Research Participants Perceptions of Their Experience in Clinical Studies
Research Participant Perception of Care Project: Part 1: Focus Groups of Research Participants and Research Professionals to Identify Key Dimensions of the Research Participant Experience
This study will examine how research volunteers experience their participation in studies in order to develop surveys to be used by research centers trying to improve the experience of their participants.
People 18 years of age and older who have participated in an NIH research protocol within the past 2 years as someone with a medical condition under study may be eligible for this study.
Eight participants will participate in a moderator facilitated focus group in a discussion about being in research studies. An observer audiotapes the discussion and takes written notes. The focus group discussion lasts about 1 to 1 (Omega) hours.
研究概览
地位
详细说明
The conduct of high quality clinical research is dependent on the ability to recruit and retain subjects who are invested in, understand, and have confidence in the clinical research process. Understanding subjects experiences as research volunteers is critical to the continual improvement of the processes of clinical research and, subsequently, to enhancing the subject s experience. Heretofore, studies evaluating the subject s comprehension of the informed consent process have served as, at best, an indirect measure of the quality of the subject s experience. Few, if any, studies have assessed the quality and efficacy of the entire clinical research process from the subject s perspective. This study is the first phase of a two-part study designed to directly measure research participants perceptions of all aspects of the clinical research process (e.g., recruitment, informed consent, education, autonomy and subject's rights, provision of clinical care) for the purposes of improving the clinical research subject s experience.
Obtaining robust, validated data requires a partnership between those with expertise in the design and analysis of surveys, and those who can articulate the needs of research participants and improve the way in which clinical research is conducted. For the former, we will be greatly advantaged by our partnership with NRC Picker, which has committed the resources necessary to assist the survey project development; conduct the focus groups, telephone interviews, and expert advisory group sessions required to further optimize the survey; collaborate in the analysis; and fund the second-stage formal validation of the survey. For the latter, we have assembled a collaborative team of research professionals from the CTSA award recipient centers, and interested GCRCs, with expertise in human subject protections, research ethics, research conduct, education and performance improvement.
The current study entails the recruitment and conduct of up to a total of 22 Focus Groups, each consisting of either 8-10 research subjects (12-16 groups) or 6-10 research professionals (6 groups), in order achieve the first goal: to assess the key dimensions of the research experience upon which to test the second part of the research, a perception of the research experience survey. The current study will involve 8-11 academic medical centers, enrolling a total of 100-128 research subjects, and 45-60 research professionals in total. A second goal of the project is to describe the process, obstacles and successes of implementing a multi-center protocol across the GCRCs and the CTSA consortium. A subsequent research protocol will concern the fielding and validation of that survey in approximately 3,700 subjects at up to 10 academic medical centers (CTSA and GCRC awardees).
研究类型
注册 (实际的)
联系人和位置
学习地点
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Maryland
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Bethesda、Maryland、美国、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
- INCLUSION CRITERIA:
You may be eligible to participate in this study if you:
- Are at least 18 years old.
- Are able to give informed consent.
- Have participated in an NIH research study within the past 2 years as someone with a medical condition under study.
- Can participate constructively and non-disruptively in the group discussion, in the opinion of the investigator.
- Are fluent in English
EXCLUSION CRITERIA:
You will not be able to be in this study if you:
- Do not sign the informed consent form.
- Do not agree to honor the confidentiality of others in the focus group.
- Do not agree to be recorded on audiotape.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
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To identify key dimensions of the clinical research process that influence participants' perception of their experience as a study participant
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次要结果测量
结果测量 |
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To describe the process, obstacles and successes of implementing a multi-center protocol across the GCRCs and the CTSA consortium.
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合作者和调查者
调查人员
- 首席研究员:David K Henderson, M.D.、National Institutes of Health Clinical Center (CC)
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 080193
- 08-CC-0193
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.