NIH PROTECT Release Notes

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.