Research Compliance Services

ClinicalTrials.gov

Title: ClinicalTrials.gov
Policy Owner: Research Compliance Services, Office of the Vice President for Research
Applies to: Employees, Faculty, Students, Other
Campus Applicability: All Campuses
Effective Date: May 25, 2018
For More Information, Contact Office of the Vice President for Research
Contact Information: (860) 486-3001
Official Website: http://research.uchc.edu/

REASON FOR POLICY

The purpose of this policy is to ensure investigators at the University comply with the requirements for registering and reporting results of clinical trials at ClinicalTrials.gov.

The University is committed to the mission of public availability of clinical trial information and to complying with the related requirements of the Food and Drug Administration (FDA), National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS) and other federal agencies and departments for using ClinicalTrials.gov.  Investigators for certain clinical trials are required to register and report results at ClinicalTrials.gov for certain clinical trials, including those involving the FDA, NIH, and CMS.  The International Committee of Medical Journal Editors (ICMJE) also imposes a similar requirement as a condition for seeking publication in participating journals.

APPLIES TO

All University faculty, employees, students, postdoctoral fellows, residents and other trainees, and agents who supervise or conduct clinical trials needing to be registered at ClinicalTrials.gov.

POLICY STATEMENT

It is the responsibility of the Principal Investigator (or other equivalent individual) supervising or conducting a clinical trial that must be registered at ClinicalTrials.gov to ensure that the registration, results reporting, related consent form and other applicable requirements are met with the required timeframes.  Any failure to fulfill these requirements may result in limitations on publications or grant submissions or other sanctions.

The University’s Protocol Registration and Results System (PRS) Administrator within Research Compliance Services is available to provide assistance in navigating the PRS system, administering requests by ClinicalTrials.gov, and with compliance questions related to these requirements.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, the University of Connecticut Student Code, and other applicable University Policies.

Authority

42 CFR part 11 (FDA)

NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NIH)

Medicare Clinical Trial Policies (CMS)

Clinical Trials (ICMJE)

POLICY HISTORY

Adopted: 5/25/2018 (Approved by President’s Cabinet)

Export Control and Economic Sanctions Policy

Title: Export Control and Economic Sanctions Policy
Policy Owner: Office of the Vice President for Research
Applies to: Workforce Members, Students, Others
Campus Applicability: All Campuses
Approval Date: November 19, 2025
Effective Date: November 19, 2025
For More Information, Contact Chief Research Security Officer, Research Security
Contact Information: exportcontrol@uconn.edu, or (860) 486-3619
Official Website: https://ovpr.uconn.edu/services/research-security/export-control/

BACKGROUND

Export control and economic sanctions regulations aim to protect the national security, foreign policy, and economic interests of the United States.  Export control regulations govern how certain information, technologies, and commodities can be transmitted overseas or to a foreign national on U.S. soil. Economic sanctions regulations restrict transactions with certain countries, institutions, and individuals. The scope of these regulations is broad: they cover exports in virtually all fields of science, engineering, and technology, apply to research activities regardless of the source of funding, and impose restrictions on activities by U.S. persons that occur outside the United States. These laws are collectively referred to as “Export Control Laws.” The University of Connecticut (UConn) encourages and supports open research and the free exchange of ideas. Although most university activities and research are exempt from export control laws, UConn engages in some activities, research, and the development of new technologies that are subject to Export Control Laws. Failure to comply with these laws can have serious consequences, both for the institution and for the individual researcher.

PURPOSE

To define the standards and responsibilities for complying with U.S. Export Control Laws and embargo regulations in all university activities, including research, instruction, travel, and the handling of controlled materials and information.

DEFINITIONS

Export Control Laws:  Laws and regulations implemented by the U.S. Department of Commerce through its Export Administration Regulations (EAR), the U.S. Department of State through its International Traffic in Arms Regulations (ITAR), as well as embargo regulations imposed by the U.S. Treasury Department through its Office of Foreign Assets Control (OFAC).

APPLIES TO

This policy applies to all workforce members, students, and all other individuals working on all University campuses, including UConn Health.

POLICY STATEMENT

UConn is committed to compliance with Export Control Laws.

The Office of the Vice President for Research (OVPR) is the designated authority charged with compliance oversight of the U.S. export control and economic sanctions requirements for UConn and has final authority on such matters.

Individuals acting on behalf of the University, including faculty, staff and students, are responsible for complying with applicable Export Control Laws, including requirements related to international travel, the proper handling, transfer, access, storage, control, and dissemination of export controlled hardware, software, information, technology, and technical data to destinations and persons outside of the U.S., as well as in some cases, to foreign nationals at the university engaging in instruction, conducting research, or providing service activities.

