Institutional Review Board (IRB)

Ensuring Safe Medical Research Studies at East Tennessee Children’s Hospital

The Institutional Review Board at East Tennessee Children's Hospital reviews research studies to ensure that appropriate steps are taken to protect the rights and welfare of human subjects participating in research. Below, you can download various Institutional Review Board resources, including checklists, applications, forms and templates.

Questions or need assistance? Please contact the IRB office at research@etch.com.

Checklists

• Exemption Determination Form - Use this form to help determine if your activity involves Human Subjects Research.
• Student Checklist - Use this form to ensure you have completed the required documentation for IRB submission.

Protocol Applications

• Exemption Worksheet & Application - Use this form for research that falls under one of the exempt categories.
• Expedited Application - Use this form for research that falls under one of the expedited categories.
• Full Board Application - Use this form for research studies requiring full board review.

Informed Consent Forms

• Consent Waiver Form - If you are requesting to waive the consent or modify elements of consent, you must submit this form with your protocol application.
• Sample Parent/Guardian Permission (Consent) Form - Sample parental permission form for research studies that involve subjects under the age of 18.
• Sample Consent Form - Sample consent form for participants 18 years of age and older.
• Sample Assent Form (14-18) - Sample assent form for teen minors ~ age 14 thru 18.
• Sample Assent Form (7-13) - Sample assent form for minors ~ age 7 thru 13.
• Guidance for Consent & Assent - Use these documents as guidance for consent & assent forms

Other Forms

• Change in Personnel Form
• Compliance Statement
• Continuing Review Form - Use this form if you need to renew your expedited or full board protocol application.
• Data Use/Confidentiality Agreement - Use this form as applicable for data use.
• Financial Conflict of Interest Form - Use this form for studies that require disclosure of FCOI.
• HIPAA Authorization Form - If using a separate HIPAA authorization, this form outlines required information
• HIPAA Authorization Waiver Form - If you are requesting to waive HIPAA Authorization, you must submit this form with your protocol application.
• HIPAA Rider
• Human Subject Research Training (CITI)
• Protocol Amendment Form
• QI Form - 9-16-2019
• Signature Page

Policies

• Financial Conflict of Interest Policy - IRB: A00240