Research Western

Post-Approval Events

Ongoing Maintenance of your Protocol

Post-Approval Forms Available on ROMEO

As of March 1, 2014, all Health Sciences Research Ethics Board (HSREB) post-approval (any submission completed following initial approval of a research study) forms will be available on, and must be submitted via, ROMEO. Hard copy forms will no longer be accepted after March 31, 2014. The office of Human Research Ethics will NOT accept online submissions (initial and post-approval forms) unless:

The submission will not be accepted for review if these conditions are not met. These guidelines are in conformity with requirements for continuing ethical review as set out in the Tri-Council Policy Statement, and in compliance with regulations governing clinical trials (Health Canada regulations for the investigational use of drugs, radiopharmaceuticals, biologics, natural health products and medical devices), ICH GCP E6, and where relevant, the U.S. Code of Federal Regulations.

NEW HSREB Post-Approval Policies:

NEW HSREB Post-Approval Online Forms:

Which Post-Approval Submissions will receive a Formal Approval Letter?

A formal approval letter will only be issued for the following post approval submissions:

Which Post-Approval Submissions will receive an Acknowledgment of Receipt?

An Acknowledgment of Receipt email will be issued for the following submissions:

An Acknowledgment of Receipt email will NOT be issued for CER Form submissions. The sender is instructed to check ROMEO that this submission has been processed and document “proof of submission” to indicate on their records that the document has been submitted to the HSREB.

Letter of Attestation

Principal Investigator (PI) and Co-Investigator (CoI)

Any post-approval form that is not submitted directly by the PI requires a separate Letter of Attestation. A Letter of Attestation is completed by the PI authorizing the submission.  An Attestation Letter must be included as an attachment.  All Letters of Attestation must include the following information:

Study Personnel Amendments – UPDATED September 2, 2014

Change in Principal Investigator (PI) and Co-Investigator (Co-I)

Changes to PI and Co-I require submission of a formal revision request in Romeo. The following documentation is required:

Change in study personnel other than the PI and Co-I

Changes in study personnel (non-PI/Co-I) may be submitted via email to the ORE. If changes in personnel are submitted via email the email must come from the Principal Investigator or the request will not be acknowledged. Send any non-PI/Co-I personnel change requests to: ethics-romeo@uwo.ca

Required Documentation:

An email from PI with the following information:

Example:

HSREB Continuing Ethics Review (CER) Form

Western’s office of Human Research Ethics approves studies on an annual basis. If your study is ongoing for more than one year, the office will issue an Annual Renewal Approval Notice for one year at a time. Depending on risk, continuing review may be required more than once per year; you will be informed if this is the case.

When your study has ended you are required to submit an End-of-Study Form.

The office of Human Research Ethics will NOT accept CER Forms unless they are submitted by the PI, or have an accompanying Letter of Attestation authorizing this submission. If a Letter of Attestation is used, please see the ‘Letter of Attestation’ section above for more details, including Attestation Letter requirements)

To help facilitate compliance, the office will issue reminder notifications for when CER forms are due. This will occur two months and one month before the due date. If a CER form is not submitted by the due date the office will send a third and final notification just before your study will expire. Should an Investigator fail to submit the CER form despite the reminder/follow-up notifications, a notice that REB approval has expired will be issued and the study will be suspended.  When suspended, the Investigator must suspend all study related activities as specified by the REB. If the CER form is still not submitted within two weeks of the study expiry date the REB may close the file and the Investigator will be required to submit a new study application.  If the CER form is submitted after the expiry date, but before file closure, this will result in a lapse in REB approval. The REB may also elect to pursue investigations for serious or continuing non-compliance.

Initiating or continuing the conduct of human participant research in the absence of REB approval does not conform to the Tri-Council Policy Statement 2 (TCPS 2) and for regulated studies, is contrary to Health Canada, FDA and OHRP regulations.

HSREB Amendment Form

All changes to the planning or conduct of approved studies are considered amendments and must be submitted to the Health Sciences Research Ethics Board (HSREB) for prior review and approval to ensure the research remains ethically sound. The Principal Investigator (PI) must ensure that amendments are submitted to the HSREB for review and that written approval is received prior to implementation.

Review process

The HSREB Chair or designee reviews the Amendment submission to determine the appropriate level of HSREB review required. Delegated review may be done when the proposed changes are minor or involve no more than minimal risk. The REB Chair or designee has the authority to direct any delegated review request to the Full Board for review.

