Reasons for wanting to take part in a clinical trial - helping medical science
People agreed to take part in clinical trials for a range of reasons. Here we look mainly at how people hoped they would help medical science and other people. (See also ‘Reasons for wanting to take part in a clinical trial - personal benefit’).
Some people were motivated mainly by a general wish to support medical science and improve knowledge. This included some people who worked in research in one way or another, but also people with no specific research background.
Sergio has always supported the idea of medical research, so when he was first diagnosed with...
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So tell me how - so you’ve been diagnosed with diabetes. At what stage were you asked to get involved in this trial?
About three or four years after I was with treatment. One of the reasons was that it’s important, your question, because I always believe in science and research in medicine. So when it was discovered, it was such a shock, that I was sure I could die any time. I was really thinking that I could die any time. I didn’t know about diabetes properly. But I said to my doctor, “Doctor, if you know about any research I will be pleased to participate.”
Well, anyway I said to the doctor, I offered myself to the doctor. And so when he was, suddenly from independent areas I received a letter if I wanted to participate in, in research. I did participate. And then I start to, probably I have done six or eight times research in general.
So the diabetes one that you took part in first.
Was that the GP who wrote to you, or the hospital?
He report, he report to the hospital - not report - but he informed the doctor that he had a patient who had offered himself for research.
What were your main reasons for wanting to take part?
Support medicine and general research. Happy if it can help me personally, but happy as well to, to help, to develop medicine to general, to the general public. So it’s one thing altogether, the idea is just one. And I always thought about that. So it’s with pleasure that I can participate and give my own experience.
Amandas main motivation is to contribute to medical knowledge and test whether there really is...
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My main motivation for taking part is to help generate knowledge, which is why, I think, the results have to be into the public domain. All of them naturally concerned conditions I had – well, the azathioprine one was really, you know, I didn’t want to be poisoned [laughs] for something that was not going to do me any good. I’d like to know that it was doing me good. I find the health professionals, in a, in a disease that comes and goes, it’s an incredibly powerful illusion - you feel terrible you take something you feel better. And to join those two up in your mind - and if you look at all the crank remedies out there and all the alternative treatments, where there’s a lot of alternative treatments and herbal treatments, they’re all for diseases that come and go -eczema, rheumatoid arthritis - all these diseases that come and go naturally. And of course because people get what I think’s a powerful illusion of benefit just because they would have got better anyway, and I think it fools the medical profession too. People, I talk to colleagues and doctors. They have a much greater sense of how much good they’re doing than the evidence suggests is true, you know.
Yeah, so mostly less about personal benefit, but that arthritis one was much more personal motivation that you wanted to--
Yeah, that one was for me personally, although I do think N of 1 trials* could add to the sum total of knowledge, if done in a, in a co-ordinated way. ...But no, and I, and I think, I think it’s a, it’s a social contract. You just think of all the diseases out there. If every treatment was to be delivered as part of a trial against the next possible better treatment, we’d, our knowledge would advance tremendously. We’d all do, we’d all be so much better off from collaborating.
*Footnote' An N of 1 trial is a clinical trial in which a single patient is the entire trial. Random allocation can be used to determine the order in which an experimental and a control intervention are given to the single patient. See Amanda’s other clips for more detail (Interview 22).
Angela does not like the idea of paying people to take part. People need to volunteer if medicine...
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I think one of the things that I actually find quite irritating is that people - I understand that money is, is an incentive. I want good health. I don’t need rewarding. I find it quite off-putting. But I do understand that in order to get volume in trials you’ve got to have some kind of incentive for people to go into them. And if they’re not aware or they haven’t got health problems of their own, then I can understand how it’s come about. I’m not comfortable with it at all.
So you’re thinking about the ones where it’s the first time they’ve tried it out in people and they pay people to come along and take part.
Well, it isn’t only just first time. I mean, quite a lot of them are well advanced in the research so, no, I just, I’m not comfortable with the idea of being rewarded to do something which I do because I think I should be doing it. It’s morally right.
If people don’t volunteer, they’re never going to make any progress. You’re going, we need to find out which is the appropriate drug and if the majority of doctors are prescribing something else - it’s quite helpful as well to know about what there is available, which you don’t know immediately you go in, but then, of course, you become informed, so yeah, yeah. It’s important that people do volunteer, if they can. I mean, I was in a fortunate position in that I’d already taken early retirement from education, so I, it wasn’t a commitment that was going to take money out of my pocket or interfere with a job. I still would have done it regardless, but it’s easier that way, mm.
