nm0285: as as some of you will know i'm very much concerned [0.2] actually [0.
2] that [0.3] medical research should involve people [0.5] er as as subjects of 
the research and obviously particularly patients [0.4] as subjects of research 
and [0.6] er i sometimes say slightly derogatory things about [0.4] tissue 
culture and animal models of s-, and so forth [0.3] of course these have their 
place [0.3] but ultimately if we're going to understand human disease [0.4] 
then we have to work with human patients [0.6] and that means that we have to 
get ethical approval [0.5] er for such research [0.3] now ethical approval for 
work with patients [0.3] actually is fairly simple compared with ethical 
approval for working with animals [0.4] as some some people have found out [0.
4] and getting ethical approval from a research ethics committee [0.5] is 
actually rather easier [0.3] in some s-, some ways [0.3] than coping with your 
local R and D committees again [0.4] some people who work in the hospital will 
well know [1.4] so what i'm going to do today is talk a 
little bit about the background [0.4] er of research medical research ethics [0.
5] er i shall talk about the sort of [0.3] way in which [0.6] er medical [0.3] 
research is [0.2] controlled in this country [0.3] and i shall go on and talk 
in a bit more detail about the actual way in which you organize [0.4] er a 
proposal so that it gets approved by the medical research ethics committee [0.
6] er and i shall [0.3] point out some of the pitfalls [0.5] okay so my 
qualifications for doing this [0.3] are as you see i'm actually the vice-
chairman of the namex of the local [0.3] research ethics committee [0.6] er 
also as you [0.5] i'm sure you know [0.3] er i've been much involved in medical 
research over some years now [0.5] and my research has exclusively dealt with 
[0.3] with people [0.3] er research into disease using er [0.2] human subjects 
[1.4] so [0.8] why do we need to regulate [0.3] medical research now to most of 
us [0.3] that would seem seem absolutely self-evident [0.5] but [0.3] take 
ourselves back fifty years [0.3] and it wasn't nearly so self-evident [0.4] er 
but you've come a long way since the time [0.3] of 
er the last [0.3] f-, er the Second World War [0.3] if anybody has any [0.6] 
doubt [0.3] about why we [0.6] need to regulate medical research i'll just 
mention these two names [0.5] Mengele and Tuskegee Mengele [0.7] was a German 
who carried out some rather frightful [0.5] er experiments with people in 
concentration camps and so on [0.9] er 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 [0.6] Tuskegee [0.6] you may not have heard about Tuskegee [0.4] is 
actually not a man [0.3] it's a place it's a place in the United States of 
America [0.4] er where over a period of some decades [0.4] a group of er 
American Africans [0.4] with syphilis were left untreated [0.5] er although 
there were perfectly acceptable perfectly good treatments available at the time 
[0.3] so that the natural history [0.2] development of the disease could be 
studied [0.4] now obviously [0.2] those are rather extreme examples [0.4] but 
er those that have been looking into the press and listening to [0.3] issues 
in the N-H-S over the last few years [0.2] know perfectly well [0.2] that there 
is an ongoing [0.3] er problem not so much problem ongoing concern [0.3] with 
medical research ethics you will remember [0.3] er the [0.2] fuss about the [0.
6] organs of children that were retained at er Liverpool a fairly recent 
example and there are still major repercussions [0.3] of these sorts of events 
[0.5] particularly i mean the availa-, the availability of [0.3] er ch-, er 
paediatric tissue for research [0.3] so namex you're nodding your head just 
then there [0.3] was that a 
sm0286: [0.6] 
nm0285: er and others [0.2] again will know [0.4] that because of these sorts 
[0.2] of scandal it's not too strong a word [0.5] it has been very difficult to 
do some kinds of research [0.8] so [1.5] regulation of medical er research is 
essential [0.5] now what happens [0.4] say [0.2] you decide oh bugger it i'm 
doing some research rather than medical research [0.2] what happens if you are 
discovered to be doing [0.3] research which should have ethical approval and 
you haven't got it [0.4] now first of all er [0.3] this really applies to 
doctors [0.3] the medical defence union cover or what is 
the equiv-, equivalent would be void [0.6] so that if anything goes wrong you 
are s-, subject to the criminal law [0.6] er [0.2] the [0.4] chief [0.2] 
executive os-, officer of the hospital [0.4] would almost certainly want to 
talk to you [0.7] er and i'll mention in a little while that i recently had a 
letter [0.3] from the chief executive officer of the namex Hospital [0.3] so i 
know that from a personal [0.2] point of view [0.5] er [0.2] if you're 
medically qualified [0.4] er the G-M-C [0.4] General Medical Council [0.4] 
could well want to talk to you [0.4] er and perhaps also the police under 
extreme circumstances so this is something we obviously [0.5] have to take [0.
5] er very seriously [1.6] now as i just hinted from time to time [0.2] er well 
not so much this [0.5] from time to time [0.3] the local hospital [0.2] trust 
[0.2] does audits [0.3] on medical research and i have just discovered that 
they do that [0.3] 'cause i had a letter from the chief executive officer 
pointing out [0.3] that some of the work done under my pr-, my supervision [0.
4] er the consent forms are not in proper [0.2] order [0.9] it was rather a 
fierce 
letter that i think you'll enjoy reading [1.8] okay [2.8] i will ask the 
question how am i supposed to s-, supervise directly [0.5] er that's the second 
issue [0.5] er so a little bit of history now i've already referred to that guy 
Mengele [0.4] er the consequence of the sorts of things he was doing not just 
him but others [0.5] er the Nuremberg Code was developed in nineteen-fif 
nineteen-forty-seven [0.4] to regulate and start start to control medical 
research [0.4] things like the Universal Declaration of Human Rights [0.4] and 
then only in nineteen-sixty-four [0.3] there was the Declaration of [0.3] 
Helsinki [0.2] which is a very large document which goes into immense detail 
about all sorts of a-, aspects of medical ethics [0.5] er many many pages i've 
never read it perhaps i should have done but i haven't [0.4] and then there er 
have been other things since then [0.4] er mon-, you've seen modification of 
the Declaration of Human Helsinki organizations such as the World Health 
Organization [0.7] the Council for International Organizations of Medical 
Science obviously the me-, the M-R-C the various Royal 
Colleges in this country and so on [0.3] all of them [0.3] sort of dig in er 
have a little bit they have a say [0.4] er about medical research ethics so 
there's [0.3] er a lot of things going on as it were [1.4] now [0.5] that's a 
bit of history [0.5] for the future [0.3] er as always the European Union [0.3] 
is lumbering in here [0.5] er and there is a regulation is drawn up by the 
European Union [0.7] called this [1.3] which is supposed to be coming into 
force this year but hadn't [0.2] won't [0.4] yeah it's here now [0.3] and i've 
had a quick look [0.5] at the med-, at the web site [0.2] and there's [0.3] 
downloaded a document of seventy-one pages [0.3] basically of definitions and 
regulations okay [0.3] dreadfully enormous document [1.0] for the moment [0.2] 
this document deals only with the conduct of clinical trials [0.4] involving [0.
