Reflections on CERES (Consumers for Ethics in Research) - Dr Naomi Pfeffer on the
work of a pioneering organisation for research volunteers
I’m now in an honorary capacity with Brian and Norma’s department, and I’m not only a social
scientist; I’m a medical historian, and what I’m going to tell you now is medical history really.
It’s been a stormy journey, hasn’t it?
Some of you might know of CERES. It’s unfortunately called Consumers for Ethics in Eesearch.
We used to agonize over our acronym, and it was established in 1988 as the Standing Committee
of User Organizations for Pregnancy Childbirth and New Developments in Reproductive
Technology. And I’m sorry Iain Chalmers isn’t here today, because it was thanks to him that the
organization got off the ground, because when he was at the National Perinatal Epidemiological
Unit in Oxford, he organized two big trials into pregnancy, and he involved representatives from
the National Childbirth Trust and the Maternity Alliance and… gosh, I’ve forgotten the name.
This happens when you get older: I can’t remember the name of Beverley Beech and Jean
Robinson’s group. Anyway, another pregnancy group, who were to be involved in the trials. And
it was a very innovative idea, a very pioneering idea. And from that CERES emerged. But we
had a very different philosophy from, I think, how Iain originally conceived the role of patients.
We were based outside of any kind of medical setting.
It’s very interesting hearing all these presentations today, that you’re all kind of organized
around some kind of clinical facility or a particular patient organization. We decided to take a
much more generic viewpoint, to try and… because we were… a lot of the pioneers of CERES
were active in the women’s health movement. We had a kind of consciousness-raising approach
to what we were doing. We wanted to work with patient organizations and get them to take up
the agenda, … and talk to their clinicians and whoever else was involved in the research, that
was our idea. And at our initial meeting, as I say, we had 24 patient groups represented, patient
organizations. And what we did was… I remember spending quite a lot of time going through
the handbook of the Association of Medical Research Charities, and what the situation then was
was that you’d have found that each medical charity would have a scientific committee, and it
was very interesting how the same names featured in many of the organizations: these eminent
scientists and physicians. And then they’d have a lay group who were basically the fundraisers,
the people who ran the charity shops and the jumble sales and whatever, and raised the money
for the scientists. And most of the research that was being conducted at the time when I looked
through the handbook, was something to do with mice or something like that, cell biology or
something like that: very little of it actually had relevance to the immediate concerns of the
patient organizations. So our idea was to change all of this. And we weren’t anti research: we
were for research, but we had a particular idea of research, of it being relevant, and also we
were… many of us sat on ethics committees at the time, and we wanted it to be ethical as well.
So we were a kitchen tableorganisation. None of us were paid. We raised money by small grants
and through the sale of our publications, and I’ll show you some of what we did.
OK, this is one of the first things that we did. At the time it was a kind of standard patient …
Actually we cobbled this together from a whole lot of information sheets that we found at
clinical trials; this is from one of your ethics committees. And this was the kind of way in which
the people would be invited to take part in research. And another of our concerns was that it was
impossible to communicate with the investigators. So you know nowadays you’d have a mobile
phone, but I remember when I was sitting on these committees I would always try and phone up
the number that the investigator had put, and invariably if you got through to anyone it would be
an answer-phone. So these were the kinds of things that I think… I hope the world’s changed
since then, but this is the world in the early 90s. And so one of the projects that we had, which
was enormously successful if I say so myself. (I have to say that I’m terribly proud of CERES.
When I prepared this talk, I would think how on earth did we ever manage to do all of this? We
did it in addition to everything else we were doing.)
So we produced this booklet - you can see it was funded by North-east Thames Regional Health
Authority, which in itself is a historical monument – and this was advising investigators how to
produce comprehensive, comprehensible patient information. It was very, very successful. I
don’t know if any of you ever came across it in your time, but it was very widely used in training
packs, and also allowed us to raise quite a lot of money. So then the other thing we did was we
produced this leaflet, which was a model leaflet for people taking part in research, and all of our
publications, we would send to the Plain English Campaign for them to read through to make
sure that it wasn’t just us who thought it was understandable, but it generally complied with their
standards, and we sold millions of these, and then it got re-done in this kind of thing, and we sold
loads and loads. This is how we survived … it became standard practice I think for many
investigators to use some of our information .
We also produced this. We did this with the Royal Brompton Hospital at the time that their
Ethics Committee was very concerned with trials into and around cystic fibrosis and about the
kind of information that people were being given, so we produced a leaflet for them which again
was widely used, but not as widely as ‘Medical research and You’. And then one of our other
projects, which was enormously difficult and I was very proud of, was with Barts and the
London Trust. We held focus groups and with various community groups in and around Barts
and the London, and we reproduced our information taking on board the sort of things … their
concerns, and we did it in various languages, and we also produced tapes. We produced tapes in
English as well for people, because the level of literacy in the country is also quite low, so we
had our information material on tape as well.
