Parental Permission and Adolescent Assent and Decision-Making in Clinical Research
Public ClinicalTrials.gov record NCT00571311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Parental Permission and Adolescent Assent and Decision Making in Clinical Research
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00571311
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 356 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 13 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 9, 2007
- Primary completion
- Not listed
- Completion
- Mar 11, 2018
- Last update posted
- Oct 8, 2019
2007 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00571311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00571311 live on ClinicalTrials.gov.