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)

“All Single Patient Expanded Access Studies (NIH)”

and

“All Studies (NIH)”  

Any system user can run these Custom Reports by logging into PROTECT, Clicking IRB tab > Reports tab > Custom Reports tab.  Click on the name of the report you want to run.  Use the filters on the report window to search for the studies you wish to yield. The report will show all of the studies that you have access to in the system.

Two important changes to consent forms and approval letters in PROTECT have been made effective 12/01/2023.

1. The consent form stamp in the footer will be changed from “IRB APPROVAL DATE” to “IRB EFFECTIVE DATE”. 
2. The NIH IRB Approval letter will include the Effective Date in the table, which will correspond with the IRB Effective date in the consent form stamp. 

These changes are to rectify the consent version date potentially being after the approval date when the IRB requires modifications to the consent document(s), which is not ideal for auditing and monitoring purposes.

Please note – A MOD or MODCR should NOT be submitted to get the new consent form stamp with the Effective date on it.  The IRBO does not have the bandwidth for an influx of administrative MODs that do not have any substantial changes associated with them.

Should you have any questions, please reach out to the IRBO inbox at irb@od.nih.gov

We have added additional columns to the My Inbox and My Reviews tabs on the Dashboard. These new columns will provide additional information and make the submissions easier to identify from the dashboard. These were added to the “My Inbox” and “My Reviews” tabs of the Dashboard as well as the “My Inbox” tab of the IRB Central Staff Dashboard and the SRC Central Staff Dashboard. The additional columns added are:

1. PI Last Name
2. PI first name
3. IC (of PI)
4. Parent protocol expiration date

When we turned on email notifications for IRB/RSC/SRC ancillary reviews in a recent release, they were only working on initial submissions.  They are now working on all follow-on submission types (MODs, CRs, etc.)

Users who are SR specialists or designated (expedited) reviewers will now be able to select an outcome of “Deferred” on the Submit Committee Review and Submit Expedited Review activities in the Scientific Review (SR) project.  As such, when this outcome is selected, and the Deferred letter is sent to the research team using the Send Letter activity, the SR will transition to a new ‘Deferred’ state on the upper left-hand side of the workspace.  This places the SR back in the research team’s court in an editable state where they may address the requirements from the SR and then submit back to the SRC so they may resume their review.  

One scenario was overlooked when considering when SRC deadline reminders should be sent - when SRs are waived, they do not require reminders emails to tell users to submit Annual or Quadrennial reviews. We have fixed this so that those are no longer sent if a determination of “Waiver Approved” is selected on the Submit Committee Review activity or Submit Expedited Review activity for any SR submission.

SRC Specialists can now run the Update Documents activity on an SR meeting workspace, allowing them to add additional documents for the committee to review at that meeting.  These documents will then appear on the Supporting Documents tab of the SRC meeting workspace.  

The documents displaying on the SR form with a MOD have been incorrectly displaying the IRB approved versions, not the documents updated on the existing MOD that is in process.  This has been fixed so that the documents that are updated with the MOD will display in the SR MOD workspace.

NOTE: When we went live with PROTECT, we did not migrate any SRC or RSC projects from iRIS, only the IRB project.  The first time you create any type of SR or RSC project in PROTECT, the system codes it as an "initial review" (even if it is a MOD/AR/QUAD review form). If the first SR project created in PROTECT is a MOD (such as in the case of a migrated study), the system will code it as an initial review, and documents updated in the MOD are not going to pull into the SRC form or Documents tab on the SR workspace for those actions.  Users will need to go to the IRB MOD workspace/form to view the docs associated with this SRC MOD.   

Eventually, this will not be a problem as an AR, at minimum, should be in the system for all protocols within one year, after which point this will no longer be an issue.

Previously, the Manage Guest List activity was not available for Single Site External studies.  This has been fixed and study teams should be able to run this now on all studies.

On the IRB Project tab, Unassigned sub-tab there is a column called ‘Parent Protocol #’.  This was Not displaying the IDs for all types of actions previously.  This has now been resolved for all actions types except RNI.

Previously, the agenda items on the IRB meeting workspace and the agenda items that appear on the IRB meeting printable agenda and minutes documents were in differing orders, creating some confusion for IRB members and IRB staff when preparing for and conducting the meeting.  These are aligned now so that the order of submission types being reviewed flow in the same order in both places now, making it easier for users to conduct their work before, during, and after the meetings.  Also, this same order has been applied to the IRB Meeting Minutes to assist the staff with finalizing post-meeting activities.  

In the IRB study form and Scientific Review form, for every document type, there is a new mandatory question that asks: Is this document active?  Yes/No.