2] basically drugs but medical products it says in general so that could be 
wooden legs [0.3] but mostly it's drugs [0.4] but you can bet your bottom 
dollar that sooner or later [0.2] this sort of er [0.2] European Union 
regulations will come in [0.2] to cover all aspects of medical 
research so [0.5] it's something we're going to have to keep our eyes on [2.3] 
okay [0.3] er in addition because of the recent fusses about [0.3] retention of 
tissues [0.2] there has been extensive er [0.6] er consultation by the 
government on these issues of retained tissues [0.3] and there will be 
regulation [0.5] and if you want to see more about that i will obviously i have 
all these [0.4] web sites if you want to look at them [0.4] and there's a 
summary of responses to the consultation report P-D-F [0.6] again a another 
very substantial document [0.2] hours of reading [1.7] okay [0.2] so let's 
leave that [0.5] and go on and talk about the basis for ethical medical 
research [1.3] er i'm not an ethici-, i'm not a professional ethicist as you 
know i'm a professional biologist [0.3] so i haven't made er ever made any sort 
of significant study of the nature of medical ethics from a from a 
philosophical moral [0.3] point of view [0.2] but i have grasped that there are 
two major points [0.4] that we have to consider when organizing medical [0.3] 
research [0.3] one is this thing to do the so-called autonomy 
of the individual [0.4] and the other is the issue of do no harm [0.3] non-
maleficence [0.5] if you want to know the technical term for that [1.0] and the 
basic point is that present harm no no sort of present harm can justify any 
sort of future good [2.3] so what do we mean [0.2] by autonomy of the 
individual again [0.3] this is er sort of a lay person's view of this [0.5] but 
as i understand it [0.2] the whole issue [0.5] is that i am in control of my 
destiny i am the person who controls my life [0.3] i am the person in theory [0.
3] er that controls everything that happens to me unless i trangress the law of 
course in which case i go to prison [0.6] er so only i [0.3] can choose what 
happens to me [0.6] now [0.3] there's an important issue here [0.8] i can only 
choose sensibly and properly if i'm fully informed [0.4] about the consequences 
of my choice [0.4] i'll give you er a non-research example [0.4] the er thing 
about [0.3] er [0.4] M-M-R vaccination a little while ago people were saying [0.
5] M-M-R vaccination may cause aut-, er autism or related illnesses [0.3] 
therefore we have 
single vaccinations [0.2] people must be given the choice of what they want to 
do for their babies M-M-R [0.2] or single vaccinations [0.3] now there's no way 
that can be an informed choice 'cause nobody knows [0.6] what are the real 
consequences of M-M-R [0.3] and the real consequences of single vaccinations so 
there is no [0.3] question of info-, or informed choice here [0.6] so in fact 
there is no choice in that issue [0.4] that's that's just an illustration 
obviously it's not to do with research but the issue is the same [0.3] in order 
to make a choice [0.3] about whether or not [0.2] to take part in medical 
research is what i'm talking about [0.4] we have to know properly [0.3] what 
are the consequences of that choice [1.6] okay now [0.3] non-maleficence [1.6] 
do no harm [1.4] basic principle throughout medicine goes back to Hippocrates 
[0.3] by the way [0.2] er doctors no longer take the hipprocra-, Hippocratic 
oath is that true namex 
nm0287: i think that's correct yeah [0.2] 
nm0285: yeah because we go get all get all these references to the Hippocratic 
oath [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 [0.4] but doctors nevertheless [0.2] do 
you sign a declaration don't you er [0.3] er which [0.2] basically covers the 
same sort of ideas [0.5] er as the Hippocratic oath and of course [0.3] a major 
principle of that h-, has to be do no harm [0.5] well now [0.3] er [1.0] in 
medical research [0.8] if we adhere strictly [0.4] to the to the concept of do 
no harm [0.5] you would do no medical research [0.4] because any medical 
intervention [0.4] potentially [0.5] has the ha-, ha-, can do harm [0.4] even 
well not [0.2] i suppose not a pinprick to take a few micrometres of blood [0.
3] but almost any any other sort of intervention any other sort of procedure [0.
4] involving er [0.6] anything to do with [0.2] treatment or or or whatever [0.
5] potentially has harm [0.9] so we have to modify [0.3] this point about non-
maleficence [0.3] otherwise there will be no medical research [0.4] so that is 
modified in in practice [3.6] okay so [0.3] to pull those two points together 
[0.6] er in order the basis for medical 
research ethical medical research [0.4] is it the [0.4] the research subject [0.
3] clearly must understand the risks [0.3] and benefits of the research [0.4] 
er and so that he can give proper informed consent [0.5] likewise [0.5] the 
risks from the research [0.3] should be proportionate to the benefits that come 
out of it [2.7] okay [0.7] so with that as the basis [0.4] when do we [0.3] 
need to apply for ethical approval [0.6] and quite simply [0.4] er we have to 
apply for medic-, ethical approval [0.2] for any research involving [0.4] 
either patients [0.3] or their carers at home say [0.4] or [0.2] medical 
personnel [0.5] and that comes as a bit of a surprise to some people [0.4] why 
medical personnel [0.4] er and the argument is [0.4] er that er [0.5] nurses 
midwives porters whoe-, whoever [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 [0.7] the issue has come up before now 
[0.4] er that medical personnel being involved in research have felt pressured 
[0.3] to take part in that research because they have felt [0.4] that if they 
didn't [0.3] then their careers may be prejudiced and however you'd say that 
that's nonsense [0.2] but anyway the point is [0.3] er this is the position 
they're in so carers and medical personnel [0.3] are also [0.4] got to be 
considered [1.0] in the in the issue of [0.4] ethical research now i'll give 
you an example where [0.3] actually [0.3] er this could have been [0.4] er a 
significant issue [0.3] there was a proposal that came before a an our research 
ethics committee [0.4] in which personnel N-H-S employees [0.4] were required 
to er speak to people in pubs [0.3] about er their sexual habits now you can 
just imagine [0.3] under certain circumstances that could have [0.2] ended up 
in a punch-up [0.9] and so the ethics committee involved said no they can't do 
that [0.3] i'm afraid you'll have to find other ways of approaching the people 
[0.3] that you want to discover the facts about their sexual practices and so 
on [0.3] not in the pub [0.3] somewhere else [0.5] of course the whole point 
was that [0.4] er they wanted to have a [0.4] er a broader group of people than 
those that came along to the [0.4] er er say they went to the [0.2] 
G-U clinic [0.6] people that [0.4] er perhaps i'll not pursue that [0.2] point 
[0.7] okay [1.5] now [1.4] curiously [0.4] research involving healthy 
volunteers [0.4] technically you don't need ethical approval [0.4] but i can 
see the days [0.3] when that is the case are [0.2] s-, [0.2] certainly numbered 
i think [0.4] before very long [0.2] er any sort of medical research whether it 
involves [0.2] patients carers medical people whatever [0.7] er including 
people like you and i fit and healthy [0.4] er [0.7] that will have to go in 
front of an ethical committee [0.8] yeah an awful lot of public health research 
[0.4] er is done with the general population for example certain questionnaires 
are sent out [0.5] er 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 [0.5] er that at the present moment doesn't require 
ethical approval 'cause it's not [0.4] directed at the patients [0.8] but if 
you look [0.3] at the web site [0.2] COREC web site [0.3] er the implication is 
that everybody because he or she 
sooner or later [1.0] is will be has been [0.2] a patient [0.3] everybody [0.2] 
is patients [0.2] and of course we all of us are patients at some stage in our 
life [0.3] so [0.2] i'm quite sure that before very long everybody will be 
involved [0.5] in this so you will not be able to do anything to people of any 
sort [0.3] without ethical approval [0.3] that's perhaps [0.4] a little way 
down the line [2.5] now er this is a thorny question what is [0.5] medical 
research [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 [0.5] er my view 
[0.2] is quite plainly any investigation of our and i've already said this [0.
