Overview of Proposed Revised Policy: Research Misconduct (Currently University Policy and Procedures Concerning Research Misconduct)

The Office of Research Compliance is recommending the revision of the Research Misconduct policy.

The proposed revised policy:

Changes policy name from University Policy and Procedures Concerning Research Misconduct to Research Misconduct.

Restructures the policy to conform to the current university policy template. Revises language throughout to improve clarity and accuracy, which includes the removal of language

inconsistent with federal regulations on research misconduct. Adds and updates definitions, most notably for “complaint,” “intentionally,” “knowingly,” “recklessly,”

“home institution,” and “preponderance of the evidence." (Definitions, pp. 1-3) Revises the purpose of the policy language to read: “To promote the university’s compliance with

federal regulations and emerging best practices for dealing with research misconduct and to protect the integrity and reputation of the university and its scholars from false or unproven allegations of research misconduct.” (Purpose of the Policy, p. 1)

Establishes a research integrity standing committee (RISC) whose members will conduct inquiries and investigations to ensure that the university’s policy and procedures for dealing with research misconduct are consistent with the federal regulations and emerging best practices (Procedure II.B, p. 10)

Delegates the authority to conduct an inquiry to the Research Integrity Officer and staff in the Office of Research Compliance, in consultation with an appropriate subject matter expert from the RISC, as needed. (Procedure II, pp.10-12)

Streamlines the investigation process so that it is consistent and uniform for all respondents regardless of their position at the university. (Procedure III, pp. 12-14)

Clarifies that the process for approving and implementing corrective action or sanctions is dictated by the position of the respondent. For example, the disciplinary process set forth in University Faculty Rule 3335-5-04 will be followed for faculty found to have engaged in research misconduct, while disciplinary processes for graduate students will follow the Graduate School Handbook Section, section C2. (Policy Details XII, pp. 7-8)

Included Documents

Proposed policy Draft Standard Operating Procedures for: Conflict of Interest (COI) Screening; Sequestration &

Retention of Records; Six-Year Time Limitation & the Subsequent Use Exception; Respondent & Complainant; Research Integrity Standing Committee (RISC); Admissions & Settlements; and Additional Allegation Intake.

Research MisconductUniversity Policy

Applies to: All university personnel involved with research activities (including faculty, staff, students, research associates and fellows, post-doctoral fellows, and other research trainees) and all visitors involved with research activities

Responsible Office Office of Research

POLICYIssued: 05/29/2008Revised: 02/16/2021 (target effective date)

The university is committed to maintaining integrity and transparency in research endeavors. The university, in carrying out its research mission, expects and encourages all members of the university engaged in research to adhere to the highest standards of research integrity to protect the accuracy and reliability of the research record and published results. This policy has been promulgated to ensure that the university’s policy and procedures are consistent with the federal regulations and emerging best practices for dealing with research misconduct and to protect the integrity and reputation of the university and its scholars from false or unproven allegations of research misconduct. This policy therefore applies to all research and scholarship conducted within the university community, irrespective of the funding source, if any, which supports the research or scholarship. In addition, the terms “research” and “scholarship” will be broadly construed, including activities ranging from scientific experimentation to creative expression, regardless of the discipline. A person against whom allegations of research misconduct are made is presumed innocent of any allegations until the contrary has been established by a final decision reached under this policy.

Purpose of the Policy To promote the university’s compliance with federal regulations and emerging best practices for dealing with research misconduct and to protect the integrity and reputation of the university and its scholars from false or unproven allegations of research misconduct.

Table of Contents

POLICY..................................................................................................................................................................................1Purpose of the Policy.........................................................................................................................................................1Table of Contents..............................................................................................................................................................1Definitions.........................................................................................................................................................................1Policy Details.....................................................................................................................................................................3

PROCEDURE........................................................................................................................................................................8Responsibilities ...............................................................................................................................................................15Resources.........................................................................................................................................................................15Contacts...........................................................................................................................................................................16History.............................................................................................................................................................................16

DefinitionsTerm DefinitionAllegation An accusation of specific falsification, fabrication or plagiarism, received through any means of

communication that triggers the procedures described in this policy.

Complainant Person who makes an allegation of research misconduct, including those persons who make allegations through the university anonymous reporting line.

Complaint All related allegations of research misconduct, one or many, against a specific respondent received at one time or sequentially.

The Ohio State University – University Policies policies.osu.edu Page 1 of 16

Term DefinitionDeciding official (DO)

Institutional official responsible for final determinations over all research misconduct matters. In the absence of any conflict, the deciding official is normally the senior vice president for research.

Fabrication Making up data or results and recording or reporting them.

Falsification Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Good faith allegations

A complainant’s or witness’s belief in the truth of their allegation(s) of research misconduct that a reasonable person in that position could have based on the information known at the time.

Home institution The institution with jurisdiction over a specific allegation because it is the institution where the research misconduct took place and which would retain and/or be responsible for the retention of the original research records.

Inquiry Preliminary information gathering and fact-finding to determine if each allegation has substance (i.e., that sufficient evidence exists that research misconduct may have occurred to warrant investigation).

Intentionally Respondent directly engaged in falsification, fabrication or plagiarism with the intent, or purpose of misleading the reader of the research record.

Investigation A formal review of all evidence to determine if research misconduct occurred and by whom, and to recommend appropriate corrective actions or sanctions.

Knowingly Respondent has actual knowledge of the falsification, fabrication or plagiarism, or acts in deliberate ignorance or plain indifference of the falsification, fabrication or plagiarism.

Plagiarism The appropriation of the ideas, processes, results, or words of another person, without giving appropriate credit.

Preliminary Assessment

Initial review to determine if each allegation fits within the definition of research misconduct and if each allegation is credible and specific so that potential evidence of research misconduct may be identified.

Preponderance of the Evidence

Proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.

Recklessly Respondent is on notice of an increased risk of falsified, fabricated, or plagiarized data being used or generated, or the risk is so obvious that a typical researcher in the relevant research community should have known, and through action or inaction, the respondent uses, or allows the use of, the falsified, fabricated or plagiarized data.

Recklessness is distinguished from negligence, where a respondent deviates from ordinary care that a typical researcher in the relevant research community would have exercised, but the respondent is unaware that there was a substantial risk of falsification, fabrication or plagiarism.

Research Any systematic investigation, including research development, testing, and reporting, designed to develop or contribute to generalizable knowledge. The term encompasses basic research, applied research, and research training activities in areas such as biomedical and life sciences, natural sciences, engineering, humanities and arts, and social and behavioral sciences.

Research misconduct

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. A finding of research misconduct requires 1) that there be a significant departure from accepted practices of the relevant research community; 2) the misconduct be committed intentionally, knowingly, or recklessly; and 3) the allegation be proved by a preponderance of the evidence. Research misconduct does not include honest error or differences of opinion.

Research record Any data or results, in any media or format, which embodies the information resulting from research. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; medical charts, patient research files; computer code; musical scores, musical composition; and choreography.

Respondent Person or persons against whom allegations of research misconduct are made or who are thought to be responsible.

Research integrity officer (RIO)

Institutional official with the primary responsibility for implementation of the procedures in this policy.

Retaliation An adverse action taken against any individual because they participate in a research misconduct proceeding, including a respondent, complainant, witness, or committee member.

The Ohio State University – University Policies policies.osu.edu Page 2 of 16

Policy DetailsI. Allegation(s)

A. Allegations of research misconduct may be filed with the university by anyone, whether associated with the university or not. Such allegations may be filed orally or in writing, and may be filed anonymously.

B. Allegations must be filed with appropriate university officials and immediately referred to the Office of Research Compliance to trigger the procedures described in the policy.

C. Complainants should file allegations only when they are confident that sufficient credible evidence supports the accusation. Allegations not made in good faith are serious charges and the filing of such allegations are an abuse of the procedures set forth in this policy, and may result in disciplinary action under other university rules or policies.

D. Informal requests for information or consultation with the Office of Research or any university official concerning research misconduct will not, in and of themselves, be construed as formal charges of research misconduct.

E. Complainants are encouraged to consult initially with a supervisor, department chair, dean, or the Office of Research Compliance before bringing research misconduct allegations.

F. If allegations are made against more than one individual, a separate decision will be reached regarding each individual.

G. All allegations that do not meet the definition of research misconduct under this policy will be referred by ORC to the appropriate university office or to the appropriate external entity. See Referral of Allegations Standard Operating Procedures. In such cases, the research integrity officer (RIO) will refer the complaint to the appropriate university or external authority for consideration under the applicable policy or regulation and, if necessary, will work with such authorities to coordinate the handling of the matter.

II. Scope of the Research Misconduct ProceedingsA. During a research misconduct proceeding, the university will pursue diligently all significant issues and leads

discovered throughout the three phases of the research misconduct proceeding, the preliminary assessment, the inquiry, and the investigation, including any evidence of additional allegations of possible research misconduct.

B. During any phase of a research misconduct proceeding, additional allegations may arise that are related to an ongoing inquiry or investigation and justify broadening the scope beyond the initial complaint. See Additional Allegation Intake Standard Operating Procedures.

C. If any new allegations arise, the RIO will notify the respondent, in writing of the decision to review the new allegation(s) with a description of the allegation(s). If a new respondent is named, the RIO will inform the new respondent in writing of the decision to review the allegation(s) with a description of the allegation(s).

D. The respondent will be furnished with, or have access to, copies of all documentary evidence regarding the new allegation(s).

III. Research Integrity Officer (RIO)A. The senior vice president for research designates a research integrity officer to be responsible for

administering this policy for the institution.B. The person appointed as institutional RIO will not be university legal counsel acting in that capacity.C. A designated RIO will manage each complaint and, in addition to administering the process of the

preliminary assessment, inquiry or investigation, will:1. Take all reasonable and practical steps to ensure that all evidence is sequestered either before or at

the same time as the institution notifies a respondent of a complaint; 2. Consult with the university Office of Legal Affairs to ensure that the requirements of law and the

university policy are being satisfied;3. Assist the appropriate officials and committees in carrying out the inquiry and investigation,

including assembling evidence and conducting interviews;4. Maintain objectivity regarding the veracity of the allegations and throughout the proceedings to

achieve consistency and fairness in inquiries and investigations;5. Serve as a neutral advisor to assist in facilitating the inquiry or investigation, and advise as to issues of

process and procedures;6. Work with and advise the various university officials and committees involved in the inquiry and/or

any investigation or disciplinary action and offer advice regarding university rules and policies governing the process;

The Ohio State University – University Policies policies.osu.edu Page 3 of 16

7. Advise members of the university community in response to requests for information or informal consultation concerning research misconduct;

8. Keep the DO informed of any complaints filed and the progress of any initial inquiry or investigation undertaken;

9. Be responsible for communications with any person or organization outside the university having a legitimate interest in the complaint, including any oversight agency or funding entity;

10. Be responsible for referring any complaints involving research that was not conducted at the university to the appropriate external entity. See Referral of Allegations Standard Operating Procedures.

