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NCT00571311 · ClinicalTrials.gov registry record
Parental Permission and Adolescent Assent and Decision-Making in Clinical Research
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 356
- Enrollment target
NCT00571311 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 356 participants.
The verdict
NCT00571311 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 356 participants
- Enrollment target
Study Summary
This study will evaluate how adolescents enrolled in clinical research and their parents: * Understood the study information presented before they agreed to participate * Made decisions about enrolling in the study * Experienced the process of assent and consent * Perceive the experience of participating in research The study will determine how adolescents and their parents evaluate risk and benefit, what information they use in making their research enrollment decisions, and how these decisions are made. In recent years the medical community and the federal government have increasingly recognized the need to conduct pediatric research. Several initiatives have resulted in an expanding number of studies that include children. With more pediatric research comes the need to ensure that protections for the rights and safety of children enrolled in research are performing well. Adolescent patients between 13 and 18 years of age who are enrolled in a research study at the NIH involving cancer, diabetes mellitus, vaccines, obesity, bipolar disorder, and HIV, as well as healthy adolescent controls, may be eligible. One parent of each adolescent also participates. Participants are interviewed at the NIH Clinical Center. Each interview will last about 30 minutes and consists of questions in the following areas: * Demographics (age, sex, ethnicity, education, socioeconomic status, etc.) * Brief medical history of the adolescent * Experience and satisfaction with the parental permission/assent process * Motivations for participating in clinical research * Decision-making process * Willingness to accept certain types and levels of hypothetical risks in a study, including those of side effects and invasive procedures * Willingness to enroll with different chances of possible benefit * Comparison with other activities * General understanding of research
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2007-12-10 |
| Est. Completion | 2018-03-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00571311
The ClinicalTrials.gov registry entry for NCT00571311 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 356 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00571311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00571311 about?
NCT00571311 is a clinical study titled "Parental Permission and Adolescent Assent and Decision-Making in Clinical Research". This study will evaluate how adolescents enrolled in clinical research and their parents: * Understood the study information presented before they agreed to participate * Made decisions about enrolling in the study * Experienced the process of assent and consent * Perceive the experience of partici...
What is the current status of trial NCT00571311?
This trial is currently completed. The enrollment target is 356 participants. The study started on 2007-12-10. Estimated completion is 2018-03-12.
Who is sponsoring clinical trial NCT00571311?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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