In March 2020, Northern Health began pausing research and evaluation activities, with some case-by-case exemptions.
Northern Health is implementing a multi-phase approach, in alignment with provincial requirements and public health guidance, to resume clinical services and access to facilities with a focus on safety, standards and maintaining capacity to respond to potential future waves of COVID-19.
Approval process for research studies at Northern Health requires the following to proceed:
- Research Ethics Approval given by Northern Health Review Committee
- Northern Health Operational Approval
- An approved NH Information Sharing Agreement (ISA), when the study requests disclosure of personal information (identifying or de-identified)
- An approved NH Privacy Impact Assessment (PIA), when the study requests to implement new technology or change existing technology
The principal investigator (PI) is required to complete a NH ISA or NH PIA and submit it to NH Privacy. NH Research will facilitate PI engagement with appropriate NH stakeholders.
Research ethics and operational approvals can be pursued simultaneously. Once the conditions for all necessary approvals are met, the Research Review Committee will issue the Northern Health Authorization Letter that will be emailed to the principal investigator and the Northern Health managers who provided operational approval for the research. Only after receiving the Northern Health Institutional Authorization Letter the study can commence.
NH Research Process Map
Research process map (PDF)
Northern Health logo use: Do not include the Northern Health logo on study materials unless the Principal Investigator’s primary appointment is with Northern Health. Northern Health staff or clinical residents who are undertaking research for academic purposes should only use the logo of their academic institution. If the research is funded by Northern Health the logo is permitted on research materials.
NH Ethics Service provides support to NH staff, patients or clients, families and investigators in four CORE areas: Clinical, Organizational ethics, Research ethics, and Education.
Regarding Research Ethics, NH Ethics Service strives to ensure the ethical acceptability of all scientific studies conducted under the jurisdiction of NH in order to protect the research participants, the researchers and the organization. This responsibility is fulfilled through the Research Review Committee (RRC).
NH RRC reviews applications for research that involves NH staff members, patients or clients, data, or facilities.
The Committee follows NH Research Policy and Principles, the Freedom of Information and Protection of Privacy Act (FIPPA) and the (TCPS-2)Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
NH RRC members, listed below, are employees, physicians, and community members skilled in diverse fields relevant to the type of scientific studies conducted at NH.
- Esther Alonso-Prieto, PhD, Bioethics, Clinical Research, Qualitative Research, NH (Chair)
- Farzana Amin, PhD, Clinical Research, NH
- Marcelo Bravo, PhD, Patient-Oriented Research and Knowledge Translation, NH
- James Bruce, RPN, Mental Health, Substance Use, NH
- Kaitlyn Greer, MSIT, Information Management and Governance, NH
- Damanpreet Kandola, PhD, Health Services, Patient-Oriented Research, Rural Health, and Knowledge Translation, NH
- Ron Klausing, Data Privacy, NH
- Roseann Larstone, PhD, Indigenous Health, NH
- Rutendo Madzima, Patient Partner
- Kerensa Medhurst, MA, Clinical Trials and Cancer Research, Public Health and Disease Prevention, Mental Health, Substance Use, NH
- Ms. Linda Nelson, Patient Partner
- Robert Pammett, M.Sc., Clinical Research, Practice Based Research, Pharmacy, NH
- Joanna Paterson, M.Sc., Mental Health, Substance Use, NH
- Rai Read, M.Sc., Mental Health, Seniors Health, Substance Use, NH
- Rebecca Sketchley, MA, BSW, RSW, Qualitative Research, Marginalized and Vulnerable Populations, NH
- Philip Smith, Community Partner
- Esther Stewart, Patient Partner
- Diane Suter, PhD, Community Partner, Scientific Methodology
RRC meeting dates and deadlines:
Deadlines for submissions to RRC full board review are strictly observed. The RRC meets on the last Friday of every month, except December. Applications should be received by noon, 15 days before the meeting. Any applications received after the deadline will be deferred to the next meeting date.
|2022 Submission deadline||2022 Meeting date|
All studies must have approval to conduct research at Northern Health from the Manager/Director of each department who has appropriate authority to assess the impact and to support the dedication of resources (e.g., human or financial resources, space in the facility) to the research (if applicable).
In addition to assessing the impact and dedication of resources, the Manager/Director will consider the benefits of the research and how the results can be used in Northern Health.
To obtain operational approval, complete the Operational Approval Form (PDF) and submit it to email@example.com. This form contains information about the roles and responsibilities of the researcher and the Northern Health operational approvers.
Please note that the operational approval process will be conducted by the Research Engagement Team. Investigators are not required to contact the operational approvers and obtain signatures.
The NH Privacy Office is committed to research activities and is engaged as part of the research review and approval process.