11. Refer relevant matters to the appropriate university authorities and cooperate with and assist in coordinating any related actions when, in the course of the research misconduct proceedings, other university policies are implicated, such as those involving the use of human subjects, the use and care of laboratory animals, the use and care of hazardous substances, conflicts of interest, and consulting;

12. Inform, within 24 hours, the relevant oversight agency or funding entity (if required), and other appropriate bodies, including law enforcement officials, the Department of Public Safety, and the Office of Human Resources, if the RIO, in consultation with the DO, believes that possible criminal conduct exists;

13. File an annual report with the Office of Research Integrity (ORI) in the U.S. Department of Health and Human Services Department containing information specified by ORI on institutional compliance with federal regulations on research misconduct; and

14. Notify federal funding entities at any time if the RIO, in consultation with the DO, believe that any of the following conditions exist:a. Health or safety of the public is at risk, including an immediate need to protect human or animal

subjects;b. Federal resources or interests, including funds or equipment, are threatened;c. Research activities should be suspended;d. There is indication of possible violations of civil or criminal law;e. Federal action is required to protect the interests of those involved in the research misconduct

proceeding;f. The research misconduct proceeding may be made public prematurely to allow the oversight agency

or funding entity to take appropriate steps to safeguard evidence and protect the rights of those involved; or

g. The research community or public should be informed.D. The RIO has the responsibility and authority to sequester any relevant evidence at any time during a

research misconduct proceeding. See Sequestration & Retention of Records Standard Operating Procedures.

IV. Deciding Official (DO)A. The DO is responsible for final institutional decisions related to all allegations of research misconduct.B. During the proceedings under this policy or any subsequent activities, the DO may take administrative actions

that are, in their judgment, appropriate to protect research funds, materials, equipment, or records, or the legitimate interests of research subjects, patients, clients, or research animals. Such administrative actions will not be deemed disciplinary in nature.

V. Duty to Cooperate A. All persons to whom this policy applies, including respondents and complainants, are obligated to cooperate

with all proceedings under this policy.B. Such cooperation includes providing research records and other relevant information to the RIO or their

designee and sending all correspondence for the inquiry or investigation committee members through the RIO.

C. The respondent has the duty to furnish research records and other relevant information in their possession, but the respondent has no duty to provide oral or written statements.

D. Under 42 C.F.R. §93.106(b), the actual or apparent failure of a respondent to retain research records may, absent extenuating circumstances, be seen as evidence against the respondent in evaluating research misconduct allegations. The destruction of, absence of, or respondent’s failure to provide research records

The Ohio State University – University Policies policies.osu.edu Page 4 of 16

adequately documenting the questioned research is evidence of research misconduct when the university establishes by a preponderance of the evidence that the respondent:1. behaved in a way that constitutes a significant departure from accepted practices of the relevant research

community; and2. intentionally, knowingly, or recklessly had research records and destroyed them; or3. had the opportunity to maintain the records but did not do so; or4. maintained the records and failed to produce them in a timely manner.

VI. ConfidentialityA. To the maximum extent possible, within the law and the need to conduct a thorough inquiry or

investigation, all participants in the process must keep confidential all information regarding the allegations and any proceedings under this policy until the university process, including any disciplinary action, has concluded and all avenues of appeal (if pursued) have been exhausted.

B. Release of information by the university about alleged research misconduct may be required under certain circumstances and will be made in accordance with all applicable laws. Examples of when release of information may occur include, but are not limited to, the following circumstances:1. As required by the rules of, or contract with, a funding entity;2. As required by the need to inform the research community of the conclusions reached in order to protect

the integrity of the research involved;3. As part of a disciplinary sanction imposed;4. As deemed necessary by the RIO and deciding official (DO) to protect the legitimate interest of human

subjects involved in the research;5. As deemed necessary by the RIO and DO, whether or not proceedings external to the university

(investigations or oversight review) are ongoing; or6. At the request of the respondent.

C. The RIO, in consultation with the DO, is responsible for determining when a release of information is necessary or appropriate. During the course of the research misconduct proceedings, if release of information outside the university is deemed necessary, the respondent may be informed of the release.

D. The goal of maintaining confidentiality does not prohibit university officials from consulting, on a confidential basis and to the extent necessary, with persons outside the university community with relevant experience or expertise to thoroughly investigate the allegations.

E. The goal of maintaining confidentiality does not prohibit university officials from disclosing information, on a need to know basis, to individuals responsible for oversight of the respondent’s research activities or to other university officials involved in the questioned research, such as department chairs or deans.

F. If confidentiality is breached improperly, university officials will take reasonable steps to minimize the damage to reputations that may result from inaccurate or untimely reports.

G. If information concerning the alleged research misconduct is disclosed in accordance with law (for example, by the respondent or government agency), university officials may comment publicly in connection with such disclosure.

VII. Conflicts of Interest A. Conflicts of interest in research misconduct proceedings exist when the financial, personal, or professional

relationships of an individual involved in the proceedings may affect the proceedings or the resolution of the allegations. Perceived or actual conflicts of interest are treated identically under this policy. See Conflicts of Interest (COI) Screening Standard Operating Procedures .1. Possible conflicts of interest may include, but are not limited to, co-authorship of work with the

respondent or complainant, or professional or personal relationship with the respondent or complainant beyond that of mere friends or colleagues (e.g., current or former student or mentor relationship, direct supervisory or subordinate job relationship, or marital/partner relationship).

2. The subordinate relationship of a respondent or complainant to their dean or chair alone does not constitute a perceived or actual conflict of interest under this policy.

B. Any individual involved in research misconduct proceedings has an obligation to disclose to the RIO if a conflict of interest arises any point in the proceedings.

C. The RIO has the responsibility and authority to evaluate all perceived or actual conflicts of interest. During the handling of the research misconduct proceedings, if conflicts of interest arise for any individual involved in the proceedings, a replacement will be designated and fully informed regarding earlier procedures and

The Ohio State University – University Policies policies.osu.edu Page 5 of 16

evidence secured, and it is not required that the process commence anew. See Conflicts of Interest (COI) Screening Standard Operating Procedures .

VIII. DeadlinesA. Due to the sensitive nature of allegations of research misconduct, each complaint will be resolved as

expeditiously as possible. The nature of some complaints may render normal deadlines difficult to meet.B. If a procedural deadline set forth in this policy cannot be met during a research misconduct proceeding, the

RIO will review and approve, where appropriate, requests for additional time.C. If a regulatory deadline set forth in this policy cannot be met, the RIO will file written notice with the

oversight agency or funding entity and the DO, setting out the reasons why the deadline cannot be met.D. The term “day” as used in this policy means “calendar day.” If the last day of a designated time period falls

on a weekend or a day on which the university is closed, the time period will expire at the close of business on the next succeeding business day.

IX. Termination of University AffiliationA. If a respondent terminates affiliation with the university before a research misconduct matter is resolved, the

proceedings under this policy will continue, to the extent possible, until a final determination is reached.

X. Time Limitations and Subsequent UseA. This policy applies only to allegations of research misconduct occurring within six years of the date the

university, oversight agency, or funding entity receives an allegation of research misconduct. Exceptions to the six-year limitation include the following:1. Subsequent use exception. The respondent continues or renews any incident of alleged research

misconduct that occurred before the six-year limitation through the citation, republication, or other use for the benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized. See Six-Year Time Limitation & the Subsequent Use Exception Standard Operating Procedures.

2. Health or safety of the public exception. If the university, following consultation with the federal oversight agency or funding entity, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

XI. RetaliationA. The university will not tolerate retaliation in any form against any individual who participates in a research

misconduct proceeding. Retaliation is a serious violation that can subject the offender to disciplinary action under appropriate university rules or policies.

B. University officials will diligently attempt to protect the positions and reputations of good faith complainants, witnesses, committee members and respondents from any retaliation by other university members.

C. University officials will take all reasonable and practical steps, to the extent possible, to rectify any injury done to the reputations of complainants, witnesses, or committee members upon a finding of retaliation by respondents or other university members.

D. Retaliation by university members, as determined by the senior vice president for research, will be referred for appropriate university disciplinary procedures.

XII. Corrective Actions and SanctionsA. Following a finding of research misconduct, appropriate corrective actions will be imposed by the university

and will be commensurate with the impact of the findings of research misconduct. In some circumstances, the senior vice president for research or the acting DO may recommend that the university take corrective action(s) during research misconduct proceedings prior to a finding of research misconduct.

B. A corrective action is taken to eliminate a respondent’s undesirable behavior or conduct and achieve performance that is consistent with expected standards of the university. Types of corrective actions include, but are not limited to, counseling, participation in training programs, development of a data management plan, or oversight of research.

C. Following a finding of research misconduct, a sanction may be imposed by the university. A sanction is a penalty or punishment imposed on the respondent(s) as discipline for findings of research misconduct. Appropriate sanctions will be imposed by the university and will be commensurate with the severity of the

The Ohio State University – University Policies policies.osu.edu Page 6 of 16

research misconduct. Sanctions include, but are not limited to, verbal or written reprimand, reassignment of duties or privileges, or termination of university affiliation.

D. The approval and implementation of all recommended corrective actions or sanctions will proceed as follows:1. When the respondent is a faculty member, their tenure initiating unit (TIU) will act pursuant to University

Faculty Rule 3335-5-04.2. When the respondent is a graduate student, the Graduate School will act pursuant to the Graduate School

Handbook Section, section C2.3. When the respondent is an undergraduate student, the University Senate Committee on Academic

Misconduct (COAM) will act pursuant to the Code of Student Conduct.4. When the respondent is a staff member, corrective actions and sanctions will be implemented by the

employee’s supervisor and Employee Relations and any other appropriate Human Resources professional, in accordance with Corrective Action and Involuntary Termination policy, Student Employment policy, and/or applicable collective bargaining agreements.

XIII. Correction of the Research RecordA. According to federal regulation 42 CFR §93.313(4), the university has the responsibility to identify whether

correction or retraction of published or submitted work is required, to ensure the integrity of the scientific record is maintained.

B. If research misconduct is found under this policy and falsified, fabricated, or plagiarized research has been published or submitted, including within grant proposals, the respondent must work with the RIO and any other institutional officials or publishers to correct, retract, or withdraw the research record.

