Part VII: Part VII. Faculty Research and Scholarship

Faculty scholarship includes the scholarship of research, the scholarship of creative activity/innovation, and the scholarship of engagement and/or outreach. Scholarship is a fundamental faculty activity, and faculty have freedom to pursue scholarship on the subjects of their choosing. The quality of the scholarly works that faculty produce should be based on the standards of the profession as determined by the community of scholars with the expertise and training to establish these standards. Part VIII of the East Carolina University Faculty Manual establishes general criteria for the evaluation of scholarship in the appointment and promotion of faculty members and requires that the relative importance of each type of scholarly activity be clearly defined in the unit code. Faculty have the obligation to adhere to the research and scholarship guidelines established by East Carolina University, the federal government, and the community of scholars. This document provides guidelines for research and scholarship established by the ECU faculty and references to research and scholarship policies, rules, and regulations (PRRs) as well as research- and scholarship-related standard operating procedures established by East Carolina University.

Research and scholarship also form a basic part and are integrally linked to the faculty members’ teaching responsibility. Original results of research and scholarship inform faculty members’ interactions with students at all levels. Deeper understanding of research and scholarship is conveyed when faculty develop students so that they may participate in research and scholarly activities. Effective mentoring of students is critical to their transition to independent research and scholarship. While this document focuses on faculty research and scholarship, it also provides references to research and scholarship related PRRs relevant to collaborative scholarly work involving faculty and students. (FS Resolution #12-39, May 2012)

Contents

1. Funded Research
2. Principles and Policy for the Protection of Human(s) in Research
3. Animal Welfare Regulations
4. Research Data and Records
5. Patents
6. Copyrights (created work)

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This section and the related policies and regulations referenced within the section, contain guidelines for ECU researchers and scholars. Many of these guidelines are dictated by federal law and institutional policies and procedures. Guidelines within this section include those for externally funded research and scholarship, protection of humans in research, animal welfare in research, retention of research data and records, patents that arise from scholarly activity, and copyright of scholarly material produced by faculty. Faculty members are expected to be familiar with and to follow the guidelines that apply to their research and scholarly activities.

I. Funded Research

As a constituent institution of The University of North Carolina, East Carolina University receives its basic financial support from appropriations by the North Carolina General Assembly and from tuition and fees paid by students. However, to achieve and maintain a higher level of excellence than is possible with those funds and in accordance with the mission and strategic plan of ECU, grants and contracts are sought from governmental and other sources as well as gifts from alumni, friends, corporate entities, and foundations.

A. Definitions

Gift - A gift is an item of value, ownership of which is voluntarily transferred from one party to East Carolina University or one of ECU’s foundations without direct compensation to the first party. Gifts may be in the form of cash or in kind (e.g., art objects, equipment, securities, real estate, services, insurance, etc.). Gifts may be solicited (given in response to a request from ECU) or unsolicited (given at the donor's own initiative). Gifts are generally classified as unrestricted, i.e., use or disposition of the gift is at the discretion of the university.

Contract – The principal purpose of a contract is the acquisition of property or services for the direct benefit or use by the Government or other sponsor. The sponsor may select from several candidates to carry out the project and typically exerts fairly strict management control over the contract recipient. Contracts are typically awarded by the federal government in response to requests for proposals (RFP's), by state and local government agencies, and by for-profit commercial entities (single owner companies, partnerships, and corporations).

Grant – The purpose of a grant is to transfer money, property, services or anything of value from the government or other sponsor to the recipient in order to accomplish a public purpose. A grant is typically awarded for projects where most or all of the factors outlined above have not yet been determined. Grants are frequently awarded for experimental projects or for projects where the idea and purpose of the award have been suggested by the grantee. The grantee works independently and has considerable latitude in accomplishing the aims and goals of the project. Grants are typically awarded by the federal government and by private nonprofit foundations and organizations. The outcomes of the project are typically not of direct benefit to the sponsor of a grant.

Cooperative Agreement –A cooperative agreement is like a grant; however, the government or sponsor expects to be more involved in project planning and implementation. The funding agency retains an interest in procedures, timetables, etc. and works cooperatively with the awardee in order to share responsibility for achievement, changes in methods, delays, etc. A cooperative agreement is most likely to be used by certain agencies of the federal government, again to accomplish a public purpose.

B. Fundraising and Gifts

While all members of the university community are encouraged to participate in the process of identifying and qualifying prospective funding sources, the vice chancellor for university advancement is responsible for the coordination of all fund raising activities at the university which are direct gift solicitations. No solicitation or acceptance of gifts shall be made by any faculty member in the name of or for the benefit of the university without prior clearance through the Division of University Advancement. Exceptions to this restriction may be documented in the PRRs for Institutional Advancement. Procedures for fundraising and the solicitation and acceptance of gifts are included in the Institutional Advancement PRRs.

ECU REG04.05.01. Gifts Affecting the Curriculum
ECU REG04.05.02. Coordination of Private Gift Fund-Raising Activities at East Carolina University

C. Contracts, Grants, and Cooperative Agreements

All proposals to governmental, private nonprofit, or corporate agencies or organizations for a contract, grant, or cooperative agreement to support research (including clinical research), instruction, public service, or other creative activities to be conducted by any faculty or staff member or other person associated with the university shall be coordinated, reviewed and approved in advance of submission to the sponsor with the Office of Research Administration.

II. Principles and Policy for the Protection of Humans in Research

East Carolina University acknowledges and accepts its responsibilities for protecting the rights and welfare of individuals who act as participants in research conducted by its faculty, staff and students. The protection of humans in research activities was dealt within a president's (chancellor's) policy memorandum dated May 22, 1970. This earlier memorandum is hereby amplified and superseded.

A. Statement of Ethical Principles

East Carolina University has adopted as a guiding statement of ethical principles the three principles as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research dated April 18, 1979, and entitled The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research include respect for persons, as implemented through the informed consent process and documents, beneficence which is applied through the analysis of known risks versus potential benefits, and justice which ensure that the burden of research is not placed on any one population and the benefits of research are open to all who might gain from their participation.

In addition, East Carolina University acknowledges and accepts the requirements set forth in the Department of Health and Human Services Title 45 Code of Federal Regulations Part 46 (45 CFR 46) for all research involving humans regardless of funding source. ECU also applies the Food and Drug Administration regulations found at Title 21 CFR Parts 11, 50, 56, 312, 600, and 812 to all human research classified as a “clinical investigation” or that involves an article that falls within FDA’s purview. ECU also applies, as applicable, regulations from the Department of Defense, Department of Education, and other DHHS agencies. With international human research, ECU applies regulations set forth by the International Council on Harmonization.

