Implementing the Assent Requirement for Research With Children

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00102076
First received: January 19, 2005
Last updated: March 5, 2008
Last verified: September 2006

January 19, 2005
March 5, 2008
November 2001
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Complete list of historical versions of study NCT00102076 on ClinicalTrials.gov Archive Site
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Implementing the Assent Requirement for Research With Children
Implementing the Assent Requirement for Research With Children

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 to participate unless the research "holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research" (46.408). Despite the importance of the assent requirement, the Federal regulations offer no guidelines on its implementation. In the present study, we propose to survey children and one of their parents in order to obtain information concerning children's role in making decisions concerning their participation in clinical research. Five elements of children's involvement in the decision-making process with respect to their participation in clinical research will be assessed: 1) receipt of information concerning the available options; 2) understanding of this information; 3) assessment of the available options; 4) expression of a preferred option; and 5) coordination with parental decision-making.

Three groups will be enrolled: 1. Minor/Parent pairs where the minor is participating in, or is in follow-up for, a drug treatment research study for cancer 2. Minor/Parent pairs where the minor is participating in, or is in follow-up for, a drug treatment research study for asthma, and 3. Minor/Parent pairs where the minor is receiving on-going clinical care for asthma. Children 7-14 years of age will be enrolled. Total enrollment will be 400 subject pairs, approximately 150 in cancer research, 150 in asthma research and 100 involved in clinical care for asthma, with approximate balance between the sites. Two formalized survey instruments - research/clinical minor, research/clinical parent - will be developed in consultation with Research Triangle Institute (RTI).

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 to participate unless the research "holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research" (46.408). Despite the importance of the assent requirement, the Federal regulations offer no guidelines on its implementation. In the present study, we propose to survey children and one of their parents in order to obtain information concerning children's role in making decisions concerning their participation in clinical research. Five elements of children's involvement in the decision-making process with respect to their participation in clinical research will be assessed: 1) receipt of information concerning the available options; 2) understanding of this information; 3) assessment of the available options; 4) expression of a preferred option; and 5) coordination with parental decision-making.

Three groups will be enrolled: 1. Minor/Parent pairs where the minor is participating in, or is in follow-up for, a drug treatment research study for cancer 2. Minor/Parent pairs where the minor is participating in, or is in follow-up for, a drug treatment research study for asthma, and 3. Minor/Parent pairs where the minor is receiving on-going clinical care for asthma. Children 7-14 years of age will be enrolled. Total enrollment will be 400 subject pairs, approximately 150 in cancer research, 150 in asthma research and 100 involved in clinical care for asthma, with approximate balance between the sites. Two formalized survey instruments - research/clinical minor, research/clinical parent - will be developed in consultation with Research Triangle Institute (RTI).

Observational
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Healthy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
September 2006
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  • 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.

Both
7 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102076
020054, 02-CC-0054
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National Institutes of Health Clinical Center (CC)
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National Institutes of Health Clinical Center (CC)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP