Implementing the Assent Requirement for Research With Children
Condition: Healthy
Study type: Observational

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).
    

Keywords: Minimal; Risk; Regulations; Parents; IRB; Surgery; Assent Requirement