Research Misconduct Policy

Policy Statement & Background:

 Stony Brook University (hereinafter referred to as the University) is committed to fostering an environment that promotes research integrity and the responsible conduct of research and deals promptly with Allegations or Evidence of possible research misconduct. Research Misconduct is contrary to the interests of University, the health and safety of the public, the integrity of research, and the responsible use of public funds. Both the institution and its institutional members have an affirmative duty to ensure the integrity of all research conducted on behalf of Stony Brook University.

Scope and Applicability

 This policy and its procedures apply to all Research (as defined herein) conducted under the auspices of the University (funded or unfunded) and is limited to addressing Research Misconduct (as defined herein), not other types of misconduct.

When an Allegation of Research Misconduct relates to activities funded by a federal agency, this policy is intended to meet the requirements of that agency, including the Public Health Service (“PHS”) Policies on Research Misconduct (42 CFR Part 93) and the National Science Foundation (“NSF”) regulations (45 CFR Part 689), as applicable. In the event anything in this policy conflicts with applicable federal regulations, the regulations will prevail.

This policy applies to all Covered Individuals. In addition, the policy requires Research sub-awardees and subcontractors to inquire into and, if necessary, investigate and resolve promptly and fairly, all instances of alleged Research Misconduct related to the subaward or subcontract in compliance with applicable federal regulations. This policy applies regardless of whether an Allegation of Research Misconduct is received from a Complainant or is otherwise discovered during the course of regular business practices.

Policy:

The University strives to reduce the risk of Research Misconduct, support all good-faith efforts to report suspected misconduct, promptly and thoroughly address all Allegations of Research Misconduct, and seek to rectify the scientific/public record and/or restore researchers’ reputations, as appropriate.

All Covered Individuals are expected to conduct research with honesty, rigor, and transparency and are responsible for contributing to an organizational culture that establishes, maintains, and promotes research integrity and the responsible conduct of research. All Covered Individuals are required to have knowledge of and abide by the University’s standards for ethical conduct and Research integrity and are prohibited from committing or facilitating Research Misconduct as defined herein and by federal regulations.

All Covered Individuals will report observed, suspected or apparent Research Misconduct, and will cooperate with the Research Integrity Officer (hereinafter referred to as the RIO) and other University officials in the review of Allegations and the conduct of Inquiries and Investigations. All parties have an obligation to provide Research Misconduct information, Research Records, and other Evidence to the RIO or other University officials.

Failure to comply with this policy may result in administrative and/or disciplinary actions.

The University will thoroughly investigate, in a fair and timely manner, all Allegations brought forward by a Complainant acting in Good Faith, in which there is a credible reason to believe that an individual or individuals (hereafter referred to as the Respondent[s]) have committed Research Misconduct.

Responsible Parties

The Assistant Vice President for Research Compliance serves as the Research Integrity Officer (hereinafter referred to as the RIO) for the University. This individual has primary responsibility for implementation of the University's policies and procedures on Research Misconduct. In doing so, the RIO may delegate some or all responsibilities to, and/or work in conjunction with, a staff member from the Office of the Vice President for Research and Innovation.

The Vice President for Research and Innovation is the Institutional Deciding Official (hereinafter referred to as the IDO) for the University. The IDO makes the final determination on Allegations of Research Misconduct and any appropriate University actions. The IDO documents their determination in a written decision that includes whether Research Misconduct occurred, and if so, what kind, who committed it, and a description of the relevant actions the University has taken or will take. The IDO’s written decision becomes part of the Institutional Record.

Procedures

A.  General 

1. Discussing possible misconduct: All faculty, staff, and students will report observed, suspected, or apparent Research Misconduct to the Research Integrity Officer (RIO). If an individual is unsure whether a suspected incident falls within the definition of research misconduct, they may confer with the RIO about concerns of possible misconduct and will be counseled about appropriate procedures for reporting Allegations if deemed appropriate. The individual may also initially meet with, or contact, the RIO to discuss the suspected Research Misconduct informally, which may include discussing it hypothetically. If the circumstances described by the individual do not meet the definition of Research Misconduct, the RIO will refer the individual or Allegation to other offices as

2. Confidentiality:The RIO will (1) limit disclosure of the identity of Respondents and Complainants and Witnesses to those who need to know in order to carry out a thorough, competent, objective and fair Research Misconduct proceeding; and (2) except as otherwise prescribed by law, limit the disclosure of any records or Evidence from which research subjects might be identified to those who need to know in order to carry out a Research Misconduct proceeding. These can include public and private entities, journals, editors, publishers, and officials at other institutions.

3. Protecting Respondents, Complainants, Witnesses, and Committee Members: University members may not retaliate in any way against Respondents, Complainants, Witnesses, Inquiry/Investigation Committee Members or others involved in the Research Misconduct process. University members should immediately report any alleged or apparent Retaliation against these parties to the RIO, who will review the matter and, where appropriate, refer the matter to applicable University officials.

4. Triage and Precedence Procedures:The RIO, with assistance of legal counsel and others as required, will determine if an Allegation impacts multiple regulatory areas (e.g., human subjects, animal subjects, conflict of interest, grant expenditures, etc.). Review of the Allegation of misconduct will precede all other internal University proceedings that relate to or arise out of the alleged misconduct unless:

1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
2. A criminal investigation is being conducted (the internal process may commence once completed).
   
   Note: Misconduct involving a collaborating site will be handled through coordination between the institutional RIOs.

5. Sequestration: Part 93.307(b) requires sequestration of “all the Research Records and Evidence needed to conduct the Research Misconduct proceeding” beginning “on or before the date on which the Respondent is notified or the Inquiry begins, whichever is earlier.”
   
   When original Research Records cannot be obtained, copies of records that are “substantially equivalent in evidentiary value” will fulfill the sequestration requirement. Sequestration should occur whenever new records become known (in addition to the initial sequestration prior to the Respondent being notified of the Allegations).
   
   The investigation report must “identify and summarize the Research Records and Evidence reviewed, and identify any Evidence taken into custody but not reviewed.” There is no requirement that discussion of sequestration in either the Inquiry report or the investigation report occur. It is required however, that the Inquiry and investigation reports include an inventory of sequestered Evidence and a description of how sequestration was conducted, except for Evidence that the institution did not consider or rely on need not be identified. 