Several people felt so strongly about the need for research that they had gone out of their way to find a trial and get themselves referred elsewhere. Some thought it should be the right of all patients to take part in research and to have more information about what was available. (See ‘Difficulties finding a trial to join’ and ‘Public awareness and involvement’).
The idea of improving care and making life better for other people in future was a common motivation for taking part, either as the main reason or as an extra benefit. This could help people feel something positive was coming out of an otherwise distressing illness. Sometimes people were thinking about helping other patients generally, and sometimes their own family or friends.
Doing your best to help others is important and if being in a trial also helps you as an individual...
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Well, all you can say is you’re doing your best for, to help other people and mankind, and we won’t get anywhere if nobody volunteers for anything. You know you’re in good hands, whoever’s looking after you will make sure that nothing – well, hopefully [laughs] nothing too awful happens to you. And it may give you some benefits. At least you know in your mind you’ve done something to help people. And if there aren’t that many of you with the illness et cetera it’s very important you volunteer. Yeah.
Ronny agreed to be screened for a prostate cancer trial because he thought it might help his...
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Well, when the letter came through the door and I read it, I nearly threw it away, to be honest. And then I stopped and I looked again and I read it again, and I says, “This is prostate cancer. This is what my brother’s got” you know. And I thought , “Well, I haven’t got it”, as I said earlier, “But if I go round there and I give them some blood, they might find something in my blood that either could help my brother or give them more information of why it’s in the family and different things.” I never ever thought I had it. And that was one of the reasons. If my brother, I think if I hadn’t have known somebody who had had prostate, I would have probably not bothered, you know. And, as I say, I went and I honestly thought that they would say, “Well, you’re fit, you’re all right” you know. But I wasn’t.
Has it sort of changed your views at all now about medical research and whether people should take part?
I think it depends on the case and, you know. But I suppose it has in a way, because if you can help somebody, if something helps somebody, you know, even if it’s just giving a bit of blood or a bit of advice, you know. It’s, I think they should have more clinical trials, you know. But it’s all money, isn’t it?
Jayne is strongly committed to the value of research and wanted something good to come out of her...
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Why are they important? They’re important because you’ve got to establish whether the new treatments or new regimes of treatment are better than the existing therapy, and for every new therapy that’s better there’s probably one that’s the same and another one that’s worse. So you’ve got to find out whether the new one is an advantage or not. It’s not just a marketing thing - it’s got to be done scientifically. So for any new treatment, be it a tablet, an op- - what amazes me is that operations aren’t subject to clinical trials, really, or haven’t done until recently, and certainly the treatments in my discipline aren’t.
But drugs were, and this was a drug so it had to go through a clinical trial. So I think they are really important from that point of view. Why did I want to take part? Well, there’s probably no point in having a disease like that if you can’t get any good out of it. You know, at the end of the day it’s pretty, it’s not a good thing to happen when you’re 33, and if there’s anything good that can come out of it, well, fine.
Quite often I hear people talking about the good that may come out of a trial being in terms of personal benefit. It sounds as though that wasn’t your perspective.
It’s, well, it’s not personal benefit, because you in the trial don’t really benefit from it - although there was some evidence at the time that people in trials, whether they’re in the winning arm or the losing arm, do better than people outside trials because of the added extras, the extra attention et cetera et cetera. But I think more recent studies have shown that there probably isn’t as much difference now as there used to be. Whether that’s because - well that’s probably because the routine care - or I would like to think it’s because the routine care has improved and people are, in clinical trials, aren’t as different, and labelled as different. But I suppose that was in the back of my mind, that I hadn’t really got anything to lose and... there was something to gain from it in the added information, but since I was diagnosed I’ve had two friends who have been diagnosed with virtually identical conditions and they’ve both had the tamoxifen and Zoladex, so I suppose that trial has helped my peers, if you like, who have been diagnosed ten, twelve years later.