C. If research misconduct is not found under this policy, but falsified, fabricated, or plagiarized research has been published or submitted, including within grant proposals, due to honest error or for any other reason, the RIO working with the researchers involved will seek to correct, retract, or withdraw the research record.

D. The university may request correction or retraction of the published work at any time during the research misconduct proceedings or during a resolution with the respondent(s) when there is clear evidence of falsified, fabricated, or plagiarized research.

E. The correction or retraction may occur before a final determination of research misconduct against a respondent has been made or if the university finds there are no research records available to support the published or submitted research.

XIV. RehabilitationA. In proceedings where the respondent is not found to have committed research misconduct, the university

may, to the extent possible, work with the respondent to rectify any injury done to the reputation of respondent, including providing a letter of the results of the investigation.

XV. Reopened ComplaintsA. Any complaint that has been closed with a determination that research misconduct did not occur may be

reopened only if, in the opinion of the RIO in consultation with the DO, new and potentially significant information of research misconduct, not previously considered, has been presented.

XVI. Official Records of Research Misconduct ProceedingsA. The official university record of research misconduct proceedings will include all reports, electronic

recordings, computer files, documentary evidence, or other relevant matter collected and used by the committee(s).

B. In all closed research misconduct proceedings the official university record will be kept in the files of the Office of Research Compliance.

C. The official university record will be kept for a minimum of ten years or as required under the applicable university data and record retention policies.

PROCEDUREIssued: 05/29/2008Revised: 02/16/2021 (target effective date)

I. Preliminary Assessment

The Ohio State University – University Policies policies.osu.edu Page 7 of 16

A. When a complaint is filed with, or referred to the Office of Research, regardless of the source of the complaint, the RIO will initiate a preliminary assessment to determine if the complaint fits within the definition of research misconduct under this policy and is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

B. The RIO will determine, to the extent possible, if each allegation within the complaint is within the six-year time limit as described in Policy Details X. Any allegation that is outside the six-year time limit and does not meet an exception to the six-year time limit will be dismissed from review under this policy. See Six-Year Time Limitation & Subsequent Use Exception Standard Operating Procedures .

C. The RIO will ensure that the dean of the college in which a respondent is employed is informed of the complaint. The preliminary assessment will be conducted by the RIO, in consultation with the dean, and includes a review the information or circumstances giving rise to the alleged research misconduct.

D. If the complaint does not name any specific respondents, the RIO, in consultation with the dean, will determine, to the extent possible, the roles and responsibilities of the individuals involved in the questioned research in order to name one or more respondents. See Respondent & Complainant Standard Operating Procedures.

E. The RIO, in consultation with the dean, may, but is not required to, interview the potential respondent(s), complainant(s), or any other witnesses and consult confidentially with the chair of the department(s) involved and others within, or external to, the university with relevant experience or expertise, as long as no conflicts of interest exist.

F. Every effort will be made to complete the preliminary assessment within thirty (30) days, or as soon as practicable, depending on the complexity of the complaint.

G. The RIO will provide a draft report of the preliminary assessment to the dean for concurrence on the proposed actions.

H. The RIO must take immediate action to sequester all data or other materials relevant to the complaint, on or before the date on which the respondent(s) is notified of the allegations. See Sequestration & Retention of Records Standard Operating Procedures.1. The RIO has authority to promptly locate and secure the originals of all research records and other

relevant materials if it is believed that such records may become relevant in the course of an inquiry or an investigation of alleged research misconduct.

2. Supervised access to the research records and other materials will be provided to the investigative bodies looking into the complaint, to the respondent(s), and to any other person who has a legitimate reason, related to the university process, to require access.

3. If research records exist outside of the university, the RIO has authority, in consultation with the DO, to contact the appropriate officials to locate and secure all research records relevant to the complaint.

I. A report of the preliminary assessment will be prepared by the RIO and dean of the college. If the RIO and dean do not concur on the final decision of the preliminary assessment, the preliminary assessment report will include each decision, and the DO will make the final determination.

J. Complaints (or allegations) outside the jurisdiction of the university1. The university’s jurisdiction encompasses allegations related to all research conducted while a respondent

was under the oversight of the university. The university does not have jurisdiction over allegations related to research conducted at another university.

2. If the RIO finds that a complaint, or any allegation within the complaint, is not under the jurisdiction of the university, the RIO will refer the complaint (or allegations) to the appropriate office at the home institution. See Referral of Allegations Standard Operating Procedures

3. The RIO may consult with all pertinent institutional officials to determine whether the research was conducted at the university, including but not limited to the dean of the relevant college, the chair of the relevant department, the Office of Human Resources, the Graduate School, and/or the Office of Sponsored Programs.

K. Complaints that fail to indicate possible research misconduct1. If the RIO and dean find that all of the allegations within a complaint do not fit within the definition of

research misconduct under this policy, or are not sufficiently credible or specific so that potential evidence of research misconduct may be identified, the RIO, in consultation with the dean, will dismiss the entire complaint.

2. The RIO and dean will provide the report of the preliminary assessment to the DO and request concurrence for dismissal of the complaint.

3. The complainant(s), if known, will be notified if the totality of the complaint is dismissed.

The Ohio State University – University Policies policies.osu.edu Page 8 of 16

4. The complainant(s) may appeal in writing to the DO within seven (7) days of receiving notice of the dismissal of the complaint.a. An appeal of the dismissal of the complaint must be based on new information provided by the

complainant(s) that was not already considered during the preliminary assessment, or on evidence from the complainant(s) that there was a substantial procedural irregularity during the preliminary assessment.

5. The DO will decide as soon as possible after receipt of appeal whether to affirm the dismissal or to refer the complaint, or any allegations within the complaint, to an inquiry.

6. The decision of the DO is final.7. If a complaint is dismissed under this policy, but any allegation within the complaint constitutes a valid

grievance under other university policies or rules, the RIO will refer the relevant portions of the complaint to the appropriate university authority or direct the complainant(s) to the appropriate university authority.

L. Complaints (or allegations) indicating possible research misconduct1. If the RIO and dean determine that any allegation within a complaint fits within the definition of research

misconduct in this policy and is sufficiently credible and specific so that potential evidence of research misconduct may be identified, the RIO will condense the complaint to the specific written allegation(s). Any specific allegation within a complaint that does not fit within the definition of research misconduct in this policy or is not sufficiently credible or specific so that potential evidence of research misconduct may be identified, will be dismissed.

2. The RIO and dean will meet with, and provide to, the respondent(s) the following:a. The written allegation(s) and notice that the allegation(s) will be reviewed in an inquiry.b. The policy for handling allegations detailed herein, including the duty to cooperate, confidentiality of

the process, and obligation to provide relevant evidence during the process.c. Information regarding consulting personal legal counsel or other appropriate advisors.

i. The respondent(s) will be informed that university counsel serves as an advisor to the university and cannot render advice to the respondent(s), but that the respondent(s) may obtain their own legal advisor at any time during the proceedings established by this policy.

ii. The respondent(s) will be informed that any person, including other university personnel, can act as an advisor as long as that person’s university position does not have any formal role in the process.

II. InquiryA. If the determination under Procedures I.L of this policy is that any allegation in a complaint indicates possible

research misconduct, an inquiry will be initiated. The purpose of the inquiry is to conduct preliminary information gathering and fact-finding to determine if an allegation has substance to warrant an investigation.

B. The DO delegates the authority to conduct an inquiry to the RIO and staff in the Office of Research Compliance, in consultation with an appropriate subject matter expert from the research integrity standing committee (RISC), as needed. See Research Integrity Standing Committee Standard Operating Procedures . If the RIO determines that the complexity of the complaint requires additional expertise, additional consultants outside of the RISC may be used to aid in performing the inquiry.

C. To the extent it has not already been done, the respondent(s) and complainant(s), if known, will be provided with written notification that an inquiry is being initiated.

D. The RIO will inform the respondent(s) in writing of the name of any expert(s) who might assist the RIO with the inquiry.1. The respondent(s) may, within seven (7) days of receiving the names of the expert(s), file a written

objection with the RIO. Such objection may be made on the grounds of a lack of the requisite expertise or possible conflicts of interest of the experts.

2. The RIO will rule on potential conflicts of interest and, if they are found to have merit, new experts will be identified to avoid the problem.

E. If not already done, the RIO will ensure that all relevant research records have been properly sequestered before or immediately after notifying the respondent(s). See Sequestration & Retention of Records Standard Operating Procedures.

F. The RIO, in consultation with any expert(s), will collect and review evidence that supports or refutes the allegation(s) and determine if each allegation has substance to warrant an investigation. An allegation with insufficient substance to warrant an investigation will be dismissed.

The Ohio State University – University Policies policies.osu.edu Page 9 of 16

G. The RIO, and the expert as needed, will formally interview the respondent(s) and any other individual having relevant information with the objective of determining whether each allegation has substance.1. The respondent(s) does not have the right to be present at interviews of witnesses or to question such

witnesses at this, or any stage, of the research misconduct proceeding.2. The respondent(s) may be accompanied by legal counsel or other advisor when interviewed, but the role

of counsel or advisor in the process is limited to advising the respondent(s). The counsel or advisor must not be a university representative with any role, or involvement in, the university’s research misconduct or disciplinary processes.

H. The respondent(s) may submit any relevant evidence for consideration by the RIO and any expert. The respondent(s) must be furnished with, or have access to, copies of all documentary evidence.

I. Scope of the inquiry1. During the inquiry, additional new allegations may arise that justify broadening the scope of the inquiry

beyond the initial complaint. See Additional Allegation Intake Standard Operating Procedures .2. The RIO, will determine whether a new allegation relates to an ongoing inquiry. The RIO, in consultation

with the expert as needed, will determine whether the new allegation is specific and credible so that potential evidence of research misconduct may be identified and whether the allegation has substance to warrant an investigation. If the new allegation is not specific and credible, the allegation will be dismissed.

3. If the new allegation involves one or more new respondents related to the ongoing inquiry, the RIO will notify the new respondent about the allegation(s) in writing, sequester additional data if necessary, and determine whether the allegation(s) will be reviewed in the ongoing inquiry.

J. Time for completion1. The inquiry should be completed within sixty (60) days of its initiation, unless circumstances warrant a

longer period as determined by the RIO, with the approval from the relevant oversight agency or funding entity, as necessary.