Full Board review may be required when the proposed change(s) represents more than minimal risk and is determined by the HSREB Chair to require more intense scrutiny by the Full REB, or is required by the regulatory body. Examples that may require full board review may include:

Amendments that qualify for full Board review are generally reviewed at the next HSREB Full Board meeting. You will be informed if your Amendment submission requires Full Board review.

Health Canada “No Objection” letters (NOLs) or equivalent must be included with Amendment submissions for regulated clinical trials when applicable. When applicable, REB approval for an Amendment will not be granted until the NOL or equivalent Health Canada authorization (ITA, NOA, etc.) is received.

Following the Amendment review, REB recommendations regarding Amendment submissions are communicated to the PI (and study staff listed in ROMEO as “research support staff) in writing. The PI will have an opportunity to submit additional information and/or a revised study documents that addresses any issues raised in the HSREB review.

Sub-Studies

The HSREB generally does not consider sub-studies, ancillary studies, rollover studies, continuation studies, or extension studies to be Amendments. You are encouraged to consult the Office of Research Ethics Officer responsible for your study prior to preparing a submission for this type of change, to ensure you prepare the correct type of submission. The Ethics Officer will facilitate obtaining a decision from the HSREB Chair/Co-Chair.

The Office of Research Ethics will NOT accept this submission unless:

Required Documentation (in addition to Amendment Form)

Revised Study Document Requirements

All revised study documents must have version dates (e.g., dd/mmm/yyyy) in the footer of each page.  Version dates identify the latest edition of study documents. A new version date is required each time the document is modified. For example, if a study document requires further modification based on comments received during the REB review process, the version date must be modified to reflect the most recent edition of that study document.

Please also ensure to submit one copy with tracked changes and a clean copy of all revised study document(s). If changes are required for the Application Form (also considered the “Western Protocol”):

HSREB Unanticipated Problem Reporting

HSREB Protocol Deviations/Violation Form

NOTE: Please see the Reporting Protocol Deviations/Violation guidance document.

Required Documentation (in addition to Protocol Deviation/Violation Form)

Adverse Event Reporting

NOTE: Please see the HSREB Unanticipated Problem Reporting guidance document to determine which Adverse Events require reporting to the HSREB. Please use the Online Adverse Events Reporting Module to enter and print copies for SAE reporting. Please submit one signed copy of any LOCAL SAE report to the office of Human Research Ethics. For Local Online registration assistance or for any other questions with the local on-line system please contact the office of Human Research Ethics.

Local Sites

Non-Local Site

HSREB Acknowledgement Request Form (FYI Form)

DO NOT use this form if what you are submitting is making any changes to the approved Application Form (also considered the “Western Protocol”) or any supporting documentation.

Updated Investigator Product Documentation

Updated Investigational Product Documentation (e.g., Investigator Brochures, Product Monographs, Device Manuals, etc.) that do not alter the benefit:risk assessment of the study should not be submitted. Only if the updated safety information requires a change to the Letter(s) of Information/Consent and/or protocol, should it be submitted to the office of Human Research Ethics as an Amendment.

Data Safety Monitoring Committee

Per article 11.7 (TCPS2) A safety monitoring plan may (but need not) include the establishment of a data safety monitoring board (DSMB) or data safety committee (DSC).

A DSMB is normally a multidisciplinary, expert advisory group that is responsible for safeguarding the interests of participants, by reviewing emerging data, assessing the safety and efficacy of trial procedures, and monitoring the overall conduct of a trial. Researchers must indicate, in their proposal for REB review, whether they or a DSMB will be communicating any new information to the REB over the course of the trial. Researchers must ensure that DSMB reports are sent to REBs in a timely manner.

Required Documentation (in addition to the DSMC Form)

HSREB End-of-Study Form

Submit when a study is completed (no further participant involvement, data collection, chart access, data clarification & data transfer).

The office of Human Research Ethics will NOT accept this submission unless: (1) it is submitted by the PI or have an accompanying Attestation Letter authorizing this submission. If a Letter of Attestation is used, please see the ‘Attestation Form’ section above for more details, including Attestation Letter requirements); and (2) all relevant documents are included (if applicable). If (1) or (2) are missing, the submission will not be accepted for review.