Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study
Objectives Obtaining 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 relativ...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/11/e066149.full |
| _version_ | 1811312288813023232 |
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| author | Kerry Woolfall Bridget Young Natalie Pattison Carrol Gamble Ingeborg Welters Lucy Frith John Trinder Anna Kearney Katie Paddock |
| author_facet | Kerry Woolfall Bridget Young Natalie Pattison Carrol Gamble Ingeborg Welters Lucy Frith John Trinder Anna Kearney Katie Paddock |
| author_sort | Kerry Woolfall |
| collection | DOAJ |
| description | Objectives Obtaining 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 methods Mixed-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.Results Analysis 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.Conclusions Participants 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. |
| first_indexed | 2024-04-13T10:34:35Z |
| format | Article |
| id | doaj.art-4019ee6f62f04d7cbad3190acb7bb028 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-13T10:34:35Z |
| publishDate | 2022-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-4019ee6f62f04d7cbad3190acb7bb0282022-12-22T02:50:05ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2022-066149Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods studyKerry Woolfall0Bridget Young1Natalie Pattison2Carrol Gamble3Ingeborg Welters4Lucy Frith5John Trinder6Anna Kearney7Katie Paddock8Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UKDepartment of Public Health, Policy and Systems, University of Liverpool, Liverpool, UKEast and North Hertfordshire National Health Service Trust, Hertfordshire, UKDepartment of Biostatistics, University of Liverpool, Liverpool, UKDepartment of Critical Care, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKCentre for Social Ethics and Policy, The University of Manchester, Manchester, UKUlster Hospital, Belfast, South Eastern Health & Social Services Trust, Belfast, IrelandDepartment of Public Health, Policy and Systems, University of Liverpool, Liverpool, UKDepartment of Childhood, Youth and Education Studies, Manchester Metropolitan University, Manchester, UKObjectives Obtaining 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 methods Mixed-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.Results Analysis 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.Conclusions Participants 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.https://bmjopen.bmj.com/content/12/11/e066149.full |
| spellingShingle | Kerry Woolfall Bridget Young Natalie Pattison Carrol Gamble Ingeborg Welters Lucy Frith John Trinder Anna Kearney Katie Paddock Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study BMJ Open |
| title | Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study |
| title_full | Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study |
| title_fullStr | Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study |
| title_full_unstemmed | Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study |
| title_short | Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study |
| title_sort | learning from stakeholders to inform good practice guidance on consent to research in intensive care units a mixed methods study |
| url | https://bmjopen.bmj.com/content/12/11/e066149.full |
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