guidance-series – Page 4 – Institutional Review Board

Certificates of Confidentiality

Certificates of Confidentiality Guidance Documents and References Points to Consider Footnotes ⏴back to Guidance Series Certificates of Confidentiality Version: April 26, 2024 Guidance Certificates of Confidentiality (CoCs) are intended to protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive information to anyone not connected to the research except when the subject consents, […]

April 26, 2024

Exempt Research

Categories: guidance-series

Exempt Research Guidance Documents and References Appendices ⏴back to Guidance Topics Exempt Research Version: March 6, 2024 Guidance Exempt research is no greater than minimal risk and fits within an exemption category (see appendices for exemption categories). These studies are exempt from most of the requirements in the federal regulations for protection of human research […]

March 6, 2024

Parental Permission and Child Assent

Categories: guidance-series

Parental Permission and Child Assent Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics 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 […]

February 16, 2024

Decisional Impairment

Categories: guidance-series

Decisional 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 […]

February 16, 2024

Payments for Referrals to Research Studies

Categories: guidance-series

Payments 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 […]

February 6, 2024

Device Studies – Investigator Responsibilities

Categories: guidance-series

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

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