Assessing the public's willingness to provide informed consent for their identifiable medical records to be accessed for different types of research.

The problem

Involvement in primary care research is often hindered by concerns about the confidentiality of patient records. Consequently there is no universal system in the UK for patients to provide prior informed consent for their identifiable medical records to be accessed for different types of research. This study investigated what patients think about such a system and how they might prefer to be invited to consent.

The approach

Phase 1 used cognitive interviews to assess patients' attitudes about researchers accessing medical records for different research purposes and the impact of recruitment documents on the opportunity to give or decline consent. Phase 2 examined the feasibility of inviting patients to provide prior informed consent for identifiable medical records research. This phase assessed the impact of two different recruitment documents and three different invitation methods on patient response rates and consent decisions.

Findings

The cognitive interviews identified several key barriers to providing consent, which included embarrassment of sharing sensitive information, fears of inappropriate data sharing, concerns about data security and lack of appropriate information. Public benefit was identified as the main incentive for providing consent for identifable medical records research. Whilst a high-quality participant research information sheet was considered important by most participants. Preliminary Phase 2 results show that involving patients in the development of participant research recruitment documents (i.e. information sheets and consent forms) had a significant effect on subsequent patient response rates. Patients were also more likely to respond and give their consent if they were approached by a researcher during a visit to their GP for a routine consultation; compared to receiving a postal invitation or when joining the practice.

Consequences

This study demonstrates that the type of research invitation method and recruitment documents can influence primary care patient response and consent rates. Therefore, we recommend that patients are closely involved in evaluating the acceptability of these documents prior to use. In terms of identifiable medical record research, patients generally have little understanding of the information held in their records or how it is used for research; nevertheless many are willing to provide their informed consent if they are invited appropriately.

Credits

• Gemma Lasseter
• Richard Huxtable
• Lesley Wye
• Chris Salisbury