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Ontario Cancer Research Ethics Board

FAQ

 Printable version

OCREB MANDATE

What types of cancer research can be submitted to OCREB?
OCREB's current mandate is restricted to multi-centre (i.e., more than 1 centre in Ontario) clinical trials. Although there is a lot of valuable multi-centre research that might benefit from a centralized REB, OCREB does not have the resources or the mandate to accept non-clinical trial research.

 

OCREB PROVINCIAL AND CENTRE APPLICANT ROLES

There are two major steps to an OCREB review and to obtaining approval to conduct a study at your centre. The first step is the submission, and approval of the provincial application to OCREB; the second step is the submission, and approval of the centre-specific application(s) to OCREB. Part of what makes OCREB more efficient for multi-centre studies is that only one investigator is required to submit the provincial application. In essence, this investigator is submitting to OCREB on behalf of all participating centres in Ontario and thus is called the "Provincial Applicant".

 

RESPONSIBILITIES OF THE OCREB PROVINCIAL APPLICANT

How do I become the Provincial Applicant?
You can be the Provincial Applicant if your centre’s Principal Investigator (PI) is the first one ready to submit a study to the REB. It’s as simple as that. If your PI is a key expert in the area under study, the sponsor also might “recommend” that your PI be the Provincial Applicant. If your PI is the NCIC Study Chair, it would be appropriate that s/he be the Provincial Applicant since s/he is in the best position to respond to questions from OCREB.

What if I don't want to be the Provincial Applicant?
While it may be true that the Provincial Applicant has more work than other participating centres using OCREB (unless you work through the OICR Central Office), the overall workload should be the same as submitting to your local REB.

I am the Provincial Applicant. Now what?
Once you have decided to participate in a study and have agreed to assume the role of Provincial Applicant, please notify OCREB (via email or during the monthly teleconference) so that the study can be listed as “pending” in the Project Submission spreadsheet where it will be visible to other Ontario centres. We will add it as a “New Submission” once the full submission is received. Be sure to contact the OICR Clinical Trials Central Office. Their role is to coordinate with the sponsor and the participating centres to facilitate a single (provincial) ethics submission, a single budget and a single contract. This will save you a lot of time and effort. Since the provincial application to OCREB contains no centre-specific information, the sponsor may be willing to help complete the provincial application. The sponsor also should provide a list of other centres that they have approached and that are considering conducting the study.

As the Provincial Applicant, what do I need to submit to OCREB?
The provincial applicant is responsible for submitting to OCREB the completed and signed provincial application form plus all of the supporting study documents including the protocol, sub-studies, budget, Investigator Brochures and/ or product monographs, provincial consent form(s), study participant materials,, the demographic page(s) of the CRF, Health Canada NOL, etc. The checklist on the front of the provincial application form will guide you as to the required documents to be submitted.

Until we move to a fully electronic system you will need to submit both a hard copy (paper) and an electronic copy of each of the documents. In addition to a paper and an electronic copy of each document, you must submit the original PLUS a copy of the signed application form.

Where do I find the OCREB forms?
The OCREB website (www.ocreb.ca) contains a wealth of information, including REB membership lists, SOPs, guidelines, forms, www.oicr.on.ca/OCREB/forms.htm and more!

Where do I submit?
Be sure that your electronic documents and your paper submission are received in the OCREB office by the end of the day on the deadline (i.e., the last Thursday of every month) prior to the meeting.

The paper submission package should be couriered to:   
Ontario Cancer Research Ethics Board
c/o Ontario Institute for Cancer Research
MaRS centre, South Tower
101 College Street, Suite 800
Toronto, Ontario, M5G A03

The electronic documents should be sent to ocreb.submissions@oicr.on.ca or included in the mailed package on CD. Be sure to include Word versions of your consent forms and of the unsigned provincial application (to allow participating centres to copy and paste from it). Your project will be assigned an OCREB number. The original signed application form will be scanned by the OCREB office upon receipt and all relevant provincial documents will be uploaded into Collaboration in the applicable study folder. As the Provincial Applicant and as a participating centre, you will be given access to that study folder in “Collaboration”.