The University typically conducts fundamental research in basic and applied science or engineering, which is widely and openly published and made available to the scientific and academic community. This allows for the Fundamental Research Exclusion, which means the research results are exempt from Export Control Laws. But Export Control Laws could apply if the research is not considered fundamental research, or if the research has restrictions on publication, foreign national participation, or restricted access to/disclosure of research results.  Please contact the Export Control Office if you have any questions on whether Export Control Laws apply to your particular activity.

The University will not permit or support travel to any country subject to a comprehensive U.S. Government embargo (as set forth in the UConn International Travel procedure), unless the travel falls within the scope of a license or exception granted by law and is reviewed and receives written approval in advance by the OVPR Export Control Office.

ENFORCEMENT

Violations of this policy and any related procedures may result in appropriate disciplinary measures in accordance with University By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, and the University of Connecticut Student Code.

The civil and criminal penalties associated with violating Export Control Laws can be severe, ranging from administrative sanctions including loss of research funding, to monetary penalties, and imprisonment.

PROCEDURES

Export control compliance protocols and procedures are available online at: Export Control | Office of the Vice President for Research

POLICY HISTORY

Policy created: 12/14/2014 (Approved by the Vice President for Research)

Revisions:
1/12/2016 (Approved and Adopted by the UConn Health Policy Committee)
7/3/2018 (Non-Substantive edits per the Office of General Counsel)
9/18/2018 (Non-Substantive edits per the Office of General Counsel)
11/17/2025 (Approved by the Senior Policy Council and President)

Policy on Alleged Misconduct in Research

Title: Policy on Alleged Misconduct in Research
Policy Owner: Office of the Vice President for Research
Applies to: Workforce Members
Campus Applicability: All Campuses
Approval Date: November 19, 2025
Effective Date: January 1, 2026
For More Information, Contact Director, Financial Conflicts of Interest and Research Integrity
Contact Information: Meg.Johnson@uconn.edu
Official Website: https://ovpr.uconn.edu/
https://ovpr.uchc.edu/

BACKGROUND

The University of Connecticut, including its Regional Campuses and its academic medical center UConn Health (together, the “Institution”), is committed to fostering an environment that promotes the responsible conduct of research, encourages reporting of any research-related concerns, protects those who report such concerns in Good Faith, and promptly and effectively addresses any Allegations or credible evidence of Research Misconduct. This policy is made available by the Institution to advise the public of this commitment and Workforce Members of associated obligations.

PURPOSE

This Policy is intended to comply with applicable regulations[1] and policy requirements for addressing Research Misconduct.

APPLIES TO

This Policy applies to all Workforce Members, regardless of funding or funding source, involved in research, training, or activities related to research, such as, but not limited to, the operation of tissue and data banks and the dissemination of research information proposed, performed, reviewed, or reported, or any Research Record generated from that research, which is conducted using the facilities, resources, or funds of the Institution.  This Policy applies to Allegations reported to the Research Integrity Officer (RIO) on or after the Effective Date.

DEFINITIONS

Accepted practices of the relevant research community: This term means those practices established by applicable regulation and funding agencies, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive such research awards.

Allegation: Allegation means a disclosure of possible Research Misconduct through any means of communication and brought directly to the attention of the Research Integrity Officer.

Assessment: Assessment means a consideration of whether an Allegation of Research Misconduct appears to fall within the definition of Research Misconduct and is sufficiently credible and specific so that readily available potential evidence of Research Misconduct relevant to the Allegation may be identified to move to an Inquiry.

Committee or Consortium (Committee): For purposes of this Policy, a Committee is a group of individuals with appropriate expertise appointed by the RIO to conduct Research Misconduct Proceedings consistent with the applicable regulation and funding agency requirements. The Committee participates in recorded interviews of each Respondent, Complainant, Witnesses, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the Investigation, pursues leads, examines records and evidence and determines, when conducting an Inquiry, whether an Investigation is warranted; and when conducting an Investigation, advises on whether the Respondent(s) engaged in Research Misconduct.  Committee or Consortium members may serve for more than one Inquiry or Investigation and/or in cases with multiple Respondents.  Committee members may also serve for both the Inquiry and the Investigation.

Complainant: Complainant means an individual who in Good Faith makes an Allegation of Research Misconduct.

Day: Day, as applied to this Policy, means calendar day unless otherwise specified. If a deadline falls on a Saturday, Sunday, or Federal holiday, the deadline will be extended to the next day that is not a Saturday, Sunday, or Federal holiday.

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.

Fabrication: Fabrication means making up data or results and recording or reporting them.

Falsification: Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the Research Record.

Good Faith:

(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. 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.

Inquiry: Inquiry means preliminary information-gathering and preliminary fact-finding as described in this Policy.

Institutional Certifying Official: Institutional Certifying Official (ICO) means the Institutional official who assures, on behalf of the Institution, that the Institution has written policies and procedures for addressing allegations of research misconduct and complies with its own policies and procedures. The Institutional Certifying Official is also responsible for ensuring the submission and certifying the content of the Institution's annual report as required by applicable law or policy.

