Institutional Approval for Research
RVU faculty, staff, or students conducting human subjects research are required to seek RVU IRB approval before initiating the study. (The location of the study and the source of funding — if there is funding — do not determine if approval is needed.)
The following questions and related information will help you determine the process required for embarking on a research study and, if needed, seeking IRB approval. Please also review the Steps to Submitting a New IRB Application document.
In addition to this information, the Research and IRB Frequently Asked Questions document provides responses to additional questions you might have related to this process.
Are you Conducting Research?
The university’s IRB has assured federal regulatory agencies that the institution will review and approve all research that meet the federal definition of human subjects research. Determining whether or not a project meets the federal definition of human subjects’ research is a two-step process. The investigator must determine if the project meets the federal definition of research and, if so, determine if the project includes human subjects.
DHHS Regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. For purposes of IRB review, RVU further defines the following terms:
A “systematic investigation” as an activity involving a prospective plan that incorporates:
- the organized collection of quantitative and/or qualitative data, or biological specimens, and
- analysis (or anticipation of analysis) of those data or specimens to answer a question or questions.
“Generalizable knowledge” is information based on results or findings that are expected:
- to be reproducible, and
- apply broadly with the expectation of predictable outcomes.
FDA Regulations defines clinical investigation as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. (21 CFR 50.3(c), 21 CFR 56.103(c), 21 CFR 312.3(b), and 21 CFR 812.3(h)).
Are You Conducting Human Subjects Research?
The Federal Policy for the Protection of Human Subjects (Common Rule) defines human subjects as “…a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Notice that the definition of human subject focuses on what information or material is obtained from people. If either of the following is true, your research activity involves human subjects.
All human subjects research, and all other activities which in part involve human subject research regardless of sponsorship, must be reviewed and approved by (or registered exempt by) the RVU IRB prior to initiation.
Please review the Research and IRB Review Process Decision Tree to confirm if your research involves human subjects.