Mahafzah Rania, Alzoubi Karem H, Khabour Omar F, Abu-Farha Rana
Department of Clinical Pharmacy, Jordan University of Science and Technology, Irbid 22110, Jordan.
Department of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, UAE.
Crit Care Res Pract. 2021 Sep 30;2021:7614517. doi: 10.1155/2021/7614517. eCollection 2021.
Proxy consent respects patients' autonomy when they are incapable of providing consent for research participation. Healthcare providers need to understand the ethical regulations and practices relevant to the proxy consent process. Thus, this study aimed to assess the knowledge and attitudes of healthcare providers about research proxy consent in the ICU setting.
A cross-sectional survey-based design was used in the study. Study participants were resident and specialist physicians, registered nurses, and registered pharmacists from ICU units in Jordan. Participants were asked to fill out a questionnaire developed to assess their knowledge and attitudes towards informed proxy consent for research studies conducted at the ICU.
In this study, 145 healthcare providers completed the study questionnaire. The healthcare providers agreed that the purpose of the proxy consent is to inform the participants about the potential benefits (66.9%) and risks (66.9%) related to the research to study and respect patient's autonomy (44%), to discuss alternative options (62.1%), and to protect the researchers from any litigation (84.1%). Regarding the assessment of proxy consent, 65.5% of respondents believed that relatives are considered as an authorized legal representative for an informed consent decision on behalf of their ICU patients (65.5%) as they are knowledgeable about patients' values and preferences and have the desire to provide the necessary help. Respondents also agreed that the informed consent process should explain research protocols and procedures (76.6%), therapeutic alternatives (84.1%), potential benefits (41.4%), and potential risks (44.1%) and that participation in the research is voluntary (66.9%). No significant differences in the responses were found among different groups of healthcare providers.
The majority of healthcare providers had inadequate awareness about the ethical aspects regarding the informed proxy consent process. Providing training regarding the informed consent process can improve the quality of the proxy consent process in clinical research studies in the ICU setting.
当患者无法对参与研究给予同意时，代理同意尊重患者的自主权。医疗保健提供者需要了解与代理同意过程相关的伦理规范和实践。因此，本研究旨在评估重症监护病房（ICU）环境中医疗保健提供者对研究代理同意的知识和态度。
本研究采用基于横断面调查的设计。研究参与者为约旦ICU科室的住院医师、专科医师、注册护士和注册药剂师。参与者被要求填写一份问卷，该问卷旨在评估他们对ICU进行的研究的知情代理同意的知识和态度。
在本研究中，145名医疗保健提供者完成了研究问卷。医疗保健提供者一致认为，代理同意的目的是向参与者告知与研究相关的潜在益处（66.9%）和风险（66.9%），以研究和尊重患者的自主权（44%），讨论替代方案（62.1%），并保护研究人员免受任何诉讼（84.1%）。关于代理同意的评估，65.5%的受访者认为亲属被视为代表其ICU患者做出知情同意决定的授权法定代表人（65.5%），因为他们了解患者的价值观和偏好，并愿意提供必要的帮助。受访者还一致认为，知情同意过程应解释研究方案和程序（76.6%）、治疗替代方案（84.1%）、潜在益处（41.4%）和潜在风险（44.1%），并且参与研究是自愿的（66.9%）。不同组别的医疗保健提供者在回答上未发现显著差异。
大多数医疗保健提供者对知情代理同意过程的伦理方面认识不足。提供关于知情同意过程的培训可以提高ICU环境中临床研究中代理同意过程的质量。
