Dynamic Consent WORKSHOP REPORT Exploring new ways for patients to consent for research & use of health data 27th November 2014 Caroline Sanders – Senior Lecturer, Medical Sociology Tjeerd Van Staa – Professor of Health eResearch Karen Spencer – Research Associate Lamiece Hassan – Patient and Public Involvement & Governance Research Officer Hawys Williams – Arthritis Research UK Centre for Epidemiology Patient & public collaborators: Jo Rose, Peter Rose, AnnMarie Lewis, Anne Brown, Steve Anslow, David Giles Will Dixon (Principal Investigator) – Director of the Arthritis Research UK Centre for Epidemiology Funded by a Medical Research Council award (MR/K006665/1) to the Health eResearch Centre (HeRC) at the University of Manchester 1 Summary Background Reusing anonymised health data from patient records provides opportunities for advancing health research. However, the media and some members of the public have raised concerns. Our current area of research explores patient views on the use of anonymous electronic patient records for research purposes. In particular, we have been exploring a new model known as ‘dynamic consent’, which would allow individuals to give consent to use their anonymised data for specific purposes (e.g. specific research projects). People could also access feedback about research results, view who had access to their data and change consent preferences over time. To explore the practicalities, we developed a prototype of an electronic ‘dynamic consent’ system for tablet devices that could be used in clinical settings. The Workshop We held a workshop at The University of Manchester on 27th November 2014, and 30 members of the public attended. The aim was to explore public views on the electronic dynamic consent system. We explained key concepts and discussed two scenarios where dynamic consent could be used. Attendees also had used and discussed a prototype of the electronic system using a tablet device. Key Messages Positive feedback included: • Attendees were positive about sharing anonymised health data for research purposes • Many liked the idea of having greater control of their data and could see themselves using the electronic system • Most valuable feature was personal feedback on how data had been used for research – this was seen as novel and would make people feel valued Considerations and concerns raised included: • Uncertainty about the degree to which people would actually specify consent preferences • The need for technical support, in person, for new users and those with particular needs • In clinical settings, a private space (or booths) should be available for people to use the system • Information should be tiered and provided in appropriate formats (e.g. balloons and flow diagrams) to allow different users to access more/less information as needed • Information/ reassurance needed about data security and confidentiality within the system Future Plans The findings from the workshop are currently feeding into a proposal for further research into developing and implementing a dynamic consent system for use in clinical settings. The plans include a co-design approach with patients and carers to make the system more user-friendly and provide appropriate information in suitable formats. A pilot study will also be designed, using private booths supplemented by support from staff and/or volunteers. (A poster format of this summary is available – see Appendix 1) 2 Introduction Whilst opportunities exist for extending the use of personal health data for research, media debates have flagged concerns about trust in the re-use of data (e.g. care.data). Negative views have mainly been articulated by key high profile individuals/ groups, and are not necessarily representative of the wider population. We are currently conducting research to explore patient views on the use of anonymous electronic patient records for research purposes, and exploring the potential use of a new and innovative model for enabling greater personal control regarding the use of such data, known as ‘dynamic consent’. Dynamic consent enables patients to give consent to use their data for specific purposes (e.g. specific research projects). Importantly, patients are not restricted to giving a universal consent for use of data, versus a universal ‘opt out’. They can also change consent status over time. We have explored this concept and the practicalities using an electronic prototype via tablet devices that could be used in clinical settings. The research has generated further questions and ideas which we aimed to explore further in a workshop with patients and members of the public, in order to inform development of a further research proposal to implement and evaluate dynamic consent. The workshop was held on the 27th November 2014. The aim was to explore public views on the circumstances and mechanisms for consent to participation in research, and the generation and use of personal health data via an electronic system for dynamic consent. This report summarises the main points of view expressed by workshop participants in relation to key questions and topics. 3 Attendees and summary of activities Twenty-five members of the public attended having been recruited via existing personal networks, patient and public involvement groups and social media. Key concepts relating to dynamic consent were explained using a brief slide presentation and a short video. The video can be viewed using the following link: https://www.youtube.com/watch?v=duFb4IfuOpQ The ‘Dynamic Consent’ electronic system was explained: Using a tablet device (like an iPad), the new system would allow patients to keep track of their data, including a record of who had used their health data for research and reasons why it had been used. Small group discussions were then facilitated by members of the project team and two scenarios incorporating dynamic consent for using electronic health records for research purposes were introduced: one in a hospital outpatient setting and the other in primary care, considering permissions for sharing electronic patient records and consent for pragmatic trials, respectively. In addition, attendees were given a working prototype of the electronic interface to test themselves on a tablet. Facilitators probed views on proposed procedures for obtaining dynamic consent using the electronic interface, including the content and format of information, consent options provided and wider contextual factors (e.g. internet access). 4 Case Studies Case study 1: Sharing electronic patient records for research purposes Mrs Barker is attending her local hospital outpatients department to see her rheumatologist about her arthritis. She sees the nurse to have her blood pressure measured before she sits down in the waiting area to see the consultant. She is then approached by one of the research nurses and directed to a new Research Booth. She goes over to the Research Booth where there is a touch screen. On pressing the screen, she sees an introductory video to explain how her electronic patient records might be used for research. After identifying herself securely, she then is offered the opportunity to opt out. It is explained that, were she to be willing for her data to be shared, then this Research Booth will show her who has accessed her anonymised data, and what the results of that research have been. Discussion questions for case study 1 • What information do you need in the introduction? • How should this be formatted? (ie video, text, audio) • Are you happy with identifying yourself on a touchscreen (like in a GP check-in)? • Would you want to select who to share your data with? Or happy to do generic non-opt out? • What information would you like fed back about the data recipients? • What information would you like fed back about the research results? • Can the booth be stand-alone? Or do you need support? If so, from whom? 5 Discussion summary for case study 1 Key points fed back in whole group discussion: • Information should be layered, perhaps using a flowchart – e.g. ‘press here if you…’ This will enable people to access different levels of information and instructions according to preference and need. Some people would want a lot of detail and others will want much more basic • Need to consider who are the recipients/ users and what parts of the system do they want to use • The system is user friendly, but not everyone will have the skills to use it • It is important to consider privacy when deciding where to place devices – If in waiting rooms, private booths would be helpful • Private booths would also be helpful because people feel stressed and under pressure if people are watching over their shoulder • It is important to consider practical things like height and support for people with different needs. For example, people may be wheelchair users, or have a visual or hearing impairment. Also, need to consider whether people have mental capacity to make decisions about consent. • Someone should be available to offer hands on support – this could be a research nurse, a volunteer, perhaps a student, someone who could be an IT champion. • People were very positive about being able to receive feedback about research conducted using their health data. This was viewed to make people feel valued • Having access to short written summaries and options to watch short videos thought to be useful. 6 Elaboration of main points and additional discussion points from small groups • Participants agreed that the system was user friendly. However, they commented that there was no explanation behind some of the headings and some people may need further explanations to understand what they are agreeing to. Information buttons would help. • It might be useful to have a bank of ‘frequently asked questions’ and options to obtain balloon style information to provide additional explanations. A flow chart and visual description of the process would be helpful. • The application should work with people’s mobile phones and support tracking for: circumstances in which consent was granted; level of access granted; beneficiaries of access.