IRB Application Tips

The goal of the Research Compliance Office and the IRB is to ensure that MTSU research adheres to federal regulations regarding the treatment of research subjects. Research involving human subjects should prioritize the participants’ well-being when completing the IRB application. Thoughtful consideration of research participants’ well-being throughout the application process demonstrates the researcher’s adherence to the Belmont Report’s core values of respect for persons, beneficence, and justice, as well as the Common Rule’s evaluation standards: “This [IRB] evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.” To help researchers comply with these federal regulations and ethical standards, below are the top tips for writing a thoughtful application. 

1. Make sure all necessary CITI trainings are completed before submitting your application* 
2. A clearly explained purpose to the study – hypothesis, procedures, and how this study would be useful/beneficial 
3. Thoughtful consideration for research participants wellbeing while writing the study design and procedures  
4. Proper recruitment documents and procedures** 
5. The subjects are adequately informed, and consent documents are proper*** 
6. All other required forms/documents, if necessary for your study, are provided. 
   • Research involving minors in a school will require support letters from the school’s administration. Similarly, enrolling prisoners or patients admitted to a hospital would also require letters of support from the prison or hospital, respectively.  
   • In all these cases, the entity—school, prison, or hospital—is responsible for the participants, and therefore their consent is mandatory. Other entities may require permission forms but the three examples above are all required by the IRB. To find more information refer to the IRB permission letters page. 
   • This list is not exhaustive. Other documents may need to be attached depending on your study. Within the Cayuse portal, the application process will show what documents you may need. Reviewers may also request documents at their discretion. 
7. If you are conducting research with a vulnerable population, make sure your whole study adheres to federal regulations. More information regarding studying participants considered vulnerable populations can be found on the IRB website. 
8. Determine the risk factors your participants may encounter. Ask yourself the following questions to help identify risks: Are there any risks? If so, are they necessary? Did the researcher take all possible steps to minimize them? What is the risk-to-benefit ratio? What risks might an impartial independent observer identify, even if they are statistically negligible? If I were a participant, what might I perceive as a risk of participating in this study? 
9. The investigators make every effort to protect the confidentiality of the participants 
10. The researchers properly explain the data usage, analysis, and storage procedures 

These tips do not guarantee any specific review level or quick approval. Review takes place in stages as noted on the Cayuse portal; researchers can be asked to add additional information at any stage and all requested information must be supplied before final approval can be granted.  

Important Links 

CITI – https://about.citiprogram.org/ 

IRB Website – https://www.mtsu.edu/irb/ 

IRB Forms – https://www.mtsu.edu/irb/forms/ 

Cayuse – https://mtsu.app.cayuse.com/ 

For students needing help with their Cayuse account or application, they can contact Research Compliance Assistant Melissa Guinn at [email protected].