Science and Technology Committee
Oral evidence: Research integrity, HC 350
Tuesday 8 May 2018
Ordered by the House of Commons to be published on 8 May 2018.
Members present: Norman Lamb (Chair); Vicky Ford; Bill Grant; Darren Jones; Liz Kendall; Stephen Metcalfe; Carol Monaghan; Martin Whitfield.
Questions 616 - 693
Witnesses
I: Mr Sam Gyimah MP, Minister for Universities, Science, Research and Innovation; and Dr Patrick Vallance, Government Chief Scientific Adviser and Head of Government Science and Engineering Profession, Government Office for Science.
Written evidence from witnesses:
– Department for Business, Energy and Industrial Strategy
Witnesses: Mr Gyimah and Dr Vallance.
Q616 Chair: Welcome. Thank you very much indeed for coming this afternoon. Could both of you very briefly introduce yourselves?
Mr Gyimah: I am Sam Gyimah, Science Minister.
Dr Vallance: I am Patrick Vallance, the new Government chief scientific adviser.
Q617 Chair: Welcome, and good luck in your post. I hope it all goes very well. Minister, thank you for attending. I appreciate that there was some to-ing and fro-ing between us on this, but we appreciate your coming to give evidence.
Can I start by asking you to set out the boundaries of your responsibilities for research integrity? What is inside and outside the remit as you see it? A supplementary point is that, as quite a lot of public money is committed to R&D through the new UKRI, making sure that the money is spent effectively and there is integrity in the system is crucially important in terms of public expenditure and acting on the results of that research. With that in mind, I would be grateful if you could respond to my question.
Mr Gyimah: Thank you. As you point out, Chair, research integrity is crucially important, because if scientific endeavour, on which we all believe so much progress relies, is to be successful, the research on which scientific discovery is based has to be robust and rigorous. It also has to be robust and rigorous because, if it is not, in some cases it could have devastating consequences, so it is crucially important.
UK Research and Innovation is now the main delivery arm for publicly funded research. The way I see my responsibilities vis-à-vis UKRI is that I have strategic oversight over the important issue of research integrity, and UKRI has day-to-day responsibility for the policies and procedures, as well as exemplifying best practice and providing expert advice to the Government. To paraphrase, policy and strategic oversight sit with the Department and Ministers, and implementation and operation sit with UKRI.
In terms of how we work together, I meet Sir Mark Walport, chief executive of UKRI, regularly—every couple of weeks—sometimes with the chairman of UKRI, John Kingman, and we talk through issues. There is also a framework document that governs how they operate and what is expected of UKRI by Ministers, and, alongside that, how we expect it to deliver in terms of the significant amount of public money that is routed via UKRI.
Separate from that, one thing I have identified as a new Minister is that there is an opportunity to become better at looking at the different aspects of research and what is effective. How do we look at basic research, applied research and discovery? How do we evaluate from the taxpayer’s point of view how successful we are? That is something I am working on with the Secretary of State, to complement the activity that will be done within UKRI, but it will sit within the Department.
Q618 Chair: In your letter to us in March, you said that BEIS supports the 2012 concordat on research integrity. Can you give us your view on the progress that has been made in implementing the concordat over that six-year period?
Mr Gyimah: As I think I said in my letter, BEIS supports it as an appropriate and proportionate way to look at research. It was put in place in 2012 and has been tightened since. A significant proportion of universities do not report annually; 104 institutions do so, and that represents 94% of funding. They have a dedicated webpage. The number of institutions providing at least one annual statement has doubled from 26% in 2016 to 54% in 2018. I do not think that is good enough, and UKRI should be using its lever of funding to get more institutions to comply. We should be aiming for 100% where it is public funding, and I take that extremely seriously. My personal expectation of every vice-chancellor is that there should be 100% compliance.
Q619 Chair: That is very helpful. According to Universities UK, the concordat was “developed in close consultation with and support from government.” What role should the Government have in relation to the concordat now? You gave a very clear response to my previous question. Just expand on that.
Mr Gyimah: Compliance is the key thing. It is not enough for any university in receipt of public funding just to have a webpage, and it is not enough for it to be an option. I am looking to work with Mark Walport to use the levers he has to make sure we get 100% compliance. That is very much at the top of my agenda.
Q620 Chair: Who should be driving implementation of the concordat? Do you think it is just down to Universities UK? I think I know the answer. You say that it is, in a sense, a combination of Universities UK and the funding bodies. Am I understanding you correctly in interpreting you in that way?
Mr Gyimah: I think so. We are working with all the organisations.
Q621 Chair: Do you see any scope for tightening the concordat so that it has explicit requirements, rather than recommendations as it currently reads?
Mr Gyimah: It could be strengthened to enhance research integrity in the UK. Together with other signatories of the concordat, UKRI is seeking to take forward recommendations in that area. UKRI can suspend and stop funding where scientific misconduct allegations are upheld, so I see it having quite a strong lever and I think we can strengthen it further.
Q622 Chair: In other words, it is a bit of a carrot-and-stick approach, encouraging people to take research integrity seriously but, where there are breaches, being quite tough on ensuring that there is compliance.
Mr Gyimah: Absolutely.
Q623 Bill Grant: Continuing the concordat approach, during our inquiry we found that 25% of Universities UK members did not comply with the concordat’s recommendations on producing annual data on research misconduct investigations. Is that acceptable? In one case, a university was not even aware of the concordat being in place. How do you raise the profile of it to get it to work more effectively?
Dr Vallance: As the Minister said, UKRI has a lot of levers at its disposal to work on this. The obvious one is funding. Mark Walport has been clear that he thinks the concordat should have 100% compliance. I think he said that when he was here.
Bill Grant: I believe he did.
Dr Vallance: That is something UKRI will look at and should look at. It seems to me that universities that are capable of applying to UKRI for funding should also be capable of complying.
Q624 Bill Grant: It incentivises them for compliance.
Dr Vallance: Yes.
Q625 Bill Grant: It proved surprisingly difficult during the inquiry to get a clear view of the current state of research integrity. There are many positives and negatives. Would your Department consider commissioning a comprehensive annual report on research integrity in the United Kingdom? Would you see that as a way forward, as another lever that could be used?
Mr Gyimah: We can look at that. UUK carries out analysis of members’ compliance, and UKRI has an annual funding assurance programme for research organisations that it funds in England, carrying out annual accountability returns for English universities. I would see any improvements being done within that framework rather than creating something completely new, but I am open-minded because the important thing is the outcome, which is 100% compliance.
Q626 Darren Jones: UUK did not really fill us with confidence when they came before the Select Committee. They did not know how many of their members had signed up to it or not, so I do not think we feel confident about saying that it is a UUK thing to do.
Perhaps I am being simple. When we talk about pulling the levers of funding, would it not be easier to say they do not get funding unless they comply and sign up? Why are we not doing that?
Mr Gyimah: UKRI has just come into existence.
Q627 Darren Jones: Is it your intention that it should do that, Minister?
Mr Gyimah: I would expect Mark Walport, who is very focused on this, as I think he made very clear when he gave evidence here, to look at the situation and use all the levers he has to make sure that we get compliance, rather than me prescribing specifically how it should be done.
Q628 Darren Jones: You do not mind whether or not it should be mandatory; you do not have a view. Surely, you must have a view on this, Minister. Is not the simple answer that it should be mandatory?
Mr Gyimah: To say that if you do not comply you do not get funding and those who comply will get funding—
Q629 Darren Jones: But you would get 100% compliance if you said, “You don’t get funding unless you sign up and comply with the concordat.”
Mr Gyimah: But you would do that work only after you had the funding.
Q630 Darren Jones: Funding is on a cyclical basis, isn’t it, so you would retract it or not allow bids for funding if they were not compliant?
Mr Gyimah: I think the Chair put it well. You need a carrot and a stick rather than for it all to be stick. I would look at all those options.
Q631 Chair: At the moment, the problem is that it is all a bit woolly. They are all signed up through Universities UK, but the recommendations in the concordat, which they say they have signed up to, are not universally met. That seems to us to be unacceptable, and I think that essentially you have agreed with that.
Mr Gyimah: I understand that quite clearly. The only reason I am hesitating slightly is on how to achieve that objective, but I definitely agree with the direction of travel.
Q632 Bill Grant: Sheffield Hallam University advised the Committee that “Rises in allegations and cases of research misconduct are healthy signs of research communities that appreciate the importance of research integrity and that are beginning to police themselves.” That is what they asserted. Do you agree that self-assessment, measuring the integrity of research and the fact that they seem to be self-policing more, so that more is coming to the surface, is effective, or is it a rather ad lib way of policing it?
Mr Gyimah: Research integrity is the responsibility of employers, funders and researchers, and I am not too sure that direct intervention from Government is necessarily the way forward. That is not to say it is not an important issue. I have said that already, but I would not say that Government should get directly involved in prescribing the way assessments are done.
Q633 Bill Grant: It firmly lies with those who commission the research at the university, the employer of the researcher, to ascertain the integrity and outcome of the research. You would wish it to remain there.
Mr Gyimah: I think so. There are a number of other ways in which we assure the integrity of research, but it is right that it rests with the employer of the researcher as well as with funders and researchers themselves.
Q634 Bill Grant: My final question is almost the opposite of that. Should we be concerned that universities of long standing never hold any research integrity investigations? Would you be suspicious if they have never challenged any research? Would you find that unusual?
Dr Vallance: Maybe I could answer this and the previous question.
Q635 Bill Grant: They are intertwined.
Chair: They go together. Always feel free to come in if you want to contribute something, Dr Vallance.
