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<title>How to cope with a Research Ethics Committee</title></titleStmt>

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<availability><p>The British Academic Spoken English (BASE) corpus was developed at the

Universities of Warwick and Reading, under the directorship of Hilary Nesi

(Centre for English Language Teacher Education, Warwick) and Paul Thompson

(Department of Applied Linguistics, Reading), with funding from BALEAP,

EURALEX, the British Academy and the Arts and Humanities Research Board. The

original recordings are held at the Universities of Warwick and Reading, and

at the Oxford Text Archive and may be consulted by bona fide researchers

upon written application to any of the holding bodies.

The BASE corpus is freely available to researchers who agree to the

following conditions:</p>

<p>1. The recordings and transcriptions should not be modified in any


<p>2. The recordings and transcriptions should be used for research purposes

only; they should not be reproduced in teaching materials</p>

<p>3. The recordings and transcriptions should not be reproduced in full for

a wider audience/readership, although researchers are free to quote short

passages of text (up to 200 running words from any given speech event)</p>

<p>4. The corpus developers should be informed of all presentations or

publications arising from analysis of the corpus</p><p>

Researchers should acknowledge their use of the corpus using the following

form of words:

The recordings and transcriptions used in this study come from the British

Academic Spoken English (BASE) corpus, which was developed at the

Universities of Warwick and Reading under the directorship of Hilary Nesi

(Warwick) and Paul Thompson (Reading). Corpus development was assisted by

funding from the Universities of Warwick and Reading, BALEAP, EURALEX, the

British Academy and the Arts and Humanities Research Board. </p></availability>




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<item n="speechevent">Lecture</item>

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<u who="nm0285"><kinesic desc="projector is on showing slide" iterated="n"/> as as some of you will know i'm very much concerned <pause dur="0.2"/> actually <pause dur="0.2"/> that <pause dur="0.3"/> medical research should involve people <pause dur="0.5"/> # as as subjects of the research and obviously particularly patients <pause dur="0.4"/> as subjects of research and <pause dur="0.6"/> # i sometimes say slightly derogatory things about <pause dur="0.4"/> tissue culture and animal models of <trunc>s</trunc> and so forth <pause dur="0.3"/> of course these have their place <pause dur="0.3"/> but ultimately if we're going to understand human disease <pause dur="0.4"/> then we have to work with human patients <pause dur="0.6"/> <vocal desc="clears throat" iterated="n"/> and that means that we have to get ethical approval <pause dur="0.5"/> # for such research <pause dur="0.3"/> now ethical approval for work with patients <pause dur="0.3"/> actually is fairly simple compared with ethical approval for working with animals <pause dur="0.4"/> as some some people have found out <pause dur="0.4"/> and getting ethical approval from a research ethics committee <pause dur="0.5"/> is actually rather easier <pause dur="0.3"/> in some <trunc>s</trunc> some ways <pause dur="0.3"/> than coping with your local R and D committees again <pause dur="0.4"/> some people who work in the hospital will well know <pause dur="1.4"/> so what i'm going to do today is talk a

little bit about the background <pause dur="0.4"/> # of research medical research ethics <pause dur="0.5"/> # i shall talk about the sort of <pause dur="0.3"/> way in which <pause dur="0.6"/> # medical <pause dur="0.3"/> research is <pause dur="0.2"/> controlled in this country <pause dur="0.3"/> and i shall go on and talk in a bit more detail about the actual way in which you organize <pause dur="0.4"/> # a proposal so that it gets approved by the medical research ethics committee <pause dur="0.6"/> # and i shall <pause dur="0.3"/> point out some of the pitfalls <pause dur="0.5"/> okay so my qualifications for doing this <pause dur="0.3"/> are as you see i'm actually the vice-chairman of the <gap reason="name" extent="1 word"/> of the local <pause dur="0.3"/> research ethics committee <pause dur="0.6"/> # also as you <pause dur="0.5"/> i'm sure you know <pause dur="0.3"/> # i've been much involved in medical research over some years now <pause dur="0.5"/> and my research has exclusively dealt with <pause dur="0.3"/> with people <pause dur="0.3"/> # research into disease using # <pause dur="0.2"/> human subjects <pause dur="1.4"/><kinesic desc="changes slide" iterated="n"/> so <pause dur="0.8"/> why do we need to regulate <pause dur="0.3"/> medical research now to most of us <pause dur="0.3"/> that would seem seem absolutely self-evident <pause dur="0.5"/> but <pause dur="0.3"/> take ourselves back fifty years <pause dur="0.3"/> and it wasn't nearly so self-evident <pause dur="0.4"/> # but you've come a long way since the time <pause dur="0.3"/> of

<vocal desc="clears throat" iterated="n"/> # the last <pause dur="0.3"/> <trunc>f</trunc> # the Second World War <pause dur="0.3"/> if anybody has any <pause dur="0.6"/> doubt <pause dur="0.3"/> about why we <pause dur="0.6"/> need to regulate medical research i'll just mention these two names <pause dur="0.5"/> Mengele and Tuskegee Mengele <pause dur="0.7"/> was a German who carried out some rather frightful <pause dur="0.5"/> # experiments with people in concentration camps and so on <pause dur="0.9"/> # i'm not quite sure what happened to him i'm i'm fairly sure that he went through the Nuremberg Trials and didn't survive <pause dur="0.6"/> Tuskegee <pause dur="0.6"/> you may not have heard about Tuskegee <pause dur="0.4"/> is actually not a man <pause dur="0.3"/> it's a place it's a place in the United States of America <pause dur="0.4"/> # where over a period of some decades <pause dur="0.4"/> a group of # American Africans <pause dur="0.4"/> with syphilis were left untreated <pause dur="0.5"/> # although there were perfectly acceptable perfectly good treatments available at the time <pause dur="0.3"/> so that the natural history <pause dur="0.2"/> development of the disease could be studied <pause dur="0.4"/> now obviously <pause dur="0.2"/> those are rather extreme examples <pause dur="0.4"/> but # those that have been looking into the press and listening to <pause dur="0.3"/> issues

in the N-H-S over the last few years <pause dur="0.2"/> know perfectly well <pause dur="0.2"/> that there is an ongoing <pause dur="0.3"/> # problem not so much problem ongoing concern <pause dur="0.3"/> with medical research ethics you will remember <pause dur="0.3"/> # <vocal desc="clears throat" iterated="n"/> the <pause dur="0.2"/> fuss about the <pause dur="0.6"/> organs of children that were retained at # Liverpool <gap reason="inaudible" extent="1 sec"/> a fairly recent example and there are still major repercussions <pause dur="0.3"/> of these sorts of events <pause dur="0.5"/> particularly i mean the <trunc>availa</trunc> the availability of <pause dur="0.3"/> # <trunc>ch</trunc> # paediatric tissue for research <pause dur="0.3"/> so <gap reason="name" extent="1 word"/> you're nodding your head just then there <pause dur="0.3"/> was that a <gap reason="inaudible" extent="1 sec"/> </u><u who="sm0286" trans="overlap"> <gap reason="inaudible" extent="1 sec"/></u><pause dur="0.6"/> <u who="nm0285" trans="pause"> # and others <pause dur="0.2"/> again will know <pause dur="0.4"/> that because of these sorts <pause dur="0.2"/> of scandal it's not too strong a word <pause dur="0.5"/> it has been very difficult to do some kinds of research <pause dur="0.8"/> so <pause dur="1.5"/><kinesic desc="changes slide" iterated="n"/> regulation of medical # research is essential <pause dur="0.5"/> now what happens <pause dur="0.4"/> say <pause dur="0.2"/> you decide oh bugger it i'm doing some research rather than <gap reason="inaudible" extent="1 sec"/> medical research <pause dur="0.2"/> what happens if you are discovered to be doing <pause dur="0.3"/> research which should have ethical approval and you haven't got it <pause dur="0.4"/> now first of all # <pause dur="0.3"/> this really applies to doctors <pause dur="0.3"/> the medical defence union cover or what is

the <trunc>equiv</trunc> equivalent would be void <pause dur="0.6"/> so that if anything goes wrong you are <trunc>s</trunc> subject to the criminal law <pause dur="0.6"/> # <pause dur="0.2"/> the <pause dur="0.4"/> chief <pause dur="0.2"/> executive <trunc>os</trunc> officer of the hospital <pause dur="0.4"/> would almost certainly want to talk to you <pause dur="0.7"/> # and i'll mention in a little while that i recently had a letter <pause dur="0.3"/> from the chief executive officer of the <gap reason="name" extent="1 word"/> Hospital <pause dur="0.3"/> so i know that from a personal <pause dur="0.2"/> point of view <pause dur="0.5"/> # <pause dur="0.2"/> if you're medically qualified <pause dur="0.4"/> # the G-M-C <pause dur="0.4"/> General Medical Council <pause dur="0.4"/> could well want to talk to you <pause dur="0.4"/> # and perhaps also the police under extreme circumstances so this is something we obviously <pause dur="0.5"/> have to take <pause dur="0.5"/><kinesic desc="changes slide" iterated="n"/> # very seriously <pause dur="1.6"/> now as i just hinted from time to time <pause dur="0.2"/> # well not so much <gap reason="inaudible" extent="1 sec"/> this <pause dur="0.5"/> <gap reason="inaudible" extent="1 sec"/> from time to time <pause dur="0.3"/> the local hospital <pause dur="0.2"/> trust <pause dur="0.2"/> does audits <pause dur="0.3"/> on medical research and i have just discovered that they do that <pause dur="0.3"/> 'cause i had a letter from the chief executive officer pointing out <pause dur="0.3"/> that some of the work done under my <trunc>pr</trunc> my supervision <pause dur="0.4"/> # the consent forms are not in proper <pause dur="0.2"/> order <pause dur="0.9"/> it was rather a fierce

letter that i think you'll enjoy reading <pause dur="1.8"/> okay <pause dur="2.8"/><kinesic desc="changes slide" iterated="n"/> i will ask the question how am i supposed to <trunc>s</trunc> supervise directly <pause dur="0.5"/> # that's the second issue <pause dur="0.5"/> # so a little bit of history now i've already referred to that guy Mengele <pause dur="0.4"/> # the consequence of the sorts of things he was doing not just him but others <pause dur="0.5"/> # the Nuremberg Code was developed in <trunc>nineteen-fif</trunc> nineteen-forty-seven <pause dur="0.4"/> to regulate and start start to control medical research <pause dur="0.4"/> things like the Universal Declaration of Human Rights <pause dur="0.4"/> and then only in nineteen-sixty-four <pause dur="0.3"/> there was the Declaration of <pause dur="0.3"/> Helsinki <pause dur="0.2"/> which is a very large document which goes into immense detail about all sorts of <trunc>a</trunc> aspects of medical ethics <pause dur="0.5"/> # many many pages i've never read it perhaps i should have done but i haven't <pause dur="0.4"/> and then there # have been other things since then <pause dur="0.4"/> # <trunc>mon</trunc> you've seen modification of the Declaration of Human <gap reason="inaudible" extent="1 sec"/> Helsinki organizations such as the World Health Organization <pause dur="0.7"/> the Council for International Organizations of Medical Science obviously the <trunc>me</trunc> the M-R-C the various Royal

