The Health Research Authority (HRA) in conjunction with Sciencewise commissioned OPM Group to run a public dialogue on identifying and recruiting participants for health research, involving 8 public dialogue workshops. [1]
Problems and Purpose
The HRA aims to protect and promote the interests of patients and the public in health and social care research, and to streamline the regulation of research. It is responsible for the governance of health and social care research involving the public, and is committed to involving patients and the public in its work.
In 2014, the HRA started to review the principles underlying health and social care research in the UK, including the methods for identifying and recruiting participants for health research, through the revision of the Research Governance Framework (last amended in 2008). At the same time, forthcoming changes to the EU Clinical Trials Regulation allow for greater proportionality to distinguish between high-risk and low-risk research. The HRA saw the potential to make changes that could make it easier for patients to learn about relevant health research and increase the number of people taking part. [2]
The Dialogue objectives were
- To inform the development of the HRA’s new UK-wide policy to replace the existing Research Governance Framework and its associated operational guidance
- To provide opportunities for members of the public and patients to discuss and explore their aspirations and concerns about the governance of health research in relation to recruitment, data and consent.
The public dialogue focused on three main areas:
- How patients’ data might be used to invite people to join research studies and who the participants think should be allowed to access patients’ records to check eligibility
- Different models for approaching potential research study participants including consenting to being approached directly about research
- The plan to develop simplified models of consent for simple and efficient clinical trials of already-licensed drugs and other interventions in common use. [2]
Background History and Context
The NHS constitution outlines the right of all patients to be informed about research studies they are eligible to take part in. However healthcare professionals may not always know about relevant research opportunities or the associated inclusion and exclusion criteria, or may be too busy to discuss research with patients.
As the HRA becomes a non-departmental public body, there is an opportunity to review the principles underlying health research in the UK including the methods for identifying and recruiting participants for health research. This comes at a time of changes to the EU Clinical Trials Regulation allowing for greater proportionality to distinguish between high-risk and low-risk research. This context provides the potential to make changes that could make it easier for patients to learn about relevant health research and increase the number of participants involved in health research.
The HRA wished to explore who the public think should have access to their data in order to tell them that they might be eligible to take part in a study, different models of consent to approach and simplified consent processes in trials of existing licensed products. These issues have been considered by the public throughout this dialogue and their views are outlined in the chapters below. [1]
Organizing, Supporting, and Funding Entities
Total budget: £132, 250 (Sciencewise contribution: £66, 650)
The public dialogue was commissioned by the Health Research Authority (HRA) in conjunction with Sciencewise in September 2014 via competitive tender processes. OPM were selected as the dialogue delivery contractor for both the workshops and the digital element of the project; 3KQ were selected as the independent evaluators for the project.
The dialogue project, including the digital engagement, was jointly funded by the HRA (a total of £65.6k made up of £35.6k cash, plus an additional £30k in time and funding videos and the internet scan exercise) and Sciencewise (£66.6K), giving a total project cost of £132.2k plus VAT. In addition, Sciencewise provided advice and support (including the involvement of a Dialogue and Engagement Specialist - DES) to the value of £15k. These costs include the governance, delivery and evaluation of the project. [3]
Health Research Authority
The purpose of the Health Research Authority (HRA) is to protect and promote the interests of patients and the public in health research.
OPM
OPM is an independent public interest company that helps public services across all sectors to improve outcomes, performance and standards. OPM is responsible for delivery of the public dialogue.
3KQ operates in the field of facilitation and stakeholder engagement and is responsible for evaluation of this project. [4]
Sciencewise-ERC
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
An Oversight Group (OG), comprising 10 stakeholders from the health research and governance fields (including two patients), a Sciencewise representative and two people from the HRA, was brought together to support the HRA and OPM (the delivery contractor) to design the dialogue process and the materials used, review the report and its findings.
There were eight workshops in total in four locations - Cardiff, Liverpool, London and Nottingham, engaging a total of 108 members of the public, 24 experts and 9 patient experts. Each location had an initial workshop, followed by a further workshop. The participants remained the same in each location, but each workshop dealt with new information.
The recruitment of public participants was undertaken by OPM’s partner recruitment company using face to face street recruitment in line with a strict quota, in four cities - Cardiff, Liverpool, London and Nottingham. The quota was developed and agreed with input from the Oversight Group, based on recruiting 28 participants per location to ensure at least 25 participants attended each workshop.
The public participants were provided with incentives for attending each three-hour workshop (£40 for the first workshop and £60 for the second), which encouraged a very high turnout rate, with at least 26 public participants attending every workshop.
The evaluation report observes that the range of ethnicities, socio-economic groups, ages and gender is very good and demonstrates a thoroughness in getting the right mixture of people into the workshops. [3]
The on-line engagement attracted 569 unique users, 51 responses to a survey and two posts onto a forum page. [3]
Methods and Tools Used
The project used three different strands of evidence building: eight 3-hour public dialogue workshops - held on weekday evenings, an interactive website and an internet scan.