Dr Vallance: On the first one, given that the pursuit of science is about trying to understand truth, you will find that most scientists want to do something about this and make sure that any malpractice is stamped out. The self‑assessment thing is okay because universities are full of people who do not want misconduct in universities, and the upswing in reporting is in part ascertainment bias. If you start talking about it a lot, people will begin to surface more. That is working, and people are looking at it. Would I be concerned if universities over a long period reported zero? I think it would be odd. It is unusual to have nothing at all.
Q636 Bill Grant: It would raise the question why that is the case.
Dr Vallance: Yes. It may be that they have things absolutely right and we can all learn from them.
Bill Grant: They have achieved perfection in the field of science.
Q637 Vicky Ford: We wrote to the departmental chief scientific advisers about the governance of research integrity in their Departments. Most of their responses focused on appropriate commissioning of research, rather than good governance during research projects. Do you think they appreciate the difference between integrity in the commissioning and during the research project itself?
Dr Vallance: The types of activity that go on in the different Departments are quite different. At one end of the spectrum, there is DFID, which is obviously a research funder, and lots of activities are on administering research funds. At the other end of the spectrum are Departments that are mainly to do with evidence synthesis; they are not commissioning much, but are using evidence that is out there. There is that whole spectrum across Departments and, therefore, you would expect the approach they took to be a bit different, but there is a very big diversity of responses, which is something that needs to be looked at.
My view is that Departments should sign up to the concordat, that the chief scientific advisers in the Departments should lead that process and that we should aim for a somewhat more consistent approach to how we think about research integrity. That is my long-winded way of answering your question. Yes, I think it needs to include more than simply commissioning.
Q638 Vicky Ford: That is good, because my follow-up questions are whether you have reviewed the responses, which clearly you have; whether you think there should be a more common understanding, which clearly you do; and whether the Government should produce their own concordat-style framework for research integrity. I think you have just said that you would like to do that.
Dr Vallance: They should sign up to the existing concordat rather than invent a new one, and we should make sure that the process of implementing that in practice is a bit more consistent across Departments.
Q639 Vicky Ford: I understand that different Departments work in different ways, and that DFID will commission organisations to do research for it, whereas others might be doing internal research. Are you aware of any research commissioned by Government Departments that was subsequently found to be lacking in integrity, or do you think there is currently a nil return by Government?
Dr Vallance: I do not have those figures. I do not know the answer to that question. I would be very surprised if over the history of Government funding there have not been some examples of problems of research integrity. I am sorry; I do not have the answer to that question.
Q640 Vicky Ford: The Minister has told us that “the standards for research funded and undertaken by Government Departments are the responsibility of the departmental CSAs.” However, the CSA role in the Department for Education has been vacant for many months. We have been told that DFE is reviewing whether or not it needs one at all. What is the latest position?
Dr Vallance: If I can answer that question more broadly and then come to the specific, my view is that the CSA network is an incredibly important group across Government. They are the senior scientific individuals who need to hold the system to account and make sure the quality is right, and they challenge input to make sure that decisions are made on the best evidence. That network is important. It is diverse in terms of the scientific disciplines covered, which is also important because very often the scientific discipline you may want may not reside in the CSA in a particular Department.
I believe that all Departments should have a CSA. Obviously, it is up to the Department to make the appointment, but I am reviewing the appointments process at the moment, and intend to make sure that I am involved from job description through to appointments committee so that we end up with the right people, because a CSA in name rather than in quality and action is not what we are looking for. We are looking for the right individuals.
The Department for Education has somebody in post at the moment: Osama Rahman, a chief analyst, who was at the Ministry of Justice, is acting as interim CSA at the moment. I met him last week and we discussed a number of areas, including how neuroscience might be important for education and how he might get input into that. He is the interim CSA at the moment, and I am going through a process of looking at how we get all the Departments with the right CSAs in post.
Q641 Chair: On that last point, I had not seen anywhere that he had been described as the interim CSA for education. Is the fact that he has that position in the public domain?
Dr Vallance: It is.
Q642 Chair: It has been published. Okay. To go back to your point, I was very encouraged that you said you would like to see Government Departments signing up to the existing concordat. Do you see it as part of your responsibility to drive the process to get Government Departments signed up to the concordat? I am pleased to see the Minister nodding. Is that something you can confirm?
Dr Vallance: Yes. The Minister and I have discussed this. I wrote to all the CSAs last week saying that I expected Departments to sign up to the concordat and would the CSAs please lead the process. My default expectation is that they will sign up and they must come back to me if they have a reason not to do so. Obviously, there are some cases where things like the commitment to transparency of publication will not work, in national security and other areas, so we need to make sure that those are appropriately covered.
Q643 Chair: Have you set yourself a timescale for getting sign-up across Government?
Dr Vallance: I have asked for a clear plan from each of them by the end of June.
Chair: Excellent.
Q644 Darren Jones: One of the other nuances that we were slightly concerned about was self-assessment and decision making within universities when there were allegations of misconduct. I entirely agree with Dr Vallance that universities are full of good people who want to get the right outcomes, but, if you compare it with any other sector, it is a bit odd that there is not an external check and balance. Even though people might want to do the right thing, surely there is an inherent conflict of interest if there is a problem in your institution. One of the proposals to deal with that is the idea of a national committee of some form that would either dip in and check the professionalism of the checks or be an external point of appeal. Do you agree with that suggestion, or do you think that is not the right thing for us to do?
