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<V2BodyCopyTray ID="x523260" Name="Definitions" IsComponent="true" Changed="20260416T19:31:30" Created="20260416T18:47:14" Published="20260416T15:04:23" SiteBaseUrl="" Locale="" XPowerPath="/Content Store/home/Policies/Procedures by Category/Compliance and Risk Management Procedures/UWW 733.A: Research Misconduct/components/Definitions" Expanded="20260416T17:08:32">
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&lt;p&gt;&lt;strong&gt;Common Rule:&lt;/strong&gt; Common Rule is a United States government's Federal Policy for the Protection of Human Subjects, regulations 45 CFR &amp;sect;46, which sets ethical guidelines for research involving people, including outlining requirements for Institutional Review Boards (IRBs), informed consent, Assurances of Compliance, and other protections, and to govern human subjects research they fund or conduct.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;CITI training:&lt;/strong&gt; A required training for all Principal Investigators and Student Principal Investigators on the rules, regulations, and ethical principles governing research involving human subjects. Renewal is required every 3 years.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Deception:&lt;/strong&gt; Deception occurs when an investigator intentionally gives research participants misleading or false information about some aspects of the research.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Human Subject:&lt;/strong&gt; Per regulations 45 CFR &amp;sect;46.102, it is a &amp;ldquo;a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Incomplete Disclosure:&lt;/strong&gt; Incomplete Disclosure occurs when an investigator intentionally withheld information from participants about the true purpose or nature of the research.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Informed Consent:&lt;/strong&gt; An ongoing educational process that takes place between the investigator and prospective subject, allowing the investigator and the participant to exchange information and ask questions.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Institutional Review Board for the Protection of Human Subjects (IRB):&lt;/strong&gt; A group that has been formally designated to review and monitor research involving human subjects to protect the rights and welfare of human research subjects, with the authority to approve, require modifications in (to secure approval), or disapprove research.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Research:&lt;/strong&gt; Per regulations 45 CFR &amp;sect;46.102, it is &amp;ldquo;a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.&amp;rdquo;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Institutional Research Compliance Specialist:&lt;/strong&gt; The person who conducts compliance activities related to research within the Office of Research and Sponsored Programs.&lt;/p&gt;</BodyCopy>
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