Implementing the Assent Requirement for Research With Children

NCT ID: NCT00102076

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-11-16
• Study Completion Date: 2006-09-18

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 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).

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 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).

Conditions

Healthy

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Locations

National Institutes of Health Clinical Center (CC)

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

02-CC-0054

Identifier Type: -

Identifier Source: secondary_id

020054

Identifier Type: -

Identifier Source: org_study_id