Helpful Research Terms

Children give assent when they agree to take part in research. Children who are old enough (usually age 7 or older) to express that they want to be in a study sign an assent form. For this study children will provide assent once they are no longer on a breathing machine.

In extracorporeal membrane oxygenation (ECMO), blood is pumped outside of the body to a heart-lung machine that removes carbon dioxide and sends oxygen-filled blood back to tissues in the body. People who need ECMO have a severe and life-threatening illness that stops their heart or lungs from working properly. For example, ECMO is used during life-threatening conditions such as severe lung damage from infection.

Each study has a list of requirements of who can and cannot participate. The items that allow someone to participate in a study are called inclusion criteria. The factors that do not allow someone to participate are called exclusion criteria.

A group of people that might include doctors, researchers, community members, pharmacists and other experts who review and approve research studies before they begin.

The individual with primary responsibility for oversight and management of the conduct of the study at all participating research sites.

Parents/guardians give permission when they agree their child can take part in research. Parents/guardians sign a consent form to confirm that they understand the study and give permission for their child to participate.

A carefully designed plan to keep study participants safe and answer specific research questions.

The individual at each site who agreed to participate in the multi-center study and is responsible for the oversight of the conduct of the study at their center.