{"id":2486,"date":"2018-03-23T00:00:00","date_gmt":"2018-03-23T04:00:00","guid":{"rendered":"https:\/\/www.med.unc.edu\/childrensresearch\/research\/clinical-trials\/information-for-patients-and-families-regarding-clinical-trials\/"},"modified":"2021-03-26T07:36:27","modified_gmt":"2021-03-26T11:36:27","slug":"frequently-asked-questions","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/childrensresearch\/research\/clinical-trials\/frequently-asked-questions\/","title":{"rendered":"Frequently Asked Questions"},"content":{"rendered":"

\"Clinical<\/p>\n

There is a lot to consider before your child participates in a clinical trial. We’ve put together answers to some of the most frequently asked questions regarding children in clinical research. If you have additional questions, we invite you to contact us or visit the National Institutes of Health’s “NIH Clinical Research Trials and You<\/a>.”<\/p>\nWhat is a clinical trial?<\/span>

Clinical research that evaluates a treatment or intervention are referred to as clinical trials. Clinical trials can be found at both the private and public level for children and adults. These studies provide researchers with data necessary to create treatments and interventions that can be used to combat diseases and improve human health. It\u2019s important to note that clinical trials should not be considered the same as individualized medical care by a provider. In a clinical trial, patients follow a pre-determined plan of care and may or may not receive benefits from whatever is being tested.<\/div>\nWhy are you performing clinical trials in children?<\/span>
Children are not just small adults. They are a vulnerable and unique population that requires special consideration in healthcare and in research. Children differ developmentally and physically from adults; however, the majority of medications given to hospitalized children is prescribed off-label, which means that it has not been studied in children. Their organs and systems are in different stages of development, and may work differently and process things differently. Performing clinical trials in pediatric populations addresses this gap and helps develop new therapies and interventions to give to children in need.<\/div>\nShould my child participate? Is it safe?<\/span>
It is always the choice of the patient and their family whether to enroll in a study. Participation is voluntary and you can change your mind at any time. Your decision not to enroll in a study does not and will not impact the clinical care you or your child receives at UNC.<\/p>\n

Many guidelines and measures are in place to protect people participating in clinical trials, with particular attention being given to children as members of a vulnerable population. The health of each participant\u00a0is a top priority and is carefully protected throughout the duration of the study.<\/p>\n

Clinical trials must be approved by an appropriate institutional or federal Institutional Review Board (IRB) before participants can enroll. An IRB is composed of a team of medical professionals who perform critical oversight of the research in the study, in order to ensure the clinical trial is safe for participants as well as scientifically relevant.\u00a0The\u00a0Office of Human Research Ethics (OHRE)<\/a> oversees all IRBs at UNC and is responsible for ethical and regulatory oversight of research at UNC-Chapel Hill that involves human subjects.<\/p>\n<\/div>\nHow do I find a clinical trial for my child?<\/span>

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