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Protections in Medical Research

Clip Number: 6 of 12
Presentation: Children and Research
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Reviewed By: Arthur Schoenstadt, MD
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There may be potential risks for those involved in research. Each study is different, and it's important to understand the risks of any study your child might be in. However, certain steps are taken in every study to reduce risk and protect the participants.
First of all, investigators themselves try to design studies that minimize risk to the subjects. Their goal is to learn from the study without exposing subjects to unnecessary risks.
Second, most research studies must be approved in advance by a committee - often called an "institutional review board," or "IRB." IRBs are made up of scientists and doctors, as well as lay people from the local community. Before allowing a research study to go ahead, the IRB reviews it to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the importance of what may be learned.
IRBs use a special set of standards when evaluating a study that involves children. They look at the level of risk involved and the possibility of benefits. As the level of risk increases, so do the requirements that must be met for a study to go forward.
If certain new and important information becomes available during the study, the research team must notify the IRB and alert the parents of children in the study.
Third, because children usually can't give informed consent for themselves, one or both parents - or the legal guardian - must give their permission before the child can be included in a study. The informed permission process is designed to help parents understand the study before they decide whether or not their child should participate. As part of this process, parents read a form that describes the risks and potential benefits of the medicine, treatment, or tests in the experiment (and of the other possible options available). This form also has a lot of other information about the study. Parents then meet with members of the research team to discuss this information and ask questions.
Fourth, some studies have on-going review boards that collect and monitor safety data. Similarly, the investigators in all studies have ways of monitoring the well-being of the subjects. Studies can be suspended - or stopped altogether - if the risks are greater than expected.
Finally, in some cases, the child must also agree to be in the study. This is called giving "assent." The need to get assent depends on the child's age and ability, and the specifics of the study. The role of a child's assent is an important topic, and is discussed more fully in the reference library.
Before allowing your child to participate in a study, you may want to find out what protections are in place to reduce risk in that study. The members of the research team can give you this information.

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