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  • 00:00

    [MUSIC PLAYING][Research Methods tutorial][Overview of the Ethical Approval Processin Clinical Trials in the UK]

  • 00:14

    CATHERINE ARUNDEL: I'm Catherine Arundel.I am a trial manager based at the University of York Charlesunit.[Catherine Arundel, Trial Manager, University of York]At the Charles unit, I've been involvedin a range of different trials, some musculoskeletal trials,and more recently I'm more involvedin wounds research and deliveringa program of things across different types of wounds.I also teach at the University of Yorkon the postgraduate programs delivering

  • 00:36

    CATHERINE ARUNDEL [continued]: a practical randomized controlled trialsmodule talking about the practicalities and the thingsyou need to do to deliver a randomized controlled trial.I'm going to talk today about researchethics or ethical approval and the processesthat you need to go through in order to do thatand particularly focusing on the processes thatare within the United Kingdom at the moment.

  • 00:56

    CATHERINE ARUNDEL [continued]: [Why is it important to learn about research ethics?]So it's really important to study and learnabout research ethics really because youneed ethical approval in order to beable to undertake research with patients or membersof the public in any setting.

  • 01:18

    CATHERINE ARUNDEL [continued]: So it's really important to think,I think, around that and the practicalitiesof how you do that and the things you need to considerto make sure that your research is both scientificallysound, but also appropriate and safe for the patientsthat are taking part too.[What ethical considerations are there for randomized controlledtrials?]

  • 01:40

    CATHERINE ARUNDEL [continued]: With randomized trials, there are a coupleof things that you need to considerfrom an ethical point of view.So firstly, there is the research ethics application,which forms part of a larger health research authorityapplication.That will be required for any study,provided that the study is researchand does need research ethical approval.And there are tools within the Health Research Authority,

  • 02:00

    CATHERINE ARUNDEL [continued]: or the HRA, and their Decision Tools websiteoffers a couple of tools to be able to assesswhether your research is, firstly, deemed to be researchand, secondly, whether it does need ethical approval.Aside from that, then, there are other elementsof ethical approval or other types of approvalthat you might need to consider depending on the type of study.

  • 02:20

    CATHERINE ARUNDEL [continued]: So if your study's using a medicinal product,you might need to think about approvals from the MedicinesHealth Regulatory Authority, or the MHRA.If you're using some types of radiology or confidentialityelements, then there are other approvals.Those don't always apply.They're for very specific types.But, again, you might need to be thinking about those depending

  • 02:42

    CATHERINE ARUNDEL [continued]: on the complexity of your research.[What tools are there for setting up ethical approval?]In terms of firstly thinking aboutwhether you need ethical approval--so the Health Research Authority, HRA, have a DecisionTools website, which allows you to determine whether you do

  • 03:03

    CATHERINE ARUNDEL [continued]: need to apply for research ethics and health researchauthority approval.If you do need to do that, then you'llneed to use what's known as the IRAS system, whichwill generate a form to allow you to submitthat application for considerationby both of those groups or one of those,depending on the type of research that you're doing.

  • 03:24

    CATHERINE ARUNDEL [continued]: Within that system, every sectionof what appears to be quite a long formdoes have some guidance for each of those sections.And so it's really useful to use that guidanceto think about the things that you need to include,particularly some of the sections where you'rethinking about design, the methodology, considerations

  • 03:45

    CATHERINE ARUNDEL [continued]: around patient consent, patient approach.There are some really useful tools in therein order to help you to think about the contentthat you need to put there.I think, as well, it's important to talk to colleagues,particularly if there are supervisors or colleagueswithin a unit or a department that have done this before.They will have some tips and suggestions

  • 04:06

    CATHERINE ARUNDEL [continued]: and be able to kind of point you in the right direction in termsof how to seek that approval.[How do you seek ethical approval for your research?]When you submit an application-- so as I say,you'll need to complete this IRAS form.And there are other forms within thatthat may be useful to complete.

  • 04:27

    CATHERINE ARUNDEL [continued]: As I've mentioned, the idea aroundif you've got a medicinal product,you might need to complete a form for the Medicinesand Health Regulatory Authority.You might also need to complete a portfolioform to allow the study to be accepted into the portfoliosystem, but that very much depends on the funding.Once you've filled in and completed your form,that form needs to be signed by your chief investigator, so

  • 04:48

    CATHERINE ARUNDEL [continued]: the person who's leading the research, and the sponsor.It's really useful, when you're gettingto the stage of having that form finalized,to prime both parties that this form will be coming.They do need to electronically sign it.And it can be really frustrating if you send that off to themand then find that one of them's on holiday for two weeks.

