Investigator Initiated Research (IIR)
Canopy Health Innovations (Canopy Health) is committed to understanding the therapeutic potential of cannabis. Through our research programs, our aim is to create natural plant-based medicines and health products derived from cannabis to improve the quality of life for those affected by acute and chronic illness. Our primary research area is within neuroscience.
We aim to support applicants who are rigorous with their research and committed to advancing cannabinoid science. If you would like to collaborate with us, please complete the request for an Investigator Initiated Research Initial Application (IIR-A). We appreciate your interest and look forward to reviewing the submission.
Type and Nature of Support
Canopy Health may support projects financially or through product provision, including placebo material, so long as the proposed request meets the following guidelines:
- Deemed to be aligned with the current research interests at Canopy Health, determined by a case-by-case review.
- Novel and interesting research, or research that complements what is currently being undertaken at Canopy Health.
- The study must not have started.
- The project meets all regulatory and ethical guidelines enforced in the study country, with patient and subject safety being paramount.
Canopy Health will not consider requests for the following activities:
- Training or instruction for investigators or team members.
- Travel costs.
- Regularly scheduled operational costs.
- Construction costs for the institution or organization.
- Product supply, technology, or equipment that would be sold to generate revenue or profit.
To determine eligibility, a request for an IIR-A must be completed and submitted. It is important that the IIR-A and request not include any sensitive or confidential information. Should the IIR-A be accepted, a Mutual Confidentiality Agreement or Non-Disclosure Agreement will be put in place for subsequent discussions and submissions, including the IIR Full Submission (IIR-B).
Proposed projects, investigators, and team members must meet the following criteria for eligibility:
- The proposed study must meet all rules, regulations, and ethical principles outlined in, but not limited to the Declaration of Helsinki and Good Clinical and Laboratory Practices.
- Must follow applicable laws, rules, and regulations in the study country.
- Necessary documentation for the proposed study must be approved and in good standing before the study begins, including but not limited to a complete Study Protocol, Research Ethics approval, Regulatory Response Documents, Section 56 Exemption from Health Canada, and Standard Operating Protocols (SOP’s).
- If necessary, the Principal Investigator (PI) must also hold and have medical licenses in good standing with appropriate institutions in the study country.
- The PI and team members must be able to prove their experience with clinical or laboratory research and must be able to speak to their knowledge in the proposed area of study. This may include submission of a curriculum vitae as part of the second application.
IIR studies operate independently of Canopy Health and its associated companies. Canopy Health will not solicit or instigate the application of IIR. No member of the Canopy Health team will direct the aims, hypotheses, design, or operational activities of the approved study. However, employees at Canopy Health and its associated companies (Canopy Growth Corporation and Canopy Animal Health) may comment on any aspect of the proposed study to ensure it is safe, based on sound principles, and has sufficient background literature to support its aims. The supply of Canopy Health products will be discussed prior to the study being approved, based on (and not exceeding) market value.
The applicant is responsible for all elements of the study, including but not limited to study design, execution, recruitment, meeting milestones, data gathering and analysis, and dissemination of the results. It is the responsibility of the PI to ensure that local laws, rules, and ethical regulations are followed during the study. It is the applicant’s responsibility to communicate the progress of the study on a mutually agreed upon schedule with Canopy Health.
It is expected that any research conducted with Canopy Health and its associated companies will:
- Ensure patient safety at all times. Should any issue arise and a research patient be subject to danger in any form, the PI must contact Canopy Health within 12 hours.
- Ensure all study products and technologies are handled appropriately.
- Will be transparent with the SOP’s and any financial documentation needed by Canopy Health or its associated companies.
- Not advertise, market, or sell Canopy Health products or associated study technology outside the proposed study, to the public, or other investigators. Should the organization or PI wish to publicize their relationship and study with Canopy Health, it must first be approved by Canopy Health.
Canopy Health retains the right to terminate a project at any time if there is deviation from the Study Protocol, Regulatory Documents, undisclosed elements of the study, or if the study does not comply with local regulations or laws.
- Step 1: Ensure the team or organization meet the Eligibility requirements and agree to the Expectations outlined above.
- Step 2: Complete the request for an IIR-A. Canopy Health will send the IIR-A within 5-10 business days.
- Step 3: Follow the instructions to complete and submit the IIR-A. If approved, Canopy-Health will be in contact to discuss the process for an IIR-B.
- Step 4: Complete and execute Confidentiality Agreements and/or Non-Disclosure Agreements.
- Step 5: Canopy Health will send guidelines for an IIR-B.
- Step 6: Follow the instructions to complete and submit the IIR-B. Wait for feedback.
- Step 7: Should the application be accepted, Canopy-Health may request additional documents, including but not limited to a Research Collaboration Agreement.