An IRB application consists of a cover sheet and a narrative (which can be in outline form) that addresses specific issues about a research project.  Enough information should be included to allow the IRB members to evaluate the project with regard to participant safety.  If insufficient information is provided, or if the information provided is not clear enough to allow for a determination about participants safety, then the application may be returned to the PI, along with recommendations for improvement.

It is the IRB college representatives’ job to determine the level of review (exempt, expedited, or full board review) for the application, NOT THE RESEARCHER.  While the labels for the levels of review can be somewhat confusing, “exempt” review simply means that a project is exempt from the full force of all Federal regulations, but is still subject to Missouri State University policies, and thus is required to be reviewed by at least one IRB member.  By the same token, “expedited” review means that a project appears to have more than “minimal risk”, and (by MSU policy) requires two IRB members to review the application.  So, in this instance, “expedited” does not refer to a faster processing of an application (the IRB tries to be as quick and efficient with all applications as possible).

1. Complete the required training.  This training will assist you in developing your research project correctly:
   • Human Participant Protection Training (CITI):
     All faculty, staff, and students involved in the design, collection and/or analysis of data in projects involving human participants must complete the online training through CITI (see IRB Training section).  The Certificate of Completion available at the completion of the training module is to be printed out and submitted with the application to the IRB.  All persons that will be involved in the design, collection and/or analysis of data must be listed on the application.  If necessary, attach a separate sheet of paper to the cover page listing additional project personnel.
     
     All personnel listed on an IRB Application, who do not have valid proof of a current Collaborative Institutional 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
   • HIPAA Training:
     If the proposed research involves protected health information (PHI), researchers also must certify completion of the training required under the MSU HIPAA policy.  This training is provided in two modules available on a secure MSU web site- HIPAA Privacy and Security Training and HIPAA Research Training.
2. Complete the application.

The cover sheet should indicate who the PI is (which is always a faculty or staff member, even with student projects like theses) and other researchers involved.  It should also indicate that all researches have completed the CITI Training, and the HIPAA training, if applicable.  The project sheets should have the PI’s and relevant Department Head’s signatures affixed (thus, sending it via email may not be sufficient, unless signatures are included).

• The body of the application should address the following areas:
  • A brief description of the project, including specific goals
  • Who the intended participants are, including information about general demographics, sample size, how and from where the sample will be obtained (including recruiting/advertising methods and tools), and how long the procedures will take
  • How informed consent will be addressed (including a sample informed consent for as an attachment)
  • What specific data will be gathered (including sample surveys and data collection tools as attachments)
  • How data will be coded, kept secure, and what the final data disposition will be
  • Any HIPAA considerations, with a plan to address them
  • A description of any circumstances that might put participants at risk (physically, psychologically, sociologically), and your plan to address these risks
  • How the information from the study will be disseminated, used, or shared, along with your plan for how to preserve confidentiality and/or anonymity.
    
    

• Finally, the project proposal MUST end with the following, verbatim (including signature lines):
  • I hereby agree to conduct this study in accordance with the procedures set forth in my project description, to uphold the ethical guidelines as set forth in the Code of Federal Regulations 45 CFR 46, 45 CFR 160 and 164, and the Missouri State University HIPAA Policy, and to report to the IRB any outcomes or reactions to the experiment which were not anticipated in the risks description which might influence the IRBs decision to sustain approval of the project.

_______________________________        ______________________________

Department Head                                                Principal Investigator (Faculty)

_______________________________        ______________________________
Other Investigators                                              Other Investigators  

Date: __________________________        Date: _________________________

• Additional information related to the project is to be included with the application (e.g. individual consent forms, survey instruments, flyers to be disseminated or other written information to be distributed to participants).

• Certification of completion of required training is also to be included with the application.

3.    Submit one completed application to the IRB representative for your college.  The College Representatives can be found in the IRB Member section on the Office of Sponsored Research and Programs website.  Applicants outside of the academic colleges should submit applications (PDF Doc; Opens in a new window) to the Staff Representative.  It is suggested that an additional copy be retained by the applicant.

4.    Wait for IRB Approval.  

• A.    Once the College IRB representative reviews an application they forward the application and their recommended designation on to the IRB Chair.  If a full board review is required, the IRB Chair ensures that the application is distributed to all board members for review and schedules the time for the review meeting (either at the next regular IRB meeting or earlier, if necessary).  If the College representative has given the application an exempt review classification, the application is sent directly to the Office of Sponsored Research and Programs (OSRP), and the project PI is sent an email letter acknowledging that their project has been approved by the IRB.  See an example of a Confirmation Letter sent to a Principal Investigator.
  
  (NOTE:  The PI should safeguard this letter for possible later use.  For instance, many more journals ask for a copy of a research project’s IRB approval before accepting a journal article for publication.  Further, if an application pertains to a student thesis, the student is required by the Graduate College to submit a copy of the IRB approval letter along with their final draft of a thesis, or it will not be accepted.) 
• B.    If the college representative gives an application an expedited review classification, the application is then sent to the IRB Chair for a second review.  If the Chair concurs with the college representative’s evaluation of the application, then the Chair forwards the application on to the OSRP, who will then send out the email approval letter.

Project approval is for a maximum of one year, but can be renewed by PI’s by submitting a new application cover sheet (indicating the renewal status), along with any changes in the project since initial submission, directly to the IRB Chair.  If a project protocol changes during the course of the project, the PI should submit these modifications (in writing) directly to the IRB Chair.

ADVERSE EVENTS

If, during the course of a project, adverse consequences of any sort befall research participants, the IRB Chair should be notified IMMEDIATELY, the project should be temporarily suspended (unless doing so would put other participants at risk), and a report of the incident should be submitted within 24 hours.  An adverse event is any unexpected negative consequence for human participants, such as an unexpected side effect or after effect from a procedure, an injury as a result of participation in a project, the inadvertent release of confidential information, or other breach of confidentiality.

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