3] patients their carers or medical staff [0.2] where the aim is to discover 
new medical knowledge [1.0] er the nature of this research can be basically 
anything qualitative research as i just alluded [0.3] to a sort of research 
which is qualitative how m-, how many times have you been to a doctor [0.4] how 
d-, how did you enjoy the experience that sort of question [0.5] to patients [0.
5] er you will have seen [0.3] research of that sort 
from our undergraduates over the last few weeks [0.4] you can understand [0.2] 
er [0.9] what is meant by qualitative in that context [0.6] some of our 
undergraduates tried to get some quantitative [0.4] data from their research 
i'm talking about [0.5] er the sorts of things that my students do they er one 
of my students for example [0.5] er compared [0.2] a group in Kenilworth [0.3] 
and a group in Bristol according to their knowledge [0.5] of er current 
carcinoma screening programmes [0.3] because there's a pilot programme locally 
there's not one in Bristol [0.5] the guys locally [0.3] knew about it the guys 
in Bristol didn't [0.2] and she was able to clearly get good statistical [0.3] 
er significance between those two groups that's the kind of quantitative 
research [0.4] because it didn't involve patients except indirectly it's a bit 
of a [0.2] sleight of hand [0.3] because it didn't involve patients it didn't 
require ethical approval [0.7] okay but you see the point that i'm trying to 
make [0.4] that's what a study if it involved patients certainly would [1.3] 
now clinical research er that 
includes things like drug trials epidemiology we know what that means i've 
mentioned drug trials there [0.3] lab based the sort of thing [0.2] that i do a 
lot [0.6] er we want bits of colorectal tissue in or carcinoma tissue [0.4] 
particularly in order to study [0.3] the processes involved in carcinomas [0.3] 
now with the tissues there's an issue i'll come later come up later bring up 
later [0.4] the tissue is removed at er the operation [0.4] er and my use of 
the tissue has very little consequences for the patient's well-being [0.5] i 
could say there's no consequences for the patient's well-being but that isn't 
quite true in fact [0.5] because the pathologist always wants a bit of that 
tissue [0.3] obviously to do the pathological study [0.5] and so if the 
researcher says well i want the biggest bit [0.4] the pathologist may be er 
some weak-kneed feeble sort of person doesn't happen of course not in my 
experience [0.3] and so he gives up [0.2] most of the tissue [0.2] so that 
would be very unethical obviously so in this situation [0.3] where basically 
we're using unwanted tissue 
you still have to have ethical approval of course we do [0.9] so that's really 
what i mean by lab based [0.5] retrospective prospective whatever [0.4] okay [0.
2] so [0.3] there we are very broad definition of medical research [1.0] now 
it's not [0.4] absolutely broad because [0.2] there's always this issue of 
audit now er medical practitioners get very concerned about what is the 
difference between reseach and audit [0.4] and [0.4] to be honest it's very 
difficult to say [0.6] but [0.8] the way i look at it [1.0] research [0.3] is 
aimed at generating [0.2] new knowledge [0.2] that if you didn't do the 
research [0.3] that knowledge would not be available you could not get it so 
you have to do the research to generate new knowledge [0.8] audit [1.0] is more 
a retrospective looking at [0.2] current practice current knowledge [0.4] er 
with the aim [0.2] of er validating or confirming the value whatever [0.3] of 
the current medical practice [0.4] so if you have a series of patients [0.2] er 
some of [0.3] women [0.2] er who give birth at home or women who give birth in 
a swimming pool [0.2] or women who give birth in an obstetrics ward [0.2] and 
you've been doing this for several years you've got [0.2] 
good numbers of all three kinds of women [0.4] er and you want to see who'd do 
better or which babies do better or whatever [0.3] that is not research because 
it's retrospective and it involves material that's [0.5] that are already 
available and it it it isn't [0.3] it's simply a means of [0.4] er establishing 
the validity of your work [0.5] and this is obviously much more medical than [0.
3] concerns us [0.7] now as i said at the bottom if in doubt [0.2] over these 
sorts of issues and this is a general principle if you're in doubt [0.4] then 
consult the local [0.5] research ethics committee [0.9] er this is a point 
which is absolutely self-evident medical research can only be done [0.3] in 
collaboration with medical practitioners [2.7] okay [0.3] so [1.6] that's got 
[0.3] some stuff out of the way [0.3] what i want to go on now is talk a little 
bit more about the actual regulation [0.4] of research ethics who does it [0.6] 
then i'll go on to say how it's done [0.8] now at present there's no legal 
framework but as i've already implied [1.5] that is going to change [0.5] er 
and that 
directive [0.2] er as i referred to earlier [0.2] is supposed to be brought 
into national law [0.4] by May of next year [0.7] now this at the moment only 
applies to drug trials [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 [1.8] [0.2] who regulates research 
ethics again [0.4] research ethics committees [0.6] R-E-Cs [0.3] now these [0.
4] are set up by the local research authority [0.2] at present [0.2] our local 
research authora-, authority has got the glorious name of [0.4] West Midlands 
South [0.3] all right not South Midlands West or South West Midlands but West 
Midlands South [0.7] er this research ethi-, er this health authority [0.4] er 
sets up [0.2] these committees and they are formal committees basically 
subcommittees called the health authority [0.6] and the members of the 
committees have indemnity so if they make the wrong decisions they don't get 
sued [0.3] that sort of thing [0.3] which is something that i'm fairly happy 
about [0.2] but we are advisory boards technically [0.6] our job the job of the 
REC [0.7] the research 
ethics committee is to advise on whether [0.3] er research proposals are 
ethically acceptable [0.3] of course nobody would ever go against the advice of 
a research ethics committee in fact this [0.3] and not er by not not not [0.4] 
really by agreement it is actual fact [0.3] but they have no legal basis [0.9] 
nm0288: namex sorry can i just ask is ethical approval [0.3] transportable from 
one research ethic [1.4] modality to another 
nm0285: that's a point i'll come to in a moment [0.4] 
nm0288: okay 
nm0285: there's a slightly different there's a different [0.3] route [0.6] er 
[0.4] i'm talking about research ethics committees generally there are research 
ethics committees which are which are strictly local [0.6] affairs [0.3] such 
as the Coventry research ethics committee [0.3] and there are larger er 
committees with more regional remit [0.4] which are called multicentre research 
ethics committees [0.5] so i'll come on to them in a moment [1.0] okay so we 
advise [0.3] on whether the work is ethically 
acceptable [0.9] there is [0.4] has been over the last five years or so [0.2] 
in fact it's been more than five years [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 [0.3] er through an organization called the Central 
Office for Research Ethics Committees [0.4] and that's [0.3] an easily 
remembered acronym i wish this thing would work [1.3] it's coming i think [0.5] 
a r-, easily r-, remembered acronym COREC- [0.4] dot-org-dot-U-K [0.3] and if 
you want to see [0.3] the glorious future for research ethics in this country 
go and look at their web site [0.4] namex [0.6] 
nf0289: er i just want to make clear because you keep saying advise [0.2] 
nm0285: yes 
nf0289: in my experience they either accept or res-, [0.4] or reject this 
nm0285: yeah mm i'll come to that 
nf0289: but that's not advise that's er 
nm0285: well it's that we're advising the health authority [0.2] not we we you 
th-, you you you could we're advising the 
health authority basing it on whether your research is ethically acceptable [0.
