The definitions below are specific to 42 CFR §93.  All other relevant definitions may be found in the Ethics in Research Policy.

Accepted Practices of the Relevant Research Community means those practices established by 42 CFR §93 and by PHS funding components, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive PHS awards.

Administrative Action is an HHS action, consistent with 42 CFR §93.407, taken in response to a research misconduct proceeding to protect the health and safety of the public, to promote the integrity of PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training, or to conserve the public funds.

Day per PHS Final Rule 93.208 means calendar day unless otherwise specified. If a deadline falls on a Saturday, Sunday, or Federal holiday, the deadline will be extended to the next day that is not a Saturday, Sunday, or Federal holiday.

Institutional Record comprises the records 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:

• Documentation of the assessment as required by 42 CFR §93.306 (c).
• 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 including the respondent’s response to the inquiry report, and the documentation of any decision not to investigate as required by §93.309 (c).                                           
• 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 §93.310 (g), information the respondent provided to the institution, and the respondent’s response to the draft investigation report.
• Decision(s) by the Institutional Deciding Official (DO), such as the written decision from the DO under §93.314.
• The complete record of any institutional appeal consistent with §93.315.
• 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.
• A general description of the records that were sequestered but not considered or relied on.

Lead Institution is the institution that takes the primary responsibility in a joint research misconduct proceeding.

Reporting Contact could be the following:  Health and Human Services (HHS), Office of Research Integrity (ORI), Division of Investigative Oversight (DIO), or the Public Health Service (PHS), National Institutes of Health (NIH), Office of Extramural Research (OER).

Research Misconduct Proceeding means any actions related to alleged research misconduct taken under 42 CFR §93 including allegation assessments, inquiries, investigations, ORI oversight reviews, and appeals under subpart E of 42 CFR §93.

Plagiarism for the purposes of 42 CFR 93.227 (a) & (b) is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.  (a) Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another’s work that materially misleads the reader regarding the contributions of the author.  It does not include the limited use of identical or nearly identical phrases that describe a commonly used methodology.  (b) Plagiarism does not include self-plagiarism or authorship or credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project.  Self-plagiarism and authorship disputes do not meet the definition of research misconduct.

RIO see Ethics in Research Policy [Chapter II 27.6 (d)(16)]

Research Integrity and Security Office (RISO) is the office charged with the oversight of the Ethics in Research Policy.

Protection of Parties in a Research Misconduct Proceeding

Regardless of whether the UI or ORI determines that research misconduct occurred, the institution will undertake reasonable and practical efforts during all stages of the research misconduct process to protect complainants who make allegations of research misconduct in good faith from negative institutional actions, as well as witnesses, committee members, subject matter experts, and UI administrators and staff involved in the research misconduct process. Those who make allegations of research misconduct with knowing or reckless disregard for the truth will be subject to discipline under applicable UI policies.  The RIO will make the sole determination as to whether an allegation is made with a knowing or reckless disregard for the truth based on the evidence available, and the RIO’s determination may be updated as more information becomes available in the process outlined below. If an allegation of retaliation is made, the RIO will assess and make a determination if the Anti-Retaliation Policy for Reporting of Misconduct in Research, Chapter 27.8, is applicable.

Multiple Respondents

If the UI identifies additional respondents during an inquiry or investigation, the UI is not required to conduct a separate inquiry or investigation for each new respondent.  However, each additional respondent must be provided notice of and an opportunity to respond to the allegation(s).

Separate inquiry and investigation reports will be written for each respondent, and each respondent will only be provided with their own report(s).

Notifying the Office of Research Integrity (ORI) of Special Circumstances

At any point during a research misconduct proceeding, as defined in 42 CFR § 93.235, the UI must notify ORI immediately if it has reason to believe any of the following conditions exist:

• Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
• Health and Human Services (HHS) resources or interests are threatened.
• Research activities should be suspended.
• There is reasonable indication of possible violations of civil or criminal law.
• Federal action is required to protect the interests of those involved in the research misconduct proceeding.
• HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.

Multiple Institutions 

Pursuant to 42 CFR 93.318, at any point during a research misconduct proceeding, the RIO may determine that multiple institutions need to be involved in the research misconduct proceeding.  When allegations involve research misconduct at multiple institutions, one institution must be designated as the lead institution if a joint research misconduct proceeding is conducted.  The RIO and Office of General Counsel (OGC) will contact the RIO or equivalent person at the other institution(s) to determine whether a joint research misconduct proceeding will be conducted and, if so, who will be the lead institution.  The RIO and OGC will work with the other institution(s) to develop a Memorandum of Understanding (MOU) that outlines how the research misconduct proceeding will occur.  In a joint research misconduct proceeding, the lead institution should obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institution(s).  By mutual agreement, the joint research misconduct proceeding may include committee members from the institutions involved. If by mutual agreement, the institutions decided to hold separate research misconduct proceedings, each institution will appoint the appropriate inquiry panels and/or investigation committees to review the matter.