Information Sharing Agreements (ISA)
When a research study requests disclosure of personal information (whether the information identifying or de-identified), a NH ISA is required. An ISA includes the terms and conditions by which NH requires the study to safeguard the information being disclosed, along with destruction timing, transfer protocols, and information included. An ISA for de-identified information is simpler than the more detailed ISA required for disclosure of identifying information.
- Sample ISA template for de-identified information (PDF)
- Sample ISA template for identifying information (PDF)
- NH ISA process steps (PDF)
Privacy Impact Assessment (PIA)
When the study requests to implement new technology or change existing technology, a NH PIA is required. Northern Health uses a PIA to evaluate privacy compliance issues, privacy risks and related mitigations before the initiative is launched. NH still requires a PIA even if no personal information is involved.
Please contact NH Privacy to schedule an orientation to the NH PIA template. After orientation, a current copy of the PIA template will be provided.
- NH PIA process steps (PDF)
You may access, privacy definitions - personal information, for insight on NH privacy definitions related to personal information.
It is expected that the requirement for an ISA or PIA has been identified during Ethics or Operational approval activity. If there is a need to contact NH Privacy outside of that process, you may do so by sending an email to Privacy@northernhealth.ca.
A clinical trial (a form of clinical research) is any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies. Clinical trials may also include questions that are not directly related to therapeutic goals – for example, drug metabolism – in addition to those that directly evaluate the treatment of participants.
- Tri-Council policy statement: Ethical conduct for research involving humans – Chapter 11: Clinical trials
Northern Health holds a monthly Clinical Trial Advisory Group meeting (CTAG). These meetings bring together specific expertise to discuss the feasibility of the study to go forward to ethics and NH operational approval.
Submission to monthly CTAG meeting:
- Two weeks prior to monthly CTAG meeting (last Tuesday of every month)
- Qualified Principal Investigator to present and answer questions at the CTAG meeting
- Prior to meeting must complete training requirements, provide Clinical Investigational Plan (CIP) and other supporting documents (informed consent form, operational challenges, etc.)
Qualified Principal Investigator training and information required:
- GCP- ICH certification through CITTI
- TCPS2 certification
- Curriculum vitae (current, signed and date)
- License numbers
- Additional training may be required as necessary by protocol
Clinical Investigative Plan (CIP):
1-2 page summary document to include:
- Clinical investigative plan number
- CIP title
- Short title
- Sponsor: Principal investigator
- Primary endpoint
- Study population
- Local recruitment population
- Involved NH department(s)
- Summary background
- Discussion points
- Any other questions or concerns
Important: Engage early, you don’t have to wait until you have ethics approval to engage with the CTAG.
For more information and submissions to the CTAG, please contact firstname.lastname@example.org.
If your research requires ethics approval from multiple organizations (e.g., Universities and Health Authorities) in BC, you may be able to proceed with a Harmonized ethics review process.
Ethics review of joint research projects involving Northern Health and external organizations in BC (e.g., Universities, including UNBC, and Health Authorities) are to be completed through the harmonized ethics review process using the PREP (RISe) platform. Learn more at Research Ethics BC.
If you obtain research ethics approval through a Harmonized Ethics Review, your study will still require operational approval before it can proceed in Northern Health.
For operational approval, complete the application for Operational Approval Form (PDF) and submit it to email@example.com. You can pursue research ethics approval and operational approval simultaneously.
- Canadian Institutes of Health Research (CIHR)
- Natural Sciences and Engineering Research Council of Canada (NSERC)
- Social Sciences and Humanities Research Council (SSHRC)
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2)
- National Council on Ethics in Human Research (NCEHR)
- Canadian Association of Research Ethics Boards (CAREB)
- Alberta Research Ethics Community Consensus Initiative (ARECCI)
- Ethics at the Canadian Institutes of Health Research (CIHR)
- CIHR Ethics
- National Aboriginal Health Organization (NAHO)
- Canadian Institutes of Health Research (CIHR)
- Institute of Aboriginal People's Health (IAPH)
- CIHR Guidelines for Health Research Involving Aboriginal People (2007-2010)
- Freedom of Information and Protection of Privacy Act Province of British Columbia (FOIPPA)
- The entire FOIPP Act
Ethics review of joint research projects involving Northern Health and external organizations in BC (e.g. Universities, including UNBC, and Health Authorities) are to be completed through the harmonized ethics review process using the PREP (RISe) platform. Learn more at Research Ethics BC.
UBC and the Health Authorities have developed a process for ethical review of these resident, intern and summer medical student research projects.
Refer to the UBC Guidance Note (posted under both the UBC BREB and CREB) for the initial application review process involving studies in Northern Health. The process involves an initial application to the UBC RISe system that will be reviewed by both UBC and Northern Health, and the completion of the Operational Approval Form (PDF) to be submitted to firstname.lastname@example.org.
You can pursue research ethics approval and operational approval simultaneously.