5] 
nf0289: yes but you are advising 
nm0285: so so we we we tell you what our opinion is [0.2] and you can modify 
your proposal [0.2] if you wish [0.7] and then you resubmit it and then we 
would advise the health authority [0.2] that your research now is ethically 
acceptable [0.3] 
nf0289: okay 
nm0285: or not [1.2] okay it's i-, the this comes the the point is of course 
there's no legal framework at the present moment [0.5] so it is purely advisory 
but that's a as i said at the beginning [0.3] if you do [0.2] er work with 
patients which yet haven't got ethical approval [0.3] then your medical 
protection [0.4] is void [0.5] or the practitions [0.5] er [0.9] is void [0.6] 
and so you if y-, something goes wrong then it's common assault [0.2] and 
you'll yeah [0.2] all all those consequences [1.4] okay [0.3] and as i've said 
already twice we're 
moving towards implementing this directive [1.2] okay to answer namex's 
question [0.4] there are two kinds of research ethics committee which we call 
multicentre MREC [0.6] and local LREC [0.4] now MRECs [0.2] these were set up 
[0.3] to cope with the situation [0.2] where if you have [0.2] er a trial where 
you want to recruit a large number of patients [0.4] but the average number of 
patients in any particular hospital is relatively small obviously you've got to 
use multiple sites multicentre [1.1] prior to the setting up of these MRECs 
each and every single [0.2] er [0.4] LREC [0.6] involved in the research would 
have to have a separate application [0.3] and very often the different LRECs 
would give conflicting [0.3] er [0.3] answers and there's a huge muddle up and 
the MRECs are similarly supposed to cut through that namex [0.8] 
nf0290: namex i know of this er but i was told that the [0.3] the cut-off point 
was five 
nm0285: it's changed [0.3] 
nf0290: it has changed right thank you now is it 
nm0285: i'm pretty sure it's two [0.3] i'm pretty sure it's two now [0.4] it 
may not have yet changed but it's certainly going to be changing in the near 
future [0.7] er two or more research sites well you see that's a quotation that 
would be a direct quotation from [0.3] from COREC site [0.7] so we'll be going 
down from 
five to two [1.4] okay [0.3] so LRECs deal with single site research well two 
site research [0.5] so it could be Coventry [0.2] and Warwick say [0.9] a 
maximum of two [0.5] er [0.4] and they also deal with local issues relating to 
multicentre research [0.4] so the typical local issues that arise [0.4] are er 
well i'll give you an example [0.4] there was a proposal that came to us last 
month [0.3] from [0.2] Scottish MREC [0.4] in which [0.3] er it was said that 
should an emergency arise the patient should be transferred to the Edinburgh 
Western General Infirmary [0.5] so obviously that's a local issue [0.3] er 
which we changed to the namex we're not quite sure that was the right thing to 
do but never mind [0.7] mustn't say evil things about the namex Hospital 
there's nobody here from the namex oh there's namex who isn't here [1.2] 
[laugh] well [0.2] yeah well i won't er say any more [0.4] okay [1.8] so [0.5] 
the way these [0.3] communities are established they include both lay [0.3] and 
professional [0.2] now the definition of lay here is peculiar sometimes [0.2] 
i'm a medical professional [0.3] er 
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 [0.5] 
but obviously i'm professional in the sense that i'm very much [0.4] involved 
in a number of aspects [0.3] of medicine research teaching [0.2] ethics [0.5] 
and other things [2.0] [0.7] so [0.9] [sniff] [2.2] let's go on and talk about 
the purpose which is obviously self-evident [0.3] and that's to balance the 
principles of personal autonomy and do no harm [0.2] against the need to carry 
on research [2.4] now [0.4] what are we looking for [0.4] er when we're judging 
a proposal for a for research [1.9] four points really [0.3] er quality of the 
research and researcher risk versus benefit whether informed consent is 
possible [0.5] well actually i should say whether informed consent [0.2] is 
possible and is adequately dealt with goes without saying [0.6] er and then 
final point is whether suitable indemnity is in place and i'll talk about all 
these points in turn [0.9] indemnity means 
compensation if something goes wrong [0.5] [sniff] [0.9] now the quality of 
research and researcher [0.6] it's taken [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 [0.4] which has got treatment aims or whatever [0.4] is by its 
nature [0.5] not ethical you should not bother patients unless you know the the 
the issue is entirely trivial [0.4] you should not bother patients or sick 
people [0.3] with research which is not well designed [0.6] that's taken as [0.
7] given [0.7] so one has to be [1.4] this issue of aims i mean all of us are 
scientists and know jolly well [0.3] that we've got to design our research 
projects so they're clear-cut [0.5] properly understood aims hypotheses and so 
on [0.4] and a proper strategy [0.4] to accomplish the aims [0.5] or falsify 
the hypothesis [0.7] er sorry er i've got to go back how do i use this [0.7] [1.
4] so [0.2] er [0.5] the next question after the aims quite obviously is the 
methodology [0.7] suitable [0.7] do your [0.4] the me-, methods you use going 
to use are they going to give you the answers you want or not [0.8] and then of 
course is the 
researcher able to deliver the goods [2.3] so the aims must be medically and 
scientifically valid [0.7] now [0.5] you can drop that requirement a little bit 
for training [0.2] purposes [0.4] er and the [0.5] the ethics committees is [0.
3] are is the ethics committee is very clear [0.4] er that where somebody is 
doing a higher degree [0.6] well no i think higher degrees things like M-Ds and 
PhDs we would we would certainly require the highest possible er [0.4] quality 
of aims and so forth [0.3] but somebody who's doing a project say for a B-S-C 
in nursing [0.4] which happens quite a lot from Coventry University less from 
us [0.3] obviously [0.5] then we can be content to d-, to drop the quality in 
the in the importance of the aims a little bit well quite a lot as it happens 
[0.5] now there's been a number of er projects as you know from our 
undergraduates [0.3] that have been quasimedical most of those [0.3] i would w-,
ca-, would would would er er s-, w-, [0.5] would consider needed some sort of 
er would [0.5] get this straight [0.2] i would consider needed ethical approval 
and i've written to those [0.4] who asked me about it and said sorry [0.2] 
you're too late [0.3] er [0.7] well the the the point is these are training [0.
2] projects which [0.2] we don't worry too much about the aims [2.1] i would 
say er to those who that supervise these projects i think [0.4] er that where 
medical where where ethics is an issue then it should be a part of the project 
and the student [0.4] involved should consider ethical [0.3] issues and if 
necessary [0.3] address them properly [1.4] now there's another [0.2] kind of 
er ai-, another aim which gives us great pain that's commercial called 
commercial projects [1.4] frequently er a drug company brings out a new 
formulation or slight alteration in the way in which a drug is delivered [0.4] 
er and they want to get this er into G-Ps' surgeries or hospital pharmacies and 
so on [0.3] so they set up a trial comparing [0.2] their new formulation [0.3] 
with [0.4] the old-fashioned stuff that they knew doesn't work properly [0.4] 
er not the new 
formulation against the old formulation but the new formulation against a drug 
which is known not to work very well [0.4] and they say look guys our new new 
[0.2] er formulation works much much better than that old-fashioned drug that 
nobody uses any more [0.4] and therefore they send out their flyers to G-Ps' 
surgeries and so on and it looks good [0.5] because they've done a trial [0.3] 
but we have tremendous difficulty in accepting that we find it hard to turn 
them down 'cause they're obviously [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 [0.4] getting the new formulation 
in front of [1.0] the purchasers [2.4] methodology [0.3] er obviously in 
control groups are they appropriate [0.3] statistical power [0.3] er this again 
really applies only to trials where you're comparing drug doses [0.4] do you 
have sufficient people enrolled in your study in order to give a clear answer 
to 
the question [0.3] you're [0.3] posing [0.4] that's often quite difficult to to 
to turn [0.6] er [0.9] do you have access to suitable laboratory facilities we 
had a proposal a little while ago [0.4] er which was very interested in P-C-R 
studies of [0.3] mi-, er mitochondrial D-N-A [0.5] er and i asked what i 
thought was a perfectly simple question 'cause it wasn't in the proposal [0.3] 
where are these P-C-Rs going to be done [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 [0.5] er so you've got to be 
sure that when you [0.3] make your proposal [0.3] not only is your methodology 
right [0.4] but you've got to have access to the cer-, to the to the facilities 
[0.4] to do the work [0.5] and [1.1] at the end of the day [0.3] a bit like 
statistical power [0.8] really you ought to have statistical advice in other 
words take statistical advice before you start not at the end [0.8] i won't 
talk about statistics at all 'cause i know what a serious bone of 
contention it is [1.0] now researcher does he have a track record in research 
do we require a C-V [0.3] namex 
nf0290: can i just ask about the power issue 
nm0285: ah right 
nf0290: because as you know 
nm0285: wish you wouldn't 
nf0290: it's very difficult 
nm0285: and 
nf0290: to find enough patients and enough money 
nm0285: yep 
nf0290: to be seeing the patients 
nm0285: i know [0.4] yep 
nf0290: or to do a pilot study [0.3] to start 
nm0285: well if you call it a pilot study yeah [0.2] i mean there are lots of 
situations where you don't have t-, in order to have those that don't know what 
this means [0.2] you have to have some data already about [0.2] a particular 
treatment [0.3] how effective it is [0.3] so you then have a new treatment [0.