6. Conflict of Interest:If a conflict of interest is alleged by any party at any point in the Assessment, Inquiry or Investigation phases of the case, the RIO will review the Allegations and determine whether a conflict exists. A conflict exists if any Committee Member or expert has any relevant unresolved personal, professional or financial conflicts of interest (whether perceived or actual) with the parties involved or the subject matter, and there is a basis to believe that the individual could not conduct themselves in a thorough, competent, and fair manner. The RIO's decision regarding the existence of a conflict shall be final. If the RIO is alleged to have a conflict of interest the Vice President for Research and Innovation or if necessary, another qualified vice president or dean, shall determine whether a conflict exists and that decision shall be

7. Interim Administrative Actions and Notifying the Office of Research Integrity(where Public Health Service funds are involved) or the Office of the Inspector General (where National Science Foundation funds are involved) of Special Circumstances: Throughout the Research Misconduct process, the RIO will review the situation to determine if there is any threat of harm to public health, 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 ORI/OIG, take appropriate interim action to protect against any such threat. Interim action might include additional monitoring of the research process and the handling of funds and equipment, reassignment of personnel or the responsibility for the handling of funds and equipment, additional review of research data and results or delaying publication. The RIO must notify ORI/OIG immediately if, at any time during a research misconduct process, the RIO has reason to believe that any of the following conditions exist:

1. 1. Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
   2. Health and Human Services resources or interests are threatened;
   3. There is reasonable indication that research activities should be suspended;
   4. There is reasonable indication of possible violations of civil or criminal law; or
   5. Federal action is required to protect the interests of those involved in the research misconduct proceeding, (or, in the case of NSF funds, of others potentially affected).

B.  Making an Allegation of Research Misconduct

Allegations of Research Misconduct may be presented verbally or in writing by the Complainant to the RIO (see contact information at the end of this policy). The Complainant is responsible for making Allegations in Good Faith, and maintaining confidentiality. The Complainant must cooperate at all phases of the research misconduct process, including Inquiry and Investigation if required. If anonymity is requested, the RIO will use its best efforts to maintain such anonymity throughout the process.

C.   Assessment

The purpose of the Assessment is to conduct an initial review of the Allegation to determine whether it is:

1. Sufficiently credible and specific so that potential evidence of Research Misconduct may be identified and sequestered; and
2. Whether the Allegation falls within the definition of Research Misconduct.
   
   Note: Allegations of Research Misconduct submitted to the University by a federal entity may be considered by the RIO in consultation with the IDO as (1) credible and specific such that potential Evidence of Research Misconduct may be verified, and (2) to fall within the definition of Research Misconduct and may move directly to Investigation.
   
   Note: Allegations of Research Misconduct submitted to the University by a sponsor agency or a professional journal that include the findings of an Inquiry process in which the Respondent was notified and had an opportunity to comment, may be considered by the RIO in consultation with the IDO as (1) credible and specific such that potential Evidence of Research Misconduct may be verified, and (2) to fall within the definition of Research Misconduct and may move directly to Investigation.

Assessment Process

The RIO will:

• • Complete the Assessment following the receipt of an Allegation of Research Misconduct;
  • Consult (confidentially and as necessary) with legal counsel and others as deemed appropriate during the Assessment period;
  • Interview the Complainant, Respondent or other Witnesses, or gather data beyond any that may have been submitted with the Allegation as necessary to determine whether the Allegation is sufficiently credible and specific so that potential Evidence of Research Misconduct may be identified;
  • Notify the Respondent (if appropriate) in writing and provide opportunities for the Respondent to review/comment/respond to Allegations, review and provide a copy of the University's Research Misconduct Policy and advise the Respondent of the option to consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to advise during the Research Misconduct process;
  • Provide the Respondent reasonable supervised access to the Research Records, where appropriate;
  • Obtain custody of, inventory, and sequester research data, records and Evidence deemed pertinent to the Allegation of Research Misconduct and maintain it securely during the course of a Research Misconduct proceeding as soon as deemed necessary, preferably on or before the date of which the Respondent is notified of the Allegation. Chain of custody will be documented. Receipts will be provided for Evidence taken into The University has a duty to obtain, inventory, and securely sequester evidence whenever additional items become known or relevant to the inquiry or investigation;
  • Keep the IDO and others who need to know apprised of the progress of the review of the Allegation of Research Misconduct; &
  • Complete a written Assessment report (documenting the outcome of the Assessment) that describes the specific Allegation(s), the date received and source, description of Evidence gathered/reviewed, reasons for determination of whether or not an Inquiry is warranted, and, in the case where an Inquiry is warranted, provide guidance to the Inquiry committee on issues it might If the RIO determines that the alleged misconduct does not meet the criteria to proceed to an Inquiry, they will write a sufficiently detailed document to permit a later review of why the University did not proceed to an Inquiry. This documentation will be retained for seven (7) years.

D. Inquiry

The purpose of the Inquiry is to conduct an initial review of the available Evidence to determine whether to conduct an investigation (i.e., as soon as the Inquiry committee believes there is (or is not) Evidence to warrant an investigation, the Inquiry committee's job is done). An Inquiry does not require a full review of all the Evidence related to the Allegation.

Inquiry Process

The Inquiry process should be completed within 90 calendar days from its initiation. The Inquiry process is considered complete when the IDO decides whether an Investigation is warranted. If the RIO determines that circumstances clearly warrant a longer period, the Inquiry record will include documentation of the reasons for exceeding the 90-day period.  The RIO will submit any required status reports that may be required by the applicable oversight entity (e.g., ORI, OGI, DOD).

During the Inquiry Phase

The RIO will:

