Going to the hospital or speaking with doctors can feel overwhelming for children and parents alike. Also, it may be confusing when a loved one is invited to take part in a clinical research study. We have made this list of terms to help you understand common words and phrases you may hear about research.
Assent
Assent refers to a child (or minor under legal age) agreeing to be in a study. Assent means the child understands and agrees to join a study without feeling pressured. A parent or legal guardian must also give consent for the child to participate. Assent is different from consent. Consent may only be given be those over age 18 (or whatever the legal age is).
Clinical Research
A way to study and learn about people, different conditions, and tests or treatments.
Control Group
A group of study participants who do not receive the treatment or intervention that is being studied.
Data
The information or samples collected before, during, and after a study used to determine the outcome.
Double Blind Study
A study in which the participants and the researchers do not know what treatment or intervention the participants are receiving in order to reduce bias.
Efficacy
The extent that a treatment or procedure in a study has the expected or beneficial effects.
Healthy Control/Volunteer
A person who is part of a study but does not have a medical condition or disease.
Inclusion and Exclusion Criteria
Inclusion: Characteristics that are required by a study to allow a person to participate.
Exclusion: Characteristics that do not allow a person to participate in a study.
Industry-sponsored Clinical Trial
A research study funded by a company to test new drugs or medical devices. These studies check if the products are safe and work well before they can be used in routine care.
Informed Consent
Researchers must explain the purpose, involvement, rights, and possible risks and/or benefits of a study to people before they decide to participate.
Institutional Review Board
Researchers must have approval from their Institutional Review Board (IRB) before they can begin a research study. The IRB includes researchers, clinicians, and community members, who review the study to ensure the safety and rights of participants are protected.
Intervention
A treatment or procedure performed during a clinical trial.
Interventional Study (clinical trial)
A type of study in which people are assigned to groups and given treatments/interventions or not. Researchers then review study participants’ responses to decide if the treatments/interventions worked.
Investigator-initiated Trial
A study created, developed, started, and performed by a researcher.
Observational Study
A study of people belonging to specific groups, whose responses are observed and recorded. They may or may not receive treatment or have a specific condition.
Peer Review
An evaluation of a researcher’s work performed by experts, who were not involved in the study. Grant applications and manuscripts for scientific journals often receive peer review to ensure the best science is funded and published.
Phase
The stage of research determined by the purpose of the work and other characteristics. There are five phases in research, from 0 (early phase) to 4 (late phase).
Placebo
A treatment or substance that does not contain the same treatment or active substance in the study.
Protocol
A written description of the specific details and steps for the study.
Principal Investigator
The person who leads the clinical trial or research study. Also known as the study chair or director.
Randomization
A way to group people in a study by chance to reduce unfairness in the study and avoid biased results.
Subject (or Participant)
A person who agrees to participate in a study or clinical trial.
Clinical trials are scientific studies used to determine the effectiveness of a treatment or procedure. The terms used for research studies are technical and can be confusing. At Nationwide Children’s Hospital, we aim to help you, and your family understand and make the entire process clearer.
Learn more about clinical research by following @NCHClinicalResearch on Instagram.
Cynthia A. Gerhardt, PhD, is a psychologist in the Pediatric Psychology and Neuropsychology Program and Chief Clinical Research Officer at Nationwide Children's Hospital. She is also a professor of Pediatrics at The Ohio State University College of Medicine.
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