K. Preliminary and final inquiry reports1. When the RIO and expert have reached a conclusion as to whether or not each allegation has sufficient

substance to warrant an investigation, the RIO will prepare a preliminary inquiry report.2. The preliminary inquiry report must set forth:

a. The names and positions of the respondent(s) and complainant(s);b. A description of the allegation(s) and a description of any known federal research support;c. The names, titles, and positions of any expert and any non-voting consultants;d. Interviews (transcripts or excerpts from interviews) that are relevant to each specific allegation;e. The basis and documentary evidence for the final determination that each allegation has, or does not

have, sufficient substance to warrant an investigation; andf. The reasons for exceeding the sixty (60) days to complete the inquiry, if necessary.

3. The respondent(s) must be provided with the preliminary inquiry report with all documentary evidence for comment. The complainant(s) may be provided with the relevant sections of the preliminary inquiry report specific to their allegation(s), or written notice of the inquiry outcome. See Respondent & Complainant Standard Operating Procedures .

4. Within fourteen (14) days of receiving the preliminary inquiry report, the respondent(s) and complainant(s) may file a written response for consideration by the RIO and any expert. The written response will be reviewed and a final decision made, normally within fourteen (14) days of receiving the response. The preliminary inquiry report will be revised to include the final decision based on a review of the respondent’s and complainant’s responses, if any.

5. The final inquiry report, including the revised inquiry report and the written response from the respondent(s) and complainant(s), will be forwarded by the RIO to the respondent(s) and the DO. Relevant sections of the final inquiry report, or written notice of the inquiry outcome, may be provided to the complainant(s).

6. The decision of the inquiry may be appealed and must be based on new information not already considered during the inquiry, or evidence that a substantial procedural irregularity occurred during the inquiry.a. The respondent(s) may appeal to the DO within seven (7) days of receiving the final inquiry report

only if the decision is that any allegation in a complaint has sufficient substance to warrant an investigation.

The Ohio State University – University Policies policies.osu.edu Page 10 of 16

b. The complainant(s) may appeal to the DO within seven (7) days of receiving the final inquiry report only if the decision is that the totality of the complaint has insufficient substance to warrant an investigation.

L. DO review1. Within seven (7) days of receiving the final inquiry report and any appeal from the respondent(s) or

complainant(s), the DO will review and rule on the decision of the inquiry. 2. If the DO affirms the decision of the inquiry that the allegation(s) has sufficient substance, and denies any

appeal from the respondent(s), the RIO will refer the complaint, the final inquiry report, and all documentary evidence to the investigation committee (IC). The RIO will provide a written notice of the final determination to the respondent(s) and complainant(s).

3. If the DO does not agree with the decision of the inquiry, the DO may not reverse the decision, but may refer the matter back to the RIO and any expert for reconsideration. Such reconsideration will normally be completed within fourteen (14) days of the DO’s decision.a. Following reconsideration, if the DO still does not concur with the decision of the inquiry, an

investigation will be initiated if the decision, from either the inquiry or the DO, is that any allegation has substance to warrant further investigation.

b. The RIO will provide a written notice of the final determination following reconsideration to the respondent(s) and complainant(s).

4. If the entire complaint is dismissed but recommendations for corrective actions for other concerns were identified during the inquiry, such action will be referred to the appropriate university authority.

5. If the final decision from the inquiry is that an investigation is warranted, the RIO will inform any cognizant oversight agency or funding entity of the allegations, as required by contract or law, and will keep the oversight agency or funding entity informed as required.

III. InvestigationA. The purpose of the investigation is to determine whether each allegation constitutes research misconduct at

the preponderance of the evidence standard and to recommend the appropriate corrective actions or sanctions.B. To the extent that it has not been done at the preliminary assessment or inquiry stages, the RIO will obtain

custody of, and sequester in a secure manner, all research records that have become known and are relevant to the investigation.

C. The DO will delegate the authority to form an investigation committee (IC) to the RIO, in consultation with the DO and relevant college dean(s).1. The IC will have a minimum of three (3) voting members selected from the research integrity standing

committee (RISC). 2. The IC will have the appropriate expertise to ensure a thorough evaluation of the evidence. The IC may

include non-voting consultants with the appropriate expertise to aid the IC in evaluating the evidence and/or recommending appropriate corrective actions or sanctions.

3. The IC will select a committee chair.4. The RIO will inform the respondent(s) in writing of the names of those appointed as IC members and as

consultants.5. The respondent(s) may, within seven (7) days of receiving the names of IC members, file a written

objection with the RIO. Such objection may only be made on the grounds of a lack of the requisite expertise or possible conflicts of interest of IC members. The RIO will rule on the objection and, if it has merit, the IC will be reconstituted to avoid the problem.

D. Investigations will include the following elements.1. The IC will examine all the documentation and conduct formal interviews, when possible, of the

respondent(s), the complainant(s), and others who may have information concerning relevant information in the complaint.

2. Investigation interviews will be recorded and transcribed. A copy of transcribed interviews will be provided to those interviewed to ensure accuracy and will be included in the investigation file.

3. The IC will investigate all complaints of research misconduct regardless of the position of a respondent(s) (faculty, postdoctoral fellow, graduate student, undergraduate student, staff, or other). If there is more than one (1) respondent involved in a complaint, the IC will make separate determinations as to whether research misconduct occurred for each respondent and separate recommendations of corrective actions or sanctions for each respondent.

The Ohio State University – University Policies policies.osu.edu Page 11 of 16

4. The IC will determine by majority vote whether each allegation constitutes research misconduct at the preponderance of the evidence standard. A tie vote will indicate that the allegation fails to meet the preponderance of the evidence standard for a finding of research misconduct.

5. After the determination that research misconduct occurred or did not occur, the IC will make a recommendation for the appropriate corrective actions or sanctions, including any correction of the research record.

E. Scope of the investigation1. During the investigation, additional new allegations may arise that justify broadening the scope of the

investigation beyond the initial complaint. See Additional Allegation Intake Standard Operating Procedures.

2. The RIO will assess whether a new allegation meets the definition of research misconduct and if it is specific and credible so that potential evidence of research misconduct may be identified.

3. If the RIO determines that a new allegation relates to an ongoing investigation, the RIO will notify the respondent(s), and the sitting IC will determine by majority vote whether each new allegation constitutes research misconduct at the preponderance of the evidence standard.

4. If the RIO determines that a new allegation relates to an ongoing investigation, but the allegation arises after the IC has determined that research misconduct has occurred, or arises after an investigation is concluded with research misconduct findings, the RIO in consultation with the IC chair and the DO, will review each new allegation for substance and determine the appropriate actions.

5. If a new allegation related to an ongoing investigation identifies one or more new respondents, the RIO will notify each new respondent about the allegation(s), sequester additional data if necessary, and determine whether the allegation(s) will be reviewed in the ongoing investigation. See Additional Allegation Intake Standard Operating Procedures .

F. Time requirements1. The investigation will commence within 30 days after the completion of an inquiry that determines an

investigation is warranted.2. The investigation will conclude within 120 days of its initiation, unless circumstances warrant a longer

period as determined by the RIO, with the approval from the relevant oversight agency or funding entity as required by federal law.

3. If an investigation cannot be completed within the 120 day period, the RIO will submit a written request for an extension to the relevant oversight agency or funding entity, if required to do so by law or contract, explaining the reasons for delay and the progress of the investigation.

G. Preliminary and final investigation reports1. When the IC has reached a conclusion as to whether or not each allegation constitutes research

misconduct, it will prepare a preliminary investigation report.2. A preliminary investigation report must include the following:

a. A description of the allegations of research misconduct;b. A description of any federal or other funding support;c. The name of the respondent(s) and complainant(s), or list as anonymous;d. The names, titles, and positions of the IC members and any non-voting consultants;e. A list of the relevant documentary evidence and interview transcripts;f. A statement of the findings, the conclusions reached, and the recommended corrective actions and/or

sanctions.3. The preliminary investigation report with documentary evidence will be provided to the respondent(s) for

comment and to the DO.a. The respondent(s) will have fourteen (14) days from receipt of the preliminary investigation report to

provide written comments to the IC.b. The IC will review the comments and, if necessary, revise the preliminary investigation report.

4. The IC chair will forward a final investigation report to the DO and the respondent(s). Any written comments from the respondent(s) will be appended to the report.

5. Within seven (7) days, the respondent(s) may appeal the IC decision that research misconduct occurred to the DO. The appeal must be based on new information not already considered during the investigation, or evidence that a substantial procedural irregularity occurred during the investigation.

H. DO decision1. The DO will review the final investigation report and appeal, if any, and provide written notice of their

decision regarding research misconduct to the RIO and to the respondent(s).

The Ohio State University – University Policies policies.osu.edu Page 12 of 16

2. If the respondent files an appeal, and the DO denies that appeal, all research misconduct findings are final. The RIO will forward the DO’s decision, the final investigation report, and the documentary evidence to the appropriate disciplinary body to administer corrective actions or sanctions as outlined in Policy Details XII.D.

3. If the DO concurs with an appeal by the respondent and/or does not concur with the IC’s determination and/or the recommended corrective actions or sanctions, the RIO will forward the DO’s decision, the final investigation report, and the documentary evidence to the executive vice president and provost, or their designee, for a final written determination.

I. The RIO will forward the notice of institutional determination and actions along with the final investigation report and documentary evidence to the relevant oversight agency or funding entity, as required by law or contract.

J. The RIO will notify the complainant(s) of the final outcome of the investigation.

IV. Admissions and Resolution with RespondentA. At any stage of the proceedings under this policy, and consistent with the requirements of the relevant

oversight agency or funding entity, the RIO may attempt to resolve a complaint. At the initiation of the resolution process, the university and the respondent will agree to terminate the research misconduct proceedings with an admission to the research misconduct, or the respondent will accept the findings of research misconduct without an admission.

B. In a resolution, the respondent must accept any and all actions the university deems appropriate as a result of the research misconduct, including but not limited to referral to other university disciplinary processes or retraction of published papers. See Admissions & Resolutions Standard Operating Procedures .

C. The RIO will work with the respondent and/or the supervisor of the respondent to thoroughly review the respondent’s research record to identify any other potential research misconduct.

D. The RIO will provide the respondent with a written document listing the full scope of research misconduct findings. A resolution with the respondent may be reached only if the respondent admits to, or accepts the findings of, the full scope of the research misconduct.

E. The RIO will inform the relevant oversight agency or funding entity, as required by law or contract, of the full scope of the research misconduct identified. A resolution with the respondent may be reached only if the relevant oversight agency concurs with terminating the research misconduct proceeding.

F. The RIO will prepare a written document including the admission, the research misconduct findings, any known federal funding, the procedures that occurred up to the point of resolution, and any recommended actions the university deems appropriate. The written document will be provided to the DO for concurrence. 1. If an admission occurs during the preliminary assessment, the RIO will work with the dean of the

respondent’s college. 2. If an admission occurs during an inquiry or investigation, the RIO will work with the sitting committee.

