General FAQs

Developing your research proposal

What is meant by ‘Health Technology’?

Health Technology is an internationally recognised term that covers any method used by those working in health services to promote health, prevent and treat disease and improve rehabilitation and long-term care. "Technologies" in this context are not confined to new drugs or pieces of sophisticated equipment. For more details see our what is HTA page.

Would my primary research idea be of interest to the HTA programme or the EME programme?

The HTA and EME programmes have worked together to produce a document to help clarify some of the differences between the two programmes. The aim of the document is to make it easier for you to decide which research programme it would be most appropriate for you to submit a proposal to. Please click the link below to view the document.

• Characteristics of the EME and HTA programmes (pdf file, 24 kb)

Is there a limit to the amount of money you can ask for for one proposal?

No. The HTA programme funds on the basis of the scientific merit of the proposal and the team put together to carry out the study. However, applicants should be aware that although they will not be competing for funds, projects have to demonstrate value for money to the NHS.

Is there a maximum length of time allowed for a research project?

There are no fixed limits on the duration of projects or funding and proposals should be tailored to fully address the problem (including long-term follow-up if necessary). Applicants should consider that there is a pressing need within the NHS for this research, and so the duration of the research must be timely. Applicants should balance the pressing need for the information with the need to follow up participants for long enough to measure important outcomes.

Who is allowed to submit proposals - is it just universities or teaching hospitals?

Anyone who considers that they can carry out high-quality health-related research, and who is prepared to submit a proposal is likely to be eligible. If you have any concerns regarding your eligibility to apply we advise that you contact us before completing an application. The HTA programme welcomes applications which are within the programme's remit from all sectors for consideration; however, applicants from non-academic or non-clinical sectors are strongly advised to consider collaborating with these sectors in their application to the HTA programme.

What is the role of a chief investigator?

The chief investigator of an HTA study has the overall responsibility for:

• the conduct of the study
• managing the research resources in a way that maximises the chances of completion within available funding
• the day-to-day running of the study and for managing the study budget
• ensuring that appropriate systems and procedures, that assure the appropriate quality of every aspect of the study, are in place
• convening the steering group (if relevant) when there are any matters arising from the conduct or management of the study that might require their advice
• supporting the steering group (if relevant)
• ensuring that clear lines of communication are established between investigators
• preparing, approving reports and sending online reports to the HTA programme as required
• notifying the HTA programme of changes to the study
• on completion of the study: analysing, writing up, reporting and disseminating the results
• ensuring that the study is conducted in accordance with research governance
• ensuring that all data and documentation associated with the trial are readily accessible for independent inspection and validation

The chief investigator is expected to ensure that their research team is of a suitable composition to assist in the delivery of these requirements.

What do you mean by a ‘sponsor’ organisation and do I need a sponsor for my project?

The MRC Guidelines define responsibilities for the Sponsor, Principal Investigator and Host of trials. The Sponsor is the organisation taking overall responsibility for the management and financing of a study. The Principal Investigator is the person responsible for the conduct of the study on a daily basis. The Host Institution is the organisation in receipt of funding from the Sponsor and in which the study is based.

All primary research projects funded by the HTA programme must have a nominated Sponsor. The DH expects that in the majority of cases the employing institution of the Principle Investigator will be nominated as the Sponsor. Other institutions may wish to take on this responsibility or agree co-sponsorship with the employing institution. The HTA programme does not insist that secondary research projects nominate a Sponsor.

Am I eligible to apply?

Anyone who considers that they can carry out high-quality research is likely to be eligible. If you have any concerns regarding your eligibility to apply we advise that you contact us before completing an application. NETS programmes welcome applications which are within the programmes' remits from all sectors. Applicants are strongly advised to consider establishing partnerships with other relevant sectors or organisations to demonstrate they have the full breadth of expertise to carry out their proposed research in their applications to NETS programmes. Applicants should always check individual call specification documents for any additional eligibility requirements.

The NIHR Health Technology Assessment programme is funded by the NIHR, with contributions from the CSO in Scotland, NISCHR in Wales, and the HSC R&D Division, Public Health Agency in Northern Ireland. Researchers from Northern Ireland and Scotland for certain NICE related calls, as indicated in the commissioning brief, should contact NETSCC to discuss their eligibility to apply.

Can NIHR Clinical lecturers and equivalent training posts apply for HTA funding as Chief Investigators?

NIHR Clinical Lectureships or equivalent training posts are fixed term positions, the programme would want to seek certain assurances that:

1.  There was suitable senior clinical support and leadership within the team, in terms of a specified co-applicant.

2.  Clear arrangements for succession planning and leadership to enable the continuation and completion of the trial at the end of the CI’s contract. Applicants should address these areas under the section ‘strengths of research team’  within the application form. If this is not addressed adequately in the application then further clarification will need to be sought during the funding assessment stage.

What issues should I consider to ensure that my application is deemed 'deliverable'?

NETSCC is working closely with the NIHR Clinical Research Networks to ensure that the studies which it funds can be successfully delivered in the NHS, securing maximum benefits to patients and value-for-money of the NETS programmes. The Medicines for Children Research Network and the Association of Medical Research Charities have produced a guide on ‘Points to consider when assessing the feasibility of research’. Many of the points discussed in the document apply to all types of clinical research, not just paediatrics. View the document.

Can I collaborate with someone outside the UK?

Eligibility is limited to those based in administrations that contribute to the relevant NIHR funding scheme unless there is insufficient capacity/capability in those administrations to meet our needs.  If there is insufficient capacity in these locations to meet our needs, we will consider commissioning research from a wider geographical area in order to meet our needs. This applies to both primary research and evidence synthesis.

What is the HTA programme's relationship with the NIHR Clinical Research Network?

The NIHR Clinical Research Network (NIHR CRN) is working on behalf of the UK Clinical Research Collaboration (UKCRC) to create a UK-wide clinical research infrastructure that will support the conduct and delivery of a range of high quality studies across the full spectrum of disease and clinical need. Substantial investment has already been made to support this work and significant progress has been made.

The NIHR CRN consists of a managed set of Topic Specific Clinical Research Networks, covering cancer, dementias and neurodegenerative diseases, diabetes, medicines for children, mental health and stroke. It is intended that, in due course, this will be extended to cover the full spectrum of disease and clinical need.

The HTA programme is committed to supporting this initiative, and has a policy of liaising with the networks at all stages of our process.

Further information on the networks can be found on the NIHR CRN website.

I am concerned about GHG emissions associated with the conduct of my research – what is the HTA programme's position on such issues?

High quality health technology assessment is essential to improving health care. However, the conduct of such work involves activities that entail the burning of fossil fuels thereby releasing carbon dioxide and other greenhouse gases (GHG) into the atmosphere. These gases are changing the global climate with serious implications for human health and for ecosystems. For this reason, it is essential that all sectors of the economy, including the health research sector, take action to reduce their GHG emissions. The HTA programme is committed to reducing the GHG associated with its activities and urges applicants to consider this carefully when undertaking HTA funded research. Further information about how to reduce GHG emissions is available from the Carbon Trust

how can I contact the funding team?

For Commissioned Calls contact:

The HTA Commissioning Team, Alpha House, University of Southampton Science Park, Southampton SO16 7NS. Telephone: 023 8059 5621 (24 hour answerphone) Fax No: 023 8059 5639, Email:htacmsng@southampton.ac.uk

For Themed Calls contact:

HTA Themed Call Team, Alpha House, University of Southampton Science Park, Southampton SO16 7NS. Telephone: 023 8059 6704 (24 hour answerphone) Fax No: 023 8059 5639, Email: htatcall@southampton.ac.uk

For Clinical Evaluation and Trials contact:

The HTA Clinical Evaluation and Trials Team on Alpha House, University of Southampton Science Park, Southampton SO16 7NS. Telephone: 023 8059 6974 (24 hour answer phone), Fax: 023 8059 5639, Email: htacet@soton.ac.uk

 

 

 

 

 

 

What is meant by the terms 'feasibility study' and 'pilot study'?

The HTA programme defines feasibility and pilot studies in the same way as several other NIHR programmes. For this definition and to see which other NIHR programmes will fund feasibility and pilot studies visit the NETSCC website glossary page.

Does the HTA programme fund tissue collection or biobanks?

We are unlikely to fund work which focuses on collection of physiological, biochemical or other information unless there is a clearly defined way in which this will be used for the benefit of patients (either directly or in terms of improving outcomes of other patients). For these reasons we generally do not fund biobanks or disease registers. If you would like to include this as an element of your research proposal, please contact us.

Will the HTA programme fund PhD research?

The NIHR does not fund PhD studentships through its research grants (Access the NIHR's main training opportunities).It is possible, however, for a researcher employed on an NIHR grant to register for a PhD based on the funded project, though NIHR will not reimburse fees.

Does the HTA Programme fund international collaborations?

Please read the NIHR Evaluation Trials and Studies Coordinating Centre FAQs 

Who owns the Intellectual Property Rights of the research you fund?

