Data Monitoring Plans Definitions Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Data Monitoring Plans Version: September 29, 2022 Definitions Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adherence to the approved investigative plan and the validity of data collected (White 2007). Federal […]
Read MoreSafety Monitoring Plans Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Safety Monitoring Plans Version: September 29, 2022 Definitions Safety Monitoring: The observations required to minimize threats to the safety and welfare of research subjects (White 2007). Federal Research Regulations and University of Utah IRB Policy The Common Rule and FDA […]
Read MoreEmployees as Research Participants Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Employees as Research Participants Version: August 24, 2022 Introduction Under certain circumstances, employees may not feel free to refuse if asked to participate in research. Employees may feel pressure to participate in research, particularly if the workplace is […]
Read MoreAdverse 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, […]
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