Creating a new research protocol entirely from scratch may feel like a daunting task to new researchers. While TC IRB offers templates, new researchers may not be sure which sections to keep and which to exclude based on their specific populations. Questions to ask yourself from the outset include:

1. Who is my population of interest? Does this population require additional protections?
2. What is the overall risk level of my study? Will it be more than minimal risk? (Review Categories)
3. What kind of data am I collecting or analyzing? Will it need a consent form, assent form, parent permission form, or a site permission form? 
4. What are my research procedures? 

IRB Application

Once these questions have been answered, researchers should prepare their IRB Application Template outlining the risk and benefits of their research, their study materials, and consent procedures. To assist researchers in the writing process, TC IRB has identified common types of studies frequently used by new researchers and created sample applications with relevant explanations. Following these sample applications does not guarantee a protocol will be approved automatically. It does, however, offer some suggestions on how to frame materials for a formal IRB review.

• Exempt Category 4 - Secondary Data Sample Application: If your research will fall under Exempt category 4, consider using this sample application as your base. You will want to clarify whether the data are public, sensitive, and/or identifiable, and how you are transferring, storing, and securing the data. 
• Multi-Activity Study Sample Application: If your research has multiple activities, you can combine these activities into one TC IRB application, so long as all activities relate to the research questions. Clearly outline each of the study activities that participants will engage in for TC IRB review. 

Consent Forms

Consent is required when enrolling human subjects, and consent forms should always be tailored to your population of interest's literacy level and cultural practices. This means if you are working with children, you may need to use simple, clear language, or visual aids to ensure the child understands what is being asked of them. TC IRB has dedicated an entire guide to The Assent Process with Minors. With adults competent to consent, consent forms should clearly outline the required activities and the use/disclosure of data. Please review TC IRB's  Audio Recorded Individual Interview and Focus Group Sample Form for an example.

Memos & More! 

TC IRB has created a plethora of examples ready for researchers to use as the basis for their work. For more samples, please check out our TC IRB Submission Document Templates & Samples guide.

— Kailee Kodama Muscente, MA, MEd