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NCT00571311
Parental Permission and Adolescent Assent and Decision-Making in Clinical Research
trial in Adolescents in 356 participants. Completed in 12 March 2018.
Quick facts
| Lead sponsor | National Institutes of Health Clinical Center (CC) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 356 |
| Start date | 10 December 2007 |
| Estimated completion | 12 March 2018 |
| Sites | 1 location across United States |
Conditions studied
- Adolescents — all drugs for Adolescents →
Sponsor
National Institutes of Health Clinical Center (CC)
Who can join
Adults 13 to 18, any sex, with Adolescents. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00571311
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Institutes of Health Clinical Center (CC) trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00571311 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC)
- Last refreshed: 9 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00571311.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing