Category: Ethics

The Office of Human Research Ethics successfully launched the first of two migration phases for its new online protocol submission platform, WREM, on September 7, 2017.

In order to continue to successfully transition the Research Ethics Board files from ROMEO to WREM they have decided to split the second migration into two phases, resulting in a total of three migrations.

Second Migration: The second migration will occur between 4pm April 6 to 12pm April 9, 2018 and will involve migrating the remaining initial submissions that were still under review as of Aug 31, 2017.

• Will include all studies approved in ROMEO after August 31, 2017
• Will not include post-approval submissions (e.g., amendments, continuing ethics reviews, reportable events, etc.)
• Will not include study documents (including the ROMEO Application Form), which will NOT be migrated into WREM

Please Note:

• Those designated as research support staff will be provided access to the file in WREM; those designated as co-Investigators, students or other will NOT be provided access to the file in WREM and will, therefore, need to be added to the file in WREM.
• WREM will not be accessible during the second migration.
• The second migration will transition the entire research community to WREM, and result in all post-approval submissions being done through WREM.
• ROMEO will remain accessible to researchers for the remainder of 2018, but only to retrieve study documents. Please ensure that if your study will remain active after 2018 that you retrieve your documents from ROMEO and store them securely as per institutional policy.

Third Migration: The third migration, which will occur at a later date, will then include all post-approval submission information (i.e., amendments, continuing ethics reviews, reportable events). The date for this migration is as yet TBD, but is estimated to be June/July 2018.

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Western Research Ethics Management (WREM) updates

Over the Christmas holidays the Office of Human Research Ethics updated a series of forms within WREM, which will become active on January 24, 2017. They include Non-Medical Research Ethics Board (NMREB) initial and amendment forms, continuing ethics review and study closure forms.

When you log in to WREM you will notice the following message appear in the Work Area at the top of your screen: “Warning: The project owner must update your project in order to submit this form.”

The message appears only when there has been an update to the application form(s). The form owner will need to accept the update prior to a) submitting an application and/or b) completing an application you have been working on when the message appeared.

Are there any implications to updating the form(s)?
Consider these three scenarios:
1) The form has not been submitted, and is still unlocked – Updating the project will have no effect, except any changes in the form you are completing will be updated.
2) The form has not been submitted, but the form has been locked (either by a signature request, or by a signature being completed) – Updating the project will break these signatures or signature requests. Any requests will need to be remade, and any existing signatures will need to be re-given, because they will have been applied to an old version of the form.
3) The form has been signed and submitted – Updating the project will have no effect on any submitted forms.

What updates have been done?
1. Administrative updates (i.e., revising, addition and removal of questions, addition of help text, etc.)

To access WREM training material and FAQs please visit the website and WREM (click Western University’s REB to access the WREM site).

If you have any questions, please do not hesitate to reach out to any member of the Research Ethics team.

WREM-Memo-updated application Jan 19 2018.pdf

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The Office of Human Research Ethics has updated a series of forms within WREM, which will become active on December 11, 2017. They include Health Sciences Research Ethics Board (REB) and Non-Medical REB initial and amendment forms, continuing ethics review and study closure forms.

When you log in to WREM you will notice the following message appear in the Work Area at the top of your screen: “Warning: The project owner must update your project in order to submit this form.”

The message appears only when there has been an update to the application form(s). The form owner will need to accept the update prior to a) submitting an application and/or b) completing an application you have been working on when the message appeared.

Are there any implications to updating the form(s)?

Consider these three scenarios:
1) The form has not been submitted, and is still unlocked – Updating the project will have no effect, except any changes in the form you are completing will be updated.
2) The form has not been submitted, but the form has been locked (either by a signature request, or by a signature being completed) – Updating the project will break these signatures or signature requests. Any requests will need to be remade, and any existing signatures will need to be re-given, because they will have been applied to an old version of the form.
3) The form has been signed and submitted – Updating the project will have no effect on any submitted forms.

What updates have been done?

