1. Complete mandatory human subjects protection training
The North York General Hospital Research Ethics Board (REB) requires that the investigators and their research staff (research coordinators, research assistants, research team members who have contact with research participants or access to identifying personal health information, volunteers and students) complete training with respect to the Privacy and Security Module for Researchers and Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans(TCPS 2).
Mandatory Privacy and Security for Researchers Module Training:
The research team members should complete Privacy and Security Module for Researchers and submit a hard copy of the signed attestation with the application for REB approval. Keep a copy for your records as it may be used for new studies submitted prior to the one year expiry date.
Mandatory TCPS2 Tutorial Course on Research Ethics (CORE) Training:
This self-paced, free online tutorial consists of eight modules which include case study examples in audio, video and text. Completing this training helps ensure the rights and welfare of human subjects are protected and also gives you important insights that will help you complete the REB application and navigate the REB process.
Access the TCPS 2 tutorial on the Government of Canada website.
Create an account using your North York General Hospital (NYGH) email address (preferred, if you use non NYGH account, please make sure to check your spam folder for confirmation email from TCPS) and enter NYGH as your institution when you are creating your account (mandatory). A printable certificate is generated at the completion of the tutorial. Please attach the copy of your completed certificate along with your REB application package.
The TCPS training is valid for a three-year period, after this time it should be retaken. Investigators must maintain current training for the duration of the project. Contact the REB Office with any questions regarding maintaining your human subjects protection training.
Additional Training Resources — CITI Canada Online Educational program:
NYGH is a member of the Networks of Networks (N2). This membership provides access to a variety of resources including the following online courses:
- Good Clinical Practice (Basic and Refresher French and English)
- Responsible Conduct of Research
- Transportation of Dangerous Goods
- Health Canada Division 5 (French and English)
2. Check dates for REB meetings and submission deadlines
Submit one hard copy and electronic copy of your complete submission to the REB office.
The application package must be received in the REB office no later than 4 p.m. on the first Tuesday of the month for consideration at the REB meeting for that month. See the scheduled dates of Research Ethic Board meetings.
3. Working with ARIEL
ARIEL is a web-based electronic platform for coordinating research ethics review and is built using modern infrastructure which exhibits a vast set of features, while maintaining an easy-to-use interface. ARIEL has been developed in partnership with Infonetica Ltd. This continued relationship ensures that ARIEL will be continuously monitored and maintained to meet the needs of researchers throughout the hospital as well as the REB itself.
ARIEL Home Page
To access the applicant login portal for ARIEL, type the following URL into the address bar of a web browser: https://apply-ariel.nygh.on.ca
Users with an NYGH email account can enter their email address and password to login. Users must have an NYGH email address to use ARIEL.
For pre-existing/ ongoing studies, research teams will need to start with an Ongoing Studies/ Legacy application. Once this submission passes screening and is administratively approved, research teams will be able to submit amendments, continuing renewals, reportable events, and study closures as sub-forms of the Legacy form. Ongoing Studies/ Legacy applications can be submitted for each open study at any time and is required prior to other submissions for each study.
For new studies, research teams will need to submit a pre-authorization for research to proceed to the REB form first. This form goes through the Office of Research and Innovation in ARIEL; and will be processed by the ORI Administrator and ORI Director. Once this submission is approved, research teams will be able to create an initial application for their new study as a sub-form.
ARIEL will help simplify the submission process, and the questions on each application form will vary depending on the answers provided.
ARIEL Instructions can abe found when logged in to ARIEL, under the Help tab at the top of the screen, under Templates. Other useful resources are also available on the Templates page.
NYGH REB members should have received a link to the ‘review’ side of ARIEL.
Please feel welcome to contact the REB Coordinator at firstname.lastname@example.org with any questions.
4. Preparing the REB application package
All research projects involving humans or their data that are performed under the auspices or within the jurisdiction of NYGH require (1) approval by the Research Ethics Board (REB) and (2) institutional authorization by the VP, Medical & Academic Affairs, which is delegated to the Director, Research & Innovation (R&I).
The first step is for the leader responsible for the project at NYGH, called the NYGH Principal Investigator (PI), to complete the “The Pre-Authorization for Research at NYGH form “ and submit it by e-mail to email@example.com. When the form, signed by the Director, R&I, is returned by e-mail, the project is pre-authorized to proceed to REB review.
The e-mail response will also indicate whether additional steps are required for institutional authorization after REB approval, such as data sharing agreement, access medical records, etc. The REB will not consider an application that omits a signed pre-authorization form.
A complete REB application package includes the following:
- Signed R& I Pre-authorization for Research Form
- REB Submission Checklist
- Mandatory Privacy and Security for Researchers Module Completion Attestation(s) and TCPS completion certificate(s).
- Toronto Academic Health Sciences Network (TAHSN) Human Subjects Research Ethics Application
- Chart Review Studies - For retrospective chart review, use Toronto Academic Health Sciences Network (TAHSN) Application to Access Retrospective Data for Research purposes — Chart Review Application
Please ensure all required signatures are in place on the TAHSN form before submission.
- Study protocol
- Informed Consent Form, if applicable
- Supplementary materials, if applicable (i.e. questionnaires, assessment tools, advertisements for recruitment, documentation from other REBs, case report/data collection forms, interview guide, telephone script, Data safety Monitoring Board [DSMB] Charter)
- Investigator's brochure or product monograph (for studies regulated by Health Canada)
- No Objection Letter (NOL), Investigational Testing Authorization (ITA) or Notice of Authorization (NOA) for studies regulated by Health Canada
- Study Budget
All REB submissions must be typed. Applications submitted on outdated forms or incomplete application packages, will be returned to the investigator which may result in a delay of the REB review.
The REB's Forms and Guidelines page contains the most current forms.
4. Need help?
Contact the office for guidance with completing REB applications or for clarification regarding any information posted on the research ethics web pages:
T: 416-756-6444 ext. 3485