What is "Collaboration"?
Collaboration is a secure online repository of study-related OCREB documents. If you are the person who submits or corresponds with the REB and maintains the REB study files for your centre, you probably need a Collaboration account. This must be authorized by your manager and the OCREB office. OCREB pays for these accounts, so be sure that you need and use it. OCREB also provides an account to an authorized institutional contact (usually someone in the research office, but sometimes it’s someone in the local REB office). This is to ensure that someone at the institution is able to view all of the studies that are taking place at your centre. Please see the OCREB Collaboration manual for details.

The provincial materials have been submitted. What now?
Almost all of the studies submitted to OCREB are considered to be more than minimal risk. Therefore, they must be reviewed at a full Board meeting. If OCREB has any concerns or questions, the PI will be notified via a formal “review letter”. The OCREB office will notify you and your PI when the review letter has been issued and uploaded into the study files in Collaboration. As Provincial Applicant, your PI is responsible for responding to any concerns. You and/or the PI will continue to work with OCREB (via the research ethics coordinators) to resolve any issues, including any necessary revisions to the provincial consent form. The OCREB office will notify you, the PI, and all potential participating centres when the provincial approval letter has been issued and uploaded to the study files in Collaboration.

What if I am a Provincial Applicant and my centre is closing the study?
If you are the Provincial Applicant and the study is closing at your centre, you should contact the PI at one of the other participating centres to request that they take over as Provincial Applicant. Alternatively, you may contact OCREB to help facilitate the transfer to a PI at another centre. The Board of Record Study Agreement requires that one of the other participating centres must agree to take over the Provincial Applicant role if necessary. A Change in Provincial Applicant form must be submitted to OCREB before the original Provincial Applicant can relinquish his/her responsibilities to the incoming Provincial Applicant.

What other responsibilities do I have as Provincial Applicant?
As the Provincial Applicant, you are responsible for submitting all study amendments, revised consents, changes to the IB, etc on behalf of all participating centres. You also are responsible for submitting all DSMB reports as well as all external serious adverse event reports (unless the sponsor has formally agreed to submit these SAE reports directly to OCREB on behalf of all centres). Please see Collaboration re memos for sponsors who are submitting external SAEs directly to OCREB.. See Appendix 1 for what the provincial applicant attests to by signing the provincial application form.

 

RESPONSIBILITIES OF THE OCREB CENTRE APPLICANT

Each centre has a study PI (Qualified Investigator) who is responsible for the conduct of the study at his/her centre. The Provincial Applicant also will be the Centre Applicant at his/her centre. The Centre PI is responsible for submitting his/her centre application to OCREB.

As a Centre Applicant, what do I do?
You should wait until the study has received provincial approval before submitting your centre application to OCREB. When your centre decides to conduct a study that has received provincial approval, contact the OCREB office for access to the study files in Collaboration (if you are the Provincial Applicant, you already will have access). You must provide the OCREB office with the full study title or otherwise demonstrate that the sponsor has authorized you to conduct the study before OCREB can grant you access in Collaboration. The sponsor should provide you with all of the necessary study documents including Protocols and Investigator Brochures which are not available in Collaboration. Your PI should review the provincial materials (provincial application, the OCREB review letter(s) and the PI response letter(s)) and prepare your centre application..

As a Centre Applicant, what do I need to submit to OCREB?
The centre application includes:

• The signed centre application form - how you will conduct the study at your centre;
• The Board of Record (BOR) Study Agreement - this designates OCREB as the REB;
• Your local consent form(s)- transfer the approved provincial consent form(s) onto your local letterhead and insert your contact information;
• PI CV and new PI form (if the PI is not already on file with OCREB).

My centre application has been submitted. What now?
Your centre application will undergo an expedited review (by a member of OCREB). The OCREB office will notify you and your designated institutional contact when your centre approval letter has been issued and uploaded to the study files in Collaboration.

