Applicant questions and answers
- Eligibility
- Funding
- Preparing an application
- Compounds
- Assessment
- Intellectual Property
- Ethics and governance
- Communications
- Other
Eligibility
1. Who is eligible to apply?
A: The Principal Investigator must be a UK-based researcher at an eligible institution (although Co-Investigators on the application can be international), or at an overseas establishment supported by the MRC.
2. Is my UK institution eligible?
A: Eligible organisations fall into three categories:
- UK Higher Education Institutions (HEIs)
- Research Council Institutes
- Independent research organisations (IROs)
The normal MRC eligibility rules apply; please see the applicant’s handbook and the Research Council UK website.
3. Is there a limit to the number of applications I can submit?
A: Individuals may be the Principal Investigator on only one application, but may act as a Co-Investigator on any number of applications. However, please note that the assessment will consider the level of engagement of Principle Investigators and Co-Investigators with the research and their capacity to meet these requirements.
4. Can MRC units and institutes apply under this call?
A: Yes. Any award to a MRC unit/institute would be made on the basis of 100 per cent directly incurred costs only and would not include indirect or estates costs.
5. Can I submit research which has previously been submitted to an MRC Research Board or Panel and was not funded?
A: Applications previously declined by the MRC or another Research Council will not be considered by the MRC within 12 months (from the date of submission to the original Research Council, as either an outline or full application) unless substantially revised.
6. Are there any scientific areas that are outside the remit of this call?
A: There are three areas of investigation that are outside the remit of this call:
- utilising compounds for ophthalmological use
- utilising compounds for dermatological use
- using multiple compounds for screening
7. If my application doesn’t fit the call remit, what options do I have?
A: If your application does not fit the remit of this call, but is within the broader sphere of MRC interest, then you may apply via other normal funding mechanisms. Please see ‘Available grants’ for more information.
8. Can I submit an application for this call which is in collaboration with another company?
A: Research proposals that are led by commercial entities are not eligible. However, applications may include collaborations with third commercial parties under the relevant agreements. Agreements will need to be in place prior to submission of full applications.
Funding
9. How much funding is available under this call?
A: The MRC has allocated up to £10 million for this call. AstraZeneca may offer to fund a project in its entirety if, based on the outline proposal, it considers that route to be the most appropriate funding mechanism for that individual study. In such cases, following feedback from MRC, these will be taken forward through direct collaboration with AstraZeneca without any further MRC involvement. Applicants who do not wish to accept this offer may continue to seek MRC support through the Call if successful at outline stage.
10. What is the expected duration of the grants under this call?
A: Depending on the nature of the research it is expected that most grants would be between 2-3 years.
11. Are applications under this call value limited?
A: No. Awards under this call will not be limited. However applications are expected to be appropriately costed and all resources requested adequately justified.
12. What start date/when will funds and compounds be available from?
A: Grants are expected to start as early as possible and no later than 6 months after the awards have been announced. Compounds will be available after a Material Transfer Agreement and relevant contracts and agreements have been signed between the applicant and AstraZeneca.
13. Will the application attract full economic costs (FEC)?
A: Yes, the application will need to be submitted on a FEC basis.
14. Will awards be pruned?
A: Only under exceptional circumstances will an award be pruned. Therefore it is important that applications are appropriately costed and represent clear value for money. If the Review Panel decide that the research proposed is not feasible given the requested resources it is likely that the application will be rejected.
15. When will the awards be announced?
A: Awards will be announced following the review panel in October 2012.
Preparing an application
16. How do I apply?
A: All applications must be submitted using the Research Councils’ Joint electronic Submission (Je-S) System. Applicants should refer to the general guidance for applicants (on Je-S Help), the Call Guidance and MRC standard terms and conditions.
17. Is there an outline stage?
A: Yes. All applicants must submit an Outline application via Je-S.
18. When is the deadline for submission of the outline proposals?
A: Outline applications must be submitted to the MRC no later than 4pm on the 2nd February 2012.
Please note that clicking ‘submit document’ on your proposal form in Je-S initially submits the proposal to your host organisation’s administration, not to MRC. Therefore, please allow sufficient for your organisation’s submission process between submitting your proposal to them and the call closing date.
19. My organisation is not registered to use the Je-S system.
A: Please contact the J-eS helpdesk as soon as possible with details of your organisation and the grant scheme you wish to apply for.
20. What is the page limit for the case for support?
A: Outline Applications must be submitted using the Outline Application Form. The Case for Support is to be included in Section 4 of the Application form and must be no more than 3 pages including references using Arial 11pt typeface.
21. Can I create my own case for support document as I would for a normal research grant?
A: No, only applications that use the Outline application form will be accepted.
