(Updated Feb 18th, 2013)
1. It says in the RFA that “This competition is exclusively for research dealing with interventions in human subjects.... Proposals addressing normal brain function, basic disease mechanisms, or animal models of disease are ineligible”. Does this mean that research can ONLY involve interventions in humans with no basic or animal research at all, or can the research also have basic science elements but it MUST include interventions in humans?
Research can only involve human interventions and does not include basic or animal research.
2. I have an idea for a proposal but am not sure if it meets the objectives of the ADRD MIRI program. How can I determine if my topic will be acceptable?
The RFA describes the focus and scope of this competition. If you think your proposal falls within that scope, then Brain Canada encourages you to submit a letter of intent. In the end, only the review committee can determine if your proposal is acceptable or not, and advice offered by anyone else is at best an attempt to guess what the committee will do. Therefore, Brain Canada staff can only confirm that a topic is covered by the scope of the RFA.
3. Can you provide some more detail around the criteria on which LOIs will be evaluated: 'innovation' for example?
We are reluctant to be too prescriptive about these definitions, because ultimately it will be the definition adopted by the Selection Committee that matters. We recommend reading the wording in the RFA very carefully, and if you need additional clarity, the NIH definitions of these criteria, available at http://grants.nih.gov/grants/peer/critiques/rpg.htm#rpg_01 may also be helpful, since many of the reviewers will be familiar with these definitions."
4. What is the definition of alternative medicine?
The working definition of complementary and alternative medicine is that of the NCCAM:"a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine". That's broad and non-specific and we'd prefer to keep it that way, so all interesting letters of intent get a chance to make their case.
5. Are all non-pharmacological interventions (diet, exercise, cognitive training) to be considered alternative?
No, because some exercise and dietary regimens are an accepted part of conventional medical practice. Others, maybe yoga, or ginseng extract, might be considered as CAM. What's important is that a proposed intervention is novel and untried, and founded on a strong scientific rationale: a challenging combination, we recognise.
6. Will surrogate cognitive end points such as neuropsychiatric testing be considered valid endpoints for this competition, rather than progression to dementia? If yes, can Brain Canada provide guidance on the nature of preferred surrogate endpoints.
This is really a matter for the Selection Committee to decide on a case-by-case basis. In general we would say that surrogate endpoints are acceptable if justified by the type of intervention and what is practical and realistic as an endpoint. A recently-issued FDA guidance document offers some sobering advice on what it would consider acceptable endpoints (www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf).
7. Within this RFA, is Brain Canada interested in research which is focused on the dementia which affects about half of people with neurodegenerative diseases such as Parkinson’s and multiple sclerosis?
The RFA is for “ADRD”, and Parkinson’s dementia is generally accepted as related dementia.
8. Research suggests that what potentially distinguishes those Parkinson’s patients who will get dementia, from those who won’t, is how much vascular disease they have. Would this competition welcome a team that focused on the question: If vascular disease aggravates and hastens this dementia, can we demonstrate that we reduce or prevent the dementia by treating the vascular disease?
Certainly, there are strong links between cerebrovascular disease and Alzheimer-type dementia, so if you can make a case for the general application of your proposal, it would certainly be eligible for the competition.
9. Is it necessary for interventions to be nutritional and pharmaceuticals?
Is it necessary to include alternative interventions?
These areas are of special interest for the Chagnon Family, however, the competition is open to proposals that will assess the effectiveness of a range of innovative interventions, including those mentioned in the question. All proposed interventions must have a sound scientific rationale, including adequate evidence of safety in humans, in order to be considered for funding.
10. Are behavioural prevention interventions eligible?
11. Is it necessary for project proposals to have multiple interventions and be multidisciplinary?
It is not necessary that there be multiple interventions in the proposal. It does seem more probable, though that effective interventions, when they are developed, will have several aspects (e.g. behavioural changes plus nutrition plus pharmaceutical).
