, up to and including unpaid suspension or termination.

However, if the respondent is a Bargaining Unit Faculty Member, the provisions of CBA Article 14 “Discipline” will apply; and if either unpaid suspension or termination is anticipated as a sanction, then the provisions of Article 15 Suspension and Tenure Removal” will apply as well.

1. Termination or Resignation Prior to Completing Inquiry or Investigation
   
   The termination of the respondent’s institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceeding or otherwise limit any of the institution’s responsibilities under this policy. If the respondent, without admitting to the misconduct, elects to resign his or her position after the institution receives an allegation of research misconduct, the assessment of the allegation will proceed, as well as the inquiry and investigation, as appropriate based on the outcome of the preceding steps. If the respondent refuses to participate in the process after resignation, the RIO and any inquiry or investigation committee will use their best efforts to reach a conclusion concerning the allegations, noting in the report the respondent’s failure to cooperate and its effect on the evidence.
    
2. Restoration of the Respondent’s Reputation
   
   Following a final finding of no research misconduct, including ORI concurrence where required by 42 CFR Part 93, the RIO will, except if the respondent declines, undertake all reasonable and practical efforts to restore the respondent’s reputation. Depending on the particular circumstances and the views of the respondent, the RIO must notify those individuals aware of or involved in the investigation of the final outcome, publicize the final outcome in any forum in which the allegation of research misconduct was previously publicized, and expunge all reference to the research misconduct allegation from the respondent’s personnel file. Any institutional actions to restore the respondent’s reputation should first be approved by the DO.
    
3. Protection of the Complainant, Witnesses and Committee Members
   During the research misconduct proceeding and upon its completion, regardless of whether the institution or ORI determines that research misconduct occurred, the RIO will undertake all reasonable and practical efforts to protect the position and reputation of, or to counter potential or actual retaliation against, any complainant who made allegations of research misconduct in good faith and of any witnesses and committee members who cooperate in good faith with the research misconduct proceeding. The DO will determine, after consulting with the RIO, and with the complainant, witnesses, or committee members, respectively, what steps, if any are needed to restore their respective positions or reputations or to counter potential or actual retaliation against them. The RIO is responsible for implementing any steps the DO approves.
    
4. Allegations Not Made in Good Faith
   
   If relevant, the DO will determine whether the complainant’s allegations of research misconduct were made in good faith, or whether a witness or committee member acted in good faith. If the DO determines that there was an absence of good faith, he/she will determine whether any administrative action should be taken against the person who failed to act in good faith.
    
5. Appeals
   
   Any person aggrieved by any action proposed as a result of an inquiry conducted pursuant to this policy shall have the right of appeal to the DO, in writing, within 30 calendar days of notification. Any person aggrieved by any action proposed as a result of an investigation conducted pursuant to this policy shall have the right of appeal to the president, in writing, within 30 calendar days of notification. All appeal procedures must be completed within 120 calendar days of the filing of the appeal.

1. General

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

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

   2. Has written policies and procedures for responding to allegations of research misconduct and reporting information about that response to appropriate federal officials.

   3. If PHS funds are involved, complies with its written policies and procedures and the requirements of 42 CFR Part 93.

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

2. Notice and Reporting to ORI and Cooperation with ORI

   The RIO is the university official who is principally responsible for ensuring that the institution:

   1. Files an annual report with ORI containing the information presribed by ORI.

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

   3. Notifies ORI immediately if;

      1. PHS funds are involved and
      2. at any time during the research misconduct proceeding, he/she has reason to believe that
         1. the health and safety of the public is at risk
         2. HHS resources or interests are threatened,
         3. research activities should be suspended,
         4. there is a reasonable indication of possible violations of divil or criminal law,
         5. federal action is required to protect the interests of those involved in the research misconduct proceedings,
         6. the research misconduct proceeding may be made public prematurely, or
         7. to the extent consistent with applicable law, the research community or the public should be informed.

   4. If PHS funds are involved, cooperates fully with ORI during its oversight review and any subsequent administrative hearings, including providing all research records and evidence under the institution’s control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.

   5. If PHS funds are involved, notifies ORI of the decision to begin an investigation on or before the date the investigation is to begin.

   6. If PHS funds are involved, within 120 calendar days of beginning an investigation, or such additional calendar days as may be granted by ORI, provides ORI with the investigation report, a statement or whether the institution accepts the investigation's findings, a statement of whether the institution found research misconduct and, if so, who committed it, and a description of any pending or completed administrative actions against the respondent.