The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution, as set out in the MOU. 

Respondent Admission of Research Misconduct  

Per 42 CFR 93.317 (a), ORI expects the UI to carry inquiries and investigations through to completion and to pursue diligently all significant issues and credible allegations of research misconduct.  UI must notify ORI in advance if the UI plans to close a research misconduct proceeding at any point (including the assessment, inquiry, investigation or appeal stage) on the basis that the respondent has admitted to committing research misconduct or a settlement with the respondent has been reached. 

If at any point in the research misconduct proceeding, the respondent admits to committing research misconduct, the research misconduct proceeding will be paused.  A respondent’s admission of research misconduct must be made in writing and signed by the respondent.  An admission must specify the falsification, fabrication, and/or plagiarism that occurred, which research records were affected, and that it constituted a significant departure from accepted practices of the relevant research community.  The admission statement must meet all elements required for a research misconduct finding under 42 CFR §93.103 and must be provided to ORI before the UI closes its research misconduct proceeding.  UI must also provide a written statement to ORI confirming the respondent’s culpability and describing how the UI determined that the scope of the misconduct was fully addressed by the admission. The admission of research misconduct does not relieve the Respondent’s duty to correct the research record, and the UI may require correction of the research records as part of the admission document or settlement agreement.  

The RISO will ensure that all related materials and exhibits are appropriately documented and labeled.  The RISO will sequester any related evidence, inventory, and securely store.  The RISO will work with the respondent to identify the scope of the research misconduct.  The RISO will draft an abbreviated report that includes the allegation(s) of research misconduct, plans for correction(s) of the research record, and any administrative action(s) or sanction(s) that are imposed.

Pursuant to 42 CFR § 93.317(c), ORI may also conduct an oversight review of the UI’s handing of the research misconduct case.

The purpose of the allegation intake is to gather sufficient information to be able to conduct an assessment.

A.        The VPR, RIO, RISO, or other appropriate UI official (e.g., Departmental Executive Officer, Collegiate Associate Dean, Collegiate) receives a reported concern of possible research misconduct.

B.        The RIO must be notified if originally not notified of reported concern.  The RIO then notifies VPR, per policy if they have not already been notified.

C.        The reported concern and any associated materials are documented and saved in RISO electronic files.  Any evidence, including research samples, electronic files, and hard copy evidence, turned over to the RISO staff at this stage will be inventoried and securely stored in an appropriate manner.  Evidence will be forensically copied/scanned and the originals returned in as timely a manner.  

D.        If deemed appropriate by the RISO and the complainant is known or if the complainant is anonymous but cooperative, then the RISO staff will attempt to gather and/or clarify the necessary information to complete the assessment.

E.        If the complainant is anonymous and wishes not to be contacted further, the RISO staff will move forward with the information available to assess and document the complaint.

F.         If any exigent circumstances are identified in the reported complaint, the RISO staff will contact the appropriate UI office(s), leadership, or oversight agency.

G.        If at any time in the research misconduct proceeding, the RISO staff becomes aware of an actual or perceived conflict of interest involving the Deciding Official (DO) and the respondent and/or complainant, the RIO will consult with the Executive Vice President/Provost Office and/or the Office of the General Counsel to select an appropriate replacement to serve as the DO.

The purpose of the assessment is to determine if an allegation(s) warrants an inquiry.

1. The RISO staff will review the allegation to determine if fabrication, falsification, and/or plagiarism is being alleged, per 42 CFR 93.306 (b)(1).
2. The RISO staff will determine if the allegation is specific and credible so that potential evidence of research misconduct may be identified, per 42 CFR 93.306 (b)(3).
3. Pursuant to 42 CRF 93.214, the RISO staff will determine if the allegation(s) is being made in good faith.  Good faith will be continuously evaluated throughout the research misconduct process.
4. The RISO staff will determine if the research misconduct allegation occurred within the last six years of the date that HHS or the UI receives an allegation of research misconduct.
   1. Exceptions to the time limit:

      1. Subsequent use exception [42 CFR 93.104 (b)(1)].  The respondent(s) continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the use of, republication, or citation to the portion(s) of the research record (e.g.: process data, journal articles, funding proposals, data repository) alleged to have been fabricated, falsified, or plagiarized for the potential benefit of the respondent(s).