HTA funded research is obliged to publish in the NIHR journal series and the contents of this journal is Crown copyright. Otherwise any foreground Intellectual Property created by our funded projects normally stays with the lead Contractor.

What is the NIHR's approach to intellectual property?

The following document outlines the NIHR's approach to intellectual property.

Can I produce and maintain a Cochrane systematic review?

If the commissioning brief encourages you to consider producing and maintaining a Cochrane systematic review, then we will support these costs. Of course, we encourage all applicants to link with or form a Cochrane Review Group

Can I claim the costs involved with maintaining a Cochrane systematic review?

Yes - if the commissioning brief you are addressing specifies that applicants are encouraged to consider producing and maintaining a Cochrane systematic review, you should include any additional costs associated with the initial preparation in your project.

How can I encourage NHS organisations to support my proposed research activity?

The HTA programme and the Department of Health places a high priority on supporting research within the NHS.  In July 2009, the Department of Health issued a letter that provides an overview of current expectations about the role of the NHS in supporting research to improve health and care.  This letter is available online at the following location: http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_102101

How does the NIHR support researchers in developing their proposals?

The NIHR provides specific support to help researchers develop and design high quality research proposals through the NIHR Research Design Service and through the involvement of Clinical Trials Units in your research. For further information visit: http://www.netscc.ac.uk/funding/developing_your_proposal.asp

Do I need to be registered with the CRD international register for systematic reviews?

Applicants undertaking systematic reviews should note the commitment of NIHR to publication in the PROSPERO database. PROSPERO was developed by the NIHR’s Centre for Reviews and Dissemination (CRD), and is the first online facility to register systematic reviews for research about health and social care from all around the world. Access is completely free and open to the public. PROSPERO registration is a condition of NIHR funding for systematic reviews that are within the scope for inclusion. For more details visit the CRD website.

Can I apply for funding if my current institutional contract does not extend to the project end date proposed in the application?

Applicants will need to provide a letter from their employing institution confirming that should the application be successful the institution would be willing to honour the chief investigators employment contract for the duration of the funded project.

What is the position for patients participating in clinical trials and their access to drugs during and post clinical trial participation, particularly those which have been appraised by NICE and have had guidance issued?

Please see the advice given in the ‘NICE Technology Appraisals and Clinical Trials Participation’ section on NICE’s webpage: 

www.nice.org.uk/usingguidance/implementationtools/implementation_tools.jsp

Assessment process

Can I find out how many proposals (and from whom) have been short listed?

Outcomes (including shortlisted outline proposals) are posted on our website following each Board meeting.

Can I ask for the deadline for proposal submission to be delayed for me?

No, unfortunately we cannot grant any requests for extensions of time. We must receive both your online application form by the stated deadline.

Do you give feedback on proposals?

Yes. Feedback will be provided to all applicants.

How do you choose external reviewers who assess the proposals?

We choose from our ‘college’ of external reviewers. The criteria for entry includes job seniority, recommendation by other recognised experts, recommendation by senior NETSCC, HTA staff or HTA programme advisors, or suggestion by the head office of a professional or charitable society.

Financial and contract issues

What is the standard research contract?

The standard research contracts are Department of Health contracts, which will not be modified. There are four standard contracts:

• For Universities (pdf, 117 KB)
• For NHS bodies (pdf, 118KB)
• For research councils and other government agencies (pdf, 121kb)
• For commercial organisations or charities (pdf, 124kb)

What should I do about VAT?

If your organisation is an 'eligible body' under HM Customs & Excise Notice 701/30 (VAT: Education and Vocational Training), e.g. you are a university or NHS Trust, the cost of any equipment should include any VAT you have to pay on purchase.

We've been shortlisted at the outline stage and are due to submit a full proposal. When working out staff salary costs should we allow for inflation?

Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by the Department of Health. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded.

Can you explain how NHS costs are categorised?

There are three types of costs associated with NHS Research and Development:

• Research Costs – These cover the costs of R&D activity itself and include: data collection; analysis; other activities needed to answer the research questions; trial registration; dissemination; and the salary and indirect costs of staff employed to carry out the research.

• Service Support Costs – These cover any additional patient-related costs, associated with the research, that end once the research activity has stopped. These may include: extra diagnostic tests; extra I/P or O/P activity; extra nursing care; and obtaining informed consent from participants.

