Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study.
Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study.
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DOI：
10.1017/cts.2021.807
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发表时间：
2021
影响因子：
2.6
通讯作者：
DuBois JM
中科院分区：
文献类型：
--
作者：
Solomon ED;Mozersky J;Baldwin K;Wroblewski MP;Parsons MV;Goodman M;DuBois JM
参与者和研究专业人员经常高估参与者对临床试验同意信息的理解和欣赏程度，而专家对参与者同意研究的能力的判断也常常存在差异。过去的研究已经开发并验证了旨在评估参与者理解和欣赏的工具，但它们的使用频率尚不清楚。我们对老年人或有认知障碍风险的临床研究人员进行了一项调查 (N = 1284)，并辅以定性访谈 (N = 60)。我们发现，使用经过验证的同意评估相对不常见，只有 44% 有机会的研究人员使用过。预测采用经过验证的评估的因素包括不将研究申办者视为障碍、对评估的积极态度以及相信自己拥有实施评估所需的资源。采用经过验证的同意评估的障碍包括缺乏意识、缺乏知识、不确定如何进行此类评估以及与实施这种做法相关的负担。增加对经过验证的同意评估的使用需要对研究人员进行实践教育并强调非常实用的评估，并且可能需要机构审查委员会（IRB）或研究赞助商支持评估的使用。
Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant’s capacity to consent to research. Past research has developed and validated instruments designed to assess participant understanding and appreciation, but the frequency with which they are utilized is unknown. We administered a survey to clinical researchers working with older adults or those at risk of cognitive impairment (N = 1284), supplemented by qualitative interviews (N = 60). We found that using a validated assessment of consent is relatively uncommon, being used by only 44% of researchers who had an opportunity. Factors that predicted adoption of validated assessments included not seeing the study sponsor as a barrier, positive attitudes toward assessments, and being confident that they had the resources needed to implement an assessment. The perceived barriers to adopting validated assessments of consent included lack of awareness, lack of knowledge, being unsure of how to administer such an assessment, and the burden associated with implementing this practice. Increasing the use of validated assessments of consent will require educating researchers on the practice and emphasizing very practical assessments, and may require Institutional Review Boards (IRBs) or study sponsors to champion the use of assessments.
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DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
影响因子：
17.7
作者：
Kim, SYH;Cox, C;Caine, ED
通讯作者：
Caine, ED
DOI：
10.1093/jnci/93.2.139
发表时间：
2001-01-17
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
Joffe, S;Cook, EF;Weeks, JC
通讯作者：
Weeks, JC
影响因子：
3.7
作者：
English T;Antes AL;Baldwin KA;DuBois JM
通讯作者：
DuBois JM
DOI：
10.1097/acm.0000000000001966
发表时间：
2018-04
期刊：
Academic medicine : journal of the Association of American Medical Colleges
影响因子：
--
作者：
DuBois JM;Antes AL
通讯作者：
Antes AL