         When the respondent(s) uses, republishes, or cites to the portion(s) of the research record that is alleged to have been fabricated, falsified, or plagiarized, in submitted or published manuscripts, submitted PHS grant applications, progress reports submitted to PHS funding components, posters, presentations, or research records within six years of when the allegations were received by HHS or the UI, this exception applies.

         For research misconduct that appears subject to the subsequent use exception, the RIO must document their determination that the subsequent use exception does not apply.  Such documentation must be retained in accordance with CFR 42 §93.318.

      2. Exception for health or safety of the public.  If ORI or the RIO, following with consultation with ORI, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public, this exception applies, per 42 CFR 93.104 (b)(2).

5. Any evidence, including research samples, electronic files, and hard copy evidence, turned over to the RISO staff at this stage will be inventoried and securely stored in an appropriate manner. Evidence will be forensically copied/scanned and the originals returned in as timely a manner.
6. Pursuant to 42 CFR 93.318 (e), if necessary, the RIO will coordinate with the appropriate officials at the other institution(s) to determine whether a joint research misconduct proceeding is necessary and who will serve as the lead institution.
7. A draft assessment report will be created by the RISO staff that includes the following:
   1. Names of complainant(s) (if known).
   2. Names of respondent(s).
   3. Date allegation(s) received.
   4. Summary of allegations.
   5. Background information.
   6. Evidence reviewed for the assessment, including, but not limited to:
      1. Publications
      2. Grants
      3. Presentations
      4. Other evidence submitted by complainant
   7. Funding sources identified, in particular PHS funding sources.
   8. Relevant definitions.
   9. Assessment of allegations.
   10. Assessment decision.
8. The RIO’s determination:
   1. If, after reviewing the allegation(s), the RIO determines the definition of research misconduct is met and the allegations are sufficiently credible and specific so that potential evidence of research misconduct can be identified, then the RIO will document in the assessment report and initiate an inquiry.  The assessment of whether or not the allegation(s) is made in good faith will continue to be ongoing.
   2. If, after reviewing the allegation(s), the RIO determines that the definition of research misconduct is not met or if the allegations are not sufficiently credible and specific so that potential evidence of research misconduct can be identified, then the RIO will document the rationale for ending the research misconduct process at this stage.  The RIO will make a final determination of good faith at this point.  The RISO staff will work with the respondent and appropriate UI Leadership to mitigate any identified compliance issues.  If necessary, the RIO will work with the respondent and appropriate UI Leadership to restore the respondent’s reputation to the degree possible.
9. The report is then finalized.
   1. The RIO notifies the Vice President of Research (VPR) and appropriate (as specified in the UI Ethics in Research Policy) UI Leadership of the assessment determination.
   2. If directed by ORI to conduct an assessment, the RISO will submit the finalized assessment report to ORI. Per § 93.306(c)(3), if the RIO determines that the requirements for an inquiry are not met, they must keep sufficiently detailed documentation of the assessment to permit a later review by ORI of the reasons why the institution did not conduct an inquiry.  Such documentation must be retained in accordance with § 93.318.

Pursuant to 42 CFR 93.307, an inquiry’s purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an investigation.  Per § 93.307(b), an inquiry does not require a full review of the evidence related to the allegation.  

Pursuant to 42 CFR 93.307, a review of all allegations must be completed and the determination that no further investigation must be made for all allegations in order for the RISO staff (or RIO) to close the research misconduct process at this stage. RISO staff would have to fully document the reasons why and notify ORI and submit the necessary inquiry records. In addition to materials sequestered, the RIO may interview relevant witnesses who may have knowledge of facts and evidence pertinent to the allegations.

The UI is not required to conduct a separate inquiry for each additional respondent.  However, each additional respondent must be provided notice of and an opportunity to respond to the allegations specific to them, consistent with the policy and 42 CFR 93.305 (d).

