Ensuring Safety in PCGC Studies

Study design
Researchers write a protocol to describe what will be learned from the study and how it will be done. It must also describe how safety will be maintained during the study.

Studies are reviewed for safety by many groups
There are several steps a study has to go through before it starts and patients can be enrolled:

  1. The protocol is reviewed and discussed in detail by members of the PCGC. The members have a wide variety of training and experience in nursing, medicine, statistics, special technologies, and managing clinical studies. Changes are made to create the best and safest study possible.
  2. The study protocol is then sent to a specially qualified, independent group appointed by the National Heart, Lung, and Blood Institute (NHLBI). This group is called the Observational Study Monitoring Board (OSMB). The OSMB may suggest changes to the protocol or consent form to ensure the safety of the study subjects.
  3. The protocol and consent form that has been reviewed by the PCGC members and the OSMB will then go to a review board at each hospital that will enroll patients in the study. These boards are called Institutional Review Boards (IRB). These boards are chosen by a hospital to review and approve a study before it starts and then at regular times, at least once each year. The primary purpose is to assure that the patients who participate in studies are protected.

Special training on patient safety is required
Each member of the research team must complete special training on how to protect subjects in clinical studies. Additional training is given to the research team on how to safely conduct each PCGC study. No one may contact a patient or family or participate in these studies unless there is proof that this training has been taken.

Dealing with adverse events
Each research team must collect and report side effects (also called adverse events) to their IRB, the PCGC, and then the OSMB. Not all adverse events will occur because of the study but may occur as a result of the condition of the study participant. Adverse events are followed closely by the doctors and nurses doing the study and they will decide what to do as soon as the adverse event is known. Serious adverse events are reviewed by the NHLBI staff within a few days of the report.

Ongoing review for safety
It is the job of the OSMB and IRB to review the study regularly to make sure that participants are safe and that the study data is reliable. They will meet as often as necessary to:

  • Assess how well each hospital is performing.
  • Review adverse events.
  • Suggest ending the study early if there are safety concerns.

All of the steps described above are taken to protect people who are enrolled in PCGC studies.

See the video and read the information on the Children and Clinical Studies website about “Safety and Precautions.”