Christine Trupin, Dr, School of Graduate Studies and Research, Meharry Medical College, 3704 Woodmont Blvd, Nashville, TN 37215, 615 327 6533, ctrupin@mmc.edu and Carolyne Szetela, Dr, Community Medicine, Meharry Medical College, 1005 DB Todd Blvd, Nashville, TN 37208.

The purpose of this qualitative study was to assess the quality of assent in a minimum-risk non-therapeutic sickle cell anemia clinical study, and to identify factors in recruitment and assent processes that might have influenced the quality of the assent observed. Results: children recalled more of what they learned from their mothers about the study than from any other sources including a visit to the research facility and the assent process. Twenty three or the 26 subjects said it was their decision to participate in the study. Even after participating in the study repeatedly, children’s knowledge of study purpose, risks and benefits was inadequate. Although subjects were readily able to recall the included entertainment activities, less than half could list without prompting a significant number of key research related activities. The right to withdraw from the study was also unclear to many.

Children’s main reason for remaining in the study was because it was fun. And the quality of assent seemed to be associated with the quality and quantify of information received from their mothers (parents) prior to the children’s decision to enter the study. The results highlighted the importance of parents’ understanding of research information and the need for their children to be well informed as a basis for decision. There is a need for collaboration among research stakeholders (investigators, parents and children) to enhance the autonomy of child research subjects, and to explore resulting effects on the quality of assent among children and adolescents.

Learning Objectives:

• At the end of the session, participants will be able to recognize the need to actively engage children and youth in the recruitment and informed consent / assent processes for purposes of enhancing their understanding of the key elements of informed consent.

Keywords: Research Ethics, Children and Adolescents

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Meharry medical College; Vanderbilt University
I have a significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
Relationship: Faculty member