NCT00102076

Implementing the Assent Requirement for Research With Children

Completed Last updated 2 July 2017

What this trial tests

trial in Healthy in 800 participants. Completed in 18 September 2006.

Timeline

16 November 2001

18 September 2006

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	800
Start date	16 November 2001
Estimated completion	18 September 2006
Sites	1 location across United States

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 7 to 14, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.