| Guidance: Is it Research? Do I Need IRB Approval? | This tool will help you determine whether your project is research as defined by the federal regulations for research with human subjects (45 CFR 46). |
| Guidance: To IRB or Not to IRB | This document describes activities that require an IRB submission. |
| Quality Assurance, Quality Improvement, Program Evaluation vs. Research | Use this guide to determine whether your project is research, quality assurance/quality improvement/program evaluation, or Human Subject Research (HSR) requiring IRB review or exemption. |
| Exemption Category 1 Guidance | Use this document to determine whether your research may qualify for Exemption 1 (Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction). |
| Exemption Category 2 Guidance | Use this document to determine whether your research may qualify for Exemption 2 (Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) and certain criteria are met). |
| Exemption Category 3 Guidance | Use this document to determine whether your research may qualify for Exemption 3 (Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry or audiovisual recording) if the subject prospectively agrees to the intervention and information collection and certain criteria are met). |
| Exemption Category 4 Guidance | Use this document to determine whether your research may qualify for Exemption 4 (Secondary research for which consent is not required). |
| Exemption Category 5 Guidance | Use this document to determine whether your research may qualify for Exemption 5 (Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs). |
| Exemption Category 6 Guidance | Use this document to determine whether your research may qualify for Exemption 6 (Taste and food quality evaluation and consumer acceptance studies). |
| IRB Initial Application Template | This tool walks you through the components of the Initial Application in Niner Research, with tips and guidance from the IRB Office. |