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Implementing the Assent Requirement for Research With Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102076
First Posted: January 20, 2005
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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).


Condition
Healthy

Study Type: Observational
Official Title: Implementing the Assent Requirement for Research With Children

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 800
Study Start Date: November 16, 2001
Estimated Study Completion Date: September 18, 2006
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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102076


Locations
United States, Maryland
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
  More Information

ClinicalTrials.gov Identifier: NCT00102076     History of Changes
Other Study ID Numbers: 020054
02-CC-0054
First Submitted: January 19, 2005
First Posted: January 20, 2005
Last Update Posted: July 2, 2017
Last Verified: September 18, 2006

Keywords provided by National Institutes of Health Clinical Center (CC):
Minimal
Risk
Regulations
Parents
IRB
Surgery
Assent Requirement