Researcher Guidance

Does my research require review?

Research activities require review by the IRB or an exempt determination if it meets the regulatory definition of human subjects research. To help determine whether your activities meet this definition, you may contact ORC and/or use the following tools:

"Is This Human Subjects Research?" – A guide for researchers
Decision Tree – Does your project require an application to Baylor IRB?
Worksheet – Determination of non-human subject research form

General Guidance

Glossary of IRB & research terminology
Tracking Changes into a Word Document
Improving Consent Form Readability & Comprehension
Use of Personal Data from the European Union

Submission Guidance

Submission Requirements for all initial reviews of exempt, expedited, and full board research.

Protocol Guidance:
G-02 Key Elements of a Protocol
G-15 Guidance on Enrollment and Accrual of Research Study Participants
T-01 IRB protocol template
T-05 Exempt IRB protocol template

Consent Form Guidance:
G-07 IRB Standard Consent Language
T-02 Consent Form Template
T-03 Assent Form Template
T-04 Parent Permission Form Template
T-06 Exempt Consent Form Template with guidance