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Health Research Authority (Establishment and Constitution) Order 2011

My Lords, I would add my words of welcome to the principles of research which have been supported by the Government. I know that the Minister has done much personally to promote this. In welcoming the Health Research Authority as a special health authority, I also echo the words: ““The problem is this: for how long and where will it lead to?””. The current regional ethics committees that are going will be covered in this, but they are only half the problem in relation to research. The other half is R&D committees in trusts. There is a separate committee for every trust and people who want to undertake multi-centre research have to take their research through them. If you are researching into rare diseases, you may have to go through every trust in the country in order to be able to recruit enough patients to enter into whatever study you are conducting. That could be 100 or so different committees. It means that researchers have to sign up at every trust. Each trust behaves quite differently. Some speed research through in about two weeks, but others become extremely fussy. Unfortunately, that fussiness often focuses on things like the patient information sheet. The committees will spend time requesting redrafts of that sheet, but the redraft may be rejected by another trust. Researchers end up going around in circles for months on end in what is in fact a pretty futile activity. That is because the original research ethics committee which looked at the proposal will have to go through everything, including the consent form, the patient information sheet and so on. The committee also has to look at the protocol of the study itself and the science behind it. If the science is bad, that is really when the research programme should be stopped in its tracks. That is the role of the ethics committee, and if it does its job properly, it could centralise all these other factors and look at them. Apart from the duplication taking time for researchers, it is duplication across the whole country with people doing exactly the same job and coming to slightly different, but often not very consequentially different, conclusions. There is duplication at many levels. One could say that if something is good enough for the research ethics committee, it really should be good enough across the board. If it is not, there is a question about the research ethics committee and the way it functions, and it needs to be looked at again because it is not up to scratch. There are quite a few things that I hope can be centralised, and it will be helpful if the Minister will clarify what will and will not be centralised. For example, will checks on the principal investigator’s qualifications to undertake the research be centralised? Will the protocol of a study and the science behind it be scrutinised with patient information sheets and patient consent forms? Will there be a way of informing the trust that that has been done adequately and does not have to be done again? At a local level, of course the trust has to look to see whether it has the right research facilities and the right infrastructure. That is not usually about the nature of the research but more about whether it is in a position to participate. That is a feasibility check at a local level. That could be done very quickly, but it needs a different mindset. I am concerned that with the push to autonomy for all the different trusts, a trust can say, ““No, we’re not going to play ball with this. We want to have our own processes and do our own research ethics rather than participate at a national level””, which might strengthen its R&D committee processes. An issue not being addressed in this order is indemnity for research. Are there plans to establish an all-England research risk pool or some kind of centralised and co-ordinated indemnity so that we free research processes and stop risk-averse behaviour at local level? Sometimes, risk aversion, which is an inappropriate interpretation of risk, is making some of these committees particularly nitpicking in their processes. I recognise that that might need primary or secondary legislation, but I urge the Minister to take away the amendments that we have tabled to the Health and Social Care Bill and think very carefully about them because they would solve quite a large part of this problem. They would not solve it all, but this order is an interim measure, and it cannot last for years because the gaps will widen and we will then carry on losing research from our shores. We are all aware of the urgent need to turn that traffic around and to bring pharmaceutical and all other types of research back because it is a strength and an economic earner for this country if we can get it right. The infrastructure is critical.