Written Evidence Submitted by the Health Research Authority

(RRE0070)

1. Who we are

The Health Research Authority (HRA) is a non-departmental public body sponsored by the Department of Health and Social Care (DHSC). Our statutory objective, as set out in the Care Act 2014, is to protect and promote the interests of patients, service users and the public in health and social care research. Our statutory functions include: co-ordinating and standardising the regulation of health and social care research with a view to promoting proportionate regulation; operating the Research Ethics Committees (RECs) in England whose review of health and social care research proposals is required; approving the processing without consent of confidential patient information for medical research, on the advice of the independent Confidentiality Advisory Group (CAG), which we also appoint; and functions as a member of the UK Ethics Committee Authority as set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031).

Today’s research is tomorrow’s treatment; as we’ve seen during the COVID-19 pandemic, research enables us to understand diseases and their impact, how to prevent them and how to treat or live better with them. It enables us to develop new healthcare technologies, devices, and services. The UK has a worldwide reputation for the quality of the research conducted here. The quality of our researchers and research institutions and the unique nature of the NHS draws global companies to conduct research here, enhancing our life sciences industry and our economy. We work to ensure that the UK builds on this reputation for quality research. We know that patients, service users and the public want to take part in or support research. When they do take part, we owe it to them to ensure that the research study is relevant to them, ethically designed, well-managed and produces findings that are useful and widely shared.

2. Reproducibility

The HRA is grateful for the opportunity to comment on the House of Commons Science and Technology Committee’s call for evidence on reproducibility and research integrity. Reproducibility is a key part of the research process; it requires transparency and allows others to understand what was done and how. However, reproducibility is a recognised and ongoing issue within the research community in which many scientific studies are difficult to replicate or reproduce. Publication bias and low-power research designs have potentially serious ramifications for many fields of medical science where significant theories are grounded on unreproducible experimental work.

The HRA and the RECs have a key role in making sure that researchers think ethically and therefore about research integrity, and we collaborate with others within the research system to ensure better research reproducibility. The HRA’s reform initiatives and strategy around registration, collaboration, automation, open methods, and reporting guidelines which we will detail below have been launched in an effort to improve transparency, which in turn will enhance reproducibility.

3. Transparency & reproducibility

Reproducibility depends upon transparency. When research is carried out openly and transparently, everyone is able to see what research is happening and the outcomes from finished studies. Research transparency supports independent verification, replication, evidence synthesis and further discovery.

Everyone involved in research – from researchers and funding bodies to registries, publishers, and the public – has a part to play in making health and social care research open and transparent. However, the HRA has a legal duty to promote research transparency and is taking a leading role on behalf of the research system across the UK to champion openness and drive improvements in performance.

The UK Policy Framework for Health and Social Care Research sets out the responsibilities for researchers, sponsors, and funders for all aspects of research, including responsibilities for the four elements of research transparency. These are: 

1. registering research studies

In order to avoid waste, information about research projects (other than those for educational purposes) is made publicly available before they start (unless a deferral is agreed by or on behalf of the Research Ethics Committee). For clinical trials (CTIMPs [clinical trial of investigational medicinal products], clinical investigations of medical devices, clinical trials of novel interventions or randomised clinical trials to compare interventions in clinical practice), not registering within six weeks of recruiting the first patient is a breach of approval conditions, unless a deferral has been agreed by or on behalf of the Research Ethics Committee.

2. reporting results

Other than research for educational purposes and early phase trials, the findings, whether positive or negative, [should be] made accessible, with adequate consent and privacy safeguards, in a timely manner after they have finished.

3. informing participants

Information about the findings of the research [should be] available, in a suitable format and timely manner, to those who took part in it, unless otherwise justified.

4. sharing study data and tissue

It is a good practice requirement that the data and any tissue collected for a research project are made accessible with appropriate safeguards.

4. Make It Public strategy

Our vision is that trusted information about health and social care research studies is publicly available for the benefit of all. Research in the UK should be visible to all so that: 

• patients and the public can see what research is taking place and access clear information about the findings
• patients, service users and carers can join studies
• health professionals, commissioners, researchers, policy makers and funders can use research findings to make informed decisions.

Research transparency will improve research reproducibility, reduce research waste and enhance public accountability. This, in turn will enhance public trust in research evidence.

While the HRA is the lead organisation on research transparency, many players across the health system also have an important part to play. The players include research funders including public funding bodies, research institutions and groups, individual researchers, and publishers. We will be working together with all of these stakeholders to make sure that we achieve our common vision.

We have made 10 commitments under three broad areas to drive through change.

We will make transparency easy by: 

• Being clear about what we expect of sponsors and researchers and what they can expect of us
• Supporting good practice through guidance, support, and clear communication
• Having a high-quality, interconnected research approvals system 
• Reminding researchers and sponsors when reporting is due.

We will make transparency the norm by: 

• Working with research funding bodies and other regulators to make sure that expectations around research transparency are consistent and aligned 
• Rewarding and celebrating good practice and highlighting poor performance 
• Taking action where researchers and sponsors do not fulfil their research transparency responsibilities.

We will make information public by:

• Ensuring that all clinical trials taking place in the UK are registered, unless the sponsor has permission to delay this to a later stage
• Publishing or sharing accessible information about individual studies and their findings 
• Working with partners to ensure that information for the public is easy to understand.

Summary

Research transparency is key to research reproducibility, by ensuring that all methods, analysis and data are reported and disseminated openly, clearly and in an accessible way.

The HRA’s programme of work to realise the vision set out in our Make It Public research transparency strategy, together with our role in helping researchers to think ethically and therefore about research integrity, will play an important component of the sector-wide response needed to address the current issues we face on research reproducibility. We look forward to working with the newly launched UK Committee on Research Integrity to address research reproducibility and promote research integrity more broadly.

(September 2021)