My Lords, first, I declare an interest as the chair of the Association of Medical Research Charities. The brief comments that I am about to make are an amalgam of those made with the Academy of Medical Sciences, Cancer Research UK and the Wellcome Trust. On behalf of all those organisations, I can say how much we welcome these amendments and the way in which the HRA has so quickly become embedded into the research psyche. The work that it is doing ensures that on each of the major obstacles—of which ethics was the first, particularly in local ethics committees, but going right through to the regulation that it is starting to streamline, particularly with the Human Tissue Authority—we are really seeing a march forward. Frankly, the progress that has been made has staggered me. I congratulate not only the chairman and chief executive of that organisation but the Minister himself.
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However, I would like briefly to explore one or two issues with Amendments 166 and 167. Leaving out “such research” in Amendment 166 and inserting,
“research that is safe and ethical (including by promoting transparency in research)”,
is welcome, but we have concerns about the definition. In particular, as the Minister has tried in Amendment 167 to expand on that definition, I would like to press him on one or two of those requirements.
The HRA itself is concerned that expectation about transparency could get ahead of itself. For instance, on the provision of data and tissue, the research authority itself does not in fact have access to or grant permission for any tissue or data that is in the possession of researchers themselves. I hope that that does not become a blind expectation. Looking at the first of the ethical requirements—paragraph (a) in Amendment 167 on the need for registration of research—while we welcome the announcement that ethics approval for
clinical trials will be conditional on trial regulation, the HRA’s remit extends beyond clinical trials to include all forms of research, including that with human participants. There is clearly no expectation or mechanism by which all research should be registered, so this requirement as tabled is currently not feasible or proportionate.
However, the HRA has indicated that it is giving further consideration to the registration of other studies, and I wonder whether the Minister—when this Bill goes back to the Commons, which is probably the most appropriate time—could suggest an alteration. Instead of saying, “the registration of research”, it perhaps should read, “the registration of clinical trials”.
Turning to paragraph (c) on the provision of access to data, we again support the emphasis on research data, but recognise that those data have to be appropriate. It would not be right to be able to give some of those data out for obvious reasons of patient and individual confidentiality. We wonder, therefore, whether the words “appropriate access” would be a better way to limit what the HRA is going to be responsible for. With respect to paragraph (d)—
“the provision of information at the end of research to participants in the research”—
again, I need to know what that means, because providing high-level summary information to every participant at the end of research would be a hugely demanding task. To aggregate it would not be, so “aggregated information” might be a more accurate way of dealing with that problem.
Finally, I come to,
“the provision of access to tissue used in research, for use in future research”.
All the organisations I am speaking for support the principle behind this requirement. It is important to recognise, however, that tissue is a limited resource. It is not always possible or appropriate to ensure that such access is provided. However, with those comments and requests for clarification, I can say that this emphasis on transparency is very warmly welcomed and we thank the Minister for it.