Consent for research in primary care.
Research type
Research Study
Full title
Assessing the public’s willingness to provide informed consent for their identifiable medical records to be accessed for different types of research.
IRAS ID
125686
Contact name
Gemma Lasseter
Contact email
Research summary
Several types of research in general practice rely on having access to identifiable information in patient’s medical records. For example, in order to invite people to give consent to participate in a research study, these individuals need to be identified and approached using information in their records. The legal and ethical position around allowing medical researchers access to patient records in this way is confused, with much guidance that is inconsistent.
One solution to these problems would be to tell patients in advance how their medical records might be used and to invite them to give prior consent for researchers working with their general practice to have access to their records within specified safeguards.
Our proposed study is interested in this initial invitation process, in particular whether standard recruitment documents that are routinely used to invite patients to participate in medical research could be improved. We will use qualitative cognitive interviews and group interviews to explore how patients feel about the idea of medical record research and how their concerns might need to be addressed. This information will be used to create new modified recruitment documents, which will be used in a feasibility study that will attempt to obtain informed consent from a sample of patients in a range of general practices.
We aim to recruit ten Primary Care Research Network (PCRN) general practices with different patient population. Staff at each practice will be responsible for identifying and inviting potential participates to join the study. All adult patients (18+ years) registered, or registering, during the study period at these practices will be eligible to participate in the study. Patients who are unable to provide informed consent for themselves will be excluded; appropriate advice will be sought from general practice staff regarding the capability of patients to participate.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1246
Date of REC Opinion
18 Sep 2013
REC opinion
Further Information Favourable Opinion