Frequently Asked Questions About the IRB Protocol Application Process
I collected data for a project I didn't think I wanted to present or publish. My results were great and now I would like to present the study at a conference. Can I get IRB approval now?
Unfortunately, no. The IRB can only approve studies before any participant recruiting or data collection has begun. If you are planning a project that you want to have the option to present at a later time, it is advisable to get IRB approval before you begin. This leaves you the option of presenting or publishing the study at a later time.
How do I know whether my project requires review?
Please see the pages titled "Quality Improvement and Control", "Does My Project Need Review" and "Class Project or Class Research" 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. The vast majority of institutions in the United States and Canada require researchers to show proof of completion of the CITI training before reviewing proposed research. The program will send investigators a certificate of completion that can be sent with the Request for Review. The certificate is good for 3 years. Find more on the CITI Program page. The CITI Course Modules page shows users what modules are included in each course.
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, submission, 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
Also find a Glossary of IRB terms here.
