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Frequently Asked Questions

What is medical research?
The terms research study, clinical trial, and experiment are all used to describe medical research. Each of these terms refers to an organized way to learn more about health in general, and also about better ways to prevent and treat children's diseases in the future. Most research studies are designed to answer a question that hasn't been answered yet.

Some studies involving little or no risk aren't expected to improve the health of those participating. In other studies, some research participants may see improvements in their health due to the experimental treatment. However, this kind of improvement is just a possibility. The specific treatment being tested may or may not end up working better than other available treatments.

For more information, see the web page titled "What is Medical Research?"

How is medical research different from medical therapy (treatment)?
Sometimes, medical research may seem very similar to the regular treatment (also called medical therapy) your child is receiving, or has received in the past. While there are similarities, there are also some important differences.

The sole purpose of medical therapy is to treat a particular child's illness or injury, and improve this child's health. The primary purpose of medical research is to gain knowledge so that treatment can be improved for ALL children. While some research studies may offer possible benefits to the subjects, direct benefit for a specific child is not the main goal.

Medical therapy can be adjusted to meet the needs and concerns of individual patients. On the other hand, for a research study to meet its scientific goals, the treatment for children in the study needs to follow the study design, or "protocol." If parents want changes in the treatment that aren't allowed by the protocol, they may withdraw their child from the study but can't have the protocol itself changed.

Parents agree to medical therapy only to improve their own child's health. In comparison, parents sometimes give permission for their child to be in a research study to help other children, and sometimes in the hopes that the experimental treatment will help their child-either now or in the future.

The primary responsibility of the health care providers involved in therapy is to treat your child's illness and improve your child's health. When health care providers conduct research, they are also responsible for following the directions of the study protocol. For example, if the study requires some children to receive the experimental treatment and others to receive the current standard treatment, the investigator must follow the rules for how children will be selected for each group.

Sometimes, medical therapy and medical research overlap. When considering enrolling your child in a research study, be sure to ask the researchers which parts of the treatment plan are research, and which are considered therapy.

For more information, see the web page titled "Differences Between Research and Medical Therapy."

What does assent mean?
Sometimes, in addition to asking the parents for permission for their child to be in a research study, the investigator will also ask for the child's "assent." Assent means that the child willingly agrees to be in the study. Assent does not simply mean that the child does not object to participating.

If the Institutional Review Board (IRB) reviewing the study decides that some or all of the children are able to give assent, the IRB must determine that adequate provisions are made for obtaining assent. In deciding whether or not assent is necessary, the IRB looks at things such as the age, maturity, and psychological state of the children involved. The IRB's decision may be made for all children who will be involved in the research study or for each child. Even if a child has the ability to assent, assent will not be required if the IRB determines that the research study offers the child the possibility of direct benefits-and that the benefit is important to the child's health and is available only through the research study.

There is no specific age at which assent must be obtained. Infants and small children cannot give assent. Many people feel that generally, children age 7 and older have the ability to give assent.

To give assent, the child does not need to have the same understanding as an adult must have to give informed consent. However, the child should understand what the study involves-in particular, what procedures, treatment, or tests will be done on the child, and how they will affect him or her. The child should know that being in the study is voluntary, and that he or she can leave the study even after it has begun. The investigator will try to provide information in a way that the child can understand. If the children who may participate are older-for example, adolescents-more information will be provided, and their understanding may be similar to that of adults.

If your child is being asked for assent, the investigator may want to speak with him or her alone. This is to answer any questions the child may want to ask in private, and to assure the child that he or she may say "no." In addition, you may want to speak to your child privately about the research study, to see if your child understands what the research involves and is not assenting just to please the investigators. In addition, your child may have questions about the research that he or she is not comfortable asking the investigator.

Even if your child's assent is not required, if you feel your child is able to help make the decision, you can involve him/her to the extent you think is appropriate.

Does my child have to participate?
Some parents believe that if they are asked to let their child participate in research, they really should say "yes." They also believe that once they agree, their child must remain in the study no matter what. Neither of these is true. You always have the right to say "no" to a research study. If you do say "yes," you may take your child out of the study at any time.

For more information, see the web page titled "Common Misunderstandings in Research."

If I enroll my child, can he or she leave the study early?
If you enroll your child in a study, you are free to withdraw him or her from the study at any time. However, you should discuss this with the research team first, so your child can be withdrawn in the safest way possible. You should also ask what else might happen when your child is withdrawn. For example, if the study involves medical equipment, will you need to return it?

For more information, see the web page titled "Common Misunderstandings in Research."

Are there risks involved with medical research?
There may be potential risks for those involved in a research study. Each study is different, and it's important to understand the risks of any study your child might be in. You can ask members of the research team what the risks of the study are, how likely it is that they will occur, and what protections are in place to reduce risks.

For more information, see the web pages titled "Why Include Children in Research?" and "Reasons for Participating in Medical Research."

What safeguards are in place to protect my child?
Certain steps are taken in every study to reduce risk and protect the participants. 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.

Many research studies must be approved in advance by a committee often called an "institutional review board," or "IRB." 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. As the level of risk increases, so do the requirements that must be met for a study to go forward.

Because children usually can't give informed consent for themselves, one or both parents (or the legal guardian) must give 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. Depending on the child's age and ability, and the nature of the study, the child must also agree to be in the study.

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.

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.

For more information, see the web page titled "Protections in Medical Research."

Will my child benefit from being in a research study?
Some parents mistakenly believe that the goal of a research study is to benefit their child personally. But the goal of a research study is to find out how to improve the health and medical treatment of children in the future. Some studies provide no possibility of personal benefit to the children participating. In others, the benefits may be similar to the benefits of receiving standard treatment outside the study. In other studies, the experimental treatment may actually be better than the standard treatment. However, this is only a possibility and not a guarantee.

For more information, see the web pages titled "Common Misunderstandings in Research" and "What is Medical Research?"

How do I decide if my child should participate?
Parents - and their children - will approach this decision differently, and there's no "right" or "wrong" answer. However, it may be helpful to gather information from people like the principal investigator and research coordinator, family members and friends, your child's regular doctor, and resources such as this website. You might want to find out what the study's purpose is-why is it being done? Has the experimental intervention been studied before? Will all the children in the study receive the experimental interventions, or will some be in a control group, and possibly receive a placebo? Are there possible benefits to your child from being in the study? Are there possible risks? You might also ask how the risks of the study will be reduced, and how the children's safety will be monitored.

In deciding whether or not your child should participate in a research study, you'll be choosing from a few different options, such as: For each alternative, you might want to ask some of the same questions you've asked about the research study, such as: In the end, your decision about medical research is likely to be influenced not only by the information you gather, but also by the unique characteristics of your child and your own family values.

For more information, see the web pages titled "Evaluating the Study" and "Choosing Among the Alternatives," and "Questions to Ask the Research Team."

What information is contained in an informed permission (consent) form?
Each research study is different, so the information contained in each form will also be different. However, most forms contain information on similar topics, some of which are discussed on this website. For example, a form will often have sections dealing with the following topics: (1) a description of the study, including how long it will last; (2) what parts of the study are experimental; (3) why the study is being done; (4) how the study is designed - such as whether there are different "study arms" and whether subjects are "randomized" into different arms and whether the study involves a placebo; (5) the possible benefits of the study; (6) the risks of harm or discomfort, if any; (7) alternatives to your child's participation; (8) confidentiality; (9) who to contact for more information; (10) the voluntary nature of your child's participation; (11) your right to take your child out of the study at any time; and (11) financial issues, such as any additional costs or any compensation provisions.

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