Applying to the IRB
The IRB reviews each application with consideration for the rights and welfare of the individuals involved, the balance of risks and potential benefits of the study, and the methods used to secure informed consent. There are three levels of review, as determined by the degree of risk to subjects. Applicants may require full review, expedited review, or be screened for exemption. The level of review is determined by the IRB. Please allow up to two weeks for a response to an exempt or expedited review (does not require full board review). Full board protocols must be submitted three weeks prior to the meeting date, otherwise it will be reviewed at the next scheduled meeting time. The reviewer will categorize the editorial comments apart from comments concerning human subject concerns. The review process will cease if there are gross grammatical errors and the protocol will be returned. Research may begin only after IRB approval.
Levels of Review
- First Level—Full Board
Any research that involves more than minimal risk, vulnerable populations, experimental drugs or devices, invasive procedures, or deception is subject to full board review. Meetings are scheduled on an as needed basis, and investigators are encouraged to attend.
- Second Level—Expedited
Certain kinds of research involving no more than minimal risk as defined by federal regulations may be subject to expedited review. Expedited review consists of review by the IRB chairperson or by one or more experienced reviewers designated by the chairperson. A study may begin only after IRB approval.
- Third Level—Exempt Status
There are six categories of research which are exempt from the requirements of the IRB. The rationale behind the six categories of exemption is that, while the research involves human subjects, it generally does not pose physical, social, or ethical risks to human subjects. A study may begin only after the IRB has confirmed that it is exempt.
- Continuing Review
All research is subject to continuing review at least every 12 months, but if the IRB feels that the research presents significant physical, social or psycho-logical risks to subjects, more frequent review may be required. An application for continuing review is scrutinized at the same level as the initial review. Research activities that are exempt from Federal regulations are subject to additional review at any time if there are any changes in the protocol.
Students must first submit applications to their faculty advisor for approval.
The faculty advisor should then submit the application to the Institutional Review Board electronically through e-mail at email@example.com.
The submission should be attached as a Word document to prevent difficulty retrieving the document.
Typed or scanned signatures will be accepted on the Assurance Page as long as
the application is received from the faculty advisor. All pages of the protocol must be numbered.
In addition to the application, the IRB requires that the researcher complete the
Institutional Review Board Tutorial. Once you have
completed the tutorial, it will be logged into our database. The tutorial takes about 30-45 minutes to complete. IRB approval must be
obtained before submission of a research request to a school system. Once approval is received from the school system, a
copy of the approval document should filed with the IRB Office. If you have any
questions concerning the application process, please contact Suzanne Barham, IRB
Compliance Officer, at 731-661-5580.
Any application approved for research using human subjects will require that the approved consent form include a stamp from the IRB giving the protocol number and the date approved. This will ensure that the correct, approved version is being used. It will also serve as a reminder of when the protocol must be reviewed again.
Waiver of IRB Application for Class Projects Using Human Subjects
This form is to be used for class projects that are conducted for educational purposes only and not as research. By identifying the work as a class project, the following must apply:
- The results and data will not be made available to the public beyond those involved in the class.
- The results and data will not be disseminated without further IRB approval.
- The results and data will not be presented at any conference, poster session, or public presentation without further IRB approval.
- Vulnerable populations (prisoners, pregnant women, persons lacking capacity to give consent) or minors are not used.
- Risk is no more than "minimal risk." Minimal risk is when the probability and magnitude of harm or discomfort in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
- Deception will not be used.
- No use of videotaping.
(If the instructor decides at a later date that the data collected for the project could be used for research/dissemination purposes, the IRB must be notified and the appropriate forms completed to permit this change in purpose to take place.)
Procedure for Submitting the Waiver of IRB Application for Class Projects Using Human Subjects (save files to own computer):
- Students submit
Student Class Project Application to instructor
(if requested by instructor),
who reviews for waiver compatibility and retains for one year.
- Instructor submits Request for Class Project Waiver of IRB Application
to IRB office for review.
- IRB reviews, requests clarification (if necessary), and issues approval or denial notice.
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