General troubleshooting

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.

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 they will be competing for limited funds and that there may be some delay to the start of approved projects.

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, anywhere, who considers that they can carry out high-quality health-related research, and who is prepared to submit a proposal.

Do you fund research outside the UK?

The HTA programme has funded proposals from outside the UK when this was the best method of meeting an NHS research requirement. The rationale for such an application should be set out and each case will be judged on its merits in consultation with the Department of Health.

Can I collaborate with someone outside the UK?

Yes, the HTA programme is not limited to applicants in the UK. Applicants must clearly explain the rationale for including such collaboration.

I have some questions about the brief - can I talk to someone about it?

For standard calls: please email your query to htacommissioning@soton.ac.uk and we will reply as soon as we are able.

For HTA Clinical Trials: please email your query to htact@soton.ac.uk and we will reply as soon as we are able.

Can you clarify what is meant on page 18 of the electronic application form by the Trust nominated signatory's declaration: 'I am satisfied by the arrangements made for indemnity'

Normal NHS Indemnity arrangements (in respect of clinical negligence) apply to NHS staff involved in research. Research involving new drugs or novel or unusual treatments carry the risk of non-negligent harm i.e. unexpected side effects, which is not covered by NHS Indemnity. The standard contract requires the lead contractor to indemnify the authority and maintain insurance policies in respect of, among other things, non-negligent harm arising from the research. NHS bodies in agreeing to participate in research are asked to confirm that arrangements for indemnity, commensurate with any risk arising from the research activity within their unit, are in place.

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 and approving 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 is the HTA programme's relationship with the UK Clinical Research Network?

(Download more information, pdf, 25kb)

The UK Clinical Research Network (UKCRN) 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 UKCRN 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 UKCRC 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

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 HTA 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 two hard copies and an electronic copy of your proposal by the stated deadline.

Do you give feedback on proposals?

Feedback will be provided to all applicants.

How do you choose referees who assess the proposals?

We choose from our ‘college’ of referees. The criteria for entry includes job seniority, recommendation by other recognised experts, recommendation by senior NCCHTA 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 HTA contract?

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

• one for universities (pdf, 120kb)
• one for NHS bodies, research councils and other government agencies (pdf, 118kb)

What should I do about VAT?

The HTA programme does not generally cover VAT on equipment as most researchers should be able to reclaim any VAT paid, via their host institution. Please contact your research support office for further guidance. However consultancy costs which incur VAT should be quoted as a daily rate with VAT included and not separated out.

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?

Yes, you should allow for inflation and annual increments when calculating salary costs.

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.

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?

You can 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.

Electronic form

I'm having problems using the electronic form - what can I do?

If you are experiencing difficulties using the form, please read the ReadMe.txt document and the Guidance Notes carefully as these do provide detailed instructions and guidance. If, having consulted these documents, you are still having problems:

For standard calls: please contact the Commissioning Team (023 8059 5621 / email: htacommissioning@soton.ac.uk) for assistance.

For HTA Clinical Trials: please contact the Clinical Trials Team (023 8059 5621 / email: htact@soton.ac.uk) for assistance.

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.

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