IRB Guidelines and Templates

GUIDELINES

For more information on how to submit your protocol to the IRB, visit the Cayuse IRB page.

Initial Review Request Guidelines - This guide is for all initial submissions including Exempt, Non-Exempt and Secondary Analysis of Existing Data.

Subsequent Event Guidelines - This guide is for all events that take place after a study's initial approval including Amendments, Continuations, Adverse Events, and Completions.

Note: Thanks to a lot of feedback from you, the IRB has unlocked the IRR form to enable tracked changes. If you are making revisions to your IRR, be sure to enable tracked changes in the review ribbon in Microsoft Word.

TEMPLATES

There are instructions to aid the investigator on each of the templates. These instructions must be removed from the final version of the document prior to submission to the IRB.

Consent Document - This template is used to obtain the legally effective informed consent of individuals before involving them in research. Prior to submitting to the IRB, delete all embedded directions to the researcher or it will be returned as incomplete.

Assent Document - This template is used to gain a child's affirmative agreement to participate in research. Prior to submitting to the IRB, delete all embedded directions to the researcher or it will be returned as incomplete.

Parental Permission - This template is used to gain a parent's permission for a child to participate in research. Prior to submitting to the IRB, delete all embedded directions to the researcher or it will be returned as incomplete.

Exemption Reviewer Checklist - This template is used by the IRB Administrator to determine if your protocol qualifies as exempt research.

Reviewer Checklist - This template is used by the Board members when reviewing a protocol.

Recruitment Flyer: Word Document or
Recruitment Flyer: PDF - This template is used as a guideline for what should be included in a recruitment flyer.

WAIVERS

Waiver of Written Documentation of Informed Consent -The purpose of this form is to provide support for IRB members when reviewing research involving the waiver of written documentation of informed consent. This form must be used to request a waiver of written documentation of informed consent based on federal regulation 45 CFR 46.117 [c].

Waiver of Informed Consent - The purpose of this form is to provide support for IRB members when reviewing research involving the waiver of informed consent. This form must be used to request a waiver of informed consent based on federal regulation 45 CFR 46.116 [d].