Institutional Deciding Official: Institutional Deciding Official (IDO) means the Institutional official who evaluates whether the burden of proof necessary for an Investigation Committee’s determination has met the burden of proof, gives due consideration to admissible, credible evidence of honest error or difference of opinion from Respondent, and makes final determinations on Allegations of Research Misconduct and any Institutional actions. The Research Integrity Officer cannot also serve as the IDO.

Institutional Record: The Institutional Record consists of the records that were compiled or generated during the Research Misconduct Proceeding, except records the Institution did not rely on, and includes:

  • A single index listing all Research Records and evidence;
  • All records considered or relied on during the Investigation;
  • A general description of the records that were sequestered but not considered or relied on.
  • Documentation of the Assessment;
  • The Inquiry Report;
  • The Investigation Report;
  • The Institutional Deciding Official’s final decision; and
  • Any information the Respondent provided to the Institution in connection with the Investigation.

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

Interview: As designated by the RIO or the Investigation or Inquiry Committee Chair, Interview during the Research Misconduct process shall mean a discussion with a Respondent, Complainant or Witness by the convened Investigation or Inquiry Committee.

Investigation: Investigation means a formal examination and evaluation of relevant facts to determine whether Research Misconduct has taken place or, if Research Misconduct has already been confirmed, to assess its extent and consequences and determine appropriate action.

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

Plagiarism: 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.

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.

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 Integrity Officer: The Research Integrity Officer (RIO) refers to the Institutional official appointed by the Vice President for Research, Innovation and Entrepreneurship who is responsible for administering the Institution’s written policies and procedures for addressing Allegations of Research Misconduct in compliance under this Policy and applicable regulations. The RIO cannot also serve as the Institutional Deciding Official.

Research Misconduct: A finding of “Research Misconduct” is required following the material completion of the processes dictated by this Policy if, by a preponderance of the evidence, it is proven that:

  1. Respondent(s) intentionally, knowingly, or recklessly committed fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results; and
  2. Such conduct represents a significant departure from the accepted practices of the relevant research community.

Research Misconduct does not include honest error or differences of opinion.

Research Misconduct Proceeding: Research Misconduct Proceeding means any actions related to alleged Research Misconduct taken under this Policy and applicable regulations including Allegation assessments, Inquiries, Investigations, funding agency oversight reviews, and appeals.

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.

Witnesses: Witnesses are people whom the Institution has reasonably identified as having information regarding any relevant aspects of the Investigation. Witnesses provide information for review during Research Misconduct Proceedings.

Workforce Members: Workforce Members are employees, volunteers, trainees, and other persons whose conduct, in the performance of work for the Institution, is under the direct control of the Institution, whether or not they are paid by the Institution.

POLICY STATEMENT

The design, conduct, oversight and reporting of research must be carried out with the highest standards of integrity and ethical behavior to ensure that the research has a fundamental value upon which scientific inquiry and discovery are founded. Therefore, Research Misconduct is prohibited.  Allegations of Research Misconduct will be addressed in accordance with this policy and applicable regulations.

Workforce members are required to comply with this Policy and applicable regulations, and violations of this Policy and/or applicable regulations may result in appropriate disciplinary measures in accordance with University By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, and, when applicable, the Student Code of Conduct.

ROLES AND RESPONSIBILITIES:

A. Responsibility to Report Misconduct

Anyone having reason to believe that a Workforce Member or Student has engaged in Research Misconduct has a responsibility to report pertinent facts in accordance with this Policy.

All Allegations must be made in Good Faith, as defined in this Policy. If at any point it is determined that an Allegation of Research Misconduct was not made in Good Faith, this finding will be conveyed in writing to appropriate University offices for review and made a part of any Inquiry or Investigative report.

B. Responsibility to Cooperate with Research Misconduct Proceedings

The Respondent, the Complainant and all Individuals who are identified as having information relevant to the Investigation must 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.

C. Responsibility to Maintain Confidentiality

All individuals involved in the Research Misconduct process have a duty to maintain confidentiality throughout the Research Misconduct Proceedings, only disclosing records and evidence, the identity of research participants and the identity of Respondent(s), Complainant(s) and Witnesses to those who need to know as determined by the Institution consistent with the purpose of a thorough, competent, objective and fair Research Misconduct Proceeding[2], or as permitted or required by applicable law. The Identity of Respondent(s), Complainant(s) and Witness(es) may be shared with other Respondent(s), Complainant(s) and Witness(es) during the Misconduct Process including through unredacted transcripts records.

The foregoing limitation on disclosure of the identity of the Respondent, Complainant, and Witnesses no longer applies once the Institution has made a final determination of whether Research Misconduct occurred. Confidentiality obligations do not prohibit the Institution from managing published data or acknowledging that data may be unreliable.

