Frequently Asked Questions About the IRB Protocol Application Process
How do I know whether my project requires review?
Please see the page for that answer.
I am a student. My old college had a shorter form for student IRB applications. Why does MSU Denver make students go through the exact same process as faculty?
The federal regulations make no distinction between student and faculty research. All researchers are required to abide by the same ethical and regulatory standards, so MSU Denver requires all investigators to follow the same process.
What is the CITI training?
It is an online training published by the University of Miami. See the page for more information.
There is a CITI training that is labeled "Course Project for Students". Is that the training I do if I am submitting a Request for Review?
No. The Course Project for Students is intended to be used as a general overview of human subjects ethics and protections. It includes 6 modules, each of which is on a different topic and has a quiz. It should take approximately an hour to complete.
All principal investigators, co-investigators, research assistants, and faculty advisors who submit a Request for Review on or after September 1st, 2012 are required to submit a certificate of completion for the appropriate training course. The possibilities are: Social and Behavioral Research, Biomedical Research, or Research with Laboratory Specimens Only.
What is a Letter of Determination?
A Letter of Determination is sent to the Primary Investigator regarding the decision the IRB has made on his or her research protocol. The possibilities for letters investigators can receive are:
- Determination of not human subjects research,
- Approval without continuing review requirement,
- Approval with continuing review requirement,
- Approval pending revisions not requiring second review,
- Modifications, resubmission, and second review required,and
- Disapproval.
There are a lot of Acronyms used in human subjects materials. What do they mean?
CFR — Code of Federal Regulations
FDA — Food and Drug Administration
FWA — Federalwide Assurance
HHS — Department of Health and Human Services
IEC — Independent Ethics Committee
IRB — Institutional Review Board
OHRP — Office for Human Research Protections
