Once patients have been found based on their potential suitability to take part in a research project, they need to be contacted about the option to take part in that research. This contact relies on information such as postal address, phone number or email address. It is important to recognise that this contact information becomes identifiable confidential patient information when used in the context of contacting them about a research study, because the contact information is linked to study criteria such as diagnosis.
When patients are contacted about an option to take part in research, it is important that they can access further information about the project and what taking part would involve, and obtain answers to any questions before expressing interest. This could be done by giving a link to a study website, for example. It would be possible for digital intermediaries, or national research information services, to create generic website templates that could be populated by ethically approved information on studies for which recruitment is being undertaken. This would have the benefit of giving wider visibility to research options, or could be given through expanding the information available through services such as ‘Be Part of Research’ or the national NHS apps. In addition, potential participants should be given the details of someone they can contact, with whom they can discuss the study, instead of simply being asked to confirm interest. National research delivery support services could give this support. Currently, research teams often provide this service.
Messages contacting people about research should proactively address concerns, explain that participation is entirely voluntary, and outline what taking part would involve. They should also provide clear and accessible ways for people to ask questions or seek further information before deciding, such as a dedicated phone line, email address, or information session. This helps to reduce anxiety, support informed decision-making, and make sure that no one is excluded simply because they have unanswered questions.
Recommendation 14
UKCRD Programme partners should consider how research network staff, and NHS research delivery staff such as clinical research practitioners, could support central research teams by providing points of contact for patients who want to find out more about participating in a study that they have been informed about, particularly for industry studies where there is no central research team.
The HRA’s work on people-centred research sets out the principles and hallmarks of people-centred research. It is important for researchers to give specific thought to potential participants’ first interaction with a research study. This includes thinking about the mechanism for contacting potential participants, for example whether a phone call, letter, text message or email would be most relevant in the project context. Researchers should consider how different people might need to access the information. Where information from NHS records is used to find potential participants, researchers should test with relevant people whether the first contact should be linked to the name of one NHS organisation, or with the NHS more generally. Researchers should also test the message used to contact potential participants with relevant people, to make sure it minimises surprises and gives people the information that they want. In discussions with potential study participants, researchers should offer up information about the eligibility criteria and give an opportunity for people to check whether they might be eligible, rather than solely focusing on eliciting lots of detailed medical history from patients before deciding they are not eligible. It is important that patients do not feel that their privacy has been invaded by giving lots of medical history before being told they are not eligible.
6.1. Contacting members of the public or patients through social media or public channels
Sometimes key eligibility criteria for a study may not be in health or care records, for example where patients are unlikely to report symptoms to doctors. Some studies are aimed at the general public to screen for symptoms or carry out tests. In these situations where eligibility of participants is not based on information that is likely to be easily accessed through care records, it may be more appropriate to invite people with relevant symptoms or meeting certain criteria using social media or public channels such as websites or advertisements. It is important that a variety of channels are used in order not to disadvantage particular communities. Interested people should also be able to easily access further information through a variety of routes and contact methods. Patient and public involvement should be used to test the best ways to do this.
These methods are particularly suited to very large-scale research, and the UK has become expert in this model through ‘UK Biobank’ and ‘Our Future Health’.