  • 05:10

    CATHERINE ARUNDEL [continued]: So prime them.Make sure that somebody's there to sign it or somebody perhapsin their absence if it's around periods of leave.Once you've got your signatures, you'llthen need to make sure that you'veloaded all of the relevant documentation thatsupports that application into a checklist.So that's things like your study protocol,your patient documentation, so your information sheet,

  • 05:30

    CATHERINE ARUNDEL [continued]: your consent form, and any other elements thatare important and integral to the research.That's quite a simple process.It's finding the file much like youdo uploading an email attachment and just uploading thosein, making sure that they're named correctly.Once you've done that, you can thencheck your form within the Submissions tabon the IRAS form, and that will make sure

  • 05:52

    CATHERINE ARUNDEL [continued]: that all of the fields are completed satisfactory.Once that's done, you then need to ringwhat's called a central booking system or service,and they then will arrange to talk youthrough a number of questions to identify the type of or levelof approval that your study can have.And there are two types.There's proportionate review, which is perhaps

  • 06:13

    CATHERINE ARUNDEL [continued]: a shorter and simpler review, or a full ethical committeereview.Generally, most randomized trials,because of their design, would end upgoing through a full ethical review.As part of that central booking system,you will then be able to identify an ethicscommittee to go to if that's the nature of the approvalsprocess.I would strongly recommend that when

  • 06:35

    CATHERINE ARUNDEL [continued]: you come to book in that you've hada conversation with your chief investigator and identified 2,3, 4, or even more potential ethics committees.Ethics committee sit on different daysof the week, different times.So they might be sitting in the morning, the afternoon,or even into the evening.And it's really useful if you and the chief investigatoror another member of the study team

  • 06:55

    CATHERINE ARUNDEL [continued]: are able to go to those meetings to answer questionsthat the research ethics committee have.The difficulty you have with the booking serviceis that if you can't pick an ethics committee,you then have to start the process again or phone themback and go through all of the questions.So having plan A, B, C, D, and so onis a really good tip there in termsof making sure that you make that one call and it's all

  • 07:16

    CATHERINE ARUNDEL [continued]: done in that process.Once the approval's been booked into an ethics committee,you'll then get a couple of lettersjust to confirm that the application has been bookedand then the details of that ethics committee meetingand subsequent validations and approvals of categorizations,

  • 07:37

    CATHERINE ARUNDEL [continued]: I should say, of that approval system.Once you've got your application submitted and bookedinto the ethics committee, you thenneed to begin to prepare for that meeting.So it's good to look back over the applicationthat you've made and consider any elements that the ethicscommittee might want to talk to you further about.So that might be things around perhaps how you'regoing to approach patients, the documentation

  • 07:59

    CATHERINE ARUNDEL [continued]: that you're going to give, the types of patientsthat you're going to include.And so it's really important to just think around those.It's good to come up with a few thoughts on howyou might deal with any elements that the ethics committee mightquery.But there will always be curveballsthat are thrown in during that meeting.They'll always be something that you haven't thought of.So when you come to the ethics committee meeting,

  • 08:20

    CATHERINE ARUNDEL [continued]: it can feel a little bit dauntingbecause you've got a number of people sat around a big table,perhaps in a meeting room, who are there to review your study.Don't feel worried about that, though.They are really there to make surethat your study is going to be well conducted and is rightand run properly for the benefit of your patients.

  • 08:44

    CATHERINE ARUNDEL [continued]: The meetings don't usually take all of that long.It might be five or 10 minutes.And of course, if you've planned this well,you'll have your chief investigator with you whocan support you through that.Once you've had the meeting, the ethics committeeusually try and provide a response to you--I think it's within five days.And that will be in writing.That will either be to approve your study

  • 09:04

    CATHERINE ARUNDEL [continued]: or perhaps they'll ask for some changes,perhaps to inclusion or exclusion criteria.They might ask for a few changes or additions to the informationsheet perhaps.Any of those changes you should alreadybe aware of from the ethics committee meeting.So you could begin to start to work through thosein advance of that letter.Once you've got the letter then, youcan submit a formal response.