B. Institutional Policy

It is the policy of East Carolina University that all research activities involving humans, through direct intervention or interaction or the use of private, identifiable information about humans, and that are conducted by its faculty, staff or students must be submitted, reviewed, and approved by an appropriately established peer-review committee known as an Institutional Review Board (IRB). At ECU, there is the University and Medical Center Institutional Review Board (UMCIRB), which supports two IRBs: the Biomedical Review Board and the Behavioral and Social Science Review Board (BSS IRB). These committees consist of scientists, non-scientists and community members. The committee must meet federally mandated membership requirements. Committee members serve four year terms, as appointed by the university's chief research officer.

The Office for Human Research Integrity (OHRI) is responsible for providing support to ECU’s IRBs, the Vice Chancellor for Research, and faculty, staff and students who wish to engage in human research activities. OHRI also is responsible for providing education, quality improvement reviews, and orientation activities to IRB members, investigators and research personnel. It is the responsibility of this Office to make recommendations for IRB membership to the Vice Chancellor of Research to ensure compliance with federal regulatory requirements.

It is the responsibility of the OHRI staff, with consultation from IRB Chairs and Vice Chairs, to determine whether a research activity meets the definition of human research. This determination cannot be made by investigators, research personnel, or other bodies within ECU.

The type of review mechanism that a proposed research activity may receive is based upon criteria set forth in the federal regulations.

Researchers wishing to conduct human research activities must first complete training in human research protections. This training is offered through the Office of Human Research Integrity and can be accessed through the UMCIRB website.

It is the responsibility of Faculty acting as mentors to students conducting human research activities to ensure that the students complete the necessary training before submitting their applications through e-PIRATE, the electronic submission and review system found on the OHRI website.

East Carolina University requires all principal investigators and their research teams to comply fully with the appropriate federal regulations, institutional policies, and the UMCIRB Standard Operating Procedures.

C. Implementation of Policy

In all activities involving human research participants, the chairperson of the pertinent department or head of the academic unit is responsible for ensuring that the proposed research activities are scientifically sound, that the methods and procedures will adequately address the research question, and that the proposed research fits with the mission of the department or academic unit as well as the university.

The principal investigator is responsible for conducting the research according to the ethical principles of the discipline, the ethical principles of the Belmont Report, university policies and procedures, and the methods and procedures approved by the Institutional Review Board.

The IRB has the federally mandated authority to approve, modify or disapprove proposed research. It also has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. The IRB is obligated to report suspension and terminations through a report to the investigator, institutional officials, and sponsoring agency, if any. Principal investigators of research studies involving humans must submit a complete protocol and address all applicable questions in e-PIRATE, upload appropriate informed consent and assent documents, and any other study related materials. Access to the electronic system, e-PIRATE, requires completion of human research protections training, registering with OHRI through e-PIRATE, and completing an Investigator Profile. A copy of all research study materials including signed informed consent and study related correspondence must be maintained by the principal investigator for at least 3 years, or longer if required by the research sponsoring agency.

If the research involves Protected Health Information or storage of data outside of ECU’s maintained servers, additional requirements must be met. More information on those requirements can be found at the UMCIRB website. Research documents that involve protected health information must be maintained for a minimum of 6 years beyond the end of the project.

Investigators are responsible for reporting the progress of UMCIRB-approved research to the Office for Human Research Integrity, through the use of a renewal or continuation review accessed through e-PIRATE. Federal regulations require that IRB approval be issued no less often than once per year as set forth in 45 CFR 46.109. In addition, research investigators are responsible for reporting promptly to their department chair and to the OHRI, any unanticipated problems which involve risks to the research participants or others.

III. Animal Welfare Regulations

The ECU Institutional Animal Care and Use Committee (IACUC), in conjunction with the University Attending Veterinarian (AV) and the Institutional Official (IO- vice chancellor for research and graduate studies), are charged with oversight of vertebrate animal care and use activities. Federal regulations require that anyone (faculty, staff, students) using vertebrate animals in research, teaching, and testing must obtain approval from the ECU IACUC prior to initiation of the activity. Animal Use Protocol (AUP) forms and additional information such as training requirements, occupational health and safety requirements, mechanisms for reporting animal welfare concerns, IACUC operations, rules and guidelines, and links to other relevant websites (e.g., the Department of Comparative Medicine home page and the Prospective Health home page are located on the IACUC website. The ECU IACUC regulations must comply with all relevant Federal regulations (for more information see USDA Animal Welfare Act and Regulations (PDF) and PHS Policy on Humane Care and Use of Laboratory Animals and Guide to the Care and Use of Laboratory Animals).

IV. Research Data and Records

A. Purpose

The preparation and retention, of accurate and appropriate records are essential components of a credible research endeavor. East Carolina University, its faculty, staff, and students have a common interest and a shared responsibility to assure that research data and records are recorded appropriately, archived for a reasonable length of time, and available for review by scholars and others under appropriate circumstances. Original research records are also essential to protect intellectual property rights, to answer ongoing questions regarding the management of a research program, and to address questions that may arise regarding the propriety of research conduct and methods. This policy defines the nature of research data and its associated records. It also describes the importance of good data and record keeping for obtaining and defending intellectual property rights, and the procedures to be used for the custody, retention, access, and transfer of research data and records.

This policy shall apply to all faculty, staff, and students of East Carolina University who are involved in the design, conduct, and/or reporting of research at or under the auspices of East Carolina University, regardless of source of funding.

B. Definition of Research Data and Records

Research data and records refers to recorded information, regardless of its form or the media on which it may be recorded, which is necessary for the reconstruction and evaluation of the reported results of a research project. Research data and records include more than just primary data (e.g., raw numbers generated by a measuring instrument; audiotapes or transcripts of survey interviews). They also include documentation or citation of a) the experimental methods for data collection, and b) the methods used for data processing and interpretation. In practice, they include, but are not limited to, the material contained in laboratory notebooks or other media such as computer disks and machine printouts. The term does not include the intellectual property generated by a research project; administrative information, such as financial data; or the tangible products of research, e.g., tissue banks, specialized tools or chemicals produced by the project. (Ownership and disposition of intellectual property or the tangible products of research are covered by other ECU policies.)

C. Intellectual Property Issues Involving Research Data and Records

Retention of maximum intellectual property rights places additional importance on the preparation and retention of research data and records. Documented research records are important in determining priority of research data, such as identifying who first conceived an invention or in defending against patent infringement. In order to protect the rights of investigators and the university to the intellectual property generated by their research programs, university technology transfer managers recommend specific record keeping and retention practices such as the use of bound laboratory notebooks. Maintaining good data records is recommended for all university laboratories, but is essential for any patentable or licensable research activity. Responsible faculty should be aware of and follow, as closely as possible, the record-keeping recommendations offered by the Office of Research Administration. The data management approaches above will also help defend an investigator and their work if there is an allegation of misconduct regarding this research.

