Step 1. Is Your Project Considered Research?
This is the first of four steps in determining whether your planned activity requires IRB review.
Why this matters
- If your activity doesn’t fit one of the definitions of research (below), you do not need to obtain Institutional Review Board (IRB) approval or a determination of exempt status.
- The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research. Use the WORKSHEET: Human Subjects Research Determination to make your own determination about whether your activity meets either of the two definitions described here.
Two definitions of “research”
Research is a systematic investigation, including research development, testing, and/or evaluation, designed to develop or contribute to generalizable knowledge.
Systematic investigation: A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.
Generalizable knowledge: The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
- Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied
- Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
The activity is research if both of the following conditions are met:
- The intent of the activity is to develop information about a drug, medical device (including diagnostic tests), or biologic substance for submission to the federal Food and Drug Administration (FDA), and
- The activity involves the prospective physical use of drug, medical device (including diagnostic tests), or biologic substance, in a way that is not completely up to the discretion of a clinical practitioner.
Activities can be considered research even if they are also considered to be program evaluation, quality improvement, public health surveillance, preliminary work, or pilot studies. For more information about these and other special situations, consult the HSD document entitled GUIDANCE: Is It Research?
Request a determination (optional)
Follow these directions if you’d like to have a formal determination about whether your activity is research. Example situations for which a determination might be appropriate: (1) you need a determination in order to obtain or access data from a source; (2) you think you might need a determination later when you publish results; (3) you have a complicated project.
- Complete the circled questions on the standard IRB Protocol form or on the No Contact version of the form.
- In Zipline, create a new application by clicking on the Create a New Study button and following the instructions. Attach your completed IRB Protocol form at the indicated place.
- HSD will assess your application and issue a formal determination.
Next step, if you think your activity is research