The Children’s Research Category was created by the HHS in July of 2018. This new category for research with children allows for certain types of research to be conducted with children, even if the risks are higher than average.
The regulations surrounding this category are very specific about what qualifies and what does not. For example, one requirement is that the study must address a problem or issue that affects, or is thought to affect, at least 1 year of life.
In this article, we will discuss some of the specifics of the Children’s Research Category and how they apply to different types of research.
The participants are selected on the basis of their status as participants in a broader study
A broader study is a larger study that includes children as participants. For example, a study on the effects of exercise on health may include children as participants.
Subpart D states that research with children may be eligible for exemption under Category 2 when the participants are selected on the basis of their status as participants in a broader study.
This is an important point because it shows that research on children may be exempt even if the broader study they are part of does not meet all of the requirements for Category 1.
Children who are part of a broader study may still be eligible for research reimbursement and benefit from additional protections if the broader study meets some criteria. Category 2 exemptions also apply to research involving only adults, so this point applies to adults as well.
However, only research involving children in Category 1 studies is specifically mentioned in Subpart D as being exempt.
The information obtained from the participants will not be identified with them
The information obtained from the participants must not be linked to the individual child. The researcher must not be able to identify the individual child when they access the information obtained from the children.
Subpart D states that any information obtained from children may not be used to identify them, their parents, or any other individuals mentioned by the children. This is for safety reasons, as well as protecting the privacy of the child.
The researcher may not use any other information obtained besides what is mentioned in Subpart D. They must also ensure that no one else accesses or uses any of this information either. It must be kept private and secure.
These regulations are put in place for good reason. It is to protect the children from potential harm or embarrassment.
The research involves no more than minimal risk to the participants
Minimal risk means that no harm, injury, or illness is likely to occur as a result of taking part in the research study.
The research study must have an ethical purpose and be designed to find out something new about the topic area being studied. The study must also have the potential to improve health or health care and/or reduce health disparities.
Minimal risk is assessed based on three factors: probability of harm or adverse effect, magnitude of such harm or adverse effect, and likelihood that the research will discover a worthwhile benefit.
Probability of harm or adverse effect refers to how likely it is that the person will experience some kind of harm or negative effect as a result of taking part in the research. Magnitude of such harm or adverse effect refers to how serious the harm or negative effect may be. Likelihood that the research will discover a worthwhile benefit refers to whether taking part in the research has the potential to improve health or health care and/or reduce health disparities.
The potential benefits to the participants outweigh the risks
As mentioned before, one of the main categories for research is whether or not the potential benefits to participants outweigh the risks.
When conducting research, it is important to understand that the entire point is to find out something new about a topic. There would be no need for research if we already knew everything there was to know.
Therefore, all research involves some level of risk. The difference lies in how much risk you are willing to take on behalf of the participants.
In order to qualify for exemption under Category 2, the potential benefits must outweigh the risks for both children and their families. This includes considering how the participation in research may affect their lives beyond just the study itself.
Parents are allowed to refuse for their child and are aware of what is happening
Parental consent is a very important part of Category 2 exemption. Parents must be allowed to refuse to have their child participate in the research.
The protocol must also inform parents about what will happen in the research and what they will be asked to consent to. This is so parents can make an informed decision about whether or not they want their child involved.
Category 2 does not require parental education, but it is recommended. Educating parents about the research can help put them at ease and increase participation.
Heather Davis is a registered nurse with more than 20 years of experience in numerous settings, including intensive care, outpatient and community hospital settings, as well as private practice nursing. She is also a certified diabetes educator (CDE) with a specialty in women’s health.(Source: Diabetes Forecast)\u2014 Diabetes Forecast | A magazine for people with diabetes and their loved ones
Furthermore, Category 2 does not require any sort of confidentiality between parent and child.
Parents are involved in the study and consent for their child
Parents are a major part of a child’s life, and their involvement can be an important part of any child research study.
Parents can provide information about the children, such as their health history or whether they have experienced certain events or circumstances.
Parents can also provide approval for the child to participate in the study, which is a crucial part of any research involving children.
Without parental approval, children cannot participate in the study, which would render the entire research project invalid. Children are not able to make these decisions for themselves, which is why parents must give approval.
Children can also feel more comfortable participating in a study if their parents are also involved. This lets the child know that someone else has trust in the researchers and what they are doing.
Children over the age of 16 can decide for themselves if they want to participate
Another important bullet point is that children over the age of 16 can decide for themselves if they want to participate in research. This is a crucial point, as child consent is very important when it comes to research.
Researchers must get child consent prior to conducting the study, and can only conduct the study if they receive child consent.
However, Subpart D states that regardless of whether children give consent, researchers must still assess whether their participation will be harmful or beneficial to them.
This assessment must be conducted through qualified professionals and/or experts in the field being researched. If it is determined that participation will not harm them, then they may participate.
Subpart D also states that if there is any doubt as to whether participation will be harmful, then they cannot be forced to participate.
Minors must have an adult guardian agree to participation with them
Minors must have an adult guardian agree to their participation in the research. This can be a parent, guardian, family member, or other adult who has responsibility over the minor.
Subpart D explicitly states that minors cannot participate in research unless an adult agrees to their participation. This is a hard rule for Category 2!
While it may seem obvious that an adult must agree to participation on behalf of a minor, this requirement is explicitly stated in Subpart D.
It is the responsibility of the researcher to ensure that an adult agrees to participation on behalf of each minor participating in the research. A researcher may not recruit participants unless they can confirm this element.
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