Status:
COMPLETED
Implementing the Assent Requirement for Research With Children
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Healthy
Eligibility:
All Genders
7-14 years
Brief Summary
One of the principal safeguards mandated by the Federal Regulations governing clinical research with children is the assent requirement: children who are capable must provide an affirmative agreement ...
Detailed Description
One of the principal safeguards mandated by the Federal Regulations governing clinical research with children is the assent requirement: children who are capable must provide an affirmative agreement ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Children in Research Studies:
- Currently enrolled in an ongoing medical intervention protocol, including follow-up, for cancer or asthma at one of the participating sites.
- Post initial visit.
- Enrolled within the previous year.
- Physically and cognitively able to participate in a 30 minute interview.
- Ability to understand and speak English.
- Age 7-14.
- Parents of Children in Research Studies:
- Parent of an eligible research child.
- Physically and cognitively able to participate in a 30 minute interview.
- Ability to understand and speak English.
- Children Receiving Clinical Care:
- Receiving clinical care at a clinic at one of the participating sites for cancer or asthma.
- Post initial visit.
- Physically and cognitively able to participate in a 30 minute interview.
- Ability to understand and speak English.
- Age 7-14.
- Parents of Children Receiving Care:
- Parent of an eligible clinical minor.
- Physically and cognitively able to participate in a 30 minute interview.
- Ability to understand and speak English.
- EXCLUSION CRITERIA:
- Inability to speak English.
- Inability to understand spoken English.
Exclusion
Key Trial Info
Start Date :
November 16 2001
Trial Type :
OBSERVATIONAL
End Date :
September 18 2006
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00102076
Start Date
November 16 2001
End Date
September 18 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, United States, 20892