• • Make a good faith effort to notify the Respondent in writing. If the Inquiry subsequently identifies additional Respondents, they will be notified in All additional Respondents will be given the same rights and opportunities as the initial Respondent. Only Allegations specific to a particular Respondent will be included in the notification to that Respondent.;
  • Make a good faith effort to identify sponsored funds associated with the Allegations and notify sponsor(s) as may be required by sponsor policies and/or funding agreements;
  • If not done during the Assessment phase, take all reasonable and practical steps to immediately obtain custody of all the Research Record s and Evidence needed to conduct the Research Misconduct process, inventory the records and Evidence and sequester them in a secure manner, except that where the Research Record s 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;
  • Determine if an Inquiry committee will be formed.
    • The University may choose to have the RIO or another designated institutional official conduct the Inquiry in lieu of a committee, and, if needed, this individual may utilize one or more subject matter experts to assist them in the Inquiry. This selected individual will complete the tasks otherwise assigned to an Inquiry committee below.
    • If an Inquiry committee will be formed:
  • Appoint an Inquiry committee and committee chair as soon after the initiation of the Inquiry as is practical. The Inquiry committee will consist of individuals who do not have a conflict of interest with those involved with the Inquiry and should include individuals who have the professional time and resources, as well as the appropriate scientific expertise to evaluate the Evidence and issues related to the Allegation(s), interview the principals and key Witnesses, and conduct the Inquiry. Notify the Respondent of the proposed Committee Membership and provide the Respondent an opportunity to object to a proposed member. Objections must be provided to the RIO within 10 calendar days of the Respondent having been notified of the names of the Committee Members. The RIO will make the final determination regarding a challenge to a proposed Committee Member; and
  • Charge the Inquiry committee, with legal counsel present, as follows:
    • Inform the Inquiry committee that they are obligated to carry the process through to completion and to pursue diligently all significant issues;
    • Set forth the time for completion of the Inquiry;
    • Describe the Allegations and any related issues identified during the Assessment phase;
    • State that the purpose of the Inquiry is to conduct a review of the Evidence, including the testimony of the Respondent, Complainant and key Witnesses, as well as conducting interviews as appropriate to determine whether an Investigation is warranted, not to determine whether Research Misconduct definitely occurred or who was responsible;
    • State that an Investigation is warranted if the committee determines: (1) there is a reasonable basis for concluding that the Allegation(s) falls within the definition of research misconduct, and (2) the Allegation(s) may have substance, based on the committee's review during the Inquiry; &
    • Inform 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

The Inquiry Committee

The Inquiry committee or RIO (if no Inquiry Committee is formed) will:

• • Examine the relevant Research Record s and materials;
  • Interview the Complainant, the Respondent, and any key Witnesses as necessary. The Complainant, Respondent and any other parties interviewed will be given a copy of the transcript of their interview to confirm, within one week, the accuracy of the record (e.g., scientific terms used etc.). Then the Inquiry committee will evaluate the Evidence, including the testimony;
  • Engage additional expert analysis (e.g. forensic, statistical, or special analysis of the physical Evidence) as necessary;
  • Decide, in consultation with legal counsel and the RIO, whether an Investigation is warranted based on the criteria in this policy and any applicable sponsor regulations. The Inquiry committee does not determine whether Research Misconduct definitely occurred, assess whether the alleged Research Misconduct was intentional, knowing, or reckless, determine definitely who committed the Research Misconduct or conduct exhaustive interviews and analyses. Rather, the Inquiry committee determines whether preliminary fact-finding indicates that the Allegation(s) may have substance. 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, and if the RIO and Inquiry committee do not believe that other potential misconduct exists; and
  • Provide a final written Inquiry

Inquiry Report

The Inquiry committee or RIO (if no Inquiry Committee is formed) will prepare a written Inquiry Report in accordance with a template provided by the RIO.

At the conclusion of the Inquiry, regardless of whether an investigation is warranted, the Inquiry committee will prepare a written Inquiry report. The contents of a complete Inquiry report will include:

1. 1. The names, professional aliases, and positions of the Respondent and Complainant(s).
   2. A description of the Allegation(s) of Research Misconduct.
   3. Details about the PHS and non-PHS funding, including any grant numbers, grant applications, contracts, and publications listing PHS support.
   4. The composition of the Inquiry committee, if used, including name(s), position(s), and subject matter expertise.
   5. An inventory of sequestered Research Records and other Evidence and description of how sequestration was conducted.
   6. Transcripts of interviews, if transcribed and attached exhibits
   7. Inquiry timeline and procedural history.
   8. Any scientific or forensic analyses conducted.
   9. The basis for recommending that the Allegation(s) warrant an investigation.

• • • The basis on which any Allegation(s) do not merit further investigation.
    • Any comments on the Inquiry report by the Respondent or the Complainant(s).
    • Any institutional actions implemented, including internal communications or external communications with journals or funding agencies.
    • Documentation of potential Evidence of honest error or difference of opinion.

Inquiry Report Review

• • University counsel will review the Inquiry report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the Inquiry
  • The Complainant and Respondent will be given ten (10) calendar days from receipt of the Inquiry Report to comment on the Inquiry Report and have their comments considered by the Inquiry committee and attached to the report. Based on the comments, the Inquiry committee may revise the draft report as appropriate and prepare it in final

Final Report and Determination

• • The RIO will transmit the final Inquiry report and any comments from the Respondent and/or Complainant to the IDO; who will determine in writing whether an Investigation is warranted. The Inquiry is completed when the IDO makes this determination. When the IDO has reached a final decision on the case, the RIO will notify both the Respondent and the Complainant in
  • The RIO will notify the Respondent and Complainant in writing within 30 days of the determination of whether or not an Investigation is warranted (notification must be made before the Investigation begins), as well as any new Allegations (not addressed in the Inquiry or in the initial Allegation of misconduct). Prior to such notice, the RIO will 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
  • In cases where the IDO determines that an Investigation is not warranted. The RIO within 30 days of such determination will notify sponsors, Witnesses and other University offices (as appropriate).

Notification to Federal Oversight Agencies (as applicable)

Within 30 calendar days of the IDO's decision that an Investigation is warranted (and prior to the beginning of the investigation), the RIO will provide to the appropriate federal oversight agency (e.g., ORI or OIG) with the IDO's written decision and a copy of the Inquiry report. The RIO will provide the following information to ORI upon request: (1) the University policies and procedures under which the Inquiry was conducted; (2) the Research Records and Evidence reviewed, transcripts or recordings of any interviews (if applicable), and copies of all relevant documents; and (3) the charges to be considered in the Investigation.

Documentation of Decision Not to Investigate

If the IDO decides that an Investigation is not warranted, the RIO shall secure and maintain for seven (7) years after the termination of the Inquiry sufficiently detailed documentation of the Inquiry to permit a later Assessment (by the ORI or other oversight entity) of the reasons why an Investigation was not conducted.

E.   Investigation

The purpose of the Investigation is to develop a factual record by exploring the Allegations in detail and examining the Evidence in depth, leading to recommended findings on whether Research Misconduct has been committed, by whom, and to what extent. The Investigation will also determine whether there are additional instances of possible Research Misconduct that would justify broadening the scope beyond the initial Allegation(s) (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). The Investigation will begin within 30 calendar days after the determination by the IDO that an Investigation is warranted.

Investigation Process

The Investigation is to be completed within 180 days of beginning it, including conducting the Investigation, preparing the report of findings, providing the draft report for comment (and sending the final report to the appropriate oversight entity, as applicable). However, if the RIO determines that the Investigation will not be completed within this 180-day period, the RIO will submit to the appropriate oversight entity a written request for an extension, setting forth the reasons for the delay. If such extension is granted, the RIO will ensure that periodic progress reports are filed if directed to do so.