• Treatment Costs – These cover patient care costs, which will continue if the patient care service continues after the R&D activity stops. Treatment Costs cover all types of patient care including: diagnostic; preventive; continuing-care services; rehabilitative-care services; and health promotion. Where patient care is being provided which differs from the normal, standard, treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given) the difference between the total Treatment Costs and the costs of the 'standard alternative' (if any) is termed the Excess Treatment Costs, but it is nonetheless part of the Treatment Cost, not a Service Support or R&D cost.

More detail is available in the DH guide Attributing revenue costs of externally funded non-commercial research in the NHS (ARCO) which gives examples of what kind of costs should be allocated in the full proposal details as research, NHS support or NHS treatment costs.

Who funds these costs?

• Research Costs are funded by the research funder e.g. HTA programme.

• (NHS) Service Support Costs are funded through the R&D Levy. Currently, this is paid to NHS organisations in the form of transitional allocations and, in a very small number of cases, through ad hoc funding. However, this process is changing and, in future, funding will be through a number of new funding streams that will include: NIHR Faculty; Technology Platforms; Biomedical Research Centres; and Networks (Topic Specific, Primary Care, and the Comprehensive Research Network for England). Details of the new funding streams can be found on the NIHR website

• Treatment Costs, including Excess Treatment Costs, are normally funded through commissioning arrangements for patient care and normal commissioning arrangements apply (the Department of Health website offers PDF format guidance documents on non-commercial, externally funded R&D in the NHS: this guidance covers responsibilities; definition of the research and associated patient care costs; NHS support and treatment costs; and procedures). In very exceptional cases, when excess treatment costs are very high and there are very few centres involved, subvention support may be available from the Department of Health to help with Excess Treatment Costs. However, even where an application meets Department of Health subvention criteria, funding will be subject to the availability of Department of Health resources and available budget.

I am one of the applicants on a proposal and am employed full time by a University/NHS Trust. Can my salary be included in the costings?

Yes, the HTA programme will reimburse your employer for the proportion of your salary relating to the time you will spend working on the HTA project.

How accurate do you expect my costs to be?

Applicants should note that it is in their interests to undertake a thorough, realistic and accurate costing of their proposal. The HTA programme expects that the costs identified should not differ between outline and full proposal stage. Any differences must be clearly explained and fully justified. The Board will pay close scrutiny to any increases.

Can I include all applicants under 'Directly Allocated Costs'?

The HTA programme fully supports full economic costing, and awards research funds on this basis to research based in Higher Education Institutions (HEIs). Under the terms of this, all applicants are allowed to charge for the proportion of their time that will be spent working on any funded proposal.

However applicants should be aware that although the HTA programme funds on the basis of the scientific merit of the research, they will be competing for limited funds. The total cost of any proposal should therefore be carefully considered.

Should I include costs for the welcome meeting in my application?

Yes, you should include costs for an initial meeting at NETSCC, HTA for all primary research projects. Please note that the HTA programme will fund a maximum of three people to attend. These meetings do not apply to evidence synthesis projects.

Can we charge for stationery items, such as paper and printer cartridges and telephone calls, if they are project specific rather and just for general use i.e telephone interviews with patients paper for questionnaires?

Yes, you can charge estates and yes, we will cover specific phone calls to patients and paper for questionnaires, but not for general office costs which should come out of indirect costs.

I am undertaking a study looking at the use of a diagnostic test, what can I allocate to Research costs?

If your study involves the use or evaluation of a diagnostic test you will find Question 37, 38 and 39 of  the FAQs in Annex B of the AcoRD Document helpful in providing some additional guidance on the allocation of costs.

Public involvement in proposals

I want to involve consumers as part of the research team. Where can I find out what kind of consumer involvement might be suitable and what rates of pay might be appropriate?

Please see our planning patient and public involvement in HTA pages for examples of how and why health technology assessment projects have addressed public involvement. You can also visit the INVOLVE (formerly Consumers in NHS Research) website where there is a set of FAQs especially for researchers wanting to find out why and how they might involve consumers in research. INVOLVE has also published guidance to applicants about involving consumers in research and a guide to paying consumers.

Online Application Form

I’m having problems submitting the online application – what can I do?

If you are experiencing difficulties, please read the Guidance Notes carefully as these do provide details instructions and guidance. Sometimes people experience problems due to the access rights that their computer has. If you are experiencing problems submitting the online application then please contact your IT support in the first instance. If having done this you are still experiencing problems then contact us. The HTA Commissioning Team, Alpha House, University of Southampton Science Park, Southampton SO16 7NS. Telephone: 023 8059 5621 (24 hour answerphone) Fax No: 023 8059 5639, Email:htacmsng@southampton.ac.uk

Where can I get help in completing my online application?

