The BC Academic Health Science Network (BC AHSN) is pleased to provide the following update on current activities within the BC AHSN organization, which includes Clinical Trials BC and the BC SUPPORT Unit.
Our update on activities for the month of April includes:
- Harmonized research ethics review finds a home in BC AHSN
- BC positioned for changing clinical trials environment
- Provincial N2 membership renewed
- BC teams shine at Rewarding Success Ideathon
- Clinical research professionals get certified
- BC SUPPORT Unit Northern Centre announces award recipients
BC AHSN is very pleased to announce Board approval to bring the BC Ethics Harmonization Initiative (BCEHI) in-house and support it as an established provincial resource to facilitate transformational health system research that crosses institutional and geographic boundaries.
BCEHI is a collaborative effort among British Columbia’s health authorities and four major research universities, who collectively conduct more than 80 percent of the province’s human subject ethics reviews.
The initiative has spearheaded development and implementation of harmonized models to make the ethics review process more timely and efficient, allowing researchers to submit a single ethics application regardless of the number of BC jurisdictions involved in a project. Harmonization also ensures the consistency and quality of ethics review, in compliance with TCPS-2, across all research ethics boards. Provincial harmonization promises to encourage more multi-jurisdictional health research and make BC a more competitive and innovative health research environment.
Since 2016, the partners have been regularly using harmonized models for minimal risk and above minimal risk studies. A shared technology platform to support an online harmonized ethics review process is currently in development and will launch later this year.
This integration into BC AHSN will provide the sustained staffing and infrastructure required to further develop and expand the provincial approach to research ethics harmonization, including partnering with more organizations. Stay tuned for further communication regarding this resource over the coming months.
Development of the BC Ethics Harmonization Initiative has been supported collectively by the partner institutions, with core funding from the Michael Smith Foundation for Health Research (MSFHR). In 2016, MSFHR provided additional funding to support ongoing management/sustainability and shared platform development.
April 1, 2018 marked the date that new international guidelines for good clinical research practices came into full effect for clinical trials in Canada.
For the past three years, Clinical Trials BC’s Regulatory Officer Jean Smart has been preparing BC investigators and institutions to comply with 26 new and updated requirements issued by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidelines are known as ICH guidance E6 (R2): Good Clinical Practice (GCP).
Initiated as part of the former BC Clinical Research Infrastructure Network (BCCRIN) and now continuing under Clinical Trials BC, province-wide support has included the following:
- Development and launch of a provincial Quality Management System (QMS); in-depth leadership workshops; QMS presentations; and ongoing support.
- Development and launch of a six-part Investigators Only (IO) program to support new investigator oversight responsibilities.
- A workshop, guidance and toolkit on good documentation practices to support records management regulations.
- Provision of the Good Clinical Practice (GCP) group training course and refresher course, as well as access to free online training on GCP via the provincial membership to N2 (Network of Networks).
- New forms and tools.
- Additional resources for more minor regulatory changes (e.g. updates to manuals, existing forms, etc.) and an ongoing workshop series on topics such as validation and risk management are also being planned.
Through Jean Smart’s involvement in international regulatory committees, Clinical Trials BC has extensive knowledge of changes in the regulatory environment and their impact – enabling BC to get ahead of the curve and ensure its competitiveness for attracting leading edge clinical trials.
BC’s clinical research community continues to receive free access to an extensive suite of online resources and training, thanks to the renewal of our provincial membership with N2 Network of Networks.
The provincial membership provides access to N2’s online clinical research tools (such as SOPs), content, and access to CITI Canada courses such as Good Clinical Practice (GCP). N2 also has many Clinical Trial education and awareness resources available for researchers and patients. Access is available without cost to all clinical researchers in BC working in health authorities and academic organizations, as well as to independent investigators.
The provincial agreement with N2 is provided by Clinical Trials BC in partnership with the BC SUPPORT Unit.
Congratulations to the three BC research teams whose pitches at a national “ideathon” in Ottawa have earned them each a $100,000 business case development grant as part of the Rewarding Success Initiative. Launched by the Canadian Institutes of Health Research (CIHR) through the Strategy for Patient-Oriented Research (SPOR), this innovative clinical trials (iCT) funding program is designed to produce interventions that will result in cost savings and/or improved efficiencies in Canada’s health care system. BC’s three successful projects are:
- A BC-wide program for Rural, Remote, and Indigenous communities to Gain Equitable Access to Kidney Transplantation: The BRRIDGE to Transplantation Initiative; led by Jagbir Gill, University of British Columbia
- Implementing and Evaluating ActionADE to Transform Medication Safety; led by Corinne Hohl, University of British Columbia
- Improving Treatment Outcomes and Value for Recurrent Clostridium difficile Infection through a Platform Adaptive Trial; led by Christine Lee, Vancouver Island Health Authority
Rewarding Success is a multi-phased experimental funding model being piloted in BC, Alberta, Manitoba, and Newfoundland & Labrador. Each selected team that advances to the iCT grant phase will receive up to $2.4 million from CIHR over four years. With required 1:1 matched funding from non-federal sources, funding for successful projects will total $4.8 million.
The BC SUPPORT Unit is partnering with CIHR to coordinate the Rewarding Success Initiative in BC, as well as supporting BC teams through the process.
To help build BC’s clinical research workforce, Clinical Trials BC offers financial and resource support for clinical research professionals at BC-based academic research sites to write their professional certification exams.
Congratulations to the following individuals who recently obtained certification from the Society of Clinical Research Associates (SoCRA):
- Nerkeza (Nera) Andjelic, Vancouver General Hospital
- Rebecca Courtemanche, BC Children’s Hospital Research Institute
- Mannie Fan, University of British Columbia
- Rebecca Grey, Vancouver Coastal Health
- Princess (Cess) King-Azote, University of British Columbia
- Nikki Koenig, University of British Columbia/Providence Health Care
- Allison Laing, University of British Columbia
- Genoveva Maclean, Vancouver Coastal Health
- Kerensa Medhurst, BC Cancer Agency – North
- Judy Needham, Providence Health Care
- Jessica Nelson, BC Cancer Agency – Genome Sciences Centre
- Shoshana Parker, Centre for Health Evaluation and Outcome Sciences
- Claudia Piechnik, Vancouver Coastal Health
- Eugenia Wu, University of British Columbia/Vancouver General Hospital
- Cristy Zonneveld, University of British Columbia
Program co-administered by Clinical Trials BC and the Centre for Health Evaluation and Outcome Sciences (CHÉOS).
The BC SUPPORT Unit Northern Centre has announced the recipients of its inaugural Developing Northern Research Collaboration Award, which supports researchers, health care providers, decision makers and patient partners to develop collaborations for person-, family- and community-centred research.
The following five projects have been awarded $10,000 each:
- Envisioning Health with Nadleh Whut’En, led by Sara de Leeuw
- Improving health outcomes for persons in long-term care facilities in northern British Columbia: Development of an intervention study aimed to improve quality of life by enhancing accessibility to the natural environment and horticulture therapy, led by Shannon Freeman
- Access to Care for Women with Complex Pregnancies in Northern BC: Patient Partner Capacity-Building, led by Sheona Mitchell-Foster
- Industry and Health in Northern BC Communities, led by Margot Parkes
- Building a Patient-Oriented Physical Activity Research Framework for Northern BC, led by Chelsea Pelletier