Pregnant Women & Fetuses Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Pregnant Women & Fetuses Version: April 26, 2024 Definitions Subpart B: This term refers to the regulations which apply to research involving pregnant women and fetuses as subjects. Subpart B is found in 45 CFR 46 (DHHS). Pregnancy: Encompasses […]
Read MoreExempt Research Guidance Documents and References Appendices ⏴back to Guidance Series 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 […]
Read MoreLegally Authorized Representative (LAR) and Surrogate Consent Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics Legally Authorized Representative (LAR) and Surrogate Consent Version: February 16, 2024 Definitions Assent: Assent is a term used to express willingness to participate in research who are too young to give informed consent or […]
Read MoreParental 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 […]
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