Detailed information on completing the online application is provided in the Guidance Notes for each call. There is also online support available in completing the application.

Data sharing

What is data sharing?

It is exactly that – the sharing of research data amongst the research community. Many researchers are already sharing their data through a variety of mechanisms, and data sharing is widely accepted as a good research practice. The HTA programme is working with the National Cancer Research Unit (NCRI) Informatics Initiative in a pilot of data sharing activity, which is intended to formalise and co-ordinate such efforts.

The HTA programme is committed to ensuring that the data generated through its funded research is put to maximum use by encouraging data sharing, therefore researchers applying for an HTA grant should consider data sharing in their proposals. The HTA programme is currently developing further policies for data sharing and information will be posted in due course. In the meantime further information on data sharing can be found on the MRC website.

Why should I share my data?

Data sharing achieves many important goals for the scientific community, such as:

• reinforcing open scientific inquiry
• encouraging diversity of analysis and opinion
• promoting new research, testing of new or alternative hypotheses and methods of analysis
• supporting studies on data collection methods and measurement
• facilitating education of new researchers
• enabling the exploration of topics not envisioned by the initial investigators
• permitting the creation of new datasets by combining data from multiple sources
• promoting data quality
• expediting the furthering of scientific knowledge benefiting contributors, those who access the data and patients

Everyone benefits, including investigators, funding agencies, the scientific community, and, most importantly, the public. Data sharing provides more effective use of organisations resources by avoiding unnecessary duplication of data collection. It also conserves research funds to support more investigators. Initial investigators have a legitimate interest in benefiting from their intellectual investment and effort, but prolonged exclusive use is not usually in the interests of the science. They will also benefit, because as the data are used and published more broadly, their reputation grows.

Do I have to share my data?

The HTA programme does not prescribe when or how researchers should share data. Some data can be shared pre-publication, whilst the value of other data may only be realised after the collection period. We aim to prompt researchers to consider what is appropriate and reasonable and make explicit provision for sharing and preservation in the planning and execution of their research.

How do I share data?

There are many ways to share data, the method for sharing that an investigator selects is likely to depend on several factors, including the sensitivity of the data, the size and complexity of the dataset, and the volume of requests anticipated. Investigators will need to determine which method of data sharing is best for their particular dataset.

• Under the auspices of the chief investigator

Investigators sharing under their own auspices may simply mail a CD with the data to the requestor, or post the data on their institutional or personal website. Although not a condition for data access, some investigators sharing under their own auspices may form collaborations with other investigators seeking their data in order to pursue research of mutual interest. Investigators sharing under their own auspices should consider using a data-sharing agreement to impose appropriate limitations on users. Such an agreement usually indicates the criteria for data access, whether or not there are any conditions for research use, and can incorporate privacy and confidentiality standards to ensure data security at the recipient site and prohibit manipulation of data for the purposes of identifying subjects.

• Data archive

You may simply share the data by transferring them to a data archive facility to distribute more widely to interested users, to maintain associated documentation, and to meet reporting requirements. Data archives can be particularly attractive for investigators concerned about a large volume of requests, vetting frivolous or inappropriate requests, or providing technical assistance for users seeking help with analyses.

• Data enclave

Datasets that cannot be distributed to the general public, for example, because of participant confidentiality concerns, third party licensing or use agreements that prohibit redistribution, or national security considerations, can be accessed through a data enclave. A data enclave provides a controlled, secure environment in which eligible researchers can perform analyses using restricted data resources.

• Mixed mode sharing

Investigators may wish to develop a “mixed mode” for data sharing that allows for more than one version of the dataset and provides different levels of access depending on the version. For example an edited dataset could be made available for general use, but stricter controls through a data enclave would be applied if access to more sensitive data were required.

Where can I get further information and advice?

The National Cancer Research Institute (NCRI) Informatics Initiative is co-ordinating a pilot of data sharing activity across a range of research funding organisations. Their website contains various draft documents. A data sharing matrix is being developed, however it is primarily focused on cancer and genomics at the moment. It is hoped that detailed information will be included for other disciplines in due course.

Unanswered questions

I have some questions not answered here – what should I do now?

Take a look at the FAQ pages for the funding stream you are interested in as further information is available on those pages.  If you are still unable to find the answer to your question then please contact us using the following details:

For HTA commissioned calls: please email your query to htacommissioning@soton.ac.uk

For HTA Clinical Evaluation and Trials: please email your query to htacet@soton.ac.uk

For HTA Themed Calls: please email your query to htatcall@soton.ac.uk 

 

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