Directions for Submission of an Application for Exempt Verification Review

Generally, research involving surveys or interviews, the use of existing data, and educational research in the classroom falls within the exempt category. This does not mean, however, that the research is exempt from the requirement to submit an application or follow federal guidelines. It means that the application involves less than minimal risk to subjects and that it is exempt from full review, but the IRB must still review the application to determine that this is the appropriate level of review (and may require modification to ensure that the research proposed poses only this minimal amount of risk). The purpose of the application for exempt IRB review is to provide concurrence that the research application does fall into the exempt research category and furnish documentation that the application has been examined.

One difference between an exempt review and other forms (expedited and full review), is that exempt research will not be monitored by the IRB on an ongoing basis. Thus, there are no reporting or record-keeping requirements with the IRB after the original report has been accepted.

In order for a study to be reviewed by the IRB as an exempt review, it must fit into one of the categories outlined below:

  1. Research in educational settings that involves normal educational practices such as:
    1. Regular and special education strategies.
    2. The effectiveness of, or the comparison among, techniques of instruction, curricula or classroom management methods.
  2. Research that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), when the data are recorded in such a way that subjects cannot be identified directly or indirectly.
  3. Research that involves survey, interview procedures, or the observation of public behavior (including the observation by participants), except where any of the following exist:
    1. Responses or observation are recorded in such a way that subjects can be identified directly or through identifiers likened to the subject.
    2. The subject's responses or recorded observations, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability, or would damage the subject's financial standing or employability.
    3. The research deals with sensitive aspects of the subject's behavior, such as illegal conduct, drug use, sexual behavior, or the use of alcohol.
  4. Research involving the collection or study of existing data, documents, or records, if these sources are publicly available or if the information is recorded by the Investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  5. Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and that are designed to study, evaluate, or otherwise examine one or more of the following:
    1. Public benefit or service programs.
    2. Procedures for obtaining benefits or services under those programs.
    3. Possible changes in or alternatives to those programs or procedures.
    4. Possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste and food quality evaluation and consumer acceptance studies that adhere to the following:
    1. If wholesome foods without additives are consumed.
    2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

There are, however, exceptions. Research which raises the level of risk to minimal or greater than minimal risk requires a higher level of review, whether expedited or full. Examples of conditions which will call for a higher level of review include:

  • Studies involving the recording of information so that participants are identifiable (audio or video recordings) require at least an expedited review
  • Studies using instruments, questionnaires, or surveys that have been generated or modified by the researchers require an informed consent and at least an expedited review.
  • Surveys or interview questions whose answers, if known outside the research, would create legal liability or adverse financial or employment consequences for the participant require a full review.
  • Surveys of interviews involving questions dealing with very personal and sensitive behavior, such as sexual activity or the use of alcohol or other drugs require a full review.
  • Studies that include members of a protected population in the pool of participants, including but not limited to children, mentally ill, prisoners, and anyone else who cannot provide informed consent require a full review.
  • Additionally, the above qualifications do not apply to survey or interview research with public officials as the sole population of subjects. Such applications almost always qualify for exempt review.

For further information, please review information regarding expedited reviews and full reviews.

Remember that neither of these lists of examples is exhaustive. As the researcher, you must consider the definitions and apply them to your circumstances. For example, research involving students might not qualify for exempt review, even if they are over the age of 18. If their grade depends upon their participation, and they have no other way to gain that credit, an element of coercion enters the picture.

To apply for an exempt review, the Principal Investigator must submit a complete application to The Institutional Review Board. This includes all supporting documentation such as:

  • Consent forms
  • Surveys or interview questions
  • Test forms
  • Subject screening forms
  • Recruitment materials (posters, phone scripts, etc.)
  • Letters of agreement, or other supporting documentation to assure the IRB that appropriate coordination has been done with outside organizations or institutions (clearances to perform research or distribute surveys, etc., at any facility or institution where the research will be conducted).

To apply for exempt verification, e-mail all documents to irb@mail.belmont.edu, with a copy to your faculty advisor(s).  The attachments must be complete and consistent; the receiver must be able to open, print and edit every document in an electronic submission.1  Then, deliver one complete paper application, with all required signatures and appendices, to the IRB office.

Exempt applications are accepted whenever you complete them, and are reviewed on a rolling basis.

Wait for written IRB approval before beginning data collection.

Sponsorship: For student research applications, the Exempt Review Application must have a faculty sponsor. The IRB will review the application for appropriateness as an exempt review and rely on the sponsoring faculty member for subject matter expertise and design issues. The IRB will not accept student research applications without the signature of the faculty sponsor.

1Supporting documents such as brochures or cited papers, which are not available to the PI in electronic form, may be sent as an appendix with the paper submission and omitted from the electronic submission.  In that case, the application must clearly refer to the paper appendices.