Whilst the majority of proposals follow a standard application process or contract negotiation there are however a number of factors with potential for complexity which may delay Institutional Authorisation to submit the application or execute the agreement, if not established and considered in the early stages of proposal development.
The application may fall into one of the following categories:
A restricted / quota call
When an external funder restricts the number of applications that may be submitted per institution, an internal process is coordinated and put in place by the Funding Strategy team in the Research Office. Each process is defined by the particular restrictions of the call and is communicated as appropriate through the Faculties and added to the list of current managed calls.
In response to an internal call
In instances when institutional level awards are made to the Vice-Provost (Research) for internal distribution, the Funding Strategy team in the Research Office* will consult, as appropriate for the award, Faculty Research Strategy Managers, other Research Office representatives, Faculty Research Services/Joint Research Office Managers and Faculty Finance Officers to agree supporting processes including communication (timeline, scheme rules and requirements) and will make scheme specific guidance available.
* For awards made by the NHS, such as the BRC scheme, the same process will apply but be coordinated and communicated by the Faculty of Medicine’s Research Strategy Manager.
To fund a Research Centre or Institute
A ‘Bid Manager’ will be required to coordinate the development of the application to ensure consultation with all parties to establish a properly scoped, costed, priced and authorised research bid. The Bid Manager will most likely be a member of the lead academic department and may (but not necessarily) be the Principal Investigator.
To be submitted to a new funding body and / or funding scheme
The terms and conditions of funding must be reviewed by Faculty Research Services as part of the approval process (before the proposal can be submitted to the Funder). In the case of new funders and / or funding schemes, extra time may be required to negotiate terms and conditions. Faculty Research Services are also required to establish the Funder’s ability to pay (Funder Credit Check) and to use this information to assess the acceptability of payment terms. The key message is, if the funder is not on InfoEd, or the scheme is new, early advice should be sought from Faculty Research Services.
Need to be stated in a foreign currency
The costing should be converted to the appropriate currency in accordance with the College’s Foreign Exchange Policy. Not all currencies are acceptable to the College (these are detailed in the College’s Preferred Terms of Trade). Faculty Research Services will provide guidance and should be contacted in the initial stages of proposal development.
The research project may fall into one of the following categories:
Require institutional contributions / commitments and associated statements of support
The Funding Strategy team in the Research Office will provide institutional statements of support where required and appropriate to the bid. Letters of support from the President, Provost or Vice Provost (Research) can be provided on request after assurance that the proposal is of appropriate quality, fits the remit of the call, and that any financial commitments on behalf of the College included in the proposal have been agreed by the budget holder. In such cases the Bid Manager must ensure that:
- the Funding Strategy team is informed of the intent to apply;
- all appropriate approvals are obtained in good time;
- the Funding Strategy team is given sufficient time (at least 10 working days) to review the bid and a draft letter of support prior to the submission deadline.
Involves external organisations such as other UK universities or overseas organisations
The development of multiple partner bids must be initiated several months before the funder deadline and where College is the lead, responsibility for their coordination is designated to a nominated Bid Manager. The lead institution will be responsible for coordinating all elements of proposal development including: defining the research scope / plan, costing and pricing (informed by third party costs), reviewing / negotiating the funding terms and conditions, oversight of tendering requirements, executing sub-agreements and subsequent project/account management (unless delegated through a formal agreement, e.g. collaboration/consortium agreement).
Research involving non-UK partners should be in line with the College’s International Strategy (and region-specific strategy if in existence). Projects involving any of the following must be referred to the International Office:
- Formation of a consortium involving overseas universities or research institutes outside of those funded by the European Commission Framework Programmes
- The creation of a physical presence abroad (e.g. institute, research cent re, etc.)
- Clauses on UG/PGT/PGR exchanges, CPD or other educational provision abroad
Faculty Research Services should be consulted in the initial stages of proposal development to advise on the: nature of the third party relationship (e.g. Research Partner or Professional Services), costing approach, contractual relationship / complexities and any additional regulatory requirements. Due to the complexity of some research collaborations their negotiation (and the negotiation of related subcontracts and third party agreements) can be a lengthy process. Principal Investigators are advised to notify Faculty Research Services at the earliest stage of proposal development to avoid subsequent delays.
The project (or an element thereof) will be carried out off-site
Where Imperial led research is to be undertaken off-site (as opposed to sub-contracted or collaborative work being undertaken at an external organisation, also see question above) implications such as additional indemnity or insurance cover and third party agreements should be considered. This is particularly important for clinical studies where there may be additional eligibility and approval considerations (e.g. researcher eligibility to conduct healthcare studies on the relevant NHS sites (honorary contracts), NHS approval, co-sponsorship etc.). Advice should be sought from the Faculty Research Services team.
