Jun 6, 2025 · Institutional Review Board (IRB) Written Procedures:Guidance for Institutions and IRBs. This guidance represents the Office for Human Research Protections’ (OHRP’s) and the …

The application or protocol, the consent/assent document (s), tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews.

To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies' regulatory requirements and guidance for human …

Jan 5, 2026 · Review the guidance for the IRB's Criteria for Approval and what to include for various Types of Research to evaluate the readiness of your protocol for review by the IRB.

A project requires Institutional Review Board (IRB) review if it includes both research and human subjects. An IRB protocol is a group of documents that conveys all the necessary information …

Which protocol template should you use? The IRB Office has developed protocol templates for use by the Northwestern University research community to describe research/human research …

Each of these templates includes instructional text that describes information to include in the protocol. The IRB looks for this information when reviewing research.

At the top of the screen, use the menu to switch to different screens, including Create IRB Protocol. Most of the information asked for should be familiar to you. The following procedure …

Mar 3, 2025 · Compiled by the UAB Office of the Institutional Review Board (OIRB), it highlights key considerations for ensuring ethical compliance, regulatory adherence, and submission …

There are questions and statements about what to consider in the protocol templates that guide investigators when developing an Investigator Protocol for submission to the IRB.