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6 maj 2024 · This activity discusses, on an introductory level, ethical principles that translate into patient rights, patient rights currently enforced in the United States, with some comparisons to past rights and rights in other countries, and a history of how these rights came to be.
15 sie 2023 · This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations.
1 lut 2022 · This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biological products.
The Investigational Device Exemptions (IDE) regulation (21 CFR 812) describes three types of device studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies. In this guidance...
FDA highlights the critical role the IRB plays in review and approving consent forms and the consent process for compliance with FDA regulations to safeguard the rights and welfare of human subjects. The guidance outlines specific areas to take into consideration when carrying out their responsibilities including:
29 cze 2023 · The most recent FDA information sheets dated August 19, 2020, are intended to provide answers to frequently asked questions about human subject protection, informed consent, review of research, and related topics in an effort to help IRBs, clinical investigators, and sponsors ensure that the rights and welfare of human research subjects are ...
This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.
