The saga continued: Did I tell you about my ethics amendment?

I have previously told you the tale of applying for NHS HRA ethical approval. I described the pain, the suffering and the long over due relief when I finally received approval back earlier this year. Well at the time my supervisors and I agreed that we had been so thorough that we wouldn’t need to go back to do an amendment- who would do that? People who hadn’t planned far enough in advance, people who were not thorough enough, people who enjoy torturing themselves, who have more time and patience than sense. Welll….soon after receiving ethical approval I realised I was one of the people I had sneered at. I realised that I needed to do an amendment to my ethics.

Once I realised (intellectually and emotionally) that I (really) needed to do an amendment I put my head down and attempted to get going. I figured that having submitted a successful ethical application in the first place please surely the amendment couldn’t be too tricky. Well let me be blunt- it was tricky. The biggest difficulty I had was finding out exactly how to do the amendment. I seemed to find a fair bit of conflicting information. And in the end I did more work than entirely necessary (from what I can tell). I did complete an IRAS amendment form and a revised protocol. The IRAS form did need to be signed off by my supervisor AND the ‘sponsor’ in UCL (the joint research office here at UCL). But I also did a few things I didn’t need to and in the wrong order. Here are a few tips and hints in case anyone out there does need to submit an amendment:

  1. Before you do anything else contact the Research Ethics Committee (REC) who approved your project and ask them what to do! I wish I had done this first- they had the most accurate information!!
  2. The HRA website is also helpful BUT also confusing
  3. Don’t ring up the IRAS people – they only really advise on the website and form features etc
  4. Only complete the ethics amendment form. Unless your told otherwise DO NOT I repeat DO NOT edit your existing IRAS form. Simply refer to or list the sections that your amendment applies to in the ethics amendment form.
  5. Check your local sponsor processes too- will they want to see a draft or just the final version? Mine only needed to see the final version to sign it off.
  6. NB: the IRAS amendment form asks for a date and a title- use the full date (including day, month and year and a title that states if this is amendment 1,2,3 etc).
  7. Once you submit the IRAS amendment form on the system this doesn’t necessarily mean it’s submitted – I had to save mine as a PDF and email it to my REC who then acknowledged its arrival.
  8. Be prepared for the REC to ask questions that need a quick response (all via email). I was on leave when mine came and I got a bit of a surprise.
  9. Be positive!!! It will be fine.

I received approval of my amendment last week and am on my way again! Phew. Chin up and keep going. I can do this PhD thing!!! I think….maybe….

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