Directions for Submission of an Application for Full Review

A full review is indicated if the study involves more than minimal risk to subjects or if there is the likelihood of substantial stress or discomfort to subjects. A full review is also required if any of the subjects or potential subjects belong to a protected population. Protected populations include but are not limited to children under the age of 18 years, pregnant women, prisoners, mentally ill, fetuses, or anyone else who cannot provide informed consent. A full review is also required for interviews or surveys in which subjects are asked about sensitive matters such as sexual behavior, alcohol use, or drug use or if subjects may be placed at risk for criminal or civil penalties or would otherwise suffer embarrassment of humiliation if the subjects' responses were to become known outside the research.

The Level of Review Determination that is part of each IRB review form contains a list of circumstances in which a full review is warranted.

If your study involves any of the following you will need to complete an application for full IRB review:

  1. Support from non‑university sources that require full IRB approval
  2. Likelihood of risk or substantial stress or discomfort to the subject
  3. Procedures that may potentially threaten or embarrass subjects
  4. Personality tests, inventories or questionnaires of a personal and sensitive nature where subjects' identities will not be anonymous to the researcher
  5. Sensitive aspects of a subject's behavior that could reasonably place a subject at risk of criminal or civil liability or be damaging to a subject's financial standing or employability
  6. Sensitive aspects of a subject's behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol and/or drugs
  7. Healthcare procedures that are not conducted for the primary benefit of the subject
  8. Diagnostic or therapeutic assessments, interventions, or measures that are not standard, generally acceptable, or common practice
  9. Exposure to surgery, drugs, or chemical agents
  10. Exposure to electromagnetic radiation (X-rays, microwaves), lasers, high frequency sound waves
  11. Deception or procedures that are not known to the subject (e.g., the subject will not be fully informed)
  12. Subjects under the age of 18 years
  13. Special populations (e.g., children, prisoners, pregnant women, fetuses, or individuals who are mentally or psychologically ill or incompetent)
  14. Greater than minimal (i.e., moderate, high) risk to subjects
  15. Collection of blood samples or other body fluids in any amount

Please keep in mind this is not an exhaustive list. Any study that causes greater than minimal risk to subjects requires a full review.

To apply for a full review, the Principal Investigator must submit a complete application to the IRB. 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).

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. The application must be signed by the PI, faculty advisor (if student PI), and the department chair. Any needed Letters of Agreement should also be signed at this point. Then wait for written IRB approval before beginning data collection.

Submission Date: These materials should be submitted to the IRB 10 working days before the next IRB meeting, as shown on the calendar. The IRB is not able to perform full reviews over the summer, since many of the IRB members are on leave during this time period. Protocols should be submitted to the IRB office. If you have questions, please call the IRB Administrator or the current Chair of the IRB.

Sponsorship: For student research applications, the Full 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.

1 Supporting 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.