D. Responsibility to Provide Relevant and/or Requested Records and Information

Complainant(s), Respondent(s), Witnesses and other Workforce Members involved in a Research Misconduct Proceeding have a duty to provide information, Research Records, and other Evidence relevant to the review.

The Respondent has an obligation to provide relevant and/or requested Research Records. Destruction of relevant and/or requested Research Records, or failure to provide relevant and/or requested Research Records, is evidence of Research Misconduct when:

  • A preponderance of evidence establishes that the Respondent intentionally or knowingly destroyed records after being informed of the Research Misconduct Allegations; and/or
  • The Respondent claims to possess the records but refuses to provide them upon request.

E. Protection of Complainants, Witnesses, Committee Members and others involved in the Research Misconduct process

The Institution will maintain confidentiality with regard to the identity of Complainants and Witnesses as provided in (C), above. The Institution will take all reasonable and practical steps to protect the positions and reputations of Committee Members, Complainants, Witnesses and others involved in the Research Misconduct process to protect these individuals from retaliation.

F. Protection of Respondent

The Institution will maintain confidentiality with regard to the identity of Respondent(s) as provided in (C) above.  If no finding of Research Misconduct is made against Respondent(s), the Institution will make all reasonable, practical efforts, if requested and as appropriate, to protect or restore the reputation of Respondent(s).

G. Notification to and cooperation with applicable funding agencies or regulatory authorities

Upon request, or as required by applicable law or policy, the Institution will cooperate with applicable agencies or regulatory authorities during any Research Misconduct Proceeding, including providing information related to the Research Misconduct Proceedings and transferring custody or copies of the Institutional Record or any component of it and any sequestered evidence to such agencies or regulatory authorities.  The Institution will address deficiencies or additional Allegations in the Institutional Record if directed by the applicable funding agency or regulatory authority.

H. Expertise and Conflicts

The Institution will take reasonable precautions to ensure that individuals responsible for carrying out any part of the Research Misconduct Proceeding do not have potential, perceived, or actual personal, professional, or financial conflicts of interest with the Complainant(s), Respondent(s) or Witnesses.  The Institution will confirm that members of any Committee or any person acting on the Institution’s behalf that conducts Research Misconduct Proceedings, has the relevant scientific expertise to evaluate the evidence and issues related to the Allegation.  The Institution will provide the requisite training and ongoing support to persons involved in evaluation of evidence and issues related to the Allegation so that the review is in compliance with applicable regulation and/or Federal policy.

PROCEDURES

Misconduct Proceedings

The stages of handling an Allegation of Research Misconduct include: Routing of the Allegation, Institutional Assessment and, if the Allegation proceeds beyond Institutional Assessment, Sequestration of Research Records and other evidence, Institutional Inquiry, Institutional Investigation, Determination and Completion. The Institution will respond to each Allegation of Research Misconduct in a thorough, competent, objective, timely, and fair manner.

I. Routing an Allegation of Research Misconduct

1. Routing of Allegations
Allegations of Research Misconduct may be directed to the RIO or through established reporting procedures, such as the Institution’s ethics hotline. Regardless of the reporting method, all reports or concerns involving actual or potential Research Misconduct must be promptly referred to the RIO.

2. Referral to Other Institutional Entities and Outside Organizations:
The RIO will refer the report of an Allegation to other appropriate offices or officials within the Institution as the RIO believes appropriate, or as required by policy or regulation. The RIO may refer an Allegation to or collaboratively evaluate Allegations with an outside organization when an Allegation involves Respondent(s) that are not Workforce Members or involves activities of a Workforce Member while at an outside organization.If the circumstances described do not meet the definition of Research Misconduct, the RIO may refer the individual or concerns raised by the Allegation to other offices or officials with responsibility for addressing the concerns raised, informing such offices or officials that the concerns do not implicate this Policy.

II. Institutional Assessment and Sequestration

1. Purpose

The Purpose of the Institutional Assessment is for the RIO or designee to determine whether an Allegation warrants an Inquiry. An Inquiry is warranted if the Allegation:

  • If proven would fall within the definition of Research Misconduct under this Policy; and
  • is sufficiently credible and specific so that potential evidence of Research Misconduct may be identified.

2. Timeline for Institutional Assessment

    The RIO or designee will conduct the Institutional Assessment as soon as practicably possible after receipt of the Allegation(s).

    3. Order of Events

    • Conduct of the Assessment
      The RIO or designee will assess the Allegation(s) based upon readily accessible information relevant to the Allegation.
    • Conclusion of the Assessment
      If the RIO or designee determines that requirements for an Inquiry are met, they will:

      • Document the outcome of the Assessment;
      • Promptly initiate an Inquiry in accordance with this Policy and applicable regulations, and
      • Promptly sequester all Research Records and other evidence in accordance with this Policy and applicable regulations.

