Neonates Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Neonates Version: September 3, 2025 Definitions Subpart B: Subpart B is found in 45 CFR 46 (DHHS) and includes additional protections for neonates involved in research (45 CFR 46.205). Neonate: Newborns from the time of delivery up until 28 days old. Nonviable […]
Read MoreSpanish-Speaking Individuals in Research Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics Spanish-Speaking Individuals in Research Version: September 2, 2025 Definitions Interpretation is the spoken exchange of communication between two languages. A certified interpreter is an individual who has passed a certification exam given by an accredited entity to […]
Read MoreWards of State Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Wards of State Version: August 6, 2025 Introduction Federal regulations require additional safeguards for certain categories of research involving wards of the state. These protections are outlined in Subpart D of 45 CFR 46 (Additional Safeguards for Children Involved […]
Read MoreMultimedia Recordings Guidance Documents and References ⏴back to Guidance Series Multimedia Recordings Version: April 25, 2025 Guidance Using multimedia tools to record the image and/or voice of an individual creates a record that requires careful handling and storage, particularly if the content of media or the purpose of the research may be considered sensitive. These […]
Read MoreDeception & Debriefing Guidance Documents and References Points to Consider ⏴back to Guidance Topics Deception & Debriefing Version: April 20, 2025 Guidance Deception is the intentional misleading of participants or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, […]
Read MoreBasic Physiological Research Guidance Documents and References Points to Consider ⏴back to Guidance Series Basic Physiological Research Version: April 14, 2025 Guidance The Food and Drug Administration (FDA) is responsible for regulating devices for human use including Investigational Device Exemptions (IDE). An IDE allows an investigational device (i.e., a device that is the subject of […]
Read MoreSponsor-Investigator Guidelines and Responsibilities Guidance Documents and References ⏴back to Guidance Series Sponsor-Investigator Guidelines and Responsibilities Version: April 9, 2025 Guidance A sponsor-investigator is an individual who both initiates and conducts a clinical investigation. The sponsor-investigator may conduct the research alone or with others. Investigators who conduct studies involving an FDA test article and for […]
Read MoreTransplantation of Fetal Tissue Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Transplantation of Fetal Tissue Version: February 26, 2025 Definitions For the purposes of this law, the term “human fetal tissue” means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or […]
Read MoreWaiver or Alteration of Consent Guidance Documents and References Points to Consider ⏴back to Guidance Series Waiver or Alteration of Consent Version: July 18, 2024 Guidance The University of Utah IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent or waive the […]
Read MorePregnant Women & Fetuses Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Pregnant Women & Fetuses Version: April 26, 2024 Definitions Subpart B: This term refers to the regulations which apply to research involving pregnant women and fetuses as subjects. Subpart B is found in 45 CFR 46 (DHHS). Pregnancy: Encompasses […]
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