Adverse Events/Unanticipated Problems Assessment Flowchart Guidance ⏴back to Guidance Series Adverse Events/Unanticipated Problems Assessment Flowchart Version: August 23, 2022 Guidance Not all adverse events constitute unanticipated problems that need to be reported to the University of Utah IRB. How do you determine whether to submit a report of an adverse event to the IRB? Use […]
Read MoreInternational Research Guidance Documents and References Points to Consider ⏴back to Guidance Series International Research Version: August 22, 2022 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 population […]
Read MorePrisoners Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Prisoners Version: August 22, 2022 Definitions Subpart C: This term refers to the regulations which apply to research involving prisoners as subjects. Subpart C is found in 45 CFR 46 (DHHS). Prisoner: A prisoner means any individual involuntarily confined or detained in […]
Read MoreEconomically or Educationally Disadvantaged Individuals Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Economically or Educationally Disadvantaged Individuals Version: August 11, 2022 Definitions Common Rule: The Federal Policy for Protection of Human Subjects found in HHS regulations in 45 CFR 46 includes four subparts. Subpart A is also known as the […]
Read MoreHuman Tissue Transfer Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Human Tissue Transfer Version: August 9, 2022 Definitions Human Tissues means any biological product or byproduct obtained from a living or deceased individual that is sufficient in type and quantity to permit an analysis of its physical or biochemical properties. […]
Read MoreInvestigators and Key Study Personnel Guidance Documents and References Points to Consider ⏴back to Guidance Series Investigators and Key Study Personnel Version: July 8, 2022 Guidance Investigators and key study personnel conducting research at the University of Utah should be listed on the ERICA application and must complete required human subject research training. This guidance […]
Read MoreTransitioning to the Final Common Rule Introduction Guidance Documents and References ⏴back to Guidance Series Transitioning to the Final Common Rule Version: April 6, 2022 Introduction The federal government changed the Common Rule (45 CFR 46) that governs human subjects research, with an effective date of January 21, 2019. Studies initiated before January 21, 2019, […]
Read MoreConcise 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 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 […]
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