What is informed assent and why is it important?

By Viviana Zuluaga Cardona

Quality leader of the CREICEC ethics committee

General Practitioner – Specialized in OSH and Health Auditing.

In Colombia, informed consent is a legal and ethical requirement, very relevant during clinical research on minors. Consent is a similar figure but for adults.

Key points:

Clinical research on minors is oriented to meet the health needs of children; consequently, it must be carried out with this population and not with adults.

The parents or legal representatives of the minor must authorize his/her participation.

The minor accepts to participate by means of the figure of assent and, in case of refusal, his/her decision is respected.

It has been concluded that children older than 12 years of age are apt to give adequate informed assent but with parental authorization.
CIOMS Standards 2002

What is informed consent in clinical research?

The United Nations Convention on the Rights of the Child refers to informed consent as the child’s right to free expression or a very personal right:

States and parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child.

Inclusion of children.

The figure of informed consent has been progressively consolidated as an instance that promotes the inclusion of children and adolescents in decision-making processes, both in the field of health care and in the participation in experimental protocols.

Ethical requirements.

Ethical requirements for clinical research are aimed at minimizing the possibility of exploitation and in relation to special populations.

Minors, ethics and clinical research.

Those of us who are committed to ethics in research follow the guidelines of the norms, among them what is stipulated in RESOLUTION Nº 008430 OF 1993.

The investigator and the ethics committees must frequently make decisions regarding the inclusion or exclusion of certain population groups, which are often referred to as special because of their particular characteristics.

The issue of special populations is essentially marked by the convergence of four criteria:

Condition of vulnerability.
Level of dependency,
Capacity/competence
Risk-benefit ratio.

Minors, this group includes persons who, because they have not reached the age of majority, are considered legally incompetent to consent.

Ethical decision-making

The ethical cores that guide the evaluation of the protocols and ethical decision-making in this case can be summarized in the following points:

The research is oriented to meet the health needs of children; consequently, it requires that it be conducted with this population and not with adults.
The parents or legal representatives of the minor must authorize his/her participation.
The minor accepts to participate by means of the figure of assent and, in case of refusal, his/her decision is respected.

*Important for parents, boys and girls:

Often, children who have not reached the legal age of consent can understand the implications that informed consent entails and go through the necessary procedures. Consequently, they may agree to participate as research subjects. Such informed acceptance, sometimes referred to as assent, is insufficient to permit participation in research unless it is supplemented by authorization from a parent, legal guardian, or other duly authorized representative.
Paragraph 14 of the 2002 CIOMS standards

Capacity to consent is recognized based on three criteria:

Age.
Psychological maturity.
State of growth and development.

Using these elements, it has been concluded that children over 12 years of age are able to give proper informed assent but with parental authorization.

Certification of a neurologist, psychiatrist or psychologist.

The RESOLUTION Nº 008430 OF 1993 in its chapter III expresses that in order to carry out research on minors or physically and mentally handicapped persons, in addition to the informed consent of those who exercise parental authority or legal representation of the minor or handicapped person in question, certification of a neurologist, psychiatrist or psychologist, on the subject’s capacity of understanding, reasoning and logic, must be obtained.

The role of the Ethics Committee in Clinical Research

It should ensure compliance with the stipulated requirements, but go beyond a legal formalism, as a process of inclusion and promotion of the child’s autonomy in decision making.

Therefore, ethics committees such as CRECIEC (Comité Regional de Ética en Investigación Clínica en el Eje Cafetero) seeking to protect the rights, safety and welfare of research participants have within their plans or guidelines with procedural and legal procedures.

By Viviana Zuluaga Cardona