Mandatory Reporting Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Mandatory Reporting Version: December 16, 2025 Guidance This guidance outlines information that should be shared with participants during the informed consent process relating to the 1) disclosure of confidential information of reportable diseases; 2) disclosure of abusive situations; and 3) disclosure […]
Read MoreInternational Research Guidance Documents and References Points to Consider ⏴back to Guidance Topics International Research Version: December 11, 2025 Guidance Investigators conducting international research must be qualified by training and experience to conduct such research. Investigators must design scientifically sound and culturally appropriate research that is relevant to the needs and conditions of the study […]
Read MoreCompensation of Research Subjects Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Compensation of Research Subjects Version: December 5, 2025 Definitions The University of Utah IRB uses the term “compensation” for payments made to research participants for participation in a study. Compensation may be provided to reimburse participants for their time, […]
Read MoreAdvertisements Guidance Documents and References Points to Consider ⏴back to Guidance Topics Advertisements Version: December 5, 2025 Guidance The IRB reviews recruitment methods, including advertisements, to ensure that they support the equitable selection of participants. The IRB also evaluates proposed advertisements and solicitations tp confirm they comply with regulatory requirements for informed consent. For more […]
Read MoreRequired Documents and Forms for IRB Applications Guidance ⏴back to Guidance Topics Required Documents and Forms for IRB Applications Version: December 4, 2025 Guidance The IRB reviews and approves supporting documents to the IRB application for the following purposes: Information included in the document is necessary for the IRB to determine if the study meets the Criteria for […]
Read MoreRecruitment Methods Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Recruitment Methods Version: December 4, 2025 Guidance The IRB reviews the process of screening, recruiting, and determining eligibility. The IRB reviews proposed recruitment procedures and advertisements to ensure that they do not violate the regulatory requirements of consent. Advertising Advertising is […]
Read MoreSuicide Risks Guidance Documents and References Appendices Footnotes ⏴back to Guidance Topics Suicide Risks Version: December 1, 2025 Guidance Some studies may involve research with participants at heightened risk of suicide, while other studies may only include a standard survey asking about a participant’s mental health (questions about depression or suicide) as part of a […]
Read MoreResearch Conducted in Higher Education Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Topics Research Conducted in Higher Education Version: November 26, 2025 Introduction This guidance focuses on research conducted in higher education (i.e., post-secondary schools) with individuals 18 and older. For more information on research conducted in elementary and secondary schools, […]
Read MoreResearch Conducted in Elementary and Secondary Schools Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Topics Research Conducted in Elementary and Secondary Schools Version: November 26, 2025 Introduction This guidance focuses on research conducted in elementary and secondary schools. For more information on research conducted in higher education, please see the IRB […]
Read MoreRisk Assessment Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Risk Assessment Version: November 21, 2025 Definitions Standard of Care: In this guidance, the term standard of care is used to refer to medically recognized standards of care. Medically recognized standards of care are treatments or procedures that have been accepted […]
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