Dr Vallance: That is similar to what happens in Australia and Canada. They have systems a bit like that. In both of those examples, what those groups do is look at the process by which institutions discharge their duties, rather than at the detail of what goes on. My experience from when I was in academia is that institutions take this very seriously. I think best practice is that when you have a full investigation you have an external person on the panel, so I do not think it is marking your own homework completely. It is in the interests of institutions to get this right.
I do not know that either the Australian or the Canadian system has yet found that the extra layer adds anything over and above the institutions doing it themselves, but I am sure that UKRI will speak to them. I have certainly been in contact with the Canadian chief scientific adviser over the intramural approach to Government R&D and how they are thinking about that.
Q645 Darren Jones: Do you not agree that, whether or not it is just at a theoretical level, there is a perceived conflict of interest? There must be, mustn’t there?
Dr Vallance: I do not think there is a conflict of interest, in the sense that the duty of a university and of science is to uncover truth. Therefore, the interest is exactly aligned.
Q646 Darren Jones: I agree that is nice, but I am a lawyer by training. If there was a misconduct issue in a law firm, there might be internal processes for dealing with it, but as someone who worked for that law firm I would want our brand and reputation to remain solid externally. Therefore, whether or not there is a real conflict of interest, you rely on others such as the Law Society to assist in certain circumstances, because there might be a perceived conflict of interest. Are you honestly saying that there could be no perceived conflict of interest in a university investigating itself?
Dr Vallance: No, I can see that.
Mr Gyimah: Prima facie, there is; if you are investigating yourself, there must be. In the Australian or Canadian example, whether it is an overarching committee or a sub-committee, as in the case of Canada, they are looking at and commenting on processes and policies rather than individual bits of research. In many ways, what we do is very similar to that layer, which I think is what Dr Vallance was alluding to. Looking at overall policies and commenting on them does not get us to where you want to get, which is that, if there is an investigation, do we need an external party carrying out the investigation in order to avoid a conflict of interest? Other than that, we are in a broadly similar place to Australia and Canada in that respect.
Q647 Darren Jones: Do you feel, therefore, that we are okay where we are and there is no further reform needed?
Mr Gyimah: I do not think I would ever say that. It is one of the things we have to keep looking at. We have to keep raising the bar for ourselves on this, but today I do not see the immediacy of creating that extra layer. That is because of the evidence of the misconduct that there is, obviously drawing a distinction between people who are doing bad science and those who are deliberating falsifying the evidence. We have to keep a watchful eye on that.
Dr Vallance: In very high-risk areas, there are external bodies that do it. In clinical trials or regulated areas such as animal experimentation, nuclear and so on, there are external bodies that also look at exactly that issue. In the highest-risk areas, there are lots of different approaches for looking at it.
Q648 Darren Jones: I can understand the risk-based approach. That seems sensible. Some of the evidence we have had during this inquiry is about where different potential conflicts of interest overlap. There is the issue about research integrity—what has been done at the bench in the lab, how data have been used and those types of questions—but inherently these things sometimes get wrapped up in employment issues as well. We have been told of cases where researchers have, through a mediated resolution of an employment dispute, signed non-disclosure agreements and been “quietly moved on” to another institution. It is that type of conflict of interest that begs the question that there might be better checks and balances. If it works in high-risk areas, why do we not want to try to learn those lessons and adopt that best practice in other areas of research?
Mr Gyimah: One way of answering the question is that, if you look at Retraction Watch figures and find that 0.75 papers are retracted for every $1 billion spent, the incidence seems quite low, so creating what you suggest would be a sledgehammer-nut situation.
Q649 Chair: Yet we have also heard evidence of surveys that suggest that significant numbers of researchers feel under pressure, and sometimes potentially succumb, to cut corners and engage in activities that fall below the standards we expect. There seems to be something of a mismatch between the numbers who feel under pressure, with surveys showing that researchers have seen examples of misconduct, and the data you have just quoted, which suggest that it is a very tiny problem. It may be that the problem is more hidden than we would want.
Mr Gyimah: I am defining misconduct as deliberately falsifying research results for publication, which is different from someone who is bad at statistics and comes out with something that is not good science.
On the pressure you mention, I think that it is now academic culture, in the sense that, if you are an academic, your output should be your research, rather than pressure that necessarily comes from, say, the REF. The REF is about driving up quality. The next REF in 2020-21 will assess how institutions approach research integrity, for example. That complements the requirement that research grant applications are also often about the research environment. I see in the REF enough checks and balances within the system as it operates, on a risk-based basis, to borrow your phrase, for us to keep it as it is, but keeping a watching brief.
