Welcome to the Research and Development Frequently Asked Questions page. Included here are some of the most common requests that we receive as a department over the phone or by email.
If you have a query about anything research related then this is the best place to start. For this section we have tried to answer each question as completely as possible, and where we can we have included links to other pages/websites that will give you even more information on that subject.
We understand though that sometimes there is just no substitute for speaking to someone in person, or you need an answer to a question that nobody has ever asked before, so please feel free to contact us if the information below doesn’t quite tell you all you wanted to know.
Any studies which were funded by NIHR should publish their results on the NIHR journals library.
It may take several months before the results of a study are available, even after a study has finished collecting data. If you’ve taken part in a study, you can ask the study team how you can find out the results.
For studies listed on Be Part of Research, we will try to update the information on our site with any publications, but you can also go back to the initial sources, ClinicalTrials.gov or ISRCTN.com where the publications may be listed.
Patients sometimes ask why a treatment, drug or device that seems to work in a research study is not always made available on the NHS once it ends.
There are a number of decisions that are made, including whether a medicine or device is licensed for use and made available in this country.
An independent public body, the National Institute for Health and Care Excellence (NICE), makes decisions about whether the NHS should buy new or existing treatments. It makes these decisions based not only on how well a treatment works, but also on whether it represents value for money. Sometimes, treatment costs only become entirely clear after a study ends.
Until a study is complete and analysed, such things are unknown. This is why it is impossible to know whether the treatment will be made available on the NHS following the drug trial or research study.
Most research studies rely on volunteers to participate. You may be reimbursed your travel expenses so it’s worth talking to the study team about what financial reimbursements are available.
If you have plans to take a holiday, do discuss this with the research team before enrolling in a study. It might impact on your availability for appointments and follow up visits or tests.
Taking part in a research study should not affect your insurance cover, providing the medical condition in question doesn’t.
The Association of British Insurers state ‘When individuals apply for travel insurance, insurers will typically ask questions about an individual’s health in order to make an accurate risk assessment. This risk assessment takes into consideration the health of the individual and the insurer will often ask questions about pre-existing health conditions and medical treatments for those conditions.’
Travel insurers do not typically ask about research. Where an insurer does ask an individual about their participation research, the insurer must ensure the question is clear and the individual should answer it accurately and honestly.
Insurers are interested in the health of an individual, not their participation in research.
My study supports the undertaking of a local service evaluation, is it eligible for NIHR Clinical Research Network support?
No, a “research project” is defined as a structured activity which is intended to provide new knowledge which is generalizable or transferable. The undertaking of a local service evaluation does not, in itself, constitute a research project (as there is no “research question”) and these activities are therefore not eligible for Clinical Research Network (CRN) support. However, if the evaluation involves services delivered in more than one NHS / care organisations (eg. NHS Trust or care home); can be scaled across other organisations or services; and the outcome can reliably extrapolated from the subjects who participated to a broader patient population and a broader range of clinical settings, then this evaluation would be considered eligible (subject to meeting the other eligibility criteria) since the activity is generating generalizable or transferable new knowledge.
My study is funded by a university, college or local healthcare organisation, is it eligible for consideration for NIHR Clinical Research Network support?
No, UK universities, colleges and local healthcare organisations (including NHS Trusts) do not fulfil the criteria for NIHR non-commercial Partner status, since funding does not meet the open competition requirement. Studies funded by these organisations are therefore not eligible for NIHR Clinical Research Network support.
Research is a vital strand of the government’s strategy to stop COVID-19. As COVID-19 is a new disease we need to find out as much as we can about it, as quickly as possible. We can only answer questions about COVID-19 with research.
Not all research into COVID-19 is research into treatment, a diagnosis or a vaccine. Some research is studying the progress of COVID-19 so we can understand it better or look at the effects of social distancing on the spread of coronavirus or on people’s well-being. All types of research are important in helping us to understand and beat COVID-19.
GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.
To obtain visit https://learn.nihr.ac.uk/course/index.php?categoryid=38
REC Research Ethics Committee: authorised by National Research Ethics Service NRES: umbrella organisation responsible for all REC across the UK (replaced COREC in 2007) NRES to review study documents for research taking place in the NHS, or social services. Some REC specialise in Clinical Trials, or topics such as research in children. All Research in NHS/social services must have been reviewed by a UK REC.
HRA Approval, the process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK Health Departments’ Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.
On 31 March 2016, HRA Approval was introduced as the process for applying for approvals for all project-based research in the NHS led from England. From 16 April 2018 this was extended to include all project-based research in the NHS in England or Wales, and is referred to as “HRA and HCRW Approval”.
Where can I go to check if my project is research?
To help you decide whether your project is classified as research we would recommend you visiting https://www.nihr.ac.uk/ ‘Is my study research?’ for a decision
The lead person at a single site designated as taking responsibility within the research team for the conduct of the study.
A CTA can be one of four things:
- CTA Clinical Trials Administrator: person providing coordinating/secretarial support for running clinical studies
- CTA Clinical Trials Agreement: contract between the legal Sponsor and the hosting research sites
- CTA Clinical Trials Associate (similar to CRA): person involved in the management of a study from initiation, through conduct/monitoring to close-out
- CTA Clinical Trials Authorisation: The regulatory approval for a clinical trial of a medicinal product issued by the MHRA
This can be one of two things:
- mCIA model Clinical Investigation Agreement: for medical devices, covers the running of the study, not design of prototype or design of protocol; standard template for the UK (use is not obligatory)
- mCTA model Clinical Trial Agreement: for IMP studies with commercial sponsor/CRO conducted; standard template for the UK (use is not obligatory)
The Organisation Information Document replaces:
- the Statements of Activities that were used for non-commercial studies, in England and Wales; and
- the NHS/HSC Site Specific Information (SSI) Form in Scotland and Northern Ireland.
There are different templates for the Organisation Information Document according to whether the study is a commercial or non-commercially sponsored project.
NHS or other organisation which only identifies participants from a database etc, but recruitment/receiving consent and study conduct are managed elsewhere.
The SoECAT is structured as a schedule of events and as such will appear familiar to many researchers. A schedule of events lists the study activities to be undertaken at the site-level in the rows of the table and lists the study schedule (e.g. clinic visits, etc.) along the columns. Traditionally the time points at which the activity is to be undertaken would be indicated by a cross or other mark in the relevant cell. The SoECAT adopts this approach for the Standard of Care tab but replaces this mark with a drop-down menu that allows each activity in a General Activity or Per Participant tab to be attributed to an AcoRD cost category. If an activity will occur multiple times on the same visit (for example, hourly blood tests) the activity will need to be added on multiple rows.
Treatment Costs are the care costs that would continue to be incurred if the patient care service in question continued to be provided following the end of the research study. The difference between the Treatment Costs and the costs of the existing standard treatment is referred to as the Excess Treatment Cost (ETC).
The costs of non -commercial research are met by different funders depending on the type of cost. Guidance from the Department of Health and Social Care (DHSC) for the Attribution of Costs for Research and Development (AcoRD) sets out the principles for determining who pays for the different costs.
ETCs are paid for by service commissioners.
AcoRD or Attributing the costs of health and social care Research and Development is there to ensure researchers have all the support they need around the attribution of study activities, we’ve pulled together a number of resources which will help you understand the principles of AcoRD, including our attribution e-learning tool.
It’s a Model Non-Commercial Agreement for clinical research studies; standard template for the UK (use is not obligatory).
Feasibility Studies are pieces of research done before a main study in order to answer the question “Can this study be done?”. They are used to estimate important parameters that are needed to design the main study.
“The marvelous thing about a good question is that it shapes our identity as much by the asking as it does by the answering.” ― David Whyte