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Parental Permission and Adolescent Assent and Decision-Making in Clinical Research

NCT00571311 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 356

Last updated 2019-10-09

No results posted yet for this 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

Conditions

  • Adolescents

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Christine Grady, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-10
Completion
2018-03-12

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 NCT00571311 on ClinicalTrials.gov