OPM designed and delivered four reconvened public workshops in England and Wales throughout November 2014. This form of engagement was chosen because it allowed the public to learn about current and potential research recruitment and consent processes, actively informed and engaged participants in discussion and debate, and provided the chance to ask questions and discuss with specialists and patients in the room. In addition OPM developed a website - with an interactive forum and a survey - and maintained a specific Twitter presence for the dialogue.
In workshop one, participants were given background information on: what health research is, the role of the HRA, and what a clinical trial is. Participants considered: What is in a medical record; who has access to medical records; different types of data (anonymised, pseudonymised and identifiable); how potential participants are identified as eligible to be invited to take part in a health study; what a research nurse is and their role; and access to data in a GP surgery and in a hospital setting in order to identify potential participants in health research.
In between workshops, the public participants were asked to consider a sample patient information sheet and feedback their thoughts on it at the beginning of workshop two.
In workshop two, participants considered the homework exercise; two consent to approach models; two models of simplified consent; what a patient information sheet should contain for simplified consent; pack leaflets that come with medicines; and a zero consent scenario.
There were four facilitators (a lead facilitator - who also facilitated at a table - plus three other table facilitators) at each workshop, with the same four present at round 1 and 2 for each location. Each round of workshops had the same lead facilitator.
What Went On: Process, Interaction, and Participation
Workshop 1
Participants were introduced to the objectives for the dialogue by the HRA officer, and the objectives for the workshop by the OPM lead facilitator.
Participants were asked some baseline questions in table discussions by the facilitator, in order to establish their knowledge of ‘what is in a medical record’ and then had a discussion about how they knew this. The HRA officer then gave a presentation outlining what is in a medical record, followed by a discussion of who participants thought had access to their medical records.
A presentation by the HRA and short mime by OPM, then introduced participants to different types of data, health research and clinical trials. An additional presentation from the HRA followed, with a stimulus video introducing the discussion topic on access to patient records. Throughout these information giving sessions, participants had the opportunity to ask any questions about what they had heard so far, drawing upon the expertise in the room.
The table discussion on access to patient records in a hospital setting was designed to understand participants’ opinions towards the topic and what was deemed as acceptable. This was followed by a second discussion topic on access to patient records in a general practice setting, introduced by the HRA through a presentation.
At the end of the first workshop participants were given a homework exercise to take away with them. They were asked to read an example of a long patient information sheet in preparation for some of the topics covered in workshop 2. As OPM state in their report of the dialogue, “This gave participants the opportunity to fully engage in the information sheet, something that would have been difficult within a workshop setting due to the length of the document.”
Evaluation forms were handed out for participants to complete at tables while table facilitators stepped outside.
Workshop 2
Participants were facilitated at tables and discussed whether they had talked about the first workshop with family and/or friends and if they had visited the website or read the homework exercise. This was designed as a warm-up session, allowing participants to re-engage with the issues discussed at the first workshop held two weeks beforehand.
A presentation by the HRA introduced participants to consent to approach principles followed by an explanation of a first model where patients are approached in a hospital waiting room and asked if they would be willing to join a register of people who might be interested in being approached about specific trials (known as the consent for consent approach). A table discussion followed, asking how acceptable participants found the first model and whether they had any concerns. Next a second model of consent to approach was explained to participants by the HRA, in which patients are sent a leaflet in the post, and participants subsequently discussed this at tables.
After the break, a stimulus video and presentation given by the HRA introduced simplified consent and participants had the opportunity to ask questions. This was followed by a discussion at tables of participants’ views on the acceptability of the proposals and what reassurances they might need.
At tables, having been provided with examples of all the items that might be covered on a patient information sheet for research together with examples of the pack insert leaflet that patients would receive with their medicine, participants were taken through a checklist, by the table facilitator, covering what may and may not be included on the proposed simplified patient information sheet. This was designed to provide an understanding of participants’ opinions on what needs to be included on a simplified information sheet.
A final table discussion looked at zero consent option following on from a brief presentation by the HRA, introducing the proposal.
As in the first workshop, participants were again provided with an evaluation form and asked to fill this out at tables while facilitators left the room. To finish, the HRA explained what would happen next and thanked participants for their insights and time.
Workhop Findings
The majority of participants did not believe that research nurses had access to patients’ notes in hospitals or GP surgeries.
Following discussions, the majority of participants were open to the idea of research nurses having access to patients’ notes, with the proviso that patients are informed and have the ability to opt-out. For research-active general practices, posters in the waiting room were not seen as being sufficient to ensure all members of the surgery were actively informed about changes to who has access to patients’ records.
While the majority of the participants accepted the use of ‘consent to approach’ lists in principle, there were concerns about both of the models reviewed. For approaches in the waiting room, participants wanted sensitive, common-sense approaches by someone who could be identified as being attached to the hospital. There was a preference for this being a member of NHS staff. For approaches by leaflet, the participants were concerned that many people would not read the leaflet or realise they had consented by default to be on the ‘consent to approach’ list. A three-week response date was not deemed to be sufficient to allow people the time to receive the letter and respond, with six to eight weeks being recommended as suitable.