Colleges in this country and so on <pause dur="0.3"/> all of them <pause dur="0.3"/> sort of dig in # have a little bit they have a say <pause dur="0.4"/> # about medical research ethics so there's <pause dur="0.3"/> # a lot of things going on as it were <pause dur="1.4"/><kinesic desc="changes slide" iterated="n"/> now <pause dur="0.5"/> that's a bit of history <pause dur="0.5"/> for the future <pause dur="0.3"/> # as always the European Union <pause dur="0.3"/> is lumbering in here <pause dur="0.5"/> # and there is a regulation is drawn up by the European Union <pause dur="0.7"/> called this <pause dur="1.3"/> which is supposed to be coming into force this year but hadn't <pause dur="0.2"/> won't <pause dur="0.4"/> yeah it's here now <pause dur="0.3"/> and i've had a quick look <pause dur="0.5"/> at the <trunc>med</trunc> at the web site <pause dur="0.2"/> and there's <pause dur="0.3"/> downloaded a document of seventy-one pages <pause dur="0.3"/> basically of definitions and regulations okay <pause dur="0.3"/> dreadfully enormous document <pause dur="1.0"/> for the moment <pause dur="0.2"/> <vocal desc="clears throat" iterated="n"/> this document deals only with the conduct of clinical trials <pause dur="0.4"/> involving <pause dur="0.2"/> basically drugs but medical products it says in general so that could be wooden legs <pause dur="0.3"/> but mostly it's drugs <pause dur="0.4"/> but you can bet your bottom dollar that sooner or later <pause dur="0.2"/> this sort of # <pause dur="0.2"/> European Union regulations will come in <pause dur="0.2"/> to cover all aspects of medical

research so <pause dur="0.5"/> <unclear>it's something we're</unclear> going to have to keep our eyes on <pause dur="2.3"/><kinesic desc="changes slide" iterated="n"/> okay <pause dur="0.3"/> # in addition because of the recent fusses about <pause dur="0.3"/> retention of tissues <pause dur="0.2"/> there has been extensive # <pause dur="0.6"/> # consultation by the government on these issues of retained tissues <pause dur="0.3"/> and there will be regulation <pause dur="0.5"/> and if you want to see more about that i will obviously i have all these <pause dur="0.4"/> web sites if you want to look at them <pause dur="0.4"/> and there's a summary of responses to the consultation report P-D-F <pause dur="0.6"/> <unclear>again a</unclear> another very substantial document <pause dur="0.2"/> hours of reading <pause dur="1.7"/> okay <pause dur="0.2"/> so let's leave that <pause dur="0.5"/> and go on and talk about the basis for ethical medical research <pause dur="1.3"/><kinesic desc="changes slide" iterated="n"/> # i'm not an <trunc>ethici</trunc> i'm not a professional ethicist as you know i'm a professional biologist <pause dur="0.3"/> so i haven't made # ever made any sort of significant study of the nature of medical ethics from a from a philosophical moral <pause dur="0.3"/> point of view <pause dur="0.2"/> but i have grasped that there are two major points <pause dur="0.4"/> that we have to consider when organizing medical <pause dur="0.3"/> research <pause dur="0.3"/> one is this thing to do the so-called autonomy

of the individual <pause dur="0.4"/> and the other is the issue of do no harm <pause dur="0.3"/> non-maleficence <pause dur="0.5"/> if you want to know the technical term for that <pause dur="1.0"/> and the basic point is that present harm no no sort of present harm can justify any sort of future good <pause dur="2.3"/><kinesic desc="changes slide" iterated="n"/> so what do we mean <pause dur="0.2"/> by autonomy of the individual again <pause dur="0.3"/> this is # sort of a lay person's view of this <pause dur="0.5"/> but as i understand it <pause dur="0.2"/> the whole issue <pause dur="0.5"/> is that i am in control of my destiny i am the person who controls my life <pause dur="0.3"/> i am the person in theory <pause dur="0.3"/> # that controls everything that happens to me unless i trangress the law of course in which case i go to prison <pause dur="0.6"/> # so only i <pause dur="0.3"/> can choose what happens to me <pause dur="0.6"/> now <pause dur="0.3"/> there's an important issue here <pause dur="0.8"/> i can only choose sensibly and properly if i'm fully informed <pause dur="0.4"/> about the consequences of my choice <pause dur="0.4"/> i'll give you # a non-research example <pause dur="0.4"/> the # thing about <pause dur="0.3"/> # <pause dur="0.4"/> M-M-R vaccination a little while ago people were saying <pause dur="0.5"/> M-M-R vaccination may cause <trunc>aut</trunc> # autism or related illnesses <pause dur="0.3"/> therefore we have

single vaccinations <pause dur="0.2"/> people must be given the choice of what they want to do for their babies M-M-R <pause dur="0.2"/> or single vaccinations <pause dur="0.3"/> now there's no way that can be an informed choice 'cause nobody knows <pause dur="0.6"/> what are the real consequences of M-M-R <pause dur="0.3"/> and the real consequences of single vaccinations so there is no <pause dur="0.3"/> question of <trunc>info</trunc> or informed choice here <pause dur="0.6"/> so in fact there is no choice in that issue <pause dur="0.4"/> that's that's just an illustration obviously it's not to do with research but the issue is the same <pause dur="0.3"/> in order to make a choice <pause dur="0.3"/> about whether or not <pause dur="0.2"/> to take part in medical research is what i'm talking about <pause dur="0.4"/> we have to know properly <pause dur="0.3"/> what are the consequences of that choice <pause dur="1.6"/><kinesic desc="changes slide" iterated="n"/> okay now <pause dur="0.3"/> non-maleficence <pause dur="1.6"/> do no harm <pause dur="1.4"/> basic principle throughout medicine goes back to Hippocrates <pause dur="0.3"/> by the way <pause dur="0.2"/> # doctors no longer take the <trunc>hipprocra</trunc> Hippocratic oath is that true <gap reason="name" extent="1 word"/> </u><u who="nm0287" trans="latching"> <unclear>i think</unclear> that's correct yeah </u><pause dur="0.2"/> <u who="nm0285" trans="pause"> yeah because we go get all get all these references to the Hippocratic oath <pause dur="0.4"/> and we see

these things in newspapers about this being contrary to the Hippocratic oath which doctors take and that's not true <pause dur="0.4"/> but doctors nevertheless <pause dur="0.2"/> do you sign a declaration don't you # <pause dur="0.3"/> # which <pause dur="0.2"/> basically covers the same sort of ideas <pause dur="0.5"/> # as the Hippocratic oath and of course <pause dur="0.3"/> a major principle of that <trunc>h</trunc> has to be do no harm <pause dur="0.5"/> well now <pause dur="0.3"/> # <pause dur="1.0"/> in medical research <pause dur="0.8"/> if we adhere strictly <pause dur="0.4"/> to the to the concept of do no harm <pause dur="0.5"/> you would do no medical research <pause dur="0.4"/> because any medical intervention <pause dur="0.4"/> potentially <pause dur="0.5"/> has the <trunc>ha</trunc> <trunc>ha</trunc> can do harm <pause dur="0.4"/> even well not <pause dur="0.2"/> i suppose not a pinprick to take a few micrometres of blood <pause dur="0.3"/> but almost any any other sort of intervention any other sort of procedure <pause dur="0.4"/> involving # <pause dur="0.6"/> anything to do with <pause dur="0.2"/> treatment or or or whatever <pause dur="0.5"/> potentially has harm <pause dur="0.9"/> so we have to modify <pause dur="0.3"/> this point about non-maleficence <pause dur="0.3"/> otherwise there will be no medical research <pause dur="0.4"/> so that is modified in in practice <pause dur="3.6"/><kinesic desc="changes slide" iterated="n"/> okay so <pause dur="0.3"/> to pull those two points together <pause dur="0.6"/> # in order the basis for medical

research ethical medical research <pause dur="0.4"/> is it the <pause dur="0.4"/> the research subject <pause dur="0.3"/> clearly must understand the risks <pause dur="0.3"/> and benefits of the research <pause dur="0.4"/> # and so that he can give proper informed consent <pause dur="0.5"/> likewise <pause dur="0.5"/> the risks from the research <pause dur="0.3"/> should be proportionate to the benefits that come out of it <pause dur="2.7"/><kinesic desc="changes slide" iterated="n"/> okay <pause dur="0.7"/> so with that as the basis <pause dur="0.4"/> when do we <pause dur="0.3"/> need to apply for ethical approval <pause dur="0.6"/> and quite simply <pause dur="0.4"/> # we have to apply for <trunc>medic</trunc> ethical approval <pause dur="0.2"/> for any research involving <pause dur="0.4"/> either patients <pause dur="0.3"/> or their carers at home say <pause dur="0.4"/> or <pause dur="0.2"/> medical personnel <pause dur="0.5"/> and that comes as a bit of a surprise to some people <pause dur="0.4"/> why medical personnel <pause dur="0.4"/> # and the argument is <pause dur="0.4"/> # that # <pause dur="0.5"/> nurses midwives porters <trunc>whoe</trunc> whoever <pause dur="0.3"/> if their employer i mean when i say medical personnel what i really mean is N-H-S employees which includes doctors and it includes everybody else as well <pause dur="0.7"/> the issue has come up before now <pause dur="0.4"/> # that medical personnel being involved in research have felt pressured <pause dur="0.3"/> to take part in that research because they have felt <pause dur="0.4"/> that if they

didn't <pause dur="0.3"/> then their careers may be prejudiced and <unclear>however</unclear> you'd say that that's nonsense <pause dur="0.2"/> but anyway the point is <pause dur="0.3"/> # this is the position they're in so carers and medical personnel <pause dur="0.3"/> are also <pause dur="0.4"/> got to be considered <pause dur="1.0"/> in the in the issue of <pause dur="0.4"/> ethical research now i'll give you an example where <pause dur="0.3"/> actually <pause dur="0.3"/> # this could have been <pause dur="0.4"/> # a significant issue <pause dur="0.3"/> there was a proposal that came before a an our research ethics committee <pause dur="0.4"/> in which personnel N-H-S employees <pause dur="0.4"/> were required to # speak to people in pubs <pause dur="0.3"/> about # their sexual habits now you can just imagine <pause dur="0.3"/> under certain circumstances that could have <pause dur="0.2"/> ended up in a punch-up <pause dur="0.9"/> and so the ethics committee involved said no they can't do that <pause dur="0.3"/> i'm afraid you'll have to find other ways of approaching the people <pause dur="0.3"/> that you want to discover the facts about their sexual practices and so on <pause dur="0.3"/> not in the pub <pause dur="0.3"/> somewhere else <pause dur="0.5"/> of course the whole point was that <pause dur="0.4"/> # they wanted to have a <pause dur="0.4"/> # a broader group of people than those that came along to the <pause dur="0.4"/> # # <unclear>say they went</unclear> to the <pause dur="0.2"/>

G-U clinic <shift feature="voice" new="whisp"/><gap reason="inaudible" extent="1 sec"/><shift feature="voice" new="normal"/> <pause dur="0.6"/> people that <pause dur="0.4"/> # perhaps i'll not pursue that <pause dur="0.2"/> point <pause dur="0.7"/> okay <pause dur="1.5"/> now <pause dur="1.4"/> curiously <pause dur="0.4"/> research involving healthy volunteers <pause dur="0.4"/> technically you don't need ethical approval <pause dur="0.4"/> but i can see the days <pause dur="0.3"/> when that is the case are <pause dur="0.2"/> <trunc>s</trunc> <pause dur="0.2"/> certainly numbered i think <pause dur="0.4"/> before very long <pause dur="0.2"/> # any sort of medical research whether it involves <pause dur="0.2"/> patients carers medical people whatever <pause dur="0.7"/> # including people like you and i fit and healthy <pause dur="0.4"/> # <pause dur="0.7"/> that will have to go in front of an ethical committee <pause dur="0.8"/> yeah an awful lot of public health research <pause dur="0.4"/> # is done with the general population for example certain questionnaires are sent out <pause dur="0.5"/> # about how many times you consulted your doctor in the last month or six months or whatever and why and did you enjoy the experience and so on and so forth <pause dur="0.5"/> # that at the present moment doesn't require ethical approval 'cause it's not <pause dur="0.4"/> directed at the patients <pause dur="0.8"/> but if you look <pause dur="0.3"/> at the web site <pause dur="0.2"/> COREC web site <pause dur="0.3"/> # the implication is that everybody because he or she

