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Parental Permission and Adolescent Assent and Decision Making in Clinical Research


N/A
13 Years
18 Years
Not Enrolling
Both
Adolescents

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Trial Information

Parental Permission and Adolescent Assent and Decision Making in Clinical Research


This study aims to better understand how adolescents enrolled in clinical research and their
parents understood the study information presented, made decisions about enrolling,
experienced the process of assent and consent, and perceive the experience of participating
in research. Interviews will be conducted with adolescents participating in clinical
research and with one of their parents. Adolescents with a number of disorders, including
cancer, chronic diseases, bipolar disorder, obesity, and HIV, as well as healthy controls
who are enrolled in NIH intramural protocols, will be interviewed.

Inclusion Criteria


- INCLUSION CRITERIA:

Inclusion Criteria- Adolescent:

1. Age 13 to 18.

2. Currently enrolled in clinical research.

3. Physically and cognitively able and willing to participate in a 30-minute interview.

4. Able to understand and speak English or Spanish.

Inclusion Criteria- Parents:

1. Parent of an eligible adolescent.

2. Physically and cognitively able and willing to participate in a 30-minute interview.

3. Able to understand and speak English or Spanish.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Christine Grady, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

080032

NCT ID:

NCT00571311

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Adolescents
  • Assent
  • Adolescent
  • Informed Consent

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892