Multidisciplinarity seems to be a fundamental requirement for a human intervention study in this field. A unidisciplinary team probably couldn’t carry out the required work. The point is that the team and the mix of disciplines and expertise that it represents is what you need to carry out the proposed study.
12. Where a team needs to have an industrial partner manufacture a new drug, is that an acceptable use of funds?
13. Does the proscription of animal studies include toxicity studies?
The RFA states that this competition is exclusively for research dealing with interventions in human subjects. But it seems likely that the Selection Committee will take into account work necessary to ensure that the proposed intervention is safe in humans. Applicants should make the case that any form of pre-clinical testing is absolutely essential, while maintaining a primary focus on the intervention in humans.
14. What is the bar for success in the LOI stage? Will there be any advice to guide the full proposal?
The number of LOI teams to advance to full applications will depend on the number and quality of submissions. The review committee will ultimately determine the threshold for competitiveness in the competition. Applicants will receive comments from the reviewers of the LOI that will help them in the preparation of the full application, if they are invited to apply.
15. What is meant by data sharing?
Simply, data sharing is just making your data available to other investigators. Brain Canada expects at the very least that data generated in the project will get published in the open literature (while taking into consideration temporary restrictions while IP is being protected). If any of your data, published or unpublished, can be deposited in an appropriate archive or database, it should be (for example SNP data in The Single Nucleotide Polymorphisms Database).
16. Can you explain the process that is envisaged for this? Is there a concept of having an intranet or Brain Canada website for the purposes of pre publication exchange of data?
This has been suggested as a possibility. Depending on what and who gets funded, Brain Canada may ask successful applicants to be open amongst themselves and share relevant data, including unpublished data.
17. CIHR is planning a “Canadian Consortium on Neurodegeneration in Aging” (CCNA). How does this relate to this initiative?
It’s important to remember that, as a Federal funding body, CIHR funds are ineligible for matching with the Canada Brain Research Fund. However, there may be collaborative opportunities between teams funded through the Chagnon Family MIRI program and the CCNA. As CIHR noted in a communique issued on January 7th, “the CCNA will support and encourage alignment of complementary research teams supported by other CIHR programs and by other agencies, such as Brain Canada and the Chagnon Family”, so we look forward to the launch of the CCNA and to further details.
18. To what extent is it legitimate to use the first couple of years of the five year funding period to develop interventions?
It seems likely that the more emphasis there is on the actual intervention itself, the more likely it will be favourably viewed by the Selection Committee, as long as the “ready-to-go” intervention has a strong scientific rationale and is safe and ethical.
19. Is there a limit to the number of PI’s or collaborators that can be included on a team?
A team must have two or more members; however, there is no limit to the number of PI’s that can be included. What is important is that the team must include the range of expertise and experience required to carry out the proposed research. It is the applicant’s responsibility to assemble the best possible team, to demonstrate how each team member is essential to the project, and to explain how the team will work together.
20. Can an applicant be listed as a co-investigator on more than one proposal?
Does Brain Canada allow multiple submissions from applicants?
Yes. Brain Canada aims to encourage imaginative proposals from the widest range of multidisciplinary teams possible and does not want to hinder collaborations by placing restrictions on the composition of teams. As such, applicants can submit multiple proposals or be co-investigators on more than one proposal. Obviously, if a team member is a co-applicant on multiple proposals, the Selection Committee will wonder about their ability to attend to all his/her responsibilities.
21. Is it allowable to add/change team members from the LOI to Full application stage?
Yes. Brain Canada recognizes that because of the rapid pace of discovery in the brain sciences, particularly in the ADRD field, there may be changes in the project description or team membership between LOI and full application. Changes that seem to alter the proposal significantly from the description in the LOI will be referred to the Chair of the Selection Committee for a ruling on acceptability. If there is agreement that the revisions have made the application more responsive to assessment criteria, the changes will be accepted. Revisions to proposal direction or team membership that are based on advice from the LOI Selection Committee will of course be accepted.
To view additional FAQ’s about the MIRI application and review process please see (MIRI FAQ’s)