Parental Permission and Child Assent Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Parental Permission and Child Assent Version: February 16, 2024 Introduction Parental permission and child assent is used prior to involving children in research. Investigators are responsible for ensuring that the permission of each child’s parents or guardian […]
Read MoreDecisional Impairment Definitions Guidance Documents and References Points to Consider Footnotes ⏴back to Guidance Topics Decisional Impairment Version: February 16, 2024 Definitions Assent means a participant’s affirmative agreement to participate in research. In this guidance, assent refers to the affirmative agreement of individuals with diminished decision-making capability to participate in research. The absence of an […]
Read MorePayments for Referrals to Research Studies Definitions Guidance Footnotes ⏴back to Guidance Series Payments for Referrals to Research Studies Version: February 6, 2024 Definitions A finder’s fee is a payment from the sponsor (or investigator) made to research personnel in exchange for referrals of a research participant. Bonus payments are payments designed to accelerate recruitment […]
Read MoreDevice 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. […]
Read MoreDrug 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, […]
Read MoreExpedited 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 […]
Read MoreShort 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 […]
Read MoreData 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 […]
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