Human Subjects Applications, Forms, and Guidance

The Determination Tools section provides self-assessment tools to assist researchers in determining if a project is human subjects research and whether human subjects research may be exempt.

The Forms and Applications section is organized by submission type. Select the relevant document for your submission. Each application assists with identifying additional materials necessary for a complete submission which are posted in the sections below:

When available, guidance specific to preparing forms and application materials is included in the right-hand column of this page. See our Guidance Library for additional topical guidance.

Submissions to Research Compliance Services must use the current version of the materials which are posted below and be submitted through the RAP.

Determination Tools

Human Subjects
Research Determination Worksheet

• Use this worksheet to determine if your project meets the definition of human subject research and requires submission of a study.
• Submit this worksheet if you need formal documentation that your study does not require further review or if you are uncertain if your project requires further review.

Human Subjects Research Determination Worksheet- Genetics

• If your project involves genetic testing or genetic information, state laws may still apply to your project even if it is otherwise not human subjects research. If your project involves genetics but you do not believe your project is human subjects research, use this worksheet to determine if your project is consistent with state laws and also whether it requires a IRB oversight for a study involving human subjects research.
• Submit this worksheet if you need formal documentation that your study involving genetics does not require further review or if you are uncertain if your project requires further review. If your study is definitely human subjects research involving genetics, include Appendix E (below) rather than this form in addition to the materials needed for a complete submission.

• For self-assessment and screening for exemption eligibility.
• Verification of exemption from RCS is required. You may not begin human subject research activities until you submit an Exempt Review Application and receive documentation of an exempt determination from RCS.