Documents that are “active” are those that are currently being used in the study.  Documents that that are no longer “active” (inactive) are those that have been retired and no are longer in use, e.g., a consent document for a cohort that has been completed or a recruitment material that is no longer being used.  For those types of documents, you should select “no” (not active).

The status of each document (Is Active?  Yes/No) will be displayed on the Documents tabs of the IRB and SRC project workspaces as well so users may easily identify these as such. The status of each document will also be displayed in the IRB, SRC, and RSC applications wherever documents appear. 

You can refer to this tip sheet that illustrates the process in PROTECT. 

PROTECT will now send notifications to the study teams to remind them to submit their Quadrennial Reviews. The ‘Quadrennial Due Date’ in the system is set behind the scenes as 4 years minus 1 day from the Initial Review's Approval Date. The system will use this date to send Quadrennial Review Reminder Notifications at 90, 60, and 30 days prior to this date. 

Previously, the CSO ancillary review group were not seeing the project in their Inbox when it was assigned in an approved state.  This has been fixed so that it will correctly appear in their inbox regardless of the workflow state the project is in.

For a multi-site study where NIH is the Reviewing IRB, PIs could see the ‘Report Continuing Review Data’ and ‘Correspond with Site’ activities but the PI Proxy could not.  This has been fixed so the proxy now has these activities.

The My Reviews tab was working inconsistently and displaying projects where the user was not a reviewer on the project, making the tab not as helpful as intended.  This has been revised so that the ‘My Reviews’ tab shows only projects where the logged in user is assigned as reviewer.

Previously, the study teams were not notified when the RSC and SRC ancillary reviewers Submitted Ancillary Reviews.  They had to track this by looking on the Reviews tab for the project.  The study teams (PI, Proxy(ies) and primary contact) will now also get an email notification when the RSC and SRC ancillary reviewers submit their ancillary review.

Previously, once a study team member “managed an ancillary review” and added a reviewer (ex. DEC), the action would appear in the reviewers’ My Inbox tab. This was inconsistently occurring before the action was submitted to the IRB for review (in the pre-submission state) appearing that it was ready to be reviewed by the ancillary reviewer. The IRB ancillary reviews should not be initiated until the submission is complete and submitted to the IRB. IRB ancillary reviewers will now only see the action in their My Inbox/My Reviews tab once it has left the Pre-Submission state and been Submitted to the IRB. 

Previously, if the outcome of an ancillary review was denied (they did not "accept" the ancillary review), that submission would remain in the reviewer’s dashboard inbox (making those assigned think it was still an action item). Now, whether the ancillary reviewer accepts the review or denies it, the submission will be removed from the inbox of the assigned reviewers for all modules (IRB, SRC, RSC) once completed.

Previously, if the outcome of an ancillary review was denied (they did not "accept" the ancillary review), that submission would remain in the reviewer’s dashboard inbox (making those assigned think it was still an action item). Now, whether the ancillary reviewer accepts the review or denies it, the submission will be removed from the inbox of the assigned reviewers for all modules (IRB, SRC, RSC) once completed.

Previously, on the Scientific Review workspace only the IRB Parent Study number would appear in the heading. We have added the protocol short study title to also appear in the heading. The caption for the protocol number is updated to read “IRB Parent Study ID” and the protocol short title will be listed underneath the protocol number after the caption “IRB Parent Study Title”. 

The IRB expedited actions report was displaying in the meeting workspace of SRC and RSC meetings. This link should not be visible to SRC and RSC members and does not need to be on these workspaces. We have removed the IRB expedited actions report from the SRC and RSC committee meeting workspaces.

Files that are uploaded in the IRB SmartForm application, page 1, NIH Addendum question will now be displayed on the Scientific Review (SR) SmartForm application page that displays IRB docs for review by the scientific review committee.  You will also see the NIH Addendum on the Scientific Review workspace Documents Tab.

Drug and device attachments that are uploaded in the IRB SmartForm application will now be displayed on the Scientific Review SmartForm application page that displays IRB docs for review by the scientific review committee.  You will also see these attachments on the Scientific Review workspace Documents Tab.

When PRIA, Pharmacy, DEC and IBC reviewers complete their ancillary reviews, the system will send out an email to the PI, Proxy, and Primary Contact for that IRB study.  This was a request of the research community that we were able to improve on in the system. 

NOTE: In an upcoming scheduled release, a notification like this will also be sent when SRC and RSC ancillary reviewers complete their reviews.

