St George's, University of London

Academic Institute

No

DARS-NIC-526384-M3T5R-v0.2

This Data Sharing Agreement authorises the use of information voluntarily provided to NHS Digital by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials. The data will be processed on behalf of the data controller, St George’s University of London, by NHS Digital as a data processor for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by St George’s University of London. The following provides background to the Permission to Contact (PtC) Service: NHS Digital has agreed to work in partnership with the National Institute of Health Research (NIHR) to build and host a first of type online Permission to Contact (PtC) Service on nhs.uk where members of the public can register their details and give their permission to be contacted by researchers working on NIHR approved UK coronavirus vaccine trials about participating in those trials. This PtC Service, which is called “Sign Up to be Contacted about Coronavirus Vaccine Studies” on the nhs.uk website was launched as a national service on 20th July 2020. This Service enables participants to: • Provide permission for NHS Digital to share an individual’s details provided through the Service with the researchers undertaking COVID-19 UK vaccine trials for the purposes of researchers contacting that individual about taking part in those trials. • Provide their permission to be contacted by NHS Digital about progress and outcomes from CV19 vaccine studies and in relation to the development of the PtC Service, including to inform them of opportunities to participate in other types of health research. The data collected from individuals who sign up includes sufficient information to achieve the following purposes: • Matching potentially eligible participants to eligibility criteria provided by the vaccine trials for their specific studies. This data will comprise of age, sex, geographic locations, type of employment, and a number health question e.g. about whether they have long-term health conditions. • Providing relevant details of potentially eligible participants which have been obtained through the Service to researchers. This will allow the researchers to contact the participants with a view to discussing their taking part in a trial and if so, to obtain their further permission to take part in the trial. • NHS Digital will provide access to the information obtained from individuals through the Service via the existing Data Access Request Service (DARS) process available to researchers working on UK COVID-19 vaccine trials sponsored by the National Institute of Health Research. The Service will only provide researchers with the data collected directly from individuals themselves through the Service. The contact details will be used to invite potentially eligible individuals to undertake an eligibility assessment and, if eligible, to give informed consent to participate in this trial. NHS Digital, as data processor acting on behalf of St George’s University of London, will be sending the email to eligible participants. This request relates specifically to a vaccine trial. This is A Phase II, randomised, single-blind, platform trial to assess safety, reactogenicity and immunogenicity of COVID-19 vaccines in pregnant women in the United Kingdom Pregnant women should be provided with a balanced and clear assessment of their risk of COVID-19 in pregnancy, taking into account their individual circumstances, local practices and available evidence. They should also be counselled with a balanced summary of the potential direct and indirect benefits of COVID-19 vaccines, and the current lack of safety data should be acknowledged. COVID-19 vaccination should not be withheld from women who have received adequate counselling and understand the uncertainties, potential harms, and potential benefits of these vaccines. However, there are important unanswered questions regarding the reactogenicity, safety, immunogenicity, and persistence of immunity in the mother and infant, as well as the efficiency of placental transfer of antibodies and the optimal schedule for pregnant women, it is important that such data are gathered in a systematic and controlled manner. In doing so, evidence based guidelines can be developed which will then benefit all pregnant women. There is a widespread call to gather such evidence for use of COVID-19 vaccines in pregnant women; however, it is possible that the window of opportunity for doing this is closing as more women receive vaccines routinely. A number of advantages therefore exist in recruiting pregnant women into a pragmatic clinical trial in which they all receive a COVID-19 vaccine (rather than a placebo). Using a platform design Preg-CoV will allow inclusion of new COVID-19 vaccines as they become licensed, as well as rapidly address new questions of relevance to the vaccine programme as they arise (different intervals, one dose schedules etc). The aim is to recruit 900 participants for the trial. The initial mailout will aim for around four / five times the number of potential participants to be recruited and therefore the estimate is for around 4,500 individuals to be contacted. The applicant has met with representatives of organisations such as The Miscarriage Association and SANDS to ensure that the content for the approved communication to members of the NHS Digital COVID-19 Vaccine Research Registry has been suitable worded to take account of the potential sensitivities around recruiting participants for a trial of this nature. Although this application relates to the use of commercial vaccines, there is no commercial element specifically attached to this application itself, the purpose of which is about influencing national vaccine rollout strategy. Although results may influence the manner in which the commercial firms role out vaccines in future, this application relates solely to an academic exercise. Although AstraZeneca, Pfeizer and Moderna have allowed the use of their vaccines for this trial, they have no responsibilities as to how the trial is conducted and therefore St. George’s University of London remain the sole Data Controller for this application. This also applies to any other commercial vaccine manufacturers that make their vaccines available for use in this trial in future.

The primary benefit of using the data will be to recruit participants for the clinical study/trial in a manner which: • Enables individuals to volunteer in advance to participate in COVID-19 vaccine trials as an alternative to other potentially more intrusive mechanisms, e.g. sharing data with researchers about individuals under section 251 consents or COPI notices, which although lawful is initially less transparent. • Allows researchers to identify a suitable cohort and recruit them quickly into the vaccine trials – thus reducing the overall time to recruit into the trials and to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives. • Reduces burden on research staff in identifying and contacting potential clinical trial participants. • Supports the Vaccines Taskforce objectives to drive forward, expedite and coordinate efforts to research and then produce a coronavirus vaccine and make sure one is made available to the public as quickly as possible.

08/09/2021

De-Personalised

Health and Social Care Act 2012 – s261(2)(c)

Consent

One-Off

TRE