D. Custody of Research Data and Records

Custody of original research data and records is the responsibility of the senior investigator of a project, usually a faculty member. This senior investigator (the responsible investigator) must ensure the integrity, preservation and security of the original research data and records. Expenses of data and record preservation and security are allowable costs to sponsored programs. As an aid to scholars and other appropriate individuals who may wish to review the research data and records, all research records must be appropriately organized and labeled to allow the identification of specific information within the records by someone who was not involved with the original project.

In situations where the vice chancellor for research and graduate studies (the designated ECU Integrity Officer) has received an allegation of research misconduct pursuant to ECU policy (Section III. below) or when patent litigation is imminent, the university may take immediate and preemptory custody of the original research data and records relating to the allegation or the patent. In this circumstance the university shall provide needed copies of data and records to the investigator that will allow active research projects to continue.

In multi-institutional studies, contractual agreements often stipulate that the home institution of the primary study director shall have custody of original primary data from all participating institutions. In situations where ECU is not the site of the home institution and will need to transfer the original data to the institution of the study director, ECU shall retain a true copy of all data and records generated for the multi-institutional study.

Senior members of research teams have obligations and are held responsible for discussing the responsibilities of data management and retention with other members of the research team. The senior member of the research team must directly oversee the data and record management of the technicians, post-doctoral fellows, students, and others working under their direct supervision.

E. Access to Research Data and Records

The university ultimately owns data and support records generated by its faculty, staff and students. Therefore the university has the right of access to (and to make copies of) the data and records for all research performed at the university or under university auspices provided such access to the records shall be for reasonable cause, at reasonable times and after reasonable notice (except in cases of misconduct allegations, see below). For example, the University Medical Center Institutional Review Board, the office for Human Research Integrity staff, the Brody School of Medicine Compliance office, and office for Research Compliance Administration, acting for the university, may review records and study data of projects that use human participants to assure compliance with regulatory human research protections. In cases involving an allegation of research misconduct, the university through the vice chancellor for research and graduate studies may request immediate, preemptory access and custody of original research records. When such records contain confidential information about human participants in research, the vice chancellor shall institute appropriate procedures to assure that participant confidentiality is maintained while the research records are in his custody.

Extramural sponsors providing support for East Carolina University and appropriate governmental officials also have the right to review the data and records resulting from that extramural support. In addition, investigators, co-investigators, students, visiting researchers, and students who are or were an integral part of a research project team have the right to review all records and data which are part of that project or support publications for which they are named authors. Similarly, investigators, co-investigators, students, visiting researchers, and students have a right to a copy of data that they personally generated or substantially analyzed unless prohibited by law, regulation, or contractual agreements. The responsible investigator in addition has the right to distribute to other scholars or individuals copies of any part the research records in his custody per the general practices of their field of study unless prohibited by law, regulation, or contractual agreements.

F. Retention of Research Data and Records

Research data and records, including the primary experimental results, should be retained for a sufficient period to allow evaluation and repetition by others of published results emanating from those data. In general, five years from the first publication date of the research results is specified as the minimum period of retention for research published in peer-reviewed journals. For sponsored research that is not published, the minimum retention period is five years from the date of the issuance of the final report to the research sponsor, unless the sponsor specifies a longer retention period. However, if an investigation, legal action or an official inquiry concerning a research project is underway, all data and records related to the project must be retained and made accessible until all issues are resolved. In addition, the records should be kept for as long as may be required to protect any patents or other intellectual property resulting from this work. If a research project is not funded with external or designated internal funds (e.g., an internal university grant), the above retention policy shall apply to these research data and records only when the project results in a publication, its data is used to support a grant or contract application, or it involves the use of animals or human participants. If research involves the generation, use, or disclosure of protected health information (PHI), the minimum retention of those records including consent and authorization agreements must be maintained for a minimum of six years beyond the end of the project. If a participant withdraws authorization of use of PHI, the researcher must consider that request to constitute the end of the project and Day 1 of the six year retention period for that sample.

G. Transfer of Research Data and Records that Support University Patents or Were Funded by Federal Grants and Contracts

Pursuant to federal regulations (OMB Circular A-110, section 53) and the need of the university to protect its patent rights, original research data and records that support university patents or were funded by federal grants and contracts must remain in the custody of the university for the required retention period as discussed above. In the event the responsible investigator transfers to another institution or leaves the university for any reason the responsible investigator shall transfer custody of these original research data and records to the university. Exceptions to this policy are discussed at the end of this section. The responsible investigator, however, may make a copy of the data and research records at university expense for their personal use at a new institution unless prohibited by law, regulations or contractual agreements. Before their departure, the responsible investigator shall transfer custody of the original research data and records to their department chair or supervisor as required by this policy. These records shall be retained in the University Archives of Joyner Library pursuant to the retention paragraph above. These data and records shall be organized in a format to permit reasonable identification of specific experiments and data by individuals not involved with the original research.

These research data and records shall be used by the university only for patent litigation, misconduct inquiries and investigations, or for other purposes required by federal regulations for US government funded research.

Exceptions:

1. Currently Active Federal Grants and Contracts: If the responsible federal agency allows the transfer of an active grant or contract to the new institution of the principal investigator, and the new institution accepts the administrative responsibility for the federal award, the original research data and records may be transferred to the new institution upon the request of that institution. The university, however, shall retain a true copy, made at university expense, of all research records produced while the research project was active and under ECU jurisdiction.
2. Faculty Request for Transfer of Original Records: Per OMB Circular A-110 section 53c, a faculty member may request authorization from the responsible federal agency to substitute true copies of the research data and records in the University Archives in place of the originals. If so authorized, the investigator may then transfer theirr original data and records to the new institution.
3. Multi-Institutional Federal Grants and Contracts: If such federal awards designate a specific institution as the depository of original data and records for a multi-institutional project, the university shall comply with this requirement. However, the university shall retain a true copy of the original records produced at university expense.

H. Transfer of other Research Data and Records

In the event the responsible investigator transfers to another institution or leaves the university for any reason, the responsible investigator shall provide a true copy at university expense of their research data and records that have been retained less than five years in the investigator’s possession per the retention paragraph above. Before their departure, the responsible investigator shall provide these true copies of the research data and records to their department chair or supervisor. These data and records shall be organized in a format to permit reasonable identification of specific experiments by individuals not involved with the
original research. These research data and records shall be used by the university only for misconduct inquiries and investigations,

I. Resolution of Disputes Involving Research Data and Records

The vice chancellor for research and graduate studies or his designee shall arbitrate all disputes involving research data ownership, retention, and access. Whenever possible, the Vice Chancellor or designee shall first attempt to mediate a resolution to the dispute acceptable to all parties. When the dispute involves faculty from the School of Medicine or the College of Arts and Sciences, the Vice Chancellor or designee shall consult with the designated Associate Deans for Research in those units.