When users run Manage Ancillary Review activity, they will now notice that the Response Required question no longer appears.  The question is still there, but just hidden from view and automatically checked as “YES” behind the scenes so ancillary reviewers will always receive a notification when this activity is run.  No changes have been made to how the system blocks submissions when ancillaries are incomplete.  We have just removed this question from the user’s view to avoid errors and to ensure that the ancillary reviewers receive a notification.

When the users tried to select a study to associate with an RSC submission, they were not able to find External IRB studies in the chooser list.  This has been fixed.

Users can now find the parent study ID # on each follow-on submission type workspaces (MOD, MODCR, CR, RNI).

Previously IRB staff were not able to Finalize Documents, Prepare Letter or Send Letter on the workspace for Study Updates.  The workflow for study updates, for both single and multi-site external IRB studies, as now been updated to include those activities so that documents submitted with a study update can be finalized in the study update itself and displayed in the parent project, and so that a letter can be prepared and sent from the study update workspace.

Users that view IRB, RSC, and SRC meeting workspaces will now notice a column titled Expiration Date.  This will display the Expiration Date for the Parent IRB Study, if the project has an expiration date.

PROTECT users who were listed on the study team, could not be selected on the Assign Specialist activity for a SR submission for that study.  We have now resolved this so that anyone who has the Scientific Review Specialist role can be selected on the Assign Specialist activity.

When a SR initial review was disapproved, the system did not register subsequent SR submissions for that study as an initial review.  For all protocols in the system, this meant that another initial scientific review could not be submitted. This has been fixed so that any SR submission created for a study after a SR is disapproved, will be an IR Scientific Review.

When a Scientific Review is created and discarded for a study, both of these activities should appear on the history log.  The Discard activity for SR was not appearing on the parent study workspace, and this has been fixed so that it now appears. 

When a Scientific Review Committee is selected for a submission, some extraneous columns appeared: such as ID, Category, and Parent Org.  We have removed these three and added in Abbreviation column so that now users can choose their SR committee more easily.

Scientific Reviews that were disapproved were incorrectly remaining in the Inbox for the users when this is not necessary since it is an end state.  This has been fixed so that any disapproved action will no longer appear in the user’s inbox. 

Two new values have been added to the drop-down list on the Manage Ancillary Reviews activity: IC Director and Scientific Director. 

In the pSite Mod form, the first question referenced NIH sites. The PI initiating a mod for their site would not know NIH enrollment numbers.  This has been revised to remove reference to the NIH.

The following red reminder text was added to the Withdraw and Discard activities so that users know to use these two activities with caution, and with help from the IRBO:
If the submission is in the IRB review state, please discuss with your IRB coordinator before withdrawing/discarding the submission.

IRBO Staff can now Edit Pre-Review for their RNIs.  Previously they did not have the ability to run this activity once they completed it.

Up until this time, there was no logic built into the IRB workflow for CRs/MODs to block IRB approval if DEC review was not completed.    This has now been fixed and a new trigger question “Does this action require review by your IC DEC office?” now appears on both the MOD, CR and MOD/CR forms.  If you answer “yes” to this question, then the action will not be able to be approved by the IRB until DEC approval has been completed.

The Finalize Updates activity was incorrectly appearing for the PI/Study Team for external single site studies when this is an IRB Staff activity.  We have revised this, so it no longer appears for the PI/Study Team.

There was a bug where the SR Committee Name was disappearing on the parent study application after a MOD was created that required Scientific Review for migrated protocols.  This has been fixed so that the committee’s name remains on the parent study application.

The consent stamp was not working on external IRB studies (both single site and multisite).  This has been fixed and a stamp with the NIH IRB number will now appear on the finalized documents for these studies.  The date of approval will not appear as it is the external IRB who has approved the consent (not the NIH IRB).

On the My Reviews and My Inbox tabs of the Dashboard, users will now see a Parent ID column.   This, in most cases, will display the parent study number. In some cases, such as RSC projects and RNIs, it will not be able to show the parent study number.  

The SR specialists could not see the expedited non-committee reviews under the Reviews tab for the submission.  They were only seeing the Final Reviewer’s comments. This has been fixed.

Question 2 on the Local Study Team Members page has been revised as follows:
Q2. List external team member(s) who are engaged in this research project, work as part of the NIH team at the NIH site, under the direction of the NIH PI, and who are not in NED:

(For example, non-NIH investigators covered by the NIH FWA via an IIA or FWA Coverage Agreement, or those relying on the NIH IRB via a reliance agreement only when the above conditions apply. Do not add collaborators who are not engaged in human subjects research in this section.)

Some SRC coordinators reported being unable to view parent studies and the follow-on submissions for the scientific review submissions they had access to.  A permissions fix has been implemented to repair this.

