Changes to the UAHPEC application software and processes

The University has introduced a new system, Infonetica Ethics Review Manager (Ethics RM), to replace InfoEd to manage ethics applications.

Ethics RM has now been successfully implemented for all University ethics committees - the Auckland Health Research Ethics Committee (AHREC), Biological Safety Committee (UABSC), Animal Ethics Committee and the University of Auckland Human Participants Ethics Committee (UAHPEC).

What are the most important changes for UAHPEC?

All new UAHPEC applications from 27 May 2020 must be developed using Ethics RM (rather than InfoEd).
As part of the introduction of Ethics RM to replace InfoEd for UAHPEC, the following key changes should also be noted:

  • Clinical / health research ethics applications
    • From 27 May 2020 all clinical research ethics applications must seek Auckland Health Research Ethics Committee (AHREC) approval, or if in scope, Health and Disability Ethics Committee (HDEC) approval. From this point on, UAHPEC will no longer accept applications for clinical research studies.
    • The UAHPEC application form includes a question asking if the application is a clinical/health research study – if the applicant selects ‘Yes’, then advice will be provided to seek HDEC or AHREC approval and it will not be possible to continue with the UAHPEC application.
    • See guidelines for providing a definition of clinical/health research and examples of what is / isn’t clinical research.
  • Applications involving the use and collection of human tissue
    • All applications involving the use and collection of human tissue as part of the research must now seek Auckland Health Research Ethics Committee (AHREC), not UAHPEC approval, e.g., collection of tissue to extract DNA to improve forensic analysis, must seek AHREC approval.
  • Responsiveness to Māori questions
    • Section F of the current UAHPEC application form has been removed.
    • Instead, the questions that were contained in section F have been incorporated into the relevant sections throughout the UAHPEC application form.
     
  • Student (PhD, Masters and Honours Students) ethics application process
    • All students (PhD, Masters and Honours Students) will now be able to complete their UAHPEC ethics applications in the Ethics RM system.

Note: PhD and Masters students will automatically have access to Ethics RM but access for Honours students must be requested by the academic supervisor once for each academic course.

  • Student applications can be created in three ways:

1.    The academic supervisor can create the shell of the application and share the application with the student:

- The academic supervisor or principal investigator (PI) can first create a ‘shell’ of the application (completing minimal details - project title and PI / supervisor name) and share the application with the student for completion.

- Once the student has completed the application in Ethics RM, they must then request their academic supervisor or PI to review and submit their application for Academic Head sign-off.

2.    The student can create the application in Ethics RM, transfer ownership of the application to their academic supervisor or PI and request they share the application with them:

- The student can initiate and complete the application form in Ethics RM noting their academic supervisor or PI as the Principal Investigator for the application.

- Once complete, the student must then transfer ownership of the application to their academic supervisor or PI and request they share the application with them. (This is necessary because a student is not permitted to submit an application – the academic supervisor or PI is responsible for submission).

3.    A Word version of the UAHPEC application form will be available for students to complete so that supervisors can continue to provide feedback on a student’s application using Word tracked changes prior to entering the application details online. Once the Word version application is finalised, the student can copy the content into the online Ethics RM form and transfer the application to their academic supervisor or PI for submission as detailed above.

  • Pre-submission sign-off
    • Applicants will need to request sign-off from their Academic Head once the application is ready for submission. Once signed-off, the application will automatically be sent to the Ethics and Integrity team for pre-screening and inclusion at a committee meeting, and a notification will be sent to the applicant.
    • A list of Academic Heads (or delegates) who will provide sign-off will be available from the sign-off page in Ethics RM.
      (Any updates to this list should be sent to humanethics@auckland.ac.nz)
    • Applicants will be responsible for following up to ensure sign-off with their Academic Head has been completed – an application will not be visible to the Ethics and Integrity team until all required sign-offs have been completed.
    • Once signed-off, the application will automatically be sent on to the Ethics and Integrity team and a notification will be sent to the applicant.
     
  • Amendment and renewal request
    • All amendment requests for applications approved through either InfoEd or Ethics RM must now be processed in Ethics RM.
    • The Ethics RM amendment and renewal process will enable specific amendment details to be captured against each applicable application question.
    • Applicants must also provide a summary of the amendments being requested at the end of the form.
    • From ‘go live’ of Ethics RM (27 May 2020), amendment requests for applications approved through Ethics RM must be processed in Ethics RM.
    • To initiate an amendment in Ethics RM, a request should be sent via Ethics RM to the Ethics and Integrity Team (see ‘Submit request for original application to be unlocked’ step in Infonetica Ethics RM – Amendment request guide for more details).
    • Until the InfoEd applications are migrated to Ethics RM at the end of July, amendment requests to completed InfoEd applications will continue to be managed in InfoEd.
    • After the end of July, once completed InfoEd applications have been migrated to Ethics RM, amendment requests for applications submitted through both InfoEd and Ethics RM must be processed in Ethics RM.
     
