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Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study.

ABSTRACT: BACKGROUND:Recruitment into research studies in the neonatal intensive care unit has been problematic. Therefore suggestions have been made to take decision making about enrollment out of the hands of the parents. OBJECTIVE:To understand parental perceptions of the process of recruitment and enrollment for research in the neonatal intensive care unit. METHOD:A questionnaire was developed and used in both a retrospective survey and a prospective study of parents whose newborns were enrolled in trials in a neonatal intensive care unit. Closed ended and open ended questions were included, as well as demographic questions. RESULTS:The retrospective survey had a 79% response rate (29 of 38). Overall, 90% of parents felt that they had made informed decisions, and 93% were against the option that a doctor decide if the newborn should be enrolled into a study, rather than the parent. Although some parents (38%) found that recruitment did add "stress to an already stressful situation", 90% felt that they had made informed decisions and understood the elements of the study. Most parents had been requested to enroll their newborn into more than one trial, and, on average, they thought that they would be comfortable with enrollment into two studies (range 0-6). When asked how the process could be improved, parents suggested that information be made available before delivery. The responses of parents in the prospective study were mostly consistent with those from the retrospective survey. CONCLUSIONS:Overall the parents did not support the suggestion that decision making about enrollment be taken away from parents and put into the hands of doctors. The healthcare team should support parents in their role of decision maker, enhance availability of the research staff, and provide more information about the research.

SUBMITTER: Burgess E

PROVIDER: S-EPMC1721584 | biostudies-literature | 2003 Jul

REPOSITORIES: biostudies-literature

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Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study.

Burgess E E Singhal N N Amin H H McMillan D D DD Devrome H H

Archives of disease in childhood. Fetal and neonatal edition 20030701 4

<h4>Background</h4>Recruitment into research studies in the neonatal intensive care unit has been problematic. Therefore suggestions have been made to take decision making about enrollment out of the hands of the parents.<h4>Objective</h4>To understand parental perceptions of the process of recruitment and enrollment for research in the neonatal intensive care unit.<h4>Method</h4>A questionnaire was developed and used in both a retrospective survey and a prospective study of parents whose newbor ...[more]

PMID: 12819158

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Project description: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.

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Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study.

Publications

Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study.

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