Writing a Review Summary Introduction Guidance Documents and References ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 19, 2025 Introduction The board reviewer checklist asks specific questions about the requirements that need to be satisfied for approval. Addressing the criteria for approval is particularly important in both the written review and […]
Read MoreWaivers of Consent for Research with Prospective Data Collection Guidance Documents and References Appendices Footnotes ⏴back to Board Member Guidance Series Board Member Guidance Series Version: July 18, 2024 Guidance The University of Utah IRB routinely grants waivers of consent for retrospective chart review and secondary data analysis studies. Investigators occasionally request waivers of consent […]
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, […]
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 […]
Read MoreExempt Research Guidance Documents and References Appendices ⏴back to Guidance Topics Exempt Research Version: March 6, 2024 Guidance Exempt research is no greater than minimal risk and fits within an exemption category (see appendices for exemption categories). These studies are exempt from most of the requirements in the federal regulations for protection of human research […]
Read MoreParental Permission and Child Assent Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Parental Permission and Child Assent Version: February 16, 2024 Introduction Parental permission and child assent is used prior to involving children in research. Investigators are responsible for ensuring that the permission of each child’s parents or guardian […]
Read MoreDecisional Impairment Definitions Guidance Documents and References Points to Consider Footnotes ⏴back to Guidance Topics Decisional Impairment Version: February 16, 2024 Definitions Assent means a participant’s affirmative agreement to participate in research. In this guidance, assent refers to the affirmative agreement of individuals with diminished decision-making capability to participate in research. The absence of an […]
Read MoreApplicable State Laws Guidance Footnotes ⏴back to Board Member Guidance Board Member Guidance Series Applicable State Laws Version: February 16, 2024 Guidance The University of Utah IRB seeks assistance from the University’s Office of General Counsel when assessing the applicability and requirements of federal and state law. Additionally, the Office of General Counsel helps resolve […]
Read MorePayments for Referrals to Research Studies Definitions Guidance Footnotes ⏴back to Guidance Series Payments for Referrals to Research Studies Version: February 6, 2024 Definitions A finder’s fee is a payment from the sponsor (or investigator) made to research personnel in exchange for referrals of a research participant. Bonus payments are payments designed to accelerate recruitment […]
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