Do You Need IRB Approval?
Does the project meet the definition of research with human subjects?
Research is defined as: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities" (Code of Federal Regulations, 45 CFR 46.102d).
A Human Subject means: "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" (Code of Federal Regulations, 45 CFR 46.102f).
The intention to contribute to the body of knowledge in a field is key to the definition, whether or not the completed research makes such a contribution or is accepted for publication.
All of the following activities may be considered research:
- Pilot studies (research development)
- Interview procedures
- Case studies
- Oral histories
- Analysis of existing data
All faculty and staff (both full-time and part-time) using human subjects or identifiable, private information about human subjects to conduct research within the course and scope of their duties are required to have prior approval from the IRB before research is initiated. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds. This policy also applies to students whose research is conducted under the advisement of a faculty member. All research proposals must be reviewed by the IRB and no individual, other than the IRB Chair, may exempt a proposal from review. Research that is conducted without IRB approval is not in compliance with UTC policy and federal regulations. In these circumstances a non-compliance report will be sent to the Provost for further action.
Do you need approval if the research does not take place at UTC?
According to UTC policies, research must be reviewed by the IRB in advance of any involvement of human subjects. This includes research conducted at another institution in this country or research conducted abroad. It includes collaboration with investigators at other institutions, and it includes research in which other institutions or researchers gather the data for a UTC researcher.
Are there any types of research that do not require an IRB application and/or approval?
There are a few categories of research that may involve human subjects but do not require IRB' applications and/or approval. These include the types of research listed below:
- UTC teacher and student evaluations;
- Program evaluation research to benefit UTC and carried out by UTC administrative officials and/or their designees;
- Projects designed to enhance or improve curricula offerings at UTC;
- UTC employee performance evaluations;
- State of Tennessee mandated program evaluations;
- Marketing research (designed to market the institution as a product).
Except for the examples above, all other research involving human subjects MUST complete an application. If the Principal Investigator has any doubt about whether or not their project meets these criteria, it is their responsibility to contact the IRB Chair for clarification. Service projects involving human subjects (including grants and programs that provide services and include an evaluative component that might be determined to be research) are encouraged to contact the IRB Chair and/or submit a proposal to ensure that they are exempt from IRB review. It is preferable to err on the side of caution and to file an application for approval if there is any doubt about the criteria. Any secondary data analyses of these data used for scholarly publication require IRB approval.