Information about SHARE for researchers
Please complete the application form and email it to Louise Dow at firstname.lastname@example.org along with ethics approval, protocol and PIL.
If you are a researcher interested in discovering more about SHARE, becoming registered and gaining access to health records for your research projects, you will find some useful information below.
SHARE introduces costs for studies
If submitting a research application then please be aware then there may be a cost recovery for utilising SHARE resources. This will be discussed on receipt of research application.
SHARE is efficient and effective for researchers
SHARE greatly enhances the efficiency and effectiveness of recruitment into health research projects in Scotland. Recruitment is a major concern for all health researchers. Most research projects experience some difficulty with recruitment, leading to delay, increased expense and, in some cases, project failure.
By gaining consent to contact people that have already expressed an interest in clinical research recruitment, retention rates can be enhanced. The direct volunteer contact allowed by SHARE registration means that the assessment feasibility and contact process is both rapid and efficient. Initial studies have suggested that recruitment rates may be as high as 60% from the SHARE register. For details of pilot studies using SHARE click here
What is SHARE?
The Scottish Health Research Register (SHARE) is working to create a resource of up to 1,000,000 adults (25% of the Scottish adult population) who consent to the access and use of their electronic health records in order to identify them as potentially eligible for research projects. Established and approved record linkage methods developed within the Scottish Health Informatics Programme (SHIP) will allow linkage to a wide variety of health databases, governed by current NHS and academic regulations.
SHARE has an extensive recruitment programme in place that communicates with the Scottish public, encouraging them to join and also participate in clinical trials.
What is GoSHARE?
GoSHARE (Genetics of the Scottish Health Research Register) is a Wellcome Trust funded pilot where, in addition to the SHARE consent, the participants are asked for "pre-consent" for the future storage and research on spare blood samples that remain after routine clinical testing. The automated interception of samples from such consented individuals has been established in the NHS Blood Sciences Laboratories of NHS Tayside, and this is currently being rolled out to NHS Fife, NHS Grampian, and NHS Lothian. For further information on the spare blood consent please click here. For details on the progress of the GoSHARE bioresource please click here. For information regarding using this resource please email: email@example.com
Using Scottish resources
In Scotland, because of “Cradle to Grave” data linkage, it is possible to interrogate clinical and administrative systems to identify people who match study inclusion and exclusion criteria.
SHARE will take advantage of the existing deterministic record-linkage capability within Scotland based on the near universal CHI number, following from the infrastructure investment in SHIP since 2008.
Linkable datasets throughout the life course in Scotland
SHARE is one of the many secure databases that can be accessed within a NHS Safe Haven environment, utilising standard operating procedures (SOPs) already developed within SHIP. That programme’s governance mechanisms, along with governance committees, will be used for the regulation and delivery of SHARE. These will be established to ensure adherence to the SOPs and to consider requests that may arise out with those SOPs. Regularly updated characteristics of patients who have volunteered to join SHARE will be presented in aggregate form on the SHARE website to enable research teams to see the range of potential recruits to studies they may be considering.
The SHARE resource comprises:
- a secure public-facing registration process-this actively builds the database
- a secure register database within the NHS network-this ensures the security of SHARE data
- Community Health Index (CHI) database on NHS network (local copy) – this allows SHARE NHS researchers to link to other patient and disease-specific data
- administrative support to elicit and manage contact with potential volunteers – allowing us to contact potential volunteers for specific studies
- managed services for hosting databases, services and applications
The basic process
When a research team has a project approved by SHARE, SHARE will carry out a feasibility forecast to determine if an appropriate number and distribution of recruits are available. If this looks satisfactory SHARE volunteers will be contacted directly by the SHARE office to advise of a research opportunity. This contact uses brief materials developed and approved by the research team. Researchers can use the SHARE approach in combination with more traditional direct from clinician contact. There will be some cost associated with the use of SHARE which are purely on a cost recovery basis. This will be discussed at the point of application.
SHARE is based on the patient data of people residing in Scotland but our resources are available to researchers based in the rest of the UK or as part of an international project.
A request to use the Register
Any research team wishing to use SHARE as their mechanism of recruitment to a clinical trial (or as one of their mechanisms of recruitment) is required to download and complete the application formand email it to Shobna Vasishta at firstname.lastname@example.org
The request may be for feasibility, resulting in a simple statement of numbers available (e.g. volunteers with a particular condition, or with a particular history, or on a particular prescription, or in a particular age group, or residing within a particular location or region). In the latter case no interrogation of health records is required since the volunteers’ postcode form part of the SHARE database; and there will be many instances where the nature of the research question posed also requires no additional knowledge about a volunteer’s health status.