1. Sequestration and Respondent Notification
   1. The RISO has a duty to take all reasonable and practical steps to obtain all research records and other evidence needed to conduct the research misconduct proceedings (§ 93.305(a)).
      1. The RISO staff will coordinate with the respondent’(s) departmental and other appropriate UI leadership for the notification of sequestration.  In the case of sponsored research, the PI, if they are not the respondent(s), will also be notified.
      2. The RISO staff will draft a formal letter notifying the respondent(s) of the allegations and the intent to move to inquiry.  The RISO staff will contact the respondent(s) to schedule an in-person notification meeting.
      3. At the time of the of the notification meeting with the respondent(s), the RIO will inform the respondent(s) of the allegations of research misconduct and the intent to move to inquiry.  Additionally, the RIO will also inform the respondent(s) of the sequestration process that will take place immediately following the meeting.  The RISO will provide the respondent(s) with an informational packet that includes the official inquiry notification letter, UI support resources, services, and related policies.
      4. The RISO staff will document the inventory of all sequestered materials.  All hard copy materials collected will be scanned into electronic files.  All hard copy materials will be stored securely in a locked RISO office until they are returned to the respondent(s).  All computers and electronic storage devices will be provided to ISPO, documented by a chain of custody form, who will then make forensic copies.  ISPO will provide a set of the forensic copies to the RISO on a secure site for working purposes.  ISPO will retain the original forensic copies on a secure site to preserve the integrity of the data.  In the instance of laboratory samples being sequestered, the RISO staff will inventory and store in an appropriate and secure manner.
      5. After the sequestered materials have been inventoried and copied, the original materials will be returned to the respondent(s) at a mutually agreed upon time.  The exception being any research samples that are collected that must continue to be stored with the RISO to ensure the integrity of the process.  Upon return of sequestered materials to the respondent(s), the Sequestration Receipt will be reviewed by the RISO staff and respondent(s) to ensure all items that can be returned, have been returned.

2. Inquiry Panel and Determination 

 1. The RIO and RISO staff will serve as the Inquiry Panel, per 42 CFR        93.307 (e)(2).

2. Where the Inquiry Panel lacks sufficient specialized expertise, the Inquiry Panel may consult with qualified subject matter expert(s) in areas relevant to the allegation in order to determine whether an investigation of the alleged misconduct is warranted.  The RISO will ensure that the subject matter expert(s) do not have any conflicts of interest, receive appropriate training on Research Misconduct and the associated procedures, and sign a confidentiality and non-disclosure agreement.  The role of the subject matter expert(s) during the inquiry phase is to provide the Inquiry Panel with advice related to the allegation, but do not make a determination if an investigation is warranted.  To the extent possible, the anonymity of the subject matter expert(s) will be protected.
3. Per 42 CFR 93.307 (e)(3), the Inquiry Panel, at their discretion, may elect to interview the complainant(s), the respondent(s), and any additional witnesses with possible information related to the allegation at hand. If interviews are conducted during the inquiry phase, they will be recorded and transcribed.  The individuals interviewed will be given a copy of the interview transcript to review for any inaccuracies.
4. The Inquiry Panel and subject matter expert(s), if retained, will review relevant evidence and data associated with the allegations.  Any additional respondents identified during the inquiry process must also be promptly notified of the allegations specific to them, per 42 CFR 93.305 (d).
5. Based on the respondent(s), complainant(s), and witnesses’ interviews (if conducted) and the evidence and data reviewed, the Inquiry Panel will, based on the preponderance of the evidence, make a determination whether an investigation is warranted. If there is a reasonable basis for concluding that the definition of research misconduct, as defined in 42 CFR §93.234 and the UI policy, may have substance, then an investigation is warranted. Findings of research misconduct cannot be made at the inquiry stage.
6. At the conclusion of the inquiry, regardless of whether an investigation is warranted, the Inquiry Panel will produce a written inquiry report(s) that includes all applicable content required by 42 CFR §93.309 and/or UI policy.  This will include:
   1. Names, professional aliases, and positions of the respondent(s) and complainant(s) (if the complainants are known).
   2. A description of the allegation(s) of research misconduct.
   3. The PHS support involved, including, for example, grant numbers, grant applications, contracts, and publications listing PHS support.
   4. The composition of the Inquiry Panel including name(s), position(s), and subject matter expertise (to maintain anonymity, name(s) of subject matter expert(s) will be redacted).
   5. Inventory of sequestered research records and other evidence and description of how sequestration was conducted.
   6. Transcripts of any transcribed interviews.
   7. Timeline and procedural history.
   8. Any scientific or forensic analysis conducted.
   9. The basis for recommending that allegation(s) warrant an investigation or do not merit an investigation.
   10. Any comments on the inquiry report by the respondent [inquiry reports will not be provided to the complainant(s)].
   11. Any institutional actions implemented, including communications with journals or funding agencies.
   12. The institutional policies and procedures under which the inquiry was conducted.
   13. The research records and other evidence reviewed and all copies of relevant documents.
   14. If there is potential evidence of honest error or difference of opinion (§ 93.307(g)(2)).
   15. The Inquiry Panel's recommendation as to whether an investigation is warranted and whether any other actions should be taken in the event an investigation is not recommended.
7. The RIO will provide the respondent(s) with a copy of the draft inquiry report(s) for comment and rebuttal. Within 20 days of receipt of the draft report(s), the respondent(s) will provide comments on the draft inquiry report(s) to the RIO. Comments submitted by the respondent(s) will become part of the draft Inquiry Report and record. Based on those comments, the Inquiry Panel may revise the report(s) as appropriate.  A separate draft Inquiry Report will be written for each respondent, and respondents will only be provided with their own report(s).  Respondent(s) will not receive copies of other respondents’ reports.
8. Per 42 CFR 93.307 (h)(2), the Inquiry Panel will complete the Inquiry Report and submit the report and recommendation(s) to the DO for institutional action within 90 days of initiating the inquiry. If during the inquiry process the RIO determines that circumstances warrant an extension, the RIO will contact ORI/DIO to request an extension and provide an update to the inquiry process and justification for the extension.  The RIO will inform the DO of the extension request and the ORI/DIO decision regarding the request.  In such cases, the inquiry record must include documentation of the reasons for the extension, and the respondent(s) must be notified of the extension.
9. The RIO will submit the draft Inquiry Report to the DO who in turn will review the Inquiry Report and either approve or reject the recommendation of the Inquiry Panel, stating in writing the reasons for that decision. During this review, the DO may also request additional information to assist in acting on the recommendation of the Inquiry Panel.  The DO will render a decision within 30 days.  The DO’s decision letter will be added to the Inquiry Report and at that point, the Inquiry Report will be considered final.
10. The RIO will notify the respondent in writing of the DO’s decision within 30 days of determining an investigation is warranted.  This notice will include a copy of the Inquiry Report and will include a copy of or refer to 42 CFR 93 and UI Ethics in Research policies and procedures.
11. Within 30 days of determining an investigation is warranted, the RIO will notify ORI/DIO of the result of the inquiry. If the UI’s decision is that an investigation is not warranted, the UI will keep detailed documentation of inquiries to permit a later assessment by ORI of the reasons why the UI decided not to investigate.  Such documentation must be retained in accordance with 42 CFR § 93.318 and the UI Record Retention Schedule.
12. The RIO will notify the respondent(s) of the result of the inquiry and provide a copy of the final Inquiry Report.
13. If deemed necessary by relevant UI leadership, interim administrative actions may be taken, as appropriate, to protect federal agency funds and equipment and the public health and safety, and to ensure that the purposes of the financial support from the federal agency are carried out.
14. Prior to the UI terminating an inquiry for any reason without completing all relevant requirements of 42 CFR 93 and UI Ethics in Research Policy Ch. 27.6 (other than closing an inquiry because no investigation is warranted), the RIO will submit a report to ORI/DIO and the UI DO, including a justification for the proposed termination, per 42 CFR 93.309 (c).

