Protocol Number: 08-CC-0032

Title:

Parental Permission and Adolescent Assent and Decision Making in Clinical Research

Number:

08-CC-0032

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

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Assent

Adolescent

Informed Consent

Recruitment Keyword(s):

Adolescent

Informed Consent

Condition(s):

Adolescents

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

Warren G. Magnuson Clinical Center

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

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.

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/30/2009