OxAMI: Consent
Research type
Research Study
Full title
Consent: An investigation of the OxAMI enrolment process
IRAS ID
138014
Contact name
Mark Sheehan
Contact email
Sponsor organisation
Clinical Trials and Research Governance
Research summary
This study examines how people feel about enrolment into the Oxford Acute Myocardial Infarction (OxAMI) research study. OxAMI recruits patients who have just had a heart attack, taking measurements for research at the same time as delivering standard clinical care. None of these recruits gives informed consent to enter the study; they are enrolled by researchers with permission of a Research Ethics Committee (REC). However, novel measures are taken to promote engagement with these patients to the extent that they are able. These measures include use of a dedicated patient “advocate“ who observes the dynamics of patient and researcher during the enrolment process.
We will interview 50 people about OxAMI’s enrolment process. They will include patients eligible for the OxAMI study, members of the OxAMI research team, other healthcare professionals, and also members of the public.
We will ask their opinions about emergency-setting research, enrolment into such research, and what they think about underpinning ethical issues and regulatory arrangements. Having gathered and analysed these opinions, we will ask a subset of those interviewed to come back for stakeholder meetings. At these meetings, we will present and discuss interview data. The result of these discussions may be to refine and improve future enrolment processes, or it may simply be to endorse the appropriateness of the process currently in operation. Importantly these meetings directly engage members of the public and researchers in dialogue about ethical and regulatory issues in emergency medical research (EMR).
This study is funded by Oxford Biomedical Research Centre and sponsored by University of Oxford.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0152
Date of REC Opinion
28 Apr 2014
REC opinion
Further Information Favourable Opinion