Only protocols that fall within the IRBs definitions of research and human participants require IRB review. Examples of research that does not require IRB approval include:
- Internal management projects, such as program evaluation, quality assurance, quality improvement, or marketing studies
- Projects that only document or report on events, situations, policies, institutions or systems without the intent to form hypotheses
- Projects which collect information about policies, practices or procedures
- Interviews or surveys which do not collect information about a person, such as interviews on government or corporate policies
- Production of creative arts, e.g., writing poetry and prose, painting, taking artistic photographs of people
- Oral history, journalism, biography, and historical scholarship or journalistic activities
- Reporting of current events, trends, newsworthy issues or stories about people or events, such as those presented in the news, magazines and on-scholarly periodicals
- Research using secondary data from publicly available sources. See the IRB’s guidance on using existing de-identified or publicly available datasets.
- Classroom projects conducted for educational purposes and not as research
When conducting such research projects, investigators are expected to adhere to ethical principles, as defined by professional associations and organizations, including appropriate informed consent, privacy and confidentiality protections and sound design and procedures.
What to do
If your project falls into one of the above categories, access the Kuali Protocols Portal to submit a review of a Not Human Subjects Research request. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating a protocol.
The ORPC will provide an analysis of your request using regulatory definitions and tools such as this comparison chart from the University of South Florida (posted courtesy of Eric Allen, Research Integrity & Compliance at University of South Florida) to determine whether the requests constitutes research involving human subjects, a quality improvement project or program evaluation.
As described elsewhere in the IRBs protocol creation guidance, investigators may make the initial determination about the type of human subjects review appropriate to the project. The final determination on the type of review, however, rests with the IRB. If another type of review is more appropriate, the investigator is notified to submit the applicable documents.
The ORPC will respond within 1-2 days with further guidance and advice.