Many parents ask me whether they should let their child participate in a research trial -- a medical study of health, disease, or treatments. Some trials are for new vaccines, but increasingly we find there are trials for new agents to improve health.

I try to evaluate the potential benefits to each patient on a per-trial basis, but it is hard to say I am totally unbiased in my assessment.

If you're considering entering your child in a study, Corinne M. Linardic, MD, one of our hematology-oncology attending doctors at Duke Children’s Hospital, gives some sound advice for parents about what to consider.

-- Dennis Clements MD, PhD, MPH

Why Should a Child Participate in a Research Study?

Corinne M. Linardic, MDPreventive health care has made remarkable strides in westernized countries. Consider our improved ability to treat childhood diabetes and childhood cancer, and our ability to prevent childhood infections through immunization.

In fact, as a medical community we know a lot more about almost all diseases, and armed with this information we have improved the care of children worldwide.

However, there are still medical conditions that we know very little about -- either the cause or the cure. Sometimes we have a reasonable treatment for a specific disease, but the treatment may be burdened with too many side effects.

So, as scientists discover new treatments, and health care providers try to implement them, each of these treatments needs to be evaluated to determine whether it is better than the old treatment, and whether it has any unanticipated side effects. That’s where research studies come in.

How a Study Works

There are many different types of research studies performed to learn more about health and disease in children. Some studies use information already available in medical databases, and do not require individual consent. Other studies involve individual participation of research subjects and require their verbal and written consent.

Before a research study can begin, it is thoroughly reviewed by a special group of medical personnel and lay people to be sure that the rights and welfare of potential participants are protected.

Research studies always include the gathering of information, and if well designed, a study will also include a plan for how the gathered information will be analyzed and applied towards treating future patients.

What’s Involved

For parents, a study can be as simple as answering a questionnaire about their newborn’s behavior, or as complicated as participating in a clinical trial where a new drug is being compared to a standard treatment to see if it offers a better cure for their child’s type of cancer.

For the study team, a study can be as simple as a single question about a teen’s attitude toward sports, carried out by an individual university researcher, or as complicated as a worldwide clinical trial to evaluate a new treatment for malaria in children.

Risks and Benefits

Regardless of the nature of the study, there are always inherent risks, which the person in charge of the study (or a designee) should tell you about.

The risks may be of minimal impact, such as risks that are encountered in every day medical care, such as bruising when getting your blood drawn. Or the risk may be high, such as the unanticipated severe side effect of a new chemotherapy drug.

Because it is a research study, and the outcome is not known ahead of time, it is imperative that the person considering participating in a study understand both the risks and benefits of the study, and give written consent before he or she chooses to participate.

Most of the time this means having a conversation with the medical provider who will discuss the details of the study procedures and then reviewing written document that clearly explains the study.

Once a decision is made to participate, the parent’s handwritten signature is required as evidence of consent. Children ages 12 to 17 years are encouraged to be part of the consenting process, and are required to give their assent to be a research subject by also signing the consent document. Children less than 12 but greater than age seven are also asked to give their assent to be in the study after the researcher and parents provide a description of the study at a level that the child can understand.

Participating in a well-designed medical study is an opportunity to be part of answering a big question that can only be answered with the participation many people.

In fact, it is only through clinical studies that the medical community can continue to make strides in understanding the causes of human disease, and identifying brand-new effective treatments. However, participating in a study is a very personal decision that demands a great deal of thought.

What to Consider

Sound advice when considering participation in a study:

• Read the study consent form carefully and thoroughly.
• Take your time to make your decision; discuss your decision-making with your friends and family.
• As much as possible, include your child in the discussion and decision to the extent that she or he is able to understand and take part.
• Don’t be afraid to ask questions!

-- Corinne M. Linardic, MD, is an attending physician at Duke Children’s Hospital and Health Center.

-- Dennis Clements, MD, PhD, MPH, is the chief of primary care pediatrics at Duke Children's Hospital.