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Glossary
Adverse Event
An unfavorable, unintended medical occurrence in a research subject. An adverse event may not necessarily be related to the research study.
Adverse Reaction
An unwanted or negative effect occurring in response to an intervention being used in a research study.
Altruism
Concern for the welfare of others; desire to help others.
Assent
The agreement of a child to participate in a research study. Assent means that the child actively agrees to be in the study, NOT that the child just doesn't object to being in the study.
Clinical Trial
An organized way to learn about health and the prevention, diagnosis and treatment of diseases and other medical conditions; often used to refer to studies involving medicine ("drug trials") or devices. For example, a clinical trial may be done to see how safe and effective a new medicine is.
Confidentiality
The protection, from unauthorized disclosure, of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission.
Conflict of Interest
An investigator has a potential conflict of interest when he or she has a stake (such as personal financial benefit) in the outcome of the research study that might be different from his or her professional duties in conducting the study. For example, if an investigator owns a lot of stock in a company making a medicine, he or she might benefit if the research study shows that the medicine is safe and effective. However, he or she would also have an obligation to conduct the study in a fair and objective manner. Most hospitals, medical centers, universities and other institutions conducting research, including Children's Hospital Boston and Harvard Medical School, have policies to help prevent or manage conflicts of interest.
Consent
Agreement to participate in research; see INFORMED CONSENT.
Control Group
A group of participants in a research study who do not receive the experimental intervention being studied. The control group serves as a comparison to one or more other groups in the study. For example, in some clinical trials, one group of participants is given an experimental intervention while the control group is given the current standard intervention, and the effects of the different interventions are compared. In some studies, participants in the control group may get no treatment or a placebo.
Data Safety and Monitoring Board (DSMB)
An independent committee, composed of scientists, physicians, statisticians, bioethicists and/or others with relevant expertise, that monitors the safety of participants and the validity and integrity of data during the course of the research study. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.
Double-Blind Study
A research study in which neither the subjects nor members of the research team know which group or arm of the study the subjects are in. For example, in a double-blinded study comparing an experimental intervention with the standard intervention, neither the subjects nor members of the research team know who is receiving the experimental intervention and who is receiving the standard intervention. A study is "double-blinded" so that the expectations of the subjects and of the research team about the intervention (or non treatment or placebo) will be less likely to affect the outcome, and the results will be more likely to be unbiased. The names of the subjects and which arms of the study they are in are kept in a safe place, and will be released if necessary for the health of the subjects. A double-blind study may also be called a "double masked" study.
Efficacy
Maximum ability of a drug/treatment to produce results regardless of dosage; ability to produce the desired effect at optimal dose; ability to produce beneficial effects.
Eligibility Criteria
Criteria, set in advance, for who can be in a particular research study. These criteria include such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. These criteria are designed to make the study scientifically useful and to avoid unnecessary risks to subjects. They are applied to all children who might want to participate in the study.
Eligibility Screening
Applying eligibility criteria to see if a person can be in a particular study.
Exclusion Criteria
Criteria, set in advance, for who may not participate in a research study. For example, all persons who have diabetes may be excluded from (or not be able to be in) a particular study. See INCLUSION CRITERIA.
Experiment (Medical)
An organized way to learn about health and the prevention, diagnosis and treatment of diseases and other medical conditions. For example, investigators might conduct an experiment to compare a less invasive surgical procedure (the experimental intervention) with the standard, more invasive surgical procedure (the standard intervention) to see if the less invasive procedure is as safe and effective as the standard procedure.
Food and Drug Administration (FDA)
The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. To visit their site click here.
Inclusion Criteria
Criteria, set in advance, for who may be able to be in a research study. For example, all persons with cystic fibrosis may be able to be considered for participation in a particular study.
Informed Consent
The voluntary, informed agreement of an adult with decision making capacity to participate in a research study, based on an understanding of the study, its possible benefits and risks, the alternatives and their possible benefits and risks, and other information provided by the investigator and other members of the research team. Informed consent is obtained through a process of interaction between the potential subject and members of the research team. This process may include discussions, questions and answers, and review of a written document called an informed consent form. See also INFORMED PERMISSION.
Informed Consent or Permission Form
A written document that describes the research study, including: its purpose; duration; the interventions that may be involved; possible benefits and risks; the alternatives and their possible benefits and risks; the rights of the participants; the confidentiality of certain information; payment or compensation to families or subjects, if any; individuals to contact for questions; and other information.
Informed Permission
Children usually do not have the capacity to give informed consent to research. Therefore, research generally cannot be conducted on children unless one or both parents/guardians voluntarily give their permission, based on an understanding of the study, its possible benefits and risks, the alternatives and their possible benefits and risks, and other information provided by the investigator and other members of the research team. Informed permission is obtained through a process of interaction between the parent(s) and members of the research team. This process may include discussions, questions and answers, and review of a written document called an informed consent or informed permission form.
Institutional Review Board (IRB)
A committee that reviews research studies to decide whether or not to allow the studies to be done at the hospital, medical center, university or other institution for which the IRB is responsible. An IRB usually includes physicians, scientists, and other health care professionals, as well as someone from the local community. The IRB's role is to help ensure that the study is well designed; that the risks are as low as possible and reasonable compared to the importance of what might be learned; and that the rights of study participants are protected. Special requirements are applied by an IRB when it reviews studies that involve children.
Legal Guardian
An individual who has been given the authority, under applicable state or local law, to make decisions on behalf of a child, including decisions about health care and participation in medical research. On this website, the word "parent" also includes "legal guardian."
