Participate in Research

Clinical research is any study involving human participants to gain a better understanding of how the body works and how diseases affect different people. Typically, clinical research comes after basic science research (experiments in cell cultures and animals).
There are many goals that clinical research can have, such as:

• Testing a new treatment to determine its effect in comparison to a mock treatment (also called placebo or sugar pill) or a treatment currently in use
• Looking for causes of a disease or a condition
• Determining the impact of a disease or an intervention on a patient’s quality of life
• Determining the best way to prevent or diagnose a disease
• Determining the prognosis of a disease (the likely course of the patient’s disease or condition)

The main difference between medical care and clinical research is their goals. The sole purpose of medical care is to improve a particular child’s health by treating their illness or injury. The primary purpose of clinical research is to gain knowledge so that treatment can be improved for all children. While some research studies may offer possible benefits to the participants, direct benefit for a specific child is not the main goal. In clinical trials, treatment is determined by a set of rules called a protocol. The protocol describes how your child will be treated, what tests your child will receive and when your child will visit their physician. Clinical trials often require the collection of more data than would be required for routine medical care, therefore more frequent visits with a physician and closer monitoring are usually associated with clinical trials.

Sometimes research studies require extra tests or treatments that may not normally be required for routine medical care but not always. If extra visits or tests are needed be assured that they have been carefully determined in order to ensure that the maximum amount of information can be gained from the clinical trial. For example, if a child were to come to the emergency department with a broken ankle it is normal for them to get an x‐ray and to return to see the Orthopedic doctor in 10 days. This would still happen but as part of the research the child might receive an MRI of their ankle and receive a follow up phone call from a research assistant after a few days to collect data on how the child is doing. All aspects of the study that are not part of regular care will be explained to you by the study doctor or researcher.

Children are not the same as adults, but without doing research in children we have to treat them as though they are. Since children are still developing their brains and bodies, treatments can affect them differently than adults, and conducting research with child participants will help us find treatments and dosages meant specifically for children

Every study has a protocol that indicates who can participate based on detailed inclusion and exclusion criteria. These criteria include factors such as age, gender, medical history, diagnosis, etc. The criteria are used to identify appropriate participants, to keep patients safe, and to help ensure that studies will give accurate results.

No, participation in research is completely voluntary. If you decide that you don’t want your child to participate in a research study, your decision will not affect your child’s medical care at CHEO.

Benefits and risks vary from study to study, but the following points can be applied to most: 

Benefits:

• Clinical trials provide an opportunity for participants to play a more active role in their own health care.
• Clinical trials provide access to experimental treatments before they are widely available.
• Participants will obtain expert medical care during the trial.
• Clinical trials help others by contributing to medical research. With increasing numbers of trials assessing genetics, the people who benefit may include your family members.

Risks:

• The experimental treatment may not be effective for the participant.
• The treatment may be effective, but the participant may be assigned to a group that does not receive the treatment.
• The protocol may require more of your time than routine medical care.

All clinical trials must be approved by CHEO’s Research Ethics Board. This process is designed to protect the rights, safety and well‐being of study participants. It is also designed to ensure that the goals and approach of the study are scientifically valid and appropriate. Research Ethics Boards contain experts in scientific areas, the conduct of research, research ethics, federal and provincial laws that govern research and at CHEO, the issues of importance to understanding children and their development.

Only the members of the research team have access to the information collected for a research study. The members of the research team may be located here in Ottawa or in other parts of the country, depending on the particular study. The data that they will have access to will be labelled with a study number and won’t include participants’ names. All of the information collected will be kept in a password‐protected database.

A parent or guardian will be asked to read and sign a form called an Informed Consent Form before their child can participate in a clinical trial. The form describes all aspects of the research study that are relevant to their decision to participate, including:

• The reason for the study
• How many people will participate
• What is involved (tests, treatment, questionnaires, etc.)
• An outline of the schedule of visits and testing required
• The risks and benefits of participating
• Any payments/incentives to you
• The alternatives to participating
• The confidentiality, privacy and rights of the participants
• Whom to contact for questions

You are encouraged to ask the research personnel to explain anything you do not understand in the Informed Consent Form. By signing the consent form, you are giving your child permission to participate in the study, but it is not a contract and you may withdraw your child from the study at any time without having to give a reason. CHEO’s Research Ethics Board reviews all Informed Consent Forms before any families see them.

Some studies require both parental permission and the child’s “assent” in order for a child to participate. Assent means that the child actively agrees to be in the study. Age, maturity, and psychological state are considered when the REB determines whether assent is necessary. If some or all of the children are deemed capable of giving assent, the REB will ensure that adequate provisions for obtaining assent are in place. Assent forms are not as detailed as informed consent forms for parents, however they provide information on the study in a way that the child can understand.

You are free to withdraw your child from a study at any time. In some cases, an abrupt or quick withdrawal from the study treatment might affect your child’s health, therefore, do not stop your child’s treatment without notifying the research team. The research team can also explain the necessary steps for withdrawing your child (i.e. if you need to return medical equipment you had for the study).

Some studies may take a few hours. Others may take a few days, months or years. Each study is different. The amount of time a study takes depends upon the research question being asked. Whenever possible, researchers always will combine the study visit(s) with the regular scheduled clinic visit(s).

Most studies involve principal investigators who have experienced research nurses and support staff working with them. All staff involved with a specific study will have received training corresponding to the research study (i.e. any common side effects). Research staff are fully prepared to give your child the same close attention and treatment that they would receive from routine medical care.

Your child’s results from routine laboratory tests and examinations can normally be given to you. However, some tests are run years after the specimens are obtained purely for research. When this is the case, your child’s results will not be returned to you

Our Research Ethics Board requires researchers to provide a means for families to see the results of the research they have participated in. Researchers do this in a variety of ways including, sending a letter to your home, posting the results on a website so all families can see them or providing a person to contact should you wish to know the results. We also have many of our studies listed in our Research Projects section, and results are shared through our Discovery Minute Videos. Study results are often published in a journal or in another form of media such as a conference presentation. To access a list of CHEO’s publications, contact [email protected]