Users reported being added as proxies to a study but still not being able to view the study.  A permissions fix has been implemented to repair this.

DEC Ancillary Reviewers reported having access to some of their reviews and then no longer being able to view them.  A permissions fix has been implemented to repair this. 

Study team members reported losing access to some of their studies.  A permissions fix has been implemented to repair this. 

Some study team members reported not being able to see the ‘Create MOD/CR’ button on some of their studies.  A permissions fix has been implemented to repair this.

Users were accidentally running "Manage Ancillary Reviews" activity on the parent study when they  intended to manage ancillaries for follow-on submissions such as a MOD. There is no valid use case when a user would need to manage ancillaries after a study is in a Review Complete state like Active/Approved. The Manage Ancillary Reviews activity will no longer be available in the following states: Active, Approved, External IRB, Human Research, Inactive, Lapsed, Not Engaged, Not Human  Research, Suspended, Terminated, Updates Complete

For external IRB study update and site modifications, there is now a question in place that asks: “Is  Scientific Review required for this modification?”. If yes, then the "Initiate SRC Modification" button  will appear in the workspace and SR modifications can now be created for all external IRB studies by the  PI/proxy. The IRB workflow has been updated so that this is a blocking question for IRB review and now  the IRB can finalize the letter when SRC review is not required. 

The "Initiate SRC Modification" button was not appearing for the proxy to create a SR modification for  studies reviewed by the NIH IRB. This has now been fixed and SR modifications can now be created for 
all NIH IRB studies by both the PI and proxy. 

The "initiate scientific review" button was not available for the migrated external IRB studies for either  the PI or proxy. This has now been fixed and for a migrated external IRB protocol, this button is available for the PI/proxy to initiate the first AR or Quad review for a migrated protocol (same as the studies reviewed by the NIH IRB).

When the first scientific review project has been created (either as a MOD or as an AR/Quad review) for the migrated external IRB studies, there will now be an “associated projects” tab on protocol workspace  to track all of the SR reviews moving forward.

Previously, only the PI and Proxy had access to the "Manage Ancillary Reviews" activity. Now, all study  team members (as they have read/write access to the study) will also have the Manage Ancillary  Reviews activity available for them to run in the IRB, SRC, and radiation modules.

There is now a question on the Scientific Review Quad and Annual Review SmartForms where users can upload attachments to accompany the submission. 

There was a question on the MOD/CR form that was not accurate because it asked if Scientific Review  was required for this Continuing Review, and SR is not ever required for IRB CR. It has been revised to read, "Is Scientific Review required for this modification?". Also, the hide/show for this question has been revised to only show if Mod or Mod/CR check boxes are selected. 

Users will now be able to run a Discard activity on Scientific Reviews for IRs, Mods, Annuals, and Quads when they create them in error. 

SRC specialists will now be able to run the "Prepare Letter" and "Send Letter" activities when the SRC  submission is in the "Approved", "Disapproved", or "Modifications Required" state. The submission will stay in its current state, but the correspondence letter will be updated accordingly when the Prepare Letter activity is run, and the same recipients should receive a notification with an updated letter when the Send Letter activity is run.

SRC specialists will be able to run the “Assign Specialist” activity on Scientific Review submissions in any state. Previously, the option to "Assign Specialist" for an SRC submission was only available prior to a pre-review being submitted. 

There was a COI rule in place where the Branch/Lab Chiefs did not have the activity to Submit Ancillary  Review if they were also a member of the study team. We had a work around where we were having them “Add Comment” on the History log to note their signoff. Branch Chiefs/Lab Chiefs will now be able to see the Submit Ancillary Review activity in EVERY state of the Scientific Review submissions  workflow up until post-review. Once the action is in post-review, the person signing off as the CD/SD etc. cannot also be a member of the study team.

In the Radiation Safety Submission form where users enter the effective dose from a study and where users enter the mCi administered dose of a radionuclide, the data fields only accepted whole numbers. These values were revised to accept decimal values (e.g., 0.089 rem or 5.5 mCi). On the RSC project workspace, “Total effective dose from all studies” was also revised to display decimals. In addition, the following two reports were revised to show decimal values: RSC Submissions: Radiography Scan & RSC Submissions: Radionuclides and Compounds. 

Previously, when adding a pSite to a protocol, the organization and person chooser was showing all of the internal NIH organizations and people in NED along with the external organizations and people. The choosers have been updated to display only the external organizations and people with external accounts, making it easier to find the institution/person that you want to select.

On the IRB tab, under reports, custom reports, there is now a report that will display all of the devices that are currently in PROTECT. You can use this report/search feature to see if a device you need is on the choice list before you enter a request to add a new device.