22. Can I include annexes in my application?
A: Applicants may only include the attachments, as separate documents, outlined in the Guidance.
23. What happens if my application is received after the deadline?
A: Any proposals received after the deadline will not be eligible for this call and will be declined.
Compounds
24. What level of information about the compounds will I receive before I write a) the outline and b) the full proposal?
A: At the Outline stage applicants will have access to the following compound information:
- brief description of action
- original development indication
- safety, tolerability and adverse events of the compound
- pre-clinical pharmacology
- previous use in clinical studies (if conducted)
- exclusions/restrictions to future studies
Following the outline stage, AstraZeneca will provide applicants with more comprehensive information about the compound that the applicant proposes to use in their research, under confidentiality if required.
25. If my proposal is successful, will AstraZeneca assure that they provide the amount I need and for the entire duration of the project?
A: AstraZeneca will supply sufficient compound for successful grants. However, AstraZeneca shall have no further obligations to supply compounds beyond the duration of the awards.
26. What if my proposal requires development of an alternative formulation?
A: The proposal will be considered, although the merits of the proposal will need to be assessed against the feasibility for AstraZeneca to prepare an alternative formulation.
27. Are these AstraZeneca compounds in active development?
A: The compounds are currently deprioritised.
28. Which compounds are safe in to use in man?
A: The majority of the compounds have been tested in man and all of the compounds referenced as “clinical or preclinical” have been assessed as having a safety profile consistent with further clinical evaluation. It is possible that some of those labelled ‘preclinical’ may be evaluated in clinical studies under certain circumstances, e.g. lower doses, shorter durations of therapy and/or different patient populations. However, the risk/benefit for any proposals will need to be assessed on a case by case basis to ensure that patient safety is protected. Further information on the compounds is available here.
29. Is there a limit to how many compounds I can request in my application?
A: There is no limit as to how many compounds can be requested in an application. However, two of the criteria that proposals will be judged against are feasibility and novelty of idea and therefore the use of multiple compounds will need to be adequately justified.
Applications that propose screening of multiple compounds are not within the remit of this call.
Assessment
30. How are proposals assessed?
A: At the Outline stage, applications will be reviewed by a Panel comprising cross-MRC Board, MRC and AstraZeneca representation. AstraZeneca will be represented on the panel at this stage in order to identify those proposals that lie outside the scope of current core AstraZeneca development plans and do not replicate previous or existing company studies. At this stage, following feedback from MRC, AstraZeneca may offer to fund a project in its entirety if it considers that route to be the most appropriate funding mechanism. In such cases, these will be taken forward through direct collaboration with AstraZeneca without any further MRC involvement. Applicants who do not wish to take up this offer may continue to seek MRC support through the Call if successful at Outline.
Additionally, projects which are considered by MRC and AstraZeneca to fall within current development pathways for the company will not be eligible for MRC funding. In such cases, applicants may discuss with AstraZeneca the possibility of direct funding.
At the Full proposal stage, applications will be sent out for international peer review and assessed by an independent review panel convened by MRC. This panel will make the final funding decisions. Full proposals will be assessed on the standard criteria for an MRC research grant. There will be no AstraZeneca involvement in the review of the full proposals or decision on funding.
31. Will AstraZeneca be involved in the research proposal other than providing compounds?
A: If a proposal is successful following the Outline stage it is expected that applicants will work closely with AstraZeneca in putting together the full application. AstraZeneca will be co-applicants on the full application.
32. Will I need to complete a MICA form?
A: MICA forms will not need to be completed for the Outline stage. All applicants invited to submit a full proposal will need to complete a MICA form as the full applications will be collaborative proposals with AstraZeneca. Please refer to the additional guidance for submitting MICA proposals which can be found here.
33. Does AstraZeneca have a final say on which proposals are funded?
A: There will be no AstraZeneca involvement in the review of the full proposals or decision on funding.
34. Will the applicant be given the opportunity to respond to the panel?
A: Applicants will be able to respond to reviewers comments following submission of a full proposal. Applicants however, will not be allowed to respond to the Panel. The Panel’s decision is final.
35. What happens if MRC receives two or more proposals with the same idea requesting the same compounds?
A: All proposals will be judged in open competition.
Intellectual Property
36. What about Intellectual Property (IP) rights?
A: AstraZeneca will retain the IP over the chemical composition of matter for the compounds. Ownership of, and access to results and intellectual property generated during the grant will be negotiated between AstraZeneca and the Researcher/Sponsor and will be based upon the Lambert Model Agreements for Pre-clinical Studies and the model Industry Collaborative Research Agreement (miCRA) for Clinical Studies as appropriate.
