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Research Participant Perception of Care Project: Part II: Fielding and Validation of the Research Participant Perception Survey Derived From Focus Group-Identified Key Dimensions of the Research Participant Experience

NCT01129869 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 743

Last updated 2018-04-05

No results posted yet for this study

Summary

Background:

* Understanding participants experiences as research volunteers is critical to improving the effectiveness of human participant protection programs and strengthening public trust in clinical research. Historically, studies that evaluate participants comprehension of the informed consent document or evaluate the informed consent process have only indirectly measured the quality of a participant s experience.
* Few studies have assessed the nature, quality and efficiency of the entire clinical research process from the participant s perspective. To address this need, researchers have developed a Clinical Research Participant Perception Survey to evaluate participants overall perceptions of clinical research.

Objectives:

\- To validate the Research Participant Perception Survey questionnaire and revise it accordingly to produce a questionnaire that other researchers can use.

Eligibility:

\- Individuals at least 18 years of age who have participated in at least one research protocol within the past 2 years. Participation may be completed or ongoing.

Design:

* Eligible participants will receive a survey by mail and will be asked to complete it and return it in the stamped envelope provided.
* The survey will ask questions about the research protocol process, including participants positive and negative experiences of participating in the research protocol....

Conditions

  • Participation Satisfaction

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • David K Henderson, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-13
Completion
2018-02-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129869 on ClinicalTrials.gov