Getting started in research – Part 2

Put simply, it’s expensive. Much, much more expensive than you would expect if unfamiliar with the processes. An example:

We wanted to perform a study giving a cheap, safe and readily available medication to <100 patients presenting to a single emergency department with a common presenting complaint. We were offering to workup the study in our own time, perform much of the recruitment activity within our existing roles, and generally just “make it happen”. Turns out that costs 150,000. Even this is a conservative estimate, with full and transparent costing amounting to more like 300,000. Members of the team that we hadn’t considered, yet who perform functions essential to the successful delivery of a trial and need to have their time/expenses paid include:

• A data manager
• A trial manager
• A statistician
• An unblinded statistician
• A trial pharmacist
• An experienced academic (and the associated University support costs)
• A group of patient and public representatives (4 people)
• A DMEC (Data Monitoring and Ethics Committee) (5 people)
• A TSC (Trial Steering Committee) (5 people)
• A TMG (Trial Management Group) (7 people)

The list goes on, and on, and on.

Also, we had grossly underestimated the time involved in writing the protocol and grant application. These are detailed in the extreme (e.g. an “outline” proposal that runs to nearly 14,000 words) as much of what we take for granted as “obvious” when it comes to clinical processes are not obvious to those who do not have a clinical role. Everything needs to be explicit to be understandable to a non-medical reviewer and to be easily reproducible across multiple study sites.

The other thing we realised was that the largest cost, by far, in delivering a study is time. For deliverability and sustainability purposes, this time has to be accurately costed and protected; “doing it in your own time” simply isn’t an acceptable option to sponsors, funders or organisations.

When it’s not research! However, this isn’t always as clear-cut as it might appear. What’s the difference between audit, service evaluation and research? This is a question often asked at interviews or in exams and is another blog in it’s own right (watch this space…). However, the Health Research Authority (HRA) decision toolis an excellent place to start. This simple online form goes through some screening questions to help guide you as to whether your proposed project would be considered research by the HRA.

If the tool comes out with a “no” then your project should be deliverable in a much shorter time frame, without the same degree of regulatory oversight, and will therefore not require anywhere near the same amount of work (and therefore funding).

Our first tip: start small, and/or involve someone who’s “been there, done that.” Funders are unlikely to (ie. the polite expression for “never going to”) give a 3m grant to someone who has never run a research study before. Even if the idea’s excellent, you’re innately “high risk” if you’re new to research and/or working in a department or organisation without a track record for delivering funded research studies.

A good place to start is internally or locally. Your department or Trust may have funding pots available; these may be branded as “seed funding”, “pump-priming grants”, “charitable funds” or any other of a number of possible options. Your department research lead or Trust Research and Development (R&D) or Innovation Team are good places to start looking for information. More information about general information sources can also be found in our first blog postin this series. These grants are typically in the region of 5 – 10,000 and will fund a pilot study, feasibility study or literature review (if costed efficiently).

There are a number of avenues of funding available through the college. PhD fellowships will be mentioned below, but there are also small grant streams: the Young Investigator’s Award and the Small Grants scheme.

Similar to the pump priming above, the RCEM grant scheme will be looking for new researchers with ideas specific to Emergency Medicine (EM). If you’re thinking about applying for one of these, a top tip is to have a look at the RCEM website and the James Lind Alliance collaboration, which created a “Top 30” list of research priorities in UK EM as applications related to these are more likely to be looked upon favourably.

Be aware that the review of these applications is rigorous, but also be reassured that a perfect product is not required, formative feedback and subsequent successful outcome is certainly a possibility. However, the money available is limited and chances of success will rise and fall depending on:

1) What else is submitted in the same round and its relative priority within EM research

2) The likelihood of attracting further external funding as a result of undertaking the current project

3) The impact the award would have on the applicant’s research career

The Young Investigator’s Award is intended for early career researchers, to help facilitate a novel project (or part of one; for example, to enable a literature review that will inform a larger grant application to an external funder). These are awarded based upon presentations delivered at the annual Clinical Studies Group meeting (usually in January) so keep an eye out for a Call for Abstracts in the latter end of the year.

The commonest funder of EM research is the National Institute for Health Research (NIHR) through one of their numerous grant programmes (RfPB, HTA, EME etc). As a relatively new researcher, the Research for Patient Benefit (RfPB) grant is likely to be the most appropriate and accessible avenue to pursue; the grants awarded are (relatively) small i.e. < 350,000 and they have a focus on early career researchers and projects “close to patient benefit”. However, even their relative accessibility should not lead you to underestimate the work involved in an application. You will need the support of experienced researchers and your trust R&D team (or a Clinical Trials Unit (CTU) or equivalent) and you can expect it to take many, many hours of work. Before considering getting started on an application like this we’d strongly suggest having discussed it with an experienced researcher (someone that has held an NIHR grant or equivalent previously). Allow upwards of a year from conception to grant application submission, and another year before you actually start your research project (if you’re successful on the first application).

There are many other funding bodies (for example The Wellcome Trust, The Health Foundation) and each has a specific focus (biomedical, process, pre-clinical etc.) so investigate them thoroughly to ensure your study falls within their remit before applying. You will get an immediate rejection by the editor if you submit something significantly out of scope.

Charities can be an excellent source of funding if your project falls within their scope. The size of the grants available varies significantly by charity (and hence by topic area), and can be anything from a few thousand pounds to multi-million pound awards. Your R&D department will likely have a list of organisations that fund medical research.

Commercial studies (e.g. drug company or device manufacturers) are often lucrative but are usually externally commissioned and take place in already research-active departments. Speak to your department research lead – if you don’t have one, you’re likely not in a position to take on a commercial study!

Multiple organisations (including the RCEM and the NIHR) offer individual awards. These are intended to support early career researchers in gaining research experience, often as part of an academic qualification such as a PhD. They are highly prestigious, very valuable and therefore (unsurprisingly) competitive. The same advice applies as for large grant funders: get expert help early and expect them to be time consuming. The rewards are excellent though, most will fund some or all of both your salary and the research study costs.