How to Qualify

This section describes eligibility and exclusion criteria, including how one meets criteria and who decides whether criteria are met.  Participants qualify by meeting the eligibility criteria.
Each study has rules about who can or cannot participate in the study. These rules, called eligibility criteria, describe characteristics that must be shared by all participants. Eligibility criteria differ from study to study. They may include age, sex, medical history, and current health status. Eligibility criteria for treatment studies sometimes make it a rule that people are a similar age, have similar disease characteristics, and/or have a certain type of genetic mutation.
Eligibility criteria include inclusion and exclusion criteria. The goal of having inclusion and exclusion criteria is to enroll a group of participants that are most likely to help answer the research question. For clinical trials that are studying a new intervention, the trials are designed to try and get an answer as quickly and efficiently as possible.
Inclusion criteria are rules about the specific characteristics that a person must have in order to be included in the study.  These can include personal characteristics, such as age and sex; disease characteristics, such as the specific mutation or symptoms a person is experiencing; or treatment characteristics, such as previous treatments.  The inclusion criteria help to select participants who are similar in characteristics that are likely to affect their reaction to a specific treatment in a measurable way, or who have a similar disease course.  People who meet the inclusion criteria will not be the same in other areas of their personal or medical life.  People who do not meet all of the inclusion criteria will not be able to enroll in the study.  Different studies have different inclusion criteria, which means not being eligible for one study does not mean you will not be able to participate in another study.
Exclusion criteria are rules that would prevent people from participating in a study, even if they met all of the inclusion criteria.  Exclusion criteria identify specific characteristics, such as other medical conditions or personal traits, which may affect the person’s condition in a way that makes participation more dangerous, or that makes the individual less likely to successfully complete the trial. 

Who decides whether a person meets eligibility criteria?

The study team members are the only people who say for sure whether a person meets the eligibility criteria. To do this, the study team will often review medical records and ask questions about previous doctor visits and medications. Parents of children may have to authorize their children’s other doctors to send medical records to the study team. (Remember, nobody can release a child’s medical information without a parent/guardian’s authorization.)
Different studies require different types of tests during the screening visit.
After reviewing medical records and examining potential participants, the study team will decide if a potential participant is a good candidate for the study. Remember that every child or adult is NOT a good candidate to participate in every study. Certain clinical trials may be studying new treatments or may require assessments that may be more risky to you (affected individual) or your child than to others. In these situations, the doctor may decide not to enroll you or your child to protect their safety. Other studies may have specific criteria of enrollment that you or your child may not meet. For example, researchers may be conducting a study in a specific age group or  in children/adults that have been off a certain medication for a specific amount of time. If this is the case, you (affected individual) or your child may not be able to participate in that study. 
If you or your child meets the requirements for a clinical trial, it is important that you understand the purpose and structure of the trial before you decide to participate. Just because you (affected individual) or your child can be in the study does not mean you should give permission for yourself or your child to participate. Keep in mind that a trial aims to tell what works best for a group of similar people, and not what works best for you or your child.  Make sure the trial is right for you and your family before agreeing to participate.  Though you are allowed to stop participating in any trial at any time, you should not begin a trial without carefully thinking about the pros and cons.