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CompletedNCT00571311Updated Oct 9, 2019

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

An observational study in Adolescents, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by National Institutes of Health Clinical Center (CC) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
356
Ages
13 Years to 18 Years
Sex
All
01

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
Read the 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.

02

Conditions studied

  • Adolescents

Keywords

  • Assent
  • Adolescent
  • Informed Consent
03

In context

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.

Browse National Institutes of Health Clinical Center (CC) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Time perspective
Prospective
Enrollment
356 participants (actual)
06

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 16319237 ↗
  • 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. PubMed 14552306 ↗
  • 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. PubMed 16109343 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2007 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2007
First posted
Dec 12, 2007
Start
Dec 10, 2007
Completion
Mar 12, 2018
Last update
Oct 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00571311
Lead sponsor
National Institutes of Health Clinical Center (CC)
Responsible party
Sponsor
First posted
Dec 12, 2007
Start date
Dec 10, 2007
Completion
Mar 12, 2018
Last update
Oct 9, 2019

Study contacts

Christine Grady, M.D.
principal investigator · National Institutes of Health Clinical Center (CC)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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