The RIO

The RIO will:

• • • Sequester any additional Research Records. 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;
    • Appoint an Investigation committee and the committee chair as soon after the beginning of the Investigation as is practical. The Investigation committee will consist of individuals who have the professional time and resources, and who do not have any conflict of interest with those involved with the Investigation. The Investigation committee should include individuals who have the appropriate scientific expertise to evaluate the Evidence and issues related to the Allegation, interview the Respondent and Complainant and any relevant Witnesses.
      • Individuals appointed to the Investigation committee may also have served on the Inquiry committee. When necessary to secure the necessary expertise or to avoid conflicts of interest, the RIO may select Committee Members from outside the University;
    • Notify the Respondent of the proposed Committee Membership to provide the Respondent an opportunity to object to a proposed member. Objections must be provided to the RIO within ten (10) calendar days of the Respondent having been notified of the names of the Committee Members. The RIO will make the final determination regarding a challenge to a proposed Committee Member;
    • Convene the first meeting of the Investigation committee, with legal counsel present, to:
      • Review the written charge to the committee, 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 procedures and federal regulations as appropriate (e.g., 42 CFR Part 93, 45 CFR 689, etc.) as well as all documents reviewed during the Inquiry. The RIO will be present or available throughout the Investigation to advise the committee as needed.
      • Inform the Investigation committee that they 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; The University has the burden of proof for making a finding of Research Misconduct. The Respondent has the burden of proving by a Preponderance of the Evidence any affirmative defenses raised, including honest error or a difference of opinion (The University will give due consideration to admissible, credible Evidence of honest error or difference of opinion presented by the Respondent);
      • Inform the Investigation committee of the definition of Research Misconduct and the standard of proof necessary to issue of finding of Research Misconduct; &
      • Inform the Investigation committee that they are responsible for preparing or directing the preparation of a written report of the Investigation that meets the requirements of this policy at the conclusion of the committee's investigation.

The Investigation Committee and the RIO

The Investigation Committee and the RIO will:

• • • Use diligent efforts to ensure that the Investigation is thorough and sufficiently documented and includes examination of all Research Records and Evidence relevant to reach a decision on the merits of each Allegation;
    • Take reasonable steps to ensure an impartial and unbiased Investigation;
    • Describe the weight given to the various Witnesses and pieces of Evidence, noting inconsistencies, credibility and persuasiveness;
    • Interview each Respondent, Complainant, and all other available individuals identified as having information regarding any relevant aspects of the Investigation, including Witnesses identified by the Respondent, and record or transcribe each interview, and will number all relevant exhibits and refer to any exhibits shown to the interviewee during the interview by that number. The RIO will provide the recording or transcript to the interviewee for correction (interviewee has 7 days to review the transcript and provide any feedback), and include the recording or transcript in the record of the Investigation;
    • Summarize each argument that the Respondent raised in his or her defense against the Allegation. Address each of the Respondent's arguments and explain whether any reasonable argument has merit, and if not, explain why not;
    • 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;
    • Note the use of additional expert analysis outside the Investigation committee including the forensic, statistical, or special analysis of the physical Evidence.
    • Identify the relevant research community, articulate the Accepted Practices in the Relevant Research Community, and how any Research Misconduct was a departure from these accepted practices (e.g., standards from professional societies, state and federal regulations and/or expert opinion); &
    • Provide a final written Investigation

Investigation Report

The Investigation committee, with guidance from the RIO, will prepare a written Investigation Report in accordance with a template provided by the RIO. The Investigation Report will include:

1. 1. Description of the nature of the Allegation(s) of Research Misconduct, including any additional Allegation(s) addressed during the Research Misconduct proceeding.
   2. Description and documentation of the PHS Support (if applicable), including any grant numbers, grant applications, contracts, and publications listing PHS Support. This documentation includes known applications or proposals for support that the Respondent has pending with PHS and non-PHS Federal agencies.
   3. Description of the specific Allegation(s) of Research Misconduct for consideration in the investigation of the Respondent.
   4. Composition of investigation committee, including name(s), position(s), and subject matter expertise.
   5. Inventory of sequestered Research Records and other Evidence, except records the institution did not consider or rely on. This inventory will include manuscripts and funding proposals that were considered or relied on during the investigation. The inventory will also include a description of how any sequestration was conducted during the investigation.
   6. Transcripts of all interviews conducted and attached exhibits.
   7. Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), PHS funding applications, progress reports, presentations, posters, or other Research Records that contain the allegedly falsified, fabricated, or plagiarized material.
   8. Any scientific or forensic analyses conducted.
   9. A copy of these policies and procedures.
   10. Any comments made by the Respondent(s) and Complainant(s) on the draft investigation report and the committee’s consideration of those comments.
   11. A statement for each separate Allegation of whether the committee recommends a finding of Research Misconduct.

If the committee recommends a finding of Research Misconduct for an Allegation, the investigation report will present a finding for each Allegation. These findings will: (a) identify the individual(s) who committed the research misconduct; (b) indicate whether the misconduct was falsification, fabrication, and/or plagiarism; (c) indicate whether the misconduct was committed Intentionally, Knowingly, or Recklessly; (d) identify any significant departure from the Accepted Practices of the Relevant Research Community and that the Allegation was proven by a Preponderance of the Evidence; (e) summarize the facts and analysis supporting the conclusion and consider the merits of any explanation by the Respondent; (f) identify the specific PHS support and other support (if applicable) and other support; and (g) state whether any publications need correction or retraction.

If the investigation committee does not recommend a finding of Research Misconduct for an Allegation, the investigation report will provide a detailed rationale for its conclusion.

Investigation Report Review

• • • University counsel will review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the Investigation
    • The RIO will give the Respondent a copy of the draft Investigation report for comment, and if requested, a copy of, or supervised access to, all documents on which the report is based. If a copy of the documents is requested, Respondent will be financially responsible for duplication costs. The Respondent will be allowed thirty (30) days from the date they receive the draft report to submit comments to the RIO. The Respondent's comments will be given to the Investigation committee for review and included in the final report. The report must be kept confidential by the
    • The RIO will provide the Complainant a copy of the draft Investigation report, or relevant portions of it, for comment. The Complainant's comments must be submitted within thirty (30) days of the date on which they receive the draft report and the comments will be included in the final report. The report must be kept confidential by the

Utilizing the Investigation Report - Decision by Institutional Deciding Official

The RIO will assist the Investigation committee in finalizing the draft Investigation report, including ensuring that the Respondent's (and Complainant's, as applicable) comments are included and will transmit the final Investigation report to the IDO, who will determine in writing: (1) whether they accept the Investigation report, its findings, and the recommended University actions; and (2) the appropriate University actions in response to the accepted findings of Research Misconduct. If this determination varies from the findings of the Investigation committee, the IDO will, as part of their written determination, explain in detail the basis for rendering a decision different from the findings of the Investigation committee. Alternatively, the IDO 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 notify both the Respondent and the Complainant in writing. After informing federal agencies as applicable (e.g., ORI, OIG), the IDO 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 IDO decisions and notification requirements of funding or sponsoring agencies.

