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Responsible Conduct of Research Policy

Introduction¹

A. Policy Statement

Faculty engaged in research at Washington and Lee University ("W&L" or "the University") will adhere to the highest professional standards in the execution of their work and the reporting of its results. Misconduct in research and reporting is inconsistent with the most basic values of W&L and the international community of science. Evidence of misconduct will be investigated by the University according to the procedures adopted pursuant to this policy.

B. Scope

This policy is intended to carry out W&L's responsibilities under the Public Health Service (PHS) Policies on Research Misconduct, 42 C.F.R. Part 93, as well as the University's responsibilities under regulations issued by other funding sources, including the National Science Foundation (NSF) Research Misconduct regulations, 45 C.F.R. Part 689.

This policy applies to allegations of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results) involving a person who, at the time of the alleged research misconduct, was employed by, was an agent of, or was affiliated by contract or agreement with W&L.

This policy will be used to respond to any allegation of research misconduct that involves research funded, in whole or in part, by PHS or NSF. Notwithstanding the previous sentence, at the discretion of the Provost, this policy may be used as a framework to respond to allegations of research misconduct involving research funded by any other source or to investigate any matter of concern in the conduct of research (however funded) that does not fall within the definition of research misconduct set forth in this policy. Unless prohibited by the applicable laws and regulations, the University may modify the procedures, timelines, or other aspects of this policy as it deems appropriate to the facts and circumstances of the particular case.

When this policy is being used to carry out W&L's responsibilities under the PHS Policies on Research Misconduct, 42 C.F.R. Part 93, it applies only to research misconduct or allegations of research misconduct involving the following:

1. Applications or proposals for PHS support for biomedical or behavioral research, research training, or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information;
2. PHS supported biomedical or behavioral research;
3. PHS supported biomedical or behavioral research training programs;
4. PHS supported activities that are related to biomedical or behavioral research, research training, or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information; or
5. Plagiarism of research records produced in the course of PHS supported research, research training, or activities related to that research or research training.

This includes any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in a grant, contract, cooperative agreement, or other form of PHS support.²

Additionally, when this policy is being used to carry out W&L's responsibilities under the PHS Policies on Research Misconduct, 42 C.F.R. Part 93, this policy and the associated procedures do not apply to authorship or collaboration disputes and apply only to research misconduct that occurred within six years of the date W&L or the appropriate federal agency received the allegation, subject to any exception that may apply under the applicable laws and regulations. ³

Definitions

Allegation

means a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to a University official or administrator or a federal agency official.⁴

Complainant

means a person who in good faith makes an allegation of research misconduct.⁵

Deciding Official (DO)

shall be the Provost or his or her designee, who will make final determinations on allegations of research misconduct and any University administrative actions taken to address such misconduct.

Evidence

means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact.⁶

Federal agency or agency

refers to either the funding branch of the department or agency or, where applicable, the investigative branch. When a report must be provided to a federal agency, it should be sent to the branch of the agency designated by the applicable federal regulations to receive the information. For example, reports regarding investigations involving PHS grants or applications are generally required to be sent to the PHS Office of Research Integrity, while those involving NSF grants are required to be sent to NSF's Office of Inspector General.

Good faith

as applied to a complainant or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's position could have based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the allegation or testimony. Good faith, as applied to a committee member, means cooperating with the purpose of helping the University meet its responsibilities under the applicable federal regulations. A committee member does not act in good faith if his or her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.⁷

Inquiry means preliminary information-gathering and prelim42 CFR § 93.212; 45 CFR § 689.2(b); see also 42 CFR §§ 93.307-93.309[/footnote]inary fact-finding that meets the criteria and follows the procedures set forth in the applicable federal regulations.⁸

Institutional member

means a person who is employed by, is an agent of, or is affiliated by contract or agreement with the University. Institutional members include, but are not limited to, officials, administrators, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, clinical technicians, postdoctoral and other fellows, students, volunteers, agents, and contractors, subcontractors, and subawardees, and their employees.⁹

Investigation

means the formal development of a factual record and the examination of that record leading to one of the following: (1) a decision not to make a finding of research misconduct; or (2) a recommendation for a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions.¹⁰

Preponderance

of the evidence means proof by information that, compared with information opposing it, leads to the conclusion that the fact at issue is more probably true than not.¹¹

Public Health Service or PHS

means the unit within the Department of Health and Human Services that includes the Office of Public Health and Science and the following Operating Divisions: Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.¹²

PHS support

means PHS funding, or applications or proposals therefore, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through: PHS grants, cooperative agreements, or contracts or subgrants or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements or contracts¹³

Records of research misconduct proceedings

means:

1. The research records and evidence secured for the research misconduct proceedings pursuant to this policy and any applicable federal regulations,¹⁴ except to the extent the RIO determines and documents that those records are not relevant to the proceeding or that the records duplicate other records that have been retained;
2. The documentation of the determination of irrelevant or duplicate records;
3. The inquiry report and final documents (not drafts) produced in the course of preparing that report, including the documentation of any decision not to investigate, as required by the applicable federal regulations;¹⁵ and
4. The investigation report and all records (other than drafts of the report) in support of the report, including the recordings or transcripts of each interview conducted.

