Clinical research is the process of asking questions and testing new approaches to learn more about a condition or disease. At Boston Children’s Hospital (BCH), research helps us discover better ways to prevent illness, treat disease, and improve health outcomes for children and families around the world. Many of the doctors you see at BCH are also researchers, working to advance care in their specialties. Research is a central pillar of BCH’s mission.
Clinical research helps us learn how to prevent, diagnose, and treat illness. The same ethical and legal standards that guide healthcare also apply to clinical research studies. In addition, clinical research is federally regulated and includes multiple safeguards to protect participants. Every study follows a carefully designed protocol that outlines what researchers will do and how safety will be monitored. During the lifecycle of the study, results may be shared with scientific and medical communities, as well as regulatory agencies to monitor progress. Participant identities are kept confidential and are never included in reports.
Participating in clinical research is a personal decision for you and your family. For some, there may be potential benefits—not only for your child, but for other children in the future.
Benefits include:
Risks include:
Our research teams will work closely with you to answer questions, explain options, and help you decide whether a clinical research study is right for your child and family.
There are several study types at BCH. Eligibility is determined by characteristics known as “inclusion and exclusion criteria.” These will vary based on condition or disease in order to protect participants and ensure that the study produces reliable results. Below are the different types of studies at BCH:
Participating in clinical research at BCH does not replace or interfere with your child’s medical care. Participation is optional, and choosing not to participate—or deciding to withdraw at any time—will not affect your child’s care. Medical care focuses on treating your child’s individual health needs. Research helps doctors learn how to improve care for children in the future, and there is no guarantee of direct benefit from participation. If you decide to participate in research, it is institutional best practice that our study teams will inform your child’s doctor regarding study eligibility and participation so that care can be coordinated appropriately. All participants are carefully monitored to help minimize risks, which are explained in advance.
A member of a study team will likely contact you in person or via a MyChart message regarding participation. Your child’s doctor may also tell you about a research study and ask if you would like your child to participate.
You may explore clinical research opportunities on your own through MyChart’s Study Finder function. This provides the option to browse studies that are currently recruiting and express interest on your own. Not all studies will have this option available, so some studies that your child may be eligible for will not be seen in the Study Finder.
EPIC is an electronic health record system used at BCH. Research records maintained in BCH research systems are only accessible to authorized BCH Employees and other authorized study staff. Research records are separated from the clinical medical record and are not shared via Care Everywhere or other health information exchanges. Only research information explicitly documented in the medical record for treatment purposes is included in the clinical chart and may be shared for clinical treatment.
Email Clinical Research Operations at BCH.CRO.Help@childrens.harvard.edu with any questions or feedback.