Do You Need IRB Approval?
When considering whether or not you need IRB approval, ask yourself these questions:
- Does the project meet the definition of research with human subjects?
- Do you need approval if the research does not take place at UTC?
- Are there any types of research that do not require an IRB application and/or approval?
- What if I just want to present my research at a UTC-hosted research conference such as the Spring Research and Arts Conference?
Does the project meet the definition of research with human subjects?
While most research involving human subjects is regulated by “The Common Rule”— regulations that most federal agencies have agreed to use in common—some studies may be subject instead to Food and Drug Administration (FDA) regulations specific to the development and testing of medical devices. This can include mobile health and/or fitness apps, AI/machine learning algorithms, and software, as well as physical items used in diagnosing, treating, or preventing disease or intended to affect the structure or any function of the body. More information about the types of projects that are FDA-regulated can be found here. If you are planning to conduct medical device research, contact [email protected] for guidance—the standard UTC IRB application process is not applicable.
Under the Common Rule, research is defined as:
"(l)...a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." (Code of Federal Regulations, 45 CFR 46.102(l)).
A Human Subject means:
"(e)(1) ...a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." (Code of Federal Regulations 45 CFR 46.102(e)(1)).
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
- Experimental interventions
- Medical chart reviews
- Case studies (involving more than three individuals or a regulated investigational drug or device)
- Analysis of identifiable, existing data.
All UTC faculty, staff, and students using human subjects or identifiable, private information about human subjects to conduct research are required to have prior approval from the IRB before the research is initiated. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds. All research proposals must be reviewed by the IRB and no individual, other than the IRB Chair or his/her designee, 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.
In some situations, the UTC IRB will defer to the IRB of record at alternate research locations. This is a formal process and involves coordination with both IRB offices and the Office of Research Integrity. For further information on this, please contact the Office of Research Integrity.
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;
- Quality Assurance/Quality Improvement programs
- Projects designed to enhance or improve curricula offerings at UTC;
- UTC employee performance evaluations;
- The state of Tennessee mandated program evaluations;
- Marketing research (designed to market the institution as a product).
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected.
- Case studies (if only including one, two, or three individuals and not involving the use of a regulated drug or device).
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/Office of Research Integrity for clarification. Service projects involving human subjects (including grants and programs that provide services and include an evaluative component that might be determined to research) are encouraged to contact the IRB Chair/Office of Research Integrity to ensure that they are exempt from IRB review. Any secondary data analysis of these data used for scholarly publication requires IRB approval.
What if I just want to present my research at a UTC research conference such as the Spring Research and Arts Conference?
Research conferences hosted by UTC are open to the community. Therefore, research results presented at these events meet the federal definition of having an "...intent to contribute to generalizable knowledge." All research with human subjects that is presented at such events must have received IRB approval prior to data collection. See the UTC Research Conference guidance page for more information.