    If the RIO or designee determines that an Inquiry is not warranted, the RIO will document the outcome of the Assessment and the Institution will keep sufficiently detailed documentation to permit a later review of the reasons why the Institution did not conduct an Inquiry and retain the documentation for the length of time as required by applicable policy or regulation, or at least seven years, whichever is longer, after completion of the Assessment.

    4. Sequestration of Research Records and other Evidence

    The RIO or designee is required and has the authority to sequester records and other evidence throughout the entirety of the Research Misconduct Proceeding. The RIO or designee will seek the cooperation of the Respondent(s) and potentially Witnesses and others involved in the Research in identifying and sequestering records and evidence.

    When Research Records and other evidence are sequestered, the RIO or designee will:

    • Inventory sequestered records and other evidence,
    • Sequester the materials in a secure manner, and
    • Maintain sequestered records in accordance with Institutional Policy and applicable law.

    If Research Records or other evidence are located on or encompass scientific instruments shared by multiple users, the Institution may obtain copies of the data or evidence from such instruments, so long as those copies are substantially equivalent in evidentiary value to the instruments.  If not, then the evidence sequestered may include the instruments.

    With reasonable notice, the Respondent(s) will be provided copies of, or reasonably supervised access to, the sequestered Research Records.

    III. Institutional Inquiry

    1. Purpose:

    The purpose of an Institutional Inquiry is to conduct an initial review of evidence following the determination of the Institutional Assessment regarding whether the Allegation:

    • Falls within the definition of Research Misconduct and is within the scope of this Policy; and
    • Is sufficiently credible and specific so that potential evidence of Research Misconduct may be identified.

    The Institutional Inquiry only evaluates whether an Investigation is warranted.  The Institutional Inquiry does not determine if fabrication, falsification or plagiarism occurred or whether alleged misconduct was Intentional, Knowing or Reckless. An Inquiry does not require a full review of all the evidence related to the Allegation.

    2. Timeline for Institutional Inquiry

    The Inquiry should be completed within ninety (90) Days after the start date of the Inquiry unless circumstances warrant a longer period. The Inquiry’s start date is the date that the RIO or designee commences the Inquiry following notification to Respondent or when the Inquiry Committee meets to review the Allegation of Research Misconduct.

    If the Inquiry takes longer than ninety (90) Days to complete, the RIO will inform the IDO and the Respondent of the basis for the extension and the Inquiry report will document the reasons for exceeding the 90 Day period.

    3. Order of Events:

    A. Notification to Respondent(s):

    At the time of initiation of the Institutional Inquiry, or prior, the RIO will make a reasonable effort to notify all identified Respondent(s) in writing that a Research Misconduct Inquiry has been initiated and describe the nature of the Allegation. During the Inquiry:

    • If additional Allegations are raised, the Respondent(s) will be notified in writing of the additional Allegations raised against them.
    • If additional Respondents are identified, the new Respondents will also be given written notification of the Allegations and will be given the same rights and opportunities as afforded to the initial Respondent. A new, separate Misconduct Proceeding for any additional Respondents is not required.
    • Only Allegations specific to a particular Respondent are to be included in the notification to that Respondent.
    • In all cases, the notification to the Respondent will include a copy of the Allegation and a copy of this policy.

    B. Conduct of the Institutional Inquiry

      The Inquiry can be conducted by either the RIO or designee with utilization of subject matter experts as needed or a Committee with members appointed by the Institutional Deciding Official (IDO). The RIO, designee or Committee will perform a preliminary review of the evidence to evaluate whether an Investigation is warranted by evaluation of:

      • Whether there is a reasonable basis for concluding that the Allegation falls within the definition of Research Misconduct under applicable regulations and this Policy; and
      • Whether preliminary information-gathering and fact-finding from the Inquiry indicates that the Allegation may have substance; and
      • Whether there is potential evidence of honest error or difference of opinion.

      C. Conclusion of the Institutional Inquiry

      Documenting the Institutional Inquiry

      Regardless of outcome, the RIO, designee, or Committee will prepare a written Inquiry report.  The Inquiry report will contain:

      • The names, professional aliases, and positions of the Respondent and Complainant(s).
      • A description of the Allegation(s) of Research Misconduct.
      • Details about applicable funding agency support, including any grant numbers, grant applications, contracts, and publications listing support.
      • The composition of the Inquiry Committee, if used, including name(s), position(s), and subject matter expertise.
      • An inventory of sequestered Research Records and other evidence and a description of how sequestration was conducted.
      • Transcripts of any interviews that were transcribed.
      • Inquiry timeline and procedural history.
      • Any scientific or forensic analyses conducted.
      • The basis for recommendations on Allegation(s) which warrant an Investigation (if any) and which any Allegation(s) do not merit further Investigation (if any).
      • 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.