Research Integrity Officer (RIO)

means the University official or administrator responsible for:

1. Assessing allegations of research misconduct to determine if they fall within the definition of research misconduct as defined by this policy and warrant an inquiry on the basis that the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified;
2. Overseeing inquiries and investigations; and
3. The other responsibilities described in this policy and Appendix A.

Research misconduct

means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. When this policy is being used to carry out the University's responsibilities under the NSF Research Misconduct regulations, 45 C.F.R. Part 689, research misconduct also means fabrication, falsification, or plagiarism in reviewing research proposals submitted to NSF.¹⁶ Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.¹⁷

Research misconduct proceeding

means any actions related to alleged research misconduct that are within this policy, including but not limited to, allegation assessments, inquiries, investigations, federal agency oversight reviews, hearings, and administrative appeals.¹⁸

Research record

means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records (both physical and electronic) progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to a federal agency or a University official or administrator by a respondent in the course of the research misconduct proceeding.¹⁹

Respondent

means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.²⁰

Retaliation

means an adverse action taken against a complainant, witness, or committee member by the University or one of its institutional members in response to a good faith allegation of research misconduct or good faith cooperation with a research misconduct proceeding. ²¹

Policy

I. Rights and Responsibilities

A. Research Integrity Officer

The Research Integrity Officer (RIO) will have primary responsibility for implementation of this policy. The RIO will be a University official or administrator who is well qualified to administer the procedures and is sensitive to the varied demands made on those who conduct research, those who are accused of research misconduct, those who make good faith allegations of research misconduct, and those who may serve on inquiry and investigation committees. The Dean of the College or his or her designee will serve as the RIO.

A detailed listing of the responsibilities of the RIO is set forth in Appendix A.

B. Complainant

The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation. As a matter of good practice, the complainant should be interviewed at the inquiry stage and given the transcript or recording of the interview for correction. The complainant must be interviewed during an investigation, and be given the transcript or recording of the interview for correction.²²

C. Respondent

The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. The respondent is entitled to:

1. A good faith effort from the RIO to notify the respondent in writing at the time of or before beginning an inquiry;²³
2. An opportunity to comment on the inquiry report and have his or her comments attached to the report;²⁴
3. Notice of the outcome of the inquiry and a copy of the inquiry report that includes a copy of, or refers to, this policy and the applicable federal regulations;²⁵
4. Written notice of the allegations to be investigated within a reasonable time after the determination that an investigation is warranted, but before the investigation begins (or within 30 days after the University decides not to begin an investigation), and written notice of any new allegations (not addressed in the inquiry or in the initial notice of investigation) within a reasonable time after the determination to pursue those allegations;²⁶
5. The opportunity to be interviewed during the investigation, to correct the recording or transcript, and to have the corrected recording or transcript included in the record of the investigation;²⁷
6. The opportunity to have any witness who has been reasonably identified by the respondent as having information on relevant aspects of the investigation interviewed during the investigation, have the recording or transcript provided to the witness for correction, and have the corrected recording or transcript included in the record of the investigation;²⁸ and
7. A copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based, and notice that any comments must be submitted within 30 days of the date on which the copy was received and that the comments will be considered by the University and addressed in the final report.²⁹

The respondent should be given the opportunity to admit that research misconduct occurred and that he or she committed the research misconduct. With the advice of the RIO and University legal counsel, the Deciding Official may terminate the University's review of an allegation that has been admitted if the University's acceptance of the admission and any proposed settlement is approved by the appropriate federal agency, if required.³⁰

D. Deciding Official

The DO will receive the inquiry report and, after consulting with the RIO, decide whether an investigation is warranted under this policy and the applicable law.³¹ Any finding that an investigation is warranted must be made in writing by the DO and must be provided to the appropriate federal agency, together with a copy of the inquiry report, within 30 days of the finding (or immediately in cases involving research funded by NSF). If it is found that an investigation is not warranted, the DO and the RIO will ensure that detailed documentation of the inquiry is retained for at least seven years after termination of the inquiry, so that the appropriate federal agency may assess the reasons why an investigation was not conducted.³²

The DO will receive the investigation report and, after consulting with the RIO and other appropriate officials and administrators, decide the extent to which the University accepts the findings of the investigation and, if research misconduct is found, decide what (if any) internal administrative actions are appropriate. The DO shall ensure that the final investigation report, the findings of the DO and a description of any pending or completed administrative action are provided to the appropriate federal agency.³³

II. General Policies and Principles

A. Responsibility to Report Misconduct

All institutional members should report observed, suspected, or apparent research misconduct to the RIO. If an institutional member is unsure whether a suspected incident falls within the definition of research misconduct, he or she may meet with or contact the RIO at 540-458-8746 to discuss the suspected research misconduct informally, which may include discussing it anonymously and/or hypothetically. If the circumstances described do not meet the definition of research misconduct as defined in this policy, the RIO will refer the individual or allegation to other offices, officials, or administrators with responsibility for resolving the matter. At any time, an institutional member may have confidential discussions and consultations about concerns of possible misconduct with the RIO, who can advise about appropriate procedures for reporting concerns.

