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Migration Information and FAQs

Migration 

The first migration will begin at 7pm  on Thursday, January 12, 2023.  In the “first wave,” the only protocols that will be migrated are approved studies that do not have an amendment or progress report in process.   Studies that do not migrate in the first wave will migrate in the “second wave” if the action is completed.  If the action is not completed by the time of the second wave, then it will migrate without that action being processed (the investigator will need to start over with the modification or CR in PROTECT). The exact date of the second wave will be determined and communicated to the community.


Note that Exempt protocols and NHSR projects will not migrate.  If you need to submit a modification for one of these types of protocols in PROTECT, enter it as a new project but refer back to the previously approved protocol and indicate that you are now submitting a modification.

Information You Need to Review for Your Studies That Have Migrated


Please refer to this document when you submit your first action to the IRB for a migrated study.    

To complete your first scientific review for a migrated protocol, please refer to this document.


Frequently Asked Questions

LOGIN/ACCOUNTS/HELP/SUPPORT

Visit our Office of Human Subjects Research Protections website and click the banner that says “Visit the NIH PROTECT Project Page…”. Here you will find links to find PROTECT experts, past trainings or you can submit a help desk ticket.

All recordings of the live user trainings delivered by OHSRP can be found on our SharePoint site.  You can login using your NIH credentials.

The PI, the Proxy(ies), and the Primary Contact. 

Submit a help desk ticket to request an account.  We have a new help desk link now:  https://ohsrp.helpdesk.nih.gov

NOTE - the process for requesting an account has not changed.

OHSRP has coordinated with NIH institutes and centers to identify and train representatives from as many ICs as possible to be considered system “experts”.   These individuals received system training directly from Huron and are available to be your first line of contact for day-to-day system questions.  These experts can be found on our website, here:  NIH PROTECT Experts.

Please consult these experts first for your initial questions about the system so you may receive assistance right away.  They can assist you in elevating your request to our Help Desk if additional assistance is needed.

All personnel who are engaged in Human Subjects Research (HSR) (e.g. associate investigators) who are working under the supervision of the NIH PI should be listed under the “Local Study Team Members” section of the study application. Contractors and Fellows, etc. (anyone with a NED account) should also be listed here if they are engaged in HSR. These personnel will no longer be separated out in a different section.


Study members who are working under the supervision of the NIH PI and are engaged in HSR but who are not in NED should be listed as an external team member.


“Protocol Navigator” is an administrative role created to allow people in this role to have read/write access to the study and to be an option to be selected as a proxy for the PI.  Only people who are serving in a regulatory role for the study who are NOT engaged in human subjects research should be identified in this role. They may be added the same way as a study team member and “Protocol Navigator” is a drop-down choice for any user when you select their name on the form.

Study Contacts in iRIS will be merged over into the “Guest” tab of a study in PROTECT and these users will have read-only access to the project.  They will not be able to edit a project or push it through the workflow.

PROXIES

A proxy is a member of the study team listed on the application that the PI designates to act on their behalf.  The proxy can do all the same actions in the system that the PI can with the exception of submitting the Scientific Review. The PI MUST submit the Scientific Review in the system.

Anyone listed on the study application as local study team members can be a proxy. These are the only personnel you will be able to choose on the Assign Proxy activity.

Only the PI can assign/remove a proxy.

Yes, a PI can assign any IRB approved local study team member listed on the application to be a proxy.

The PI will log into PROTECT, navigate to the study workspace, and click the “Assign PI Proxy” activity listed on the left side to add or remove proxies.

No, only the PI can assign or remove proxies.

A proxy can initiate and submit all actions in the system except when it comes to Scientific Review. A proxy can initiate and draft the Scientific Review but only the PI can ultimately submit the Scientific Review form.
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