Want to Join a Research Study? Learn How Inclusion Criteria Guide Who Can Participate in Clinical Trials
My mother-in-law hoped to enroll in a research study at her local medical center but was told that she did not meet the inclusion criteria. She felt disappointed, confused, and even a little annoyed. Being excluded from a research study does not happen all the time, but it is important to understand why it might.
Clinical research studies are designed to learn something new. For example, a study may test a drug that is not yet sold on the market and does not have FDA approval. In this case, the ‘study drug’ is not yet known to be effective. It may not work as expected, or it could even cause harm.
Being eligible to participate in a research study, like a vaccine trial, involves several steps. First, you will meet with the research team, learn more about the study, and be asked if you agree to take part. Next, you will be ‘screened’ to see if the study is a good option for you, and if you meet the criteria to be included in the study.
My mother-in-law went for a screening visit and had to meet certain guidelines to take part in the study. These guidelines are defined as inclusion criteria and are set before a research study begins enrolling participants. To be enrolled, one must meet the inclusion criteria and they differ from study to study.
Examples of inclusion criteria are:
· Including people within a certain age range
· Allowing only people with the health condition being studied
· Including only healthy people with no health conditions
· Limiting the kinds of medications people in the study use
The safety of study participants is most important
Researchers set inclusion boundaries to keep people safe. Researchers seek to ‘do no harm’ and the practice of establishing boundaries around who can take part in the study helps to ensure the safety of participants.
Having inclusion criteria also helps to ensure that the group of people in the study have things in common. No two people are alike and trying to determine how a drug affects a wide variety of people has many challenges. By setting up guidelines for inclusion, the amount of variety is reduced, which helps at the end of the study when scientists look to determine how the drug worked in study participants.
Research trials and their inclusion criteria are based on scientific and medical evidence. While it might have seemed more inclusive to accept my mother-in-law into the study, she may have been put at a higher risk of experiencing side effects than other people in the study. So, to ensure her safety, she was disqualified.
What you might experience before you participate
The research team may ask you to share information about yourself after you sign a consent form and agree to participate. They may ask about your health history, including any prescription or over-the-counter medicines you take. They may take a sample of blood, perform other testing, or have you fill out questionnaires.
During this screening, YOU are making the decision to participate along with the researcher. Being open and honest about your health, the medicines you take, and your lifestyle is important so that you both can make an informed decision. You may end up being excluded, but it will be for valid reasons.
Meeting study inclusion guidelines throughout study participation
Determining if the study is safe for you is an ongoing process! You should let the research team know if your health changes, you begin new medicines, get injured, or have new symptoms since beginning the study. Evaluating if you continue to meet the inclusion criteria lasts for the entire time you are in the study.
Being excluded can be disappointing. Ask the researcher to explain why you were excluded, if you would be excluded from other studies, or if there is something you can do to affect that decision. It is their responsibility to explain why you are, or are not, included. My mother-in-law was told that she was excluded from the study because her blood sugar was too high. Although she was disappointed, she learned something about herself that day and received a copy of her lab work. She was also able to join another research study instead.
Like my mother-in-law, everyone that participates in research is part of making new scientific discoveries happen and help all of us live healthier lives!
ResearchMatch is supported by a collaboration of leading research institutions including Vanderbilt University Medical Center to educate and empower people to participate in research. This includes understanding how their participation makes a difference and contributes to scientific discoveries. Interested in joining ResearchMatch? Click here to sign-up and be “matched” with research studies that are of interest to you!
