Discussion and Analysis
Discussion and Analysis
Children are a unique population with distinct developmental and physiological differences from adults. Clinical trials in children are essential to develop age-specific, empirically-verified therapies and interventions to determine and improve the best medical treatment available. Children cannot give informed consent because consent implies a full understanding of the potential risks and other considerations of a clinical trial. Parents, as the child's advocates, must decide if they wish to give permission in place of informed consent. Federal regulations require that consent to participate in research on behalf of a child be provided by a parent or an individual authorized under applicable state or local law to provide consent on the childs behalf to general medical care. Under Massachusetts law, a parent is generally authorized to consent to general medical care on behalf of their child. The European Clinical Trials Directive required parental consent for all clinical trials on minors. parent consent is the guide to allow for research, The parents have the right to agree for consent or refuse because they have the power of authority for their child and they want the better for them by involving them in researches. As a nurse before allowing the parent to sing the consent, nurse and researchers have to explain all facts ,benefit and risk. Clinical trials yield important information on a medical product's safety, dosing, and effectiveness, which is the basis for food and drug administration (FDA) approval and product labeling. There are many advantage for participating in clinical trials, firstly if the child have a disease that cannot be treated with an existing drug or regimen, participation might provide a successful treatment before it becomes available to others. Secondary, if the child is debilitated in some way, you may have the opportunity to test a regimen that would improve your quality of life. Moreover, If the child are qualified to participate in a study for a particular disease or condition, and you have had trouble finding good care for the disease or condition to that point, access might be needed to improved care since the investigators involved in the study focus directly on the medical problem being studied. Also, the drugs and protocols offered during clinical trials are
often provided at no cost to participants. Patients who have trouble affording the drugs or treatment they need may consider enrolling in a clinical trial in order to access the protocols that may help them. In addition, some patients have no alternatives for treatment and permanent debilitation or death is imminent. In such cases, participation in a clinical trial may give them hope or possibilities that do not exist otherwise. Doing research is necessary to develop the medicine and pharmacology. Day by day the medicine is developing and new medication are produced to cure the diseases which thought to be untreated. research may change practice and give important results and if any side effects happen children are in hospital and could be treated as soon as possible.