Problems and Purpose

The Health Research Authority (HRA) is an NHS organisation established on 1 December 2011 as a Special Health Authority. The purpose of the HRA is to protect and promote the interests of patients and the public in health research in order to support both their confidence and participation in health research, and improvements in the nation’s health. 

The HRA has responsibility for protecting patients from unethical research, while enabling them to benefit from participating in research. It has been tasked with streamlining and simplifying the research approval process and removing duplication from the current system for research review and approval. In the course of reviewing these processes, the HRA was keen to take the opportunity to listen to the public and patients on the benefits and risks of clinical trials and other health research, and to take account of their views in developing new approaches. Talking with patients was not new to the HRA, but talking to the general public face-to-face was quite new and different. 

The resulting public dialogue was a relatively small-scale project that has had significant impacts on the governance and regulation of health research, and on the future strategy of the HRA. 

The dialogue focused on the benefits and risks of clinical trials and research involving patients. It examined the ethical issues that might arise, and the procedures required to approve health research as well as protect the patients and the public. 

The key objectives for the elements of the public dialogue were to: 

• Understand public views on the perceived risks for individuals agreeing to participate in health research (different types of research and different individuals) and to what extent the public feel protected by the current systems in place to approve such research
• Explore the extent to which the public and others trust the views of their doctor in advising if they should participate in research. Who else would they trust in giving such advice and what needs to be in place to gain or maintain that trust? 
• Explore to what extent the trust held by the public varies according to the type of researcher/research organisation (that is, pharmaceutical, charitable, academia versus NHS). 
• The HRA is tasked to protect and promote the interests of patients and the public in health research. Given the current awareness in the public of research ethics committees, what needs to be in place to ensure that they can fulfil their role? 
• Understand the patient perspective as to how the HRA should engage with the public in the future, including the extent to which the HRA should engage directly with the public and what should be influenced by such engagement 
• Understand what the dialogue and research tells the HRA about the common and different views that emerge from different types of public. For example, how does the general public perspective differ from that of patients? 

Background History and Context

Health research covers a vast span of clinical science and academic disciplines, funded by both private and public sectors. Clinical trials form an important element of this work, which can be therapeutic in patient studies or non-therapeutic, such as Phase 1 trials in healthy volunteers. This can range from testing new pharmaceuticals in clinical trials; large-scale biometric studies; through to the piloting of the most advanced genetic therapies. 

The HRA has been tasked with streamlining health research approvals processes, while protecting and promoting the interests of patients and the public. The Select Committee inquiry on clinical trials noted that the clinical trials market is worth £29 billion per year and that the UK’s share of the market had dropped since 2000 – the UK did have the third largest share of global trials but, by 2006, it had dropped to ninth place. 

In reviewing research approvals processes, the HRA commissioned a series of public dialogue events and a general public omnibus survey so that some findings emerging from the public dialogue workshops could be tested with the wider population. In addition, the HRA themselves conducted a series of dialogue events with patients recruited through existing patient and public involvement (PPI) networks. This was to enable a comparison to be made between these active service user network members and the general public. The types of research referred to in the dialogue sessions covered a range of conditions or therapy areas such as cancer, diabetes, cardiovascular, and mental health.

Organizing, Supporting, and Funding Entities

Health Research Authority was the primary organizer. The purpose of the Health Research Authority (HRA) is to protect and promote the interests of patients and the public in health research.

A leading UK research company, Ipsos MORI was the dialogue deliverer, and Cardiff University was the project evaluator.

Sciencewise-ERC is a Department for Business, Innovation and Skills funded programme to bring scientists, government and the public together to explore the impact of science and technology in our lives. It helps Government departments and agencies commission and use public dialogue to inform policy making, involving science and technology issues. Its core aim is to develop the capacity of Government to carry out good dialogue, to gather and disseminate good practice, have successful two-way communications with the public and other stakeholders, and to embed the principles of good dialogue into internal Government processes.

