Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102076
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-01-19
Brief Title:
Implementing the Assent Requirement for Research With Children
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Implementing the Assent Requirement for Research With Children
Status:
COMPLETED
Status Verified Date:
2006-09-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 46408 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 childrens role in making decisions concerning their participation in clinical research Five elements of childrens 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 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for cancer 2 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for asthma and 3 MinorParent 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 - researchclinical minor researchclinical parent - will be developed in consultation with Research Triangle Institute RTI
Three groups will be enrolled 1 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for cancer 2 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for asthma and 3 MinorParent 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 - researchclinical minor researchclinical 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 46408 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 childrens role in making decisions concerning their participation in clinical research Five elements of childrens 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 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for cancer 2 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for asthma and 3 MinorParent 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 - researchclinical minor researchclinical parent - will be developed in consultation with Research Triangle Institute RTI
Three groups will be enrolled 1 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for cancer 2 MinorParent pairs where the minor is participating in or is in follow-up for a drug treatment research study for asthma and 3 MinorParent 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 - researchclinical minor researchclinical parent - will be developed in consultation with Research Triangle Institute RTI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CC-0054 | None | None | None |