The majority of participants supported the use of simplified consent. There were fewer concerns raised about the impact on patient-GP relationships for the opt-in model than there were for the deemed-consent model. Most participants agreed with using a simplified patient information sheet that did not repeat the information contained on medicine pack inserts. Most people agreed with the use of zero consent in the mattress example.
Common themes arising from the discussions at the workshops included raising public awareness of the role of NHS patients in health research; ensuring patients were made aware of changes to who can access their data by more pro- active methods than using posters; eliminating the potential for ‘scope creep’ when allowing more people access to records or introducing zero consent; and ensuring personal data would not be passed on for commercial use (including by insurance companies). [2]
Influence, Outcomes, and Effects
In July 2015, the HRA issued a response report summarising all the feedback it had considered on the draft guidance on ‘Seeking Informed Consent for Simple and Efficient Trials in the NHS’, including the feedback from the public dialogue workshops. The draft guidance was open for comment in 2014 at the same time as the dialogue workshops were held. The 2015 response report included the HRA’s responses to the feedback it received and the subsequent plans it developed. The results of the public dialogue and resulting HRA plans are specifically covered in the report in relation to:
- The use of information sheets
- Simplified consent processes
- Deemed consent/opt-out approach on randomised cluster trials at GP surgeries
- Whether verbal consent should be sought and documented in medical notes to access the patient’s medical data for the purpose of research.
Future guidance was planned on the use of short information sheets, which were also covered in the dialogue project.
In October 2015, the HRA commenced development of guidance on two specific issues based on the input of the public and patient participants at the public dialogue workshops:
The first set of guidance focuses on proportionate consent in research including that in pragmatic clinical trials. The HRA plans to put out its revised guidance on proportionate consent in research to public consultation, and to finalise and launch the guidance in 2016.
Prior to the formal consultation process, the HRA held a major event in December 2015 in Oxford to raise the problem of this issue among key stakeholders. The HRA presented the dialogue results at this event, which was also attended by speakers who all contributed to the dialogue.
The second set of guidance focuses on how people are identified and recruited to take part in health research, which has implications in terms of access to patient records and shared data. The HRA has been developing draft guidance, but this was delayed pending the completion of a wider Government review of consent on access to data led by Dame Fiona Caldicott. Therefore, the guidance will be completed following the publication of the report of that wider review.
Analysis and Lessons Learned
What Worked Well
The dialogue was timely, met all its objectives and was expected to inform the relevant strands of HRA policy and guidance covering access to data, approaches for consent and simplified consent.
The OG had a strong governance and review role, enabling the HRA to work with a range of stakeholders to help shape the dialogue and contribute to the content of the materials. This approach made good use of the range of organisations and individuals on the OG.
Recruiting participants worked well. The range of participants involved was very diverse in terms of socio-economics, age, gender and ethnicity.
Workshop design and delivery. The range of clear information provided was critical to helping participants get a grasp of the subjects they were discussing. OPM worked with the HRA, with commentary from the OG, to design a process that owed from one topic to the next. Rather than a ‘first workshop educate, second workshop deliberate’ model, participants were given the opportunity at each workshop to understand issues and reflect on them. The facilitators and presenters were clear in their explanation of materials, tasks and issues for discussion; kept the conversations going; and ensured that people were all given the opportunity to speak. Specialist input was also valued by the public. A video were also commissioned as stimulus material for the workshops.
What Worked Less Well
Time was very tight for the research and production of materials, and the design of the workshops. This put a lot of pressure on the team. Given more time and budget, an engagement with the wider field of stakeholders might have produced a larger range of perspectives on the issues being discussed. Ideally, the OG would have been established earlier and there would have been more opportunities for the members to meet. They would also have had more time to consider materials, the shape of the dialogue, and/or consider engaging a wider stakeholder group to test the representativeness and potential bias of materials and processes used in the dialogue.
The digital strand of the engagement was intended to enable wider participation and enable a comparison with the public dialogue workshop findings. However, due to budgetary limits, not all activities planned to promote this aspect were implemented and lower than anticipated response rates were achieved. In addition, the Internet scan was not as thorough as it might have been. Consequently, it did not yield any useful information. [2]
See Also
References
[1] OPM (2015) “Final Report: Identifying and recruiting participants for health research”, OPM Group, 24 June 2015
[2] Sciencewise (2016) “Case Study: Identifying and recruiting participants for health research”
[3] Reynolds, C (2016) “Public Dialogue on Recruiting Participants for Health Research, HRA: Final Evaluation Report”, 3KQ, January 2016
[4] Sciencewise (2017) “HRA Health Research Policy” Sciencewise [ONLINE] Available at: https://webarchive.nationalarchives.gov.uk/20170110132727/http://www.sciencewise-erc.org.uk/cms/hra-health-research-policy-public-dialogue-health-research-recruitment-data-use-and-consent/