Perspectives (version 1)
Research type
Research Study
Full title
PERSPectives on Enhancing Consent and recruiTment in IntensiVe carE Units
IRAS ID
217436
Contact name
Bridget Young
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
2 years, 5 months, 29 days
Research summary
Clinical research in intensive care units (ICUs) is important for improving treatments for critically ill patients. However, being invited to participate in research can be complicated. Studies in ICUs often take place within a narrow time window, patients will often be unconscious and therefore unable to consent for themselves, so consent must be sought from representatives; usually patients’ relatives. However, conversations about research may seem less important to relatives, who may be overwhelmed with the situation and struggle to absorb information, wanting to focus on the clinical care of their relative. It may feel difficult for them to make decisions on behalf of a loved one.\n\nDespite these challenges, there is little good quality evidence on patient and other stakeholder perspectives to inform how recruitment and consent procedures are carried out. This study explores the perspectives of stakeholders, including former ICU patients, their relatives, and staff involved with the recruitment and consent of patients to studies in ICUs. We want to develop good practice guidance on the recruitment and consent of ICU patients to clinical research studies. The study has 4 streams:\n\nWork stream 1: qualitative telephone interviews with clinician/researchers and research partners/advocates, who have designed and/or implemented an ICU-based study.\n\nWork stream 2: surveys of ICU patients’, relatives’, and clinicians’ perspectives on the enrolment process, and their experiences of ICU research. Patients/relatives will be recruited by research nurses prior to their discharge from hospital. Clinicians will be recruited via key contacts at each site.\n\nWork stream 3: Qualitative interviews with patients, relatives, and clinicians, about their experiences of ICU research. Participants will also be asked their views of ICU research, including risk/benefits and consent methods. Sampling and topic guides will be informed by work stream 2.\n\nWork stream 4: The development of good practice guidance, informed by established procedures for the production of guidance
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0339
Date of REC Opinion
13 Jun 2017
REC opinion
Favourable Opinion