SBU Guidance on Minors as Research Subjects: The Requirement of Assent

Introduction

With every study involving minors, assent (i.e., agreement to participate) of the child is required, unless otherwise waived by CORIHS. There are criteria that must be met in order to waive assent:

If CORIHS determines that:

• the capability of some or all of the children is so limited that they cannot reasonably be consulted,
OR
• the intervention or procedure involved in 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,

then the assent of the children is not a necessary condition for proceeding with the research. This waiver can extend to the entire minor population to be studied, or on a child by child basis.

When Assent is Required…

If CORIHS has determined that assent of the minor subjects is required, it means that:

• those minors who are approximately 11 to 17 years of age should have their assent documented via a CORIHS approved assent form,
AND
• those who are younger than the age range above should be initially assessed for willingness, and monitored for continued willingness, to participate in the research activity.

CORIHS can waive assent on a case by case basis in situations where the minor population to be studied has a wide range of ability to provide informed assent. Some potential subjects may lack the cognitive or developmental ability to provide assent, regardless of chronologic age. Some children will have the capacity to assent, while others will not. In this situation, CORIHS may require the PI to have a plan of assessing and documenting each child’s capability of assenting, and of being able to comply with the study procedures.

An Example

Most children will not willingly submit to a blood drawing procedure for their own clinical care, let alone for a research study. If CORIHS determines that assent is required for a research study involving blood draws or other painful procedures, CORIHS expects that the investigator will speak with each child in a simple manner about why the child is being asked to do something they don’t have to do, and honestly explain the study in terms of what is expected, what will hurt, and how long they will be asked to be in the study. If initial assent is obtained (and documented for older children), reasonableness must be the guide in monitoring assent. For example, most children require that a parent hold their arm or hug them/shield their eyes when blood is being drawn. However, significant distress at the time of the blood draw or other procedure, characterized by verbal or behavioral indications of an unwillingness to continue with the procedure, implies that the child is not assenting to the procedure. His or her wishes must be respected, and the procedure should not be done. Depending on the extent of the child’s distress, s/he should be removed from the study, with reasons documented in the subject’s study file.

Whether Assent is Required or Waived

Whether assent is required or waived, no physical or chemical means of restraint may be used on a minor subject unless specifically approved prior to use by CORIHS.

 

If you have any comments or questions about minor subjects in research activities and required/waived assent, please call the Office of Research Compliance at 631-632-9036.