B. Cooperation with Research Misconduct Proceedings

University employees will cooperate with the RIO and other University officials and administrators in the review of allegations and the conduct of inquiries and investigations. Institutional members, including respondents, have an obligation to provide relevant evidence regarding research misconduct allegations to the RIO or other University official or administrator.

C. Confidentiality

The RIO shall limit disclosure of the identity of respondents and complainants to those who need to know in order to carry out a thorough, competent, objective, and fair research misconduct proceeding.³⁴ The RIO also shall limit the disclosure of any records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding, except as otherwise prescribed by law. The RIO should remind University employees about their obligation under University policy not to make further disclosure of identifying information and should use written confidentiality agreements to obtain similar assurances from institutional members not employed by the University.

D. Protecting complainants, witnesses, and committee members

Institutional members may not retaliate in any way against complainants, witnesses, or committee members. Institutional members should immediately report any alleged or apparent retaliation against complainants, witnesses, or committee members to the RIO, who shall review and investigate the matter, as appropriate, and make all reasonable and practical efforts to counter any potential or actual retaliation and to protect or restore the position and reputation of the person against whom the retaliation is directed.³⁵ The RIO, in consultation with the DO, may take steps to discipline University employees found to have engaged in retaliation and to implement administrative actions against non-employee institutional members found to have engaged in retaliation.

E. Protecting the Respondent

As requested and as appropriate, the RIO and other University officials and administrators shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.³⁶

During the research misconduct proceeding, the RIO is responsible for ensuring that respondents receive all notices and opportunities provided for in this policy and by the applicable law. Respondents may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal adviser to interviews or meetings on the case. During meetings and interviews, the role of the counsel or personal advisor shall be limited to listening and providing personal advice to the respondent outside of the room where the meeting or interview is taking place or during breaks in the meeting or interview. The counsel or personal advisor shall not be permitted to communicate with any representatives of the University on behalf of the respondent during meetings or interviews that he or she attends. Outside of meetings and interviews, any communication between the respondent's counsel or personal advisor and the University must be through University legal counsel.

F. Interim Administrative Actions and Notifying the Appropriate Federal Agency of Special Circumstances

Throughout the research misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, federal funds and equipment, or the integrity of the research process. In the event of such a threat, the RIO will, in consultation with other University officials and administrators and the appropriate federal agency, take appropriate interim action to protect against any such threat.³⁷ Interim action might include additional monitoring of the research process and the handling of federal funds and equipment, reassignment of personnel or of the responsibility for the handling of federal funds and equipment, additional review of research data and results or delaying publication. The RIO shall, at any time during a research misconduct proceeding, notify the appropriate federal agency immediately if he or she has reason to believe that any of the following conditions exist:

1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
2. Federal agency resources, reputation, or other interests are threatened or need protection;
3. Research activities should be suspended;
4. There is a reasonable indication of possible violations of civil or criminal law;
5. Federal action is required to protect the interests of those involved in the research misconduct proceeding or others potentially affected by the research misconduct proceeding;
6. The research misconduct proceeding may be made public prematurely and federal agency action may be necessary to safeguard evidence and protect the rights of those involved; or
7. The research community or public should be informed.³⁸

III. Conducting the Assessment and Inquiry

A. Assessment of Allegations

Upon receiving an allegation of research misconduct, the RIO will immediately assess the allegation to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified, whether the allegations should be handled under this policy (including a determination of whether PHS or other federal or non-federal funding is involved), whether it falls within the six-year limitations period, and, if so, whether any agency-specific regulations are applicable.³⁹ An inquiry must be conducted if these criteria are met.

The assessment period should be brief, preferably concluded within a week. In conducting the assessment, the RIO need not interview the complainant, respondent, or other witnesses, or gather data beyond any that may have been submitted with the allegation, except as necessary to determine whether the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

B. Initiation and Purpose of the Inquiry

If the RIO determines that the criteria for an inquiry are met, he or she will immediately initiate the inquiry process. The purpose of the inquiry is to conduct an initial review of the available evidence to determine whether to conduct an investigation (NOTE: In cases involving research funded by NSF, an inquiry consists of preliminary information-gathering and preliminary fact-finding to determine whether an allegation or apparent instance of research misconduct has substance and if an investigation is warranted.).⁴⁰ An inquiry does not require a full review of all the evidence related to the allegation.⁴¹

C. Notice to Respondent; Sequestration of Research Records

At the time of or before beginning an inquiry, the RIO must make a good faith effort to notify the respondent in writing, if the respondent is known. If the inquiry subsequently identifies additional respondents, they must be notified in writing. On or before the date on which the respondent is notified or the inquiry begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence and sequester 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.⁴² The RIO may consult with the appropriate federal agency for advice and assistance in this regard.

