Intensive care unit patients’ opinion on enrollment in clinical research: A multicenter survey

Abstract

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

Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes

“…Patients and HCPs were supportive of data being used in the case of patient death or up until the point of declining to continue in a study [ 26 , 35 , 38 , 50 ]. While this preserves the validity of trial results by preventing selection bias, ethical questions are raised on whether families should be informed of their relatives’ inclusion after death.…”

“…Participants were generally accepting of the use of deferred consent [ 25 , 26 , 29 , 30 , 32 , 35 , 36 , 38 , 40 , 41 , 43 – 45 , 47 , 49 , 50 ]. However, even in studies reporting positive views, a wide range of acceptability was observed (50–95.6%) [ 36 , 44 ].…”

“…Respondents also acknowledged the importance of benefits for future patients. Altruistic motives for supporting deferred consent were commonly expressed as a precondition for emergency research by patients even when direct benefit to those individuals was unlikely [ 26 , 27 , 35 , 44 ]. The need to conduct research in order to advance scientific knowledge was highlighted by several patients who were willing to take part in emergency trials as a result [ 28 , 39 , 44 ].…”

“…As well as patient death, the use of data upon declining consent to continue in a study introduces similar issues. Studies reporting a patient preference for the use of collected data up to the point of refusal of continued participation concluded that the majority of patients and surrogates approved of this practice [ 26 , 35 , 38 ].…”