V. Patents

East Carolina University is dedicated to the pursuit of instruction, research and scholarship, as well as engagement and innovation development activities, in an environment that is open to collaboration and publication. Inventions, discoveries and other intellectual assets sometimes arise as a result of these activities. These assets may qualify for intellectual property protection in the form of patents, copyrights, trademarks, and trade secrets. The Board of Governors of the University of North Carolina has determined that patenting and commercialization of these intellectual assets are consistent with the mission of the university.

The patent policy of the University of North Carolina is contained in Part 500.2 of the University of North Carolina Policy Manual. The patent policy of East Carolina University is available at POL10.40.01 (East Carolina University Patent Policy). These policies address ownership of university inventions, distribution of income derived from licensing, assignment, or commercialization activities related to university inventions, and management of disputes. The patent policies also recognize limited circumstances in which publication of scholarly works may be delayed for short periods of time to allow for filing of patent applications. Premature publication or public use of an invention can constitute a statutory bar to the granting of a patent. In most cases, inventors may publish, present, and discuss their inventions freely once a patent application has been filed.

VI. Copyrights (created work)

The mission of East Carolina University to become a national model for student success, public service, and regional transformation includes using creative learning strategies and delivery methods, discovering new knowledge, and fostering innovation and entrepreneurship. Products of these activities include the development and use of copyrightable materials. The creation of copyrightable materials in the form of literary, dramatic, and other intellectual works by the university community is encouraged as a measure of productivity and commitment to the dissemination of knowledge and creative activity for public benefit. The university supports an open and free environment for its faculty, staff, and students to carry out their scholarly work, and encourages publication without constraint. These policies are in accord with applicable laws and pertinent university regulations. The Copyright policies of the University of North Carolina (Part 500.2 and 500.2.1 of the University of North Carolina Policy Manual) and East Carolina University (REG10.40.02 East Carolina University Copyright Regulation) address ownership and use of copyrightable works. (FS Resolution #12-39, March 2012 and FS Resolution #15-70, May 2015)

Contents

1. Introduction
2. Definitions
3. Rights and Responsibilities
4. General Policies and Principles
5. Conducting the Assessment and Inquiry
6. The Inquiry Report
7. Conducting the Investigation
8. The Investigation Report
9. Completion of Cases; Reporting Premature Closures
10. Institutional Administrative Actions
11. Other Considerations

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I. Introduction

A. General Policy

All East Carolina University faculty have the responsibility to seek honestly and to promulgate ethically the truth in all phases of work. This responsibility governs not only the production and dissemination of research and creative activities, but also all applications for funding, reports to funding agencies, and teaching and publication of teaching materials.

B. Scope

This policy applies to allegations of research misconduct (fabrication, falsification, or plagiarism) involving East Carolina University faculty. This policy does not apply to authorship or collaboration disputes [see Part VII, Section II (VI.)].

II. Definitions

1. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Creative Activity refers to scholarship of research, scholarship of creative activity/innovation, and the scholarship of engagement and/or outreach, as defined in the ECU Faculty Manual Part VII, Section I. For the purposes of this policy, Research includes all basic, applied, and demonstration research in all academic and scholarly fields. Research and creative activity fields include, but are not limited to: the arts, the basic sciences, liberal arts, applied sciences, social sciences, clinical sciences, the professions, and research involving human subjects or animals.
2. Research and Creative Activity Misconduct (hereinafter misconduct) is defined as fabrication of results, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting the results. Research misconduct does not include honest error or differences of opinion.
3. Fabrication of results is making up data or results and recording or reporting them.
4. 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. The research record is the record of data or results that embody the facts resulting from the research inquiry and includes, but is not limited to research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, books, dissertations, and journal articles.
5. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
6. Allegation means a disclosure of possible misconduct through any means of communication. The disclosure may be a written or oral statement or other communication to an ECU administrator or Research Integrity Officer (RIO) (see L. of this section).
7. Complainant means a person who in good faith makes an allegation of misconduct. There may be more than one Complainant in a given case.
8. Respondent means a person against whom is made an allegation of misconduct. There may be more than one Respondent in a given case.
9. Good faith as applied to a complainant or witness means having a belief in the truth of one's allegation or testimony. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member means cooperating with the research misconduct proceeding by carrying out the duties assigned impartially for the purpose of helping an institution meet its responsibilities under this definition. A committee member does not act in good faith if their acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
10. Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.
11. Research Record means the record of data or results that embody the facts resulting from research and creative activity, including but not limited to, research proposals, laboratory records both physical and electronic, progress reports, abstracts, theses, dissertations, oral presentations, internal reports, journal articles, creative works, and any documents and materials provided to a sponsoring agency having jurisdiction and authority or an institutional official by a respondent in the course of the research misconduct proceeding. A research record also includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports, laboratory notebooks, notes, correspondence, videos, photographs, X-ray film, slides, biological materials, computer files and printouts, manuscripts and publications, equipment use logs, laboratory procurement records, animal facility records; human and animal subject protocols, consent forms, medical charts, and human subject research files.
12. Research Integrity Officer (RIO) is the institutional official responsible for: (1) assessing allegations of research misconduct to determine if they fall within the definition of research misconduct, are covered by law, regulation, or research sponsor policy, and warrant an inquiry on the basis that the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified; (2) overseeing inquires and investigations; and (3) the other responsibilities described in this policy. The RIO for ECU is the Director of the Office of Research Compliance Administration.
13. Deciding Official (DO) means the institutional official who makes final determinations on allegations of research misconduct. The Deciding Official will not be the same individual as the Research Integrity Officer and should have no direct prior involvement in the institution's inquiry, investigation, or allegation assessment. A DO's appointment of an individual to assess allegations of research misconduct, or to serve on an inquiry or investigation committee, is not considered to be direct prior involvement. The DO for ECU is the Vice Chancellor for Research and Graduate Studies. In the event that the Vice Chancellor for Research and Graduate Studies has a conflict of interest for a particular case then the Chancellor shall appoint a designee as the DO for that particular case.

