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
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.
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).
- 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
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.