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

NCT00571311 | Completed

• 2 other identifiers: 08003208-CC-0032
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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

Conditions

Adolescents

Keywords

Assent; Adolescent; Informed Consent

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 13 to 18.
• Currently enrolled in clinical research.
• Gave assent to participate in the primary study within the previous 6 months.
• Physically and cognitively able and willing to participate in a 30-minute interview.
• Able to understand and speak English or Spanish.
• Parent of an eligible adolescent
• Physically and cognitively able and willing to participate in a 30 minute interview.
• Gave permission for their child to participate in the primary study within the previous 6 months
• Able to understand and speak English or Spanish

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 16319237 BACKGROUND

• 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.

  PMID: 14552306 BACKGROUND

• 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.

  PMID: 16109343 BACKGROUND

Study Officials

• Christine Grady, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: December 10, 2007
• Study Completion: March 12, 2018
• Last Updated: October 9, 2019

Record last verified: 2018-03-12

Locations

US (1)