Ethical Issues of Recruitment and Enrollment of Critically Ill and Injured Patients for Research

Richmond, Therese S.; Ulrich, Connie M.

doi:10.4037/15597768-2007-4003

Cited by 3 publications

(4 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…24 Recommendations to enhance enrolment include monitoring decision-making capacity, using consent processes that parallel study-risk and designing scalable multisite strategies. 47…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

2021

View full text Add to dashboard Cite

Background: Critical care trials are limited by problems with participant recruitment, and little is known about the most effective ways to enhance trial participation. Despite clinical research improving in the past decades within intensive care, participant recruitment remains a challenge. Not all eligible patients are identified, and opportunities for enrolment into clinical trials are often missed. Interventions to facilitate recruitment need to be identified to improve trial conduct in the critical care environment. Therefore, we aimed to establish the effectiveness of recruitment strategies in critical care trials in order to inform future research practice. Methods: Databases including MEDLINE, Embase, CINAHL and PsycINFO were searched for English language papers from inception to February 2020. The objectives were to: (1) establish the effectiveness of recruitment strategies and (2) recommend how effective recruitment strategies can inform research practice. Two reviewers independently assessed papers for inclusion and critically appraised the quality of the studies. Discrepancies were discussed within the research team. Relevant data were extracted and thematically coded into five overarching themes using a narrative synthesis approach. The review was prospectively registered on PROSPERO (CRD42019160519). Results: The search resulted in 2509 initially identified articles, with 15 that met the inclusion criteria. Articles reported a combination of quantitative, mixed methods and qualitative studies and a range of low-, moderate- and high-quality studies. Although, in-keeping with narrative synthesis approaches, none were excluded based on methodological quality. Five themes were identified relating to: patient eligibility identification, who provides information and seeks consent, resource limitations, research culture or environment and the consent model used. The relative success of recruitment strategies was dependent upon the experience and availability of the staff involved in the approach, trial design, the application of the strategy to the specific intensive care environment, the acceptability of the recruitment and consent models used, and the efficiency of the recruitment procedures. Opportunities for consent were missed in a proportion of eligible patients in most studies, suggesting that clinicians may avoid recruiting more complex patients or in more complex situations and that further development of strategies is needed. Conclusion: More effective recruitment strategies are required to enhance recruitment and the representativeness of the patient sample obtained in critical care trials, in order to expand the evidence base for treatments in this field. Greater focus is needed on assessing the performance of different recruitment strategies within different types of studies and critical care research environments. Future research should explore key stakeholders’ experiences of, and attitudes towards, recruitment and establish the most important and feasible modifiable barriers to recruitment.

show abstract

“…24 Recommendations to enhance enrolment include monitoring decision-making capacity, using consent processes that parallel study-risk and designing scalable multisite strategies. 47…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

2021

View full text Add to dashboard Cite

show abstract

“…The identified challenges in including critically ill patients in clinical studies raise concerns regarding how to ensure respect for the autonomy of patients [5][6][7][8][9][10][11][12][13]. Regarding this, researchers have to work within the local legal framework and practice shared decision-making.…”

Section: Legal or Ethical Reasons (N = 40)mentioning

confidence: 99%

“…Previous studies have identified obstacles when performing research in critically ill patients at intensive care units (ICU) related to challenges in the recruitment process [1][2][3][4]. Some studies have described practical, ethical or legal challenges in obtaining informed consent [5][6][7][8][9][10][11][12][13]. Other studies have debated that such patients have compromised autonomy and reduced capacity to decide [14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

Barriers and challenges in the process of including critically ill patients in clinical studies

Dahlberg

Eriksen

Robertsen

et al. 2020

Scand J Trauma Resusc Emerg Med

View full text Add to dashboard Cite

Background: Clinical research in severely ill or injured patients is required to improve healthcare but may be challenging to perform in practice. The aim of this study was to analyse barriers and challenges in the process of including critically ill patients in clinical studies. Methods: Data from critically ill patients considered for inclusion in an observational study of venous thromboembolism in Norway were analysed. This included quantitative and qualitative information from the screening log, consent forms and research notes. Results: Among 279 eligible critically ill patients, 204 (73%) were omitted from the study due to challenges and barriers in the inclusion process. Reasons for omission were categorised as practical in 133 (65%), medical in 31 (15%), and legal or ethical in 40 (20%) of the patients. Among 70 included patients, 29 (41%) consents were from patients and 41 (59%) from their next of kin. Several challenges were described herein; these included whether patients were competent to give consent, and which next of kin that should represent the patient. Furthermore, some included patients were unable to recall what they have consented, and some appeared unable to separate research from treatment. Conclusions: Barriers and challenges in the inclusion process led to the omission of near three out of four eligible patients. This analysis provided information about where the problem resides and may be solved. The majority of challenges among included patients were related to issues of autonomy and validity of consent. Trial registration: ClinicalTrials.gov (NCT03405766).

show abstract

“…Effective planning may reduce potential barriers. Several reviews of the challenges experienced by investigators in this type of research have appeared in the literature [1–5].…”

Section: Introductionmentioning

confidence: 99%

Obtaining surrogate consent for a minimal-risk research study in the intensive care unit setting

et al. 2012

View full text Add to dashboard Cite

show abstract

Ethical Issues of Recruitment and Enrollment of Critically Ill and Injured Patients for Research

Cited by 3 publications

References 5 publications

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

Barriers and challenges in the process of including critically ill patients in clinical studies

Obtaining surrogate consent for a minimal-risk research study in the intensive care unit setting

Contact Info

Product

Resources

About