      Opportunity to Comment on the Draft Inquiry Report

      The RIO or designee will give the Respondent a copy of the draft Inquiry report for review and comment, along with a copy of this Policy and a copy of or reference to the applicable Research Misconduct regulations.  The Respondent must provide any comments in writing within ten (10) Days of receipt of the draft Inquiry Report.  The RIO may, but is not required to, provide relevant portions of the report to a Complainant for comment.  The Complainant must provide any comments in writing within ten (10) Days of receipt of the draft Inquiry report.

      Final Inquiry Report and Notification

      The RIO will prepare the final Inquiry report, which will include any comments on the report by the Respondent and/or Complainant(s). The RIO will notify the Respondent of the Inquiry’s final outcome and provide the Respondent with copies of the final Inquiry report along with a copy of this Policy and a copy of or reference to the applicable Research Misconduct regulations. The RIO may, but is not required to, notify a Complainant of whether the inquiry found that an Investigation was warranted.  If the Institution provides such notice to one Complainant involved in the Inquiry , it must provide notice, to the extent possible, to all Complainants involved in the Inquiry.

      If the Inquiry results in a determination that an Investigation is warranted, the RIO or designee will:

      • Provide written notification to Respondent(s) as outlined above, along with any Allegations of Research Misconduct not addressed during the Inquiry; and
      • Provide the applicable funding agency or regulatory authority with a copy of the written decision and Inquiry report (with all attachments) within 30 days of determination.
      • In cases involving current or former students, the Institution will only release educational records to third parties or those within the Institution without a need to know to the extent required or permitted by applicable law (including, without limitation, lawfully issued subpoena or court order).[3]

       If the Inquiry results in a determination that an Investigation is not warranted, the Institution will:

      • keep sufficiently detailed documentation of the Inquiry to permit a later review by an applicable funding agency or regulatory authority of why the Institution did not proceed to an Investigation;
      • store such documentation in a secure manner for the length of time as required by applicable funding agency policy, or at least seven years, after the termination of the inquiry, and
      • provide such documentation to applicable funding agency or regulatory authority upon request.

      IV. Institutional Investigation

      1. Purpose

      The purpose of an Investigation is to formally develop a factual record, pursue leads, examine the record, and recommend finding(s) to the Institutional Deciding Official (IDO) in order to facilitate the IDO’s final decision, based on a preponderance of evidence, on each Allegation and any Institutional actions.

      2. Timeline

      The Institution shall begin the Investigation within 30 Days after an Inquiry determination that an Investigation is warranted.

      All aspects of the Investigation shall be completed within 180 Days. If the Investigation requires more than 180 Days to complete, the Institution will ask the applicable funding agency or regulatory authority in writing for an extension, including circumstances or issues warranting additional time in excess of the 180-day Investigation period, file progress reports with applicable agencies or regulatory authorities if directed and document the reasons for exceeding the 180 Day Investigation period in the final Investigation Report.

      3. Order of Events

      A. Appointment of Investigation Committee:

      The IDO will appoint an Investigation Committee and Investigation Committee Chair with appropriate scientific or other expertise who are also free of unresolved personal, professional or financial conflicts of interest in relation to the Investigation.  The Committee may include members from outside of the Institution when necessary to secure expertise or to avoid conflicts of interest.

      The Complainant(s) and Respondent(s) will be provided with a list of the Inquiry Committee’s membership.  The Complainant(s) and/or Respondent(s) may object to any Committee member who they believe in Good Faith has a personal, professional, or financial conflict of interest.  Any such objection must be in writing specifying the basis for asserting a conflict of interest and be submitted to the RIO no more than 10 Days following notification regarding the committee membership. The RIO will submit the objection to the IDO, who will review it and determine whether any action should be taken with respect to such Committee member(s).

      In the event a Committee member becomes unable or unwilling at any point to serve on the Committee, the IDO may appoint a replacement member. The RIO is available to the Committee but may not serve as a member of the Committee.

      Once the Committee Members and Chairs are identified, the IDO will appoint the Committee and Committee Chair in writing, and provide to the Committee a written charge which:

      • informs the Committee of the purpose of Investigation, as described in this Section;
      • informs the Investigation Committee that it must conduct the Investigation in accordance with this Policy;
      • identifies the Respondent(s);
      • defines “Research Misconduct”;
      • describes the Allegation(s) and related issues identified during the Inquiry; and
      • informs the Investigation Committee that it must prepare a written Investigation Report that meets the requirements of Section IV.3.C. and IV.3.D. below.

