What is Human Subject Research?
General Definition of Research (DHHS): A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
A systematic investigation is an activity that is planned in advance and that uses data collection and analysis to answer a question.
Generalizable knowledge is information that expands the knowledge base of a scientific discipline or other scholarly field of study.
Definition of a Human Subject: A living individual about whom an investigator conducting research obtains
- data through intervention or interaction with the individual, or
- identifiable private information.
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
FDA Definition of a Clinical Investigation: Use of a drug or medical device other than the use of an approved drug or medical device in the course of medical practice, when data will be gathered, submitted to, or held for inspection by the FDA in support of an FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, and infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product.
General Definition of De-Identified (HIPAA): Information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual. This includes that there is no means to re-identify individuals after the data have been de-identified (e.g., using a code or other means of record identification). Generally, use of the Safe Harbor De-Identification standard ensures that data are de-identified.
What is Non-Human Subject Research?
Any project that does not involve research, a human subject, or a clinical investigation, as defined above.
What are some examples of Non-Human Subject Research?
Projects that involve quality improvement, case reports, program evaluation, marketing and related business analysis, and surveillance activities may not be considered human subject research, so long as the project does not involve
- A systematic investigation designed to develop or contribute to generalizable knowledge using human subjects, or
- A clinical investigation.
For more information about case reports, see the following documents:
Additionally, use of existing de-identified or publicly available datasets may not be considered human subject research. For more information, see the Investigator Guidance Series: Secondary Analysis of Public Use Datasets.
The IRB uses the following guidances to determine if a project is or is not human subject research:
- IRB SOP 401a: Non-Human Subject Reseach
- DHHS Human Subject Regulations Decision Charts
- DHHS/OHRP Guidance on Engagement of Institutions in Human Subjects Research
- DHHS Quality Improvement Activities FAQ
- Centers for Disease Control and Prevention (CDC) guidance on Distinguishing Public Health Research and Public Health Nonresearch
- VHA Operation Activities That May Constitute Research
What are the expectations when conducting a project that is Non-Human Subject Research?
Investigators are expected to adhere to ethical principles for non-human subject research projects, including the following when appropriate:
- Informed consent
- Privacy and confidentiality protections
- Sound design and procedures
Projects using protected health information (PHI) must still follow HIPAA regulations for authorization and confidentiality protections, including projects using PHI about non-living individuals. Below are additional forms that may be needed for these projects:
Need Advice?
Contact the IRB to discuss whether or not your project meets the definition of Human Subject Research or a Clinical Investigation.
801-581-3655
irb@hsc.utah.edu
To secure a formal determination of Non-Human Subject Research from the IRB, you must submit a Non-Human Subject Research Request as part of the New Study Application in the ERICA system.