Participant Recruitment and Selection

Public Dialogue 

A total of 60 participants, who were recruited to reflect the demographic diversity of people living in England, attended the initial series of four, 3-hour long evening workshops. One week later, 56 of those returned for the second set of reconvened workshops. Workshops were held in Bristol, London, Manchester and Newcastle. The events were facilitated by two professional facilitators with additional input from the HRA. A minimum of two clinical researchers attended each reconvened workshop session to answer questions, raise issues, and generate further dialogue among participants. [1]

Patient Dialogue

Eight workshops were conducted in March and April 2013 across England, involving a total of 68 participants; seven of the workshops were with patients and one with Phase 1 clinical trial healthy volunteers. The patients were recruited via the National Institute for Health Research (NIHR) Research Networks, major health charities and industry; as such, they were particularly well informed.

The patient workshops involved the following groups:

• Mental Health (Birmingham)
• Parkinson’s (London)
• Diabetes (London)
• COPD (London)
• Cancer (Sheffield)
• Stroke Survivors (Newcastle)
• The Phase One Workshop occurred in London
• A Mixed group workshop (children and young people) in Liverpool [5]

Many of the patients acted as patient representatives; some had been participants in research studies and others reviewed research proposals as part of patient and public involvement. Some patients had been trained in research methods in order to take part in patient and public involvement; a couple of patients even formally recruited other patients to take part in clinical trials. The Phase 1 participants were recruited directly from companies conducting Phase1 studies. 

Ipsos MORI also undertook a face to face survey of the general public: interviewing 1,295 participants.

Methods and Tools Used

Public Dialogue Workshops

The primary purpose of the first set of workshops was to inform participants about health research in the UK, and focused mainly on clinical research trials to illustrate ethical and research governance issues. Hypothetical case studies were used to prompt thinking about different research projects. The second set of workshops focused on informed dialogue about the research approvals process, starting with the current system and then discussing the HRA’s plans for streamlining the process. 

Patient dialogue workshops

Eight patient workshops were held across England, seven with patients and one with clinical trial healthy volunteers. Each session lasted for three hours. Researchers were present at five of the eight workshops.

The workshops used the following materials:

• Quiz questions and answers 
• Case studies 
• Flip charts – 1 per room/ table 
• PowerPoint/ Multimedia 
• Signage 
• Participant incentives 
• Consent forms 
• Further information for facilitators – case study notes for facilitators and map [4]

Omnibus survey

As part of a wider weekly omnibus survey, Ipsos MORI conducted a face-to-face survey with 1,295 participants, which involved 11 questions. This article will focus on the dialogue elements of the project. 

What Went On: Process, Interaction and Participation

Public Dialogue Workshops

First workshop: to inform and educate participants about health research in the UK. Clinical research trials were used as a primary example of health research to illustrate many of the ethical and research governance issues that need to be addressed when evaluating health research proposals. In this workshop, participants were largely engaged in thinking about the issues presented from the perspective of being a ‘potential research participant’.  

Second workshop: to engage participants and researchers in an informed dialogue about the research approvals process. The initial focus was on the current approvals system, shifting to a discussion about the HRA’s proposals for streamlining the approvals process by taking a more central role in co-ordination of research governance, and enhancing specific aspects of the process. In this workshop, participants were encouraged to think about the issues from a broader ‘citizen’ perspective and thus to consider the wider societal implications for health research and the strategic role of the HRA.  

Patient Workshops

The patient workshops, unlike the public workshops, were not reconvened. Patient workshops took place just once for each group and were just three hours long. A decision was made not to reconvene the patient groups as they were starting from a more informed base. Patients were already familiar with health research and clinical trials. In some cases, they had an awareness of the function of the Research Ethics Committees which meant that more time could be devoted to the HRA’s proposals to streamline the research approval process and other initiatives. Researchers were present at five out of eight patient/participant workshops. There were a small number of carers also present in the patient groups. 