3] and you do the power calculations and calculate [0.3] how many patients need 
to enter into your study [0.4] to get [0.3] say [1.0] if you're looking for say 
a twenty per cent [0.4] better outcome with treatment [0.2] 
that you'll be able to do that at the s-, [0.2] significance level of point-o-
five or something like that that's that's w-, what a power calculation is an 
asset [0.4] now if you don't have sufficient data in advance to do the power 
calculation [0.4] then you can't [0.6] so really you should describe it as a 
pilot study [0.5] because it's an effort to find out what are the parameters 
that matter [0.3] for a full-blown study you can do a pilot study [0.4] at 
least you should end end up with enough data [0.4] to be able to say we need X-
hundred patients to do a statistically significant trial [0.9] yeah [0.4] but 
[0.4] obviously [0.3] er a research ethics committee very often will obviously 
will appreciate [0.5] er that in the absence of prior knowledge [0.6] it's a 
new study a new technique whatever [0.2] you've got to start you've got to put 
it on the water some time [0.8] er s-, at some stage and so we're fairly 
relaxed about that [0.8] if there is data and you haven't done a power 
calculation then [0.2] you'll be told to do a power calculation [1.2] [laugh] 
[0.2] 
nf0290: 
if you haven't enough patients and will never have enough patients to do the 
study twenty-five years 
nm0285: well i would have said that there's absolutely no point doing the study 
then is there [0.4] 
nf0290: so 
nm0285: if you're not going to i mean this this goes back to the 
nf0290: yeah but for meta-analysis then this is 
nm0285: for meta-analysis well then i would say if it's important enough to do 
the study then you have got to try and [0.4] excite people enough to do a 
multicentre trial 
nf0290: mm 
nm0285: or something like that [0.8] er er i know what you're talking about 
when you say meta-analysis and i think [0.7] it's you know not [0.3] quite the 
[0.3] 
nf0290: yeah i 
nm0285: getting on in that direction 
nf0290: i share your views yeah [0.2] 
nm0285: okay [3.5] so [1.3] okay well this this i've already mentioned really 
[0.5] i told you this [0.3] it's risk versus benefit [0.8] okay i've i've 
talked about that [1.5] right informed consent [1.6] i'm not going to talk in 
detail about this but 
i do want to mention [0.5] that [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 [0.7] well we both are in the 
research project i'm involved with [1.8] is the subject competent to give 
consent children [0.2] aagh [0.7] unconscious individuals [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 [1.1] okay [0.2] 
and people you need to understand [0.3] that there is no such thing as proxy 
consent for adults [0.6] so no parent or guardian or a friend or whatever is in 
a position to give consent for somebody [0.4] who has been knocked down in a 
traffic accident if that person's over eighteen [1.5] well we'll go with that 
but it's obviously a major problem [1.1] and i'll remind you about th-, the 
Gillick case those that don't know about Gillick [0.4] er i can't 
remember the exact details of the case but her daughters one of her daughters 
who was [0.4] under eighteen but [0.2] can't remember her age she was over 
sixteen [0.3] er [0.2] got contraceptive advice from her doctor her doctor told 
Mrs Gillick [0.2] Mrs Gillick made a big fuss and there was a High Court case 
[0.4] and that what came out of that [0.4] was that [0.2] the issue of consent 
for people who are under eighteen [0.3] technically not adults [0.5] if the 
patient understands the consequence of the treatment or the research whatever 
[0.6] then that patient that person is in a position to give conf-, er [0.2] 
informed consent [0.5] and therefore that patient [0.4] can [0.3] give consent 
for research or treatment or whatever [0.6] independent of parents or guardians 
[0.3] and in fact it's a moot point but in that situation whether [0.3] er the 
parent or guardian should in fact be consulted of course [0.4] obviously in a 
situation like the Gillick situation [0.6] the patient [0.6] the young girl [0.
5] would have been [0.2] fantastically was fantastically embarrassed about the 
way the whole situation arose [0.4] so there are plenty of cases situations 
where you could argue [0.5] er that research involving children [0.7] er even 
if they're under sixteen [0.7] er you need to get the patient the the child's 
consent and the parents' consent may not be relevant [0.5] now [0.4] that again 
raises all sorts of difficulties and as a sort of practical [0.2] way out in 
our research ethics committees [0.3] we say that the the the the child's 
consent must be sought first [0.3] and then the parent informed as a matter of 
courtesy [0.2] and i'm not sure about that but that's the way the committee 
does it [2.1] indemnity [0.3] er now if something goes wrong [0.6] then o-, 
obviously the patient should be in some way compensated [3.5] there's two kinds 
[0.3] of compensation [0.4] the compensation [0.4] er which [0.2] you have to 
demonstrate negligence [0.7] for [0.7] and the compensation which is called no 
fault compensation [0.5] where whatever the situation [0.4] if a patient 
suffers injury as a consequence of taking part in a research 
programme [1.7] is injured [0.2] then he or she should be compensated 
automatically irrespective of why the injury occurred [0.4] think for example 
er that a research subject called into the hospital for a simple blood test [0.