  • 09:24

    CATHERINE ARUNDEL [continued]: That does require you perhaps to reopen the IRAS form,and so you'll need to have conversationswith the health research authority or ethics committeein order to do that.So you can upload new documents and resend those three.Once that's done, though, hopefullythen the ethics committee are all happy,and they'll then issue you with a letter that says,yes, your research is ethically sound,

  • 09:46

    CATHERINE ARUNDEL [continued]: and we're happy for this to go ahead.There is then the other level of the Health Research Authority,and they will then sort of complete the final rubberstamp, as it would be, for the study in terms of then saying,yes, this is all legally and sensibly right.And so, yes, we agree to this taking part.

  • 10:07

    CATHERINE ARUNDEL [continued]: You do need to make sure that you'vegot both of those documents full and finaland signed off before you start your study.[What challenges could arise in the ethical approval process?]So in terms of the biggest challenges,I think it's really making sure that your application'sclear about what you intend to do.

  • 10:29

    CATHERINE ARUNDEL [continued]: And as I've mentioned, following the guidance that the IRASsystem gives you is a really good wayto make sure that you've covered all of the elements.Particularly, as well, it's thinkingabout your documentation that will support that applicationand particularly around the information or documentationthat's going to be patient facing.It's really important to get that right and to make sure

  • 10:50

    CATHERINE ARUNDEL [continued]: that the information is readable and also it's clear.Some of the concepts that we think aboutin randomized trials can be quite complex even for usas researchers.And so it's important to try and explain thosein as clear and plain English as you can.Again, there are tools that are able-- they are out thereto help you with that.

  • 11:10

    CATHERINE ARUNDEL [continued]: So the HRA decision tools and havesome good examples and advice on how to design those documents.And again, talking to colleagues who've got experience in thiscan be really useful too.[How did you overcome challenges in ethical approvalfor your own research?]As an example, we've recently submitted

  • 11:33

    CATHERINE ARUNDEL [continued]: a study looking at wounds care.And so when we came to submit that, we'd done a lot of workalready.We thankfully or fortunately had done a pilot earlier.So we could use a lot of the thinkingthat we'd done there to help to develop the applicationfor this full main trial.In terms of the challenges that we faced,

  • 11:53

    CATHERINE ARUNDEL [continued]: I think the first one would be we'd got an ethics committeemeeting booked.Myself and the chief investigatorhad planned to travel to the meeting.But whilst I was traveling to the meeting,the ethics committee had realizedthat the person that was supposedto be in before us wasn't going to come along, so they movedthe meeting forward, which meant I arrived

  • 12:14

    CATHERINE ARUNDEL [continued]: as the chief investigator came out of the meeting.So it's really important and my tipwould be to make sure that you get there in good time.In terms of other things then--so within that meeting, the ethics committeedid bring up a really good point around inclusionage of patients and whether that should be dropped to 16.And thankfully, the chief investigator

  • 12:35

    CATHERINE ARUNDEL [continued]: was able to think around that clinicallyand couldn't see any issue with that.So we have reduced that age down.They did also ask both themselves, research ethicscommittee, and the Health Research Authorityfor a couple of minor additions just to the patient informationsheet just to make it absolutely clear to the patients whatwe were doing, particularly around takingphotographs of patients.

  • 12:57

    CATHERINE ARUNDEL [continued]: And so we, again, were asked to do thatand made those changes ready for the application to be approved.[MUSIC PLAYING]

Video Info

Publisher: SAGE Publications, Ltd.

Publication Year: 2021

Video Type:Tutorial

Methods: Clinical trials, Clinical research, Research ethics, Ethical approval, Consent, Research proposals

Keywords: clinical research; clinical trials; ethical approval; measurement in health services research; randomized control trials; research administration; research design; research ethics; research ethics committees; research proposals ... Show More

Segment Info

Segment Num.: 1

Persons Discussed:

Events Discussed:

Keywords:

Abstract

Catherine Arundel, Clinical Trial Manager at the University of York, discusses the ethical approval process in clinical trials in the UK, including the need for research ethics, ways to seek ethical approval, and overcoming challenges to the ethical approval process.

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Overview of the Ethical Approval Process in Clinical Trials in the UK

Catherine Arundel, Clinical Trial Manager at the University of York, discusses the ethical approval process in clinical trials in the UK, including the need for research ethics, ways to seek ethical approval, and overcoming challenges to the ethical approval process.

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