Key messages from the public 

The dialogue found that public participants had very little knowledge about health research, how clinical trials worked, and the role of regulators. The public’s decisions about taking part in trials were most likely to be based on the costs and benefits to them as individuals, with societal benefits being considered less important. They were keen to eliminate or minimise safety risks, and ensure that the best care and information is available to those participating, both during and after trials. Patient participants were less concerned about risk and safety, and more concerned about non-compliance and poorly managed studies.

Most participants were positive about the role of public and patient engagement by the HRA as part of its strategic decision-making. The broad view was that, as health research is of significant importance to individuals and society at large, there was an ethical imperative to involve the public in this work. 

Many participants believed the proposed streamlining of the research approvals process could tackle many of the problems with the current system. Most were enthusiastic about the HRA co-ordinating the process and believed this would improve efficiency without affecting patient safety. Some were more sceptical about how this would work in practice. 

Participants talked most about transparency when discussing what happens at the end of a study and the publication of research results. Some believed it was an ethical duty of researchers to publish all research and the duty of the HRA or research ethics committees to ensure that happens. There was a general call to bridge the public’s knowledge gap through improved information and accessibility. 

The HRA and NHS staff were very highly regarded by participants and trusted to protect public health and wellbeing above other considerations. In contrast, pharmaceutical companies were seen as having vested interests in the conduct of research and were not trusted to behave ethically. Patient participants were less critical than the public of the pharmaceutical industry. 

The main feedback on patient information sheets was that individuals have different reading preferences. Therefore, researchers should make available information sheets with a varying level of detail. Some participants also noted a need for information to be made available for the lifetime of the project. Patient participants proposed a new heading in patient information sheets on patient and public involvement to encourage the early consideration of the issue by researchers. [1]

A large majority of the public were positive about the idea of the HRA continuing to work with and engage with both patients and the public to inform its ongoing strategy and policy. To some extent, this conflicts with their dismissive attitude towards the inclusion of lay members on research ethics committees. The majority of patients on the other hand feel that future engagement should be restricted to patients and carers only. All groups were supportive of a panel model of engagement. [2]

Findings on Patients Workshops

The patients who attended the workshops were particularly well-informed about health research and most had either been a participant in a research study or taken part in Patient and Public Involvement in the research process. Some had undertaken training in research and so their perceptions of health research were broadly accurate. 

Many patients in the workshops had a clear view as to how treatments came through development, what was in the pipeline, and what had been launched recently elsewhere within their area of interest. They also generally had a clear understanding of how the pharmaceutical industry worked with the NHS to develop and test new products and the subsequent benefits, not just to themselves, but also for others. [2]

Influence, Outcomes, and Effects

Janet Wisely, Chief Executive of the HRA, and Simon Denegri, Chair of the dialogue project Oversight Group, gave evidence at the House of Commons Select Committee on Science and Technology inquiry on clinical trials in July 2013. They provided written and oral evidence drawing directly on the dialogue findings. 

The Select Committee’s report (September 2013) refers directly to the findings of the dialogue. It draws particular attention to the finding on public suspicions of the pharmaceutical industry and the sense that making a profit was incompatible with developing products of benefit to patients. The HRA response to the Select Committee’s report (October 2013) also refers to the dialogue and its findings, and explains that the dialogue has informed the HRA’s transparency strategy. The Government’s response to the Select Committee’s report (November 2013) specifically referred to the need to address the issue of public suspicions of the pharmaceutical industry, and the work to make patient information sheets more user friendly. 

The project was pivotal to the strategic direction of the HRA as it is a relatively new organisation seeking to establish a precedent of transparency and openness. 

The project also fed directly into the wider debate launched by the HRA on the transparency of research through publication of research findings. The HRA published its views in its paper ‘Transparent Research’ (May 2013), which refers directly to the dialogue project findings. 

The findings of the dialogue triggered the HRA to develop guidance for researchers on ‘Information for patients at the end of a study’ and informed the development of the ‘HRA Strategy for public involvement’ – both these initiatives were consulted on in late 2013/early 2014. Dialogue findings are also informing revisions to the standard template for patient information sheets that are used by most health researchers. 

