Single IRB Help

If you are in the planning stages or ready to submit a study that is subject to the Single IRB Mandate, click here for additional information and resources on SIRB submssions.

 

Handbooks for Use:

The Investigator’s Handbooks for the Protection of Human Participants in Biomedical Research and in Social and Behavioral Research are resource manuals for researchers. These manuals will assist the Investigators in smoothly navigating the IRB process and adhering to the federal regulations and IRB policies related to human research protections. The manuals are located on the HRPP website.

 

Research Study Compliance Assessment Tool

This compliance assessment tool is a self-assessment tool to assist principal investigators and their study teams with conducting a self-audit of their study, along with preparing for a directed audit and/or post-approval monitoring review.  This document is intended as a tool for the research community for the purpose of reviewing their study.  This compliance assessment tool will not be reviewed by the IRB unless the study team chooses to submit with continuing review.

 

Documentation of Informed Consent Process Tool

This tool was developed to assist study teams to meet the requirements for IRB Policy IV.B. which includes a process for documentation of informed consent process that is outside of the signing of the consent document. This tool is available for use with any study and can be printed for your study document/regulatory binder or kept electronically. 

 

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