Niagara Health ensures that all research is performed ethically, and in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
Niagara Health has entered into a service agreement with the Research Institute of St. Joe’s Hamilton to provide support to researchers entering into contracts to conduct research. Niagara Health has also centralized ethics review for clinical research and clinical trials under the Hamilton integrated Research Ethics Board (HiREB). HiREB is also one of Clinical Trials Ontario (CTO) qualified review boards.
The Hamilton integrated Research Ethics Board (HiREB) is a collaboration of St. Joseph's Healthcare Hamilton, Hamilton Health Sciences and McMaster University's Faculty of Health Sciences. To view the required documentation and information, please visit the HiREB website.
HiREB requires proof of completion of Good Clinical Practice training in order to gain approvals. There are links to these modules on the Research Institute of St. Joe’s Hamilton website.
The Research Institute of St. Joe’s Hamilton reviews, drafts and negotiates research agreements on behalf of affiliated Researchers, including: Non-Disclosure Agreements (Confidentiality Agreements), Data Transfer Agreements, Material Transfer Agreements, Research Study Agreements, Clinical Trial Agreements and Service Agreements.
Please follow these steps when submitting research projects with Niagara Health.
Research Agreement Review Process
H = Niagara Health; PI = Principal Investigator; RSJ-H = Research St. Joes’s – Hamilton
Step 1
Task: Affiliate with RSJH
Responsible Party: NH PI
Resource: New Niagara Health Researcher Guidance Document. Any inquiries regarding the contract review process please contact: researchcontracts@stjoes.ca
Step 2
Task: Complete Mandatory Research Training
Responsible Party: NH PI and study team
Resource: Please see further comments below in training section of this document
Step 3
Task: Upload contract for review or request contract be drafted through the RSJ-H portal
Responsible Party: Funder or Sponsor (note that the NH PI/NH may be the Sponsor)
Resource: https://rsjh.ca/contracts/
The contract should be discussed and reviewed in partnership with the Niagara Health Program Director, Manager and Department Chief.
Step 4
Task: Review and negotiate contract
Responsible Party: All parties to the contract and RSJH
Step 5
Task: Bind contract by signing
Responsible Party: Authorized signatory from each party to the contract. Note: this usually includes the NH PI signing in their personal capacity
Resource: The contract is to be shared and approved by the Niagara Health Program Director, Manager and Department Chief.
Step 6
Task: Archive of Contract
Responsible Party: All parties to the contract
Finance Account Opening Process
Step 1
Task: Obtain all documents:
- REB approval
- Fully executed contract
- Receive cheque
Responsible Party: NH PI
Step 2
Task: Complete Finance Account Opening Form and attach cheque
Responsible Party: NH PI
Website link: NH Account Form. Complete form and attach cheque to NH Finance Department
Step 3
Task: Provide Account number and open Research Finance Account
Responsible Party: Finance Department
Mandatory Research Training
| Type of Study | Required Training | Duration |
| Clinical studies that require approval from a Research Ethics Board (REB) and require the use of patient chart(s) (e.g. Meditech) and/or identifiable information |
|
Every two (2) years Every two (2) years Annual |
| Clinical studies that require approval from a Research Ethics Board (REB) and are regulated by Health Canada |
|
Every two (2) years Every two (2) years |
| Retrospective studies not involving human subjects |
|
Every two (2) years Annual |
| Studies involving humans sponsored by any of the Tri-Council Agencies of Canada (CIHR, NSERC, SSHRC) |
|
Every two (2) years |
*Should research studies fall under more that one of the categories listed, both categories’ required training must be completed.
ICH GCP = International Council of Harmonisation Good Clinical Practice
CITI = Collaborative Institutional Training Initiative
NH = Niagara Health
TCPS2 = Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
CIHR = Canadian Institutes of Health Research
NSERC = Natural Sciences and Engineering Research Council of Canada
SSHRC = Social Sciences and Humanities Research Council of Canada
Training Modules can be Located as Follows:
| Training Module | Location | Contact |
|
ICH GCP Division 5 Privacy |
https://about.citiprogram.org/en/homepage/ HiREB requires proof of completion of Good Clinical Practice (GCP) training in order to gain approvals for clinical research. GCP training for certification or recertification is available free of charge through the Collaborative Institutional Training Initiative (CITI), link above. |
Accessing CITI Program Training For more information, please contact Adam Weerdenburg, Research Quality Assurance Officer at RSJ-H, aweerden@stjoes.ca or at 905 522 1155 ext. 35280 |
| TCPS2 |
Our institution ensures that all research is performed ethically, in accordance with the Tri-Council Policy Statement (TCPS): Ethical Conduct for Research Involving Humans. The Tri-Council Policy Statement online tutorial can be found at the link above. TCPS provides an excellent foundation on the ethical principles of research involving humans. |
|
|
Privacy |
http://ethics.mcmaster.ca/chart/ All investigators (including students and research personnel) conducting review of health records as part of their research are required to provide evidence of training for privacy protection of human subjects prior to submission of HiREB applications. This requirement for training may be met by completing the brief web-based program found at the link above. Upon successful completion of the tutorial, print a certificate for your own record and enter the certificate number in the appropriate place on the HiREB application. |
Please send questions or comments about the tutorial to the Research Ethics Officer |
|
Privacy WHMIS |
LERNH – Niagara Health e-Learning Management System | For more information, please contact Eva Ayers, Manager Learning Management System (LMS) & Policies, eva.ayers@niagarahealth.on.ca or 905-378-4647 ext. 33030 |
