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Health Research Authority (Establishment and Constitution) Order 2011

My Lords, this instrument is to set up the Health Research Authority as a special health authority. The main reason given for taking this step rather than the primary legislation route is because there is some urgency in finding a home for the national research ethics committees that will soon find themselves homeless when the strategic health authorities and the National Patient Safety Agency go out of business. I can, of course, understand why it is necessary to go down this rapid secondary legislation route because even if the Health Research Authority were to find a place in the current Health and Social Care Bill, it would still be a couple of years before it would be fully enacted and we need something sooner. However, there remains the question of why it cannot be put into the Bill as well so that there can be a smooth transition from this temporary solution to a more permanent one. No doubt, we will be exploring that when we come to debate it later in the Bill. The anxiety remains that we will have to wait a considerable amount of time before we see another round of primary legislation to set up a permanent agency. In our debates on the Bill yesterday, we heard about the doubts being expressed about when we will see further legislation. Can the Minister enlarge on the hint he gave in the debate last week that we might see something relevant to this in 2012? It might be helpful if I said a few words about why the establishment of a health research authority or agency is so important. It comes directly from the recommendations in the Academy of Medical Sciences’s report A New Pathway for the Regulation and Governance of Health Research which the Government commissioned last year and which, to their credit, they have endorsed enthusiastically. The report described in great detail the current regulatory burden faced by clinical researchers and proposed a number of solutions, the most important of which was setting up this agency. It pointed out how the UK research effort is being undermined by an overly complex regulatory and governance environment and how this has caused a fall in the UK’s global share of patients in clinical trials of all types, as well as a marked increase in the time needed to navigate a very complex research approval process. Regulation has grown as new regulatory bodies have been set up, often in response to some scandal or other, and often with seemingly good reason, but without any consideration of the overall impact of yet another new hurdle and without any evidence whatever that they have improved the safety of patients or the public. The problem is confounded by the delays and duplication in the governance arrangements within individual NHS trusts. They are now thought to be the single greatest barrier to health research, especially where several trusts are involved in multicentre trials, for example. There is a definite need for a regulatory pathway that allows us to cut through all this unnecessary and complex bureaucracy while at the same time ensuring the safety and interests of patients. Now we have a research regulatory authority as an important government response, and we have to see how it is going to achieve all that is expected of it. First, the National Research Ethics Service, with its 80 or so local ethics committees, has done a marvellous job in the past few years in streamlining the ethics approval process. It has, for example, made it much easier for those engaged in multicentre research proposals to gain approval. Preserving its function has been vital, but unfortunately moving it by itself from one body to another will do no more than preserve the status quo. It simply moves it from one home to another, yet the research regulatory agency was expected to do so much more. My questions for the noble Earl are: will the authority have any more responsibilities? For example, will it have any of the responsibilities currently undertaken by the ethics and confidentiality committee of the National Information Governance Board? That committee advises the Secretary of State on whether permission should be given to researchers wanting to use data about patients where it is not possible to gain consent. It is a very important safeguard for patients, but it means that researchers have to have two sets of ethical permission to do the research, one from a normal ethics committee and another from this committee, and that causes all sorts of delays. Can we expect some streamlining here? I see in the Explanatory Memorandum to this order that that might be on the horizon. If so, can the Minister give any further information on that and on when it might happen? Then there is the problem posed by the delays caused by the local R&D committees in each of the NHS trusts. They can hold up research for months, especially if more than one trust is involved in multicentre research proposals. For example, Cancer Research UK said that the average time for a multicentre research grant to be approved was over 600 days. Can the noble Earl say whether the new authority will have any role in easing that problem, perhaps by ensuring that limits are set on the times that trusts can take in considering proposals? Will it, for example, be able to vet research proposals in such a way that it can save local R&D committees from each having to repeat much of the straightforward common areas of a proposal, leaving them to check on aspects of specific local importance? That would certainly help to speed up the process. The excellent report from the academy outlines a whole range of other regulatory bodies and functions that could and should be rolled up into the new authority. I shall not go into them, save to recommend that noble Lords who have not read the report might find it of some interest. A research regulatory authority or agency has enormous potential for good if we can get it right. If we do, all will benefit—the researchers, certainly, but most importantly the patients, who will access new treatments sooner and more efficiently. We will gain economically too, because we will regain something that we are already losing: the investment from the pharmaceutical industry, which is watching our debates with interest. We owe a debt of gratitude to the Government for setting up this authority and removing the uncertainty surrounding the ethics committee, but much more needs doing. I look forward with interest to the response of the noble Earl, Lord Howe.