F. University Administrative Actions

If the IDO 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, legal counsel, and others as deemed appropriate. The administrative actions may include:

• Withdrawal or correction of all pending or published abstracts and papers emanating from the research where Research Misconduct was found;
• Disciplinary actions in accordance with any applicable labor agreements;
• Restitution of funds to the grantor agency as appropriate; and
• Other action as appropriate.

G. Other Considerations

Additional Allegations

If during the Research Misconduct process additional Allegations of Research Misconduct are brought forth against the Respondent, the RIO shall notify the Respondent in writing within ten (10) days of receipt of the additional Allegations.

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 process or otherwise limit any of the University's responsibilities.

If the Respondent, without admitting to the misconduct, elects to resign their position after the University receives an Allegation of Research Misconduct, the Assessment of the Allegation will proceed, as well as the Inquiry and Investigation, as appropriate based on the outcome of the preceding steps. If the Respondent refuses to participate in the process after resignation, the RIO and any Inquiry or Investigation committee will use their best efforts to reach a conclusion concerning the Allegations, noting in the report the Respondent's failure to cooperate and its effect on the Evidence.

Finding of No Research Misconduct: Notification of Outcome and Expunging of Records

Following a final finding of no Research Misconduct (including, where applicable, ORI concurrence where required by 42 CFR Part 93), the RIO will, at the request of the Respondent and with approval by the IDO, undertake all reasonable and practical efforts to notify involved parties (Witnesses, etc.) of this outcome. Depending on the particular circumstances and the views of the Respondent, the RIO may 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.

Protection of the Complainant, Respondent, Witnesses, and Committee Members

During the Research Misconduct process and upon its completion, regardless of whether the University or applicable oversight agency (e.g., ORI, OIG) determines that Research Misconduct occurred, the RIO will undertake all reasonable and practical efforts 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 process. The IDO will determine, after consulting with the RIO, and with the Complainant, Witnesses, or Committee Members, respectively, what steps, if any, are needed to restore their respective positions or reputations or to counter potential or actual Retaliation against them. The RIO is responsible for implementing any steps the IDO approves.

H. Federal Agency Requirements

PHS Funded Activities

The Office of Research Integrity (ORI) oversees and coordinates PHS activities relating to misconduct.

Where PHS funds are involved, the requirements at 42 CFR 93 must be met by the University. Possible actions to be taken by ORI (including initiation of its own Investigation) are identified in 42 CFR 93, and should be noted.

Unless an extension has been granted, the RIO will, within the 180-day period for completing an Investigation, submit the following to ORI: (1) a copy of the final Investigation report with all attachments referenced in the report (include a list of attachments); (2) a statement by the IDO 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.

The RIO will maintain and provide to ORI upon request "records of Research Misconduct proceedings" (as defined by 42 CFR 93.317). Unless custody has been transferred to HHS or ORI has advised in writing that the records no longer need to be retained, records of Research Misconduct proceedings will be maintained in a secure manner for seven (7) years after completion of the proceeding or the completion of any PHS proceeding involving the Research Misconduct Allegation. The RIO is also responsible for providing any information, documentation, Research Records, Evidence or clarification requested by ORI to carry out its review of an Allegation of Research Misconduct or of the University's handling of such an Allegation.

The RIO will notify ORI promptly if there are plans to close a case at the Assessment, Inquiry or Investigation stages on the basis that Respondent has admitted guilt, a settlement with the Respondent has been reached, or for any other reason, except closing of a case at the Inquiry stage on the basis that an Investigation is not warranted.  The institution must provide the ORI with the Respondent's written admission, which details the misconduct and confirms that all elements for a finding of Research Misconduct under 42 CFR § 93.103 have been met. Additionally, an institutional statement must be submitted, explaining how the admission fully addresses the scope of the misconduct. 

If the Respondent admits to Research Misconduct, the institution will not close the case until providing ORI with the Respondent’s signed, written admission. The Respondent will sign a written statement specifying the affected Research Records and confirming the misconduct was falsification, fabrication, and/or plagiarism; committed Intentionally, Knowingly, or Recklessly; and that it constituted a significant departure from Accepted Practices of the Relevant Research Community.

For PHS funded activities, this policy applies only to Allegations of Research Misconduct that occurred within six years of the date the University or federal agency received the Allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions in 42 CFR 93.105(b) of PHS policy. The subsequent use exception applies to e-publication, or citation in processed data, journal articles, funding proposals or data repositories, submitted or published manuscripts, PHS grant applications, progress reports, posters, presentations, and other Research Records. If the subsequent use exception does not apply, institutions will document (and retain) how this determination was made.

National Science Foundation (NSF) Funded Activities

The Office of the Inspector General (OIG) oversees and coordinates NSF activities related to misconduct.

Where NSF funds are involved, the requirements set forth at 45 CFR 689 must be met by the University. Possible actions to be taken by OIG (including initiation of its own Investigation) are identified in 45 CFR 689, and should be noted.

If the University wishes NSF to defer conducting its own Inquiry and Investigation on the matter in question (specifically if the Allegations went directly to the NSF), NSF requires:

• • Immediate notification if an initial Inquiry supports a formal Investigation
  • Updates throughout investigations
  • Notification prior to decision to conduct an investigation if:
    • The seriousness of apparent misconduct warrants
    • If immediate health hazards are involved
    • If NSF's resources, reputation, or other interests needs protecting
    • If federal action may be needed to protect the interests of a subject of the Investigation or of others potentially affected, or
    • If the scientific community or the public should be informed.
  • Submission of the final report from any Investigation. The Office of the Inspector General (OIG) will assess the accuracy and completeness of the report and whether the investigating entity followed reasonable procedures.
  • Periodic status reports if the Inquiry stage takes longer than 90 days, or if the Investigation takes longer than 180 days (at which point, NSF may commence with its own Investigation).
  • Institutions must provide appropriate safeguards for informants and subjects of Allegations, but NSF does not have specific anti-retaliation or restoration of reputation provisions.