Per 42 CFR 93.310, the investigation of a research misconduct allegation must be initiated within 30 days of the DO's decision that an investigation is warranted. The RIO shall notify the respondent in writing of the DO decision prior to the start of the investigation.  If the Research Misconduct Committee (RMC) becomes aware of any additional allegation(s) that were not addressed during the inquiry, the RMC (facilitated by the RISO) must provide the respondent(s) written notice of the additional allegation(s) within a reasonable amount of time of deciding to pursue such additional allegation(s).  

If the RMC identifies additional respondent(s) during the investigation, the RMC may but is not required to conduct a separate inquiry for each new respondent.  If any additional respondent(s) are identified during the investigation, the RMC (facilitated by the RISO) must notify them of the allegation(s) and provide them an opportunity to respond.  While an investigation into multiple respondents can convene with the same investigation committee members, separate investigation reports and research misconduct determinations are required for each respondent.

Per 42 CFR 93.305 (a)(2), the RIO may also sequester any additional research records or evidence required to conduct the investigation not previously sequestered during an earlier stage of the research misconduct proceeding.

A. Investigation Committee Formation 

The UI will take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable.

1. The RIO will consult the Provost’s Office, and other appropriate academic leadership such as Associate Deans for Faculty and Research from the appropriate college, for recommendations regarding faculty to serve on the Research Misconduct Committee (RMC) who are not conflicted with any of the parties involved in any way and have the appropriate expertise relative to the investigation (e.g., subject matter, methodologies).  Based on the recommendations of the Provost, ADR, ADF, other college leadership, and RISO, the VPR shall appoint the RMC of no less than three faculty members. Members of the RMC must not have any unresolved personal, professional, or financial conflicts of interest relevant to the investigation. RMC members should collectively possess an appropriate level of subject matter expertise to competently evaluate the evidence of alleged research misconduct.
2. The prescribed procedures and standards for the conduct of the investigation includes the necessity for confidentiality, developing a specific investigation plan, and ensuring a thorough (which includes examination of all research records and other evidence relevant to reaching a decision on the merits of each allegation) and sufficiently documented investigation.  The RMC will take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, consistent with 42 CFR 93.310 (f).