G. In instances where a resolution cannot be reached with the respondent, or where resolution is not approved by the DO and/or the oversight agency, the research misconduct proceedings will proceed through preliminary assessment, inquiry and investigation, as necessary.

Responsibilities Position or Office Responsibilities

This table will be completed after university feedback has been received and integrated.

Resources Governance Documents

42 C.F.R. Part 93, Public Health Service Policies on Research Misconduct; Final Rule ori.hhs.gov/sites/default/files/42_cfr_parts_50_and_93_2005.pdfCode of Student Conduct, trustees.osu.edu/sites/default/files/documents/2019/03/CodeStudentConduct.pdfCorrective Action and Involuntary Termination policy 8.15, hr.osu.edu/wp-content/uploads/policy815.pdfGeneral Records Retention Schedule, library.osu.edu/osu-records-management/retention-schedulesGraduate School Handbook, gradsch.osu.edu/handbook

The Ohio State University – University Policies policies.osu.edu Page 13 of 16

Office of Research Records Retention and Disposition Schedule, orc.osu.edu/files/ORrecordsretention.pdfResearch Data policy, orc.osu.edu/files/ResearchDataPolicy.pdf Research Misconduct Standard Operating Procedures, [link to be added]

Additional Allegation IntakeAdmissions & ResolutionsConflict of Interest (COI) Screening Referral of Allegations Research Integrity Standing Committee (RISC)Respondent & ComplainantSequestration & Retention of RecordsSix-Year Time Limitation & the Subsequent Use Exception

Rules of the University Faculty, Chapter 3335-5-04 Hearing procedures for complaints against faculty members; trustees.osu.edu/university-faculty-rules/3335-5;Rules of the University Faculty, Chapter 3333-13-08 Research Misconduct, trustees.osu.edu/university-faculty-rules/3335-13Student Employment policy 10.10, hr.osu.edu/wp-content/uploads/policy1010.pdf

Contacts Subject Office Telephone E-mail/URLPolicy questions or to file a complaint Office of Research

Compliance614-292-9258 ResearchIntegrity@osu.edu

To file an anonymous complaint Anonymous Reporting Line 866-294-9350 ohio-state.ethicspoint.com

HistoryIssued: 05/29/2008Revised: 02/16/2021 (target effective date)

The Ohio State University – University Policies policies.osu.edu Page 14 of 16

Research Misconduct Standard Operating Procedures

Office of Research

These Standard Operating Procedures (SOPs) support the implementation of the university’s Research Misconduct policy. These SOPs are designed to be read and followed in conjunction with the Research Misconduct policy.

All individuals and units involved in research misconduct proceedings must comply with these SOPs.

Referral of Allegations – Standard Operating Procedures

I. Policy Authority and Requirement

The Office of Science and Technology Policy on Research Misconduct (Federal Register V 65, No, 235, December 6, 2000, pgs. 76260-76264), Section III - “Responsibilities of Federal Agencies and Research Institutions states:

Agencies and research institutions are partners who share responsibility for the research process. Federal agencies have ultimate oversight authority for Federally funded research, but research institutions bear primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with their own institution.

The Preamble section “What criteria will be used for selecting the research institution that will handle the response to the allegation of research misconduct?” states:

In most cases, agencies will rely on the researcher’s home institution to respond to allegations of research misconduct. However, in cases where the subject has switched institutions, it may be more appropriate for the institution where the alleged research misconduct occurred to respond to the allegation. The institution where the questioned research was conducted may have better access to the evidence and witnesses and therefore will have the capability to undertake a more efficient and thorough response.

The Ohio State University’s authority and jurisdiction as the ‘home institution’ for allegations of possible research misconduct and the requirement to refer allegations not under the University’s jurisdiction derive directly from the federal provisions above. The Research Misconduct policy (the “Policy”) Procedures I. J. states:

J. Complaints (or allegations) outside the jurisdiction of the university 1. The university’s jurisdiction encompasses allegations related to all research conducted while a

respondent was under the oversight of the university. The university does not have jurisdiction over allegations related to research conducted at another university.

2. If the RIO finds that a complaint, or any allegation within the complaint, is not under the jurisdiction of the university, the RIO will refer the complaint (or allegations) to the appropriate office at the home institution.

3. The RIO may consult with all pertinent institutional officials to determine whether the research was conducted at the university, including but not limited to the dean of the relevant college, the chair of the relevant department, the Office of Human Resources, the Graduate School, and/or the Office of Sponsored Programs.

Page 1 of 20

Research Misconduct Standard Operating Procedures

Office of Research

II. Referral of allegations within the University

Complaints (or allegations) obtained during the intake of an allegation, preliminary assessment, inquiry, and/or investigation may not meet the definition of research misconduct, but rather may constitute a valid complaint under other University rules or policies.

Examples of such complaints include, but are not limited to, authorship disputes, patent application and inventorship disputes, poor mentorship issues, the protection of human subjects, the use and care of laboratory animals, the use and care of hazardous substances, conflicts of interest, and other external professional activities.

In such cases, as required under the Policy Details I.G., the RIO shall be responsible for referring the complaint to the appropriate University authority for consideration under applicable university policy and shall work with such authorities to coordinate the handling of the matter, as necessary.

III. Referral of allegations of possible research misconduct or other matters to external entities

The University’s jurisdiction includes the handling of allegations related to research conducted while the respondent(s) was under the oversight of the University. The University does not have jurisdiction over allegations related to research conducted at another University or Institution. The RIO will refer all complaints (or allegations) that are not under the jurisdiction of the University to the appropriate office at the home institution of a named Respondent as required under the Policy Details III.C.10. The RIO may consult confidentially with all other institutional officials to determine whether the research was conducted at the University.

IV. Referral of allegations to external entities without a named Respondent

Allegations of Research Misconduct may be raised by external, and often anonymous, Complainants, who do not identify a specific Respondent. Upon receipt of such allegations that are related to a published paper without a named Respondent, if the author affiliation does not list Ohio State for any author, the RIO will refer the complaint to the home institution of the listed corresponding author.

If the publication lists author affiliation with multiple Universities, including Ohio State, the RIO will take the following steps:

1. Identify any author(s) listing affiliation with Ohio State and determine the role of that person in the questioned research. If the Ohio State author did play a role in the questioned research, the RIO will work with the home institution to obtain access to the research records related to the alleged misconduct, if they are no longer at the University.

2. If the Ohio State author did not play a role in the questioned research, the RIO will refer the matter to the home institution with the information obtained.

3. If the first and/or corresponding authors on the paper do not have affiliation with Ohio State and list the same home institution, the RIO will refer the allegation(s) to the home institution of these authors.

4. If the first and/or corresponding authors on the paper do not have affiliation with Ohio State and list different home institutions, the RIO will refer the allegation(s) to the home institution of the corresponding author, with a request for that institution to coordinate with the home institution of the first author, as necessary.

Page 2 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Conflicts of Interest (COI) Screening – Standard Operating Procedures

I. Regulatory and Policy Authority and Requirement

The Public Health Service (PHS) Policies on Research Misconduct, 42 C.F.R. Part 93 (the “PHS Policies”), require institutions to include protections against conflicts of interest on the part of those involved in any stage of a research misconduct proceeding. Specifically, various sections of 42 C.F.R. Part 93 include statements to ensure institutions avoid conflicts of interest, as follows:

§ 93.300 General responsibilities for compliance. Institutions under this part must—(b) Respond to each allegation of research misconduct for which the institution is responsible under this part in a thorough, competent, objective and fair manner, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional or financial conflicts of interest with the complainant, respondent or witnesses;

§ 93.304 Institutional policies and procedures. Institutions seeking an approved assurance must have written policies and procedures for addressing research misconduct that include the following— (b) A thorough, competent, objective, and fair response to allegations of research misconduct consistent with and within the time limits of this part, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional, or financial conflicts of interest with the complainant, respondent, or witnesses;

§ 93.310 Institutional investigation. Institutions conducting research misconduct investigations must: (f) Ensuring a fair investigation. Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, including participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry or investigation.

The Research Misconduct policy (the “Policy”), Policy Details VII. A, defines conflicts of interest as follows:

A. Conflicts of interest in research misconduct proceedings exist when the proceedings and the resolution of the allegations may be affected, such that an independent observer might reasonably question the bias or objectivity of the individuals involved in the proceedings. Perceived or actual conflicts of interest are treated identically under this policy.

The Policy, Procedures II. D and III. C.5, allow a Respondent to object to the individuals involved in the Inquiry or to the membership of the Investigation Committee (IC) and such objection must be based on the grounds of a lack of the requisite expertise or possible conflicts of interest. At all stages of a research misconduct proceeding, all persons involved shall be vigilant to prevent any real or perceived conflicts of interest, or personal conflicts or relationships between colleagues, from affecting the outcome of the proceedings and resolution of the allegations.

II. Evaluation of Conflicts of Interest

Page 3 of 20

Research Misconduct Standard Operating Procedures

Office of Research

The Research Integrity Officer (RIO) has the responsibility and authority to evaluate all conflicts of interest, including those that may be perceived by a reasonable person to constitute a conflict of interest. The RIO will perform an initial screening for any potential conflicts of interest that may exist between the Respondent(s) or Complainant(s) in a Research Misconduct matter and all potential individuals that may participate in an Inquiry or Investigation. The RIO will also screen for potential conflicts of interest between the Respondent(s) or Complainant(s) with institutional officials involved in the proceedings, which may include the RIO, Counsel, Department Chair, College Dean, Senior Vice President for Research (SVPR), and the Provost.

Under the Policy Details VII. A.1 and A.2, possible conflicts of interest may include, but are not limited to, co-authorship of work with the Respondent or Complainant, or professional or personal relationships with the Respondent or Complainant beyond that of mere friends or colleagues (e.g., current or former student or mentor, direct supervisory or subordinate job relationship, or marital/partner relationship). The subordinate relationship of a respondent or complainant to their dean or chair alone does not constitute a perceived or actual conflict of interest under this Policy. The RIO will screen for conflicts of interests as follows:

1. Perform an OSU search of the potential committee member or institutional official, generally reading their departmental pages, bios, etc. for any similarities in research interests, etc. to the Complainant or Respondent.

2. Perform an OSU website search combining the names of the potential committee member or institutional official and respondent(s) or complainant(s). Investigate any hits and look for any meaningful collaborations, publications, supervisory or advisory relationships, etc.