This was very little-used, in fact, despite the fact that Barts and The London Ethics Committee
sponsored it [laughter]. The people in the trust didn’t seem to know about it, but anyway. So
why did we do the other activities? We held all these meetings. We held 24 meetings, public
meetings with patient organisations, and we would always get patients to speak for us. Many of
the things that you do now, we were pioneering; I have to say what we was very radical at the
time.
I particularly wanted to talk about this particular meeting because two things came out of it that
were very interesting. One, it was very well-attended. People came from all over the country to
attend it, and one of the things that came out of it was that there was a clinical trial going on at
the time, I think it was into Sickle Cell, and people were very concerned because the patient
information material was so poor. There had been a previous trial into a substance which had
been very toxic. It proved to be very toxic, and the trial, the current trial was into a similar
substance which had similar kind of name, which they hoped wouldn’t be as toxic. And the
patient information leaflet didn’t actually engage with the different levels of toxicity, so people
were very concerned about that, and it just once again highlighted the poverty of information that
was being handed out by investigators at the time.
And the other thing that came out of it was from people with sickle cell - that they wanted fewer
studies into pharmacological substances. They wanted more into the kind of, social factors that
would prevent them - that might prevent them going into crisis. So it was more that they wanted
a social research, rather than clinical research. So those were the kinds of things that would come
out at the meetings, and we would always publish our... we would always write it up in a
newsletter. If anyone wants to see a CERES archive, I’m very happy to share it with people. I’m
thinking of putting it in the Wellcome thing, but there are some in my house at the moment.
This was a big conference that we had, A Voice for the Guinea Pig. Some of you may find that
an objectionable term, So what else did I want to say? So we decided to close in 2006. The final
nail in our coffin was the Parexel trial, because we found that the company, the facility was
handing out ‘Medical research and You’ to people, which was completely inappropriate
information for healthy volunteers. And we realised then that we were being... we were
providing material that allowed investigators to claim that they were complying with all the
regulations around the grand clinical trials. And we didn’t want that to be the case, we didn’t
want to be seen to be sanctioning trials that we had no... we suddenly realised that we might be
in danger of sanctioning trials that we had no knowledge of, and that worried us.
But prior to that, we had, over the course of our existence - we were increasingly being contacted
by research subjects who had had worries about trials that they’d either been invited to take part
in, or they had been part of and that there’d been some problems about, and that there was no one
for them to go to, to have their concerns taken up. There was no kind of organisation that had the
expertise to support them through making their concerns known. And we didn’t have the
resources at the time to do it, but it so happened that the draft of the EU Clinical Trials Directive
- I don’t know how many of you have been unfortunate enough to read it at the time, but it did
have in it, one of the clauses, one of the proposals was to have an independent voice for research
subjects. And at the time, the Department of Health decided to support us to try and develop an
advice and information service for research subjects. And we worked tirelessly on it, in trying to
put it together, because it was a very complicated project. But then, no one told us at the last
minute, that through - I don’t know what the pressures were, we had support from the ABPI,
from various other prestigious organisations - but at the last minute, that particular clause was
dropped, and so the whole scheme was a dead duck.
NP
What are the lessons? I’m going to shut up, the lessons are that, what we came up with,
there’s no single research subject’s view, you know, it was very controversial at our public
meetings. There’s no - we never came up with one, and I still haven’t heard it - agreement why
you’re doing it. Why you should take note of research subjects, and I put forward these for you
to think about.
 Is it for better science? That was one of the reasons put forward, that the science
somehow would be improved by having... involving research subjects,
 that it would somehow be more ethical to have them, that you would have less subjectobject relationship.
 That it would facilitate, if the research was more user-friendly, that it would be easier to
recruit the research subjects. That’s something else that’s put forward,
 and then you’ve had here today, there’s been more appropriate healthcare by having userinvolvement.
 Another one that I heard today, which I forgot to put on, was that it would help
dissemination, that you put pressure on as the drug companies do, put pressure on
healthcare providers to pay for whatever it is that you’ve just come up with.
 There again, the creation of new markets, that’s the point that I was making just now.
 And the one that we were most concerned with, that it would be confirming that they
were complying with GCP or the other regulations, that they have to go through.
And finally, I just know that what I think that we learned, is that there are enormous inequalities
in power, that however you call people, participants, whatever you want to call them, you do
eventually confront these enormous inequalities in power. And that however nice you are to
[those in power] and whatever you want to call them, there’s nothing you can do about them, that
they still won’t tell you that they’ve removed this clause from the draft of the EU Clinical Trials
Directive. And finally, the landscape of clinical research changes, I mean, nowadays I think
we’ve seen globalisation, restructuring, a whole lot of developments since CERES was in place.
What you were talking about, Oonagh, has kind of, got much more elaborate now, with
international companies having different sites all over. So what does it mean to have a patient
voice in this kind of scenario? I’m sorry I’ve talked too long, but thank you very much.