sooner or later <pause dur="1.0"/> is will be has been <pause dur="0.2"/> a patient <pause dur="0.3"/> everybody <pause dur="0.2"/> is patients <pause dur="0.2"/> and of course we all of us are patients at some stage in our life <pause dur="0.3"/> so <pause dur="0.2"/> i'm quite sure that before very long everybody will be involved <pause dur="0.5"/> in this so you will not be able to do anything to people of any sort <pause dur="0.3"/> without ethical approval <pause dur="0.3"/> that's perhaps <pause dur="0.4"/> a little way down the line <pause dur="2.5"/><kinesic desc="changes slide" iterated="n"/> now # this is a thorny question what is <pause dur="0.5"/> medical research <pause dur="0.4"/> some people say that medical research is anything that's funded by a medical research agency well you know my feelings on that <pause dur="0.5"/> # my view <pause dur="0.2"/> is quite plainly any investigation of our and i've already said this <pause dur="0.3"/> patients their carers or medical staff <pause dur="0.2"/> where the aim is to discover new medical knowledge <pause dur="1.0"/> # the nature of this research can be basically anything qualitative research as i just alluded <pause dur="0.3"/> to a sort of research which is qualitative how <trunc>m</trunc> how many times have you been to a doctor <pause dur="0.4"/> how <trunc>d</trunc> how did you enjoy the experience that sort of question <pause dur="0.5"/> to patients <pause dur="0.5"/> # you will have seen <pause dur="0.3"/> research of that sort

from our undergraduates over the last few weeks <pause dur="0.4"/> you can understand <pause dur="0.2"/> # <pause dur="0.9"/> what is meant by qualitative in that context <pause dur="0.6"/> some of our undergraduates tried to get some quantitative <pause dur="0.4"/> data from their research i'm talking about <pause dur="0.5"/> # the sorts of things that my students do they # one of my students for example <pause dur="0.5"/> # compared <pause dur="0.2"/> a group in Kenilworth <pause dur="0.3"/> and a group in Bristol according to their knowledge <pause dur="0.5"/> of # current carcinoma screening programmes <pause dur="0.3"/> because there's a pilot programme locally there's not one in Bristol <pause dur="0.5"/> the guys locally <pause dur="0.3"/> knew about it the guys in Bristol didn't <pause dur="0.2"/> and she was able to clearly get good statistical <pause dur="0.3"/> # significance between those two groups that's the kind of quantitative research <pause dur="0.4"/> because it didn't involve patients except indirectly it's a bit of a <pause dur="0.2"/> sleight of hand <pause dur="0.3"/> because it didn't involve patients it didn't require ethical approval <pause dur="0.7"/> okay but you see the point that i'm trying to make <pause dur="0.4"/> that's what a study if it involved patients certainly would <pause dur="1.3"/> now clinical research # that

includes things like drug trials epidemiology we know what that means i've mentioned drug trials there <pause dur="0.3"/> lab based the sort of thing <pause dur="0.2"/> that i do a lot <pause dur="0.6"/> # we want bits of colorectal tissue in or carcinoma tissue <pause dur="0.4"/> particularly in order to study <pause dur="0.3"/> the processes involved in carcinomas <pause dur="0.3"/> now with the tissues there's an issue i'll come later come up later bring up later <pause dur="0.4"/> the tissue is removed at # the operation <pause dur="0.4"/> # and my use of the tissue has very little consequences for the patient's well-being <pause dur="0.5"/> i could say there's no consequences for the patient's well-being but that isn't quite true in fact <pause dur="0.5"/> because the pathologist always wants a bit of that tissue <pause dur="0.3"/> obviously to do the pathological study <pause dur="0.5"/> and so if the researcher says well i want the biggest bit <pause dur="0.4"/> the pathologist may be # some weak-kneed feeble sort of person doesn't happen of course not in my experience <pause dur="0.3"/> and so he gives up <pause dur="0.2"/> most of the tissue <pause dur="0.2"/> so that would be very unethical obviously so in this situation <pause dur="0.3"/> where basically we're using unwanted tissue

you still have to have ethical approval of course we do <pause dur="0.9"/> so that's really what i mean by lab based <pause dur="0.5"/> retrospective prospective whatever <pause dur="0.4"/> okay <pause dur="0.2"/> so <pause dur="0.3"/> there we are very broad definition of medical research <pause dur="1.0"/><kinesic desc="changes slide" iterated="n"/> now it's not <pause dur="0.4"/> absolutely broad because <pause dur="0.2"/> there's always this issue of audit now # medical practitioners get very concerned about what is the difference between reseach and audit <pause dur="0.4"/> and <pause dur="0.4"/> to be honest it's very difficult to say <pause dur="0.6"/> but <pause dur="0.8"/> the way i look at it <pause dur="1.0"/> research <pause dur="0.3"/> is aimed at generating <pause dur="0.2"/> new knowledge <pause dur="0.2"/> that if you didn't do the research <pause dur="0.3"/> that knowledge would not be available you could not get it so you have to do the research to generate new knowledge <pause dur="0.8"/> audit <pause dur="1.0"/> is more a retrospective looking at <pause dur="0.2"/> current practice current knowledge <pause dur="0.4"/> # with the aim <pause dur="0.2"/> of # validating or confirming the value whatever <pause dur="0.3"/> of the current medical practice <pause dur="0.4"/> so if you have a series of patients <pause dur="0.2"/> # some of <pause dur="0.3"/> women <pause dur="0.2"/> # who give birth at home or women who give birth in a swimming pool <pause dur="0.2"/> or women who give birth in an obstetrics ward <pause dur="0.2"/> and you've been doing this for several years you've got <pause dur="0.2"/>

good numbers of all three kinds of women <pause dur="0.4"/> # and you want to see who'd do better or which babies do better or whatever <pause dur="0.3"/> that is not research because it's retrospective and it involves material that's <pause dur="0.5"/> that are already available and it it it isn't <pause dur="0.3"/> it's simply a means of <pause dur="0.4"/> # establishing the validity of your work <pause dur="0.5"/> and this is obviously much more medical than <pause dur="0.3"/> concerns us <pause dur="0.7"/> now as i said at the bottom if in doubt <pause dur="0.2"/> over these sorts of issues and this is a general principle if you're in doubt <pause dur="0.4"/> then consult the local <pause dur="0.5"/> research ethics committee <pause dur="0.9"/><kinesic desc="changes slide" iterated="n"/> # this is a point which is absolutely self-evident medical research can only be done <pause dur="0.3"/> in collaboration with medical practitioners <pause dur="2.7"/><kinesic desc="changes slide" iterated="n"/> okay <pause dur="0.3"/> so <pause dur="1.6"/> that's got <pause dur="0.3"/> some stuff out of the way <pause dur="0.3"/> what i want to go on now is talk a little bit more about the actual regulation <pause dur="0.4"/> of research ethics who does it <pause dur="0.6"/> then i'll go on to say how it's done <pause dur="0.8"/> now at present there's no legal framework but as i've already implied <pause dur="1.5"/> that is going to change <pause dur="0.5"/> # and that

directive <pause dur="0.2"/> # as i referred to earlier <pause dur="0.2"/> is supposed to be brought into national law <pause dur="0.4"/> by May of next year <pause dur="0.7"/> now this at the moment only applies to drug trials <pause dur="0.5"/> so we don't you you don't need to fret about it most of you don't need to fret about it <pause dur="1.8"/> <vocal desc="clears throat" iterated="n"/> <pause dur="0.2"/> who regulates research ethics again <pause dur="0.4"/> research ethics committees <pause dur="0.6"/> R-E-Cs <pause dur="0.3"/> now these <pause dur="0.4"/> are set up by the local research authority <pause dur="0.2"/> at present <pause dur="0.2"/> our local research <trunc>authora</trunc> authority has got the glorious name of <pause dur="0.4"/> West Midlands South <pause dur="0.3"/> all right not South Midlands West or South West Midlands but West Midlands South <pause dur="0.7"/> # this research <trunc>ethi</trunc> # this health authority <pause dur="0.4"/> # sets up <pause dur="0.2"/> these committees and they are formal committees basically subcommittees called the health authority <pause dur="0.6"/> and the members of the committees have indemnity so if they make the wrong decisions they don't get sued <pause dur="0.3"/> that sort of thing <pause dur="0.3"/> which is something that i'm fairly happy about <pause dur="0.2"/> but we are advisory boards technically <pause dur="0.6"/> our job the job of the REC <pause dur="0.7"/> the research

ethics committee is to advise on whether <pause dur="0.3"/> # research proposals are ethically acceptable <pause dur="0.3"/> of course nobody would ever go against the advice of a research ethics committee in fact this <pause dur="0.3"/> <unclear>and not # by</unclear> not not not <pause dur="0.4"/> <unclear>really by agreement</unclear> it is actual fact <pause dur="0.3"/> but they have no legal basis </u><pause dur="0.9"/> <u who="nm0288" trans="pause"> <gap reason="name" extent="1 word"/> sorry can i just ask is ethical approval <pause dur="0.3"/> transportable from one research ethic <pause dur="1.4"/> modality to another </u><u who="nm0285" trans="overlap"> <gap reason="inaudible due to overlap" extent="1 sec"/> that's a point i'll come to in a moment </u><pause dur="0.4"/> <u who="nm0288" trans="pause"> okay </u><u who="nm0285" trans="latching"> there's a slightly different there's a different <pause dur="0.3"/> route <pause dur="0.6"/> # <pause dur="0.4"/> <vocal desc="clears throat" iterated="n"/> i'm talking about research ethics committees generally there are research ethics committees which are which are strictly local <pause dur="0.6"/> affairs <pause dur="0.3"/> such as the Coventry research ethics committee <pause dur="0.3"/> and there are larger # committees with more regional remit <pause dur="0.4"/> which are called multicentre research ethics committees <pause dur="0.5"/> so i'll come on to them in a moment <pause dur="1.0"/> okay so we advise <pause dur="0.3"/> on whether the work is ethically

acceptable <pause dur="0.9"/> there is <pause dur="0.4"/> has been over the last five years or so <pause dur="0.2"/> in fact it's been more than five years <pause dur="0.3"/> an attempt of the Department of Health to try and bring together and organize and regulate the chaos that had existed ten years ago <pause dur="0.3"/> # through an organization called the Central Office for Research Ethics Committees <pause dur="0.4"/> and that's <pause dur="0.3"/> an easily remembered acronym i wish this thing would work <pause dur="1.3"/> it's coming i think <pause dur="0.5"/> a <trunc>r</trunc> easily <trunc>r</trunc> remembered acronym COREC-<pause dur="0.4"/>dot-org-dot-U-K <pause dur="0.3"/> and if you want to see <pause dur="0.3"/> the glorious future for research ethics in this country go and look at their web site <pause dur="0.4"/> <gap reason="name" extent="1 word"/> </u><pause dur="0.6"/> <u who="nf0289" trans="pause"> # i just want to make clear because you keep saying advise </u><pause dur="0.2"/> <u who="nm0285" trans="pause"> yes </u><u who="nf0289" trans="overlap"> in my experience they either accept or <trunc>res</trunc> <pause dur="0.4"/> or reject this <gap reason="inaudible due to overlap" extent="1 sec"/></u><u who="nm0285" trans="overlap"> yeah mm i'll come to that </u><u who="nf0289" trans="overlap"> but that's not advise that's # </u><u who="nm0285" trans="overlap"> well <unclear>it's that</unclear> we're advising the health authority <pause dur="0.2"/> not we we you <trunc>th</trunc> you you you could we're advising the

health authority basing it on whether your research is ethically acceptable </u><pause dur="0.5"/> <u who="nf0289" trans="pause"> yes but you are advising <gap reason="inaudible due to overlap" extent="1 sec"/> </u><u who="nm0285" trans="overlap"> so so we we we tell you what our opinion is <pause dur="0.2"/> and you can modify your proposal <pause dur="0.2"/> if you wish <pause dur="0.7"/> and then you resubmit it and then we would advise the health authority <pause dur="0.2"/> that your research now is ethically acceptable </u><pause dur="0.3"/> <u who="nf0289" trans="pause"> okay </u><u who="nm0285" trans="overlap"> or not <pause dur="1.2"/> okay it's <trunc>i</trunc> the this comes the the point is of course there's no legal framework at the present moment <pause dur="0.5"/> so it is purely advisory but that's a as i said at the beginning <pause dur="0.3"/> if you do <pause dur="0.2"/> # work with patients which yet haven't got ethical approval <pause dur="0.3"/> then your medical protection <pause dur="0.4"/> is void <pause dur="0.5"/> or the practitions <pause dur="0.5"/> # <pause dur="0.9"/> is void <pause dur="0.6"/> and so you if <trunc>y</trunc> something goes wrong then it's common assault <pause dur="0.2"/> and you'll yeah <pause dur="0.2"/> all all those consequences <pause dur="1.4"/> okay <pause dur="0.3"/> and as i've said already twice we're

