Clinical trial NCT00571311: Parental Permission and Adolescent Assent and Decision-Making in Clinical Research
Official title: Parental Permission and Adolescent Assent and Decision Making in Clinical Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescents
Keywords: Assent
Adolescent
Informed Consent
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2007-12-12
Enrollment: 356
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief 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

Detailed description: 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.

Eligibility criteria: * INCLUSION CRITERIA:

Inclusion Criteria- Adolescent:

1. Age 13 to 18.
2. Currently enrolled in clinical research.
3. Gave assent to participate in the primary study within the previous 6 months.
4. Physically and cognitively able and willing to participate in a 30-minute interview.
5. 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. Gave permission for their child to participate in the primary study within the previous 6 months
4. Able to understand and speak English or Spanish

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Christine Grady, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burke TM, Abramovitch R, Zlotkin S. Children's understanding of the risks and benefits associated with research. J Med Ethics. 2005 Dec;31(12):715-20. doi: 10.1136/jme.2003.003228.
citation: Brody JL, Scherer DG, Annett RD, Pearson-Bish M. Voluntary assent in biomedical research with adolescents: a comparison of parent and adolescent views. Ethics Behav. 2003;13(1):79-95. doi: 10.1207/S15327019EB1301_10.
citation: Brody JL, Annett RD, Scherer DG, Perryman ML, Cofrin KM. Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. J Adolesc Health. 2005 Sep;37(3):229-35. doi: 10.1016/j.jadohealth.2004.09.026.