2] just a [0.3] slips and breaks his leg [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 [0.3] therefore [0.3] the injury is [0.3] a consequence of the 
research [0.3] in that situation if you have no fault indemnity in place [0.7] 
then that will compensate that patient [0.8] and no fault has to be 
demonstrated [1.4] okay the application the main components description of 
research [0.5] the patient information and consent form er er i'm [0.3] 
conscious of time a little bit [1.0] er [0.2] now the description of the 
research [0.6] this has been a er a fierce battle in the ethics committee o-, 
over the years [0.2] how much detail for the research do you write [0.4] i 
would say not much [0.2] for two reasons [0.6] er one is that [0.2] many of the 
people on the research ethics committee are not going to understand [0.4] er 
the depth of detail that 
some scientists have to provide [1.7] the second point [0.2] is [0.2] that if 
you are too prescriptive in the detail you provide in your research then [0.2] 
if you change [0.3] the way in which you run your polyacrolein gel [0.4] 
technically that changes th-, your project [0.4] technically you should [0.3] r-
, er [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 
pr-, prescriptive [0.9] er [1.0] but you've got to have enough detail [0.3] to 
allow the committee to make a judgement of the quality of the research that 
goes without saying [1.1] if you've got evidence of peer review like your rese-,
research that's being supported by the Wellcome Foundation that would be 
accepted as [0.2] adequate [3.2] more particularly you've got to describe in 
detail what would happen to the patient [0.2] and i think from the point of 
view of ethical review that's what matters [0.2] it do-, [0.4] it doesn't 
matter what happens to the patient's tissue with m-, [0.2] reservations [0.7] 
but what happens to the patient [0.5] 
is very important [2.5] we'll come back to that presently [0.6] et cetera [0.2] 
you provide C-Vs things like [0.3] anonymity details [0.4] should you tell the 
G-P because [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 [0.9] finance is an issue can you pay for your research 'cause if you stop 
your research halfway through then that's [1.1] because you ran out of money [0.
3] well then you can say that that is unethical because you [0.3] have wasted 
[0.4] er the patients' involvement [2.0] okay so let's get on to what actually 
matters and that's the patient's patient information sheet [0.7] there are 
guidelines at this COREC site i've already mentioned [0.5] but the guidelines 
that are provided there are what i call heavy-duty [0.4] er they are intended 
[0.7] er to [0.4] cover all possible eventualities [0.3] and really [0.2] 
they're designed er for drug trials [1.3] but our general view is that you 
should use these guidelines as the basis for a patient information 
sheet [1.1] which is sometimes abbreviated [0.4] P-I-S which i don't like [0.4] 
er [1.2] but you don't in my view [0.4] have to use all [0.2] those parts and 
you can modify those parts provided you basically [0.4] er are following the 
guidelines that are there [0.4] use your common sense [0.4] er and develop the 
information sheet which suits your project [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 [1.3] i'm not going to run through this in 
detail because er i suggest that if you are involved with a patient information 
sheet you look at the guidelines [0.6] er and then come and ask me but there's 
a few points that i might [0.5] just bring out [1.3] i should say that [0.4] 
poor quality patient information sheets are the commonest reason for a project 
to go back to the author [1.1] one [0.3] absolute no-no [0.4] at the end [0.3] 
er let me go back [0.7] what i've got printed here set out here [0.5] is 
actually de-, taken directly from the web site okay [0.2] co-, cut and pasted 
in [0.5] copied 
and pasted in [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 [0.5] some guys [0.2] put at the end of their patient information 
shee-, sheet [0.2] thank you for taking part in this research [0.4] and that's 
an absolute no-no it's surprising how many people put it in [0.4] er and it 
comes straight back because it's considered coercive so it's things like that 
that you need to know [3.3] now the purpose of the study this is tremendously 
important [0.6] and plainly this mus-, must be in in proper lay language not 
patronizing language [0.3] lay language in which you clearly explain [0.4] er 
what the project's about [0.4] in a manner that er your average [0.9] man in 
the street [0.2] er [0.3] will understand i won't [0.3] the average man in the 
street [0.2] i-, i-, 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 [0.4] and it depends on 
the patient [0.6] for example er many patients with er 
transplants [0.2] are very sophisticated indeed in an understanding of their 
disease and the treatment for it [0.4] so you can go into perhaps a greater 
level [0.3] o-, of sophistication in your description of the project with such 
patients [1.0] but for most people it's got to be fairly straightforward [2.8] 
do i have to take part no of course the patient doesn't have to take part [0.6] 
what will happen to me now this matters also [0.4] er there was a a a [0.2] a 
[0.3] project that was submitted [0.4] a little while ago [0.3] er to do with 
immune responses to cancers patients were being recruited in namex [0.2] but 
all the testing [0.4] was going on in namex's Hospital in namex i shouldn't be 
mentioning names in namex [0.6] er and this the these tests [0.2] involved 
multiple visits up to namex [0.3] and you know where they'd have to spend 
several hours in the clinic [0.3] this wasn't properly explained in the [0.3] 
in the patient information sheet [0.7] one has the this suspicion that it 
wasn't 
explained properly in the patient information sheet because the proposers [0.3] 
knew jolly well [0.2] if a patient's understood what was expected of them they 
wouldn't ever be recruited [0.6] having been recruited they would probably feel 
involved and w-, a-, a-, a-, and committed and do it [0.7] so we insisted that 
[0.3] the there was [0.2] proper explanation of what was expected of the 
patient in the in-, [0.3] information sheet [0.4] i don't know if they 
recruited any patients for that study [1.9] okay risk benefit analysis has got 
to be honest obviously [0.4] and of course mostly there's no benefit to the 
patient [1.5] what happens if dru-, if something goes wrong [0.3] now [1.1] 
there's [0.2] this [0.3] it brings up this whole issue of no fault compensation 
again [0.4] now the Association of British British Pharmaceutical Industries [0.
3] require all pharmaceutical companies to have in place [0.4] suitable no 
fault compensation arrangements so they have [0.2] er er er er er an insurance 
policy [1.8] so if it's if if it's a a drug trial organized by Smith Kline and 
we-, [0.2] Glaxo [0.4] then there's no problem [0.6] the problem arises when 
it's er er an investigator [0.4] er originated [0.2] project [3.5] then you've 
got there's this horrid paragraph if you are harmed by taking part in this 
research project there are no special compensation arrangements [0.6] if you 
are harmed [0.2] due to [0.2] er negligence then you may have grounds for legal 
action [0.3] but you may have to pay for it [0.8] er and regardless of this if 
you wish to complain or have any concerns about any aspect of the way [0.7] 
blah blah blah the normal Health Service complaints mechanism should be 
available to you i think this is an appalling statement but it is it is the one 
which is standard [0.4] and recently i have been in a position [0.6] of of [0.
7] er having [0.4] to put this statement in even though i thought it was 
grossly imperfect and you just [0.6] you do what you're told by r-, a Research 
Ethics Committee basically [1.2] er now [0.5] it's the wording [0.3] is based 
on medical research council [0.3] and N-H-S practice because both these 
organizations being government organizations do not [0.4] insure themselves [0.
4] okay [1.2] now [0.3] universities [1.4] being [0.2] basically independent 
independent private corporations [0.6] are in an entirely different position 
and this university has [0.3] full no fault indemnity [0.5] which is actually 
equivalent to the A-B-P-I indemnity in place the hospitals don't [1.3] now [0.
3] when i say no fault full no fault indemnity [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 [0.2] terrible document [0.5] er it specifically talks about clinical trials 
[0.5] clinical trials are defined as those involving drug treatments [0.3] so 
the sorts of things that you and i basically do [0.3] probably [0.3] do not 
come under this [0.7] under this insurance policy [0.3] and i have been trying 
to get them to clarify this point [0.3] trying to get them to broaden the 
definition of clinical trials in that document without success [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 [0.5] you must be a member of the university [0.4] you've 
got to inform the insurance office about it [0.3] and you've got to say in the 
[0.4] in the patient's information sheet that you do have done this [1.0] okay 
[0.4] you can get get anybody that wants detail obviously i can e-mail this 
presentation to them [0.2] [1.9] okay so that brings me to the last stage our 
local business [0.4] we have monthly meetings which is a great ba-, advance on 
the two monthly meetings that we used to have till quite recently [0.4] i've 
forgotten the exact deadlines obviously there's a deadline for receipt of a pro-
, proposal i think it may be fourteen days rather than twenty-one [0.5] the 
proposal goes to every member of the committee but there is a lead speaker [0.
