My Lords, I am very grateful to noble Lords for their questions and comments. Without spending too much time, I shall try to cover the questions raised. Anything I do not cover, I undertake to answer in a letter. My noble friend Lord Willis asked a number of questions about how he should interpret the provisions in Amendment 167 in particular. Incidentally, it is important to point out that the way Amendment 167 is framed means that the HRA may do other things to promote transparency and research, not just the things that are listed in the amendment. The HRA should do what is set out in paragraphs (a) to (e), but it is not an exclusive list.
My noble friend asked me whether we should not be talking about registration of clinical trials instead of research. The amendment requires the HRA to promote the registration of research because we want to encourage transparency in all health and social care research. Greater knowledge about what research is under way or has already been undertaken is essential, so that new research can build on it, minimising the risks, intrusions and burdens for patients. We think that that applies to all research, not just clinical trials. The amendment requires the HRA to promote registration of research; it does not create a requirement for all research to be registered. I hope that that will ease my noble friend’s mind a little.
In delivering its objective of facilitating safe and ethical research, I would expect the HRA to take into account what databases are available for the registration of research, any existing requirements to register research, the need for requirements on registration to be proportionate and practical, and what is happening internationally. In doing so, presumably the HRA would consult stakeholders on achieving this part of its objective.
My noble friend asked me what is meant by,
“promoting … the provision of access to data on which research findings or conclusions are based”.
It is important that the data generated during research are made available to others, where possible, while protecting patient confidentiality. That helps to ensure that we maximise the benefit from investment in research. The Health Research Authority special health authority is currently planning to strengthen the research ethics committee review of researcher intentions, to make findings, data and tissue available. It is undertaking a pilot to consider whether the introduction of ethics officers will increase the proportion of favourable opinions at first review, improve the timelines of review and reduce the administrative burden on research ethics committees. That includes a review of researcher intentions to make findings, data and tissue available.
My noble friend referred to patient confidentiality. I stress, as I have on previous occasions, that in promoting the provision of access to data on which findings or conclusions are based, the common law duty of confidentiality and the Data Protection Act 1998 apply. The HRA will need to take account of these in delivering this part of its objective. We do not believe that it is necessary to state this explicitly in paragraph (c) of Amendment 167.
The noble Lord asked what is meant by,
“promoting … the provision of information at the end of research to participants in the research”.
Participants who take part in research have said that they want to be able to access the results of the research, and that was confirmed by recent HRA public engagement work. The HRA is working with others to set standards and provide guidance on how information should be provided to participants. Consideration of these plans against agreed standards will continue to be an issue for research ethics committees to review at approval. That work will continue through the HRA’s involvement work stream.
My noble friend questioned whether the results should be released to every participant, perhaps in aggregated form. It will be for the HRA, as an NDPB, to set out in its guidance for researchers its expectations as to the information they should provide to research participants at the end of the study. We would expect the HRA to develop its expectations, not only with stakeholders but with research participants themselves. We do not think that it is necessary to state explicitly that information should be in aggregated form.
As regards access to tissues, my noble friend made a good point. Human tissue is a valuable resource for research. Disposal should be a last resort. Making tissue available at the end of a study allows other researchers to make use of material already collected. Maximising potential for research from tissue collected helps to reduce the risks, burdens and intrusions placed on people by minimising the need to collect further tissue. Making tissue available at the end of a research study might involve the tissue being transferred to an appropriately licensed tissue bank, for example. We recognise that tissue has a limited life, and, through quality and assurance systems, tissue that should be disposed of is identified by either the tissue bank or the researcher. I can expand on that for my noble friend if he would like me to.
The noble Baroness, Lady Wheeler, asked whether the Government would ensure that CCGs and NHS staff engage in research. I am pleased to remind her that CCGs have a duty to promote research under the Health and Social Care Act 2012. I hope that that has covered at least the majority of the questions.