Research Quality and Compliance
Lawson Health Research Institute’s experienced and skilled administration team assists principal investigators and other research partners in preparing, conducting and completing research to ensure each study meets both internal and external standards and regulations.
Lawson has rigorous approval processes for both basic science research and clinical research.
All clinical research is subject to Research Ethics Board Approval and Lawson Approval. Clinical research applies to any scientist, staff or student involved with human research participants or their data or biospecimens.
- Western University’s Health Sciences Ethics Board (REB): Western University’s Office of Research Ethics manages the approval and monitoring process for human participant research at Lawson.
- Ontario Cancer Research Ethics Board (OCREB): For multi-centre Ontario oncology clinical trials, managed through the Ontario Institute for Cancer Research.
Clinical Trials Registration
According to the International Committee of Medical Journal Editors (ICMJE), clinical trials must be registered with a public registry before the enrollment of the first patient. Registration ensures that key information about every clinical trial whose principal aim is to shape medical decision-making is available to the public, whether it is published or not.
At Lawson, clinical trials must be registered through ClinicalTrials.gov, a service of the National Institutes of Health (NIH) and developed by the U.S. National Library of Medicine.
Regulations and Guidelines
Research at Lawson may be subject to a number of different internal and external policies, depending on the type of research being conducted. Review the related regulations and guidelines.
Standard Operating Procedures
Lawson’s Standard Operating Procedures (SOPs) have been designed to align the work of investigators with clinical research regulations. They are detailed, written instructions to ensure that research is conducted in a manner that protects the rights, safety and well-being of research participants, and the integrity of the research data.
Our SOPs have been authored by the Network of Networks (N2), a not-for-profit incorporated organization and alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity. N2’s SOPs have been developed to be a national standardized set of operating procedures with the goal of developing one set of well-written SOPs that are applicable to any therapeutic area in any given institution of research environment. N2 ensures the SOPs are externally reviewed by an independent expert every two years, or sooner if dictated by changes in the regulations or guidance documents. Lawson Health Research Institute is a member of N2.
Topics support a wide range of clinical research tasks and functions covering all stages of research conduct, including:
- Investigator-initiated studies
- Externally sponsored studies (e.g. industry)
- Study start-up/activation, conduct and closure
- Data Management
- Study database development and maintenance
- Recruitment, screening, Informed consent
- Safety reporting
- Research Ethics Board Submissions and communications
- Confidentiality and Privacy
- Monitoring, Auditing and Inspections
- Document creation and maintenance (e.g. protocols, case report forms, informed consents and manuals)
Anyone conducting clinical research at Lawson is subject to participation in Quality Assurance (QA) Reviews. These reviews are collaborative learning tools that are designed to support the continuous improvement of clinical research processes.
Regular lab audits are completed to ensure that all laboratories associated with Lawson are running safely and efficiently.