III. Rights and Responsibilities

A. Research Integrity Officer

The Research Integrity Officer (RIO) will have primary responsibility for implementation of this policy. These responsibilities include the following duties related to misconduct proceedings:

1. Consult confidentially with persons uncertain about whether to submit an allegation of misconduct;
2. Receive allegations of misconduct;
3. Assess each allegation of misconduct in accordance with V. (A.) of this Section to determine whether it falls within the definition of misconduct and warrants an inquiry;
4. As necessary, take interim action and notify sponsors of special circumstances, in accordance with IV. (F.) of this Section 4.6 of this policy;
5. Sequester data or other products of scholarly activities and evidence pertinent to the allegation of misconduct in accordance with V. (C.) of this Section and maintain it securely in accordance with this policy and with applicable law and regulation;
6. Provide confidentiality to those involved in the misconduct proceeding as required by applicable law and university policy;
7. Notify the respondent and provide opportunities for them to review/ comment/respond to allegations, evidence, and committee reports in accordance with III.(C) of this Section;
8. Inform respondents, complainants, and witnesses of the procedural steps in the misconduct proceeding;
9. Ensure that the Deciding Official appoints the chair and members of the inquiry and investigation committees, ensure that those committees are properly staffed, that the members are without conflicts, and that there is expertise appropriate to carry out a thorough and authoritative evaluation of the evidence;
10. Determine whether each person involved in handling an allegation of misconduct has any unresolved personal, professional, or financial conflict of interest and take appropriate action, including recusal, to ensure that no person with such conflict is involved in the misconduct proceeding;
11. In cooperation with other institutional officials, take all reasonable and practical steps to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members and to counter potential or actual retaliation against them by respondents or other institutional members;
12. Keep the Deciding Official and others who need to know apprised of the progress of the review of the allegation of misconduct;
13. Notify and make reports to sponsoring agencies as required by applicable law or regulation;
14. Take appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards of corrective actions; and
15. Maintain records of the misconduct proceeding and make them available to sponsoring agencies as appropriate under VIII. (D). of this.

B. Complainant

The Complainant is responsible for making allegations in good faith, maintaining confidentiality [as defined in IV.(C.)], and cooperating with the inquiry and investigation. As a matter of good practice, the complainant should be interviewed at the inquiry stage and given the transcript or recording of the interview for correction.

The RIO may provide to the complainant for comment: (1) relevant portions of the inquiry report (within a timeframe that permits the inquiry to be completed within sixty (60) calendar days of its initiation, unless an extension of time is granted in accordance with the terms of this policy); and (2) relevant portions of the draft report of the investigation. Any comments on the draft investigation report must be submitted within thirty (30) calendar days of the date on which the complainant received the draft report. The University must consider any comments made by the complainant on the draft investigation report and include those comments in the final investigation report. See IV.(D.) of this Section for rights and protections of the Complainant.

C. Respondent

1. The Respondent is responsible for maintaining confidentiality [as defined in IV. (C.)] and cooperating with the conduct of an inquiry and investigation. The Respondent is entitled to:
   1. A good faith effort from the RIO to notify the respondent in writing at the time of or before beginning an inquiry;
   2. An opportunity to comment on the inquiry report and have their comments attached to the report;
   3. Be notified of the outcome of the inquiry, and receive a copy of the inquiry report that includes a copy of, or refers to this policy;
   4. Be notified in writing of the allegations to be investigated within a reasonable time after the determination that an investigation is warranted, but before the investigation begins (usually within thirty (30) calendar days after the institution decides to begin an investigation), and be notified in writing of any new allegations, not addressed in the inquiry or in the initial notice of investigation, within a reasonable time after the determination to pursue those allegations;
   5. Be interviewed during the investigation, have the opportunity to correct the recording or transcript, and have the corrected recording or transcript included in the record of the investigation;
   6. Have interviewed during the investigation any witness who has been reasonably identified by the Respondent as having information on relevant aspects of the investigation, have the recording or transcript provided to the witness for correction, and have the corrected recording or transcript included in the record of investigation; and
   7. Receive a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based, and be notified that any comments must be submitted within thirty (30) calendar days of the date on which the copy was received and that the comments will be considered by the institution and addressed in the final report.
2. The Respondent should be given the opportunity to admit that misconduct of research or creative activity occurred and that he/she committed the misconduct. With the advice of the RIO and/or other institutional officials, the Deciding Official may terminate the institution's review of an allegation that has been admitted, if the institution's acceptance of the admission and any proposed settlement is approved by any sponsoring agency having authority and jurisdiction. See Part IV. (D.) of this Section on rights and protections of the Respondent.

D. Deciding Official

1. The DO will receive the inquiry report and after consulting with the RIO and/or other institutional officials, decide whether an investigation is warranted. Any finding that an investigation is warranted must be made in writing by the DO and, where required by applicable law or regulation, must be provided to any sponsoring agency with authority and jurisdiction, together with a copy of the inquiry report, within thirty (30) calendar days of the finding. If it is found that an investigation is not warranted, the DO and the RIO will ensure that detailed documentation of the inquiry is retained for at least seven (7) years after termination of the inquiry, so that any sponsoring agency with authority and jurisdiction may assess the reasons why the institution decided not to conduct an investigation.
2. The DO will receive the investigation report and, may request all other associated documentation, after consulting with the RIO and/or other institutional officials, decide the extent to which he/she accepts the findings of the investigation and, if research misconduct is found, refer the matter to the appropriate Vice Chancellor to decide what, if any, institutional administrative actions are appropriate. The DO shall ensure that the final investigation report, the findings of the DO and a description of any pending or completed administrative actions are provided to any sponsoring agency with jurisdiction and authority, as required by law or regulation.

IV. General Policies and Principles

A. Responsibility to Report Misconduct

1. ECU faculty will report observed, suspected, or apparent misconduct to the RIO. If an individual is unsure whether a suspected incident falls within the definition of misconduct, they may meet with or contact the RIO to discuss the suspected misconduct informally, which may include discussing it hypothetically. If the circumstances described by the individual do not meet the definition of misconduct, the RIO will refer the individual or allegation to other offices or officials with responsibility for resolving the problem, if any.
2. At any time, an institutional member may have discussions and consultations about concerns of possible misconduct with the RIO and will be counseled about appropriate procedures for
   reporting allegations.

B. Cooperation with Misconduct Proceedings

All ECU faculty will cooperate with the RIO and other institutional officials in the review of allegations and the conduct of inquiries and investigations. These individuals, including Respondents, have an obligation to provide evidence relevant to misconduct allegations to the RIO or other institutional officials.

C. Confidentiality

The RIO shall: (1) limit disclosure of the identity of respondents and complainants to those who need to know in order to carry out a thorough, competent, objective and fair misconduct proceeding; and (2) except as otherwise prescribed by law, limit the disclosure of any records or evidence from which human research participants might be identified to those who need to know in order to carry out a research misconduct proceeding. The RIO should use written confidentiality agreements or other mechanisms to ensure that any person and/or entity receiving information about the case does not make any further disclosure of identifying information.

D. Protecting complainants, witnesses, and committee members

ECU faculty may not retaliate in any way against complainants, witnesses, or committee members. Any such retaliation is itself serious, and shall be subject to sanction. Any alleged or apparent retaliation against complainants, witnesses or committee members should be immediately reported to the RIO, who shall review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed.

E. Protecting the Respondent and Use of Legal Counsel

1. As requested and as appropriate, the RIO and other institutional officials shall make all reasonable and practical effort to protect or restore the reputation of persons alleged to have engaged in misconduct, but against whom no finding of misconduct is made.
2. During the misconduct proceeding, the RIO is responsible for ensuring that respondents
   receive all the notices and opportunities provided for in this policy. Respondents may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the personal advisor or legal counsel to interviews or meetings on the case. The role of the respondent's legal counsel is restricted to advising the respondent(s) and he/she may not act in a representative capacity or otherwise actively participate in interviews, meetings, or hearings.
3. The University shall provide legal counsel to assist the RIO, DO, Inquiry Panel, and Investigation Committee. The role of counsel is to advise and not to act in a representative capacity or otherwise actively participate in interviews, meetings, or hearings; provided, however, University counsel may be present at such interviews, meetings, or hearings, and must be present whenever respondent's legal counsel is present.