FOOTNOTE' There has been some evidence that people who take part in a trial – whatever treatment group they are allocated to - have better health outcomes than people who do not take part in trials. This is known as the ‘trial effect’. However, more recent reviews of the evidence have shown no significant differences in outcomes for people given similar treatments within a trial or just as part of their normal care.
In trials involving genetic research there may be a very direct benefit for your own family, as Julian pointed out.
Testing treatments that target people with cancer who have the BRCA genetic mutation may be of...
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I do have some mild side effects. I get intermittently every day a little bit of nausea and stomach discomfort but it’s not terrible. And most of the other patients also have had only mild side effects. A few people have had more troubling things.
In the long term, nobody knows what the effect of the drug might be, so I’m quite interested in staying alive for long enough to see what the long term side effects are. And I’ve got strong reasons to be interested in that question, because I’ve got three daughters and they’re at risk, and so it would be nice to know whether they should consider taking the drug, you know, if something goes wrong, or even taking the drug prophylactically to prevent disease from ever developing. That’s something that would not be contemplated now.
Because we don’t have the evidence about long term side effects, and as I say, it’s potentially quite a worrying drug.
But it’d be, you know, if I live a good long time then that would be a bit of evidence that maybe it’s a good idea to start the drug treatment very early and maybe even before any disease is apparent.
Have they been tested for the mutation?
No, they haven’t. They know the situation, but we thought, my wife and I thought that they should be left to make their own decision about whether to get tested.
So they’ve not had tests so far.
Sometimes people who had joined a trial hoping it would benefit them personally had been disappointed, but were glad it might still have helped other people, even if this was not one of their reasons for taking part originally.
Elvan joined a trial mainly because he hoped it would benefit him but it made little difference...
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Do you think it’s important for people to take part in research projects?
I would say yes. Because, because of that they get to know how not to or a way how to treat certain conditions, certain sicknesses, certain disease, yeah.
So even though it didn’t seem to work in your case?
Not wholly [laughs]. I think partially. I think it worked partially, not wholly.
Because that’s, that’s quite interesting, because you, you went in hoping that you would benefit.
Yeah, totally, uh-huh. I wished that would happen.
And now, looking back, actually even though you didn’t really benefit a great deal, you’re still quite happy to have done it?
Yes, I am, yes. Mm.
My experience, from my experience, I would say, well, if, if you’re asked to take a trial for whatever purpose, I would say, “Go ahead and do it, yeah.” It can only, good can only come of it, in my estimation, yeah. And that is you’re helping yourself and help other people who might come after you.
How important was it to you thinking about helping other people when you decided to take part? Was that part of your decision?
Not really. No, my decision was personal, really. But I know that what is good for me is good for the goose or the gander as well. So [laughs], so from my point of view if I, if I could , there’s somebody else who might need the same type of treatment to make them good. So it’s all right.
A few people talked specifically about helping out doctors and researchers.
As someone who has worked in healthcare, Caroline took part as a favour to the staff, because she...
It was during one of those visits to a clinic for a scan, I think, that I was approached by one of the midwives, who established that I’d had a first caesarean, and would I be amenable to taking part in some research to do with modes of delivery of information for women deciding on subsequent labours after a caesarean? Because you are given the choice of whether you want to choose a caesarean the second time around and have a pre-booked caesarean, or whether you want to try for a natural birth. So I said, “Sure.” Although at that stage I think I’d pretty much decided that I was going to try for a natural birth anyway.
And from then, what kind of information were you given about the trial? Can you remember what they told you the different arms of the trial were?
I don’t remember a great deal of detail about it. I know I was given written information. She spoke to me about it and told me what was involved and what the purpose of it was, and that it was to enable, to equip women to be more knowledgeable in their decision-making, and that they were going to use some CD-ROMs, I think it was. And I was given some information sheets as well with, I think I had two A4s that were printed on both sides, so, yeah, four sides of information about it. But I don’t remember large amounts of information. It was more what I would have to do, rather than the overall context of the research, I think.
Do you think they could have told you more about that? Would you have liked to know more?
I’m not sure that I would at that stage, to be honest. I think I just felt that I was doing them a favour, really, because I’d already pretty much made my decision. And I don’t think I thought that anything they could tell me would influence it, whether it was on a CD-ROM or whatever, because I had already found out everything I thought I needed to know. But being involved in healthcare myself, I know that it’s always, people are looking for people to take part in research trials, and I always want to help out, really.
