My Lords, I strongly support my noble friend in Amendments 58B, 58C and 59. This clause is about taking note of the regulation and the regulation of research activities, but not of people who are engaged in research. It is important to involve those who regulate the professions—the General Medical Council, the General Dental Council, the Nursing and Midwifery Council—as well as the nurses. I agree entirely with the statement that the nurses should be included. In saying this I should also mention the pharmacists, who play an important part in research. I have been approached by those involved in pharmacy regulation to indicate that they also have an interest here.
I wish to speak particularly to Amendment 60, which is in my name, and to Amendments 61 and 62. On Amendment 60, I emphasise the important part played by the local R&D committees of NHS trusts, which the noble Lord, Lord Hunt, mentioned. We now have the Health Research Authority, which is doing a really remarkable job in speeding up the process for approval of research by bringing together the different research ethics committees and the special ethical approval for research, using data where patients are no longer able to give consent. It has developed a single portal of entry and a single application, which is having an enormously helpful effect, but there remains one major hurdle in the way of those trying to carry out multicentre clinical trials: the local R&D committees of NHS trusts. Some are good and speedy while others are slow and capricious, and the whole clinical trial is determined by the slowest and most capricious of those who have to give approval.
When the Academy of Medical Sciences reviewed research regulation, it identified the local R&D committees as the most difficult and time-consuming concerned, with delays of almost a year in too many instances, so in Amendment 60 we are trying to give the HRA the responsibility of rationalising and improving the approval
processes in R&D committees. If it can get the approval of all trust R&D committees to rely on and accept a single robust assessment, covering all their various concerns, it will not only relieve them of that burden but give them the confidence that the review has been properly performed. It will also speed up the process for researchers. I hope that we can include this message in the Bill at a time when I know that the HRA itself is working hard to achieve it. The amendment is simply intended to offer it the support that it needs for its efforts.
Amendment 61, in the name of the noble Lord, Lord Willis, who unfortunately still cannot be with us, gets at the problem of ensuring that all providers of services for the NHS, including the private sector, should have the same responsibilities for research and innovation as the rest of the NHS. The HRA should have a role in ensuring that they do. It is important that their staff have opportunities to engage in research; certainly, they should be encouraged to introduce innovation into their practice.
Amendment 62 is also in the name of the noble Lord, Lord Willis. We welcome the explicit mention of the responsibilities of NHS trusts in the Bill. However, there is further need to ensure that trusts not only have regard to guidance issued by the HRA but actively comply with such guidance. I would welcome further clarification of how the requirement to have regard to such guidance will be ensured and how trusts’ compliance with such guidance might be strengthened.