F. Interim Administrative Actions

1. Throughout the misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, animal health, sponsor funds, equipment, or the integrity of the sponsored research process. In the event of such a threat, the RIO will, in consultation with other institutional officials and any sponsoring agency with jurisdiction and authority, take appropriate interim action to protect against any such threat. Interim action might include additional monitoring of the research process and the handling of equipment or sponsor funds,
   freezing or limiting access to fund accounts, reassignment of personnel or of the responsibility for the handling of human research participants or animal research subjects, equipment or sponsor funds, additional review of research data or creative activity products, or delaying publication.
2. The RIO shall, at any time during a misconduct proceeding, notify any sponsoring agency with jurisdiction and authority immediately if he/she has reason to believe that any of the following conditions exist:
   1. Health or safety of the public is at risk, including an immediate need to protect human participants or animal subjects;
   2. Resources or interests of sponsor are threatened;
   3. Research or creative activities should be suspended;
   4. There is a reasonable indication of possible violations of civil or criminal law;
   5. Action is required to protect the interests of those involved in the misconduct proceeding;
   6. The misconduct proceeding may be made public prematurely and action may be necessary to safeguard evidence and protect the rights of those involved; or
   7. The scholarly community or the public should be informed.

V. Conducting the Assessment and Inquiry

A. Assessment of Allegations

1. Upon receiving an allegation of misconduct, the RIO will immediately assess the allegation to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified and whether the allegation falls within the definition of misconduct. An inquiry must be conducted if these criteria are met.
2. The assessment period should be brief, concluded within a reasonable time period as warranted by the nature of the allegations, typically within seven (7) to twenty-one (21) calendar days. In conducting the assessment, the RIO need not interview the complainant, respondent, or other witnesses, or gather data beyond any that may have been submitted with the allegation, except as necessary to determine whether the allegation is sufficiently credible and specific so that potential evidence of misconduct may be identified. The RIO shall, on or before the date on which the respondent is notified of the allegation, obtain custody of, inventory, copy as warranted, and sequester all records and evidence [see II. (K.)] needed to conduct the misconduct proceeding, as provided in V.(C.) of this Section.
3. If the criteria required to investigate are not met, the RIO is responsible for preparing a final report to be distributed to the respondent, complainant, and the DO within thirty (30) calendar days.

B. Initiation and Purpose of the Inquiry

If the RIO determines that the criteria for an inquiry are met, they will immediately initiate the inquiry process. The purpose of the inquiry is to conduct an initial review of the available evidence to determine whether to conduct an investigation. An inquiry does not require a full review of all the evidence related to the allegation.

C. Notice to Respondent; Sequestration of Research Records and Evidence

At the time of or before beginning an inquiry, the RIO must make a good faith effort to notify the respondent in writing, if the respondent is known. If the inquiry subsequently identifies additional respondents, they must be notified in writing. On or before the date on which the respondent is notified, or the inquiry begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the misconduct proceeding. The RIO will inventory the records and evidence and sequester them in a secure manner. There may be exceptions where the records or evidence encompass scientific instruments (or other tools or equipment essential to the research or creative activity in question) which are shared by a number of users. In those cases, custody of the records may be limited to copies of the data or evidence on or recorded in such instruments, so long as copies can be made substantially equivalent to the evidentiary value of the equipment itself. The RIO will provide a receipt of sequestered items to the respondent(s) or other individuals who have information relating to the inquiry. The RIO may consult with any sponsoring agency with jurisdiction and authority for advice and assistance in this regard.

D. Appointment of the Inquiry Panel

The DO, in consultation with the RIO and other institutional officials as appropriate, will appoint an Inquiry Panel of at least three individuals, as soon after the initiation of the inquiry as is practical. The majority of the committee shall be faculty without administrative appointment. The Inquiry Panel must consist of individuals who have no unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry and should include individuals with the appropriate scientific or other relevant expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. The committee members may be selected from inside or outside the University as warranted. The respondent, once known, will be notified in writing of the proposed committee membership and may object to a proposed member based upon a personal, professional, or financial conflict of interest. Any such objections must be submitted to the RIO no more than ten (10) calendar days from the date of the notification. The RIO will make the final determination of whether a conflict exists.

E. Charge to the Committee and First Meeting

1. The RIO will prepare a charge for the Inquiry Panel that:
   1. Sets forth the time for completion of the inquiry;
   2. Describes the allegation(s) and any related issues identified during the allegation
      assessment;
   3. States that the purpose of the inquiry is to conduct an initial review of the evidence, including the testimony of the respondent, complainant and key witnesses, to determine whether an investigation is warranted, not to determine whether misconduct definitely occurred or who was or were responsible;
   4. States that an investigation is warranted if the committee determines: (1) there is a
      reasonable basis for concluding that the allegation falls within the definition of misconduct;
      and, (2) the allegation(s) may have substance, based on the committee's review during the
      inquiry.
   5. Informs the Inquiry Panel that they are responsible for preparing or directing the preparation
      of a written report of the inquiry that meets the requirements of this policy and applicable
      law or regulation.
2. At the committee's first meeting, the RIO will review the charge with the committee, discuss
   the allegations, any related issues, and the appropriate procedures for conducting the inquiry,
   assist the committee with organizing plans for the inquiry, and answer any questions raised by
   the committee. The RIO will be present or available throughout the inquiry to advise the
   committee as needed.

F. Inquiry Process

The Inquiry Panel may interview the complainant, the respondent and key witnesses as well as examining relevant research records and materials. Then the Inquiry Panel will evaluate the evidence, including the testimony obtained during the inquiry. After consultation with the RIO, the committee members will decide whether an investigation is warranted based on the criteria in this policy. The scope of the inquiry is not required to, and does not normally, include deciding whether misconduct definitely occurred, determining definitely who committed the misconduct or conducting exhaustive interviews and analyses. However, if a legally sufficient admission of misconduct is made by the respondent, misconduct may be determined at the inquiry stage if all relevant issues are resolved. In that case, as required by applicable law or regulation, the institution shall promptly consult with any sponsoring agency with jurisdiction and authority, to determine the next steps that should be taken (See IX. of this Section).

G. Time for Completion

The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, must be completed within sixty (60) calendar days of initiation of the inquiry, unless the RIO determines that circumstances clearly warrant a longer period. If the RIO approves an extension, the inquiry record must include documentation of the reasons for exceeding the 60 calendar day period. The respondent will be notified in writing of the extension.

VI. The Inquiry Report

A. Elements of the Inquiry Report

1. A written inquiry report must be prepared that includes the following information: (1) the name and position of the respondent; (2) a description of the allegations of misconduct; (3) the identification of any sponsor support, including, for example, grant numbers, grant applications, contracts and publications; (4) the basis for recommending or not recommending that the allegations warrant an investigation; (5) any comments on the draft report by the respondent or complainant.
2. Institutional counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the Inquiry Panel. The inquiry report should include: the names and titles of the committee members and experts who conducted the inquiry; a summary of the inquiry process used; a list of the records and other evidence reviewed; summaries of any interviews; and whether any other actions should be taken if an investigation is not recommended.

B. Notification to the Respondent and Complainant and Opportunity to Comment

1. The RIO shall notify the respondent and the complainant whether the inquiry found an investigation to be warranted, include a copy of the draft inquiry report for comment(s) usually within fourteen (14) calendar days, and include a copy of or refer to this policy. The complainant will receive only a copy of the portions of the draft inquiry report that address the claimant's role and opinions in the investigation for comment. The complainant shall execute in advance a written confidentiality agreement in a form approved by the Office of the University Attorney as a condition for access to the report.
2. Any comments that are submitted by the respondent and the claimant, respectively, will be attached to the final inquiry report. Based on the comments, the Inquiry Panel may revise the draft report as appropriate and prepare it in final form. The committee will deliver the final report to the RIO.

C. Institutional Decision and Notification

1. Decision by Deciding Official
   The RIO will transmit the final inquiry report and any comments to the DO, who will determine in writing whether an investigation is warranted. The inquiry is completed when the DO makes this determination.
2. Notification to External Sponsoring Agencies
   Within thirty (30) calendar days of the DO's decision that an investigation is warranted, as required by applicable law or regulation, the RIO will provide any sponsoring agency with authority and jurisdiction with the DO's written decision and a copy of the inquiry report. The RIO will also notify those institutional officials who need to know of the DO's decision. As required by applicable law or regulation, the RIO must provide the following information to such sponsoring agency upon request: (1) the institutional policies and procedures under which the inquiry was conducted; (2) the research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and (3) the allegations to be considered in the investigation.
3. Documentation of Decision Not to Investigate
   If the DO decides that an investigation is not warranted, the RIO shall secure and maintain for seven (7) years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by sponsoring agencies with authority and jurisdiction of the reasons why an investigation was not conducted. These documents must be provided to such agencies upon request.

VII. Conducting the Investigation

A. Initiation and Purpose

The investigation must begin within thirty (30) calendar days after the determination by the DO that an investigation is warranted. 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 misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trials, potential harm to human participants or animal subjects, the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation must be set forth in an investigation report.

B. Notifying Respondent; Sequestration of Research Records

1. As required by applicable law or regulation, on or before the date on which the investigation begins, the RIO must: (1) notify any sponsoring agency with jurisdiction and authority of the decision to begin the investigation and provide such sponsoring agency a copy of the inquiry report; and (2) notify the respondent in writing of the allegations to be investigated. The RIO must also give the respondent written notice of any new allegations of misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.
2. The RIO will, prior to notifying respondent of the allegations, take all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the misconduct proceedings that were not previously sequestered during the inquiry. 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.

C. Appointment of the Investigation Committee

The DO, in consultation with the RIO and other institutional officials as appropriate, will appoint an investigation committee of at least five (5) individuals, as soon after the beginning of the investigation as is practical, preferably within ten calendar days. The investigation committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation and should include individuals with the appropriate scientific or other relevant expertise to evaluate the evidence and issues related to the allegation, interview the respondent and complainant and conduct the investigation. The majority of the committee should be faculty without administrative appointment. Individuals appointed to the investigation committee may also have served on the Inquiry Panel. When necessary to secure the necessary expertise or to avoid conflicts of interest, the DO may select committee members from outside the University. The respondent will be notified of the proposed committee membership and given an opportunity to object to a proposed member based upon a personal, professional, or financial conflict of interest. If so, the respondent must submit objections in writing to the RIO no more than ten (10) calendar days from the date of the notification. The RIO will make the final determination of whether a conflict exists.

D. Charge to the Committee and the First Meeting

1. Charge to the Committee - The RIO will define the subject matter of the investigation in a written charge to the committee that:
   1. Describes the allegations and related issues identified during the inquiry;
   2. Identifies the respondent(s);
   3. Informs the committee that it must conduct the investigation as prescribed in VII.(E.) of this Section;
   4. States the following: “Research and Creative Activity Misconduct (hereinafter misconduct) is defined as fabrication of results, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting the results. Research misconduct does not include honest error or differences of opinion.”
   5. Informs the committee that it must evaluate the evidence and testimony to determine whether, based on a preponderance of the evidence, misconduct occurred and, if so, the type and extent of it and who was responsible;
   6. Informs the committee that in order to determine that the respondent committed misconduct it must find that a preponderance of the evidence establishes that: (1) misconduct, as defined in this policy, occurred (respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion); (2) the misconduct is a significant departure from accepted practices
      of the relevant community; and (3) the respondent committed the misconduct intentionally, knowingly, or recklessly; and
   7. Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy and applicable law or regulation.
2. First Meeting
   The RIO will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of this policy and any applicable federal or state law or regulation governing the investigation. The RIO will be present or available throughout the investigation to advise the committee as needed.

E. Investigation Process

The investigation committee and the RIO must:

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

F. Time for Completion

The investigation is to be completed within one-hundred twenty (120) calendar days of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report for comment and, as required by applicable law or regulation, sending the final report to any sponsoring agency with jurisdiction and authority. However, if the RIO determines that the investigation will not be completed within this time period, as required by applicable law or regulation, he/she will submit to any sponsoring agency with jurisdiction and authority a written request for an extension, setting forth the reasons for the delay. The RIO will ensure that periodic progress reports are filed with such agency, if the agency grants the request for an extension and directs the filing of such reports. If no sponsoring agency is involved, any request for extension of time must be approved in writing by the DO and the respondent notified in writing of such approval.

VIII. The Investigation Report

A. Elements of the Investigation Report

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

1. describes the nature of the allegation of misconduct, including identification of the respondent;
2. describes and documents any relevant external sponsor support, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publications listing the sponsor support;
3. describes the specific allegations of misconduct considered in the investigation;
4. includes the University policies and procedures under which the investigation was conducted;
5. identifies and summarizes the records and evidence reviewed and identifies any evidence taken into custody but not reviewed; and
6. includes a statement of findings for each allegation of misconduct identified during the investigation. Each statement of findings must: (1) identify whether the misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly; (2) summarize the facts and the analysis that support the conclusion and consider the merits of any reasonable explanation by the respondent, including any effort by respondent to establish by a preponderance of the evidence that the act in question was not misconduct but was instead an honest error or difference of opinion; (3) identify the specific sponsor support; (4) identify whether any publications need correction or retraction; (5) identify the person(s) responsible for the misconduct; and (6) list any current support or known applications or proposals for support that the respondent has pending with any sponsoring agencies.