So that was more the motivation for you rather than what you were going to get out of it?
Others talked about a general moral or social duty. For example Amanda (above) described it as a ‘social contract’, a responsibility to others in society. The phrase ‘giving something back’ summed this up for some people, in gratitude for care received or a longer life in some cases. This included the idea of repaying a debt to others who had volunteered in the past, or a debt to the NHS as an institution.
Tony says medical advances cannot be made unless people volunteer. He has benefited from drugs...
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Anyway, I later developed ED, erectile dysfunction, and was referred by my GP to the same specialist who had been the urologist who had dealt with the prostate problem. And as he knew me, and was at that time being asked by the drug manufacturers to take on a trial of a drug which was supposedly going to be of benefit to people with erectile dysfunction, he asked whether I would be prepared to be part of the group on whom it was to be trialled. He explained very carefully the possible side effects, which were manifold, and explained that it was a double-blind trial, which meant that neither he nor I would know whether or not the medication which I was given was in fact the real thing or a placebo. I was quite happy to accept this risk of possible side effects. Partially the reason for taking the trial was self-interest in so far as it could be of benefit to me, and partially it was because I know that medical advances cannot be made unless people are prepared to enter into trials.
I know that there have been some very, very nasty problems - no names, no pack drill - but this was something with which I was prepared to go along.
It’s something which I realise is extremely important. I know that great strides are constantly being made. And unless research is tested on human beings, as well as on such lab animals as are necessary, the results aren’t going to be totally fully understood. Clinical trials are necessary for all drugs. I have been the beneficiary of drugs which have previously been trialled by other people, and if I’m in a position to do the same for the next generation then there’s no reason at all that I shouldn’t do so.
Tony mentions hearing that some volunteers in clinical trials have had “some very, very nasty problems.” Memories were still fresh in people’s minds of one particular Phase 1 trial at a commercial research unit at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. This caused a lot of reflection on the balance of personal risk, personal benefit, and benefit to others. A copy of the Inquiry Report of this incident can be downloaded from the National Archives (Expert Group on Phase One Clinical Trials: Final report).
Understandably there were limits to how far people were willing to go to help others. Some said they would not want to be in a placebo-controlled trial where they might not get a treatment they felt they might benefit from. Others said it would depend how invasive or risky the treatments were, and therefore whether there were any negative consequences. (See also ‘Side effects and queries’, ‘Feelings about being in a placebo-controlled trial’, ‘Deciding not to take part in a clinical trial’ and ‘Attitudes to taking part in another trial’).
Rose volunteered to give something back. She knew both treatments were tried and tested, and...
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I found the going into hospital for the radium, they did ask me, which I found was funny, was I disappointed that I wasn’t having the chemo as well? I couldn’t understand that one. But I think with the research, with it being already proven things that had cured cancer I accepted the INCH* trial, but otherwise I very much doubt whether I would have. No matter how much literature I read, if they had told me that I was having something that was untried, I think I would, really wouldn’t have done it. You know, if it had been tried on animals - and I would have had to be really desperate to follow through with that.
I felt that both of them had been used and proved to be successful on many people who had cancer, so therefore it didn’t really matter to me which I had, providing it cured it. You know, I think you’re willing to go to any lengths, and I also have always felt that you can’t just take - you’ve got to give back. So this trial I felt, “Well, at least I could give something back.” You don’t get anything in this life unless you give something back, do you? So really I would have preferred not to. I understood them not wanting the chemotherapy because the side effects are awful. I understood that, but I really, that wouldn’t be in my head. Like them saying to you, “Were you disappointed?” I couldn’t understand. “Were you disappointed that you didn’t get the chemo and the radium?” And I thought at the time - well I think anybody would think - that I’ve got the better choice, just the radium.
* INCH = a trial comparing INduction CHemotherapy followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) with CHART alone.
Rosamund supports medical research, but it depends how invasive the different interventions are....