   7. If PHS funds are involved, seeks in advance ORI approval if the institution plans to close a case at the inquiry or investigation on the basis that the respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except the closing of a case at the inquiry stage on the basis that an investigation is not warranted or a finding of not misconduct at the investigation stage.

   8. If PHS funds are involved, cooperates fully with ORI during its oversight review and any subsequent administrative hearins, including providing all research records and evidence under the institution's control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.

3. Research Misconduct Proceeding

   1. General

      The RIO is responsible for:

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

      2. Taking all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings, including, but not limited to their providing information, research records, and evidence.

      3. Providing confidentiality to those involved in the research misconduct proceeding as required by applicable laws and regulations (including 42 CFR 93.108), and institutional policy.

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

      5. Keeping the Deciding Official (DO) apprised of the progress of the review of the allegation of research misconduct.

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

      7. Making all reasonable and practical efforts, as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.

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

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

      10. At the direction of the DO, ensuring that administrative actions taken by the institution and, if applicable, ORI are enforced and taking appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards, of those actions.

      11. Consulting/sharing information gathered on a student respondent with the Director of Student Judicial Services (DSJS), who will decide whether the allegations, if substantiated, will affect the academic credit status of the student.

   2. Allegation Receipt and Assessment

      The RIO is responsible for:

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

      2. Receiving allegations of research misconduct.

      3. Assessing each allegation of research misconduct to determine, with the concurrence of the DO, if an inquiry is warranted because the allegation falls within the definition of research misconduct, is within the jurisdictional criteria of §2101.2, and is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

   3. Inquiry

      The RIO is responsible for:

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

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

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

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

      5. Preparing a change for the inquiry committee in accordance with the institution’s policies and procedures.

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

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

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

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

      10. Assisting the inquiry committee in preparing a draft inquiry report, and taking appropriate action to protect the confidentiality of the draft report.

      11. Sending the respondent a copy of the draft report for comment within a time period that permits the inquiry to be completed within the allotted time, taking appropriate action to protect the confidentiality of the draft report, receiving any comments from the respondent, and ensuring that the respondent’s comments are attached to the final inquiry report.

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

      13. Within 30 calendar days of a DO’s decision that an investigation is warranted, notifying those institutional officials who need to know of the decision, and, if federal funds are involved, providing the appropriate federal office with the written finding and a copy of the inquiry report.

      14. Notifying the respondent whether the inquiry found an investigation to be warranted and including in the notice copies of or a reference to the institution’s research misconduct policies and procedures.

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

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

   4. Investigation

      The RIO is responsible for:

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

      2. On or before the date on which the investigation begins:

         1. notifying the respondent in writing of the allegations to be investigated, and
         2. if PHS funds are involved, notifying ORI of the decision to begin the investigation and providing ORI a copy of the inquiry report;

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

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

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

      6. Convening the first meeting of the investigation committee and at that meeting:

         1. briefing the committee on the charge, the inquiry report, and the procedures and standards for the conduct of the investigation, including the need for confidentiality and developing a specific plan for the investigation; and
         2. providing committee members a copy of the institution’s policies and procedures and, if applicable, 42 CFR Part 93.

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

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

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

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

      10. Assisting the investigation committee in preparing a draft investigation report that meets the requirements of the institution’s policies and procedures, sending the respondent a copy Of the draft report for his/her comment within 15 calendar days of receipt, taking appropriate action to protect the confidentiality of the draft report, receiving any comments from the respondent, and ensuring that the comments are included and considered in the final investigation report.

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

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

      13. Transmitting the final investigation report to the DO and:

          1. if the DO determines that further fact-finding or analysis is needed, receiving the report back from the DO for that purpose and proceeding with further fact-finding and analysis; or
          2. if the DO determines whether or not to accept the report, its findings, and the recommended institutional actions, transmitting to ORI, if required, within the time period for completing the investigation, a copy of the final investigation report with all attachments, a statement of whether the institution accepts the findings of the report, a statement of whether the institution found research misconduct, and if so who committed it, and a description of any pending or completed administrative actions against the respondent.

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

      15. If PHS funds are involved, maintaining and providing to ORI, upon request, all relevant research records and records of the institution’s research misconduct proceedings, including the results of all interviews and the transcripts or recordings of those interviews.