IRB Protocol Submission and Review
The Institutional Review Board (IRB) conducts review and approval of research that involves human participants. IRB protocols are submitted through the Cayuse IRB submission system. The Office of Research Integrity encourages all researchers without previous experience with the Cayuse IRB system to contact an IRB Administrator to receive guidance on using the system and obtaining a user account.
- Prior to developing an IRB protocol, it is worth ensuring that your research project requires IRB oversight. The only appropriate method for making this determination is by contacting an IRB Administrator to discuss your project, as Rice Policy 326 prohibits investigators from making this determination on their own.
- If the IRB determines a project does not meet the regulatory requirements for IRB oversight, a Determination Letter will be provided to the investigator which states IRB approval is not required (i.e., that the project is "Not Human Subjects Research", or NHSR). Otherwise, the investigator will need to submit a protocol application in Cayuse IRB for review and approval.
- If an investigator has incorrectly determined that their research does not require IRB oversight, the IRB will not be able to retroactively grant IRB review. Additionally, conducting human subject research without an approved protocol violates both Rice Policy and federal regulations. In this event, an Incident Report must be filed, and Rice may be required to report the situation to cognizant agencies.
- Although Rice Policy 326 dictates that this determination can only be made by the IRB or an IRB Administrator, we find it helpful for investigators to know the general rules that trigger IRB oversight.
- OHRP Regulated Oversight: -- Generally known as "The (Revised) Common Rule", regulations from the OHRP are located at 45 CFR 46, and dictate that activity requires IRB oversight if it is "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" and if an investigator either "obtains information or biospecimens through intervention or interaction with living individuals, and uses, studies, or analyzes the information or biospecimens", or "obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens" about living individuals.
- FDA Regulated Oversight: -- Regulations from the FDA are located at 21 CFR 50, 21 CFR 56, and additional locations, and generally dictate that activity requires IRB oversight if it, A) involves one or more human research participants, B) involves the study of one or more test articles that are under investigation, and C) either information will be submitted to the FDA to support licensure of the test article or the test article is an investigative new drug or an investigative medical device. However, IRB regulations for FDA oversight tend to be considerably more complicated than The Common Rule, so the IRB strongly encourages investigators to reach out early if they believe that their study may trigger FDA oversight to ensure a timely review process.
- As a general rule, IRB oversight of FDA projects is slightly slower than projects receiving oversight under the regulations of The Common Rule. Additionally, please anticipate that most FDA projects will receive Full Board Review at both their Initial Review and subsequent Modifications and Continuing Reviews.