How do I know if I need IRB approval for my research?
If your research will be published (even as a thesis or dissertation) or given as a presentation outside of a UT Knoxville classroom, you will need IRB approval for your research. Research done for a class presentation, unless it is to be published or presented elsewhere, does not require an IRB approval.
If I need to complete an IRB protocol for my research where do I begin?
Begin with your advisor. They can help you get started. Your department also has someone who approves IRB protocols at that level. At any time you can contact the IRB office at (865) 974-7697. Don’t be afraid to ask questions. It’s better to ask ahead of time than find out later that you left something out.
When do I need to obtain IRB approval?
IRB approval is required BEFORE starting any data collection. This is very important. If you begin your research and start collecting data without prior IRB approval you risk losing all of that data and must begin again with the collection process.
Effective September 1, 2014, all IRB applications must be submitted through iMedRIS.
What information do I need to include in my application?
The IRB has created step-by-step instructions for completion of an initial application for a new project. This document shows each screen you might encounter. The questions you see are based on your responses to previous items. Specific advice is given, with special attention given to questions that have been confusing to researchers in the past. At any time you may contact the IRB office at (865) 974-7697.
You may also find this sample application useful. It is much like the one you will submit via iMedRIS. (You will need a UT NetID to log in and view the document.)
How do I know if my human subject research is “Exempt”?
Exempt research is based on risk to the human subjects. Research that is low risk undergoes an exempt review and is approved at your departmental level. It must be certified by the IRB office before you can begin data collection. Turn-around time is generally one week once it is received by the IRB office. Research involving children and other vulnerable populations is not eligible for Exempt review. An example of Exempt research is an anonymous survey, either online or on paper, with no identifying data.
What else is required if my research is Exempt?
Exempt research requires completion of an Information Sheet for consent. A sample of your Information Sheet should accompany your iMedRIS submission.
If my research is not Exempt what do I do?
If your research does not qualify as Exempt, it will require “Expedited” or “Full-board” review. If the research is considered to have “minimal risk” to the human subject, it may qualify as “Expedited.” Expedited review takes approximately 2-3 weeks. Research that is considered to be more than minimal risk to the subject will require Full-board approval. Typically, the most substantial risk in behavioral and social science research at UT Knoxville involves loss of confidentiality. Research involving children and other vulnerable populations may be either Expedited or may require Full-board review. Full-board review can take up to four weeks from the time of submission to receive the outcome of the IRB’s assessment. Responses to questions from the IRB will be reviewed within 1-2 weeks of resubmission. Remember that you may not begin any data collection until you have IRB approval. If you have any questions about your research protocol contact the IRB office at 865-974-7697.
All IRB applications must be submitted through iMedRIS.
What else do I need to submit with my IRB form?
A draft of all methods of data collection, such as interview questions, instruments to be completed, etc is also needed for the IRB.
If I choose to use audio or video tapes or digital recordings in my research how long must I maintain the originals?
The original recordings should be destroyed when they are transcribed. If your research requires that you keep the recording for a longer period of time you must state where they will be stored, who will have access to them while stored, and when they will be destroyed.
What about consent from the subject for Expedited or Full-board research?
Informed consent is required for all Expedited or Full-board research, unless a waiver to obtain consent is requested. “Informed consent” requires a signature from the subject before approaching a child for participation. For the child, you will also need to include an “Assent” form. Even if the child assents to research, you must obtain a signature from the parent on an “Informed Consent” form. Examples of Informed Consent and Assent are available on the Forms page.
If I want to do research at a local school, what is the procedure for consent?
You must obtain the consent of the following individuals:
- The Administrator of the school district where the research is to be performed (on letterhead).
- The Principal of the school where the research is to be performed (on letterhead).
- The Teacher(s)
- The Parent(s)/legal guardian(s) – “Informed Consent” – written at a 6th grade reading level
- The child – “Assent” – written to the child’s level of understanding
What do I need to do if my research is in a facility outside of UT?
A letter(s) from the facility/facilities, on their letterhead, must be submitted with the IRB form. Informed consent/assent forms are required of the participants before research is conducted. There may be changes in contact information for participants recruited at UT Knoxville or the Knoxville community.
What if my research includes observation in a public-access facility such as a coffee shop?
No letter is required for public-access facilities such as coffee shops.
What if I merely want to observe children in a classroom setting?
You must still get parental “Informed Consent” and each child’s “Assent.” For any child who does not obtain parental consent, that child may not be included in the research even if that child assents to participate in the research.
What if I want to have a “focus group” for my research?
Each person in the focus group must sign an informed consent form that has information that states confidentiality may not be guaranteed once the group disbands.
How long must I store my research data?
Storage of the signed consent forms for three (3) years past completion of the study is required. If you will no longer be at UT Knoxville you must work with your advisor to determine where the data will be stored and when it will be destroyed. Signed consent form must be stored at UT. Transcripts can be maintained indefinitely as long as there is no identifying information.
How long does my IRB approval last?
IRB approval is for a 12-month period from time of original approval. A renewal notice will be sent 60 days and 30 days prior to your expiration date of your study by an automated notification through iMedRIS. To renew your study, log into the electronic system, iMedRIS, and submit the continuing review form. If your continuing review is not received, reviewed, and approved prior to the expiration date, you will receive a notice of study termination.
What if I have an “adverse event” occur during my data collection?
Adverse events must be reported immediately to your advisor and the Compliance office.
What do I need to do if I need to modify my methods of data collection?
To make changes to your study, including adding procedures, research personnel, or documentation, log into iMedRIS and submit the “Change Request & Amendments” form. This form will give you an opportunity to modify your original application and submit new documentation to the IRB for review and approval.