moving towards implementing this directive <pause dur="1.2"/><kinesic desc="changes slide" iterated="n"/> okay to answer <gap reason="name" extent="1 word"/>'s question <pause dur="0.4"/> there are two kinds of research ethics committee which we call multicentre MREC <pause dur="0.6"/> and local LREC <pause dur="0.4"/> now MRECs <pause dur="0.2"/> these were set up <pause dur="0.3"/> to cope with the situation <pause dur="0.2"/> where if you have <pause dur="0.2"/> # a trial where you want to recruit a large number of patients <pause dur="0.4"/> but the average number of patients in any particular hospital is relatively small obviously you've got to use multiple sites multicentre <pause dur="1.1"/> prior to the setting up of these MRECs each and every single <pause dur="0.2"/> # <pause dur="0.4"/> LREC <pause dur="0.6"/> involved in the research would have to have a separate application <pause dur="0.3"/> and very often the different LRECs would give conflicting <pause dur="0.3"/> # <pause dur="0.3"/> answers and there's a huge muddle up and the MRECs are similarly supposed to cut through that <kinesic desc="puts hand up" iterated="n" n="nf0290"/> <gap reason="name" extent="1 word"/> </u><pause dur="0.8"/> <u who="nf0290" trans="pause"> <gap reason="name" extent="1 word"/> i know of this # but i was told that the <pause dur="0.3"/> the cut-off point was five </u><u who="nm0285" trans="latching"> it's changed </u><pause dur="0.3"/> <u who="nf0290" trans="pause"> it has changed right thank you <gap reason="inaudible due to overlap" extent="1 sec"/> now is it </u><u who="nm0285" trans="overlap"> i'm pretty sure it's two <pause dur="0.3"/> i'm pretty sure it's two now <pause dur="0.4"/> it may not have yet changed but it's certainly going to be changing in the near future <pause dur="0.7"/> # two or more research sites well you see that's a quotation that would be a direct quotation from <pause dur="0.3"/> from COREC site <pause dur="0.7"/> so we'll be going down from

five to two <pause dur="1.4"/> okay <pause dur="0.3"/> so LRECs deal with single site research well two site research <pause dur="0.5"/> so it could be Coventry <pause dur="0.2"/> and Warwick say <pause dur="0.9"/> a maximum of two <pause dur="0.5"/> # <pause dur="0.4"/> and they also deal with local issues relating to multicentre research <pause dur="0.4"/> so the typical local issues that arise <pause dur="0.4"/> are # well i'll give you an example <pause dur="0.4"/> there was a proposal that came to us last month <pause dur="0.3"/> from <pause dur="0.2"/> Scottish MREC <pause dur="0.4"/> in which <pause dur="0.3"/> # it was said that should an emergency arise the patient should be transferred to the Edinburgh Western General Infirmary <pause dur="0.5"/> so obviously that's a local issue <pause dur="0.3"/> # which we changed to the <gap reason="name" extent="1 word"/> we're not quite sure that was the right thing to do but never mind <pause dur="0.7"/> mustn't say evil things about the <gap reason="name" extent="1 word"/> Hospital there's nobody here from the <gap reason="name" extent="1 word"/> oh there's <gap reason="name" extent="1 word"/> who isn't here <pause dur="1.2"/> <vocal desc="laugh" iterated="n"/> well <pause dur="0.2"/> yeah well i won't # say any more <pause dur="0.4"/> okay <pause dur="1.8"/><kinesic desc="changes slide" iterated="n"/> so <pause dur="0.5"/> the way these <pause dur="0.3"/> communities are established they include both lay <pause dur="0.3"/> and professional <pause dur="0.2"/> now the definition of lay here is peculiar sometimes <pause dur="0.2"/> i'm a medical professional <pause dur="0.3"/> #

and sometimes a lay person depending on the convenience of the committee at the time 'cause i'm lay in the sense that i have no medical qualifications <pause dur="0.5"/> but obviously i'm professional in the sense that i'm very much <pause dur="0.4"/> involved in a number of aspects <pause dur="0.3"/> of medicine research teaching <pause dur="0.2"/> ethics <pause dur="0.5"/> and other things <pause dur="2.0"/><kinesic desc="changes slide" iterated="n"/><vocal desc="clears throat" iterated="n"/><pause dur="0.7"/> so <pause dur="0.9"/> <vocal desc="sniff" iterated="n"/> <pause dur="2.2"/> let's go on and talk about the purpose which is obviously self-evident <pause dur="0.3"/> and that's to balance the principles of personal autonomy and do no harm <pause dur="0.2"/> against the need to carry on research <pause dur="2.4"/> now <pause dur="0.4"/> what are we looking for <pause dur="0.4"/> # when we're judging a proposal for a for research <pause dur="1.9"/><kinesic desc="changes slide" iterated="n"/> four points really <pause dur="0.3"/> # quality of the research and researcher risk versus benefit whether informed consent is possible <pause dur="0.5"/> well actually i should say whether informed consent <pause dur="0.2"/> is possible and is adequately dealt with goes without saying <pause dur="0.6"/> # and then final point is whether suitable indemnity is in place and i'll talk about all these points in turn <pause dur="0.9"/> indemnity means

compensation if something goes wrong <pause dur="0.5"/> <vocal desc="sniff" iterated="n"/><pause dur="0.9"/><kinesic desc="changes slide" iterated="n"/> now the quality of research and researcher <pause dur="0.6"/> it's taken <pause dur="0.2"/> as accepted that badly designed research that is research that's not going to give a proper answer or research that's designed <pause dur="0.4"/> which has got <unclear>treatment</unclear> aims or whatever <pause dur="0.4"/> is by its nature <pause dur="0.5"/> not ethical you should not bother patients unless you know the the the issue is entirely trivial <pause dur="0.4"/> you should not bother patients or sick people <pause dur="0.3"/> with research which is not well designed <pause dur="0.6"/> that's taken as <pause dur="0.7"/> given <pause dur="0.7"/> so one has to be <pause dur="1.4"/> this issue of aims i mean all of us are scientists and know jolly well <pause dur="0.3"/> that we've got to design our research projects so they're clear-cut <pause dur="0.5"/> properly understood aims hypotheses and so on <pause dur="0.4"/> and a proper strategy <pause dur="0.4"/> to accomplish the aims <pause dur="0.5"/> or falsify the hypothesis <pause dur="0.7"/> # sorry # i've got to go back <unclear>how do i use this</unclear> <pause dur="0.7"/> <gap reason="inaudible" extent="1 sec"/><pause dur="1.4"/> so <pause dur="0.2"/> # <pause dur="0.5"/> the next question after the aims quite obviously is the methodology <pause dur="0.7"/> suitable <pause dur="0.7"/> do your <pause dur="0.4"/> the <trunc>me</trunc> methods you use going to use are they going to give you the answers you want or not <pause dur="0.8"/> and then of course is the

researcher able to deliver the goods <pause dur="2.3"/><kinesic desc="changes slide" iterated="n"/> so the aims must be medically and scientifically valid <pause dur="0.7"/> now <pause dur="0.5"/> you can drop that requirement a little bit for training <pause dur="0.2"/> purposes <pause dur="0.4"/> # and the <pause dur="0.5"/> the ethics committees is <pause dur="0.3"/> are is the ethics committee is very clear <pause dur="0.4"/> # that where somebody is doing a higher degree <pause dur="0.6"/> well no i think higher degrees things like M-Ds and PhDs we would we would certainly require the highest possible # <pause dur="0.4"/> quality of aims and so forth <pause dur="0.3"/> but somebody who's doing a project say for a B-S-C in nursing <pause dur="0.4"/> which happens quite a lot from Coventry University less from us <pause dur="0.3"/> obviously <pause dur="0.5"/> then we can be content to <trunc>d</trunc> to drop the quality in the in the importance of the aims a little bit well quite a lot as it happens <pause dur="0.5"/> now there's been a number of # projects as you know from our undergraduates <pause dur="0.3"/> that have been quasimedical most of those <pause dur="0.3"/> i would <trunc>w</trunc> <trunc>ca</trunc> would would would # # <trunc>s</trunc> <trunc>w</trunc> <pause dur="0.5"/> would consider needed some sort of # would <pause dur="0.5"/> get this straight <pause dur="0.2"/> i would consider needed ethical approval

and i've written to those <pause dur="0.4"/> who asked me about it and said sorry <pause dur="0.2"/> you're too late <pause dur="0.3"/> # <pause dur="0.7"/> <vocal desc="clears throat" iterated="n"/> well the the the point is these are training <pause dur="0.2"/> projects which <pause dur="0.2"/> we don't worry too much about the aims <pause dur="2.1"/> i would say # to those who that supervise these projects i think <pause dur="0.4"/> # that where medical where where ethics is an issue then it should be a part of the project and the student <pause dur="0.4"/> involved should consider ethical <pause dur="0.3"/> issues and if necessary <pause dur="0.3"/> address them properly <pause dur="1.4"/> now there's another <pause dur="0.2"/> kind of # <trunc>ai</trunc> another aim which gives us great pain that's commercial called commercial projects <pause dur="1.4"/> frequently # a drug company brings out a new formulation or slight alteration in the way in which a drug is delivered <pause dur="0.4"/> # and they want to get this # into G-Ps' surgeries or hospital pharmacies and so on <pause dur="0.3"/> so they set up a trial comparing <pause dur="0.2"/> their new formulation <pause dur="0.3"/> with <pause dur="0.4"/> the old-fashioned stuff that they knew doesn't work properly <pause dur="0.4"/> # not the new

formulation against the old formulation but the new formulation against a drug which is known not to work very well <pause dur="0.4"/> and they say look guys our new new <pause dur="0.2"/> # formulation works much much better than that old-fashioned drug that nobody uses any more <pause dur="0.4"/> and therefore they send out their flyers to G-Ps' surgeries and so on and it looks good <pause dur="0.5"/> because they've done a trial <pause dur="0.3"/> but we have tremendous difficulty in accepting that we find it hard to turn them down 'cause they're obviously <pause dur="0.3"/> properly organized trials there's no particular ethical issues that they arise except that we know that the purpose is not really research the purpose is simply <pause dur="0.4"/> getting the new formulation in front of <pause dur="1.0"/> the purchasers <pause dur="2.4"/> <kinesic desc="changes slide" iterated="n"/> methodology <pause dur="0.3"/> # obviously in control groups are they appropriate <pause dur="0.3"/> statistical power <pause dur="0.3"/> # this again really applies only to trials where you're comparing drug doses <pause dur="0.4"/> do you have sufficient people enrolled in your study in order to give a clear answer to

the question <pause dur="0.3"/> you're <pause dur="0.3"/> posing <pause dur="0.4"/> that's often quite difficult to to to turn <pause dur="0.6"/> # <pause dur="0.9"/> do you have access to suitable laboratory facilities we had a proposal a little while ago <pause dur="0.4"/> # which was very interested in P-C-R studies of <pause dur="0.3"/> <trunc>mi</trunc> # mitochondrial D-N-A <pause dur="0.5"/> # and i asked what i thought was a perfectly simple question 'cause it wasn't in the proposal <pause dur="0.3"/> where are these P-C-Rs going to be done <pause dur="0.4"/> the guy said well i thought Warwick University does P-C-Rs i said yes we do which lab were you collaborating with i didn't hear from him again <pause dur="0.5"/> # so you've got to be sure that when you <pause dur="0.3"/> make your proposal <pause dur="0.3"/> not only is your methodology right <pause dur="0.4"/> but you've got to have access to the <trunc>cer</trunc> to the to the facilities <pause dur="0.4"/> to do the work <pause dur="0.5"/> and <pause dur="1.1"/> at the end of the day <pause dur="0.3"/> a bit like statistical power <pause dur="0.8"/> really you ought to have statistical advice in other words take statistical advice before you start not at the end <pause dur="0.8"/> i won't talk about statistics at all 'cause i know what a serious bone of