The results are also being fed into the wider Research Governance Framework, which is being revised in 2014 by the HRA for research across the UK and, in the longer term, into revision of the Governance Arrangements for Research Ethics Committees. 

From stakeholder interviews, the project evaluators concluded that, as a result of the project, the HRA has emerged as a role model in patient and public engagement. The project has helped the HRA establish its credibility as a new organisation, resulted in those in the health research field buying into the organisation and built strong new partnerships. [1]

Analysis and Lessons Learned

What worked well

Structuring the dialogue around separate patient and public strands worked very well to identify the contrast between patient and public experiences and responses, and where there was consensus. The project generated a cogent set of results, which faithfully articulated the views and attitudes expressed by participants. The results provided the HRA with unique insight and valuable intelligence in respect of public and patient perspectives on, and recommendations for, the research approval and governance process. 

The project generated higher-than-average trust among public participants in the likely influence of the project in mobilising change compared with other dialogue projects. 55% of these participants believed that the dialogue project would have an influence on the HRA decision-making on the issue, 35% were uncertain and 11% thought the project would have no influence. The seniority and status of the specialists attending the second set of workshops (senior academics and health researchers) may have influenced participants’ belief in the importance and, thus, likely influence of the findings. Having researchers in the room worked very well in supporting the deliberative process because: “They make it real for the public in a way a third party can’t do.” (HRA) [1]

The motivation to do the dialogue was partly that the HRA was a new organisation with a mission to protect patients and the public, and had not actually asked them before. The HRA wanted to test what was comfortable for these constituencies and what was at risk in terms of proposals for the future. In the event, this was achieved, and the project was seen by stakeholders as providing: “an important barometer of ‘where the public are’ and the kind of communication role/strategy the HRA should adopt.” (HRA) [1]

The most valuable aspect was finding out what the public thought: “It was refreshing to hear from the general public that don’t have a vested interest or come from a particular health experience” and “Finding out what patients and the public think rather than just talking to researchers.” (HRA) 

What worked less well 

There were no experts at the first round of public events, leaving the provision of information and answering of questions to the facilitators. They presented information on the nature of clinical research and the structure of research governance frameworks, but were unable to answer detailed follow-up questions. In the confusion of roles between facilitation and provision of information, participants sometimes lost confidence and became frustrated. There was a lack of consistency in the facilitators used at different events and so, they were unable to build up expertise about the project and less able to deal with questions from the participants. 

Equally, too many experts overbalanced some other discussions. In three of the four second sets of workshops, there were three experts present – often two sitting at a single table of seven or eight public participants – resulting, on occasion, in public participants sitting back and listening to a debate between the experts, unmediated by the facilitator. In a few cases, the experts directed the discussion by asking the participants questions to focus the discussion.

Public participants raised a number of issues and how they could be addressed. These included timing – more time for events and avoiding finishing too late in the evening, better facilitation, clearer roles for experts in terms of how they support participants’ discussions and a better mix of participants.

See Also

Sciencewise

Health Research Authority Policy Framework Dialogue

Health Research Authority

References

[1] Sciencewise (2013) “Case Study: HRA Patient and Public Engagement”, Sciencewise

[2] Hunn, A (2013) “Patient and Public Engagement Project: Patient and Public Dialogue Workshops” Ipsos MORI, July 2013

[3] Sciencewise (2017) “HRA Patient and Public Views” Sciencewise [ONLINE] Available at:https://webarchive.nationalarchives.gov.uk/20170110132733/http://www.sciencewise-erc.org.uk/cms/hra-patient-and-public-views/

[4] Ipsos MORI (2013) “Public Dialogue Workshops”, Ipsos MORI, 12 June 2013

[5] Watermeyer, R and Bartlett, A (2013) “Evaluation of the Project: Health Research Authority (HRA) Public and Patient Engagement (PPE Project”, Cardiff University

External Links

https://sciencewise.org.uk/ 

Notes