Q650 Darren Jones: I should be clear. We recognise that British universities are already very good and are recognised for their excellence. What we are trying to suggest is that in this new world, where excellence in academic research will be increasingly important when we look to things like Horizon in Europe and to potential relationships in the future, there may be things that we can do on this issue and on the concordat to ramp it up even more. That is what we are trying to get to.
Dr Vallance: I would like to comment on that, to support what the Minister said. It is really important to distinguish between deliberate, fraudulent misconduct in research and the much broader issue of whether the research has been done well.
Q651 Chair: Both are important.
Dr Vallance: Both are incredibly important, and the latter is a much more common thing and needs to be looked at. It is everything from, frankly, data mistakes—the transposition errors that everyone has seen, where a 1.6 becomes a 16 when it is transferred from one system to another—through to inadequate design and inadequate analysis aligned to design, where the analysis changes post hoc. Those are really important things. Universities need to spend a lot of time making sure that they get them right. They are a broader problem with regard to research quality, I believe.
Q652 Chair: Darren made a point about potential conflict of interest within an organisation or employer. We have heard that there is quite variable practice with regard to the involvement of an outside person in an investigation, in the panel that might consider an allegation of misconduct by a university. Is that one area where you think the concordat could be improved or tightened? It seems to me that, particularly when there are serious allegations of misconduct, having an independent party on an investigation panel has a lot of merit. Do you have any thoughts on that?
Mr Gyimah: It is definitely a point I am willing to consider.
Q653 Chair: Do you agree with that, Dr Vallance?
Dr Vallance: I do.
Q654 Vicky Ford: This is just an observation. Some of the evidence we took was about concerns about medical research trials. Am I right in thinking that some of those trials may not necessarily have had a university involved in them? If you were trying to track it through the universities’ research integrity methodology, you might not identify a medical research trial that happened in partnership between the NHS and, say, a private research organisation, and did not have a university involved.
Dr Vallance: It is theoretically possible. I do not know how often it would happen. Most private organisations would have a university involved somewhere, but I cannot say for sure that that is always the case.
Q655 Vicky Ford: That particular area—clinical trials—was brought to our focus.
Dr Vallance: Of course, they are heavily regulated. The data are looked at independently, usually by the FDA. The FDA looks at data. The EMA looks at summary results more than original data. Those sites are audited by the regulators, of course. There are very strict rules around that, and they do pick up problems.
Chair: We will explore clinical trials a bit further.
Q656 Martin Whitfield: When Dr Ben Goldacre gave us evidence, he said: “Since 2014, there has been a guideline requiring all trials of medicinal products conducted in a European country to report their results, within 12 months of completion.” However, Dr Goldacre went on to tell us that, within the university sector, the track records on publishing clinical trials vary hugely. Some are as high as 75%, but some are as low as 10% or, indeed, lower. What do you feel your responsibility is, as Minister, to encourage the full reporting of trials?
Dr Vallance: I feel quite strongly about this. Taking part in a clinical study is something that inevitably puts you at risk for the benefit of others. Therefore, the data should be made public. I do not think there should be any exceptions.
Q657 Chair: Comprehensively—in every case.
Dr Vallance: In every case. I think that is true for industry and for academia. In fact, in a previous role, I went further and said that the raw data should be available. By definition, many studies cannot be repeated, because they are too big and too complicated, so you need to be able to see the data in order to know their validity. In clinical experimentation, there should be no exceptions, that I can think of, to making the data public.
Q658 Chair: Does it concern you that, four years on from the 2014 guidance, there is such variable practice among academic institutions? Industry appears to comply quite well.
Dr Vallance: There is a cost associated with it, which needs to be built into the research system. Just to be clear, a lot of the failures are timeline failures, rather than not making things public.
Q659 Chair: Do you mean delays?
Dr Vallance: Yes, in getting the whole thing written up and completed. Sometimes the delays are because it is not a single study, but two or three studies that most naturally get grouped together. Personally, I think it would be a mistake to put in a very rigid timeline by which everything must be published, but they should all be published and there needs to be some timeline around that.
Q660 Chair: And transparency about who is performing and not performing. Ought we not to know which universities are failing to comply with the 2014 guidance?
Dr Vallance: It ought to be visible. Again, that is an issue that does not necessarily affect only universities.
Q661 Martin Whitfield: Given that, interestingly, the data are going to be published in the very near future, what would your message be to institutions with poor compliance rates?
Dr Vallance: Sort it out.
Q662 Martin Whitfield: Would it be any stronger than that, or just, “Sort it out”?
Dr Vallance: It is not my accountability to do that. I have given you my position. All of these trials need to be in the public domain, for all the reasons that Ben Goldacre and AllTrials talk about.
Q663 Chair: Presumably, Minister, you agree.
Mr Gyimah: You want institutions to comply with best practice of their own accord. I would certainly concur with the suggestion that they should sort it out.
Q664 Chair: You would agree that there should be transparency, that we ought to know who is complying.
Mr Gyimah: Absolutely.