B.  RMC Investigation and Expectations 

Consistent with 42 CFR 93.310 (g), the RMC must make every reasonable attempt to interview each respondent, complainant, and any other available person/witness who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent.

1.  Interviews during the investigation must be recorded and transcribed.
2. Any exhibits shown to the interviewee during the interview must be numbered and referred to by that number in the interview.
3. The transcript of the interview must be made available to the relevant interviewee for correction(s).
4. Transcripts with any corrections and numbered exhibits must be included in the institutional record of the investigation.
5. The respondent must not be present during the witnesses’ interviews but must be provided a transcript of the interview.
6. Consistent with 42 CFR § 93.305 (d), the RMC will consider the prospect of additional researchers being responsible for the alleged misconduct.
7. If multiple institutions are involved, the research misconduct proceeding will be conducted consistent with 42 CFR § 93.305 (e).
8. The RMC will pursue diligently all significant issues and leads discovered that are determined relevant to the investigation including any evidence of additional instances of possible research misconduct and continue the investigation to completion.  If additional allegations are raised, the respondent(s) must be notified in writing of the additional allegations raised against them.
9. If a respondent/complainant/witness refused to cooperate, the RISO would consult with OGC, relevant UI leadership and potentially with ORI/DIO for guidance. If respondent/complainant/witness can’t be compelled to cooperate, then the RMC would proceed with what information it had and document the lack of cooperation and the potential impact it does or does not have on a finding(s).

The RMC will complete all aspects of an investigation within 180 days of beginning it including conducting the investigation, preparing the draft investigation report for each respondent, providing the draft report to each respondent for comment in accordance with 42 CFR § 93.312, and transmitting the institutional record including the final investigation report and decision by the UI DO to ORI in accordance with 42 CFR § 93.316.

If the RMC is unable to complete the investigation in 180 days, the RIO will ask ORI for an extension in writing that includes the circumstances or issues warranting additional time, per 42 CFR § 93.311 (b).  If ORI grants an extension, it may, at their discretion, direct the RIO to file periodic progress reports.  If the investigation takes longer than 180 days to complete, the investigation report must include reasons for exceeding the 180-day period.  The RIO will notify/update the UI DO and other appropriate UI leadership of any extension requests and ORI’s decision regarding the requests.  The respondent(s) must be notified of extensions to the investigation.

C.  Role of RIO and RISO in RMC Investigation 

1. The RISO attends all meetings of the RMC to assist the committee in its work.
2. The RIO will convene the first meeting of the RMC to conduct an orientation that includes the definition of research misconduct (and what research misconduct is not), the necessity for confidentiality throughout the investigation (which may include agreement to a non-disclosure agreement by each RMC member), review of the RMC charge, and the Inquiry Report. Voting procedures will be reviewed with the RMC, including the counting of only ‘yes’ or ‘no’ votes when deciding upon findings of research misconduct. Additionally, the RMC must be educated on the definitions of intent:  intentionally, knowingly, and recklessly, per 42 CFR 93 Subpart B.  It is within the purview of the RMC to review prior allegations and research integrity concerns, including those that were not brought forward from the inquiry phase.
3. The RMC, at their discretion, may engage with consultants or content experts to provide information or specialized content knowledge but the consultants or content experts cannot be present during final committee deliberations and are not members of the committee.
4. The work of the RMC during the investigation may include (but is not limited to):
   1. Scheduling meetings as needed to conduct the work for the investigation in a timely manner.
   2. Reviewing and analyzing data and evidence (this can include, but it not limited to, labeling of figures, images, audio files, transcripts).
   3. Preparing and conducting of interviews.
   4. Documenting evidence, data, or any pertinent information reviewed.
   5. Making findings of whether research misconduct did or did not occur. If a finding of research misconduct is made under 42 CFR § 93.103, there must be:
      1. a significant departure from accepted practices of the relevant research community.
      2. evidence that the research misconduct was committed intentionally, knowingly, or recklessly; and
      3. proof as determined by a preponderance of the evidence.
   6. Per 93.313 (l)(i-iv), a formal vote on each allegation of research misconduct and intent is required by the RMC. A unanimous vote is not required for a finding of research misconduct or determination of intent.  Individual votes of the RMC on a finding of research misconduct or determination of intent will not be recorded.  In the instance of multiple respondents, a separate vote will be conducted for each respondent regarding research misconduct and intent.
   7. Drafting the analysis of the allegation(s), drafting the finding(s) of the RMC, and drafting recommended administrative actions and sanctions.  The RISO will draft the remainder of the investigation report.
5. Per 42 CFR 93.313, the RMC will prepare a comprehensive written investigation report. The RIO will ensure that the appropriate ORI requirements for an investigation report are followed.  In the instance of a research misconduct proceeding with multiple respondents, the RMC will prepare separate investigation reports for each respondent. 