contention it is <pause dur="1.0"/><kinesic desc="changes slide" iterated="n"/> now researcher does he have a track record in research do we require a C-V <pause dur="0.3"/> <gap reason="name" extent="1 word"/> </u><u who="nf0290" trans="overlap"> can i just ask about the power issue </u><u who="nm0285" trans="overlap"> ah right </u><u who="nf0290" trans="overlap"> because as you know </u><u who="nm0285" trans="overlap"> wish you wouldn't </u><u who="nf0290" trans="latching"> it's very difficult </u><u who="nm0285" trans="overlap"> and <gap reason="inaudible" extent="1 sec"/></u><u who="nf0290" trans="overlap"> to find enough patients and enough money </u><u who="nm0285" trans="overlap"> yep </u><u who="nf0290" trans="overlap"> to be seeing the patients </u><u who="nm0285" trans="overlap"> i know <pause dur="0.4"/> yep </u><u who="nf0290" trans="overlap"> or to do a pilot study <pause dur="0.3"/> to start <gap reason="inaudible due to overlap" extent="1 sec"/></u><u who="nm0285" trans="overlap"> well if you call it a pilot study yeah <pause dur="0.2"/> i mean there are lots of situations where you don't have <trunc>t</trunc> in order to have <gap reason="inaudible" extent="1 sec"/> those that don't know what this means <pause dur="0.2"/> you have to have some data already about <pause dur="0.2"/> a particular treatment <pause dur="0.3"/> how effective it is <pause dur="0.3"/> so you then have a new treatment <pause dur="0.3"/> and you do the power calculations and calculate <pause dur="0.3"/> how many patients need to enter into your study <pause dur="0.4"/> to get <pause dur="0.3"/> say <pause dur="1.0"/> if you're looking for say a twenty per cent <pause dur="0.4"/> better outcome with treatment <pause dur="0.2"/>

that you'll be able to do that at the <trunc>s</trunc> <pause dur="0.2"/> significance level of point-o-five or something like that that's that's <trunc>w</trunc> what a power calculation is an asset <pause dur="0.4"/> now if you don't have sufficient data in advance to do the power calculation <pause dur="0.4"/> then you can't <pause dur="0.6"/> so really you should describe it as a pilot study <pause dur="0.5"/> because it's an effort to find out what are the parameters that matter <pause dur="0.3"/> for a full-blown study you can do a pilot study <pause dur="0.4"/> at least you should end end up with enough data <pause dur="0.4"/> to be able to say we need X-hundred patients to do a statistically significant trial <pause dur="0.9"/> yeah <pause dur="0.4"/> but <pause dur="0.4"/> obviously <pause dur="0.3"/> # a research ethics committee very often will obviously will appreciate <pause dur="0.5"/> # that in the absence of prior knowledge <pause dur="0.6"/> it's a new study a new technique whatever <pause dur="0.2"/> you've got to start you've got to put it on the water some time <pause dur="0.8"/> # <trunc>s</trunc> at some stage and so we're fairly relaxed about that <pause dur="0.8"/> if there is data and you haven't done a power calculation then <pause dur="0.2"/> you'll be told to do a power calculation <pause dur="1.2"/> <vocal desc="laugh" iterated="n"/> </u><pause dur="0.2"/> <u who="nf0290" trans="pause">

if you haven't enough patients and will never have enough patients to do the study <gap reason="inaudible due to overlap" extent="1 sec"/> twenty-five years </u><u who="nm0285" trans="overlap"> well i would have said that there's absolutely no point doing the study then is there </u><pause dur="0.4"/> <u who="nf0290" trans="pause"> so <gap reason="inaudible due to overlap" extent="1 sec"/></u><u who="nm0285" trans="overlap"> if you're not going to i mean this this goes back to the </u><u who="nf0290" trans="overlap"> yeah but for meta-analysis then this is <gap reason="inaudible due to overlap" extent="1 sec"/></u><u who="nm0285" trans="overlap"> for meta-analysis well then i would say if it's important enough to do the study then you have got to try and <pause dur="0.4"/> excite people enough to do a multicentre trial </u><u who="nf0290" trans="overlap"> mm </u><u who="nm0285" trans="overlap"> or something like that <pause dur="0.8"/> # # i know what you're talking about when you say meta-analysis and i think <pause dur="0.7"/> it's you know not <pause dur="0.3"/> quite the <gap reason="inaudible" extent="1 sec"/> <pause dur="0.3"/> </u><u who="nf0290" trans="pause"> yeah i <gap reason="inaudible due to overlap" extent="1 sec"/></u><u who="nm0285" trans="overlap"> getting on in that direction </u><u who="nf0290" trans="overlap"> <gap reason="inaudible" extent="1 sec"/> i share your views yeah </u><pause dur="0.2"/> <u who="nm0285" trans="pause"> okay <pause dur="3.5"/><kinesic desc="changes slide" iterated="n"/> so <pause dur="1.3"/> okay well this this i've already mentioned really <pause dur="0.5"/> i <unclear>told you this</unclear> <pause dur="0.3"/> it's risk versus benefit <pause dur="0.8"/> okay i've i've talked about that <pause dur="1.5"/><kinesic desc="changes slide" iterated="n"/> right informed consent <pause dur="1.6"/> i'm not going to talk in detail about this but

i do want to mention <pause dur="0.5"/> that <pause dur="0.2"/> patients must obviously be competent to give research and he must keep a proper record of his consent and this is what's what what i'm in trouble for at the moment <pause dur="0.7"/> well we both are in the research project i'm involved with <pause dur="1.8"/><kinesic desc="changes slide" iterated="n"/> is the subject competent to give consent children <pause dur="0.2"/> aagh <pause dur="0.7"/> <shift feature="voice" new="laugh"/>unconscious individuals <shift feature="voice" new="normal"/><pause dur="0.9"/> mentally impaired individuals we have great problems with research involved with these and and we are going to be particularly concerned with the quality of the research if it involves people falling into those categories <pause dur="1.1"/> okay <pause dur="0.2"/> and people you need to understand <pause dur="0.3"/> that there is no such thing as proxy consent for adults <pause dur="0.6"/> so no parent or guardian or a friend or whatever is in a position to give consent for somebody <pause dur="0.4"/> who has been knocked down in a traffic accident if that person's over eighteen <pause dur="1.5"/> well <unclear>we'll go with</unclear> that but it's obviously a major problem <pause dur="1.1"/><kinesic desc="changes slide" iterated="n"/> and i'll remind you about <trunc>th</trunc> the Gillick case those that don't know about Gillick <pause dur="0.4"/> # i can't

remember the exact details of the case but her daughters one of her daughters who was <pause dur="0.4"/> under eighteen but <pause dur="0.2"/> can't remember her age she was over sixteen <pause dur="0.3"/> # <pause dur="0.2"/> got contraceptive advice from her doctor her doctor told Mrs Gillick <pause dur="0.2"/> Mrs Gillick made a big fuss and there was a High Court case <pause dur="0.4"/> and that what came out of that <pause dur="0.4"/> was that <pause dur="0.2"/> the issue of consent for people who are under eighteen <pause dur="0.3"/> technically not adults <pause dur="0.5"/> if the patient understands the consequence of the treatment or the research whatever <pause dur="0.6"/> then that patient that person is in a position to give <trunc>conf</trunc> # <pause dur="0.2"/> informed consent <pause dur="0.5"/> and therefore that patient <pause dur="0.4"/> can <pause dur="0.3"/> give consent for research or treatment or whatever <pause dur="0.6"/> independent of parents or guardians <pause dur="0.3"/> and in fact it's a moot point but in that situation whether <pause dur="0.3"/> # the parent or guardian should in fact be consulted of course <pause dur="0.4"/> obviously in a situation like the Gillick situation <pause dur="0.6"/> the patient <pause dur="0.6"/> the young girl <pause dur="0.5"/> would have been <pause dur="0.2"/> fantastically was fantastically embarrassed about the

way the whole situation arose <pause dur="0.4"/> so there are plenty of cases situations where you could argue <pause dur="0.5"/> # that research involving children <pause dur="0.7"/> # even if they're under sixteen <pause dur="0.7"/> # you need to get the patient the the child's consent and the parents' consent may not be relevant <pause dur="0.5"/> now <pause dur="0.4"/> that again raises all sorts of difficulties and as a sort of practical <pause dur="0.2"/> way out in our research ethics committees <pause dur="0.3"/> we say that the the the the child's consent must be sought first <pause dur="0.3"/> and then the parent informed as a matter of courtesy <pause dur="0.2"/> and i'm not sure about that but that's the way the committee does it <pause dur="2.1"/> <kinesic desc="changes slide" iterated="n"/> indemnity <pause dur="0.3"/> # now if something goes wrong <pause dur="0.6"/> then <trunc>o</trunc> obviously the patient should be in some way compensated <pause dur="3.5"/><kinesic desc="changes slide" iterated="n"/> there's two kinds <pause dur="0.3"/> of compensation <pause dur="0.4"/> the compensation <pause dur="0.4"/> # which <pause dur="0.2"/> you have to demonstrate negligence <pause dur="0.7"/> for <pause dur="0.7"/> and the compensation which is called no fault compensation <pause dur="0.5"/> where whatever the situation <pause dur="0.4"/> if a patient suffers injury as a consequence of taking part in a research

programme <pause dur="1.7"/> is injured <pause dur="0.2"/> then he or she should be compensated automatically irrespective of why the injury occurred <pause dur="0.4"/> think for example # that a research subject called into the hospital for a simple blood test <pause dur="0.2"/> just a <gap reason="inaudible" extent="1 sec"/> <pause dur="0.3"/> slips and breaks his leg <pause dur="0.2"/> on the way into the hospital he wouldn't have come to the hospital if he wasn't going to take part in that research <pause dur="0.3"/> therefore <pause dur="0.3"/> the injury is <pause dur="0.3"/> a consequence of the research <pause dur="0.3"/> in that situation if you have no fault indemnity in place <pause dur="0.7"/> then that will compensate that patient <pause dur="0.8"/> and no fault has to be demonstrated <pause dur="1.4"/><kinesic desc="changes slide" iterated="n"/> okay the application the main components description of research <pause dur="0.5"/> the patient information and consent form # # i'm <pause dur="0.3"/> conscious of time a little bit <pause dur="1.0"/><kinesic desc="changes slide" iterated="n"/> # <pause dur="0.2"/> now the description of the research <pause dur="0.6"/> this has been a # a fierce battle in the ethics committee <trunc>o</trunc> over the years <pause dur="0.2"/> how much detail for the research <unclear>do you write</unclear> <pause dur="0.4"/> i would say not much <pause dur="0.2"/> for two reasons <pause dur="0.6"/> # one is that <pause dur="0.2"/> many of the people on the research ethics committee are not going to understand <pause dur="0.4"/> # the depth of detail that

