u6063341 – Page 6 – Institutional Review Board

Device Studies – Investigator Responsibilities

Device Studies – Investigator Responsibilities Introduction Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Device Studies – Investigator Responsibilities Version: February 22, 2023 Introduction Federal Research Regulations The FDA is responsible for regulating devices for human use. Investigators conducting clinical trials involving devices have specific responsibilities outlined in 21 CFR 812. […]

February 22, 2023

Drug Studies – Investigator Responsibilities

Categories: guidance-series

Drug Studies – Investigator Responsibilities Introduction Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Drug Studies – Investigator Responsibilities Version: February 22, 2023 Introduction Federal Research Regulations The FDA is responsible for regulating drugs for human use. Investigators conducting clinical trials involving drugs have specific responsibilities outlined in 21 CFR 312, […]

February 22, 2023

Expedited Review of Research

Categories: guidance-series

Expedited Review of Research Guidance Appendices Footnotes ⏴back to Guidance Topics Expedited Review of Research Version: February 21, 2023 Guidance Research activities may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. All the following must be true in order for the application to be […]

February 21, 2023

Short Forms Consent Process Instructions For Use

Categories: guidance-series

Short Forms Consent Process Instructions For Use Guidance ⏴back to Guidance Series Short Forms Consent Process Instructions For Use Version: December 13, 2022 Guidance The IRB may approve an oral consent process (see 45 CFR 46.117(b)(2), and 21 CFR 50.27(b)(2), for FDA regulated research). This process requires that the IRB review and approve: A written […]

December 13, 2022

Safety Monitoring Plans

Categories: guidance-series

Safety 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 […]

September 29, 2022

Data Monitoring Plans

Categories: guidance-series

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 […]

September 29, 2022

Employees as Research Participants

Categories: guidance-series

Employees 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 […]

August 24, 2022

Adverse Events/Unanticipated Problems Assessment Flowchart

Categories: guidance-series

Adverse Events/Unanticipated Problems Assessment Flowchart Guidance ⏴back to Guidance Topics 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 […]

August 23, 2022

Prisoners

Categories: guidance-series

Prisoners 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 […]

August 22, 2022

Economically or Educationally Disadvantaged Individuals

Categories: guidance-series

Economically 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 […]

August 11, 2022