3. Perform a Google search of the potential committee member or institutional official and respondent(s) or complainant(s). Investigate any hits for meaningful collaborations, publications, prior employment overlaps, supervisory or advisory relationships.

4. Perform an OSU PI Portal search. Use the “Set PI” function to look up each potential committee member and institutional official for any sponsored projects in common with the respondent(s) or complainant(s) if applicable. From the main page, look for any co-investigators named on each project. Click on the title of each project, then the “Personnel” tab to check for any naming of or payment to the respondent(s) or complainant(s).

5. If a graduate student’s thesis is involved, query the OSU Library system for the thesis to identify the dissertation committee members, graduate faculty representative and/or any acknowledgments that might be linked to the potential committee member or institutional official

6. The RIO will complete a Conflict of Interest Screening Form (link to be added) to include with the case file.

7. When the initial screening for conflicts of interest are complete, the RIO will question all potential participants in the Inquiry or Investigation about potential conflicts with any involved parties.

8. The RIO has the authority to rule on potential conflicts of interest. Conflicts will be resolved as follows:a. If a participant in the Inquiry or Investigation has a conflict, the RIO will designate a replacement to

avoid the problemb. The DO will designate a replacement for a conflict identified with the dean, department chair, or the

RIO. c. The president of the university will designate a replacement for a conflict identified with the senior

vice president for research or the executive vice president for academic affairs and provost.

Page 4 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Sequestration and Retention of Records – Standard Operating Procedures

I. Regulatory and Policy Authority and Requirement

The PHS Policies on Research Misconduct (42 C.F.R. Part 93) require an institution to identify, sequester, and protect evidence pertinent to the review of an allegation of Research Misconduct in a timely manner. The federal regulation 42 C.F.R. §93.305 states:

Responsibility for maintenance and custody of research records and evidence. An institution, as the responsible legal entity for the PHS supported research, has a continuing obligation under this part to ensure that it maintains adequate records for a research misconduct proceeding. The institution must—

(a) Either before or when the institution notifies the respondent of the allegation, inquiry or investigation, promptly 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 them in a secure manner, except that 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;

(b) Where appropriate, give the respondent copies of, or reasonable, supervised access to the research records;

(c) Undertake all reasonable and practical efforts to take custody of additional research records or evidence that is discovered during the course of a research misconduct proceeding, except that 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; and

(d) Maintain the research records and evidence as required by §93.317.

The federal regulation states that for an institutional inquiry, 42 C.F.R. §93.307(3)(b), that on or before the date on which the respondent is notified or the inquiry begins, whichever is earlier, the institution must promptly take all reasonable and practical steps to obtain custody of all the research records; and for an institutional investigation, 42 C.F.R. §93.310(d), to the extent the institution has not already done so at the allegation or inquiry stages, take all reasonable and practical steps to obtain custody of all the research records including whenever additional items become known or relevant to the investigation.

Under Research Misconduct policy (the “Policy”), Policy Details III.C.1, and Procedures I.H., II.C, and III.B, the Research Integrity Officer (RIO) has the responsibility and authority to sequester any relevant evidence at the earliest opportunity in a research misconduct proceeding; the RIO shall take immediate action to sequester all data or other materials relevant to the complaint, on or before the date on which the respondent(s) is notified of the allegation(s), and shall obtain custody of, and sequester in a secure manner, all research records that have become known and are relevant to the investigation.

Under the Policy, Research Record is defined as:Any data or results, in any media or format, which embodies the information resulting from research. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records;

Page 5 of 20

Research Misconduct Standard Operating Procedures

Office of Research

animal facility records; human and animal subject protocols; medical charts, patient research files; computer code; musical scores, musical composition; choreography; etc.

Basic assumptions and core principles when preparing for sequestration of research records are: In the absence of information identifying the specific respondent(s), the corresponding author of any

questioned manuscript or publication is considered the putative Respondent. The first author is also typically considered a putative Respondent.

For grant proposals, the PI, as defined on the PA-005 and/or designated in the grant proposal is considered the putative Respondent.

A primary goal in the meeting to notify a putative Respondent(s) about the allegation(s) is to determine the responsibility of the Respondent(s) for each specific allegation.

Sequestration should encompass all email, electronic and physical records relevant to allegation(s). The practice of the Ohio State Office of Research Compliance (ORC) is that when there is doubt,

sequester broadly. Any sequestered data that is subsequently determined to be unrelated to the allegation(s) may be returned to the Respondent(s).

Should new allegations or identification of Respondents necessitate the sequestration of additional materials, email accounts, etc., steps will be taken to do so as soon as possible according the procedures in this SOP.

II. Sequestration

Email sequestration

Sequestration of Email is handled separately from sequestration of other types of electronic research records. University E-Mail Services and/or Medical Center Information Technology (IT) control email services and the contents of the sequestered email account(s) are transferred to ORC, under specific conditions listed below.

Prior to Respondent’s notification of allegations: When the Respondent(s) are identified, the RIO will send a notification email to Senior Associate

General Counsel, Office of Legal Affairs, the Associate Vice President and Deputy General Counsel, Legal Affairs, and Assistant Vice President for Compliance Operations and Investigations, OUCI. The email will state that the university received an allegation of possible research misconduct and will request that a litigation hold be put on each Respondent’s email account. The request will state that the hold be done without notification to the Respondent.

In the absence of specific information naming a Respondent, litigation holds will be placed as broadly as needed (e.g., all Ohio State authors listed on a questioned manuscript or publication). The litigation holds are done in the background and have no impact on the individuals. When specific Respondents are identified, unnecessary holds can be lifted.

Subsequent to the Respondent’s notification of allegations: If a committee requests access to specific emails, the RIO will make the request through the Office of

Legal Affairs/OUCI for the specific email that the Committee requires, usually by time frame, and will provide potential search terms and a justification for what is being requested. Searches will be approved by Legal Affairs/OUCI and will be conducted by University Email Services/Medical Center IT.

If emails contain protected health information (PHI) or other HIPAA protected information they will be screened for PHI by the Medical Center Privacy officer prior to release to the committee.

Electronic file sequestration (non-email based)

Prior to Respondent’s notification of allegation(s):

Page 6 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Based on the allegation(s), the RIO and ORC staff will assess the specific electronic data to sequester, the likely format of the data, and how it will be stored.

The RIO and ORC staff will contact the local college or department IT to determine how many and what types of computer systems, file servers, networked laboratory machines, etc., the Respondent(s) uses.

The RIO and ORC staff, in conjunction with local IT, will determine what electronic files can be forensically imaged in the background prior to notifying the Respondent(s) of the allegation(s).

The RIO and ORC staff with local IT will establish and initiate a plan to capture all available electronic images prior to Respondent’s notification – if it can be done silently in the background.

The RIO and ORC staff with local IT will determine if any cloud based services may hold relevant data and whether it is possible to access relevant files (university hosted verses external vendor).

The Office of Research Information Systems (ORIS) will assist in the process of obtaining electronic data for offices that do not have expertise in forensic imaging.

Coincident with or immediately after Respondent’s notification of allegations: As appropriate, the RIO will arrange for local IT and ORIS to assist with electronic records capture

subsequent to meeting with the Respondent. The local IT and ORIS will do the following:

o Make forensic images of any computer system that could not be remotely imaged before meeting with the Respondent. This may include laptops, stand-alone analytical machines, or other systems not connected to the network;

o Pull hard drives for imaging – note location, machine #, serial number, equipment tag #, take a photo of system in situ;

o When necessary, sequester entire system (e.g., laptops, Macs) – note location, machine #, serial number, equipment tag #;

o Have IT support capture data from lab machines where drives cannot be removed (e.g., those running lab instruments);

o Determine encryption status on all systems, may need users to provide decryption keys. Forensic images should be taken using Encase or equivalent programs. If forensic copies cannot be

made by the local IT, the hard drive will be removed and a forensic copy will be made by ORIS. For personally owned computer systems containing university data:

o Those owned by students, need a consent form signed for imaging their personal computer (see "Consent to Image or Access Research Records" [link to be updated]).

o For those owned by Faculty no consent form is needed prior to imaging. ORIS will make a cloned image of each hard drive image in addition to Forensic Image for use by

RIO/Committee during inquiry/investigation. o Evidence/Chain of Custody tags attached to the cloned image drives are signed and dated to

document the sequence of custody following the initial generation of cloned images. o As needed, a Custody Form is may be completed when the use of the cloned image is required

(see Custody Form/Data Transfer 2020 [link to be added]).

Physical file/materials sequestration

Prior to Respondent’s notification of allegations: The RIO(s) will determine what physical evidence needs to be sequestered and any special storage

requirements that might be needed (e.g., freezer, refrigerator, protected from light, biohazardous, radioactive, strong odor).

Identify and acquire appropriate secure storage based on any special needs. Determine the different locations where evidence may be found (e.g., office spaces, lab spaces, core

facilities). If multiple sites are involved, plan for parallel or sequential sequestration processes and coordinate with the College for assistance.

Page 7 of 20

Research Misconduct Standard Operating Procedures

Office of Research

If possible, try to arrange sequestration during a time that minimizes the presence of extraneous people.

Coincident with or immediately following Respondent’s notification of allegations: The RIO(s) will go with Respondent directly to all locations identified as having physical evidence.

There should be at least two people present during all phases of sequestration and copying of evidence (ORC, IT, other administrative personnel)

The Respondent will be asked to identify all physical evidence (lab notebooks, documents, any kind of physical record, slides, x-ray films, blots, etc.) related to the allegations.

Good practices for the RIO(s) identifying and collecting physical files are, if possible, to:o take a picture of the materials in situ;o log what the item is with brief description;o log where the item was located (e.g., lab room #, bay #, desk of X, top shelf);o try to keep materials for each Respondent or possible witnesses separate from each other.

If a general sequestration sheet is generated while the RIO(s) is with the Respondent, the Respondent signs the sheet. Once initial sequestration is complete, the RIO creates a detailed data sequestration log (see "Data Sequestration Sheet" [link to be updated]) listing all the materials sequestered; this is usually performed in ORC offices. The RIO sends an email with a copy of the catalogued Data Sequestration log to the Respondent(s) as a receipt of their records.

Items/Equipment needed to support sequestration activities:o Chain of custody formso Hard drives/Thumb driveso Boxeso Evidence bagso Digital camerao Audio recordero Anti-static bags for electronicso Notebook for logging intake

ORC will make high quality copies of any materials required by the Respondent to continue their work. Copies are usually provided within 24 hours but large requests require more time.

III. Retention

Physical file/materials retention

Immediately upon sequestration and for the duration of a case, physical materials will be retained in a double-locked, limited-access fashion at the Research Administration Building, 1960 Kenny Road, Columbus, Ohio.