      B. Conduct of the Investigation

      As part of its Investigation, the Institution, through the Investigation Committee, will pursue diligently all significant issues and relevant leads, including any evidence of additional instances of possible Research Misconduct, and continue the Investigation to completion. In the course of the Investigation, the Institution will:

      • Use diligent efforts to ensure that the Investigation is thorough, sufficiently documented, and impartial and unbiased to the maximum extent practicable.
      • Notify the Respondent(s) in writing of any additional Allegation(s) raised against them during the Investigation
      • Number all relevant exhibits and refer to any exhibits shown to the interviewee(s) during the interview(s) by that number.
      • Record and transcribe interviews during the Investigation and make the transcripts available to the interviewee for correction.
      • Include the transcript(s) with any corrections and exhibits in the Institutional Record of the Investigation.

      The Respondent(s) will not be present during Witness interviews, but the Institution will provide the Respondent(s) with a transcript of each interview.

      C. Investigation Report

        1. Draft Investigation Report

      The Institution will prepare a draft Investigation Report for each Respondent.  The Investigation report for each Respondent will include:

      • Description of the nature of the Allegation(s) of Research Misconduct, including any additional Allegation(s) addressed during the Research Misconduct Proceeding.
      • Description and documentation of funding support, including any grant numbers, grant applications, contracts, and publications listing funding support. This documentation includes known applications or proposals for support that the Respondent(s) has pending with applicable agencies.
      • Description of the specific Allegation(s) of Research Misconduct for consideration in the Investigation of the Respondent.
      • Composition of Investigation Committee, including name(s), position(s), and subject matter expertise.
      • 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 sequestration was conducted.
      • Transcripts of all interviews conducted.
      • Identification of the specific published papers, manuscripts submitted but not accepted for publication (including online publication), funding applications (funded and/or pending), progress reports, presentations, posters, or other research records that contain the allegedly falsified, fabricated, or plagiarized material.
      • Any scientific or forensic analyses conducted.
      • A copy of this Policy (if not already provided).
      • A statement for each separate Allegation where the Committee recommends a finding of Research Misconduct.
      • Distribution of draft Investigation Report, Comment Period

      The Institution will give the Respondent a copy of the draft Investigation Report and, concurrently, a copy of, or supervised access to, the Research Records and other evidence that the Investigation Committee considered or relied on.  The Institution will provide the opportunity for Respondent(s) to comment on the draft Investigation Report. The Respondent must submit any comments to the Institution within thirty (30) Days of the date on which they received the Report.

      If the Institution chooses to share a copy of the draft Investigation report or relevant portions of it with the Complainant(s) for comment, the Complainant’s comments will be submitted within 30 days of the date on which they received the Report.

        1. Final Investigation Report

      The final Investigation Report will include the information outlined above, and will also include any comments made by the Respondent(s) and Complainant(s) on the draft Investigation Report and the Committee’s consideration of those comments.

      The Institution will give the Respondent a copy of the draft Investigation Report and, concurrently, a copy of, or supervised access to, the Research Records and other evidence that the Investigation Committee considered or relied on.  The Institution will provide the opportunity for Respondent(s) to comment on the draft Investigation Report. The Respondent must submit any comments to the Institution within thirty (30) Days of the date on which they received the Report.

      If the Institution chooses to share a copy of the draft Investigation report or relevant portions of it with the Complainant(s) for comment, the Complainant’s comments will be submitted within 30 days of the date on which they received the Report.

        D. Committee Recommendation

        In order to recommend a finding of Research Misconduct, the Committee must determine, by a preponderance of the evidence, that:

        • There was a significant departure from accepted practices of the relevant research community; and
        • The misconduct was committed intentionally, knowingly or recklessly.
          1. If the Committee recommends a finding of Research Misconduct for an Allegation

        These written findings will:

        • Identify the individual(s) who committed the Research Misconduct;
        • Indicate whether the Research Misconduct was falsification, fabrication, and/or plagiarism;
        • Indicate whether the Research Misconduct was committed intentionally, knowingly, and/or recklessly;
        • Identify any significant departure from the accepted practices of the relevant research community;
        • Summarize the facts and analysis, including consideration of any explanation by the Respondent(s), that the evidence supports the Committee’s findings that the Allegation(s) of Research Misconduct have been proven by a preponderance of the evidence;
        • Identify the specific funding support;
        • State whether any publications need correction or retraction; and
        • Identify any current, pending or applications for applicable funding agency support.
          1. 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.

        E. Review and Decision

        The IDO will review the Investigation Report and the Investigation Committee recommendation, and make a final written determination of whether the Institution found Research Misconduct and, if so, who committed the misconduct.  In this statement, the IDO will include a description of relevant Institutional actions taken or to be taken.

        F. The Institutional Record

        The Institution will add the IDO’s written decision to the Investigation Report and prepare the Institutional Record for submission in accordance with applicable funding agency or regulatory requirements.

        The Institution will maintain the Institutional Record, all sequestered Research Records and other evidence in a secure manner for the length of time as required by applicable funding agency policy or regulation, or at least seven years after completion of the Institutional proceeding, whichever is longer, and will provide the Institutional Record to the applicable funding agency or regulatory authority as required by law or policy.