OIG may initiate its own Inquiry, or contact the University to encourage the initiation of an Inquiry if alleged misconduct is brought to its attention by means other than via reporting from the University.

If NSF conducts a formal Investigation, prompt written notice will be made to the individual or institutions to be investigated, unless notice would prejudice the Investigation, or unless a criminal Investigation is underway or under active consideration. In the case of consideration of a criminal Investigation by the Department of Justice, Federal Bureau of Investigation, etc., the OIG will determine what information may be disclosed to the subject of the Investigation. Specific procedures pertaining to inquiries, investigations and appeals are available in the NSF regulations on the matter (see 45 CFR 689).

There is no statute of limitations on NSF funded research. This includes the proposal or performance of NSF-funded research; reviewing research proposals submitted to the NSF; or reporting research results funded by NSF.

Department of Defense (DOD) Funded Activities

The DOD regulations cover a wide range of research and advanced technology development activities that use DOD resources.

The institution will have primary responsibility for responding to Allegations of Research Misconduct that it receives; however, DOD component may conduct the review if it determines that the institution is unable to conduct a thorough and unbiased Inquiry and investigation; or it is in the public interest for DOD to conduct the Inquiry/investigation; or Allegation involves a small organization or individual that can’t reasonably be expected to respond.

The institution must report to DOD official specified in award if Inquiry will proceed to investigation. The institution must provide the investigation report and evidentiary record to DOD official designated in the award. The institution must immediately notify DOD of special circumstances specified in Sec. E.4.1.6 of Enclosure 4 of DOD Instruction 3210.7. DOD funding components are responsible for developing their own implementing procedures based on this instruction. Implementing procedures may retain for the DOD component the right to exercise authorities that would otherwise be delegated to the institution.

The DOD includes an adjudication stage, with a time limit set by the DOD funding component, when the investigation outcome is reviewed and corrective outcomes are determined.  

There is no statute of limitations on DOD funded research.

Environmental Protection Agency (EPA) Funded Activities

The EPA regulations apply to all research conducted, sponsored or funded, in whole or in part, by the EPA and to research proposals submitted to EPA, including research conducted or managed for EPA by contractors, and funded by EPA and performed at research institutions (including universities and industrial facilities). Contractors must report to EPA Allegations of Research Misconduct occurring in research directly or indirectly under their control.

The institution generally will conduct the Inquiry or investigation, but EPA OIG has the option to do so, or may intervene in a proceeding conducted by the institution at any time. If the OIG begins an investigation, the institution must suspend its investigative work.

If the institution cannot, or believes it should not, conduct the Inquiry, it must report this to EPA and the contracting officer. At end of investigation, the recipient must provide an investigative report, evidentiary record, recommendations made to adjudicating official, and Respondent's written response (if any) to OIG. The EPA also includes an adjudication stage where consideration is given to what remedial actions are required. Recipient must forward adjudicating official's decision and notify OIG and EPA grants official of corrective actions taken. Institution is afforded a “reasonable period of time” to conduct adjudication.

After reviewing the Inquiry or investigation report, the EPA may request additional investigation, request OIG to conduct an investigation, or take administrative action as appropriate.

The institution must notify OIG immediately of the existence of any of the special circumstances listed under Sec. 7 of EPA Order 3120.5.

United States Department of Agriculture (USDA) Funded Activities

The USDA policy applies to all USDA-funded basic, applied, and demonstration research. The institution has the primary responsibility for conduct of Inquiry, investigation, and adjudication, but USDA reserves the right to conduct its own Inquiry and investigation in certain circumstances. Before the USDA will rely on an institution to conduct Research Misconduct proceedings, the institution must provide the USDA with its Research Misconduct policies and procedures for review and acceptance.

The institution must promptly notify USDA’s Agency Research Integrity Officer (ARIO) of any Allegations that move to investigation. At the conclusion of Inquiry, the institution must prepare a written report of the Inquiry that includes copies of all supporting documentation. However, the institution only needs to maintain the Inquiry report at the institution unless it is requested by the USDA.

The USDA reserves the right to conduct its own Inquiry, investigation, and adjudication into Allegations of Research Misconduct at the institution after the institution has conducted its own proceedings, including in instances where the institution did not follow its processes, did not conduct fair/unbiased proceedings, or did not complete the proceeding in a timely manner, or for any other reasons it considers appropriate. 

The institution must prepare an investigation report and provide report, evidentiary record, recommendations made to the adjudicating official, adjudicating official's determination, corrective action and any written response of Respondent to ARIO at completion of investigation. The institution must notify USDA OIG and ARIO of any of the special circumstances listed in 2 CFR 422.1(7).

The DOE has an adjudication stage where outcome of investigation is reviewed and appropriate corrective actions are taken. All stages are to be completed in a “timely manner.” 

Department of Energy (DOE) Funded Activities

The DOE policy applies to Allegations of Research Misconduct in connection with proposal, performance, or review of research for the DOE under a DOE contract or financial assistance agreement.

The DOE will include Research Misconduct requirements in contracts & financial assistance agreements that make the institution primarily responsible for handling Allegations of research misconduct.

If DOE receives Allegations directly, the DOE funding unit must consult with DOE OIG, and OIG may elect to investigate the Allegation or refer it to the institution.

The DOE has a formal review of record of investigation of alleged Research Misconduct to determine whether and what corrective actions and sanctions should be taken. This must be completed in 60 days of receipt of record of investigation. Regulations at 10 C.F.R. Part 733 do not specifically mention review phases.

National Aeronautics and Space Administration (NASA) Funded Activities

The NASA policy applies to research wholly or partially funded or supported by NASA, including any research conducted by a public or private entity receiving NASA funds or using NASA facilities, equipment or personnel, under a contract, grant, cooperative agreement, Space Act agreement, or other transaction with NASA.

The institution has primary responsibility for Inquiry, investigation, and adjudication for Research Misconduct alleged to have occurred at the institution. If Allegations are made directly to OIG, OIG may defer to the institution and wait for the results of the institution's review or conduct its own investigation. If OIG defers to the institution and does not receive results within a reasonable time, or it determines that the institution should cease handling the proceedings (e.g. NASA involvement is necessary to protect public health and safety; or the institution is too small to handle investigation; or the NASA program or project could be jeopardized by the research misconduct; or the institution does not provide necessary notifications to NASA), OIG can take over the investigation, conduct its own inquiry, or demand NASA’s direct involvement to ensure proper handling and protect the interests of NASA.

Notify NASA OIG if Inquiry supports moving to investigation. Provide NASA OIG with investigation report, including recommendations to adjudication official, evidentiary record, and any written comments from the Respondent. If an institution extends an Inquiry beyond 60 days or an investigation beyond 180 days, NASA may require it to provide progress reports. Notify NASA OIG of any special circumstances listed in 14 CFR 1274.103.

