Process for Research Studies Conducted at Niagara Health

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

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

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 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

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

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