Forms and Documents

Adverse Events

Adverse Event Reporting Form Microsoft Word document
An adverse event is defined as "any happening not consistent with routine expected outcomes that result in bodily injury and/or psychological, emotional, or physical harm or stress." Adverse events must be report to the IRB promptly using the Adverse Event Reporting Form.

Application for Revision to a Previously Approved Protocol

Application for Revision to a Previously Approved Protocol Microsoft Word document
It is the PI's responsibility to obtain IRB approval prior to implementing a research protocol or using an informed consent document that has been revised or altered in any way (following initial IRB review and approval). Any changes to an approved protocol or informed consent document may not be implemented without prior written approval of the IRB. This document is to be used to submit requests for changes to the IRB.

Attachments

Children as Research Participants Microsoft Word document
Employees and Students as Research Participants Microsoft Word document
Illiterate Subjects as Research Participants Microsoft Word document

Exempt Research

Exempt Research Checklist Microsoft Word document
This form is provided as a method to help investigators more easily determine possible exempt status of a research project. Please include this checklist with an exempt project submission to the IRB.

Informed Consent

Basic Elements of Informed Consent Microsoft Word document
Guidelines for Developing the Informed Consent Document Microsoft Word document
Informed Consent Template Microsoft Word document
Waiver of Informed Consent Microsoft Word document

Project Updates/Closures

Project Update and Closure Form Microsoft Word document
This form should be used for continuing review and for closing a completed project. If you are submitting a project for continuing review, please note that you need to also submit a copy of a signed informed consent document as well as a "clean" version that can be stamped with the approval and expiration date.

Protocol Submission Forms

Protocol Submission Guidebook Microsoft Word document
The guidebook contains documents necessary for IRB protocol submission. Including in the guidebook are the following:

Protocol Submission Forms

Recruitments

Advertisements for Research Subjects Microsoft Word document
This document outlines the information that needs to be included in all recruitment materials.

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