NASA has a formal procedure for reviewing and evaluating an investigation report and evidentiary record to determine whether to accept recommended findings and administrative actions. Investigation and adjudication must be completed in 180 days.

Definitions*:

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

Administrative Record: Administrative Record comprises the Institutional Record; any information provided by the Respondent to ORI, including but not limited to the transcript of any virtual or in-person meetings under § 93.403(b) between the Respondent and ORI, and correspondence between the Respondent and ORI; any additional information provided to ORI while the case is pending before ORI; and any analysis or additional information generated or obtained by ORI. Any analysis or additional information generated or obtained by ORI will also be made available to the Respondent.

Allegation: Allegation is a disclosure of possible Research Misconduct through any means of communication and brought directly to the attention of an institutional or HHS official.

Assessment: Assessment means a consideration of whether an Allegation of Research Misconduct appears to fall within the definition of Research Misconduct or activities related to that research or research training; and is sufficiently credible (convincing) and specific so that potential Evidence of Research Misconduct may be identified. The Assessment only involves the review of readily accessible information relevant to the Allegation. The RIO will promptly determine whether the Allegation (a) falls within the definition of research misconduct, (b) is within the applicability criteria of 42 CFR Part 93 § 93.102, as well as other regulations from other entities and (c) is credible and specific enough to identify and sequester potential Evidence. The Assessment will be conducted promptly upon receipt of the Allegations.

Committee Members: Committee Members refers to those individuals serving on either an Inquiry or Investigation committee. Committee Members are experts who act in Good Faith to cooperate with the Research Misconduct proceedings by impartially carrying out their assigned duties for the purpose of helping Stony Brook University meet its responsibilities under 42 CFR Part 93. Committee Members will have relevant scientific expertise and be free of real or perceived conflicts of interest with any of the involved parties.

Committee Members or anyone acting on behalf of Stony Brook University will conduct Research Misconduct proceedings consistent with the PHS regulations. They will determine whether an investigation is warranted, documenting the decision in an Inquiry report. During an investigation, Committee Members participate in recorded interviews of each Respondent, Complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including Witnesses identified by the Respondent (s). They will also determine whether or not the Respondent engaged in Research Misconduct and document the decision in the investigation report. They will consider Respondent and/or Complainant comments on the Inquiry/investigation report and document considerations in the investigation report.

Complainant: Complainant means an individual who in Good Faith makes an Allegation of research misconduct. The Complainant brings Research Misconduct Allegations directly to the attention of an institutional or HHS official through any means of communication. The Complainant will make Allegations in Good Faith, as it is defined in the PHS regulation, as having a reasonable belief in the truth of one’s Allegation or testimony, based on the information known to the Complainant at the time.

Covered Individual: For the purposes of this policy, any individual proposing, applying, conducting, assisting, advising, administering, facilitating, supervising, observing, having knowledge of, or in any manner participating in any aspect of research at, or under the auspices of, Stony Brook University. Covered Individuals may include, but are not limited to, faculty (including part-time faculty), staff, students, trainees, technicians, guest researchers, collaborators, consultants, and University affiliates. 

Evidence: Evidence means anything offered or obtained during a Research Misconduct proceeding that tends to prove or disprove the existence of an alleged fact. Evidence includes documents, whether in hard copy or electronic form, information, tangible items, and testimony.

Good Faith: (a) Good Faith as applied to a Complainant or witness means having a reasonable belief in the truth of one’s Allegation or testimony, based on the information known to the Complainant or witness at the time. An Allegation or cooperation with a Research Misconduct proceeding is not in Good Faith if made with knowledge of or reckless disregard for information that would negate the Allegation or testimony. (b) Good Faith as applied to an institutional or Committee Member means cooperating with the Research Misconduct proceeding by impartially carrying out the duties assigned for the purpose of helping an institution meet its responsibilities under 42 CFR Part 93. An institutional or Committee Member does not act in Good Faith if their acts or omissions during the Research Misconduct proceedings are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the Research Misconduct proceeding. The institution will take all reasonable and practical steps to protect the positions and reputations of good-faith Committee Members and to protect these individuals from Retaliation.

Inquiry: Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of § 93.307 through § 93.309 as well as regulations from other entities.

Institution: Institution means any person who applies for or receives PHS Support for any activity or program that involves the conduct of biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training. This includes, but is not limited to, colleges and universities, PHS intramural biomedical or behavioral research laboratories, research and development centers, national user facilities, industrial laboratories or other research institutes, research institutions, and independent researchers.

Institutional Deciding Official: Institutional Deciding Official (IDO) means the individual who makes final determinations on Allegations of Research Misconduct and any institutional actions. The Institutional Deciding Official cannot serve as the Research Integrity Officer.

Institutional Record: The Institutional Record is comprised of: (a) The records that the institution compiled or generated during the Research Misconduct proceeding, except records the institution did not consider or rely on. These records include but are not limited to (1) documentation of the Assessment as required by § 93.306(c); (2) if an Inquiry is conducted, the Inquiry report and all records (other than drafts of the report) considered or relied on during the Inquiry, including, but not limited to, Research Record s and the transcripts of any transcribed interviews conducted during the Inquiry, information the Respondent  provided to the institution, and the documentation of any decision not to investigate as required by § 93.309(c); (3) if an investigation is conducted, the investigation report and all records (other than drafts of the report) considered or relied on during the investigation, including, but not limited to, Research Records, the transcripts of each interview conducted pursuant to § 93.310(g), and information the Respondent  provided to the institution; (4) decision(s) by the Institutional Deciding Official, such as the written decision from the Institutional Deciding Official under § 93.314; (b) a single index listing all the Research Records and Evidence that the institution compiled during the Research Misconduct proceeding, except records the institution did not consider or rely on; and (c) a general description of the records that were sequestered but not considered or relied on.

The institution will provide information related to the alleged Research Misconduct and proceedings to ORI upon request and transfer custody or provide copies of the Institutional Record or any component of it and any sequestered Evidence to HHS, regardless of whether the Evidence is included in the Institutional Record. Additionally, the institution will promptly notify ORI of any special circumstances that may arise. All sequestered Evidence, regardless of whether it is part of the Institutional Record, will be maintained for the prescribed period [42 CFR 93.318(a)].

Intentionally: To act Intentionally means to act with the aim of carrying out the act.