6. To comply with 42 CFR 93.313, a final investigation report for each respondent must be in writing and include:

Names, professional aliases, and positions of the respondent(s) and complainant(s) (if the complainants are known).

1. Description of the nature of the allegation(s) of research misconduct, including additional allegation(s) addressed during the research misconduct proceeding.
2. Description and documentation of the PHS support, including, for example, any grants and numbers, grant applications, contracts, and publications listing PHS support.
3. Description of the specific allegation(s) of research misconduct for consideration in the investigation of each respondent.
4. Composition of the RMC, including name(s), position(s), and subject matter expertise.
5. Inventory of sequestered research records and other evidence, except records the institution did not consider or rely on; and a description of how any sequestration was conducted during the investigation.  This inventory must include manuscripts and funding proposals that were considered or relied on during the investigation.
6. Transcripts of all interviews conducted, as described in 42 CFR §93.310 (g).
7. Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other research records that allegedly that contained the falsified, fabricated, or plagiarized material.
8. Any scientific or forensic analysis conducted.
9. If not already provided to ORI, the institutional policies and procedures under which the investigation was conducted.
10. Any comments made by the respondent on the draft investigation report and the investigation committee’s consideration of those comments.
11. A statement for each separate allegation whether the investigation committee recommends a finding of research misconduct.
12. If the investigation committee recommends a finding of research misconduct for an allegation, the investigation report must, for that allegation:
    1. Identify the individual(s) who committed the research misconduct.
    2. Indicate whether the research misconduct was falsification, fabrication, and/or plagiarism.
    3. Indicate whether the research misconduct was committed intentionally, knowingly, or recklessly.
    4. State whether the other requirements for a finding research misconduct, as described in 42 CFR §93.103, have been met.
    5. Summarize the facts and analysis which support the conclusion and consider the merits of any explanation by the respondent.
    6. Identify the specific PHS support.
    7. Identify whether any publications need correction or retraction.
13. If the investigation committee does not recommend any findings of research misconduct for an allegation, the investigation report must give a detailed rationale.
14. List any current support or known applications or proposals for support that the respondent has pending with PHS and non-PHS federal agencies.
15. The RIO will provide each respondent a copy of their draft investigation report for comment. Concurrently, the RIO will provide the respondent a copy of, or supervised access to, the research records and other evidence that the RMC considered or relied on, per 42 CFR § 93.312 (a). The respondent(s) will be allowed 30 days to review and comment on the draft report. The respondent(s)’ comments will be attached to the draft investigation report. The RMC may consider any factual corrections or consider any new evidence or statements provided in the respondent’s response to the draft investigation report.  The RMC, at their discretion, may draft an addendum addressing the respondent's response.
16. Per 42 CFR 93.314, the draft investigation report is then provided to the DO, who is then responsible for making a final determination of research misconduct findings.  The RIO may meet with the DO to discuss the report. The DO can accept the RMC’s findings, reject the RMC’s findings, or send the report back to the RMC for further consideration.

8. If the DO accepts the RMC's findings without modification, the DO's determination, together with the RMC's investigation report, the respondent’s response, and the addendum of the final administrative action(s) and sanction(s), constitutes the final UI investigation report. 

9. If the DO’s determination differs from the RMC's findings, the DO will explain in their determination letter the detailed basis for reaching a conclusion different from the RMC. The DO’s written explanation should be consistent with requirements in 42 CFR §93, including the definition of research misconduct, and the UI Ethics in Research Policy.  The DO’s decision should also be based on the evidence reviewed by the RMC to which the respondent has had an opportunity to respond.

10. If the DO sends the report back to the RMC for further consideration, the DO must specify in writing which allegations, findings, or evidence must be reconsidered.  The RMC must respond to the DO in writing that they reviewed the specified concerns or issues, along with any changes (if applicable), that were made to the report.  If changes were made to the report, the respondent must be given 15 days to respond to the updated report.  The RMC response to the DO will include any additional comments from the respondent.  The RIO may meet with the DO to discuss the updated report, and the DO will render a determination.

