Authors: Rachelle Sherman, Andrew Tabner, Graham Johnson / Editors: Charlotte Kennedy, Govind Oliver / Codes: CC20, HAP29, SLO10 / Published: 04/07/2019
Approvals – what you need, from who, when by, and how
HRA, IRAS, MHRA, CTIMP, REC, TTFN, CPMS, EDGE, SSC, DIM, ETC, CTU, R&D, CRN, NIHR…The list is endless. The above are all acronyms related to research (well, all but 2…bonus points if you can spot the odd ones out!) However, fear not; by the end of this blog you’ll know what at least 7 of them mean. You can pick up another couple in the previous blogs here and here. In this edition we’re joined by our Clinical Trials Manager, Rachelle Sherman, who is a bottomless-pit of research knowledge to help ensure we get everything right.
As mentioned in the previous blog, the first step in a research project is deciding whether it’s actually research. Seems obvious, but sometimes the distinction can be a little hazy; this online HRA tool is really helpful in justifying your decision on this point. If you need a bit more detail, there is another tool here from the Healthcare Quality Improvement Partnership. If it’s not research then it’s exempt from a number of the regulatory processes we’re about to discuss and will therefore inevitably be both faster and cheaper (likely free).
If it’s clinical audit or a service evaluation (or you’re still not sure), you should get in touch with your clinical audit team as you’ll still need to let them know what you’re doing.
Once you’re sure it’s research, you need to work out whether it:
a) Enrols staff
b) Uses anonymised, routinely collected data
c) Doesn’t enrol anyone, but uses patient-identifiable data
d) Enrols patients
The approvals required for each of the above categories (and we’re not claiming that they’re exhaustive or mutually exclusive) are different; we’ll go through each in turn below as well as how to apply for them.
But before you address approvals, there are other bits to have in place (again, check the first couple of blog posts for more details). In short, you’ll need an idea, a protocol, a team and some money (possibly more money than you think…). Any kind of research in health and social care also needs a sponsor. They don’t necessarily provide funding for the study, but officially they will take on responsibility for your project, ensuring it is set up, financed and managed appropriately. In non-commercial research it will be the NHS Trust (courtesy of the R&D department) or the research governance team at a University who will take on that role. Don’t leave it too late to identify a sponsor as their involvement will vary from institution to institution.
If your potential participants are identified purely by virtue of their role as a member of NHS staff, you’re only going to ask them for their opinions/experiences (rather than doing things to them), and you’re not going to ask them anything that could be deemed “sensitive/intrusive” (think sexual history, political views etc.) then you get away with what’s probably the lightest approval requirement. However, you WILL still need HRA approval – this stands for Health Research Authority, and they’re responsible (along with other bodies) for overseeing health research in the UK.
An example of this kind of research would be asking your data team to generate a report comparing time of presentation to the Emergency Department and length of time in the department, then comparing the two. This would also require HRA approval (unless you could bill it as service evaluation) but it wouldn’t require REC approval. REC, as many of you may know, stands for Research Ethics Committee. They review your proposal with the patient’s best interests at heart and will often make suggestions or require changes to your research plan.
This will require both HRA and REC approvals (although there may be an option for proportionate review – more information here). It’s also worth bearing in mind that you’ll either need consent from each patient (tricky in a large database study) or be compliant with the Confidentiality Advisory Group (CAG) guidance. This is a fairly large topic but in brief, it’s probably ok to review patient notes without consent if you’re part of the usual care team i.e. you’d usually have reason to look at their notes. Precisely how this is defined varies from one Trust to another, and will likely require discussion with your Caldicott Guardian and/or the Information Governance team.
Unsurprisingly, this is the most closely regulated form of research. Again unsurprisingly, giving drugs to patients is even more closely regulated (this type of trial is referred to as a Clinical Trial of an Investigational Medicinal Product or “CTIMP”). If you’re doing this kind of research you definitely need to be talking to your Research and Development or Research and Innovation (R&D/R&I) team and/or a local Clinical Trials Unit (CTU). You’ll definitely need HRA and REC approvals, and CTIMPs will require MHRA approvals too (Medicines and Healthcare Products Regulatory Agency). Remember the amount of green pen on the first drug card you wrote as an F1? Yeah, that’s how an MHRA application tends to feel…
How do you apply for approvals?
First, make sure your protocol is pinned down as far as possible; it’s a good idea to liaise with R&D for this. You will draw heavily on this whilst completing the IRAS form (Integrated Research Application System). This form acts as a single point of access for HRA, REC and MHRA approvals and is intended to reduce the duplication of effort in making multiple applications. It looks very intimidating and clunky, but is actually fairly digestible once you get your head around how it works. Our top tip: don’t forget to use the little green ticks to indicate parts you’ve filled in completely / finished!
There are sections of the IRAS form that WILL require input from other people – think study monitoring, record archiving etc. Don’t struggle on with this by yourself, but ask for help early (R&D again). There are people around whose job it is to complete this kind of thing – they will probably be better at it than you, and they’ll certainly be quicker!
You’ll need all your study documents completed before you can submit your forms to the relevant authority. This includes the protocol but also things like Patient Information Sheets, Consent Forms etc. Be pedantic with version numbers and dates or you’ll just get pulled up later.
Finally, from experience, don’t send for sign-off until everything’s completed. The form will need signing off by the Chief Investigator (which may be you) and a sponsor’s representative e.g. head of R&D. These electronic signatures disappear if ANYTHING on the form is changed after they’re applied and you have to begin the sign-off process all over again. You’ve been warned…(Us, bitter? Nah…).
Overall the approvals process for research can feel complex and there are a few quirks. Get expert help early (and WELL before you’re actually thinking of applying.) Also be aware of how long these processes can take (think months, not weeks) so start early and be mindful of this when setting yourself deadlines e.g. telling a funder when you’ll start recruiting participants. It’s better to be conservative and have approvals in place sooner than expected than to be optimistic and miss your deadlines…
As always, feel free to contact us with any questions!