Intensive care unit patients’ opinion on enrollment in clinical research: a multicenter survey - Study data bank

Background: In most emergency situations or severe illness,
patients are unable to consent for clinical trial enrollment. In such
circumstances, the decision about whether to participate in a scientific
study or not is made by a legally designated representative.
Objective: To address the willingness of patients admitted to the
intensive care unit (ICU) to be enrolled in a scientific study as
volunteers, and to assess the agreement between patients’ and their legal
representatives’ opinion concerning enrollment in a scientific study.
Methods: This survey was conducted in two hospitals in São Paulo,
Brazil. Patients (≥18 years) with preserved cognitive functions
accompanied by a surrogate admitted to the ICU were eligible for this
study. A survey containing 28 questions for patients and 8 questions for
surrogates was applied within the first 48h from ICU admission. The survey
for patients comprised three sections: demographic characteristics,
opinion about participation in clinical research and knowledge about the
importance of research. The survey for legal representatives contained two
sections: demographic characteristics and assessment of legal
representatives’ opinion in authorizing patients to be enrolled in
research. Results: Between January 2017 and May 2018, 208 pairs
of ICU patients and their respective legal representatives answered the
survey. Out of 208 ICU patients answering the survey, 73.6% (153/208) were
willing to be enrolled in the study as volunteers. Of those patients,
65.1% (97/149) would continue participating in a research even if their
legal representative did not support their
enrollment.  Agreement between patients’ and surrogates’
opinion concerning participation was poor [Kappa=0.11 (IC95% -0.02 to
0.25)]. If a consent for study participation had been obtained, 69.1%
(103/149) of patients would continue participating in the study until its
conclusion, and 23.5% (35/149) would allow researchers to use data
collected to date, but would withdraw from the study on that occasion.
Conclusion: The majority of patients admitted to the ICU were
willing to be enrolled in a scientific study as volunteers, also after a
deferred informed consent procedure has been used. Nevertheless,
contradictory opinions between patients and their and their legal
representatives’ concerning enrollment in a scientific study were
often observed.