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Well, my first thoughts were that I was pleased that that this trial had been organised. Ovarian cancer is known as the silent killer, and the problem with it is, that by the time people have symptoms, it’s often too late to do anything, so this is clearly an area where some kind of effective screening could, in theory, prevent many deaths. So I was pleased that the trial was happening. And I felt that I ought to take part, that I had a moral responsibility to take part. However, my second thought was, “I don’t want to be in the groups that are having these particular approaches to screening.” And that’s quite interesting, because, as somebody who has actually, you know, organised trials myself, I know that the main problem with people refusing is actually amongst people who are randomised to the control group, who are dissatisfied and want to be receiving whatever intervention it is, and my attitude was different. I wanted to be in the control group [laughs] and not in the two screening groups. So I’m not sure what I would have done had I been randomised to one of the screening groups. I think I probably would have dropped out, and I would have argued to myself that since most people, as I’ve just said, most people who drop out drop out for the opposite reason, I would just be balancing numbers.
Can you imagine yourself in the situation in the future where you were diagnosed with something and how you would feel about having that decision?
Yeah. I would feel that I needed to check out the statement, “We don’t know which treatment is best.” And if that was really true, then I think I would say, “Okay.” It’s easier I think when, you know, what your - [sighs] well, no - I mean when the choices are between different treatments that are much the same in terms of physical side effects or inconvenience or whatever. If there was a big difference, as I felt there possibly was with the ovarian cancer trial, then I think it’s more difficult. You know, if being in one group means that you’ve got to go to hospital every month [laughs] and have something which hurts, as opposed to going every six months and having something that doesn’t hurt, then it is a decision with consequences.
Like Rose and Rosamund, a number of people said it was easier to take part if they could see few negative consequences for themselves, or there was little difference between the treatments involved in the trial they were offered. Comments included ‘I had nothing to lose’, ‘why not?’ or ‘it wasn’t really a huge decision’.
Consenting to the trial was not a huge decision. Both groups had chemotherapy, one every two...
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I think my appointment was probably about ten days after diagnosis. And it was at that time my husband and I went up to the oncology and they brought it up then and he just did a diagram for us and told us what was involved. And there again, I thought, “Oh, two weeks, that sounds good.” [laughs] But this actually finishes at the beginning of September.
Were you happy with the amount of information and how easy to understand it was
Yeah. It was, you know, like I say I didn’t have to decide whether to have one particular treatment compared to another. It was just a timing thing, and it seemed, you know, it didn’t seem like a huge thing. I’m having the same treatment, and I’m responding well to it and I think that’s - so I didn’t feel that I had, you know, had to come home and mull it over or think about it or anything like that.
So did you decide on the day?
Well, I told them I wanted the two week one but he said, “Well, it just goes into a hat so we have no control over that at all.” And then the research nurse phoned in the afternoon and said, “Unfortunately, it’s three weeks.” I said, “Oh okay, never mind.” And I was really quite upset about it, because I really thought, you know, my stepdaughter’s getting married in August and I thought, “Well, it would just be nice to get it all done.” But a lot of people have since said, you know, I know a lot of people in the NHS and they’ve said, “Actually, it can be quite gruelling.” But I’ve responded so well I don’t think it would have been for me, but anyway, it doesn’t matter, and I am on the three-week one and I’m completely reconciled with that now. So it’s not a problem.
And when you were thinking about whether or not to take part, what were the main factors that made you want to take part?
Well, research, I just think it’s so important, and they’ve already done the trial in Germany and it’s showing that the every two weeks is, is perhaps better.
The surgical study Shirley was invited to join was to check that local surgeons could perform a...
The result [of a breast core biopsy] was inconclusive still, and I was then booked in for wide excision on a wire guideline, which happened on October 1st …I had to go in and have a sort of scan and the wire inserted… And I was in and done terribly quickly, and out the next day. And it was actually remarkably pain free and good, because it was only a tiny little bit, I think, removed.
So I was home on the third. I went back on the 18th to the [specialist hospital], saw the second-in-command again, and the result was positive. And having been told it was positive I was sort of - it would be unkind to say bombarded, but I was asked more or less immediately if I’d take part in the Sentinel Node Trial, and I said, “Yes”, because it seemed pointless not to and it might help other people etcetera.
And he said, “Do you mind? We have to get forty people into a trial, and discover if it’s going to be a good thing just to take out four, or up to four [lymph nodes].” They might get it down to just one, I think. And I didn’t feel that there in fact was any justification to say no, because I was going to have to have it done anyway, and if it helped others, it was, you know, why not?