1. The most important update is the PI can delegate a study team member to submit a re-submission (i.e., response to REB recommendations). The PI must still submit all initial application forms, but may choose to sign-off electronically on all re-submissions or may delegate this task to another qualified individual. NOTE: The PI is still fully responsible for the study’s scientific and ethical conduct. The REB recommends keeping a log of to whom the PI has delegated authority to submit re-submission forms.
2. Administrative updates (i.e., revising, addition and removal of questions, addition of help text, etc.)

To access WREM training material and FAQs please visit the website and WREM (click Western University’s REB to access the WREM site).

If you have any questions, please do not hesitate to reach out to any member of the Research Ethics team.

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Additional information about the launch of the new online protocol submission platform – Western Research Ethics Manager (WREM) – on September 7, 2017:

Attestation
A previous memo indicated chairs, chiefs and department heads will now be responsible for providing a one-time initial attestation. To clarify, the one-time attestation will only be required on submissions that have been determined by the REB to require a full board review (i.e., delegated submissions will not require a chairs, chiefs and department heads attestation) and the REB review will NOT be delayed while waiting for the attestation but an REB approval letter will not be issued until the attestation has been documented in WREM.

ROMEO Shutdown
ROMEO will shut down at midnight on August 31, 2017 and you will begin using WREM as of September 7. To allow for a successful data migration between the two systems, you will not have access to ROMEO or WREM between these dates.

Migration

1st Migration – September 7, 2017

• All studies approved in ROMEO up to Aug 31, 2017 will be migrated to WREM.
• There will be no access to ROMEO or WREM during Sept 1-6 as data migration will be taking place during this time.
• All new submissions and any post approval submissions (for those studies that were initially migrated to WREM) are to be created using the new platform.
• Information that will be initially migrated will include: REB number, full study title, PI name, initial approval date, expiry date, those designated as Research Support Staff.
• Important notes:
  o No information about post-approval submissions (e.g., amendment, CER, reportable events, etc.) will be migrated during the 1st migration. This information will be migrated during the 2nd migration.
  o No study documents (incl. the ROMEO Application Form (“Western Protocol”)) will be migrated into WREM.
  o All those designated as Research Support Staff in a ROMEO file will also have access to the migrated file in WREM.

2nd Migration – date TBD

• If your initial submission or post-approval submission has been submitted – but not approved – in ROMEO by August 31, it will be migrated during the 2nd migration.
• To help minimize delays, please save copies of ALL currently approved documents (e.g., ROMEO Application Form (“Western Protocol”), Letters of Information, etc.) from ROMEO to your secured network drive for easy access.

Training
Training for WREM began on July 11. Please visit the dedicated rollout website to register for an upcoming session, schedule individual training, or for additional information.

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The Office of Human Research Ethics (OHRE) is launching a new online protocol submission platform, Western Research Ethics Management (WREM), on September 7, 2017. Below are some updates related to process and timing:

Migration
All studies approved in ROMEO prior to September 7, 2017 will be migrated to WREM, and, as of this date, all new submissions are to be created using the new platform. If your initial submission or post-approval event has been submitted – but not approved – in ROMEO by September 7, it will be migrated at a later date. Migration will include: PI name, REB number and the study title; the Western protocol form, supporting documents, co-investigators and study team members will not be migrated.

To help minimize delays, please be aware of the following:

1. You should ensure you save copies of ALL currently approved documents from ROMEO to your secured network drive for easy access.
   As of midnight, September 6, 2017, you will no longer be able to access ROMEO to submit any new studies or post-approval events (e.g., amendments, continuing ethics review, protocol deviations, etc.). ROMEO will only remain available to finalize outstanding recommendations from the Office of Human Research Ethics (OHRE) and to access old files.
2. OHRE cannot guarantee any new studies, responses or post-approval events submitted to ROMEO after August 7, 2017 will be migrated during the first migration.

Training
Training for WREM began on July 11. Please visit the dedicated rollout website to register for an upcoming session, schedule individual training, or for additional information.

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