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Assent
The term assent refers to the verbal or written agreement to engage in a research study. Assent is generally applicable to children between the ages of 8 and 18 years, although assent may apply to other vulnerable populations also.
Vulnerable populations are those composed of individuals who are unable to give consent due to diminished autonomy. Diminished autonomy occurs when an individual is incapacitated, has restricted freedom, or is a minor. Understanding the relevance of assent is important because without obtaining the assent of a participant, the researcher has restricted the freedom and autonomy of the participant and in turn has violated the basic ethical principle of respect for persons. Assent with regard to vulnerable populations is discussed here, along with the process of obtaining assent and the role of institutional review boards in the assent process.
Vulnerable Populations
Respect for persons requires that participants agree to engage in research voluntarily and have adequate information to make an informed decision. Most laws recognize that a person 18 years of age or older is able to give his or her informed consent to participate in the research study. However, in some cases individuals lack the capacity to provide informed consent. An individual may lack the capacity to give his or her consent for a variety of reasons; examples include a prisoner who is ordered to undergo an experimental treatment designed to decrease recidivism, a participant with mental retardation, or an older adult with dementia whose caretakers believe an experimental psychotherapy group may decrease his or her symptoms. Each of the participants in these examples is not capable of giving permission to participate in the research because he or she either is coerced into engaging in the research or lacks the ability to understand the basic information necessary to fully consent to the study.
State laws prohibit minors and incapacitated individuals from giving consent. In these cases, permission must be obtained from parents and court-appointed guardians, respectively. However, beyond consent, many ethicists, professional organizations, and ethical codes require that assent be obtained. With children, state laws define when a young person is legally competent to make informed decisions. Some argue that the ability to give assent is from 8 to 14 years of age because the person is able to comprehend the requirements of the research. In general, however, it is thought that by the age of 10, children should be able to provide assent to participate. It is argued that obtaining assent increases the autonomy of the individual. By obtaining assent, individuals are afforded as much control as possible over their decision to engage in the research given the circumstances, regardless of their mental capacity.
Obtaining Assent
Assent is not a singular event. It is thought that assent is a continual process. Thus, researchers are encouraged to obtain permission to continue with the research during each new phase of research (e.g., moving from one type of task to the next). If an individual assents to participate in the study but during the study requests to discontinue, it is recommended that the research be discontinued.
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