Q665 Carol Monaghan: Dr Vallance, you said that you feel there should be complete compliance when we are talking about medical raw data. In the course of this inquiry, I have asked a number of times about a particular medical study, the PACE trial, which was hugely controversial. The raw data from that study have never been fully published. In fact, Queen Mary University of London has spent over £200,000 on lawyers to prevent those data from being published. Can you offer any comment on that particular example?
Dr Vallance: I have been in post for four weeks.
Carol Monaghan: Apologies.
Q666 Chair: Come on—sort yourself out.
Dr Vallance: I am not sure that I know many details on that specific example. Mark Walport wrote a reply, didn’t he?
Q667 Carol Monaghan: He did indeed. He said, “We have been assured that there has not been data lost. Access to data may be requested by contacting the co-principal investigators.” That is probably news to the people who have been fighting to have the data released.
Dr Vallance: I know that the Wellcome Trust has asked to join the CSDR—the clinical studies data repository. The CSDR was initially set up by a small number of pharmaceutical companies, and 13 have now joined. It makes raw patient-level data available, through an application process. One of the problems, of course, is that the data sometimes have privacy constraints around them. Therefore, there needs to be a process to apply for access to data. I do not think that it should be a free-for-all.
Q668 Carol Monaghan: It would all be on the understanding that they would be anonymised data, not personal data. Nevertheless, the anonymised data are important for peer review and for further scrutiny.
Dr Vallance: I agree with that, but I want to make one other point. The CSDR process was set up as a review panel, which looks at the request. The reason for that is that you can data-trawl large datasets and come up with very bad post hoc analysis, so the CSDR process mandates that the research question is properly specified, the method is specified and the analysis is specified. Provided that is okay, you can get access to it. I do not think it should be a complete free-for-all, where anyone can do anything they like with the data.
Q669 Martin Whitfield: You mentioned the AllTrials campaign, which has produced an online tool to assess compliance. Why is it being left to others to collect this information on trials that have and have not reported? Why isn’t the information provided trial by trial, through the Health Research Authority? Would that not be a better vehicle?
Dr Vallance: I cannot answer as to why that is not happening. It is important that trial data are transparent. Obviously, there are rules around some of it, such as ClinicalTrials.gov in the US, where trials have to be posted for industry. You can see when they are and are not complete. It is a relatively straightforward process.
Q670 Chair: Would you encourage the HRA to look at this again and, perhaps, consider a more robust role for it in ensuring complete reporting and transparency?
Dr Vallance: There are now systems in place in the EMA that do the same. Those systems work, so they could be applied more broadly.
Q671 Vicky Ford: Again, this is just an observation. When Dr Goldacre was here, he was very focused on the point that all trials needed to report their results —not necessarily the raw, granular data, but the results—especially if trials had not shown positive benefits from treatments, so that that was known. I want to hear from the Minister whether he is backing the campaign to make sure that all trial results become known. The suggestion was that, at a minimum, people who routinely do not publish their trial results should find it more challenging to receive public funding for future trials.
Mr Gyimah: As I said, I am very focused on transparency in what is done. In terms of the actual results, I do not see why not. I am happy to write to the Committee to set that out in more detail, so that we reflect all the complexity of that.
Q672 Chair: Minister, I have one further point. For the HRA to carry out a full audit of which research trials have not published their results—we know that a substantial number of them have not—there is a financial implication. Has the HRA come to you with a request for funding to enable it to do that? Would you like it to do that, so that we achieve the transparency you have both said you are committed to?
Mr Gyimah: No, it has not come to me. I asked to write to the Committee precisely because of some of these issues and how we tackle them.
Chair: If you could look at that, I would be very grateful.
Q673 Stephen Metcalfe: I want to talk a bit about potential sanctions in a moment. I am sure that we all recognise that scientists take their personal integrity and the integrity of their institutions very seriously. We must not allow the thought to permeate that this is a very widespread problem, but there is a problem, and it falls into various categories, as you have explained.
When things have gone wrong and it is a deliberate act, what potential sanctions are there? We have talked about funding. When we talked to Sir Mark, he talked about the potential to blacklist researchers for serious misconduct. He thought there was a good argument for doing that. Do you agree?
Mr Gyimah: Absolutely. Of course, you have to look at every issue on a case-by-case basis, in terms of what the specific case is. Sir Mark has outlined some sanctions. It is possible that there will be other situations in which a criminal offence may have been committed, in which case you would expect a criminal prosecution to be brought under criminal law, where it already exists. I would not go as far as to say that deliberately falsifying research results should be made a criminal offence, but, where a criminal offence is committed, the criminal law should allow a prosecution to be brought.
Q674 Stephen Metcalfe: From what you have just said, I think you are not that supportive of a new criminal offence of misconduct in research. Obviously, if that were an offence in its own right, it would make it easier to create a list of those who had been charged with it. Therefore, you would have your blacklist, effectively, of scientists who could no longer work.
