Step 2. Does Your Research Involve Human Subjects?
This is the second of five steps in determining whether your planned activity requires IRB review and, if yes, by which IRB.
Why this matters
- If your research does not involve human subjects, 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 “human subject”
Definition 1: FDA-regulated research
Applies to: Research that is regulated by the Food and Drug Administration (FDA) and that involves the use of a drug, device, or other item regulated by the FDA.
Human subject: A living individual who participates in a research investigation, as (a) a recipient of an item regulated by the FDA; (b) as a control; or (c) on whose specimen an investigational device is used.
Definition 2: Research that is not regulated by the FDA
Applies to: All research that is not described in Definition 1.
Human subject: A living individual about whom a researcher obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. See the WORKSHEET: Human Subjects Research Determination for definitions of the bolded words.
Relationship to obtaining consent
Individuals may be human subjects before they have provided consent, if the criteria defining a “human subject” have been met. This is most likely to occur when with screening or “pre-screening” activities, such as examining identifiable medical records in order to select possible participants.
- Deceased individuals. This refers to individuals who are not alive, as defined by applicable local and national laws. Although deceased individuals are not considered to be human subjects, Washington State law requires IRB approval or research that will use identifiable Washington State PHI without the consent of the patient (whether living or deceased) or the patient’s legally authorized representative.
- Specimens, records, data (no interaction or contact with living individuals). Private identifiable specimens, records and data about individuals are considered to be human subjects, even if the researcher has no contact or interaction with the individuals.
- “Third party” or “secondary” subjects. This refers to situations in which the researcher obtains information about one individual (“A”) through interaction with another individual (“B”). If the information about A is private and identifiable, then A is a human subject. Example: Subjects in a cancer study are asked about the cancer history of their relatives. If the information is provided in a way that is not individually identifiable to the researchers, then the relatives are not subjects. If the information is individually and readily identifiable to the researchers, then the relatives are subjects.
- Newborn blood spots. Federal law defines newborn blood spots collected on or after March 18, 2015 as “human subjects”, regardless of whether the bloodspots are identifiable, coded, de-identified, or anonymous. Federally-funded research using these bloodspots must obtain IRB approval.
Request a determination (optional)
You may perform and document a self-determination, following the instructions in the SOP Human Subjects Research Determination. Otherwise, follow these directions if you’d like to have a formal determination about whether your activity involves human subjects. 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.