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.

 APPLICATIONS:

  • Application for Initial Review (This form is now used for all levels of review)
       - Word    - Acrobat


    Application for Continuing Review
       - Word    - Acrobat

    Students must submit applications to their faculty advisor for approval before submitting to the Institutional Review Board. As much of the application as possible should be submitted to the IRB Office electronically through e-mail at irb@uu.edu. The submission should be attached as a Word document to prevent difficulty retrieving the document. You should receive an email confirming receipt of your protocol from the IRB Office within five working days of the submission.  If you do not receive a confirmation email, please call Suzanne Barham at (731) 661-5580.  Please note that the last page of the application includes signature lines for assurances. This page, along with any attachments to the application that cannot be emailed, should be forwarded to Suzanne Barham, IRB Compliance Officer, Union University, 1050 Union University Drive, Jackson, TN 38305 (or faxed to (731) 661-5187) after it has been signed by the Investigator and the Advisor. If the protocol requires revisions, a new signature page must be resubmitted with the revised protocol. All pages of the protocol must be numbered. In addition to the application, the IRB requires that the researcher complete the Human Subject Assurance Training found on the IRB website at http://www.uu.edu/programs/irb/ and submit the certificate of completion with the application.  The tutorial takes about 20-30 minutes to complete. If applicable, the approval document from the School of Education Research Review Committee must also be submitted. IRB approval must be obtained before submission of 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. For more information call 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:

    (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):

    1. Students submit Student Class Project Application to instructor, who reviews for waiver compatibility and retains for one year.
    2. Instructor submits Request for Class Project Waiver of IRB Application to IRB office for review.
    3. IRB reviews, requests clarification (if necessary), and issues approval or denial notice.

    Get the complete IRB Guidelines
       - Word    -Acrobat

    IRB Tip Sheet

    See the complete list of forms