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:
- They are submitted by the PI or, if not submitted by the PI, a separate attestation form authorizing the submission is included and signed and dated by the PI; and
- All relevant documents are included (if applicable).
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:
- Changes in Study Personnel
- Letter of Attestation
- Unanticipated Problem Reporting
NEW HSREB Post-Approval Online Forms:
- Continuing Ethics Review (CER) Form
- Amendment Form (Previously “Revision Form”)
- Acknowledgement Request Form (FYI Form)
- Data Safety Monitoring Committee Form
- Updated Approval Form
- End of Study Form
- Protocol Deviation/Violation Form
Which Post-Approval Submissions will receive a Formal Approval Letter?
A formal approval letter will only be issued for the following post approval submissions:
- Amendment Forms
- Updated Approval Forms
Which Post-Approval Submissions will receive an Acknowledgment of Receipt?
An Acknowledgment of Receipt email will be issued for the following submissions:
- Change in Study Personnel (other than PI and CoI)
- Acknowledgement Request Form (FYI Form)
- Data Safety Monitoring Committee Form
- End-of-Study Report Form
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:
- HSREB file number
- Study Title
- PI Name
- Name of post-approval form being accompanied with the attestation letter
- Statement of acknowledgment from the PI authorizing the post-approval submission (ensure to state what type of submission it is)
- PI signature
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:
- HSREB Amendment Event Form (ROMEO)
- Tracked and Clean copies of any previously approved study documents affected by the change in PI/Co-I
- HSREB Amendment: Change in PI Form (ONLY if the change is to the PI)
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: firstname.lastname@example.org
An email from PI with the following information:
- Subject line: “HSREB” + HSREB file number + “Change in Personnel”
- Body: Title, First Name, Last Name, Role, Status (incoming/outgoing), contact
- HSREB 123456 – Change in Personnel
- Dr. John Doe, Research Student, Incoming, email@example.com
- Mr. Michael Smith, Biostatistician, Outgoing, firstname.lastname@example.org
- Dr. Jane Doe, Research Analyst, Outgoing, email@example.com
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.
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:
- Proposed changes to the scientific intent of the research;
- Reports of any changes significantly affect the conduct of the research or increasing the risk to research participants; and/or
- New information that may adversely affect the safety of the research participants or the conduct of the research.
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.
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:
- 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
- All relevant documents are included (if applicable). If either is missing, the submission will not be accepted for reviewed.
Required Documentation (in addition to Amendment Form)
- Separate summary of the changes page detailing what is being changed and why (if available)
- Revised Application Form (see below for instructions)
- New or revised Letter(s) of Information & Consent
- Other study related documents that require changes
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”):
- In ROMEO: Export a Word copy of the Application Form;
- In Microsoft Word: make changes (including version date) to the document using the ‘track changes’ function. This is your “Tracked” copy;
- Save Tracked copy in Word format. Duplicate the Tracked copy and accept all changes. Save in PDF format. This is your “Clean” copy;
- Attach the Tracked and Clean copies to the submission. PLEASE ENSURE TO INCLUDE A VERSION DATE (e.g., dd/mmm/yyyy) in the footer of all study documents; and
- Every time an amendment is made to this document, please remember to revise the version date to reflect the changes made and re-submit the entire document.
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)
- Protocol deviation/violation form that was submitted to the sponsor (if available).
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.
- Serious, unexpected adverse events or reactions regardless of causality for participants enrolled at the Local site;
- Report Due: Within seven (7) days of discovery of the event or reaction;
- AER Module: Use the module to enter details of the SAE;
- Submit: 1 hard copy of Western University HSREB Local Adverse Events Report (generated through the On-Line Adverse Events Reporting Module). Please ensure YOU forward the hard copy of each event within seven (7) days.
- Serious, unexpected adverse reactions or events related to the study intervention that occur at all non-local or external sites;
- Report Due: Within 30 days of being notified of the event or reaction;
- AER Module: Use the module to enter details of the SAE;
- Submit: Not applicable, hard copies are no longer accepted by the ORE.
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)
- Copy of the Data Safety Monitoring Committee findings/report 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.