D. Appointment of the Inquiry Committee

The RIO, in consultation with other University officials and administrators as appropriate, will attempt to appoint an inquiry committee and committee chair within 10 days of the initiation of the inquiry or as soon thereafter as practical. The inquiry committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry and should include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry.⁴³

E. Charge to the Committee and the First Meeting

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

1. Sets forth the time for completion of the inquiry;
2. Describes the allegation and any related issues identified during the allegation assessment;
3. States that the purpose of the inquiry is to conduct an initial review of the evidence (including the testimony of the respondent, complainant, and key witnesses) to determine whether an investigation is warranted, not to determine whether research misconduct definitely occurred or who was responsible;
4. States that an investigation is warranted if the committee determines there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct and the allegation may have substance, based on the committee's review during the inquiry; and
5. Informs the inquiry committee that they are responsible for preparing or directing the preparation of a written report of the inquiry that meets the requirements of this policy and any applicable federal regulations.⁴⁴

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

F. Inquiry Process

The inquiry committee will generally interview the complainant, the respondent, and key witnesses, in addition to examining relevant research records and materials. Then the inquiry committee will evaluate the evidence, including the testimony obtained during the inquiry. After consultation with the RIO, the committee members will decide whether an investigation is warranted based on the criteria in this policy and any applicable regulations.⁴⁵ The scope of the inquiry is not required to and does not generally include finding whether research misconduct occurred, determining who committed the research misconduct, or conducting exhaustive interviews and analyses. However, if a legally sufficient admission of research misconduct is made by the respondent, misconduct may be determined at the inquiry stage if all relevant issues are resolved. In that case, the University shall promptly consult with the appropriate federal agency to determine the next steps that should be taken.

G. Time for Completion

The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, must be completed within 60 days (or 90 days in cases involving research funded by NSF) of initiation of the inquiry, unless the RIO determines that circumstances clearly warrant a longer period. If the RIO approves an extension, the inquiry record must include documentation of the reasons for exceeding the 60-day period (or the 90-day period in cases involving research funded by NSF).⁴⁶ Any extension of time that requires notice to or approval by a federal agency should be submitted to the appropriate federal agency in accordance with the applicable laws and regulations.⁴⁷ The RIO should ensure that periodic progress reports are filed with the appropriate federal agency, if required.⁴⁸

IV. The Inquiry Report

A. Elements of the Inquiry Report

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

1. The name and position of the respondent;
2. A description of the allegations of research misconduct;
3. The source of funding, including, for example, grant numbers, grant applications, and contracts and publications listing such funding;
4. The basis for recommending or not recommending that the allegations warrant an investigation; and
5. Any comments on the draft report by the respondent or complainant.⁴⁹

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

B. Notification to the Respondent and Opportunity to Comment

The RIO shall notify the respondent whether the inquiry found an investigation to be warranted, include a copy of the draft inquiry report for comment within 10 days, and include a copy of or refer to this policy and any applicable federal regulations.⁵⁰ The University may notify the complainant whether the inquiry found an investigation to be warranted and provide relevant portions of the inquiry report to the complainant for comment within 10 days.⁵¹ A confidentiality agreement should be a condition for access to the report.

C. University Decision and Notification to the Appropriate Federal Agency

1. Decision by Deciding Official

The RIO will transmit the final inquiry report and any comments to the DO, who will determine in writing whether an investigation is warranted. The inquiry is completed when the DO makes this determination.

2. Notification to the Appropriate Federal Agency

Within 30 days of the DO's decision that an investigation is warranted (or immediately in cases involving research funded by NSF), the RIO will provide the appropriate federal agency with the DO's written decision and a copy of the inquiry report.⁵² The RIO will also notify those University officials and administrators who need to know of the DO's decision. The RIO must provide the following information to the appropriate federal agency upon request:

1. This policy or the University policies and procedures under which the inquiry was conducted;
2. The research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and
3. The charges to be considered in the investigation.⁵³

3. Documentation of Decision Not to Investigate

If the DO decides that an investigation is not warranted, the RIO shall secure and maintain for seven years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by the appropriate federal agency of the reasons why an investigation was not conducted. These documents must be provided to the appropriate federal agency upon request.

V. Conducting the Investigation

A. Initiation and Purpose

The investigation must begin promptly, but not later than 30 days, after the determination by the DO that an investigation is warranted.⁵⁴ The purpose of the investigation is to develop a factual record by exploring the allegations in detail and examining the evidence in depth, leading to recommended findings on whether research misconduct has been committed and by whom. The investigation will also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged research misconduct involves clinical trials or potential harm to human subjects or the general public, or if it affects research that forms the basis for public policy, clinical practice, or public health practice.

