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 MoreCertificates of Confidentiality Guidance Documents and References Points to Consider Footnotes ⏴back to Guidance Series Certificates of Confidentiality Version: April 26, 2024 Guidance Certificates of Confidentiality (CoCs) are intended to protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive information to anyone not connected to the research except when the subject consents, […]
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