Mr Gyimah: No, I am not supporting a new criminal offence. I am saying that, where there is misconduct in research, say, in some of the higher-risk areas, such as the use of animals or clinical trials, which could have quite serious consequences, the criminal law as it stands would allow for a prosecution to be brought against the individual concerned, without the need to have a new criminal offence.
Q675 Stephen Metcalfe: Are there any other sanctions that have been looked at? You mentioned that there might be.
Mr Gyimah: I am very much in agreement with what Sir Mark has already outlined.
Q676 Stephen Metcalfe: I will move on to the role of UKRIO—the UK Research Integrity Office. When they came to talk to us, they told us that they have no official status and no funding beyond that provided by subscribers. Do you see a role for Government in providing them with funding or supporting their role in some way?
Mr Gyimah: This feels like a cross-examination. You have already examined one witness, Sir Mark, who confirmed that UKRI would be happy to talk to UKRIO, that it has a clear role in promoting engagement and that public funds should be used for integrity wherever possible. That is a good place to be.
Q677 Stephen Metcalfe: You see it as a role for UKRI, rather than the Government, to support UKRIO directly.
Mr Gyimah: Yes.
Q678 Stephen Metcalfe: Do you think that, if they were put on to a more statutory footing, it would send the message that research integrity is taken seriously?
Mr Gyimah: Research integrity is taken seriously.
Q679 Stephen Metcalfe: I am allowing you to put that on the record.
Mr Gyimah: Yes. I would dispute the assertion that somehow it has not been taken seriously and is now being taken seriously. The relationship that Sir Mark envisages with UKRIO is one that could be as effective as we need it to be.
Q680 Chair: Minister, while you are here, I would like to get a quick catch-up, or clarification, of where we are with the Galileo project. We are acutely aware that you met representatives of the European Space Agency last Monday. We are aware of it largely because we were supposed to be meeting them in Brussels, but they were here in London seeing you—hence their cancellation of our meeting. Thankfully, we had many other people to visit as well.
I would be really grateful if you could give us an indication of the outcome of that meeting. Obviously, there is a lot of concern about the situation with the Galileo project, and a need for clarity and reassurance as far as the industry is concerned. Can you tell us what emerged from that meeting?
Mr Gyimah: I met Jan Wörner, the director-general of the ESA. This was, first, an introductory meeting, but of course Galileo came up during the discussion. We discussed the fact that the EU Commission is excluding the UK from the security aspects of Galileo. The director-general recognised that the UK has played an important part up to this point. As you know, the ESA is independent of the European Commission, so the substantive discussion around Galileo and our position did not happen in that meeting. A substantive discussion has been going on in Brussels with the Commission, at the highest levels of the Government. The Secretary of State has been involved. I, as well as a number of diplomats, have had conversations, because it is a matter of serious concern to us.
Q681 Chair: Is there any update on where we are with regard to the proposed freeze on the procurement process, which has excluded UK companies from participation in future programmes? The Secretary of State proposed a freeze while it is sorted out between the two sides. Have we secured a freeze, so that there can be those further discussions? Where are we at?
Mr Gyimah: The discussions are ongoing. As you know from his letter of 19 April, the Secretary of State has made very clear the UK’s position that involvement must be on terms that the UK considers acceptable, including that it should be fair and open to UK industry, and that there should be access to and participation in the secure and sensitive parts of Galileo. That is one aspect of our position. The second aspect is that the UK is willing to look at all alternatives, including building a British national satellite and navigation system.
We have been absolutely clear and up front with the Commission on what our options are, and on what we need to see to continue to participate fully in Galileo. We believe that the position that it has taken is inconsistent with the December joint report, which said that, during an implementation period, we would continue to be part of it. It goes against all the guidelines. We have been absolutely up front. The conversations are ongoing.
Q682 Chair: Do you think that any progress has been made on resolving the dispute?
Mr Gyimah: I am not in a position to comment on that at this stage. Our message has got through.
Q683 Chair: Is there any progress on the specific point of the freeze in the procurement process? As I understand it, it was supposed to close last week. I have heard some suggestion that it has been extended for a month, at the request of others. Is that the position? Have they agreed to what we want in terms of a postponement?
Mr Gyimah: There has not been a formal agreement on that yet, as far as I am aware, but I know that the discussions are ongoing.
Q684 Chair: Are you hopeful that you will get to a resolution?
Mr Gyimah: I hope that the Commission realises that failure to have the UK as part of Galileo would increase the cost of the programme massively, which means that every member state would pay a lot more for it. It would also mean losing UK expertise in the programme. I hope that that realisation will bring us to a point where we can all agree to carry on as we have been doing.
Q685 Chair: Presumably, it rather undermines the Prime Minister’s desire to have a comprehensive security relationship with the EU if we are having difficulty with this specific programme.
Mr Gyimah: I do not think that it undermines it, but it is at odds with that position. The Commission is praying in aid security concerns on Galileo, while at the same time it is open to security co-operation post the UK’s exit. That is why this is so egregious. It is also why it is one of the few negotiating issues that has brought remainer and Brexiteer together. It is egregious not just as far as the UK interest is concerned, but as regards EU-UK interests on defence and security co-operation.