B. Notifying the Respondent; Sequestration of Research Records

On or before the date on which the investigation begins, the RIO must notify the respondent in writing of the allegations to be investigated.⁵⁵ The RIO must also give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.⁵⁶

The RIO will, prior to notifying the respondent of the allegations, take all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct proceeding that were not previously sequestered during the inquiry. Where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. The need for additional sequestration of records for the investigation may occur for any number of reasons, including the University's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.⁵⁷

C. Appointment of the Investigation Committee

The RIO, in consultation with other University officials and administrators as appropriate, will appoint an investigation committee and the committee chair within 10 days of the beginning of the investigation or as soon thereafter as practical. The investigation committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation and should include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the respondent and complainant and conduct the investigation. Individuals appointed to the investigation committee may also have served on the inquiry committee.

The RIO will notify the respondent of the proposed committee membership within five days of its formation.

D. Charge to the Committee and the First Meeting

1. Charge to the Committee

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

1. Describes the allegations and related issues identified during the inquiry;
2. Identifies the respondent;
3. Informs the committee that it must conduct the investigation as prescribed in paragraph E. of this section;
4. Defines research misconduct;
5. Informs the committee that it must evaluate the evidence and testimony to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, the type and extent of it and who was responsible;
6. Informs the committee that in order to determine that the respondent committed research misconduct it must find that a preponderance of the evidence establishes that:
   1. Research misconduct, as defined in this policy, occurred (respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion);
   2. The research misconduct is a significant departure from accepted practices of the relevant research community; and
   3. The respondent committed the research misconduct intentionally, knowingly, or recklessly; and
7. Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy and any applicable federal regulations.⁵⁸

2. First Meeting

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

E. Investigation Process

The investigation committee and the RIO must:

1. Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of each allegation;⁵⁹
2. Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical;⁶⁰
3. Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent, and record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of the investigation;⁶¹ and
4. Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continue the investigation to completion.⁶²

F. Time for Completion

The investigation is to be completed within 120 days (or 180 days in cases involving research funded by NSF) of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report for comment, and sending the final report to any federal agency, if required. However, if the RIO determines that the investigation will not be completed within this 120-day period (or the 180-day period in cases involving research funded by NSF), he or she will submit a written request for an extension to the appropriate federal agency, setting forth the reasons for the delay. The RIO will ensure that periodic progress reports are filed with the appropriate federal agency, if such agency grants the request for an extension and directs the filing of such reports.⁶³

VI. The Investigation Report

A. Elements of the Investigation Report

The investigation committee and the RIO are responsible for preparing a written draft report of the investigation that:

1. Describes the nature of the allegation of research misconduct, including identification of the respondent;
2. Describes and documents the source of funding for such research, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publications listing such funding;
3. Describes the specific allegations of research misconduct considered in the investigation;
4. Includes this policy or the University policies and procedures under which the investigation was conducted, as well as any applicable federal regulations, unless those policies and procedures were previously provided with the inquiry report;
5. Identifies and summarizes the research records and evidence reviewed and identifies any evidence taken into custody but not reviewed; and
6. For each separate allegation of research misconduct identified during the investigation, provides a finding as to whether research misconduct did or did not occur, and if research misconduct is found to have occurred:⁶⁴
   1. Identify whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly;
   2. Summarize the facts and the analysis that support the conclusion and consider the merits of any reasonable explanation by the respondent, including any effort by respondent to establish by a preponderance of the evidence that he or she did not engage in research misconduct because of honest error or a difference of opinion;
   3. Identify the specific source of funding or support;
   4. Identify whether any publications need correction or retraction;
   5. Identify the person(s) responsible for the misconduct; and
   6. List any current support or known applications or proposals for support that the respondent has pending with any federal agencies.⁶⁵

B. Opportunity for Review/Comment on the Draft Report and Finalizing the Report

1. Respondent

The RIO must give the respondent a copy of the draft investigation report for comment and, concurrently, a copy of, or supervised access to, the evidence on which the report is based. The respondent will be allowed 30 days from the date he or she received the draft report to submit comments to the RIO. The respondent's comments must be included and considered in the final report.⁶⁶

2. Complainant

The University may provide the complainant a copy of the draft investigation report, or relevant portions of it, for comment. If the University chooses to do so, the complainant's comments must be submitted within 30 days of the date on which he or she received the draft report and the comments must be included and considered in the final report.⁶⁷

3. Confidentiality

In distributing the draft report (or portions thereof) to the respondent and complainant, the RIO will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the RIO may request the recipient to sign a confidentiality statement or to come to his or her office to review the report.

4. Review for Legal Sufficiency

University legal counsel should review the investigation report at the draft stage for legal sufficiency.

5. Finalizing the Report

The RIO will assist the investigation committee in finalizing the draft investigation report, including ensuring that the comments from the respondent, complainant, and University legal counsel are included and considered, and transmit the final investigation report

C. Decision by Deciding Official

The DO will determine in writing:

1. Whether the University accepts the findings of the investigation; and
2. The appropriate University actions in response to any accepted findings of research misconduct.⁶⁸

If the DO's determination varies from the findings of the investigation committee, the DO will, as part of his or her written determination, explain in detail the basis for rendering a decision different from the findings of the investigation committee. Alternatively, the DO may return the report to the investigation committee with a request for further fact-finding or analysis.

