Acceptability and perceived barriers and facilitators to creating a national research register to enable ’direct to patient’ enrolment into research: the Scottish Health Research Register (SHARE)

Abstract

BackgroundDifficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers.MethodsWe undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups.ResultsThe concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population.ConclusionsThis work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers.

Moving from trust to trustworthiness: Experiences of public engagement in the Scottish Health Informatics Programme

“…Previous research has highlighted that commercial involvement is an area of public concern (Grant et al 2013; Hill et al 2013; Nair et al 2004). It has also often been assumed that members of the public have little or no understanding of the current role of commercialisation in research (Millstone and van Zwanenberg 2000; Van Gend 2002).…”

“…It has also often been assumed that members of the public have little or no understanding of the current role of commercialisation in research (Millstone and van Zwanenberg 2000; Van Gend 2002). Yet, qualitative and deliberative research which has engaged with this topic has found that while members of the public have concerns about the commercialisation of research they are often aware of its role and acknowledge the relevance of private company involvement in research (Davidson et al 2013; Grant et al 2013; Haddow et al 2007). Moreover, Haddow et al (2007) found that members of the public may be accepting of commercialisation so long as appropriate conditions are met (e.g.…”

Big Data and Public-Private Partnerships in Healthcare and Research

“…One aspect that requires particular consideration in PPPs is the commercialisation of data in the private sector. Research consistently demonstrates significant public reluctance to allow commercial players access to health data (Grant et al 2013). In response, some data access policies limit access by commercial entities (Shabani and Borry 2016).…”

Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients

“…In developing ReSKU, it was important to first recognize how current registries operate and how an ideal modern registry would compare since traditional registry design and data entry are accompanied by challenges that hinder their implementation. These include labor-intensive data entry, cost of registry maintenance, patient confidentiality with meeting Health Insurance Portability and Accountability Act (HIPAA) requirements and human subjects research regulations, manpower for maintaining and organizing a database, concerns for how data will be stored and used, and interference with day to day clinical care [3][4][5][6] ( Table 1).…”

“…2 Unfortunately, most registry efforts still rely on manual data entry, which results in expensive, laborintensive long-term maintenance. 3 Data entry for traditional registries is time-consuming and labor intensive. We hypothesized that by designing a registry tied to an electronic health record (EHR), we could significantly decrease the time of data extraction.…”