If your child is considering becoming a research volunteer in a depression study, all of the procedures can seem a little confusing. However, knowing what to expect from being a volunteer in a research study can help you and your child make a confident decision about participation.
Information and Informed Consent
The first step in the research process is the information and consent process. One of the researchers will explain the study process to you and your child. This will include why your child has been selected to participate in the study, what is being researched, the potential risks and benefits of participation, what procedures will occur, and your child's rights as a research volunteer.
One of the most important steps in a research study is the informed consent process. Prior to a research study, an investigator must create an informed consent document, which explains all study procedures and rights of participants. A parent or guardian must read and sign the informed consent form for a child under the age of 18, agreeing to participation.
Also, a child who is cognitively able to must provide verbal (and sometimes written) consent, which is called assent.
A parent or guardian and the child must both agree to participate in the study. If either person disagrees, the child cannot participate.
The screening process is important because it allows the researchers to determine if your child meets the study inclusion criteria and is eligible for participation. The inclusion and exclusion criteria is always determined prior to starting the study, and must be followed strictly. Inclusion criteria may include a psychiatric or physical illness, like major depressive disorder, or specific laboratory values or assessment scores.
Study Group Assignment
In certain types of research, if your child is determined to be a good fit for the study, study group assignment may be a next step. This means that your child will be assigned to one of several study groups. Typically, there are treatment groups, in which the child receives the experimental treatment being researched, like an antidepressant drug, or control groups, where the child either receives no treatment, a placebo (inactive substance), or an already accepted treatment method, like Prozac.
Usually, study group assignment is random, which means that a child is assigned to a group by chance, like the flip of a coin. In some cases, you may or may not know which study group your child has been assigned to.
Assessments and Procedures
Study assessments and procedures may include physical exams; diagnostic testing, like x-rays or laboratory tests; or psychological assessments, depending on the study.
Assessments may occur at different time intervals. Study participants may be required to complete assessments on their own at home, like keeping diaries of their feelings or side effects they experience, or may be asked to complete standardized assessment questionnaires.
All study assessment procedures are pre-determined and are designed to gain knowledge and keep participants safe.
Safety is always of utmost importance when it comes to a depression study. Your child will be closely monitored during study assessments to make sure that her symptoms are never getting worse.
If, during your child's participation in a study, her symptoms ever worsen or she develops new or worsening side effects, it is important to contact the study investigator as soon as possible. This contact information will be provided to you at the start of the study.
Rights as a Research Volunteer
Your child's rights as a research volunteer are very important. Your child has the right:
- To choose to participate in the study or not
- To withdraw from the study at any time without penalty
- To ask any questions and receive answers about her participation in the study
- To refuse any study procedures (however, this may result in study withdrawal)
In some cases, your child may receive compensation, such as money or movie tickets, for participation. The study investigator will let you know at the beginning of the study if this can be expected.
Knowing what to expect from a research study can help a parent and child feel at ease. While the extra steps of research can sometimes seem overwhelming to a child, many parents and children who have participated in research report feeling good about it. Becoming a research participant can help children learn about their depression and feel good about themselves for potentially helping others to learn more about the disorder.
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