11. Per 42 CFR 93.314, the DO’s determination of research misconduct findings must be provided in a written decision that includes:

2. Whether the institution found research misconduct, and, if so, who committed the research misconduct; and
   1. A description of relevant institutional actions taken or recommended administrative action(s) or sanction(s) to be taken.
3. Once the DO has made their determination and if a finding(s) of research misconduct has been made, then the DO will confer with the UI Office of the Executive Vice President and Provost on administrative action(s) and sanction(s).  The Executive Vice President and Provost enacts any administrative action(s) or sanction(s).
   1. The Executive Vice President and Provost will notify the RIO of the final administrative action(s) and sanction(s) to be enacted.
   2. The RIO will attach an addendum to the investigation report detailing any enacted administrative action(s) and sanction(s) by the Executive Vice President and Provost.  The addendum added to the investigation report, respondent’s response, and the DO’s decision constitutes the final RMC investigation report.
4. The DO has 30 days to complete their determination.
5. Per 42 CFR 93.313, the respondent will be notified in writing at the conclusion of the investigation of its outcome. The respondent will be provided a copy of the institution's final investigation report.
6. If the DO’s decision concludes there are findings of research misconduct, those findings cannot be appealed by the respondent to the UI.  Only the UI’s administrative action(s) and sanction(s) may be appealed by a respondent.

1. In the Case of Findings of Research Misconduct:

Once the DO has accepted the investigation report and accepted or amended any recommended administrative action(s) or sanction(s) to be taken in response to the findings, the RIO is responsible for complying with any notification requirements to ORI, the PHS or other Reporting Contact(s) funding the research. The UI will comply with any actions required by ORI, the PHS or other Reporting Contact(s), which may include the obligation to make restitution for the funding or other grant-related actions.

The Executive Vice President and Provost imposes any administrative action(s) and sanction(s) if applicable.  All administrative action(s) and sanction(s) are to be enacted and enforced pending and during an appeals process.  The oversight of any audits and corrective action(s) that may be required as a result of the findings of the investigation will be the responsibility of the Executive Vice President and Provost. 

If the UI and the respondent(s) reach a settlement, the settlement cannot include a stipulation that the UI will not provide the final investigation report to ORI and any other relevant funding agencies.

The RIO will discuss with the DO the appropriate action(s), if any, to ensure the scientific record is corrected.  The UI will ensure that any PHS funds or any other Reporting Contact funds are returned, if applicable.

The final institutional report’s findings are final and are not subject to the UI appeal process.  However, the respondent may appeal the sanctions and administrative actions resulting from a finding(s) or admission of research misconduct.  Respondents should follow the appropriate UI policy that corresponds to their position at the UI.  The sanctions and administrative actions will be enacted and enforced prior to and during the UI appeal process.

If ORI/DIO accepts the UI’s findings of research misconduct, the respondent may appeal the findings to ORI/DIO, per 42 CFR 93.501.

Policy Manual Grievance Process for Faculty:

• PM III-15.3b
• PM III-29
• PM III-29.9

Policy Manual Grievance Process for P&S Staff:

• PM III-28.4

Policy Manual Grievance Process for Merit Staff:

• PM III-28.3

Grievance Process for Postdoctoral Trainees

• Graduate College – Postdoctoral Employment Standards

Grievance Process for Graduate Assistants:

• Graduate College – Graduate Student Employment Standards

Disciplinary action related to other categories of individuals within the University, not covered above, including professional students and undergraduates, will be undertaken by the Executive Vice President and Provost or the vice president responsible for such individuals, as applicable.

If the RIO has reason to believe that the administrative action(s) and sanction(s) will be appealed by the respondent to the UI, then the RIO will consult with ORI on the timing of submission of the institutional record to ORI.  

If the RIO believes the respondent will not appeal the administrative action(s) or sanction(s), the RIO will submit the institutional record following the DO’s decision.

2. In the Case of No Findings of Research Misconduct:

If the institutional final report has no finding(s) of research misconduct, the RIO will consult with the respondent and undertake all reasonable, practical, and appropriate efforts to restore the respondent's reputation. Depending on the circumstances, the RIO should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in meetings in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct allegation from the respondent's personnel file. Any UI actions to restore the respondent's reputation must first be approved by the Executive Vice President and Provost in consultation with the VPR.

Upon completion of an investigation, the RIO will consult with the complainant and determine what steps, if any, are needed to restore the position and reputation of the complainant. The same process will also be followed to protect or restore the position and reputation of any witness or committee member, if needed. Any UI actions to restore the complainant’s reputation must first be approved by the Executive Vice President and Provost in consultation with the VPR. The RIO is responsible for implementing any steps the Executive Vice President and Provost and VPR approves.

All records, including the institutional record and all sequestered evidence including physical objects (regardless of whether the evidence is part of the institutional record), shall be kept in accordance with the record-keeping requirements of the UI Official Record Retention Schedule or as specified in 42 CFR §93.318, whichever is longer.