Posts Tagged ‘documentation’

Permit A 38, NHS REC, IRAS and R&D Approval

My role on CHI+MED is primarily to do field studies in hospitals, to investigate the design and use of medical devices by asking questions like: are they usable? are there design issues with devices? how could they be improved? One of the big differences of doing this sort of research in healthcare, rather than in other domains, is trying to negotiate access to NHS staff, patients and contexts for research purposes. Unfortunately, this puts off good researchers working in this area.

Generally you need to fill out very lengthy forms to get approval from a Research Ethics Committee (REC), you need separate documentation to get personal access – something like a research passport; and local R&D approval at the site you want to enter. Different people give different views about what is required. Many forms are slightly different repetitive versions of other forms. There always seems to be some surprise, bug, hiccup or something you have forgotten to delay progress and to generate more administrative work. Days turn into weeks, weeks turn into months, and it seems months go on and on.

This process is notoriously a bit of a headache – ‘a place that sends you mad’ which we’ll come to in the Asterix cartoon. Here are some nuggets to demonstrate what it is like:

  • For one project, after going through all access hoops described above, some suggested it was all unnecessary, i.e. we should have sought to gain access via an audit route rather than getting NHS research ethics.
  • A friend of mine doing the same thing was advised to speak to person A to get through the next step. They phoned and spoke to person B who explained that person A was on holiday for two weeks. They waited. When person A was back they spoke to them and he explained that he really needed to speak to person B, who of course was there all along.
  • I was advised to send forms through and follow-up the following week. I sent the forms through and phoned the next week and the person that was dealing with this request had left – so I was left in limbo.
  • I was advised to phone the REC to book an appointment and get a REC number before getting authorisation on my IRAS form – once you have authorisation the forms are locked. The REC people said get the authorisations first. I brought up the fact that doing it this way meant that the document was locked and so I couldn’t enter my REC number on the system. The lady suggested I print it out, write it on the form by hand, and then scan it in!
  • I’m now dealing with a separate body for NIHR CSP. They said don’t active the SSI form before they give the go ahead, instead email them everything first. The JRO said this duplicates all the work and that I shouldn’t need to do this. However, I’m just doing this to keep the CSP people happy otherwise I suspect it will cause them some headache, which in the end will probably cause me more headache.
  • Some hospitals require CRB checks, some immunisations, some very little, some require GCP training, and all of it seems a bit random.
  • One colleague thought he had done everything, then someone decided all his documentation needed to be peer reviewed so he was back to the drawing board. He only wanted to interview three managers in three different hospitals about purchasing – 6 months later he’s still not achieved access.
  • Another colleague was through, at least she thought she was, but not quite. The hospital required a change to some forms at the R&D stage, so she had to go back and get an amendment from the REC. She’s an MSc student who has been working on trying to get access for 6 months or so.
  • I was told that our whole project team would need GCP training for this new project we are starting – even researchers that would never step foot inside the hospital. I raised this with someone else who said it was wrong and they found documentation to support this view. We don’t have to because we’re a non-CTIMP study. Again, more work that wasn’t strictly necessary, misinformation and hoop jumping.

There’s lots of documentation and advice on these processes, although I imagine only a few people have a real grasp of the rules and workarounds that go on. My favourite resource for getting a feel for what this process is like sometimes is captured nicely in this video where Asterix is given the rather simple administrative task of getting Permit A 38 (it also serves as a bit of light relief):

If you’re working in this area you might find our new books interesting. They are aimed at researchers that are new to healthcare and just coming into it, although they would be a good source of reflection and debate for more seasoned researchers too. The first volume covers 12 case studies of researchers carrying out HCI and human factors fieldwork in healthcare. The second volume will be published in summer 2014.