some scientists have to provide <pause dur="1.7"/> the second point <pause dur="0.2"/> is <pause dur="0.2"/> that if you are too prescriptive in the detail you provide in your research then <pause dur="0.2"/> if you change <pause dur="0.3"/> the way in which you run your polyacrolein gel <pause dur="0.4"/> technically that changes <trunc>th</trunc> your project <pause dur="0.4"/> technically you should <pause dur="0.3"/> <trunc>r</trunc> # <pause dur="0.3"/> send it to the committee as an amendment to your project and wait two months for it to be approved well i'm not going to do that so don't be too <trunc>pr</trunc> prescriptive <pause dur="0.9"/> # <pause dur="1.0"/> but you've got to have enough detail <pause dur="0.3"/> to allow the committee to make a judgement of the quality of the research that goes without saying <pause dur="1.1"/> if you've got evidence of peer review <unclear>like</unclear> your <trunc>rese</trunc> research that's being supported by the Wellcome Foundation that would be accepted as <pause dur="0.2"/> adequate <pause dur="3.2"/><kinesic desc="changes slide" iterated="n"/> more particularly you've got to describe in detail what would happen to the patient <pause dur="0.2"/> and i think from the point of view of ethical review that's what matters <pause dur="0.2"/> it <trunc>do</trunc> <pause dur="0.4"/> it doesn't matter what happens to the patient's tissue with <trunc>m</trunc> <pause dur="0.2"/> reservations <pause dur="0.7"/> but what happens to the patient <pause dur="0.5"/>

is very important <pause dur="2.5"/> we'll come back to that presently <pause dur="0.6"/><kinesic desc="changes slide" iterated="n"/> et cetera <pause dur="0.2"/> you provide C-Vs things like <pause dur="0.3"/> anonymity details <pause dur="0.4"/> should you tell the G-P because <pause dur="0.3"/> if it's a drug trial again you must tell the G-P because that could be in conflict with other drugs the patient is taking for other problems or <pause dur="0.9"/> finance is an issue can you pay for your research 'cause if you stop your research halfway through then that's <pause dur="1.1"/> because you ran out of money <pause dur="0.3"/> well then you can say that that is unethical because you <pause dur="0.3"/> have wasted <pause dur="0.4"/> # the patients' involvement <pause dur="2.0"/><kinesic desc="changes slide" iterated="n"/> okay so let's get on to what actually matters and that's the patient's patient information sheet <pause dur="0.7"/> there are guidelines at this COREC site i've already mentioned <pause dur="0.5"/> but the guidelines that are provided there are what i call heavy-duty <pause dur="0.4"/> # they are intended <pause dur="0.7"/> # to <pause dur="0.4"/> cover all possible eventualities <pause dur="0.3"/> and really <pause dur="0.2"/> they're designed # for drug trials <pause dur="1.3"/> but our general view is that you should use these guidelines as the basis for a patient information

sheet <pause dur="1.1"/> which is sometimes abbreviated <pause dur="0.4"/> P-I-S which i don't like <pause dur="0.4"/> # <pause dur="1.2"/> but you don't in my view <pause dur="0.4"/> have to use all <pause dur="0.2"/> those parts and you can modify those parts provided you basically <pause dur="0.4"/> # are following the guidelines that are there <pause dur="0.4"/> use your common sense <pause dur="0.4"/> # and develop the information sheet which suits your project <pause dur="1.0"/> that said if you leave bits out there's always going to be a somebody on the committee that says you should put it back in so you allow for that <pause dur="1.3"/><kinesic desc="changes slide" iterated="n"/> i'm not going to run through this in detail because # i suggest that if you are involved with a patient information sheet you look at the guidelines <pause dur="0.6"/> # and then come and ask me but there's a few points that i might <pause dur="0.5"/><kinesic desc="changes slide" iterated="n"/> just bring out <pause dur="1.3"/> i should say that <pause dur="0.4"/> poor quality patient information sheets are the commonest reason for a project to go back to the author <pause dur="1.1"/> one <pause dur="0.3"/> absolute no-no <pause dur="0.4"/> at the end <pause dur="0.3"/> # let me go back <pause dur="0.7"/> what i've got printed here set out here <pause dur="0.5"/> is actually <trunc>de</trunc> taken directly from the web site okay <pause dur="0.2"/> <trunc>co</trunc> cut and pasted in <pause dur="0.5"/> copied

and pasted in <pause dur="2.2"/> at the end of what's called the invitation paragraph where the patient is being asked to take part in the research it says thank you for reading this <pause dur="0.5"/> some guys <pause dur="0.2"/> put at the end of their patient information <trunc>shee</trunc> sheet <pause dur="0.2"/> thank you for taking part in this research <pause dur="0.4"/> and that's an absolute no-no it's surprising how many people put it in <pause dur="0.4"/> # and it comes straight back because it's considered coercive so it's things like that that you need to know <pause dur="3.3"/><kinesic desc="changes slide" iterated="n"/> now the purpose of the study this is tremendously important <pause dur="0.6"/> and plainly this <trunc>mus</trunc> must be in in proper lay language not patronizing language <pause dur="0.3"/> lay language in which you clearly explain <pause dur="0.4"/> # what the project's about <pause dur="0.4"/> in a manner that # your average <pause dur="0.9"/> man in the street <pause dur="0.2"/> # <pause dur="0.3"/> will understand i won't <pause dur="0.3"/> the average man in the street <pause dur="0.2"/> <trunc>i</trunc> <trunc>i</trunc> in a way it depends on the nature of the project the depth to which you'll go into the explanation of what it is <pause dur="0.4"/> and it depends on the patient <pause dur="0.6"/> for example # many patients with #

transplants <pause dur="0.2"/> are very sophisticated indeed in an understanding of their disease and the treatment for it <pause dur="0.4"/> so you can go into perhaps a greater level <pause dur="0.3"/> <trunc>o</trunc> of sophistication in your description of the project with such patients <pause dur="1.0"/> but for most people it's got to be fairly straightforward <pause dur="2.8"/> <kinesic desc="changes slide" iterated="n"/> do i have to take part no of course the patient doesn't have to take part <pause dur="0.6"/> what will happen to me now this matters also <pause dur="0.4"/> # there was a a a <pause dur="0.2"/> a <pause dur="0.3"/> project that was submitted <pause dur="0.4"/> a little while ago <pause dur="0.3"/> # to do with immune responses to cancers patients were being recruited in <gap reason="name" extent="1 word"/> <pause dur="0.2"/> but all the testing <pause dur="0.4"/> was going on in <gap reason="name" extent="2 words"/>'s Hospital in <gap reason="name" extent="1 word"/> i shouldn't be mentioning names in <gap reason="name" extent="1 word"/> <pause dur="0.6"/> # and this the these tests <pause dur="0.2"/> involved multiple visits up to <gap reason="name" extent="1 word"/> <pause dur="0.3"/> and you know where they'd have to spend several hours in the clinic <pause dur="0.3"/> this wasn't properly explained in the <pause dur="0.3"/> in the patient information sheet <pause dur="0.7"/> one has the this suspicion that it wasn't

explained properly in the patient information sheet because the proposers <pause dur="0.3"/> knew jolly well <pause dur="0.2"/> if a patient's understood what was expected of them they wouldn't ever be recruited <pause dur="0.6"/> having been recruited they would probably feel involved and <trunc>w</trunc> <trunc>a</trunc> <trunc>a</trunc> <trunc>a</trunc> and committed and do it <pause dur="0.7"/> so we insisted that <pause dur="0.3"/> the there was <pause dur="0.2"/> proper explanation of what was expected of the patient in the <trunc>in</trunc> <pause dur="0.3"/> information sheet <pause dur="0.4"/> i don't know if they recruited any patients for that study <pause dur="1.9"/> <kinesic desc="changes slide" iterated="n"/> okay risk benefit analysis has got to be honest obviously <pause dur="0.4"/> and of course mostly there's no benefit to the patient <pause dur="1.5"/> what happens if <trunc>dru</trunc> if something goes wrong <pause dur="0.3"/> now <pause dur="1.1"/> there's <pause dur="0.2"/> this <pause dur="0.3"/> it brings up this whole issue of no fault compensation <gap reason="inaudible" extent="1 sec"/> again <pause dur="0.4"/> now the Association of British British Pharmaceutical Industries <pause dur="0.3"/> require all pharmaceutical companies to have in place <pause dur="0.4"/> suitable no fault compensation arrangements so they have <pause dur="0.2"/> # # # # # an insurance

policy <pause dur="1.8"/> so if it's if if it's a a drug trial organized by Smith Kline and <trunc>we</trunc> <pause dur="0.2"/> Glaxo <pause dur="0.4"/> then there's no problem <pause dur="0.6"/> the problem arises when it's # # an investigator <pause dur="0.4"/> # originated <pause dur="0.2"/> project <pause dur="3.5"/> then you've got there's this horrid paragraph <reading>if you are harmed by taking part in this research project there are no special compensation arrangements <pause dur="0.6"/> if you are harmed <pause dur="0.2"/> due to <pause dur="0.2"/> # negligence then you may have grounds for legal action <pause dur="0.3"/> but you may have to pay for it <pause dur="0.8"/> # and regardless of this if you wish to complain or have any concerns about any aspect of the way</reading> <pause dur="0.7"/> blah blah blah <reading>the normal Health Service complaints mechanism should be available to you</reading> i think this is an appalling statement but it is it is the one which is standard <pause dur="0.4"/> and recently i have been in a position <pause dur="0.6"/> of of <pause dur="0.7"/> # having <pause dur="0.4"/> to put this statement in even though i thought it was grossly <unclear>imperfect</unclear> and you just <pause dur="0.6"/> you do what you're told by <trunc>r</trunc> a Research Ethics Committee basically <pause dur="1.2"/> <kinesic desc="changes slide" iterated="n"/> # now <pause dur="0.5"/> it's the wording <pause dur="0.3"/> is based on medical research council <pause dur="0.3"/> and N-H-S practice because both these

organizations being government organizations do not <pause dur="0.4"/> insure themselves <pause dur="0.4"/> okay <pause dur="1.2"/> now <pause dur="0.3"/> universities <pause dur="1.4"/> being <pause dur="0.2"/> basically independent independent private corporations <pause dur="0.6"/> are in an entirely different position and this university has <pause dur="0.3"/> full no fault indemnity <pause dur="0.5"/> which is actually equivalent to the A-B-P-I indemnity in place the hospitals don't <pause dur="1.3"/> now <pause dur="0.3"/> when i say no fault full no fault indemnity <pause dur="1.3"/> there is a problem here in that i in that in in the insurance policy which i've read quite carefully it's a <pause dur="0.2"/> terrible document <pause dur="0.5"/> # it specifically talks about clinical trials <pause dur="0.5"/> clinical trials are defined as those involving drug treatments <pause dur="0.3"/> so the sorts of things that you and i basically do <pause dur="0.3"/> probably <pause dur="0.3"/> do not come under this <pause dur="0.7"/> under this insurance policy <pause dur="0.3"/> and i have been trying to get them to clarify this point <pause dur="0.3"/> trying to get them to broaden the definition of clinical trials in that document without success <pause dur="0.6"/> so i am not so sure but it wouldn't do any harm to have the university's indemnity policy

behind you to do that <pause dur="0.5"/> you must be a member of the university <pause dur="0.4"/> you've got to inform the insurance office about it <pause dur="0.3"/> and you've got to say in the <pause dur="0.4"/> in the patient's information sheet that you do have done this <pause dur="1.0"/> okay <pause dur="0.4"/> you can get get anybody that wants detail obviously i can e-mail this presentation to them <pause dur="0.2"/> <gap reason="inaudible" extent="1 sec"/> <pause dur="1.9"/> <kinesic desc="changes slide" iterated="n"/> okay so that brings me to the last stage our local business <pause dur="0.4"/> we have monthly meetings which is a great <trunc>ba</trunc> advance on the two monthly meetings that we used to have till quite recently <pause dur="0.4"/> i've forgotten the exact deadlines obviously there's a deadline for receipt of a <trunc>pro</trunc> proposal i think it may be fourteen days rather than twenty-one <pause dur="0.5"/> the proposal goes to every member of the committee but there is a lead speaker <pause dur="0.4"/> who provides a written report <pause dur="0.6"/> right <pause dur="0.7"/> you <trunc>sh</trunc> do not need to attend the meeting if you unless you're asked

