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Tasmeen Singh, Research Coordinator, talks about the number of safety precautions and protections taken in a research study.

Safety and Protections

Every parent wants to know Who is watching out for my child in a study?

The answer is lots of people.

While research can have risks, there is a lot that goes on "behind the scenes" to ensure safety before families are invited to be in a study.

  • Many people review a study in detail before a single person is enrolled. These people include
    • the scientists who focus on identifying the right treatment,
    • the statisticians who help to design the right study with the right number of participants to get good results, and
    • the medical investigators (nurses, doctors, pharmacists, psychologists, and technicians) who will make sure that the study is done in the right way with the right participants.
  • Informed consent documents are developed to describe why a study is being done, what will happen, and risks and benefits.
  • Institutional Review Boards (IRBs) are independent committees that review research plans and consent forms to make sure that people in a study are informed and protected when in studies. They review studies both before they start and throughout the study. They are also known as Research Ethics Boards (REBs) or Ethics Committees (ECs).

Safety measures

There are safety measures in place to protect children while they are in a study.

  • There are many clearly defined government rules for protecting human subjects in clinical research with special protections for children (this link will take you to the Office for Human Research Protections for more information about Special Protections for Children as Research Subjects).
  • Each study has a research team responsible for running the study and making sure people are safe.
  • Some studies have a Data and Safety Monitoring Board that regularly monitors safety. This impartial Board oversees studies and says if a study should be changed or closed at any time for safety issues.
  • Some studies have a Medical Monitor, usually a doctor or nurse not associated with the study, who reviews side effects that occur in a study.

Be comfortable

As a parent, you must be comfortable with what your child will be doing in a study.

  • Even with efforts to make your child safe, remember there may still be risks. Make sure you understand the possible risks and benefits and understand how they apply to your child.
  • Get familiar with the study team, whose job it is to protect your child.
  • Find out what resources are available to help you understand your rights.
  • Ask questions.

Clinical Studies don't just "happen." Before your child is even asked to participate, the procedure or medication being researched has likely been through a series of steps:

This figure visually represents the concept that there are stages of clinical research. The first stage represented is testing in a lab (biochemistry), followed by testing in animals, followed by testing in adults and older children (where possible). The next stages are: Phase I clinical studies (small doses to test tolerance/side effects), phase II studies to test effectiveness (does it do anything to the disease) and phase III studies (does it make sense to adopt the medication).

"...there are individuals whose only concern is making sure that the safety of the child is protected..."
Dr. William Rodriquez, Pediatrician

"The only way to really find out whether or not a proposed new medication is safe and whether or not it is effective is to test it."
Dr. David Wendler, Bioethicist

"The whole point of the study was not to know whether your child was receiving the drug or not you might hesitate to give it to them [if you knew what they were on]."
Jose, father of child in heart defect study

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