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| ID | Type | Description | Link |
|---|---|---|---|
| 08-CC-0032 |
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This study will evaluate how adolescents enrolled in clinical research and their parents:
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:
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.
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Inclusion Criteria- Adolescent:
Inclusion Criteria- Parents:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Grady, M.D. | National Institutes of Health Clinical Center (CC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16319237 | Background | 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. | |
| 14552306 | 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. |
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| 16109343 | 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. |