On this page:
- Recruiting participants in health research
- Public dialogue workshops
- Participants reflect on taking part in the project (video)
- Key findings
- Evaluation report
The HRA recently completed a public dialogue exercise focusing on the identification and recruitment of people into health research. The workshops were delivered by OPM in four locations across England and Wales. The project was part funded and supported by Sciencewise and an Oversight group was set up to oversee and manage the project.
Workshops were held in London, Liverpool, Nottingham and Cardiff in late 2014. Two workshops were held in each location two weeks apart giving participants time to consider the issues. Each workshop was three hours long and attended by 30 members of the public together with a small number of patients and specialists. A variety of material was used to stimulate debate including two videos. In total 110 members of the public attended the workshops.
The overall objective was to engage members of the public and patients in a dialogue on the issues raised in recruiting suitable participants for health research including the use of patient data to identify participants and the concept of simplified consent in order to inform the HRA’s new research policy framework and operational guidance for health research.
The dialogue provided 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, especially:
- Who can access my notes in order to tell if I am eligible to take part in a study? [YouTube video]
- different models for approaching potential research study participants including consenting to being approached (also known as consent4consent) directly about research (e.g. clinical trials); this might include, for example, allowing the public/patients to register their interests in advance so that researchers can make a direct approach to them should they be eligible to take part in a study.
- The plan to develop simplified models of consent for simple and efficient clinical trials of already licensed drugs and other interventions in common use. [YouTube video]
- The majority of participants did not believe that research nurses currently had access to patient notes in hospitals or GP surgeries. However the majority of participants were open to the idea of research nurses having access to patient notes with the proviso that patients are informed and have the ability to opt-out. For research active 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 access to patient records.
- Whilst the majority of the participants accepted the use of consent to approach (or consent4consent) 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 identifiable as being attached to the hospital. There was a preference for this being a member of NHS staff., not by other patients or third parties.
- For approaches by post, 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 sufficient length of time was required before participants were assumed not to have opted out.
- The majority of participants supported the use of simplified consent. The opt-in model raised fewer concerns about the impact on patient- GP relationships than the deemed consent model. Most participants agreed with using a simplified patient information sheet which did not repeat the information contained on drug pack inserts. Most people agreed with the use of zero consent in an appropriate low risk example as might be allowed in future cluster design trials under forthcoming regulations.
The HRA commissioned 3KQ to carry out an independent evaluation of their 2014 public dialogue project – read the evaluation report.