Contents of the sequestered material will be documented by ORC staff on the ORC Records Inventory Spreadsheet.

Any and all entry into the secured storage location will be tracked via the Sequestered Data Access Log located within the storage unit. Specific information to be recorded includes:o Date In/Outo Time In/Outo Nameo Signatureo Reason for entry/Case nameo Whether or not evidence was removed. If yes, identify and complete (see Custody Form/Data

Transfer 2020 [link to be added]).

Page 8 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Page 9 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Access to sequestered materials Access to sequestered materials may be provided to the investigative bodies looking into the complaint

and to any other person who has a legitimate reason related to the university process to require access (e.g. Legal Affairs). o Removal of materials from local, secured ORC storage will be documented by ORC staff on the

Sequestered Data Access Log. o Materials may be signed in/out of ORC secured storage (see Custody Form/Data Transfer 2020

[link to be added]).) and will be returned immediately upon request or at a predetermined date. o Materials that have been signed out must remain in a locked secure location when not in use by the

person who signed them out. Supervised access to any physical, sequestered material shall be provided to the respondent(s), and to

any other person who requires access, as determined by the RIO to have a legitimate reason related to the university process (ex., the Complainant).o Requests for data review must be submitted with appropriate notice to ORC. Date and time of data

review are to be coordinated between and mutually agreeable to ORC and requesting party. o Removal of materials from local, secured ORC storage will be documented by ORC staff on the

Sequestered Data Access Log. o An ORC staff member must be present with the sequestered materials at all times during the

supervised review. o As required, ORC will make high quality copies of any materials for the Respondent. Copies are

usually provided within 24 hours but large requests require more time.

Long-term storage Once a case has closed, physical materials will be transferred to long-term storage (currently located at

2650 Kenny Road) per the Office of Research Records Retention and Disposition Schedule. Transfer to long-term storage will be documented by ORC staff on the ORC Records Inventory

spreadsheet. A File Storage Index Form will be completed with one physical copy accompanying each box sent to long-term storage and an electronic copy filed with ORC.

Page 10 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Six-Year Time Limitation & the Subsequent Use Exception – Standard Operating Procedures

The Public Health Service Policies on Research Misconduct, 42 C.F.R. Part 93, apply a time limitation for allegations of research misconduct that occurred outside six years from the date HHS or an institution receives an allegation of research misconduct. The federal regulations provide an exception at 42 C.F.R §93.105(b)(1) for those allegations that fall outside of the six-year time limitation as follows:

(b) Exceptions to the six-year limitation. Paragraph (a) of this section does not apply in the following instances:

(1) Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the citation, republication or other use for the potential benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized.

Consistent with 42 C.F.R Part 93, the Research Misconduct policy, (the “Policy”), Policy Details X. states:

V. Time Limitations and Subsequent UseA. This policy applies only to allegations of research misconduct occurring within six years of the date

the university, oversight agency, or funding entity receives an allegation of research misconduct. Exceptions to the six-year limitation include the following:1. Subsequent use exception. The respondent continues or renews any incident of alleged

research misconduct that occurred before the six-year limitation through the citation, republication, or other use for the benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized. See Six-Year Time Limitation & the Subsequent Use Exception Standard Operating Procedures.

2. Health or safety of the public exception. If the university, following consultation with the federal oversight agency or funding entity, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.

The University has jurisdiction over all allegations of research misconduct that occur within six years of the date that the institution receives the allegation. Upon receipt of research misconduct allegations that fall outside of the six-year time limitation for a named Respondent, the Office of Research Compliance (ORC) will review each allegation for ‘Subsequent Use’ by determining if the named respondent cites, republishes, or uses the allegedly falsified, fabricated or plagiarized research record within six years of the date that the allegation was received by the Institution.

To determine Subsequent Use, ORC will examine the citation, republication, or use of the questioned data, the conclusions or results derived from the questioned data, and/or the allegedly plagiarized text, as follows:

1. In any manuscripts in preparation or publications that are submitted, under review, and/or published on which the Respondent is listed as an author; or

2. In a Respondent’s grant proposals (funded or unfunded), including the specific aims, research strategy, selected publications, and/or other substantive sections, and any research performance progress reports for a funded proposal to which the University has access. The entire period of a funded grant will be examined (i.e., from submitted proposal(s) through final award close out, including No Cost Extension periods).

Page 11 of 20

Research Misconduct Standard Operating Procedures

Office of Research

In order to be considered Subsequent Use, the questioned data, or the conclusions or results derived from the questioned data, or the allegedly plagiarized text, must be cited, republished, or used as a direct reference in some manner to support the respondent’s ideas, claims, theories, or conclusions. Simply including a citation to a time-limited publication without scientific context would not be considered ‘Subsequent Use’.

For example, if a Respondent’s grant biosketch simply cites a time-limited publication, with no specific use of or reference to the allegedly falsified, fabricated or plagiarized data or to the conclusions or results from that data, then the time-limited publication would not meet the requirement of Subsequent Use and the allegation(s) in that time-limited publication would be omitted from the University’s assessment, inquiry, and/or investigation.

Similarly, if a Respondent cites a time-limited publication, but the citation is to information in the publication that is unrelated to the allegedly falsified, fabricated or plagiarized data, or to the conclusions or results from the allegedly falsified, fabricated or plagiarized data, then time-limited publication would not meet the requirement of Subsequent Use and the allegation(s) in that time-limited publication would be omitted from the University’s assessment, inquiry, and/or investigation.

The following example is presented for an allegation submitted in 2017, involving questioned data in a paper published in 2008.

Example – Citation or Use in grant proposals

Research misconduct is alleged in a paper published in 2008 and thus would be outside the original six-year time limitation in 2017 (2011-2017). However, data from the 2008 publication was cited and/or used by the Respondent as supporting evidence in the specific aims section of a NIH grant proposal submitted in 2012.

The citation or use of the data from the 2008 paper in a grant application submitted in 2012 would qualify under the “Subsequent Use Exception”. The subsequent use of the questioned data as supporting evidence from the 2008 paper in 2012 would bring it into the six-year time limitation (2011-2017) and would therefore be included in the University’s assessment, inquiry and/or investigation.

Conversely, if instead, the data was cited and/or used in a NIH grant proposal submitted in 2010 that would not bring it into the six-year time limitation (2011-2017) and would therefore not be included in the University’s assessment, inquiry and/or investigation.

Page 12 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Page 13 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Six-Year Time Limitation and Subsequent Use Exception for Allegations with No Named Respondent(s)

When research misconduct allegations are submitted without a specifically named Respondent on publications that are outside the six-year time limitation, the data and/or text in question may have been subsequently used or cited by one or more of the authors.

An inequity may arise in situations where the subsequent use exception allows one author who potentially committed research misconduct and did subsequently cite, republish, or use the questioned work to be held accountable, while another author who potentially committed research misconduct, but did not subsequently cite, republish, or use the questioned work, would not be held unaccountable.

To reduce the possibility of disparity, when allegations are submitted with no named Respondent, ORC will examine the Subsequent Use of the questioned data and/or text by the first, senior, and/or corresponding authors who are affiliated with the University. If either the first, senior, or corresponding author(s) used, cited, or republished the questioned work in some manner to support the that person’s ideas, claims, theories, or conclusions, within the six-year time limitation, the allegation(s) will be included in the University’s assessment, inquiry and/or investigation as detailed above.

Page 14 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Respondent & Complainant – Standard Operating Procedures

Regulatory and Policy Authority and Requirement

The Public Health Service (PHS) Policies on Research Misconduct, 42 C.F.R. Part 93 (the “PHS Policies”), define the Respondent and Complainant as follows:

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

§ 93.203 Complainant. Complainant means a person who in good faith makes an allegation of research misconduct.

The Research Misconduct policy (the “Policy”), defines Respondent and Complainant as follows:

Respondent – Person or persons against whom allegations of research misconduct are made or are thought to be responsible.

Complainant – Person who makes an allegation of research misconduct, including those persons who make allegations through the university anonymous reporting line.

The Policy provides certain rights to Respondents and Complainants throughout a research misconduct proceeding. Specifically, the Respondent will be:

provided notice when a preliminary assessment moves into an inquiry; interviewed during an inquiry and during an investigation; provided with access to all evidence; provided with a preliminary inquiry report or investigation report, for comment, and the final inquiry

and investigation reports, including all documentary evidence; notified of the final Deciding Official (DO) decision regarding the inquiry, including whether the DO

had remanded the decision of the inquiry back to the RIO and any expert for reconsideration; allowed to appeal to the DO if the inquiry decision is to move on to an investigation.

The RIO will work with the dean of the college of the potential respondent(s). If a faculty respondent has an appointment in more than one college, the RIO will inform the dean of the college, or the department chair, of the faculty respondent’s tenure initiating unit.

If a complaint is received that does not name a specific respondent, (e.g., if the allegations are related to specific figures in a published paper), the RIO will determine during the preliminary assessment, to the extent possible, the roles and responsibilities of the individuals involved in the questioned research in order to name a respondent. In the absence of a specific named respondent and any credible information to assign individual responsibilities, the RIO may identify potential respondents as the senior and/or corresponding author and the first author of the publication. In such cases, the individual(s) who may be responsible for the potential research misconduct in question will be determined during the inquiry.

The Policy provides certain rights to Complainants throughout a research misconduct proceeding. Specifically, the Complainant:

Page 15 of 20

Research Misconduct Standard Operating Procedures

Office of Research

will be provided notice if a preliminary assessment moves to an inquiry; may appeal to the DO if a complaint is dismissed at preliminary assessment; may be interviewed during an inquiry and during an investigation, as needed; may be provided with the relevant sections of the preliminary inquiry report specific to their

allegation(s), and/or the relevant sections of the final inquiry report, or other written notice of the inquiry outcome; the inquiry reports without the documentary evidence, will be redacted as needed;

will be allowed to appeal to the Deciding Official (DO) if the inquiry decision is that a complaint is to be dismissed and not move on to an investigation;

will be notified of the final Deciding Official (DO) decision regarding the inquiry, including whether the DO had remanded the decision of the inquiry back to the RIO and any expert for reconsideration;

will be notified of the final outcome of the investigation relevant to the Complainant’s allegation(s).

The Complainant may be asked to sign a non-disclosure agreement between the Complainant and the University before any information from a research misconduct proceeding is provided to the Complainant. The University is not required to provide notice or reports as described above if the Complainant is anonymous or uses a pseudonym. If a Complainant is known, but requests confidentiality, the identity of the Complainant will not be revealed to anyone involved in the research misconduct proceedings.

