NIH PROTECT Release Notes

A “Discard” activity will be available for initial single IRB of record (sIRB) sites, which was not previously available for these types of submissions. This will be useful if a pSite was created by mistake, it can now be discarded up until the point in the workflow just prior to approval.

IRB Staff will now be able to Discard IRB submissions.  This will be useful when the submission has been with the study team awaiting clarifications for an extended period of time. 

Fixed an issue where a PI proxy was not able to Report Continuing Review Data on sites and external studies. Previously, the PI proxy (or for sites at single IRBs of record, the PI proxy of the multi-site study) was not able to run the “Report Continuing Review Data” activity. This has been fixed so that the PI proxy can Report Continuing Review Data on sites and external studies, and so can the multi-site study PI proxy for sites at single IRBs of record.

A new "Scope" column has been added to the "Follow-on Submissions" tab for both initial studies and sites. This column now displays the type of modification, which for Initial studies will read either, "Other parts of the study" or "Study team member information" in cases where there is a Modification or a Mod/CR. For Sites, it will read as either blank or “Other parts of the site”.

On the IRB tab > In-Review tab, there is now a column called “Expiration Date”. It displays the initial study expiration date, when applicable. 

The leaders in our IRB and Compliance offices have coordinated an effort to review and improve some of the IRB SmartForm Application questions and the system’s “help text” (the question mark icon bubble text) to be easier for users to understand and to gain more complete responses on the forms.

NIH PROTECT system users can look forward these improvements in the following IRB Submission Type forms: Initial Study Application, Modification/Update Application, Continuing Review/Study Closure Application, Reportable New Information Application.

NOTE: We made sure in our optimizations to be sure not to change the meaning of any questions, nor did we add any new questions. 

Previously, there was an issue where study updates were not being synced in the initial submission for external single site studies. When the sIRB review was updated during a study update for an external single site study, the changes were not updated on the parent study once the update was completed. This has been fixed. 

Previously, the pSite contacts were not being notified when the pSite modification was approved. Now the pSite PI, PI proxy, and primary contact are being notified along with the NIH Staff.

Under IRB tab > Reports tab > Standard Reports tab, there is a new report called “New Information Reports by Category”. It displays the RNIs the user has access to see, and their category (major protocol deviation, non-compliance, new information, etc.).
NOTE: The category that is displayed in the report is the category the user selects on the form when submitting the report, not the IRB determination of the event.

Previously, only the creator of an RNI could edit or submit the RNI form.  Now, the PI and Proxies on a related submission can both edit and submit an RNI form that was created by a different person.  For this feature to work, there has to be a related submission added to the RNI form.

There is a new activity on the RNI workspace that allows IRB Specialist, IRB Director, and RNI Creator to select users from the system to be additional RNI editors on that submission form.

Previously, users could not edit RNIs in an Action Required state. This has been revised so that the RNI creator, responsible parties, and additional editors are able to edit RNIs in this state. 

We have added a new activity called ‘Close SR’. The ‘Close SR’ activity allows the Scientific Review Specialists at each IC to close Approved Initial Scientific Review submissions that no longer require review (e.g. The IRB study has been closed or the study is in data analysis).  Once the SR specialist runs this activity the Approved Initial Scientific Review submission then moves to the ‘SR Closed’ state and can be later found on the Scientific Review tab > Archived tab.

Note: SRC Specialists may only close SRC Initial Reviews with this activity.  If any SR Mods, Quads, or Annuals are in-process (not yet approved) when the Approved Initial Scientific Review is closed, the system will automatically discard these other SR submissions and move them all into a ‘Discarded’ state. 

After the Initial Scientific Review is moves to SR Closed state, the Study Team will receive an email notifying them that their IC SRC has closed their SR submission.  The study team will no longer receive unnecessary system notification reminders to submit Annual and Quadrennial reviews.

In addition, when the SR project is closed, the question in the IRB MOD form that states: “Is Scientific Review required for this modification?” will now default to “no”  (since SR is no longer needed).

Revised SRC User Guides:
SRC Researcher's Guide
SRC Staff Guide
Located at: PROTECT > SRC tab > Help Center tab > Guides tab

The intramural procedures for managing human fetal tissue (HFT) oversight review have changed and are found in the Sourcebook at: https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations

For new use of HFT, the PI must first initiate a new IRB protocol or modify an existing IRB protocol in PROTECT, and within PROTECT manage the “ancillary review” for the proposed use of human fetal tissue. The PI is required to download and fill out an HFT ancillary review form (located in the PROTECT Library) and have it signed by the Scientific Director or their delegate, and then attach the signed form to the HFT ancillary review in PROTECT. The HFT ancillary review form contains new fields that add additional criteria for the use of HFT and replaces the Intramural Research Program (IRP) use of “Attestation” forms. The review of the proposed use of HFT will be managed by the Agency Intramural Research Integrity Office. Only when the ancillary review is completed and the use of HFT is approved, will the IRB act upon the submitted protocol or modification.

The new process will ensure that human fetal tissue is used for non-transplantation research in the IRP only when scientifically justifiable, in the least amount possible to achieve scientific outcomes, and to ensure that the acquisition and use of human fetal tissue by the IRP complies with all applicable laws and HHS/NIH policies. This process has been approved by the Board of Scientific and Clinical Directors and by the Deputy Director for Intramural Research.

Researchers are reminded that they must secure approval prior to any new acquisition of, or commencing work with, human fetal tissue. Please contact Kathryn.partin@nih.gov if you have any questions about using human fetal tissue.

New HFT User Guides:
HFT Researchers Guide
HFT Reviewer Guide
Located at: PROTECT > IRB tab > Help Center tab > Guides tab

Revised Tip Sheets:
PROTECT Training and Tip Sheets (nih.gov)