  • New amendments or renewal requests for applications migrated from InfoEd (previously approved in InfoEd)

• All amendment requests for applications approved through either InfoEd or Ethics RM must now be processed in Ethics RM.

o To initiate an amendment for a project previously approved in InfoEd:
1. Your project(s) from InfoEd have been moved to Ethics RM. To find the InfoEd application, go to the Ethics RM Work Area and search for the project by typing in the InfoEd protocol number (this number is added as a suffix to the project title).
 
2. Open the project and use the correspondence tab to send a request to the Ethics team to unlock the form (see ‘Submit request for original application to be unlocked’ step in Infonetica Ethics RM – Amendment request guide for more details).
 
3. You will be notified when your project is unlocked.
 
o To initiate an amendment for a project approved in Ethics RM:
1. Send a request via Ethics RM to the Ethics Team to unlock the form (see ‘Submit request for original application to be unlocked’ step in Infonetica Ethics RM – Amendment request guide for more details).
 
  • Managing InfoEd applications that are not yet approved in InfoEd

Submitted applications that are not yet fully approved (e.g., conditionally approved, applications sent for rework, applications pending re-submission) will continue to be processed in InfoEd until approval.

  •  Renewal notifications
    • Ethics RM will send an email notification to the Principal Investigator 90 days before an ethics approval is about to expire to remind them to submit a renewal request if the research is continuing beyond the expiry date of the ethics approval (note; one three year extension is possible).
  • Access to Ethics RM when off-campus
    • Ethics RM can be accessed from anywhere via a web browser and using a University username and password (there is no need to use VPN when accessing Ethics RM off campus).
      More details of some of the benefits of using Ethics RM can be found in the following document UAHPEC - Application Process Key Changes document:

Managing InfoEd applications that are incomplete on ‘go live’ of Ethics RM for UAHPEC  

Applications that are in preparation but not yet submitted:

  • Applications that are currently in preparation in InfoEd must be submitted for UAHPEC review by 2 June. Any application not submitted in InfoEd by 2 June that is continuing will need to be re-keyed by the applicant into Ethics RM.  

Submitted applications that are not yet fully approved (e.g., conditionally approved, applications sent for rework, applications pending re-submission):

  • Will continue to be processed in InfoEd until the end of August (3 months after UAHPEC ‘go-live’ in Ethics RM).
  • Any application not completed in InfoEd by the end of August will be managed on a case by case basis.
     

When did this change happen?

Target ‘go-live’ date for accepting new UAHPEC ethics applications in Ethics RM was 27 May 2020 for low risk (expedited) review and for full review at the UAHPEC meeting of 8 July 2020 at the earliest.

Applications that are currently in preparation in InfoEd must be submitted for UAHPEC review by 2 June 2020. Any application not submitted in InfoEd by 2 June 2020 that is continuing will need to be rekeyed by the applicant into Ethics RM.

Submitted applications that are not yet fully approved (e.g., conditionally approved, applications sent for rework, applications pending re-submission) must be completed in InfoEd by the end of August. Any application not completed in InfoEd by the end of August will be managed on a case by case basis.

At the same time:

  • All clinical / health research studies that require ethics approval, and are eligible for Auckland Health Research Ethics Committee (AHREC) review, must be submitted to AHREC from 27 May 2020 for expedited review and full review at the meeting of 13 July 2020 at the earliest.
  • All applications involving the use and collection of human tissue as part of the research must now seek Auckland Health Research Ethics Committee (AHREC), not UAHPEC, approval, e.g., collection of tissue to extract DNA to improve forensic analysis, must seek AHREC approval.
     

What training is available?

Quick Reference Guides are available to provide guidance on how to use Ethics RM (note you will be redirected to the AHREC website).

In addition, some classroom training sessions have been scheduled – please use the Career Tools course links below to book into a classroom training session:

Infonetica Ethics RM, Create and Submit an Application
Infonetica Ethics RM, Signing Off an UAHPEC application

 

More information

Four remote webinars were held that provided an overview of Ethics RM for UAHPEC and walked through some of the key changes for both UAHPEC and AHREC. A recording of one of the webinar and the presentation used during the webinars are below.

Please be patient, these take a little while to load.

For any additional questions not covered in the above:

  • For guidance in relation to completing your UAHPEC application, please refer to the UAHPEC intranet pages.
  • For technical assistance please raise a service request with the University Staff Service Centre or contact them on ext 86000.
  • For any further questions please: