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<V2BodyCopyTray ID="x523291" Name="Definitions" IsComponent="true" Changed="20260417T12:32:03" Created="20260416T20:16:07" Published="20260417T08:00:43" SiteBaseUrl="" Locale="" XPowerPath="/Content Store/home/Policies/Policies by Category/Compliance and Risk Management Policies/Research Misconduct/components/Definitions" Expanded="20260417T10:04:42">
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  <BodyCopy type="xhtml" UID="b499bbe189fda381e651ff7c4ade1c56" label="Body Copy" readonly="false" hidden="false" required="false" indexable="false" openByDefault="false" CharacterLimit="" Height="" CIID="">&lt;p&gt;&lt;strong&gt;Accepted practices of the relevant research community: &lt;/strong&gt;Those practices established by 42 CFR Part 93 and by PHS funding components, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive PHS and non-PHS awards.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Administrative record:&lt;/strong&gt; Comprises: the institutional record; any information provided by the respondent to ORI, including but not limited to the transcript of any virtual or in-person meetings under &amp;sect; 93.403(b) between the respondent and ORI, and correspondence between the respondent and ORI; any additional information provided to ORI while the case is pending before ORI; and any analysis or additional information generated or obtained by ORI. Any analysis or additional information generated or obtained by ORI will also be made available to the respondent.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Allegation: &lt;/strong&gt;A disclosure of possible research misconduct through any means of communication and brought directly to the attention of an institutional or HHS official.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Assessment: &lt;/strong&gt;A consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct; appears to involve PHS or non-PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training; and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The assessment only involves the review of readily accessible information relevant to the allegation.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Complainant: &lt;/strong&gt;An individual who in good faith makes an allegation of research misconduct.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Evidence:&lt;/strong&gt; 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.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Fabrication: &lt;/strong&gt;Making up data or results and recording or reporting them.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Falsification:&lt;/strong&gt; 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.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Good faith:&lt;/strong&gt; (a) Good faith as applied to a complainant or witness means having a reasonable belief in the truth of one&amp;rsquo;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 performing the duties assigned for the purpose of helping an institution meet its responsibilities under this Policy. 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.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Inquiry:&lt;/strong&gt; Preliminary information gathering and preliminary fact-finding that meets the criteria and follows the procedures of &amp;sect; 93.307 through &amp;sect; 93.309. It is information gathering and initial fact-finding to determine if the allegation or apparent instance of misconduct warrants an investigation.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Institution:&lt;/strong&gt; Any person who applies for or receives PHS or non-PHS support for any activity or program that involves the conduct of biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training. This includes, but is not limited to, colleges and universities, PHS intramural biomedical or behavioral research laboratories, research and development centers, national user facilities, industrial laboratories or other research institutes, research institutions, and independent researchers.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Institutional Deciding Official:&lt;/strong&gt; The institutional official who makes final determinations on allegations of research misconduct and any institutional actions. The same individual cannot serve as the Institutional Deciding Official and the Research Integrity Officer.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Institutional member(s): &lt;/strong&gt;An individual (or individuals) who is employed by, is an agent of, or is affiliated by contract or agreement with an institution. Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, technicians, postdoctoral and other fellows, students, volunteers, subject matter experts, consultants or attorneys, or employees or agents of contractors, subcontractors, or sub-awardees.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Institutional record:&lt;/strong&gt; Comprises: (a) The records that the institution compiled or generated during the research misconduct proceeding, except records the institution did not consider or rely on. These records include but are not limited to (1) documentation of the assessment as required by &amp;sect; 93.306(c); (2) if an inquiry is conducted, the inquiry report and all records (other than drafts of the report) considered or relied on during the inquiry, including, but not limited to, research records and the transcripts of any transcribed interviews conducted during the inquiry, information the respondent provided to the institution, and the documentation of any decision not to investigate as required by &amp;sect; 93.309(c); (3) if an investigation is conducted, the investigation report and all records (other than drafts of the report) considered or relied on during the investigation, including, but not limited to, research records, the transcripts of each interview conducted pursuant to &amp;sect; 93.310(g), and information the respondent provided to the institution; (4) decision(s) by the Institutional Deciding Official, such as the written decision from the Institutional Deciding Official under &amp;sect; 93.314; (5) the complete record of any institutional appeal consistent with &amp;sect; 93.315; (b) a single index listing all the research records and evidence that the institution compiled during the research misconduct proceeding, except records the institution did not consider or rely on; and (c) a general description of the records that were sequestered but not considered or relied on.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Intentionally:&lt;/strong&gt; To act with the aim of conducting the act.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Investigation: &lt;/strong&gt;The formal development of a factual record and the examination of that record that meets the criteria and follows the procedures of &amp;sect;&amp;sect; 93.310 through 93.317. It is a formal presentation, examination and evaluation of all relevant facts to determine whether misconduct has occurred, the severity of the alleged misconduct and its impact, and the recommendations for specific actions to be taken to address the misconduct.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Knowingly:&lt;/strong&gt; To act with awareness of the act.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Office of Research Integrity (ORI): &lt;/strong&gt;The federal office to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS-supported activities.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Plagiarism:&lt;/strong&gt; The appropriation of another person&amp;rsquo;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&amp;rsquo;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.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Preponderance of the evidence:&lt;/strong&gt; Proof by evidence that, compared with evidence opposing it, leads to the conclusion that the fact at issue is more likely true than not.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Public Health Service (PHS) support: &lt;/strong&gt;PHS funding, or applications or proposals for PHS funding, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through funding for PHS intramural research; PHS grants, cooperative agreements, or contracts; subawards, contracts, or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements, or contracts.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Recklessly:&lt;/strong&gt; To propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Research:&lt;/strong&gt; A systemic investigation designed to develop or contribute to generalizable knowledge including, but not limited to, scientific, applied, behavioral and social-sciences research and/or any such activity for which funding is available from federal agencies.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Research Integrity Officer (RIO):&lt;/strong&gt; The institutional official responsible for administering the institution&amp;rsquo;s written policies and procedures for addressing allegations of research misconduct in compliance with 42 CFR Part 93.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Research misconduct: &lt;/strong&gt;Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Research misconduct proceeding: &lt;/strong&gt;Any actions related to alleged research misconduct taken under 42 CFR Part 93, including allegation assessments, inquiries, investigations, ORI oversight reviews, and appeals under subpart E of 42 CFR Part 93.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Research record: &lt;/strong&gt;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.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Respondent: &lt;/strong&gt;The individual against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Retaliation: &lt;/strong&gt;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.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Small institution: &lt;/strong&gt;An institution that may be too small to conduct an inquiry or investigation into an allegation of research misconduct as required by 42 CFR Part 93 without actual or apparent conflicts of interest.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Suspension and Debarment Official (SDO): &lt;/strong&gt;The HHS or, as applicable, a non-PHS official authorized to impose suspension and debarment, which are the actions that Federal agencies take to disqualify persons deemed not presently responsible from doing business with the Federal Government.&lt;/p&gt;</BodyCopy>
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