37. How is my IP/know-how going to be protected at the outline stage?
A: A confidentiality agreement has been signed between MRC and AstraZeneca to ensure that investigators intellectual property is protected. For successful applicants invited to submit full proposals investigators will need to sign individual confidentiality agreements with AstraZeneca.
38. What IP rights do I have?
A: The investigator will retain all rights to any IP that is proposed prior to any collaboration with AstraZeneca. Ownership of and access to results and IP generated during the grant will be negotiated between AstraZeneca and the Researcher/Sponsor and will be based upon the Lambert Model Agreements for Pre-clinical Studies and model Industry Collaborative Research Agreement (miCRA) for Clinical Studies as appropriate.
39. What right to/level of access is there to AstraZeneca’s IP?
A: AstraZeneca will retain its background IP relating to the compounds including IP covering the chemical composition of the compounds. As outlined above, ownership of any IP generated during the award will be negotiated between AstraZeneca and the investigator.
40. How can I protect my IP from being used throughout AstraZeneca?
A: At the Outline stage investigators IP will be protected through the confidentiality agreement signed between MRC and AstraZeneca. Successful Outline applicants will be expected to sign relevant confidentiality agreements with AstraZeneca which will protect both parties IP.
41. Who signs the CDA with AstraZeneca on behalf of the investigator?
A: The investigator’s University, usually through the Technology Transfer Office, will be expected to sign the CDA with AstraZeneca. This will only be required for investigators proceeding to the full application process.
42. How are you going to decide who gets what in the emergent IP between AstraZeneca and the investigator?
A: The MRC does not deal with IP rights arising from research funded grants for extramural research. Ownership of and access to results and IP generated during the grant will be negotiated between AstraZeneca and the Researcher/Sponsor and will be based upon the Lambert Model Agreements for Pre-clinical Studies and model Industry Collaborative Research Agreement (miCRA) for Clinical Studies as appropriate.
43. What rights do AstraZeneca have to first refusal on licensing/buying my IP and at what value?
A: This will be dependent on the Agreement that has been negotiated between the investigator and AstraZeneca, which will be based on the Lambert or mICRA agreements. A potential scenario would be for AstraZeneca to have the first right to negotiate an exclusive licence or assignment of IP rights arising from the research, with the proviso that it wouldn’t be offered to someone else at more favourable terms than offered to AstraZeneca.
Ethics and governance
44. Do I need full ethics permission and regulatory approvals for any human studies in the grant proposal? If so, when should I apply for this?
A: The MRC does not require ethics permissions and regulatory approvals to be in place when you submit an application. However, given that research requiring the use of human tissue/organs may raise various ethical and regulatory issues, applicants will be required to demonstrate that they have adequately considered these matters. Early discussions with regulatory bodies may be required to ensure that all requirements can be met in a timely manner once an application is successful. It is the responsibility of your host institution to ensure that the appropriate ethics approval(s) has been obtained and that no research requiring such approval is initiated before it has been granted. Please read the MRC terms and conditions.
45. Who will be the Sponsor of the study?
A: As outlined in MRC’s Terms & Conditions it is expected that the Research Organisation will identify itself as the sponsor (or one of a group of individuals/organisations that accepts the sponsor’s responsibilities).
46. Who has liability and indemnity responsibilities for the clinical studies?
A: Liability and indemnity responsibilities will follow those outlined in the Lambert Model Agreements for Pre-clinical Studies and the model Industry Collaborative Research Agreement (miCRA) for Clinical Studies. Briefly, it is expected that the responsibilities for the conduct of the study will lie with the Sponsor of the research and the responsibility for the quality of the compounds will lie with AstraZeneca.
Communications
47. How will you let me know if my application has been successful?
A: The Principal Investigator will be notified of the decision by email communication.
48. Will you publish a list of the awards that are made?
A: Following the funding decisions a list of awards will be made available on the MRC website (the list will be inclusive of name, title of grant, host institution and value awarded).
Other
49. If my query is not answered by the FAQ’s, or I have a scientific query regarding my application, who do I contact?
A: For scientific queries please contact Dr Joanna Latimer at
joanna.latimer@headoffice.mrc.ac.uk
For queries regarding preparation and submission of your application, in the first instance please refer to all documentation relating to the scheme, particularly the Guidance Notes and Je-S Help which will guide you through the standard processes for preparing a proposal and costing your proposals. If you still have a query, contact the Je-S helpdesk:
Je-S Helpdesk: Monday – Friday 9.00am – 5.00pm
Telephone: +44 (0) 1793 44 4164
Email: JeSHelp@rcuk.ac.uk
Web: https://je-s.rcuk.ac.uk