You need an IRB protocol when you are doing research on human subjects. Research means any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject is a living individual about whom a research investigator (whether faculty, staff or student) obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information or records. (See page 2 of the Policy and Procedures Manual.) A protocol is not required for program review unless you intend to disseminate the results with the intent to develop or contribute to generalizable knowledge. Dissemination may include publication, presentation at a conference or seminar, or participation in the Graduate or Undergraduate Research Symposia.
All of the following research activities involving human subjects are subject to the review and approval of the IRB:
Only ISU faculty members, faculty associates or staff can act as the Principal Investigator on a protocol. All requests to modify or continue a protocol must come from the PI.
As of December 15, 2015 we will begin transitioning to IRBNet.org for all new protocols as well as for modification, and continuation of existing protocols. This all-electronic submission system will allow for increased review transparency and faster turnaround times for investigators. We will complete the transition by January 31, 2016, after which all new protocols, modifications and continuations must be submitted through IRBNet. Following are general instructions on submitting protocols through IRBNet. For more complete instructions, including screenshots, please view the PowerPoint for PIs and Departmental Representatives.
For more complete instructions, including screenshots, please view the PowerPoint on New User Registration and User Profiles.
This section covers both new projects as well as continuation and modification requests for projects not already in IRBNet. For more complete instructions, including screenshots, please view the PowerPoint for Creating New Projects.
You will use "Create New Project" to submit new protocols or to revise protocols that were not previously submitted through IRBNet. Please note that submissions in IRBNet are termed "projects" and the numbering system will be different from our current system. Initial submissions will be assigned a number such as 175296-1. The main number will stay with the project throughout its history, but the suffix indicates the version number and will change with each subsequent revision.
***Your protocol will not be reviewed if it has not been submitted by the PI, electronically signed by the PI, PI's CITI training is not linked to the package, or documents/Appendix are missing.***Revisions for Existing Projects in IRBNet
You will need to add an additional package to your current submitted package to respond to requests for approval, submit modifications, or submit continuation requests.
Continuation requests are required annually for Expedited and Full Review protocols. If a continuation request is not approved prior to the expiration date shown on your approval letter, the protocol will expire, and no further work or data analysis can be performed until a new protocol is approved. If the protocol is in IRBNet, expiration alerts will be sent to the PI 60 days and 30 days prior to the expiration. These alerts are a courtesy to the PI; it is the PI's responsibility to submit the continuation request form and any required documents in IRBNet according to the timeline shown below. For instructions, including screenshots, please view the Continuation Request job aid.
The package will be reviewed through appropriate procedures once submitted. PI's and anyone with whom the package has been shared will receive communications notices to prompt you to login to IRBNet via email from IRBNet, including updates on review status, approval letters being posted, and notifications regarding expiration dates.
Researchers can review their review letter by going to the "Reviews" tab, once you are in your project. You will then need to click on the paper icon to review your letter. Once the results of the review are communicated to the researchers, any revisions to be made to secure approval must also be submitted through IRBNet.