Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study

Abstract

ObjectivesObtaining informed consent from patients in intensive care units (ICUs) prior to enrolment in a study is practically and ethically complex. Decisions about the participation of critically ill patients in research often involve substitute decision makers (SDMs), such as a patient’s relatives or doctors. We explored the perspectives of different stakeholder groups towards these consent procedures.Design and methodsMixed-methods study comprising surveys completed by ICU patients, their relatives and healthcare practitioners in 14 English ICUs, followed by qualitative interviews with a subset of survey participants. Empirical bioethics informed the analysis and synthesis of the data. Survey data were analysed using descriptive statistics of Likert responses, and analysis of interview data was informed by thematic reflective approaches.ResultsAnalysis included 1409 survey responses (ICU patients n=333, relatives n=488, healthcare practitioners n=588) and 60 interviews (ICU patients n=13, relatives n=30, healthcare practitioners n=17). Most agreed with relatives acting as SDMs based on the perception that relatives often know the patient well enough to reflect their views. While the practice of doctors serving as SDMs was supported by most survey respondents, a quarter (25%) disagreed. Views were more positive at interview and shifted markedly depending on particularities of the study. Participants also wanted reassurance that patient care was prioritised over research recruitment. Findings lend support for adaptations to consent procedures, including collaborative decision-making to correct misunderstandings of the implications of research for that patient. This empirical evidence is used to develop good practice guidance that is to be published separately.ConclusionsParticipants largely supported existing consent procedures, but their perspectives on these consent procedures depended on their perceptions of what the research involved and the safeguards in place. Findings point to the importance of explaining clearly what safeguards are in place to protect the patient.

Guidance to inform research recruitment processes for studies involving critically ill patients

“…Further details of empirical research methodology are outlined in our related publications. 6,7 The PERSPectives on Enhancing Consent and recruiTment in IntensiVe carE Studies (The Perspectives Study) explored the views and experiences of patients, their family members, and healthcare practitioners regarding recruitment procedures of studies that take place in ICUs. The Perspectives study began in September 2016 and concluded in May 2020.…”

“…Versions of written study information should be tailored to patients, to their families/friends who are consulted about the study (referred to as personal representatives in Clinical Trials of Investigational Medicinal Products (CTIMPs) and personal consultees (in non-CTIMPs), and to practitioners who are not connected with the study (referred to as professional representatives (CTIMPs) or consultees (non-CTIMPs). 7,14 This written information should include a short summary section to assist the tailoring of information to the capacity of patients and personal representatives/consultees and avoid information overload. Hard copies of documents can be lost during the ICU stay and patients/family members often wish to keep all information about their/the patient's ICU stay.…”

“…Hard copies of documents can be lost during the ICU stay and patients/family members often wish to keep all information about their/the patient's ICU stay. 7 Study teams should provide the option of access to online participant information materials (e.g. via links in patient ICU diaries to study websites).…”

“…However, family members will have had little experience of medical research and personal consultee/consent processes may seem burdensome for some family members in the context of critical illness. 7 Research staff should approach family members to discuss research at the earliest appropriate opportunity. Also consider whether there may be additional factors causing stress at that moment in time, such as whether the family recently arrived in the ICU for the first time, if the patient's condition has recently deteriorated, or they have recently received bad news.…”

“…However, family members will have had little experience of medical research and personal consultee/consent processes may seem burdensome for some family members in the context of critical illness. 7…”