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Process for Research Studies Conducted at Niagara Health

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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 partnered with Hamilton Health Sciences (HHS) 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. 

Hamilton Health Sciences reviews, drafts and negotiates research agreements on behalf of 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

NH = Niagara Health; PI = Principal Investigator; HHS = Hamilton Health Sciences

Step 1

Task: Complete Mandatory Research Training

Responsible Party: NH PI and study team

Resource: New Niagara Health Researcher Guidance Document

Step 2

Task: Complete Contract Request Form 

Step 3

Task: Send contract to researchagreements@hhsc.ca  with a CC to Barbara.Wiinholt@niagarahealth.on.ca

Include the following information: 

  • Name and contact information of the person responsible for review and negotiation of the agreement at the sponsor or collaborator level
  • Highlight any concerns or questions you may have around publication, intellectual property, liability or budget
  • Highlight any timelines if there are urgent turn-around times required
  • If you are submitting on behalf of another investigator please include his/her name in the submission
Responsible Party: Funder or Sponsor (note that the NH PI or NH may be the Sponsor)

Resources: Tips and Tricks for Research Budget Review (courtesy of Hamilton Health Sciences)

Note: 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: HHS and all parties to the contract

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
  • ICH GCP
  • CITI Privacy Training
  • NH Privacy Training
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
  • ICH GCP
  • Division 5 of the Canadian Food and Drug Regulations
Every two (2) years
Every two (2) years
Retrospective studies not involving human subjects
  • CITI Privacy Training
  • NH Privacy Training
  • McMaster Privacy Tutorial
Every two (2) years
Annual
Studies involving humans sponsored by any of the Tri-Council Agencies of Canada (CIHR, NSERC, SSHRC)
  • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2)
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 Elaina Orlando, Research Manager, Elaina.Orlando@niagarahealth.on.ca or 905-378-4647 ext: 44544

TCPS2

https://tcps2core.ca/

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 Chris Henderson, Manager Learning Management System (LMS) & Policies, Christopher.Henderson@niagarahealth.on.ca  or 905-378-4647 ext. 33030

HIREB Process for Retrospective Review of Medical Charts & Health Data

Please follow the steps found in the HIREB Process for Retrospective Review of Medical Charts & Health Data document here.

HIREB Process for General Research Application

Please follow the steps found in the HIREB Process for General Research Application here.

 

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