Chair: I want to ask a question about the other programme, Copernicus. Before I do, I will bring in Darren.
Q686 Darren Jones: I want to challenge your last statement, Minister. I do not think that it is quite right. The Galileo problem is not necessarily a technology or satellite problem; it is a security problem. It is exactly the same problem that is being faced in terms of British businesses being able to bid into the European defence industrial plan under the PESCO arrangements. Basically, the Commission is saying, “Security issues are for EU members. If you are not going to be an EU member, you are not part of defence procurement.”
That is the problem that faces us for the Galileo system. Is it not right that, on this first test of security co-operation, there has been a complete failure and, somewhat disappointingly, a public escalation on both sides of the argument, with arguments taking place via statements in the press? Do you regret that position? Are you part of conversations with your colleagues in the Ministry of Defence on this as well?
Mr Gyimah: I am part of conversations that are going on across Government—with the Ministry of Defence and, obviously, with DExEU, where the negotiations are being driven from. The escalation is inevitable. It is right that we fight for our interests, using all the resources that are available to us. If we did not do so, you would ask me, “What did you do to make sure that this did not happen?” More importantly, there has been a need for us to make clear to all the relevant member states what the stakes are. This is not just about the Commission. It is also about other key member states really understanding the full implications of the UK not remaining in the programme.
Q687 Chair: Do we have allies in that regard?
Mr Gyimah: A number of countries are sympathetic to the British view.
There was another part of your question that I did not answer. You said that this was the first test of defence co-operation. Defence co-operation is definitely an aspect, but there is also the impact on industry. Who seeks to benefit? For us, this is not just about UK industry benefiting; it is about security. We have invested in it, and we want to continue to participate.
Q688 Darren Jones: I agree with you entirely. The issue is, who makes Chinook helicopters, who makes aircraft carriers, and who makes satellite systems? We are in an argument with the European Commission about our future involvement in all those issues. It has not been resolved whether UK businesses can bid to be part of those procurement contracts.
To stress the Chair’s point, there are hundreds of workers, including in my constituency of Bristol North West, whose jobs rely on getting this right. We have not had a clear answer today about whether the procurement decision has been postponed until we can come to a conclusion on security, while those people’s jobs may be on the line. We need a clearer answer to that, and more quickly. When do you think we will be able to make a public statement to those workers that we have got this sorted?
Mr Gyimah: I speak to the chief executives of all the British companies. I had a round table with them about three weeks ago, where we discussed all these issues and what the implications are for each of their businesses. They have also been involved in shaping our negotiating position. I am very alive to the potential impact on British industry, and we are working very closely with them.
You asked when it will be resolved. We have made our position clear. It is up to the EU to come back to us. You made the point that there is an argument. Of course it is an argument. You are a lawyer. We are exiting. There is an ongoing debate, and these things have to be thrashed out as part of it.
Darren Jones: To conclude, I would rather they were negotiated in a professional environment, not via the press, and, hopefully, with some swift resolution.
Q689 Vicky Ford: I, too, have a large employer in my constituency that takes part in this. It is a smaller company than yours, but it is a leading member of the European Space Agency.
Minister, I asked your predecessor on the Floor of the House whether it was the Government’s intention to continue to be a full member of the European Space Agency. He confirmed that that was the Government’s wish. I would like to understand whether that is still the case. I understand that you cannot discuss in a public meeting such as this what may be price-sensitive issues for some of the companies and their employees, but I would be very interested to know more about the legal advice that we are getting about the legality of British companies potentially not being involved in these contracts, given that the European Space Agency is not within the normal EU framework.
Mr Gyimah: We are looking at every avenue that is available to ensure that our interests, and the interests of UK companies, are protected.
Q690 Chair: Is it the Government’s intention to remain in the European Space Agency?
Mr Gyimah: Yes.
Q691 Chair: It is not an EU institution as such, although this is an EU-funded programme.
Mr Gyimah: Absolutely. There are huge opportunities for UKspace with the European Space Agency. I do not see a scenario in which we do not carry on working with the European Space Agency.
Q692 Chair: Can I ask about Copernicus? Do you think there are similar risks with regard to that programme, or are the issues that have arisen specific to Galileo because of the defence aspects of its deployment?
Mr Gyimah: From what I understand, they are specific to the defence and security aspects of Galileo. Having said that, I would not be surprised if, as we go through the negotiations, there were other issues such as that. We have to be mindful of that and to make sure that we fight our corner very hard.
Q693 Chair: To conclude, you, the Secretary of State and, indeed, the Prime Minister are giving this the highest priority, to get it sorted out and—to take Darren’s point—to do so urgently, because of the damage that the uncertainty causes to British business.
Mr Gyimah: This is being taken very seriously at the highest levels of the UK Government, on the diplomatic side, the political side and the departmental side.
Chair: That concludes our questions to you. Thank you both for the evidence that you have given this afternoon.