Guidelines
All SCN research must be undertaken in accordance with the terms and conditions of the Network agreement. While investigators are expected to be familiar with the agreement three areas where questions frequently arise are as follows:
1. Finance rules
All Stem Cell Network research grants must adhere to CIHR funding guidelines unless specific written permission has been received to apply NSERC or SSHRC guidelines instead. The guidelines for CIHR, NSERC and SSHRC are included in the Use of Grant Funds guide, which includes specific reference to financial adminstration rules as they pertain to each of the Tri-Council.
2. Human pluripotent stem cells regulation (including human embryonic stem cells)
In Canada, the Guidelines for Human Pluripotent Stem Cell Research (updated June 30, 2010) apply to all research involving human pluripotent stem cells that is funded by the Agencies (CIHR, NSERC, SSHRC), or is conducted under the auspices of an Institution that receives any Agency funding.
3. Publication of SCN funded research
SCN expects funded investigators to disseminate their research findings through peer-reviewed publications such as journals, manuscripts and books to maximize the impact and utility of their work. When acknowledging SCN as a source of funding in publications please refer to the Network as “the Stem Cell Network” or use the following statement: This research was supported by a research grant from the Stem Cell Network.
4. Clinical trials policy
One of SCN's core mandates is to bridge the gap between basic research and clinical trials, and over the past years several SCN-funded research projects have moved into early phase clinical trials for diseases as diverse as stroke, pulmonary hypertension, corneal replacement and neuroblastoma. SCN funding has been used to support translational basic research and proof-of-concept experiments in small and large animal models prior to human studies, as well as infrastructure costs of cell processing facilities. SCN funding has never been used to support the direct patient costs of such trials.
On March 26, 2010, the SCN Board reaffirmed that SCN funds must not be used to support direct patient costs of clinical trials. The decision flows from a number of factors including the distinct mandate of the NCE program versus CIHR, the likely inconsequential impact of such an investment given the large funding required to support a clinical trial, and the Network's capacity to assess, manage and defray the risks inherent in funding this type of research.
While SCN is unable to provide direct funding for clinical trials, Clinical Trials Committee (CTC) remains available to Network members to offer constructive advice in the preparation of clinical trial applications to Health Canada or the FDA. Members of the CTC include Dr. Gary Levy (UHN), Dr. George Daley (Harvard), Dr. Bartha Knoppers (McGill), Dr. Laurie Zoloth (Northwestern), Jill Sheedy RN (UHN) and Dr. Michael Rosu-Myles (Health Canada).
If you have any questions or concerns about this policy, or would like to gain input from the CTC, please contact Drew Lyall at dlyall@stemcellnetwork.ca.