4] who provides a written report [0.6] right [0.7] you sh-, do not need to 
attend the meeting if you unless you're asked 
to [0.5] or you want to [3.4] if the proposal is approved [0.7] a letter will 
be issued within fourteen days of the meeting [0.3] in and if there are minor 
modifications required [0.2] you'll be told what they are [0.3] and provided 
you [0.2] er ac-, accede to the minor modifications [0.3] chairman's action 
will chair's action will [0.4] er approve the project [1.4] now [0.2] if the 
project is rejected [0.5] er we will give [0.2] full reasons for why that is [0.
3] now when i function as committee [0.3] chairman [0.5] i like to give 
verbatim written report [0.4] of the lead speaker that is not approved of by [0.
4] the rest of the committee and so you will probably get [0.3] a paraphrase [0.
3] of [0.2] the lead speaker's er comments [0.2] plus [0.2] some spirit [0.3] 
of the debate [1.1] not always given in a very clear fashion [1.5] okay [0.8] 
briefly with an MREC proposal that i've touched on [0.4] er we can't reject an 
MREC proposal [0.4] except as i said on the grounds or on local local o-, on 
grounds of local issues [1.7] okay [0.9] why are proposals [0.4] rejected [0.4] 
now none of us are fools it's rare [0.3] that a 
proposal is rejected on major ethical grounds none of us [0.4] is going to do 
[0.2] research which is going to seriously [0.3] endanger the patient of course 
not [3.1] there may be problems with s-, [0.2] the study design control groups 
exclusions of patients inclusions of patients [0.3] power [0.6] and all that 
sort of thing [0.5] but most often [0.4] revision is required because of the 
poor quality of the patient information sheet [0.5] badly written [0.5] is the 
usual problem [0.2] ungrammatical English [0.3] not knowing where to put commas 
[0.4] things like that [0.6] all adds up as you know [0.4] those of us that 
read undergraduate issues undergraduate essays [0.5] very much aware that th-, 
there's an accumulation [0.4] of grammatical errors that doesn't half screw up 
[0.7] er the quality of the document [2.1] but they wouldn't reject it on the 
basis that there's a comma wrong [2.4] very briefly [0.3] er some current [0.2] 
Coventry issues [1.9] this is the big one a big one rather [0.4] er that's very 
current [0.2] consent consent [0.3] 
for research use of discarded tissue [0.4] discarded tissue is stuff [0.5] that 
would normally be binned incinerated [0.4] er it used to be in earlier and 
happier days [0.5] that you could take it out and do research with it and 
there's no problem so the pathologist [0.3] cuts out a chunk of a tumour [0.7] 
bins the rest of it [0.4] you catch it [0.6] so it doesn't actually go in the 
bin [0.2] take it back to the lab and work with it [0.4] now that used to be no 
problem [0.5] with the the the various scandals i alluded to earlier [0.2] that 
has all changed you can no longer do that you've got to have full [0.2] 
approval [0.2] full consent for working with this kind of tissues [0.5] now it 
seems to be moving back [0.5] er [0.2] in in various i've recently seen [0.6] 
well recently about four or five months ago six months ago [0.5] er the 
surgical consent form from the namex Hospital [0.3] some of you may have seen 
this pink form which [0.3] er is there so that the patient gives consent for 
the surgery there is a paragraph [0.4] which says [0.3] will you give approval 
[0.2] for any discarded tissue to be used for research yes 
or no tick it [0.4] okay [0.3] so that looks g-, like we've gone back to the 
earlier and happier situation where you've just sort of got blanket generic 
approval [0.8] no [0.3] the research ethics committee won't allow that you've 
got to have specific approval for the project [0.3] in hand [0.4] so that er 
that paragraph in the surgical consent form is redundant [0.4] and should be 
removed [0.4] er hospital authorities being what they are [0.3] God knows when 
if [0.7] that will happen [1.2] and they know it should [1.7] a second issue [0.
3] which is also [0.2] iffy [0.3] is banking of human material [0.8] and 
subsequent use for research [0.4] which wasn't included in the original 
research proposal [0.5] now [0.4] i would say [0.5] that if you've got a bank 
of tissue D-N-A whatever [0.6] if you reuse that for a different project [0.4] 
that is the ethical approach 'cause it means you don't have to bother the 
patient again [1.0] you've got the stuff in your freezer use it [0.5] no [0.2] 
the research ethics committee says you can only use that tissue [0.3] for the 
purpose for which [0.4] er you have [0.5] intended it in 
your original proposal [0.4] and if you want to use that tissue for some other 
purpose [0.3] you have to go and get consent from the patient in order to do 
that [0.4] now there are some wonderful banks of tissue in the country [0.3] 
for example in Saint Mark's Hospital in London [0.4] there are lumps of 
colorectal carcinoma going back to the nineteen-twenties now and there's no 
question of [0.5] g-, getting consent [0.4] for the reuse of that [0.2] so it's 
wholly impractical in fact [0.2] in practice [0.3] in reality [0.5] so the 
committee has backtracked a little bit [0.3] so if you include if you have the 
sense [0.3] to include on your [0.2] consent form [0.3] i give consent [0.3] 
for the reuse [0.3] of this material at a later date for other projects yes or 
no [0.5] okay the patient ticks the yes box no problem if he ticks the no box 
[0.5] well then you bin it [0.4] after your project [0.3] after your research 
is done [1.5] and you can put specific inclusions in there you can say for 
example [0.3] i guarantee that this material will not be used to 
clone another human being [1.1] now that sounds er to us a bit bloody silly 
doesn't it [0.3] but honestly i have had [0.3] questions of that nature from 
people from whom we've taken umbilical cords [0.3] okay you think about how [0.
7] how dodgy that might seem to some people [2.9] in fact that's another 
current issue [0.2] umbilical cords er [0.4] we used to [0.5] we used them for 
endothelial cell fibration there are other uses for them of course [1.2] 
placenta also [0.3] it used to be no problem [0.3] it's going into the bin so 
the researcher can have it [0.3] not any more [0.3] er for our current research 
project we've been required [0.4] er to go to the mother prior [0.4] to the 
birth in the antenatal clinic [0.3] and get her to give specific [0.3] consent 
for the research project that we are carrying out [0.3] for the use of her [0.