Deciding whether something is too risky or invasive is a matter of personal choice and perception, however. For example, several people thought they’d be worried about being in a trial where you would be allocated to have surgery or not to have surgery. This struck people as much more invasive than a drug trial or a screening trial. However, Alex said surgery did not seem invasive to him. This may have been partly because he had a slight preference to have surgery anyway.
It did not worry him that he might be allocated to have surgery. Compared with other people around him on the ward his problems seemed minor and he was willing to help.
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And it sounded as though you had quite strong views about almost a duty to take part in research if it’s offered. I mean you said, “Why wouldn’t you?” as if it’s a kind of--
Yes, yes I mean this wasn’t any, it wasn’t going to change anything or it wasn’t going to make anything worse.
Do you feel--
It wasn’t going to be obstructive or invasive in any way. It was going to help a lot of people like myself, right, research* – only more important, because they’re actually helping people rather than solving obscure mathematical problems like I do. So yes, it was pretty obvious to me, yes, you can - I didn’t think about it this way, but now you’ve called it a duty, yes, maybe you could call it this way.
A sort of moral kind of--
--level to it.
Yeah, I’m interested that you say it wasn’t going to be invasive in any way.
[laughs] Hearing the account of your surgery.
Well, I mean to say, well, if you come to think of that this is not the - I mean compared to, this was the lightest injury that, among people on my ward, both times. I mean people had broken spines, people had multiple injuries. I mean maybe if I was in really serious trouble, you know, in really serious pain, I wouldn’t want, you know, any extra hassle. Maybe I just wouldn’t be able to think straight [laughs]. Or maybe - but that’s another reason, because, well, it’s a, it’s a chance to help medical science and people who do medical science. And it wasn’t invasive - not just the trial itself wasn’t invasive, but I mean I was lucky enough not to get into more serious trouble and I mean.
That was, that was the least I could do, yes? And it wasn’t going to give me any extra trouble, and the trouble wasn’t comparatively serious to start with.
* Footnote' In referring to helping ‘people like myself’, Alex means fellow scientific researchers rather than fellow patients – he is a maths researcher.
Some people commented that it is perhaps easier to take an altruistic, or unselfish, approach to helping medical science if you are not seriously ill. For a seriously ill person, the highest priority may be personal benefit and survival. (See also ‘Deciding not to take part’). On the other hand, people facing life-threatening illness may also feel they have nothing to lose by taking part and may help others who come after them.
Joannas husband was in a trial because he would do anything to help his leukaemia. She took part...
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And to be honest I don’t think my husband would have minded either way. He wasn’t particularly interested in the intellectual side of it. He was interested in the personal side [laughs]. And if it was helping he wanted to go on. And he wasn’t going to accept that it wasn’t helping unless it was really clear that it wasn’t, you know. So I think there’s very different reasons why people might stay engaged or want to be engaged, depending on whether they’re ill. I mean in my case I didn’t think I had ovarian cancer, so a screening thing was entirely to be altruistic, and because it wasn’t going to involve me in great pain and grief, or theoretically wasn’t, I was perfectly happy to do that. But I think if you’re actually ill, the situation is quite different. What your choices are very different.
I thought, “Well, you know, I’ve been asked. There’s no reason why I shouldn’t. It’s obviously a sensible thing to do. And it’s the right and proper thing to do” - so at some rather low level, an ethical thing to do. I think people would imagine that it’s unethical to bounce you into something at a moment when you aren’t in a position to understand the choices. I have to say I think when you are actually ill, you are in a very poor position to make any decisions of that sort. So in a way people may be very often pressured by their own circumstance into taking part, in situations where maybe it’s not the most intelligently set up research, or the most well-framed, or the most relevant to them. But I think one can say that there’s, you know, we all have, we all owe something to the Health Service. So if one can help and do something in that respect, there is a sort of a duty, as sort of the flip side of our right to free treatment. Difficult to put that into people’s individual personal contexts once they become critically ill.
In another part of her interview, Joanna commented that people with terminal illness ‘have to be jolly altruistic at one level, or pretty desperate, to go in for certain sorts of trials.’ (See also ‘Reasons for taking part in a clinical trial – personal benefit’).
Last reviewed September 2018.
Last updated September 2018.
Last reviewed September 2018.
Last updated September 2018.