Over the last few decades, the healthcare industry has come to recognize that research on children is necessary to determine the safest and most effective treatments for pediatric patients. Whether your institution is part of a nationally renowned research program or participates in a few pharmaceutical research studies a year, the following two issues are critical when structuring research studies that involve pediatric patients.
Ensuring appropriate safeguards for children participating in research
In addition to the general regulatory requirements applicable to all research studies, when research involves children, there are additional safeguards that institutions and internal review boards (IRBs) must address. When approving a research study, the IRB must determine whether the study involves greater than minimal risk and assess the potential benefit for the child. In addition, the IRB is charged with considering the potential benefits, risks, and discomforts to children participating in the research and assessing the justification for their inclusion in the research.
Such tasks may frequently require the IRB to balance the competing interests of various parties other than the research subjects themselves. For example, investigators may be less cognizant of the risk and discomfort a particular treatment will have on a child because of their desire to further their research. Parents may want to enroll their child in a trial despite the fact that a child’s disease is too advanced for participation to be beneficial. With all of these factors, the hospital and the IRB play a pivotal role in balancing the potential benefits of the research against the risks.
In order to achieve the above, institutions should have a formal process to assess the risks and potential benefits of each study. Your institution may want to consider having a checklist of factors to consider in this process that may include:
- The child’s age;
- The child’s ability to understand what participation in the research will involve;
- The child’s health status;
- Potential risks to the child;
- Level of discomfort the child is likely to endure;
- Potential benefits to the child; and
- Potential benefits to other children with the disease or society as a whole.
In addition, carefully consider the makeup of your IRB. For example, including an individual on the IRB who has participated in pediatric clinical trials in the past – whether as a parent or as a child – may be invaluable in assessing the various risks and benefits and may help maintain focus on protecting children.
Informed consent for research involving children
Obtaining informed consent to perform research on a child is uniquely challenging because the person giving the consent is not the person who will participate in the research. As a result, the consent process has two elements: parental permission and child assent. While much of the consent process focuses on the rights of the parents, it is important to balance that with the child’s right to assent. While the federal regulations do not specify the age at which a child has to begin assenting, experts agree that this age is around 7. Further, a child’s assent or dissent should be given more consideration beginning in the pre-teen years.
A child who does not assent to research may still participate in the research in certain cases. Assent will not be required if the child is not capable of providing assent due to their psychological state, maturity, or other factors. If a child who is capable of assent does not assent to the research, he or she can still participate if there is a potential direct benefit from a treatment that is only available through research and the parents’ consent to the child’s participation.
To ensure the appropriate process is followed to obtain a child’s assent, your institution may want to consider having different processes/requirements for different age groups. For example, it might be appropriate to have one process for children under the age of 7, another process for ages 7 to 11, and yet another process for ages 12 to 17.
As is true with all informed consent, it is not the patient’s or parent’s signature at the bottom of the informed consent document that results in informed consent being given. Informed consent is a process, and while written documents are required and can be helpful, make sure your process takes the proper steps to ensure parents are informed and agree to the research and that the child is involved to the appropriate extent.
Pediatric clinical research can present a number of compliance challenges. If your institution can get a handle on these two issues, you will have less of a chance that your research on “little” subjects will get you in big trouble. If you have any questions, please contact Cori Turner, Wakaba Tessier or one of our other healthcare attorneys.