What other responsibilities do I have as a Centre Applicant?
You will need to submit all local SAEs, privacy breaches, and protocol deviations to OCREB. Local SAEs are reviewed, signed and uploaded to Collaboration. Receipt of protocol deviations and privacy breaches are acknowledged via email. OCREB will send you a request if further information is required. Due to the sensitive nature of protocol deviations and privacy breaches, they are not uploaded to Collaboration.
Per the Board of Record Study Agreement, you may be asked to take on the Provincial applicant responsibilities if the Provincial applicant needs to withdraw during the conduct of the trial.

See Appendix 1 for what the centre PI attests to by signing the centre application form.

APPENDIX 1 – APPLICANT ATTESTATIONS

Provincial Applicant/Investigator Agreement:

• I attest that this application as submitted is in compliance with the Tri-Council Policy Statement; ICH Good Clinical Practice Consolidated Guidelines; Division 5, Canadian Food and Drug Regulations, and the applicable laws and regulations of Ontario;
• I attest that the information in the application is complete and accurate to the best of my knowledge;
• I attest that this application contains the current and complete protocol, including any sub-studies;
• I am aware that the OCREB review materials (i.e., provincial application form, correspondence between the PI and OCREB, approval letter) will be shared with all Ontario sites participating in this study;
• As provincial applicant, I acknowledge that I am responsible for reporting to OCREB any proposed modifications or amendments to the protocol, all external (non-local) SAEs, and updated Investigator Brochures or Product Monographs unless the sponsor formally agrees to do so on my behalf;
• I will submit an OCREB Application for Approval of Centre Participation for review/approval to conduct the study at my centre;
• I am aware that OCREB will provide the following study information to all Ontario oncology trial sites: OCREB project I.D. #, sponsor name, sponsor protocol #, REB review status, name of provincial applicant (i.e., submitting PI), and list of participating centres.

Centre Applicant Investigator Agreements:

• I attest that the information in this application is complete and accurate to the best of my knowledge;
• I assume full responsibility for the scientific and ethical conduct of the study at this institution;
• I agree to conduct this study in compliance with the Tri-Council Policy Statement; ICH Good Clinical Practices: Consolidated Guidelines; Division 5, Canadian Food and Drug Regulations; the provisions of the Ontario Personal Health Information Protection Act and its applicable Regulations; and the applicable laws and regulations of Ontario;
• I attest that I have sufficient space, time and resources to conduct this research;
• I certify that all sub-investigators, researchers and other personnel (Research Team) involved in this project at this institution are appropriately qualified and experienced, or will undergo appropriate training to fulfill their role in this project;
• I agree to promptly report to OCREB all local unexpected, serious and research related adverse events (SAEs) in respect of the study and any new information (including but not limited to protocol violations) that may adversely affect the safety of the participants or significantly affect the conduct of the study;
• I certify that this application form has been completed accurately and that OCREB approval and all external and local institutional approvals will be obtained before the trial will commence;
• I will review all provincial OCREB review materials (i.e., provincial application, correspondence between OCREB and provincial applicant, OCREB approval letter, approved model consent form);
• I certify that the Research Team will adhere to the protocol and consent form as approved by OCREB and in accordance with any conditions placed on the OCREB approval.

Privacy and Security Acknowledgement:

• On behalf of all members of my research team, I recognize the importance of maintaining the confidentiality of personal health information and the privacy of individuals with respect to that information. 
• I will ensure that the personal (health) information is used only as necessary, to fulfill the specific research objectives and related research questions described in the application approved by the OCREB. This includes all conditions and restrictions imposed by the OCREB and the Institution in which the study is being conducted, governing the use, security, disclosure, return or disposal of the research participants’ personal health information. 
• I agree to take any further steps required by the OCREB or the Institution to ensure that the confidentiality and security of the personal health information is maintained in accordance with the Personal Health Information Protection Act (PHIPA), its accompanying regulations, and the Tri-Council Policy Statement.