Page 16 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Research Integrity Standing Committee (RISC) – Standard Operating Procedures

Overview

The creation of a Research Integrity Standing Committee (RISC) is consistent with the specific recommendations from a 2017 external review of the Office of Research Compliance. The RISC is authorized and appointed by the University Research Committee, in consultation with the Senate Executive Committee, to ensure that the University’s policy and procedures for dealing with research misconduct are consistent with the federal regulations and emerging best practices. The RISC will consist of a pool of senior faculty to serve as experts for the Inquiry and on Investigation Committees, with expertise and training to participate in Research Misconduct proceedings.

(A) Membership.

1. The Research Integrity Standing Committee (RISC) members will be populated with senior faculty selected by the University Research Committee in consultation with the deans of various colleges and the Senate Executive Committee.

2. The RISC will be composed of a pool of 20 - 30 senior University faculty selected from multiple disciplines.

3. Each RISC member shall serve a staggered 3-year term with training in the university’s research misconduct policy and procedures and in the federal regulations. The term of membership for RISC members is renewable at the discretion of the appointing authority, in consultation with the university Research Integrity Officer (RIO).

4. The RISC pool will include at least three (3) faculty members that represent the interests of the Graduate School.

(B) Duties and Responsibilities.

1. RISC members will be selected to serve as an expert during the Inquiry or appointed to an Investigation Committee (IC), as needed and shall conduct research misconduct proceedings consistent with the federal policies on Research Misconduct and the University Policy on Research Misconduct.

2. All RISC members are voting members, except as specified below (C.6 and C.7) for non-voting consultants.

(C) Organization.

1. Experts for the Inquiry or IC members will be chosen from the RISC pool by the RIO, in consultation with college deans and/or the DO.

2. A given IC will be composed of at least three (3) RISC members.3. The expert for the Inquiry and IC members will work with the RIO to ensure compliance with university

rules and federal regulations.4. If the RIO identifies a conflict of interest for any expert for the Inquiry or IC members, the RIO will select

new members from the RISC to replace the conflicted member.5. As necessary during the course of an Inquiry or Investigation, if additional substantial subject matter

expertise is required for the duration of a given Inquiry or Investigation, internal or external subject matter experts shall be named as temporary appointees to the RISC and will serve as voting members.

6. When limited experience or expertise is needed for specific, focused questions related to an Inquiry or an Investigation, internal or external subject matter experts shall be temporary appointees to the RISC to serve as non-voting consultants to aid in a given Inquiry or Investigation.

Page 17 of 20

Research Misconduct Standard Operating Procedures

Office of Research

7. For any allegation(s) against staff members, Human Resource (HR) representatives shall be appointed to the RISC to serve as non-voting consultants to aid in the recommendation of appropriate corrective actions or sanctions.

8. The RISC shall meet for training sessions provided by the Office of Research Compliance, as required, related to the University Research Misconduct Policy and the federal regulations regarding Research Misconduct.

9. When selected to serve for Research Misconduct proceedings, RISC members will meet as often as required for a given Inquiry or Investigation.

Page 18 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Admissions & Resolutions – Standard Operating Procedures

I. Regulatory and Policy Authority and Requirement

The Public Health Service (PHS) Policies on Research Misconduct, 42 C.F.R. Part 93 (the “PHS Policies”), and the Research Misconduct policy (the “Policy”) specify the responsibilities of institutions for acting on alleged research misconduct activities. Under 42 C.F.R. §93.316, regarding the completion of the research misconduct process, an institution may close a matter at any stage of the process under the conditions where a respondent has admitted guilt, reached a resolution, or for any other reason.

42 C.F.R. § 93.316 Completing the research misconduct process. (a) ORI expects institutions to carry inquiries and investigations through to completion and to pursue diligently all significant issues. An institution must notify ORI in advance if the institution plans to close a case at the inquiry, investigation, or appeal stage on the basis that the respondent has admitted guilt, a resolution 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 no misconduct at the investigation stage, which must be reported to ORI under § 93.315.

The Policy, Procedures IV.A. states:

At any stage of the proceedings under this policy, and consistent with the requirements of the relevant oversight agency or funding entity, the RIO may attempt to settle a complaint. At the initiation of the resolution process, the university and the respondent will agree to terminate the research misconduct proceedings with an admission to the research misconduct, or the respondent will accept the findings of research misconduct without an admission.

II. Criteria for Admissions and Resolutions

In settling a research misconduct matter under the Policy Procedures IV., the following specific criteria must be met.

1. Resolution actions shall be handled in accordance with the general responsibilities for compliance as described in 42 C.F.R. §93.300(b), which states that the institution must respond to each allegation of research misconduct “in a thorough, competent, objective and fair manner, including precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have unresolved personal, professional or financial conflicts of interest with the complainant, respondent or witnesses.”

2. When the respondent admits to the finding(s) of research misconduct, the University will review the respondent’s research record relevant to the allegation(s) and/or other research as required, to determine whether the admission comprises the full scope of the respondent’s research misconduct.

3. When the respondent admits to the finding(s) of research misconduct, the respondent will agree to accept any and all corrective action(s) or sanction(s) the university deems appropriate, including referral to other University disciplinary processes and correction or retraction of published papers.

4. Case closure with an admission must have the approval of the DO and the relevant oversight agency or funding entity, as required by law or contract.

Page 19 of 20

Research Misconduct Standard Operating Procedures

Office of Research

5. When the respondent settles a matter with the University without an admission to the research misconduct, the respondent agrees to terminate the research misconduct proceedings but neither accepts nor denies responsibility for the allegations. The respondent must accept any and all of the university’s finding(s) of research misconduct and any and all action(s) the university deems appropriate. Under such a resolution, one or more of the following conditions will apply: a. respondent confirms that the full scope of the potential research misconduct is identified;b. respondent was cooperative with the proceedings; c. respondent demonstrated remorse; d. respondent took steps to correct or prevent recurrence of future research misconduct; and/or e. respondent took, or will take, steps to correct the research record.

6. Case closure with such a resolution must have the approval of the DO and the relevant oversight agency or funding entity, as required by law or contract.

7. At any stage of the proceedings under the policy, and acting consistently with any requirements of the relevant oversight agency or funding entity, the RIO may attempt to resolve the matter to the satisfaction of all involved parties and terminate the proceedings. The RIO will describe in writing any such resolution. Such resolution action must have the approval of the DO and the relevant oversight agency or funding entity, as required by law or contract.

8. In any resolution, if approval by the DO or the relevant oversight agency or funding entity is not obtained, the research misconduct proceedings will proceed through assessment, inquiry, and investigation, as necessary.

Page 20 of 20

Research Misconduct Standard Operating Procedures

Office of Research

Additional Allegation Intake – Standard Operating Procedures

I. Regulatory and Policy Authority and Requirement

The Public Health Service (PHS) Policies on Research Misconduct, 42 C.F.R. Part 93 (the “PHS Policies”), and the Research Misconduct policy (the “Policy”) specify the responsibilities of institutions for acting on allegations of research misconduct. Under 42 C.F.R. §93.310(h), an institution conducting a research misconduct investigation must pursue any additional instances of possible research misconduct as follows:

Institutions conducting research misconduct investigations must: (h) Pursue leads. 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.

The Policy, Procedures I., II., and III. describe the Preliminary Assessment, Inquiry, and Investigation phases the university will follow when allegations of research misconduct are raised. Additional allegations may arise during the course of a research misconduct proceeding expanding the scope of a research misconduct matter, as described in Policy Details II.B. and II.C. as follows:

B. During the preliminary assessment, inquiry, or investigation, additional allegations may arise that are related to an ongoing inquiry or investigation and justify broadening the scope beyond the initial complaint.

C. If any new allegations arise, the RIO will notify the respondent, in writing of the decision to review the new allegation(s) with a description of the allegation(s). If a new respondent is named, the RIO will inform the new respondent in writing of the decision to review the allegation(s) with a description of the allegation(s).

II. New Allegations Received at Inquiry or Investigation

1) When an additional allegation is received that is related to an ongoing inquiry or investigation, the allegation will be assessed by the RIO to determine if it the allegation is specific and credible so that potential evidence of research misconduct may be identified. If insufficient information is provided, the RIO will work with the Complainant, if known, to obtain additional information for the assessment.

2) For an additional allegation that is related to an ongoing inquiry or investigation and is not specific and credible, the RIO, in consultation with any expert conducting an inquiry or with the investigation committee (IC) chair, will determine if the allegation will be dismissed.

3) A new allegation received that is related to an ongoing inquiry and is specific and credible, will be handled as follows.

a. If the allegation(s) is related to the ongoing inquiry and received before the inquiry decision has been made as to whether an investigation is warranted, the RIO will notify the respondent(s) of the additional allegation(s) and the additional allegation(s) will be examined during the inquiry to determine whether the new allegation(s) has substance to warrant an investigation.

b. If the allegation(s) is related to the to the ongoing inquiry and received after the inquiry decision has been made as to whether an investigation is warranted, the RIO will notify the Respondent(s) of the

Page 21 of 20

Research Misconduct Standard Operating Procedures

Office of Research

additional allegation(s) and the RIO, in consultation with any expert participating in the inquiry, will determine whether the allegation(s) has substance to warrant that it be included in an investigation.

c. If the allegation(s) is related to the ongoing inquiry, but involves a new Respondent, the RIO will notify the new Respondent about the allegation(s) and sequester additional data if necessary. The RIO will determine whether the Respondent will waive their right to a preliminary assessment and have the allegation(s) reviewed in the ongoing inquiry. If so, the RIO will get the new Respondent’s decision in writing and the allegation(s) will be examined during the inquiry to determine if the allegation(s) has substance to warrant an investigation.

4) A new allegation(s) received that is related to an ongoing investigation that is specific and credible, will be handled as follows:

a. If the allegation(s) is related to the ongoing investigation, the RIO will notify the Respondent(s) of the new allegation(s) and include the additional allegation(s) in the IC’s review.

b. If the allegation(s) is related to the ongoing investigation, but involves a new Respondent, the RIO, will notify the new Respondent of the allegation(s) and sequester additional data if necessary. If the new Respondent waives their right to a formal inquiry and agrees that the allegation(s) will be reviewed in the ongoing investigation, the RIO will get the Respondent’s decision in writing, and in consultation with the IC chair, will then determine if the allegation(s) has substance for further review in the ongoing investigation.

c. If the new allegation involves a new Respondent who does not agree that the allegation(s) should be reviewed in the ongoing investigation, the RIO will initiate a new inquiry for the new Respondent.

Page 22 of 20