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

D. Notice to the Appropriate Federal Agency of University Findings and Actions

If required, the RIO must submit the following to the appropriate federal agency within the 120-day period (or the 180-day period in cases involving research funded by NSF) for completing the investigation, unless an extension has been granted:

1. A copy of the final investigation report with all attachments;
2. A statement of whether the University accepts the findings of the investigation report;
3. A statement of whether the University found misconduct and, if so, who committed the misconduct; and
4. A description of any pending or completed administrative actions against the respondent.⁶⁹

E. Maintaining Records for Review by Federal Agencies

The RIO must maintain and provide to the appropriate federal agency upon request records of research misconduct proceedings. Unless custody has been transferred to such federal agency or such federal agency has advised in writing that the records no longer need to be retained, records of research misconduct proceedings must be maintained in a secure manner for seven years after completion of the proceeding or the completion of any proceeding involving the research misconduct allegation.⁷⁰ The RIO is also responsible for providing any information, documentation, research records, evidence or clarification requested by the appropriate federal agency to carry out its review of an allegation of research misconduct or of the University's handling of such an allegation.⁷¹

VII. Reporting Premature Closures

The RIO must notify the appropriate federal agency in advance if there are plans to close a case at the inquiry or investigation stage on the basis that respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except:

1. Closing of a case at the inquiry stage on the basis that an investigation is not warranted; or
2. A finding of no misconduct at the investigation stage, which must otherwise be reported to the appropriate federal agency, as prescribed in this policy and the applicable federal regulations.⁷²

VIII. University Administrative Actions

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

1. Withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;
2. Removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment;
3. Restitution of funds to the grantor agency as appropriate; and
4. Other action appropriate to the misconduct.

XI. Other Considerations

A. Termination or Resignation Prior to Completing Inquiry or Investigation

The termination of the respondent's University employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceeding or otherwise limit any of the University's responsibilities to the relevant federal agency.

If the respondent, without admitting to the misconduct, elects to resign his or her position after the University receives an allegation of research misconduct under this policy. If the respondent refuses to participate in the process after resignation, the RIO and any inquiry or investigation committee will use their best efforts to reach a conclusion concerning the allegation, noting in the report the respondent's failure to cooperate and its effect on the evidence.

B. Restoration of the Respondent's Reputation

Following a final finding of no research misconduct, including concurrence by the appropriate federal agency if required, the RIO will, at the request of the respondent, make all reasonable and practical efforts to protect or restore the respondent's reputation.⁷³ Depending on the particular circumstances and the views of the respondent, the RIO should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in any forum in which the allegation of research misconduct was previously publicized, and expunging all reference to the research misconduct allegation from the respondent's personnel file. Any University actions to restore the respondent's reputation should first be approved by the DO.

C. Protection of the Complainant, Witnesses, and Committee Members

During the research misconduct proceeding and upon its completion, regardless of whether the University or a federal agency determines that research misconduct occurred, the RIO will undertake all reasonable and practical efforts to protect the position and reputation of, or to counter potential or actual retaliation against, any complainant who made allegations of research misconduct in good faith and of any witnesses and committee members who cooperate in good faith with the research misconduct proceeding.⁷⁴ The DO will determine, after investigating any concerns, as appropriate, and after consulting with the RIO and with the complainant, witnesses, or committee members, respectively, what steps, if any, are needed to protect or restore their respective positions or reputations or to counter potential or actual retaliation against them. The RIO is responsible for implementing any steps the DO approves.

D. Allegations and/or Actions Not Made in Good Faith

The DO will review and investigate any allegation brought forward by the respondent or any other institutional member that the complainant's allegations of research misconduct (or the testimony or actions of a witness or committee member) were not made in good faith, as defined by this policy. The DO will determine whether the complainant's allegations of research misconduct were made in good faith, or whether a witness or committee member acted in good faith. If the DO determines that there was an absence of good faith he or she will determine whether any administrative action should be taken against the person who failed to act in good faith.

Appendix A

Research Integrity Officer Responsibilities

I. General

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

1. Takes all reasonable and practical steps to foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.
2. Has written policies and procedures for responding to allegations of research misconduct and reporting information about that response to the appropriate federal agency, as required by such policies and procedures and the applicable law.
3. Complies with its written policies and procedures and the requirements of the applicable law.
4. Informs its institutional members who are subject to the written policies and procedures regarding research misconduct about its research misconduct policies and procedures and its commitment to compliance with those policies and procedures.
5. Takes appropriate interim action during a research misconduct proceeding to protect public health, federal funds and equipment, and the integrity of the research process.