        4. Appeal

        A Respondent may file a written appeal to the IDO regarding the Institution’s finding(s) of Research Misconduct based on (1) procedural errors or (2) new information that could reasonably impact the determination.  The written appeal must be submitted within ten (10) Days of Respondent’s receipt of the determination.  The IDO will review the appeal request and, if the IDO agrees that the errors or new information could reasonably impact the determination the IDO will convene a new Investigation Committee.  After conclusion of any reconsideration, no further appeals are available. Any appeals of recommended Institutional actions to be implemented by areas other than the Office of the Vice President for Research will be handled in accordance with applicable University By-Laws or other applicable policies and any applicable collective bargaining agreement.

        The Institution will notify the applicable funding agency or regulatory authority of the appeal, and:

        • If the Institutional Record has not yet been submitted, hold submission of the final Institutional Record until completion of the Appeal and include the complete record of the Appeal in the Institutional Record
        • If the Institutional Record has already been submitted, the Institution will transmit a complete Record of the appeal once the appeal has been concluded.

        5. Actions Following Investigation

          If a finding of Research Misconduct is made, the IDO will direct the Office of the Vice President for Research to take any necessary actions related to research at the Institution, including but not limited to removal from awards, restriction on ability to serve as Investigator or restriction on ability to conduct or participate in Research. Institution will take steps to manage published data or acknowledge that data may be unreliable in accordance with this Policy and applicable law, regulation or funding agency policy. Respondent(s) are required to cooperate with efforts to correct inaccurate research data or findings in publications or grant applications and/or ensure the completion of such corrections as directed.

          V. Special Circumstances

          1. Admission of Research Misconduct

          If a Respondent admits to Research Misconduct at any point during a Research Misconduct Proceeding, the Respondent will submit a written, signed admission which specifies the falsification, fabrication and/or plagiarism that occurred, meets the elements required for a Research Misconduct finding and identifies which Research Records were affected.

          In the event of an admission of Research Misconduct, the Institution will notify any applicable funding agency or regulatory authority containing information as required by funding agency or regulatory authority.

          In addition to any Institutional action, any applicable funding agency or regulatory authority with jurisdiction may take action, including:

          • Approve or conditionally approve closure of the case or
          • Direct the Institution to complete the full review process or
          • Direct the Institution to address deficiencies in the Institutional Record or
          • Direct the Institution to refer the matter to the funding Agency or regulatory authority for further Investigation or
          • Take compliance action in addition to any action imposed by Institution.

          2. Health, Safety and other Interests

          At any time during a Research Misconduct Proceeding, the Institution may be required under applicable policy or regulation to notify the applicable funding agency or regulatory authority with appropriate jurisdiction immediately if it has reason to believe that any of the following conditions exist:

          • Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
          • Funding agency resources or interests are threatened.
          • Research activities should be suspended.
          • There is reasonable indication of possible violations of civil or criminal law.
          • Federal action is required to protect the interests of those involved in the Research Misconduct Proceeding.
          • The funding Agency may need to take appropriate steps to safeguard evidence and protect the rights of those involved.

          3. Multiple Institutions/Organizations

            When Allegations involve Research conducted at multiple Institutions, the Allegation may be reviewed through a joint Research Misconduct Proceeding.  In a joint Research Misconduct Proceeding:

            • One Institution will be designated as the lead Institution
            • The lead Institution will obtain Research Records and other evidence pertinent to the Proceeding, including Witness testimony, from the other relevant 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.
            • An Investigation into multiple Respondents may convene with the same Committee members but there will be separate Investigation reports and separate Research Misconduct determinations for each Respondent.

            REFERENCES

            PHS 42 C.F.R. Part 93

            NSF 45 C.F.R. 689

            POLICY HISTORY

            Policy revisions:

            9/15/17 (Approved by President’s Cabinet)

            11/17/2025 (Approved by Senior Policy Council)

            [1] When the Allegation of Research Misconduct relates to activities funded by the U.S. Public Health Service (PHS), the Institution applies the requirements of the PHS regulations at 42 C.F.R. Part 93.

            When the Allegation of Research Misconduct relates to activities funded by the National Science Foundation (NSF) the Institution applies the requirements of the NSF at 45 C.F.R. 689

            When the Allegation of Research Misconduct relates to activities funded by other agencies or sponsors, the Institution applies the requirements of those agencies or sponsors.

            When the Allegation of Research Misconduct relates to activities that are not otherwise funded or supported, or where there are no funding agency or regulatory authority specific requirements, the Institution will apply the standards, limitations and definitions found in 42 C.F.R Part 93.

            [2] Those who need to know may include but is not limited to: Institutional compliance review committees, journals, editors, publishers, co-authors, and other institutions/entities.

            [3]  See 34 CFR § 99.31.