to <pause dur="0.5"/> or you want to <pause dur="3.4"/><kinesic desc="changes slide" iterated="n"/> if the proposal is approved <pause dur="0.7"/> a letter will be issued within fourteen days of the meeting <pause dur="0.3"/> in and if there are minor modifications required <pause dur="0.2"/> you'll be told what they are <pause dur="0.3"/> and provided you <pause dur="0.2"/> # <trunc>ac</trunc> accede to the minor modifications <pause dur="0.3"/> chairman's action will chair's action will <pause dur="0.4"/> # approve the project <pause dur="1.4"/><kinesic desc="changes slide" iterated="n"/> now <pause dur="0.2"/> if the project is rejected <pause dur="0.5"/> # we will give <pause dur="0.2"/> full reasons for why that is <pause dur="0.3"/> now when i function as committee <pause dur="0.3"/> chairman <pause dur="0.5"/> i like to give verbatim written report <pause dur="0.4"/> of the lead speaker that is not approved of by <pause dur="0.4"/> the rest of the committee and so you will probably get <pause dur="0.3"/> a paraphrase <pause dur="0.3"/> of <pause dur="0.2"/> the lead speaker's # comments <pause dur="0.2"/> plus <pause dur="0.2"/> some spirit <pause dur="0.3"/> of the debate <pause dur="1.1"/> <unclear>not</unclear> always given in a very clear fashion <pause dur="1.5"/> <kinesic desc="changes slide" iterated="n"/> okay <pause dur="0.8"/> briefly with an MREC proposal that i've touched on <pause dur="0.4"/> # we can't reject an MREC proposal <pause dur="0.4"/> except as i said on the grounds or on local local <trunc>o</trunc> on grounds of local issues <pause dur="1.7"/><kinesic desc="changes slide" iterated="n"/> okay <pause dur="0.9"/> why are proposals <pause dur="0.4"/> rejected <pause dur="0.4"/> now none of us are fools it's rare <pause dur="0.3"/> that a

proposal is rejected on major ethical grounds none of us <pause dur="0.4"/> is going to do <pause dur="0.2"/> research which is going to seriously <pause dur="0.3"/> endanger the patient of course not <pause dur="3.1"/> there may be problems with <trunc>s</trunc> <pause dur="0.2"/> the study design control groups exclusions of patients inclusions of patients <pause dur="0.3"/> power <pause dur="0.6"/> and all that sort of thing <pause dur="0.5"/> but most often <pause dur="0.4"/> revision is required because of the poor quality of the patient information sheet <pause dur="0.5"/> badly written <pause dur="0.5"/> is the usual problem <pause dur="0.2"/> ungrammatical English <pause dur="0.3"/> not knowing where to put commas <pause dur="0.4"/> things like that <pause dur="0.6"/> all adds up as you know <pause dur="0.4"/> those of us that read undergraduate issues undergraduate essays <pause dur="0.5"/> very much aware that <trunc>th</trunc> there's an accumulation <pause dur="0.4"/> of grammatical errors that doesn't half screw up <pause dur="0.7"/> # the quality of the document <pause dur="2.1"/> but they wouldn't reject it on the basis that there's a comma wrong <pause dur="2.4"/> <kinesic desc="changes slide" iterated="n"/> very briefly <pause dur="0.3"/> # some current <pause dur="0.2"/> Coventry issues <pause dur="1.9"/> this is the big one a big one rather <pause dur="0.4"/> # that's very current <pause dur="0.2"/> consent consent <pause dur="0.3"/>

for research use of discarded tissue <pause dur="0.4"/> discarded tissue is stuff <pause dur="0.5"/> that would normally be binned incinerated <pause dur="0.4"/> # it used to be in earlier and happier days <pause dur="0.5"/> that you could take it out and do research with it and there's no problem so the pathologist <pause dur="0.3"/> cuts out a chunk of a tumour <pause dur="0.7"/> bins the rest of it <pause dur="0.4"/> you catch it <pause dur="0.6"/> so it doesn't actually go in the bin <pause dur="0.2"/> take it back to the lab and work with it <pause dur="0.4"/> now that used to be no problem <pause dur="0.5"/> with the the the various scandals i alluded to earlier <pause dur="0.2"/> that has all changed you can no longer do that you've got to have full <pause dur="0.2"/> approval <pause dur="0.2"/> full consent for working with this kind of tissues <pause dur="0.5"/> now it seems to be moving back <pause dur="0.5"/> # <pause dur="0.2"/> in in various <gap reason="inaudible" extent="1 sec"/> i've recently seen <pause dur="0.6"/> well recently about four or five months ago six months ago <pause dur="0.5"/> # the surgical consent form from the <gap reason="name" extent="1 word"/> Hospital <pause dur="0.3"/> some of you may have seen this pink form which <pause dur="0.3"/> # is there so that the patient gives consent for the surgery there is a paragraph <pause dur="0.4"/> which says <pause dur="0.3"/> will you give approval <pause dur="0.2"/> for any discarded tissue to be used for research yes

or no tick it <pause dur="0.4"/> okay <pause dur="0.3"/> so that looks <trunc>g</trunc> like we've gone back to the earlier and happier situation where you've just sort of got blanket generic approval <pause dur="0.8"/> no <pause dur="0.3"/> the research ethics committee won't allow that you've got to have specific approval for the project <pause dur="0.3"/> in hand <pause dur="0.4"/> so that # that paragraph in the surgical consent form is redundant <pause dur="0.4"/> and should be removed <pause dur="0.4"/> # hospital authorities being what they are <pause dur="0.3"/> God knows when if <pause dur="0.7"/> that will happen <pause dur="1.2"/> and they know it should <pause dur="1.7"/> a second issue <pause dur="0.3"/> which is also <pause dur="0.2"/> iffy <pause dur="0.3"/> is banking of human material <pause dur="0.8"/> and subsequent use for research <pause dur="0.4"/> which wasn't included in the original <unclear>research</unclear> proposal <pause dur="0.5"/> now <pause dur="0.4"/> i would say <pause dur="0.5"/> that if you've got a bank of tissue D-N-A whatever <pause dur="0.6"/> if you reuse that for a different project <pause dur="0.4"/> that is the ethical approach 'cause it means you don't have to bother the patient again <pause dur="1.0"/> you've got the stuff in your freezer use it <pause dur="0.5"/> no <pause dur="0.2"/> the research ethics committee says you can only use that tissue <pause dur="0.3"/> for the purpose for which <pause dur="0.4"/> # you have <pause dur="0.5"/> intended it in

your original proposal <pause dur="0.4"/> and if you want to use that tissue for some other purpose <pause dur="0.3"/> you have to go and get consent from the patient in order to do that <pause dur="0.4"/> now there are some wonderful banks of tissue in the country <pause dur="0.3"/> for example in Saint Mark's Hospital in London <pause dur="0.4"/> there are lumps of colorectal carcinoma going back to the nineteen-twenties now and <gap reason="inaudible" extent="1 sec"/> there's no question of <gap reason="inaudible" extent="1 sec"/> <pause dur="0.5"/> <trunc>g</trunc> getting consent <pause dur="0.4"/> for the reuse of that <pause dur="0.2"/> so it's wholly impractical in fact <pause dur="0.2"/> in practice <pause dur="0.3"/> in reality <pause dur="0.5"/> so the committee has backtracked a little bit <pause dur="0.3"/> so if you include if you have the sense <pause dur="0.3"/> to include on your <pause dur="0.2"/> consent form <pause dur="0.3"/> i give consent <pause dur="0.3"/> for the reuse <pause dur="0.3"/> of this material at a later date for other projects yes or no <pause dur="0.5"/> okay the patient ticks the yes box no problem if he ticks the no box <pause dur="0.5"/> well then you bin it <pause dur="0.4"/> after your project <pause dur="0.3"/> after your research is done <pause dur="1.5"/> and you can put specific inclusions in there you can say for example <pause dur="0.3"/> i guarantee that this material will not be used to

clone another human being <pause dur="1.1"/> now that sounds # to us <shift feature="voice" new="laugh"/>a bit <shift feature="voice" new="normal"/> bloody silly doesn't it <pause dur="0.3"/> but honestly i have had <pause dur="0.3"/> questions of that nature from people from whom we've taken umbilical cords <pause dur="0.3"/> okay you think about how <pause dur="0.7"/> how dodgy that might seem to some people <pause dur="2.9"/> in fact that's another <shift feature="voice" new="laugh"/>current issue <shift feature="voice" new="normal"/><pause dur="0.2"/> umbilical cords # <pause dur="0.4"/> we used to <pause dur="0.5"/> we used them for endothelial cell <unclear>fibration</unclear> there are other uses for <unclear>them</unclear> of course <pause dur="1.2"/> placenta also <pause dur="0.3"/> it used to be no problem <pause dur="0.3"/> it's going into the bin so the researcher can have it <pause dur="0.3"/> not any more <pause dur="0.3"/> # for our current research project we've been required <pause dur="0.4"/> # to go to the mother prior <pause dur="0.4"/> to the birth in the antenatal clinic <pause dur="0.3"/> and get her to give specific <pause dur="0.3"/> consent for the research project that we are carrying out <pause dur="0.3"/> for the use of her <pause dur="0.3"/> # for the <trunc>pre</trunc> <pause dur="0.4"/> for the <trunc>umbilica</trunc> for <trunc>umbilic</trunc> <trunc>umbilic</trunc> umbilical cord <pause dur="0.2"/> now i'll i'll just remind you of the consent issue <pause dur="0.2"/> relating to children <pause dur="0.2"/> the mother <pause dur="0.6"/> cannot give consent for research <pause dur="0.4"/> on the child <pause dur="1.3"/> okay <pause dur="0.5"/> now the umbilical cord is the child's tissue

not the mother's so that's <pause dur="0.3"/> something <pause dur="0.3"/> # which shows up some of the lack of logicality of of </u><u who="nf0291" trans="overlap"> <trunc>wh</trunc> <pause dur="0.3"/> who who can then give # consent for the # <pause dur="0.9"/> # umbilical cord </u><u who="nm0285" trans="overlap"> manifestly nobody can </u><pause dur="0.2"/> <u who="nf0291" trans="pause"> mm-hmm </u><pause dur="0.2"/> <u who="nm0285" trans="pause"> <vocal desc="laugh" iterated="n"/></u><u who="nf0291" trans="overlap"> so what do we do </u><pause dur="0.5"/> <u who="nm0285" trans="pause"> well we get consent from the mother <pause dur="0.4"/> 'cause the research ethics committee <pause dur="0.3"/> tells us that that's what we'll do so that's what we do <pause dur="0.8"/> # and it has to it <trunc>ha</trunc> it has to be in the antenatal clinic <pause dur="0.7"/> you're not allowed to go and approach <pause dur="0.5"/> the mother when she's in the labour ward because you know she's going into labour she doesn't want to be distracted and upset <pause dur="0.2"/> you know <pause dur="0.2"/> are they going to clone my baby from the umbilical cord all those sorts of issues that are likely to come up <pause dur="0.3"/> when a woman is going into labour <pause dur="0.3"/> is that right <gap reason="name" extent="1 word"/> </u><pause dur="0.5"/> <u who="nf0290" trans="pause"> oh absolutely </u><pause dur="0.2"/> <u who="nm0285" trans="pause"> <vocal desc="laughter" iterated="y" n="sl" dur="1"/> <pause dur="2.2"/><kinesic desc="changes slide" iterated="n"/> okay so finally # and only just before <pause dur="0.5"/> the hour is up <pause dur="0.6"/> if you're in doubt <pause dur="0.2"/> you

