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We are back! Just in time for the start of the fall quarter, we are reviving our Research Matters blog to bring you the latest information and updates from DU’s IRB. We want to keep the conversation going with news about reviews and tools you can use. If there’s a topic you want to hear more about, email us at IRBAdmin@du.edu.

Updating Research Personnel in IRBNet

In an effort to streamline the process of verifying training, the DU IRB implemented a new process for adding research team members in IRBNet. This should save Principal Investigators (PIs) from having to gather and upload CITI training certificates from all their research team members when applying for initial review. Plus, CITI will automatically link the completion of any refresher courses to IRBNet.�� The trade-off is that research personnel (faculty, staff and students) will need to:

1. Register in – make sure to use your du.edu email address when you register. This will help ensure IRBNet and CITI can “talk” to each other effectively.
2. Link your CITI account in your IRBNet profile – Follow the instructions here to link your CITI training account. Once linked, your training will automatically appear in IRBNet so your dedicated IRB administrators can easily verify all training at a glance.

If you need to add or remove staff from your study over the course of your research, simply submit an amendment request form. All the steps for adding staff are detailed in section 2.2 of our Amendment Request Form, including helpful instructional links.��

To add/remove staff:

1. Add/remove staff from Table A.2.1 in the IRB application
2. Use the ‘Share This Project’ function in IRBNet to give all new study team members access to the study.
3. Search for the name of the staff member you wish to add (or remove) and select the appropriate level of access.��

PI Eligibility

The principal investigator (or PI) is the lead researcher for the study, team members and research participants. Whether you are a seasoned researcher with NIH funding or a student doing your thesis on a shoestring budget, it’s important to know who can act as the PI on a study and who needs to have a Faculty Sponsor.

Full-time faculty and staff at DU are eligible to act as PI on their own. This includes assistant, associate and research professors. Students, both graduate and undergraduate, may still be listed as PI on research applications, but will need to have a Faculty Sponsor that is either full-time faculty OR staff at DU. The Faculty Sponsor is responsible for reviewing the project prior to IRB submission and electronically signing their project in IRBNet. Other roles that are required to enlist the help of a Faculty Sponsor include part-time staff, post-doctoral staff/fellows, as well as adjunct and visiting faculty.

The PI (or Faculty Sponsor in the case of student research) assumes ultimate responsibility for the conduct of the study and reporting to the IRB. You can find more information in our PI Eligibility guidance document, located on our website. If you have any questions about an upcoming project and whether or not you need to have a Faculty Sponsor, please email us at IRBAdmin@du.edu.

IRB Approval or Determination Letters: Boring but Important!

You filled out all the forms, answered all the queries and proofread all the consent forms. You finally got IRB approval to conduct your study! What more could we possibly ask of you?��

Read your IRB approval letter; we worked hard on it.

I know it’s hard to believe, but we put really important information in those approval letters. And you’ll never know all the cool stuff we tell you if you don’t log into IRBNet, navigate to your project and open the approval letter from the “Reviews” project administration button. We’ll always include the regulatory category and when you need to submit your progress reports (i.e. continuing review or request to extend next report due date). We include information about required follow-up with the IRB. For amendments that require consent form revisions, the approval letter may instruct you to reconsent affected subjects.

So, when you get that automated email from IRBNet informing you that your study has been approved (or exempt), go that extra step to log in and review your approval or determination letter. You never know what information you might miss if you don’t.