Human Subjects Application Form:

All research projects must be renewed annually.  Renewals (without changes) are sent directly to the Institutional Review Board (IRB) chair and typically require only a brief review. Any meaningful changes in procedures must also be reviewed.  Applications involving changes in approved procedures are sent to the College Representative.

The Human Subjects Application Form seeks to guide researchers in the procedures to complete an application for research using human subjects.

For research receiving funds from External Sources, an Internal Approval Form (IAF; PDF document) must be completed which will be processed through the Office of Sponsored Research and Programs, as well as completing the IRB Application. [What is the Internal Approval Form?]

Once the IRB has made their recommendation, the form will be sent to the Office of Sponsored Research and Programs, who will then send a confirmation letter by e-mail to the Principal Invesigator (and any other persons associated with the research) advising of the decision of the IRB.

See an example of a Confirmation Letter sent to a Principal Investigator.

All personnel listed on an IRB Application, who do not have valid proof of a current Collaborative IRB Training Initiative (CITI) education WILL NOT BE SENT A  CONFIRMATION LETTER advising of IRB approval. The PI will be contacted so as to ensure compliance of the training requirements for the human subjects protection. The IRB requires that all investigators complete the CITI Basic Course and take a refresher course every three years.

Please note that the decision of the IRB regarding the proposed activity will be based on the content of the application, so care should be exercised to ensure that it is completed carefully and completely.  Approval of an application which omits substantive information regarding procedures to be used cannot be construed as approval of the proposed project.  Any substantive changes in the project must be approved by the IRB except those changes necessary to eliminate apparent immediate hazards to the participant which shall be promptly reported to the IRB.

Please refer to the form for your IRB College Representative.

Form:
Human Subjects Application Form - Word Document 
Human Subjects Application Form - PDF Document

Missouri State University, St. John's Hospital Cooperative Agreement:

 Please find document outlining the collaborate agreement between the Missouri State and St. John's IRB.

Common Mistakes to Avoid:

• Not submitting the right application forms. Always download the most current version of the IRB forms from the OSRP IRB website. Application forms and any attachments must be attached.
• Not submitting the CITI Certification of Training. The training is valid for three years * and this certificate must be on file for each research team member (Principal Investigator, student researcher, staff member, etc.) before the review of the IRB application will begin. This certificate must be printed when you have sucessfully completed the CITI Training. See CITI Training web site. (https://www.citiprogram.org/default.asp).
  * Please note that your Human Subjects training must be valid as of three years prior to the current date of your proposal.
• Not including the recruitment materials. "Information about the study will be shared with participants verbally" is frequently stated in IRB applications. If that is the case, forward a copy of the information (or script) to be shared verbally with prospective participants with the IRB application.
• Not including an informed consent document. A signed consent document may be waived in certain situations, but in most situations a participant must still receive a written copy of the informed consent information. Err on the side of caution, and submit an informed consent document with the IRB application. An informed consent document template can be found on the OSRP IRB website.
• Not proofreading the documents. All submitted materials must be written using clear, easy to understand language (this includes proper grammar). The Writing Center is a resource available to OSRP faculty, staff, and students; more information is available at http://www.missouristate.edu/writingcenter/.
• Not numbering the pages of the protocol or attachments. (e.g., interview guides, survey or questionnaires)
• Listing the student researcher as the Principal Investigator. Students may not be listed as the PI on the IRB application or attachments (protocol, informed consent documents, recruitment materials, etc.). Only Missouri State faculty and staff members are eligible to serve as PIs on a project.
• Using technical or scientific jargon. Lay language must be used throughout the application. Non-scientists must be able to understand the information presented in the IRB application. Using technical terms is permissible as long as the terms are defined in easily understood language.

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