B. Comments on the Draft Report and Access to Evidence

1. Respondent
   The RIO must give the respondent a copy of the draft investigation report for comment and, concurrently, a copy of, or supervised access to the evidence on which the report is based. The respondent will be allowed thirty (30) calendar days from the date he/she received the draft report to submit comments to the RIO. The respondent's comments must be included and considered in the final report.
2. Complainant
   The RIO must give the complainant a copy of the portions of the draft investigation report that address the claimant's role and opinions in the investigation for comment. The complainant will be allowed thirty (30) calendar days from the date he/she received the draft report to submit comments to the RIO. The complainant's comments must be included and considered in the final report. The complainant shall execute in advance a written confidentiality agreement in a form approved by the Office of the University Attorney as a condition for access to the report.
3. Confidentiality
   In distributing the draft report, or portions thereof, to the respondent, the RIO will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality.

C. Decision by Deciding Official

1. The RIO will assist the investigation committee in finalizing the draft investigation report, including ensuring that the respondent's(s') comments are included and considered, and transmit the final investigation report to the DO, who will determine and state in writing: (1) whether the institution accepts the investigation report, its findings, and the recommended institutional actions; and (2) the appropriate institutional actions in response to the accepted findings of research misconduct. If this determination varies from the findings of the investigation committee, the DO 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 DO may return the report to the investigation committee with a request for further fact-finding or analysis.
2. When a final decision on the case has been reached, the RIO will normally notify both the respondent and the complainant in writing. After informing ORI, the DO will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which relevant reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

D. Notice of Institutional Findings and Actions

In accordance with applicable law or regulation, unless an extension has been granted, the RIO must, within the 120-day period for completing the investigation, submit the following to any sponsoring agency with jurisdiction and authority: (1) a copy of the final investigation report with all attachments; (2) a statement of whether the institution accepts the findings of the investigation report; (3) a statement of whether the institution found scholarly misconduct and, if so, who committed the research misconduct; and (4) a description of any pending or completed administrative actions against the respondent.

E. Maintaining Records for Review by Sponsoring Agencies

In accordance with applicable law or regulation, the RIO must maintain and provide to any sponsoring agency with jurisdiction and authority upon request records of misconduct proceedings. Unless custody has been transferred to the sponsoring agency or that agency has advised in writing that the records no longer need to be retained, records of research misconduct proceedings must be maintained in a secure manner for seven (7) years after completion of the proceeding or the completion of any sponsoring agency proceeding involving the research misconduct allegation. The RIO is also responsible for providing any information, documentation, research records, evidence or clarification requested by the sponsoring agency to carry out its review of an allegation of research misconduct or of the institution's handling of such an allegation.

IX. Completion of Cases; Reporting Premature Closures to Sponsoring Agencies

Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently. In accordance with applicable law or regulation, the RIO must notify any sponsoring agency with jurisdiction and authority in advance if there are plans to close a case at the inquiry or investigation stage on the basis that respondent has admitted guilt, a settlement with the respondent has been reached, or for any other reason, except: (1) closing of a case at the inquiry stage on the basis that an investigation is not warranted; or (2) a finding of no misconduct at the investigation stage, which must be reported to the sponsoring agency, as prescribed in this policy.

X. Institutional Administrative Actions

If the DO determines that misconduct is substantiated by the findings, they will refer the case to the appropriate Vice Chancellor to decide on the administrative actions to be taken, after consultation with the RIO, the DO, and respective dean and director or chair. The administrative actions may include:

1. Withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;
2. Removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment;
3. Restitution of funds to the grantor agency as appropriate; and
4. Other action appropriate to the research misconduct, including, but not limited to, the imposition of sanctions, up to and including termination from employment.

Respondent may appeal imposition of sanctions through the appropriate appellate committee as described in the East Carolina University Faculty Manual, Part XII, Section I, subsection III Due Process Before Discharge or Imposition of Serious Sanctions or, if discharge or serious sanctions are not imposed, through East Carolina University Faculty Manual, Part XII, Section II Faculty Grievance Procedures and Appeals of Non-Conferral of Early Tenure.

XI. Other Considerations

A. Termination or Resignation Prior to Completing Inquiry or Investigation

1. The termination of the respondent's institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceeding or otherwise limit any of the University's responsibilities to investigate the alleged misconduct.
2. If the respondent, without admitting to the misconduct, elects to resign his or her position after the University receives an allegation of 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.

B. Restoration of the Respondent's Reputation

Following a final finding of no misconduct, including concurrence of any sponsoring agency with jurisdiction and authority where required by law or regulation, the institution must undertake reasonable and practical efforts to restore the respondent's reputation. Depending on the particular circumstances and the views of the respondent, the RIO should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in any forum in which the allegation of misconduct was previously publicized, and expunging all reference to the misconduct allegation from the respondent's personnel file. Any actions by the RIO to restore the respondent's reputation should first be approved by the DO.

C. Protection of the Complainant, Witnesses and Committee Members

During the research misconduct proceeding and upon its completion, regardless of whether the institution determines that research misconduct occurred, the RIO must undertake all reasonable and practical efforts to protect the position and reputation of, or to counter potential or actual retaliation against, any complainant who made allegations of research misconduct in good faith and of any witnesses and committee members who cooperate in good faith with the research misconduct proceeding. The DO 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 DO approves.

D. Allegations Not Made in Good Faith

If relevant, the DO will determine whether the complainant's allegations of misconduct were made in good faith, or whether a witness or committee member acted in good faith. If the DO determines that there was an absence of good faith he/she will refer the matter to the appropriate Vice Chancellor to determine whether any administrative action should be taken against the person who failed to act in good faith.

E. Other Considerations

Respondent may appeal imposition of Institutional sanctions through the appropriate appellate committee as described in the East Carolina University Faculty Manual, Part XII, Section I, subsection III Due Process Before Discharge or Imposition of Serious Sanctions or, if discharge or serious sanctions are not imposed, through East Carolina University Faculty Manual, Part XII, Section II Faculty Grievance Procedures and Appeals of Non-Conferral of Early Tenure.

Related Policies:
UNC Policy Manual 500.7
REG02.07.11 University Regulation on Academic Integrity

East Carolina University Faculty Manual Part VI, Section II Summary of Academic Integrity Violation (AIV) Regulations and Procedures at East Carolina University

Additional References:
National Science Foundation Research Misconduct Regulation 45 CFR 689
Public Health Service Research Misconduct Regulation 42 CFR 93
Research Compliance Administration Website

(FS Resolution #13-63, April 2013)