In cases where a researcher requires the eventual possibility to contact a potential participant, then it is anticipated that a minimum requirement for access will be that the intended study has obtained ethical approval for SHARE to be used as a conduit of approach. Then the process is as follows:
• first approach from SHARE, including a brief description of the proposed activity
• a second approach after two weeks
Only on receipt of an affirmative response will the potential recruit’s contact details be provided to the researcher, whose procedures for approach, screening, information provision, consent, recruitment and management thereafter will all accord to principles developed within the research team and are approved; these are not the responsibility of the SHARE team.
However, as part of the methodology for measuring the effectiveness of SHARE as successful mechanism of recruitment, part of the agreement reached between SHARE and the research team will be to receive statistics on approach, recruitment and retention, following that first affirmative response.
Implementation of a request to use the Register
When a request from a research team is approved, then the search criteria are posed, by SHARE to the gatekeepers for the appropriate database. The required approvals are sought and gained on a per search basis.
The result of the search will be a list of CHIs which can be matched to names and addresses. SHARE contacts the volunteer advising them of a forthcoming study, for which they appear to have the required attributes for inclusion. This communication includes a brief description about the study, provided by the research team, and a request for permission to allow a first approach to the volunteer by the research team.
Only on a positive response from the volunteer are their contact details passed to the researcher. These searches have received research ethics committee approval for this search mechanism. The ongoing processes of recruitment and consent to the particular study and participation are managed by the research team.
Use the public to help design your research project.
Public and patient involvement (PPI) is a way of making sure that the people who are most affected by your research have an opportunity to share their views of the research design, procedures and materials with the research team. The difficulty for researchers is finding members of the public and patients to help them.
SHARE can help. The SHARE register currently contains over 60,000 people who want to help with research. All you need to do to start the process is complete a simple SHARE form (which can be downloaded here) and give some details of the type of person you need for your PPI. Remember, specific ethical approval does not need to be sought when involving the public in research design and management activities so you can use SHARE for PPI linked to the design of your research without the need for ethical approval. See this document from INVOLVE and the National Research Ethics Service for more details.
The cost of using SHARE for PPI will vary depending on your selection criteria (the more there are, the more it will cost).
Using SHARE for PPI is a collaboration with Trial Forge (www.trialforge.org), an initiative that aims to improve the efficiency of trials.
Proper approval and governance is a fundamental principle in the way that SHARE operates. SHARE has two principle governance committees with four sub-committees in place:
Advisory Board (independent and international)
Project Management Committee (investigators and all stakeholders)
Project Management Sub-Committee (day-to-day project planning and delivery)
Data Management Sub-Committee (registration, security, data flow)
Access Sub-Committee (provision of SHARE facilities to research teams)
Funding Sub-Committee (funding, tariffs, budget management)
These committees all have patient (volunteer) representation and their membership comprises Scottish EHR gatekeepers, R&D Directors, Data Protection Officers, Caldicott Guardians, REC Scientific Advisers, CHI Advisory Group members and Directors and Research Directors of healthcare charities, additional to SHARE personnel and HIC data experts.
The governance structure mirrors that in place for SHIP and, in most cases, our processes rely upon existing SHIP procedures and SOPs. Meetings with governance administrators have provided useful clarifications and led to simplifications of process.
The implementation of the Register is managed by an experienced administrative staff and multi-stakeholder Project Management Committee (PMC). This group comprises patients, researchers, governance administrators, network managers, other national and regional database custodians and controllers and representatives of NHS Boards and the funding body. The PMC will be accountable for overseeing the development of the resource. It meets every six months either by teleconference or face-to-face.
The Data Management Sub-Committee (DMSC) has responsibility for overseeing all issues pertaining to the security and reliability of data entry, data movement and data storage, communications and agreements with other gatekeepers, and for the security and integrity of all SHARE-related transactions within the Scottish EHR infrastructure.
The Finance Sub-Committee (FSC) has financial oversight of the programme with responsibility for staffing the project and considering the setting of tariffs for use of the Register by research teams.
An Access Sub-Committee (ASC) will consider applications for the use of SHARE for national and international projects. Local sub-committees are being established for each of the main regions. This enables rapid responses to requests for access to the Register for regional projects.
Registration and informed consent
The SHARE mechanism for submitting registrations allows for a secure onward despatch to an NHS safe haven (currently, in Dundee). The joining requires a minimum amount of information for unambiguous identification of the registrant: name, date of birth and postcode (see Register page https://www.registerforshare.org/register.php), with the opportunity to provide preferred contact details and preferred number of approaches to be made annually by SHARE advising the volunteer of possible research opportunities.
Before a registration form can be submitted, the volunteer must explicitly acknowledge their understanding of the terms and conditions (highlighted below). Each person’s registration is acknowledged in writing within two weeks of them joining.
If you decide to join SHARE you are agreeing to allow us to use the coded data in your various NHS computer records to check whether you might be suitable for research projects about health. If you are suitable we will contact you to let you know about relevant studies. Once you hear more about any study you will have the opportunity to decide whether to take part.