Intervention
Any diagnostic tests or procedures (including laboratory tests, diagnostic surgery, and behavioral tests); illness or injury prevention measures (for example, vaccines); and any medical treatment - including medications, surgery, and behavioral therapy.
Medical Research
Medical research refers to an organized way to learn more about health in general, and also about better ways to prevent and treat children's diseases in the future.
Medical Therapy
Professional care, rendered to a patient, to improve the patient's health; interventions applied to enhance the well being of an individual patient who is sick or injured; in its broadest sense, includes medical, surgical, and behavioral treatment. Compare with MEDICAL RESEARCH.
National Institutes of Health (NIH)
The NIH, comprising 27 separate Institutes and Centers, is one of eight health agencies of the Public Health Service, which, in turn, is part of the U.S. Department of Health and Human Services. The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by: conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of medical and health sciences information. To visit their website click here.
Open Label
An open label study occurs when everyone involved in the study, including parents, children, and the investigators, know which study treatment the child is receiving.
Participants
People who are in a research study. Participants are also sometimes called subjects.
Permission
The agreement of a child's parent(s) or legal guardian to the child's participation in a research study. See INFORMED PERMISSION.
Pharmacokinetics
How the body absorbs, handles, and gets rid of a medicine.
PI
See PRINCIPAL INVESTIGATOR.
Placebo
A placebo is an inactive pill, substance or other intervention that is believed not to affect the disease or condition being studied. (One example of a placebo is a so-called "sugar pill.") In some research studies, some of the subjects will receive the experimental intervention and some will receive a placebo. The results of using the experimental intervention can then be compared with the results of using the placebo. Use of a placebo is intended to help investigators determine whether or not the subject's response is the result of the experimental intervention. There are ethical guidelines to help ensure that the use of placebos does not cause any serious or lasting harm to research subjects.
Placebo Controlled Study
A research study in which a placebo is used in one group or arm of the study. For example, in some placebo-controlled studies, subjects in one arm of the study receive a placebo while subjects in another arm receive an experimental medication. The results obtained in the two arms are then compared.
Pre-Clinical Testing
Laboratory and animal tests done on a medicine, medical product, or procedure before it is tested on human subjects.
Principal Investigator
The individual scientist, physician, researcher or other health care professional responsible for the conduct and direction of a research study. He or she carries the ultimate responsibility for the research activities directly related to the study.
Protocol
A plan that sets forth the major components of a research study, including: the scientific basis for the study; the question being asked in the study; the type and schedule of interventions, assessments, and tests conducted during the study; the use of control groups, if any; the length of the study; the goals of the study; the eligibility criteria for participants; the possible benefits, if any; the risks, if any; and other important information. The protocol is designed to help ensure that the study produces useful results and that the risks to participants are minimized.
Randomization
A method based on chance by which study participants are assigned to one group or arm of the study. Randomization is considered to be the most reliable method for creating groups that, prior to the start of the study, are balanced in terms of various characteristics (for example, age, ethnicity, and severity of illness). Each participant has an equal chance of being assigned to each of the arms of the study. While the selection is often done by computer, it is similar to the common practice of "flipping a coin" to choose between 2 alternatives.
Randomized Clinical Trial
A clinical trial in which participants are randomly (that is, by chance) assigned to the groups or arms of the study - for example, to the control group or the group receiving the experimental intervention.
Refuse
To decline participation in research; to say "no."
Research
A systematic investigation (including gathering and analysis of data ) designed to develop or contribute to generalizable knowledge.
Research Coordinator
The person on the research team who oversees the administrative aspects of the research study, including on-going monitoring of various aspects of the study. The principal investigator delegates these duties and oversees the performance of the research coordinator.
Research Nurse
A nurse who helps conduct the study and may also serve as a research coordinator.
Research Study (Medical)
An organized way to learn about health and how to prevent, diagnose and treat illness and other medical conditions; includes medical experiments and clinical trials.
Research Team
The principal investigator, any co-investigators, the research coordinator, and other scientists and health care professionals who are conducting a research study.
Side Effect
Any action or effect of a intervention other than the effect for which the intervention is used. Usually, "side effect" is used to mean a negative or adverse effect such as headache, nausea, hair loss, skin irritation, infection, or other physical problem.
Single-Blind Study
A research study in which the participants (or subjects) do not know which group or arm of the study they are in. For example, in a single blind study comparing an experimental intervention to the current standard intervention, the subjects do not know whether they are receiving the experimental intervention or the standard intervention. A study is "blinded" so that the subjects' expectations about the intervention will be less likely to affect the outcome, and the results will be more likely to be unbiased. A blinded study may also be called a "masked study." See also DOUBLE-BLIND STUDY.
Sponsor
A government agency (such as the National Institutes of Health, the Department of Defense, or the Department of Veteran's Affairs), non-profit organization (such as a foundation or charity), medical institution, university, for-profit company (such as a pharmaceutical or medical device company), or group of individuals (such as physicians) who fund or pay for the research study. A sponsor may also take responsibility for initiating and managing the research study.
Standard Intervention
Intervention that, based on current knowledge, is generally considered to be better for most patients with a particular disease or condition than other options available outside of research studies; the intervention commonly used to treat a disease or condition (also called "standard medical treatment").
Study
See RESEARCH STUDY.
Study Arm
Some studies divide the participants into groups for purposes of comparison; each group is called a study arm or "arm." For example, in some studies, the participants (or subjects) who are in one arm may receive the experimental intervention and those who are in the other arm may receive the current standard intervention, so that the two interventions can be compared.
Subjects
Those people who participate in a research study. Research subjects are also referred to as participants or study participants.
Therapy
See MEDICAL THERAPY.
Trial
See CLINICAL TRIAL.
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