II. Notice and Reporting to Federal Agencies and Cooperation with Federal Agencies

The RIO has lead responsibility for ensuring that the University:

1. Files an annual report with each appropriate federal agency containing the information prescribed by such agency, if required.
2. Sends to each such federal agency with the annual report such other aggregated information as such agency may prescribe on the University's research misconduct proceedings and the University's compliance with the applicable laws.
3. Notifies the appropriate federal agency immediately if, at any time during the research misconduct proceeding, it has reason to believe that the health or safety of the public is at risk (including an immediate need to protect human or animal subjects), federal agency resources, reputation, or other interests are threatened or need protection, research activities should be suspended, there is a reasonable indication of possible violations of civil or criminal law, federal action is required to protect the interests of those involved in the research misconduct proceeding or others potentially affected by the research misconduct proceeding, the research misconduct proceeding may be made public prematurely and federal agency action may be necessary to safeguard evidence and protect the rights of those involved, or the research community or public should be informed.⁷⁵
4. Provides the appropriate federal agency with the written finding by the responsible University official or administrator that an investigation is warranted and a copy of the inquiry report, within 30 days of the date on which the finding is made (or immediately in cases involving research funded by NSF).
5. Notifies the appropriate federal agency of the decision to begin an investigation on or before the date the investigation begins.
6. Within 120 days (or 180 days in cases involving research funded by NSF) of beginning an investigation, or such additional days as may be granted by such federal agency, provides the appropriate federal agency with the investigation report, a statement of whether the University accepts the investigation's findings, a statement of whether the University found research misconduct and, if so, who committed it, and a description of any pending or completed administrative actions against the respondent.
7. Seeks advance federal agency approval if the University plans to close a case at the inquiry, investigation, or appeal stage on the basis that the respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except the closing of a case at the inquiry stage on the basis that an investigation is not warranted or a finding of no misconduct at the investigation stage.
8. Cooperates fully with each federal agency during its oversight review and any subsequent administrative hearings or appeals, including providing all research records and evidence under the University's control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.

III. Research Misconduct Proceeding

A. General

The RIO is responsible for:

1. Promptly taking all reasonable and practical steps to obtain custody of all research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner.
2. Taking all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings, including, but not limited to their providing information, research records and evidence.
3. Providing confidentiality to those involved in the research misconduct proceeding as required this policy and the applicable law.
4. Determining whether each person involved in handling an allegation of research misconduct has an unresolved personal, professional or financial conflict of interest and taking appropriate action, including recusal, to ensure that no person with such a conflict is involved in the research misconduct proceeding.
5. Keeping the Deciding Official (DO) and others who need to know, including the appropriate federal agency, apprised of the progress of the review of the allegation of research misconduct.
6. In cooperation with other University officials and administrators, making all reasonable and practical efforts if requested and as appropriate to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members and to counter potential or actual retaliation against them by respondents or other institutional members.
7. Making all reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.
8. Assisting the DO in implementing his or her decision to take administrative action against any complainant, witness, or committee member determined by the DO not to have acted in good faith.
9. Maintaining records of the research misconduct proceeding in a secure manner for seven years after completion of the proceeding, or the completion of any federal agency proceeding involving the allegation of research misconduct, whichever is later, unless custody of the records has been transferred to such federal agency or such federal agency has advised that the records no longer need to be retained.
10. Ensuring that administrative actions taken by the University and the appropriate federal agency are enforced and taking appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards, of those actions.

B. Allegation Receipt and Assessment

The RIO is responsible for:

1. Consulting confidentially with persons uncertain about whether to submit an allegation of research misconduct.
2. Receiving allegations of research misconduct.
3. Assessing each allegation of research misconduct to determine if an inquiry is warranted because the allegation falls within the definition of research misconduct as set forth in this policy and the applicable law and is sufficiently credible and specific so that potential evidence of research misconduct may be identified.

C. Inquiry

The RIO is responsible for:

1. Initiating the inquiry process if it is determined that an inquiry is warranted.
2. At the time of, or before beginning the inquiry, making a good faith effort to notify the respondent in writing, if the respondent is known.
3. On or before the date on which the respondent is notified, or the inquiry begins, whichever is earlier, taking all reasonable and practical steps to obtain custody of all research records and evidence needed to conduct the research misconduct proceeding, inventorying the records and evidence and sequestering 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 the instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.
4. Appointing an inquiry committee and committee chair as soon after the initiation of the inquiry as is practical.
5. Preparing a charge for the inquiry committee in accordance with this policy.
6. Convening the first meeting of the inquiry committee and at that meeting briefing the committee on the allegations, the charge to the committee, and the appropriate procedures for conducting the inquiry, including the need for confidentiality and for developing a plan for the inquiry, and assisting the committee with organizational and other issues that may arise.
7. Providing the inquiry committee with needed logistical support, including, but not limited to, expert advice (including forensic analysis of evidence) and clerical support (including arranging witness interviews and recording or transcribing those interviews).
8. Being available or present throughout the inquiry to advise the committee as needed and consulting with the committee prior to its decision on whether to recommend that an investigation is warranted on the basis of the criteria in this policy and the applicable law.⁷⁶
9. Determining whether circumstances clearly warrant a period longer than 60 days (or 90 days in cases involving research funded by NSF) to complete the inquiry (including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted), approving an extension if warranted, and documenting the reasons for exceeding the 60-day period (or the 90-day period in cases involving research funded by NSF) in the record of the research misconduct proceeding.
10. Assisting the inquiry committee in preparing a draft inquiry report, sending the respondent a copy of the draft report for comment (and the complainant at the University's option) within a time period that permits the inquiry to be completed within the allotted time, taking appropriate action to protect the confidentiality of the draft report, receiving any comments from the respondent (and the complainant at the University's option), and ensuring that the comments are attached to the final inquiry report.
11. Receiving the final inquiry report from the inquiry committee and forwarding it, together with any comments the RIO may wish to make, to the DO who will determine in writing whether an investigation is warranted.
12. Within 30 days of a DO decision that an investigation is warranted (or immediately in cases involving research funded by NSF), providing the appropriate federal agency with the written finding and a copy of the inquiry report, if required, and notifying those University officials and administrators who need to know of the decision.
13. Notifying the respondent (and the complainant at the University's option) whether the inquiry found an investigation to be warranted and including in the notice copies of or a reference to the applicable federal regulations and this policy.
14. Providing to the appropriate federal agency, upon request, this policy or the University policies and procedures under which the inquiry was conducted, the research records and evidence reviewed, transcripts or recordings of any interviews, copies of all relevant documents, and the charges to be considered in the investigation.
15. If the DO decides that an investigation is not warranted, securing and maintaining for seven years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by the appropriate federal agency of the reasons why an investigation was not conducted.