Investigation: Investigation means the formal development of a factual record and the examination of that record that meets the criteria and follows the procedures of §§ 93.310 through 93.317 as well as regulations from other entities.

Knowingly: To act knowingly means to act with awareness of the act.

Multiple Institutions: Stony Brook University may work closely with the other affected institutions to determine whether a joint Research Misconduct proceeding will be conducted. For Allegations involving multiple institutions, one institution must be designated the lead in misconduct proceedings and will be responsible for obtaining Research Record s and witness testimonies from the other institutions.  By mutual agreement, the joint Research Misconduct proceeding may include Committee Members from the institutions involved. The determination of whether further Inquiry and/or investigation is warranted, whether Research Misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.

Multiple Respondents: Institutions must consider whether additional researchers are involved in the alleged misconduct. Specifically, institutions need to consider principal investigators, co-authors on publications, co-investigators, collaborators, and laboratory members during the Assessment, Inquiry, and investigation stages. Stony Brook University has the right to exercise judgment in deciding to consider whether other researchers are implicated.

If any additional Respondent (s) are identified during the investigation, the institution will notify them of the Allegation(s) and provide them an opportunity to respond consistent with the PHS regulation. If the institution identifies additional Respondent s during the investigation, it may choose to either conduct a separate Inquiry or add the new Respondent (s) to the ongoing investigation. The institution will obtain the original or substantially equivalent copies of all Research Record s and other Evidence, inventory these materials, sequester them in a secure manner, and retain them for seven years after its proceeding or any HHS proceeding, whichever is later.

An investigation into Multiple Respondents may convene with the same investigation Committee Members or anyone acting on behalf of Stony Brook University, but there will be separate investigation reports and separate Research Misconduct determinations for each Respondent. Stony Brook University may either conduct a separate Inquiry for each new Respondent or add them to the ongoing proceedings. The institution must give additional Respondent(s) notice of and an opportunity to respond to the Allegations. Committee Members may serve for more than one investigation, in cases with Multiple Respondents. Committee Members may also serve for both the Inquiry and the investigation.

Preponderance of the Evidence: Preponderance of the Evidence means proof by Evidence that, compared with Evidence opposing it, leads to the conclusion that the fact at issue is more likely true than not.

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

Recklessly: To act Recklessly means to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.

Research: Any systematic investigation, including research development, testing, and reporting, designed to develop or contribute to the body of knowledge in any field. The term research encompasses basic research, applied research, and experimental development (including research conducted as part of research training) in areas such as, but not limited to, biomedical and life sciences, natural sciences, engineering, humanities and arts, and social and behavioral sciences.

Research Integrity Officer: The Research Integrity Officer (RIO) refers to the institutional official responsible for administering the institution’s written policies and procedures for addressing Allegations of Research Misconduct in compliance with 42 CFR Part 93.

Research Misconduct: Research Misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

• Fabrication is making up data or results and recording or reporting them.
• Falsification is manipulating research materials, equipment, or processes or changing or omitting data or results such that the research is not accurately represented in the Research Record.
• Plagiarism means the appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit. (a) Plagiarism includes the unattributed verbatim or nearly verbatim copying of sentences and paragraphs from another’s work that materially misleads the reader regarding the contributions of the author. It does not include the limited use of identical or nearly identical phrases that describe a commonly used methodology. (b) Plagiarism does not include self-plagiarism or authorship or credit disputes, including disputes among former collaborators who participated jointly in the development or conduct of a research project. Self-plagiarism and authorship disputes do not meet the definition of research misconduct. Note: The National Science Foundation defines Research Misconductas fabrication, falsification, or plagiarism, whether committed by an individual directly or through the use or assistance of other persons, entities, or tools, including artificial intelligence (AI)-based tools, in proposing or performing research funded by NSF, reviewing research proposals submitted to NSF, or in reporting research results funded by NSF.

Research Misconduct may include the destruction, absence of, or Respondent's failure to provide Research Records where these actions constitute a significant departure from accepted practice of the relevant research community. Honest errors or differences of opinion are not considered to be Research Misconduct.

Research Misconduct exists when:

• • • There is a significant departure from Accepted Practices of the Relevant Research Community; and
    • The misconduct is committed Intentionally, knowingly, or Recklessly; and
    • The Allegation is proven by a Preponderance of the Evidence.

Research Misconduct Proceeding: Research Misconduct Proceeding means any actions related to alleged Research Misconduct taken under 42 CFR Part 93, including Allegation Assessments, inquiries, investigations, ORI oversight and reviews under subpart E of 42 CFR Part 93.

Research Record: Research Record means the record of data or results that embody the facts resulting from scientific Inquiry. Data or results may be in physical or electronic form. Examples of items, materials, or information that may be considered part of the Research Record include, but are not limited to, research proposals, raw data, processed data, clinical Research Records, laboratory records, study records, laboratory notebooks, progress reports, manuscripts, abstracts, theses, records of oral presentations, online content, lab meeting reports, and journal articles.

Respondent: Respondent means the individual against whom an Allegation of Research Misconduct is directed or who is the subject of a Research Misconduct Proceeding.

Retaliation: Retaliation means an adverse action taken against a Complainant, witness, or Committee Member by an institution or one of its members in response to (a) a Good Faith Allegation of Research Misconduct or (b) Good Faith cooperation with a Research Misconduct proceeding.

Suspension and Debarment Official: Suspension and Debarment Official or SDO means the HHS official authorized to impose suspension and debarment, which are the actions that Federal agencies take to disqualify persons deemed not presently responsible from doing business with the Federal Government.

Witnesses: Witnesses are people whom Stony Brook University has reasonably identified as having information regarding any relevant aspects of the investigation. Witnesses provide information for review during Research Misconduct proceedings. Witnesses will cooperate with the Research Misconduct proceedings in Good Faith and have a reasonable belief in the truth of their testimony, based on the information known to them at the time

Contact:

Additional information about this policy is available here:

Office of Research Compliance 

Assistant Vice President for Research Compliance and Research Integrity Officer (RIO)

W5530, Frank Melville Jr. Memorial Library 

Stony Brook, NY 11794-3368

Phone: (631) 632-9036

Fax: (631) 632-9839

https://www.stonybrook.edu/commcms/research-compliance/index.php

Relevant Standards, Codes, Rules, Regulations, Statutes and Policies:

• DHHS: Federal Research Misconduct Policy
• DHHS: ORI Policy on Plagiarism
• Stony Brook Office of Research Compliance Website, Research Misconduct

*All terminology herein follows the definitions established under the Public Health Service (PHS) regulations. In instances where another funding agency defines a term differently, the definition provided by that agency will govern.