seek advice <pause dur="1.1"/> you may get advice from them <pause dur="0.4"/> if you're extraordinarily lucky <pause dur="0.5"/> you will get advice from them <pause dur="1.0"/> in <trunc>retro</trunc> in in retrospect don't even think about that <pause dur="1.0"/> # i am the <shift feature="voice" new="laugh"/> last resort <shift feature="voice" new="normal"/> <pause dur="0.6"/> # i am happy to give advice for people who are preparing # research ethics proposals <pause dur="0.7"/> but i have <pause dur="0.5"/> found myself embarrassingly in the situation <pause dur="0.3"/> before now giving advice which i thought was sensible <pause dur="0.4"/> right <pause dur="0.3"/> ethical <pause dur="0.3"/> and it's been turned down by the rest of the committee and i have had conflicts with the committee on that issue <pause dur="0.5"/> most recently on this issue of umbilical cords and i became <pause dur="0.2"/> quite speechless <pause dur="0.4"/> at this oh i'll stop talking now <pause dur="0.9"/> so finally <pause dur="0.6"/><kinesic desc="changes slide" iterated="n"/> good luck <pause dur="7.0"/> <vocal desc="laughter" iterated="y" n="ss" dur="1"/><kinesic desc="applause" iterated="y" n="ss" dur="5"/> obviously if you have i think you've answered most of the questions <pause dur="0.5"/> but i am very sincere that if if you are preparing research ethics <pause dur="0.2"/> proposal proposal for the LREC <pause dur="0.6"/> then i'm happy to help you with it although i'm uncertain to the extent to which my

assistance <pause dur="0.7"/> is <pause dur="0.3"/> effective </u><pause dur="1.3"/> <u who="nf0290" trans="pause"> i have got a question <pause dur="0.7"/> # <pause dur="0.8"/> as you know the R and D produces <pause dur="0.2"/> a list of standard paragraphs that one is now expected to put into <pause dur="0.6"/> the patient information sheet <pause dur="0.5"/> and if you just string them all together you <pause dur="0.2"/> get a substantial <pause dur="0.6"/> amount of writing which approaches two sides of A-four <pause dur="0.8"/> without even telling the patient anything about the project </u><u who="nm0285" trans="overlap"> before you start <pause dur="0.4"/> mm </u><pause dur="0.8"/> <u who="nf0290" trans="pause"> # <pause dur="0.4"/> and <pause dur="0.2"/> patients may get not just one of these <pause dur="0.2"/> when they come through they may get several so i'm actually getting really quite concerned about the volume of information that we're giving patients if it's just going to </u><u who="nm0285" trans="overlap"> well i'm i'm also deeply concerned about that </u><u who="nf0290" trans="latching"> ignore it </u><u who="nm0285" trans="overlap"> # and it's <pause dur="0.2"/> i'm not sure that we should discuss these issues <pause dur="0.4"/> # <pause dur="0.6"/> live as it were </u><u who="nf0290" trans="overlap"> okay </u><u who="nm0285" trans="latching"> # but i am very disturbed by the way in which the R and D committee seems to be succeeding

subsuming <pause dur="0.5"/> # and bureaucratizing overbureaucratizing <pause dur="0.4"/> # what is properly the remit of the research ethics committee <pause dur="0.4"/> if the research ethics committee says <pause dur="0.3"/> a patient information sheet <pause dur="0.3"/> is adequate <pause dur="0.3"/> and we require this patient information sheet then i do not see that there should be any other <pause dur="0.5"/> # i'm glad you're telling me that 'cause i didn't know <pause dur="1.4"/> i mean i <trunc>i</trunc> it baffles me that the R and D committee are doing this without even informing <pause dur="0.2"/> the research ethics committee <pause dur="0.9"/> and this is an issue which runs deep in the N-H-S doesn't it <pause dur="1.1"/> <vocal desc="sigh" iterated="n"/> </u><pause dur="0.2"/> <u who="nf0290" trans="pause"> the <trunc>oth</trunc> the other issue that <pause dur="0.2"/> that <pause dur="0.2"/> springs to mind is that one's ethics approval <pause dur="0.4"/> has to be kept up to date </u><u who="nm0285" trans="latching"> yes </u><pause dur="0.5"/> <u who="nf0290" trans="pause"> # and i was told recently that that was <pause dur="0.2"/> that for a year <pause dur="0.6"/> so i was wondering whether it was </u><u who="nm0285" trans="overlap"> no # <trunc>th</trunc> that's something which we're debating i can't actually remember the details

of the debate can you <gap reason="name" extent="1 word"/> </u><u who="nf0293" trans="overlap"> three years three years </u><u who="nm0285" trans="overlap"> it's three years </u><u who="nf0292" trans="overlap"> three years </u><u who="nm0285" trans="overlap"> three years </u><u who="nf0292" trans="overlap"> is what i was told <gap reason="inaudible due to overlap" extent="1 sec"/> </u><u who="nm0285" trans="overlap"> yeah three years <pause dur="0.3"/> # we didn't debate it but it might have been brought down to <gap reason="inaudible" extent="1 sec"/> but the reason why we <trunc>di</trunc> didn't have the <gap reason="inaudible" extent="1 sec"/> had nothing to do with inconvenience of researchers <pause dur="0.3"/> it's a question of convenience of the research ethics committee would we read <pause dur="0.3"/> that many reports the answer is no we wouldn't <pause dur="0.3"/> so we put it back to three years </u><u who="nf0290" trans="latching"> i think that's something else that may <pause dur="0.2"/> be <pause dur="0.7"/> kind of <pause dur="0.2"/> different information for different places </u><u who="nm0285" trans="overlap"> yeah well as i say if if in doubt <pause dur="0.2"/> actually <pause dur="0.4"/> talk directly to the research ethics committee <pause dur="0.5"/> okay <pause dur="0.4"/> <gap reason="inaudible" extent="1 sec"/> whatever <pause dur="2.1"/> <vocal desc="laugh" iterated="n"/> </u><u who="nf0290" trans="overlap"> mm </u><pause dur="0.3"/> <u who="nm0285" trans="pause"> <gap reason="name" extent="1 word"/> </u><u who="nm0287" trans="pause"> # you're saying that the <pause dur="1.8"/> <unclear>ethicalism</unclear> R and D committee seems to be subsuming the role <pause dur="0.2"/> of ethics <pause dur="0.4"/> but i think it's a widely held belief <pause dur="0.2"/> that the opposite is also true and as you said the <pause dur="0.2"/>

majority of rejections of applications <pause dur="0.2"/> are not down to any <pause dur="0.3"/> ethical concern it all comes down to study design <pause dur="0.3"/> finance <pause dur="0.2"/> and the like and this <pause dur="0.2"/> this surely is an opportunity between the two <pause dur="0.3"/> bodies </u><u who="nm0285" trans="overlap"> well we'd like to think so </u><u who="nm0287" trans="overlap"> to streamline and prove that really more from a researcher's point of view <pause dur="0.3"/> if there are very few that are actually posing an ethical issue to our </u><u who="nm0285" trans="latching"> yeah </u><u who="nm0287" trans="latching"> patients then </u><u who="nm0285" trans="latching"> yep yep no </u><u who="nm0287" trans="overlap"> # i think it becomes <gap reason="inaudible due to overlap" extent="1 sec"/> </u><u who="nm0285" trans="overlap"> 'cause as i said as i said quite clearly <pause dur="0.5"/> poor research is by its nature <pause dur="0.4"/> unacceptable ethically <pause dur="0.7"/> # one of the requirements that's coming in with the new regulations is that you have to provide peer <pause dur="0.4"/> # peer review <pause dur="0.3"/> of your research <pause dur="0.9"/> if you can do that and <trunc>th</trunc> that's a positive peer review <pause dur="0.3"/> well then i'm quite sure that the research ethics committee will accept it as i said if it's from the <trunc>well</trunc> if you're if you're funded by the <trunc>r</trunc> <pause dur="0.3"/> Wellcome Foundation <pause dur="0.4"/> nobody will argue about the

quality of your research <pause dur="0.9"/> <gap reason="ethics" extent="13 secs"/> <pause dur="0.6"/> # <pause dur="1.9"/> and the peer review that's suggested can be your mate in the next office <pause dur="0.5"/> okay <pause dur="0.4"/> under some circumstances it can be a single individual <pause dur="0.3"/> so i'm afraid <pause dur="0.3"/> the research ethics committee will always take a look at the quality of the research always </u><gap reason="break in recording" extent="uncertain"/> <u who="nf0294" trans="pause"> how do you cope with things like because if you you say if you're funded by Wellcome that's okay in terms of peer review <pause dur="0.5"/> but often you'd be going for ethical approval for research that'd be going into a grant application you need the ethical approval before you can apply </u><u who="nm0285" trans="overlap"> yes i know that's so </u><u who="nf0294" trans="overlap"> so you've not got the funding in place <pause dur="0.6"/> or the peer review </u><u who="nm0285" trans="overlap"> no you see you haven't got the peer review in that situation that's right </u><u who="nf0294" trans="overlap">

but you can't apply for the grant until you've got the ethical approval </u><u who="nm0285" trans="overlap"> well with any <gap reason="inaudible" extent="1 sec"/> <unclear>grant that that</unclear> circle that that we do need to have <pause dur="0.3"/> the research ethics committee actually doing # a review of the quality of the research <pause dur="0.7"/> yeah </u><pause dur="0.3"/> <u who="nf0294" trans="pause"> mm </u><u who="nm0285" trans="latching"> # and i will never never accept that the R and D committee's # # <pause dur="0.4"/> # assessment is adequate <pause dur="2.5"/> unless it's done properly <pause dur="0.5"/> through a proper peer review process in which there are independent experts reviewing the research <pause dur="2.1"/> mm <pause dur="1.8"/> what would you think <gap reason="name" extent="1 word"/> </u><pause dur="1.5"/> <u who="nm0287" trans="pause"> # i i think this <pause dur="0.8"/> problem started <pause dur="0.9"/> <gap reason="inaudible" extent="1 sec"/> <unclear>going up and</unclear> <pause dur="0.4"/> a little bit more from the persons making the application # to them it's not <pause dur="0.2"/> the politics of one person versus the other</u><u who="nm0285" trans="overlap"> no</u><pause dur="0.2"/> <u who="nm0287" trans="pause"> it's the <trunc>s</trunc> it's the process and the system </u><u who="nm0285" trans="overlap"> yeah </u><pause dur="0.3"/> <u who="nm0287" trans="pause"> whereby it's as streamlined as possible and allows researchers to get back <pause dur="0.3"/> their ethical <pause dur="0.5"/> approval as quickly as possible </u><u who="nm0285" trans="overlap"> well you've have to excuse me when i say that it's the R and D committee that's

bureaucratizing the process the the the LREC the research ethics committee actually keeps a fairly simple procedure compared with what the R and D committee does <pause dur="0.5"/> and we have tried to keep it <pause dur="0.4"/> fairly simple <pause dur="2.2"/> i mean <trunc>a</trunc> as i was trying to say <pause dur="0.4"/> we're not overly concerned with the details of the research provided we're satisfied that they're adequately designed <pause dur="1.4"/> because indeed it is the ethics issues which concern us <pause dur="0.4"/> and i suspect that the R and D committee maybe should take more interest in the research design <pause dur="0.3"/> and less interest in ethical issues in fact keep out of ethical issues it's not their business <pause dur="2.3"/> except <unclear>that</unclear> it was put to me <pause dur="0.4"/> # that through governance within the hospital <pause dur="0.8"/> the hospital has to be has to <pause dur="0.4"/> assure itself that the research is carried out in an ethical

manner so they do do this audit which i mentioned right at the beginning which i've fallen foul of <pause dur="0.9"/> # and now <pause dur="0.4"/> i would say actually it's the R and D committee it's not it's it's the <trunc>re</trunc> research ethics committee's <pause dur="0.6"/> # role <pause dur="0.2"/> to do such audit <pause dur="0.6"/> # and the R and D <pause dur="0.2"/> committee did not inform <pause dur="0.3"/> the research ethics committee that this audit was under way <pause dur="0.6"/> i find all those things absolutely extraordinary <pause dur="0.7"/> # <pause dur="0.2"/> but the <trunc>i</trunc> <pause dur="0.3"/> <trunc>r</trunc> research ethics committee cannot do that audit because they haven't sufficient staff <pause dur="0.3"/> and the reason for the delays that occurr <pause dur="0.5"/> as you well know is a there's a single person <pause dur="0.6"/> working in the research ethics committee <pause dur="0.3"/> generating all your letters <pause dur="0.3"/> and she wants a holiday occasionally and sometimes she's poorly <pause dur="1.6"/> and that's when the delays happen