D. Investigation

The RIO is responsible for:

1. Initiating the investigation within 30 days after the determination by the DO that an investigation is warranted (NOTE: In cases involving NSF, the investigation must be initiated promptly after the determination by the DO that an investigation is warranted.).
2. On or before the date on which the investigation begins, notifying the respondent in writing of the allegations to be investigated.
3. Prior to notifying respondent of the allegations, taking all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct proceeding that were not previously sequestered during the inquiry.
4. In consultation with other University officials and administrators as appropriate, appointing an investigation committee and committee chair as soon after the initiation of the investigation as is practical.
5. Preparing a charge for the investigation committee in accordance with this policy.
6. Convening the first meeting of the investigation committee and at that meeting:
   1. Briefing the committee on the charge, the inquiry report, and the procedures and standards for the conduct of the investigation, including the need for confidentiality and developing a specific plan for the investigation; and
   2. Providing committee members a copy of this policy or the University policies and procedures under which the investigation is being conducted and any applicable federal regulations.
   3. Providing the investigation committee with needed logistical support, including, but not limited to, expert advice (including forensic analysis of evidence) and clerical support (including arranging interviews with witnesses and recording or transcribing those interviews).
7. Being available or present throughout the investigation to advise the committee as needed.
8. On behalf of the University, the RIO is responsible for each of the following steps and for ensuring that the investigation committee:
   1. Uses diligent efforts to conduct an investigation that includes an examination of all research records and evidence relevant to reaching a decision on the merits of the allegations and that is otherwise thorough and sufficiently documented;
   2. Takes reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical;
   3. Interviews each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent, and records or transcribes each interview, provides the recording or transcript to the interviewee for correction, and includes the recording or transcript in the record of the research misconduct proceeding; and
   4. Pursues diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continues the investigation to completion.
9. Upon determining that the investigation cannot be completed within 120 days (or 180 days in cases involving research funded by NSF) of its initiation (including providing the draft report for comment and sending the final report with any comments to the appropriate federal agency, if required), submitting a request to the appropriate federal agency for an extension of the 120-day period (or the 180-day period in cases involving research funded by NSF) that includes a statement of the reasons for the extension, if required. If the extension is granted, the RIO will file periodic progress reports such federal agency, if required.
10. Assisting the investigation committee in preparing a draft investigation report that meets the requirements of this policy and the applicable law, sending the respondent (and complainant at the University's option) a copy of the draft report for his or her comment within 30 days of receipt, taking appropriate action to protect the confidentiality of the draft report, receiving any comments from the respondent (and complainant at the University's option) and ensuring that the comments are included and considered in the final investigation report.
11. Transmitting the draft investigation report to University legal counsel for a review of its legal sufficiency.
12. Assisting the investigation committee in finalizing the draft investigation report and receiving the final report from the committee.
13. Transmitting the final investigation report to the DO and:
    1. If the DO determines that further fact-finding or analysis is needed, receiving the report back from the DO for that purpose; or
    2. If the DO makes a determination to accept or reject the findings of the investigation and recommends University action, transmitting to the appropriate federal agency, within the time period for completing the investigation, a copy of the final investigation report with all attachments, a statement of whether the University accepts the findings of the report, a statement of whether the University found research misconduct, and if so, who committed it, and a description of any pending or completed administrative actions against the respondent, if required.
14. When a final decision on the case is reached, notifying both the respondent and the complainant in writing and determining whether law enforcement agencies, professional societies, professional licensing boards, editors of involved journals, collaborators of the respondent, or other relevant parties should be notified of the outcome of the case.
15. Maintaining and providing to the appropriate federal agency upon request all relevant research records and records of the University's research misconduct proceeding, including the results of all interviews and the transcripts or recordings of those interviews.