Concise Summary Guidance Documents and References ⏴back to Guidance Series Concise Summary Version: February 3, 2022 Guidance The revised “common rule” (effective January 21, 2019) requires that key information be included in the beginning of the informed consent in a concise and focused presentation. The University of Utah IRB refers to this as a “concise […]
Read MoreChildren Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Children Version: February 2, 2022 Definitions Subpart D: This term refers to the regulations which apply to research involving children as subjects. Subpart D is found in both 45 CFR 46 (DHHS) and 21 CFR 50 (FDA). Children: By regulatory definition, “children” […]
Read MoreSecondary Analysis of Public Use Datasets Introduction Guidance ⏴back to Guidance Series Secondary Analysis of Public Use Datasets Version: January 20, 2022 Introduction Secondary analysis of publicly available data is a common method of research. One of the main sources of such data is the federal government (e.g., Bureau of Labor Statistics). Increasingly, federal agencies […]
Read MoreSuicide Risks Guidance Documents and References Appendices Footnotes ⏴back to Guidance Topics Suicide Risks Version: September 14, 2021 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 MoreRegulatory References – Consent Language for Future Use of Information or Biospecimens Introduction Definitions Guidance ⏴back to Guidance Series Regulatory References – Consent Language for Future Use of Information or Biospecimens Version: July 16, 2021 Introduction Prior to the implementation of the revised Common Rule (effective date January 21, 2019), the University of Utah policy […]
Read MorePregnancy During Research Participation Guidance Documents and References Points to Consider ⏴back to Guidance Series Pregnancy During Research Participation Version: April 28, 2021 Guidance For some research protocols, women of childbearing age are advised to avoid pregnancy or nursing for a time during or following the research to protect the health and safety of the […]
Read MoreCompensation of Research Subjects Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Compensation of Research Subjects Version: April 13, 2021 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 MoreGenetic Research Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Genetic Research Version: February 2, 2021 Introduction Information developed during genetic studies may vary considerably with respect to its impact and value to subjects. When using the following guidance, it is acknowledged that there are many ways of responding to […]
Read MoreMandatory Reporting Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Series Mandatory Reporting Version: January 20, 2021 Guidance This guidance document 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) […]
Read MoreConsent During the COVID-19 Public Health Emergency Guidance Documents and References Points to Consider ⏴back to Guidance Series Consent During the COVID-19 Public Health Emergency Version: September 22, 2020 Guidance During the COVID-19 public health emergency, the IRB realizes that investigators must plan for adjustments to the consent process and documentation of consent. This guidance […]
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