3] er for the pre-, [0.4] for the umbilica-, for umbilic-, umbilic-, umbilical 
cord [0.2] now i'll i'll just remind you of the consent issue [0.2] relating to 
children [0.2] the mother [0.6] cannot give consent for research [0.4] on the 
child [1.3] okay [0.5] now the umbilical cord is the child's tissue 
not the mother's so that's [0.3] something [0.3] er which shows up some of the 
lack of logicality of of 
nf0291: wh-, [0.3] who who can then give er consent for the er [0.9] er 
umbilical cord 
nm0285: manifestly nobody can [0.2] 
nf0291: mm-hmm [0.2] 
nm0285: [laugh] 
nf0291: so what do we do [0.5] 
nm0285: well we get consent from the mother [0.4] 'cause the research ethics 
committee [0.3] tells us that that's what we'll do so that's what we do [0.8] 
er and it has to it ha-, it has to be in the antenatal clinic [0.7] you're not 
allowed to go and approach [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 [0.2] you know [0.2] are they going to clone my baby from the umbilical 
cord all those sorts of issues that are likely to come up [0.3] when a woman is 
going into labour [0.3] is that right namex [0.5] 
nf0290: oh absolutely [0.2] 
nm0285: [laughter] [2.2] okay so finally er and only just before [0.5] the hour 
is up [0.6] if you're in doubt [0.2] you 
seek advice [1.1] you may get advice from them [0.4] if you're extraordinarily 
lucky [0.5] you will get advice from them [1.0] in retro-, in in retrospect 
don't even think about that [1.0] er i am the last resort [0.6] er i am happy 
to give advice for people who are preparing er research ethics proposals [0.7] 
but i have [0.5] found myself embarrassingly in the situation [0.3] before now 
giving advice which i thought was sensible [0.4] right [0.3] ethical [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 [0.5] most recently on this issue of umbilical 
cords and i became [0.2] quite speechless [0.4] at this oh i'll stop talking 
now [0.9] so finally [0.6] good luck [7.0] [laughter] obviously if you have i 
think you've answered most of the questions [0.5] but i am very sincere that if 
if you are preparing research ethics [0.2] proposal proposal for the LREC [0.6] 
then i'm happy to help you with it although i'm uncertain to the extent to 
which my 
assistance [0.7] is [0.3] effective [1.3] 
nf0290: i have got a question [0.7] er [0.8] as you know the R and D produces 
[0.2] a list of standard paragraphs that one is now expected to put into [0.6] 
the patient information sheet [0.5] and if you just string them all together 
you [0.2] get a substantial [0.6] amount of writing which approaches two sides 
of A-four [0.8] without even telling the patient anything about the project 
nm0285: before you start [0.4] mm [0.8] 
nf0290: er [0.4] and [0.2] patients may get not just one of these [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 
nm0285: well i'm i'm also deeply concerned about that 
nf0290: ignore it 
nm0285: er and it's [0.2] i'm not sure that we should discuss these issues [0.
4] er [0.6] live as it were 
nf0290: okay 
nm0285: er but i am very disturbed by the way in which the R and D committee 
seems to be succeeding 
subsuming [0.5] er and bureaucratizing overbureaucratizing [0.4] er what is 
properly the remit of the research ethics committee [0.4] if the research 
ethics committee says [0.3] a patient information sheet [0.3] is adequate [0.3] 
and we require this patient information sheet then i do not see that there 
should be any other [0.5] er i'm glad you're telling me that 'cause i didn't 
know [1.4] i mean i i-, it baffles me that the R and D committee are doing this 
without even informing [0.2] the research ethics committee [0.9] and this is an 
issue which runs deep in the N-H-S doesn't it [1.1] [sigh] [0.2] 
nf0290: the oth-, the other issue that [0.2] that [0.2] springs to mind is that 
one's ethics approval [0.4] has to be kept up to date 
nm0285: yes [0.5] 
nf0290: er and i was told recently that that was [0.2] that for a year [0.6] so 
i was wondering whether it was 
nm0285: no er th-, that's something which we're debating i can't actually 
remember the details 
of the debate can you namex 
nf0293: three years three years 
nm0285: it's three years 
nf0292: three years 
nm0285: three years 
nf0292: is what i was told 
nm0285: yeah three years [0.3] er we didn't debate it but it might have been 
brought down to but the reason why we di-, didn't have the had nothing to do 
with inconvenience of researchers [0.3] it's a question of convenience of the 
research ethics committee would we read [0.3] that many reports the answer is 
no we wouldn't [0.3] so we put it back to three years 
nf0290: i think that's something else that may [0.2] be [0.7] kind of [0.2] 
different information for different places 
nm0285: yeah well as i say if if in doubt [0.2] actually [0.4] talk directly to 
the research ethics committee [0.5] okay [0.4] whatever [2.1] [laugh] 
nf0290: mm [0.3] 
nm0285: namex 
nm0287: er you're saying that the [1.8] ethicalism R and D committee seems to 
be subsuming the role [0.2] of ethics [0.4] but i think it's a widely held 
belief [0.2] that the opposite is also true and as you said the [0.2] 
majority of rejections of applications [0.2] are not down to any [0.3] ethical 
concern it all comes down to study design [0.3] finance [0.2] and the like and 
this [0.2] this surely is an opportunity between the two [0.3] bodies 
nm0285: well we'd like to think so 
nm0287: to streamline and prove that really more from a researcher's point of 
view [0.3] if there are very few that are actually posing an ethical issue to 
our 
nm0285: yeah 
nm0287: patients then 
nm0285: yep yep no 
nm0287: er i think it becomes 
nm0285: 'cause as i said as i said quite clearly [0.5] poor research is by its 
nature [0.4] unacceptable ethically [0.7] er one of the requirements that's 
coming in with the new regulations is that you have to provide peer [0.4] er 
peer review [0.3] of your research [0.9] if you can do that and th-, that's a 
positive peer review [0.3] well then i'm quite sure that the research ethics 
committee will accept it as i said if it's from the well-, if you're if you're 
funded by the r-, [0.3] Wellcome Foundation [0.4] nobody will argue about the 
quality of your research [0.9] [0.6] er [1.9] and the peer review that's 
suggested can be your mate in the next office [0.5] okay [0.4] under some 
circumstances it can be a single individual [0.3] so i'm afraid [0.3] the 
research ethics committee will always take a look at the quality of the 
research always 
nf0294: 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 [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 
nm0285: yes i know that's so 
nf0294: so you've not got the funding in place [0.6] or the peer review 
nm0285: no you see you haven't got the peer review in that situation that's 
right 
nf0294: 
but you can't apply for the grant until you've got the ethical approval 
nm0285: well with any grant that that circle that that we do need to have [0.3] 
the research ethics committee actually doing er a review of the quality of the 
research [0.7] yeah [0.3] 
nf0294: mm 
nm0285: er and i will never never accept that the R and D committee's er er [0.
4] er assessment is adequate [2.5] unless it's done properly [0.5] through a 
proper peer review process in which there are independent experts reviewing the 
research [2.1] mm [1.8] what would you think namex [1.5] 
nm0287: er i i think this [0.8] problem started [0.9] going up and [0.4] a 
little bit more from the persons making the application er to them it's not [0.
2] the politics of one person versus the other
nm0285: no [0.2] 
nm0287: it's the s-, it's the process and the system 
nm0285: yeah [0.3] 
nm0287: whereby it's as streamlined as possible and allows researchers to get 
back [0.3] their ethical [0.5] approval as quickly as possible 
nm0285: 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 [0.5] and we have tried to keep it [0.4] fairly simple [2.2] i 
mean a-, as i was trying to say [0.4] we're not overly concerned with the 
details of the research provided we're satisfied that they're adequately 
designed [1.4] because indeed it is the ethics issues which concern us [0.4] 
and i suspect that the R and D committee maybe should take more interest in the 
research design [0.3] and less interest in ethical issues in fact keep out of 
ethical issues it's not their business [2.3] except that it was put to me [0.4] 
er that through governance within the hospital [0.8] the hospital has to be has 
to [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 [0.9] er and now [0.4] i would say actually it's the R and 
D committee it's not it's it's the re-, research ethics committee's [0.6] er 
role [0.2] to do such audit [0.6] er and the R and D [0.2] committee did not 
inform [0.3] the research ethics committee that this audit was under way [0.6] 
i find all those things absolutely extraordinary [0.7] er [0.2] but the i-, [0.
3] r-, research ethics committee cannot do that audit because they haven't 
sufficient staff [0.3] and the reason for the delays that occurr [0.5] as you 
well know is a there's a single person [0.6] working in the research ethics 
committee [0.3] generating all your letters [0.3] and she wants a holiday 
occasionally and sometimes she's poorly [1.6] and that's when the delays happen