Consideration should also be given to the impact on the Full Economic Cost (an adjustment may be required to the Estates Rate and / or if the off-site provider is to invoice the College these costs may be allowable within the costing).
Involve creation of new buildings and / or major modifications to existing buildings, installation o
Projects requiring capital investment must be referred to the monthly College Portfolio Review Board (PRB) for approval prior to submission of the proposal to the funding body.
Involve humans, their tissue and / or data (i.e. healthcare projects)
'Healthcare research’ includes all health related research projects involving humans, their tissue and/or data. Human tissue is defined as material that has come from the human body, which consists of, or includes human cells (cell lines are excluded, though the original cells from which the lines are created are not excluded).
For clinical/healthcare research, the design of the protocal/research plan must comply with regulatory requirements (such as the Human Fertilisation and Embryology Act 1990, Data Protection Act 1998, Medical Devices Regulations 2002, Medicines for Human Use (Clinical Trials) regulations 2004, and Human Tissue Act), the Research Governance Framework and Good Clinical Practice.
Healthcare projects must have an identified sponsor. The sponsor is the organisation responsible for project initiation, administration, management and ensuring financial arrangements are in place. Identification of the sponsor must be followed by formal confirmation from the sponsor that they are willing to act as such (sponsorship assessment). Ethics approval cannot be sought or a UK grant application submitted before sponsorship assessment has been completed.
The additional steps associated with developing healthcare projects and clinical trials are:
- Registering with the Joint Research Compliance Office to ensure the College meets its obligations as the employing organisation
- Assessing what approvals and conditions are required for research conduct and oversight
- Insurance assessment (certain exclusions in College policies mean that College insurance cannot be assumed and may prove particularly complex for multi-centre overseas studies)
- Sponsorship assessment
- Ethics and other regulatory approvals
Guidance on regulations, procedures and restrictions can be found on the Joint Research Compliance Office website.
Requires non-NHS ethics approval
Proposals requiring non-NHS ethics approval must be referred to Imperial College Research Ethics Committee (ICREC).
The project and/or the relationship of the parties involved fall into one of the following categories:
Be considered ethically unsound, a reputational risk or politically sensitive
The College is committed to operating to the highest ethical standards. The Ethics Code sets out the conduct expected from the College community to promote and support good ethical behaviour. Research that compromises the College’s independence, objectivity of judgement or reputation must be avoided. Within the context of proposal development; research proposals and related agreements must not compromise the College’s commitment to honesty, integrity and fairness.
Proposed relationships with third parties (e.g. research funders and collaborators) should be considered within the context of the College’s Ethics Code and Relationship Review Policy, and potential risks should be documented and escalated within the defined framework.
Research that may involve or generate materials, methods or knowledge that may be considered ethically unsound, politically sensitive or may be misused (e.g. research which could be misused for criminal, terrorist or unethical military purposes, such as development of materials and technologies that could be used in weapons production, operation or dissemination) may not be entered into without fully documented risk assessment and appropriate referral / escalation.
Involve persons whom could be perceived as having a conflict of interest
Any arrangement that may constitute a real, perceived or potential conflict of interest relating to any College / connected person within the scope of the project (e.g. an Investigator in receipt of an associated consultancy) must be referred to the appropriate authority for consideration in line with the College’s Conflict of Interest policy and funder’s requirements.
The National Institutes of Health have recently updated their Financial Conflict of Interest policy, and Investigators (including Principal Investigators, Co-Investigators, named researchers, and other named staff) must complete Financial Conflict of Interest training prior to applying for funding from the National Institutes of Health.
Involves research materials which could be used or modified for military use
UK export controls are designed to restrict the export and communication of sensitive technology or strategic goods, which have or may have military application, with the aim of preventing weapons of mass destruction (WMD) proliferation and countering international threats such as terrorism. The Controls apply equally to the academic community as to any other exporter, and cover physical export (tangible items), electronic transfer, non-electronic transfer (which may include verbal), or transfer by any other means, thus encompasses non-tangible tranfers (eg. software and technical know-how) as well as physical items such as equipment.
The Controls are managed by ‘lists’ which specify equipment or technologies that are sensitive or present a proliferation risk. Where a transfer or export falls under one or more of these lists and the Controls a licence may be required in order to continue, or in extreme circumstances the transfer may not be permitted to take place. Export controls and any licences required are administered by the Export Control Organisation (ECO). There are few exemptions to the requirement to obtain an export licence for controlled technologies, most notably the ‘basic scientific research’ exemption, which will cover a majority of university activity, however, it is prudent to always check whether a licence is required. It should be noted that failure to obtain an appropriate licence to export controlled goods may result in a criminal offence being committed.
Further information can be found here Export Controls [pdf].