Ethics
In this section you find out ethical issues surrounding clinical research with children.
Clinical research involving children raises special ethical issues that do not arise in the context of adults and genetic research. These are related to capacity to consent to participate in research, the evaluation of research risks and benefits, confidentiality, and the return of results.
The issues surrounding the conservation and secondary use of genetic information (for example, through the creation of biobanks) as well as those concerning the familial implications of genetic information also apply to children.
1. Consent to research
2. Children’s assent/dissent to research
3. Risks and benefits of research
4. Communication of results
5. Confidentiality
6. More links on ethics and clinical trials in children
In law, informed consent requires the ability to fully understand the nature of a research project as well as the consequences of participating in research. Because children’s decision-making capacity is less developed, they are considered legally incompetent to understand all the relevant aspects of participation in research required in order to provide their informed consent. Therefore, you as a child’s parent or legal guardian must provide consent for the child’s participation in research.
2. Children’s assent/dissent to research
Although children are not legally competent to consent to participate in research, they do have a say. There is a process called "assent". Assent is an expression of a child’s willingness to participate in research. Dissent, on the other hand, is a child’s refusal to participate in a research project.
In most cases, this means that children are given basic facts about a research study and are asked to be part of the decision. Children can be asked to give assent from as young as six or seven. Sometimes they can be older or, depending on the study, assent may not be required.
To obtain assent from a child, the nature and the consequences of research should be communicated in a way that is adapted to the child’s language, comprehension, and maturity level. Sometimes a parent and child can't agree. But often disagreements can be worked out with the help of the study team. In fact, there are advocates and ethics experts involved in most studies who can help with just these situations.
read more on your child's say in clinical research>>
3. Risks and benefits of research
Parents who are asked to enter their child into a study will want to know, "Will being in this study help MY child?" While most studies are not done to help a specific child, does this mean there are no benefits to being in a study?
It is very important to understand that research is done to gain information about a disease, condition, drug or treatment that will benefit children in the future. It is different from regular medical treatment that is given to help a specific child. Those issues can be potential benefits when entering a clinical study.
When recruiting children to participate in genetic research, researchers must ensure that the potential benefits and risks of the research are reasonably balanced. When direct benefits for the child participant may be expected from research, the risks must be justified in relation to these expected benefits for the individual participant. However, there is a limit to the risks that children can be subjected to in research: children may not be subjected to research that involves a serious risk to health.
Research that does not hold the prospect of direct benefit for child research participants must hold prospect of benefits to persons in the same age category or having the same disease or handicap as participants. The risk to which the child may be exposed should be minimal or similar to the risk associated with his/her medical or psychological condition.
Research participants have the right to be informed of general research results. At times, they may also receive personal results. Where individual research results exist, those results are disclosed to the child’s parents or legal guardian, who then decide whether it is in the best interest of the child that he or she be informed as well. This decision is made based on the child’s age, development, and maturity level.
The right to confidentiality of research, testing and screening results is exercised by their parents or legal guardians. Results are returned to the child’s parents.
6. More links on ethics and clinical trials in children
- Ethical considerations for clinical trials performed in children. Recommendations of the Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use
source: modified from HumGen