Vaccine Research Registry Communications System requirements specification

System Directions 2022 permit NHS Digital to communicate non-COVID-19 research opportunities to NHS COVID-19 Vaccine Volunteer Registry (VRR) participants and continue to encourage participants to sign up to the Be Part of Research Volunteer Registry (BPR VR). This activity is intended to support the transition from the VRR to the BPR VR and to enable the VRR to continue to be used to support both COVID and non-COVID research.

NHS Digital has been working with the National Institute of Health Research (NIHR) to host the VRR on nhs.uk, where members of the public can register their details and give their permission to be contacted by researchers, about participating in COVID-19 vaccine clinical trials. NHS Digital was directed by DHSC to deliver the VRR for COVID-19 purposes, under the COVID-19 Public Health Directions 2020. The VRR was setup as a finite tool to support the recruitment of members of the public into urgent COVID-19 vaccine trials. During the sign-up process members of the public were asked if they wanted to hear about developments to the service, including the chance to take part in other types of research.

The following questions were asked:

1. Do you give permission for researchers to contact you about taking part in approved UK Coronavirus vaccine studies?
2. Do you give NHS Digital permission to email you about how Coronavirus studies are going?
3. Do you give NHS Digital permission to email you about the developments to this service including the chance to take part in other types of health research?

As the demand for COVID-19 vaccine trials reduced, NHS Digital and NIHR started to discuss closure of the VRR and signposting of VRR participants to the Be Part of Research Volunteer Registry. The BPR VR includes a range of improvements and enhancements compared to the VRR which was established at pace during the pandemic. BPR volunteers will be able to select specific areas of research, can update their own details and will have a better user experience which in turn is expected to encourage them to continue to be engaged with clinical trials.

As part of the initial communications notifying members of the VRR that the registry was closing a number of stakeholders expressed concern that some of the VRR volunteers who may not choose to transfer to the new service may be lost to research.

It is further recognised that COVID-19 is here for good, and the future development of the disease remains unpredictable. Therefore, the need for COVID-19 vaccine research is likely to continue over time and potentially may need to be linked to non-COVID conditions like influenza.

In addition, DHSC has determined that by maintaining the registry beyond COVID-19 purposes, we are enabling those volunteers who agreed to be approached about wider research opportunities to continue to be engaged. Both in wider research but also to enable further work with NIHR to encourage these volunteers to sign up to the new BPR VR.

Therefore, DHSC has requested that the VRR is not closed, and this Direction will enable NHS Digital to establish the Vaccine Research Registry Communications System (the System) for NHS Digital to send communications by email about wider opportunities for health research participation to those individuals registered on the VRR who have agreed to be contacted by NHS Digital about broader health research opportunities (the Service). At an agreed point the VRR will be closed to new sign-ups, and any new volunteers signposted to the BPR VR.

Members of the VRR, who have signed up and provided the relevant details and permissions.

NHS Digital will develop a system for:

• NHS Digital to provide members of the VRR who answered “yes” to the permission question “Do you give NHS Digital permission to email you about the developments to this service including the chance to take part in other types of health research?” with regular newsletters informing them of wider research opportunities i.e., beyond COVID-19 purposes
• NHS Digital to provide members of the VRR who answered “yes” to the permission question “Do you give NHS Digital permission to email you about the developments to this service including the chance to take part in other types of health research?” with information about signing on to the BPR VR managed by NIHR
• de-duplicating members of the VRR who have already signed up to the BPR VR service so that they do not receive repeat messages

This Direction is to develop the System to deliver the Service. To deliver the Service, NHS Digital will use data it already holds as data controller in the VRR. NHS Digital’s incidental powers under paragraph 10 of Schedule 18 of the Health and Social Care Act 2012 shall provide a basis for the processing of personal data for the limited purpose of sending the communications about health research opportunities and to invite volunteers to join the BPR VR.

The existing VRR communication service will be developed to enable NHS Digital to query the VRR data asset to create a recipient list based on any relevant criteria contained within the asset. The cohort list may be checked against a list of BPR VR members, provided by NIHR to de-duplicate and prevent members of both registries receiving the same communication twice.

NIHR will provide the list of BPR VR members to NHS Digital on a controller-to-controller basis for NHS Digital to use for de-duplication purposes. NHS Digital and NIHR will enter into a separate data sharing agreement to cover this sharing of data. The list of BPR VR members will be sent to NHS Digital using a Secure Electronic File Transfer (SEFT) mechanism.

The de-duplication process might also apply to COVID-19 vaccine research invitations sent through BPR VRR, i.e. to ensure people signed up for COVID-19 vaccine research on BPR VR do not receive duplicate invitations from NHS Digital. The de-duplicated recipient list will be used by NHS Digital to send email communications via the NHS Digital Contact Centre including those advising of opportunities to join wider research studies and/or to signpost recipients to join the BPR VRR.

The ability to withdraw permission to receive these communications will be included in each communication and data will also be processed to do this.

1. Advise contact centre of proposed communications issue date

2. Engage with DME and produce recipient list.

3. De-dupe and produce recipient list. 

4. Receive sign off for content and inform contact centre. 

5. Contact centre provide test email for NHR.

6. Make any final amends.

7. Contact centre issue communications.

7. Customer receives communications and decides actions to take.  

The following data items will be used to process the sign posting service, within the email communication.
1. Name
2. Address
3. Postcode
4. Email address
5. BPR VR email list for the purposes of de-duplication. See above for further information.
6. Demographic and medical condition information provided by individuals when joining the VRR, for the purposes of developing email lists for specific research categories.

The Directions are given by the DHSC in exercise of the powers conferred by regulation 32 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013.

NHS Digital’s incidental powers under paragraph 10 of Schedule 18 of the Health and Social Care Act 2012 shall provide a basis for the processing of personal data for the limited purpose of sending the communications about health research opportunities and to invite volunteers to join the BPR VR. NHS Digital is the data controller of the data being used to deliver the Service.

In relation to the BPR VR list of email addresses that NIHR will share with NHS Digital for the purposes of de-duplication, NHS Digital will process this data as a controller under paragraph 10 of Schedule 18 of the Health and Social Care Act 2012. NHS Digital and NIHR will enter into a separate data sharing agreement to cover the sharing of this data.

Internal processing

Additional incidental processing related to this system delivery direction includes the provision of statistics and aggregate data reporting on various aspect of the delivery of the system e.g., reports generated from CRM on delivery and opening of emails, continued provision of VRR dashboards and reports on numbers removed through de-duplication processes.

Following initial engagement around the potential closure of the VRR consideration was given to whether to decommission the service or to extend it use to purposes beyond COVID-19. DHSC identified the need for its continuation following consultation with Ministers, NIHR and the Devolved Nations.

Changes to this Specification will be confirmed in writing to NHS Digital by DHSC. Any changes will include consultation with the NHIR.