What are the Essential Pre-Submission Steps of an IRB Application?
The following IRB definitions are used very frequently during the review process. It is essential that the researchers familiarize themselves with these terms:
- Principal Investigator (PI) name and department - PI is an individual who is the highest beneficiary of the proposed research study and this person has the most responsibility in ensuring the welfare of human participants
- Faculty Advisor (FA) is the person who is ultiamtely responsible for the study if the PI is a student
- Full names, email addresses and affiliation for all other investigators (key-personnel
- All of the investigators must have completed CITI training or equivalent
- CITI training completion in course(s) relevant to human subject research
- Level of review of your study (Exempt, Expedited or Full Review)
- Information on where the research will be conducted
- The source of your funding, if you have funding - like NSF/NIH or other agencies
- The number of subjects you would like to enroll in your study - use statistical methods to arrive at this number
- Whether you will be enrolling any subjects who are a member of a vulnerable population.
- Pregnant women/fetuses/neonates
- Decidedly/cognitively-impaired individuals
- Educationally/economically disadvantaged individuals
- Transnational participants
- In addition to the federal statute on vulnerability, theMTSU IRB also classifies participants
potentially exposed to certain types of vulnerability under this federal statute to
provide more protection to the subjects. These are few more examples:
- Students who enroll as human subjects in studies conducted by their course directors and thesis mentors
- Subordinates and MTSU employees who serve as participants in research projects conducted by their superiors
- Other scenarios that may expose participants to adversities or unforeseen backlash depending on the geopolitical environment and opinion of the general public will also require additional protection
- A clear step-by-ste description of the study procedures, recruitment strategies, risks/benefits, consent process, etc. must be presented
- A protocol (for Full Board studies), an Informed Consent Statement (if a waiver is not being requested), a HIPPA Authorization for Release of Health Information (if applicable), Drug or Biological Products or Medical Device form(s) (if applicable).