Definitions of Research Terms
- Adjuvant Therapy
- Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
- Adverse Effect
- An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
- Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
- A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.
- Blinded studies
- Blinded studies are done so that neither the researchers’ nor the participants’ expectations about the experimental treatment can influence the study results.
- Single-blinded trials
- Participants do not know which group they are in – and therefore which intervention they are receiving – until the conclusion of the study.
- Double-blinded trials
- Neither participants nor the investigators know to which group the participant has been assigned until the conclusion of the study.
- Clinical trial
- A clinical trial is a research study designed to test the safety and/or effectiveness of drugs, devices, treatments, or preventive measures in humans. Clinical trials can be divided into four categories or “phases.”
Phase I trials are the first experiments using an investigational new drug in humans. Normally, healthy participants are enrolled in Phase I studies; however, participants with the disease being studied may, under certain circumstances, be enrolled into the trial. Phase I studies are designed to determine how the drug is broken down in the human body and how it interacts with the human body. Phase I studies reveal some of the side effects associated with increasing doses. When possible, some Phase I studies provide early evidence of effectiveness. Researchers use information from Phase I studies to design Phase II studies. The total number of participants included in Phase I studies varies with the drug, but is generally a small number of participants or a few dozen.
Phase II trials continue to test the safety of the drug, and begin to evaluate how well the new drug works. Researchers collect additional safety and effectiveness information, study short-term side effects and risks, and collect additional information about the proper dose and dosing schedule. Phase II studies are closely monitored and typically involve control groups.
Phase III trials are done after Phase I and Phase II studies have shown some evidence of effectiveness. They are longer-term research studies and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit/risk relationship of the drug. At the end of most Phase III trials the new drug will be found to be inferior, equal or superior to the standard treatment.
Phase IV trials are done after the new drug has been approved by the U.S. Food and Drug Administration. Researchers continue to gather information about an approved drug’s risks, benefits and best uses associated with large-scale usage in “real-life conditions.” Phase IV studies can also include trials of different doses or schedules of administration, other stages of disease, cost studies, quality-of-studies or use of the drug over a longer period of time.
- Cognitively impaired
- Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
- A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
- Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
- Control Group
- A control group is a group of participants who receive the standard treatment/care or a placebo. At the end of the study, the results of the control group and experimental/intervention group are compared.
- Data and safety board monitoring
- This refers to the process by which scientists, physicians, statisticians and others collect and analyze data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.
- Experimental group
- An experimental group is a group of participants who receive the drug, device, treatment or intervention under study. Participants in a controlled study will be assigned either to an experimental group or to a control group.
- False negative
- When a test wrongly shows an effect or condition to be absent (for example, that a woman is not pregnant when, in fact, she is).
- False positive
- When a test wrongly shows an effect or condition to be present (for example, that a woman is pregnant when, in fact, she is not).
- Food and Drug Administration (FDA)
- The FDA is the U.S. government agency that approves all drugs for marketing before they are made available to the public. The agency is responsible for enforcing laws on the manufacturing, testing and use of drugs and medical devices.
- Full board review
- Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
- Gene therapy
- The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germline (reproductive) cells.
- Human subject (participant)
- A human subject is a volunteer participant in a research study. Any person who enrolls in a research study is known as a human subject (participant). Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual or 2) identifiable private information
- Informed consent
- Informed consent is a process in which a research participant learns the key facts about a clinical trial before he or she decides to participate in the study. In addition to talking about the facts of the study with the researcher, all information will be included in a written consent form. The participant will be able to take the consent form home to read and discuss with family members. Participants may continue to ask questions before, during and after the consent form is signed. The participant’s agreement to be in a study after being fully informed about what participating will involve, length of the study, benefits and risks, costs, confidentiality, purpose of the study, alternative treatments and withdrawal participation is informed consent.
- Institutional Review Board (IRB)
- An IRB is a committee/group that is given the responsibility by an
institution to review research projects involving human subjects. The
purpose and role of the IRB is to assure the protection and safety,
rights and welfare of research participants (human subjects). Rush has two Institutional Review Boards.
- Longitudinal study
- A study designed to follow subjects forward through time.
- Minimal risk
- A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
- National Institutes of Health (NIH)
- The National Institutes of Health
is one of eight health agencies of the Public Health Services, which, in turn,
is part of the U.S. Department of Health and Human Services. NIH is comprised of 27 separate components, mainly institutes and centers.
- The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s) and the proposed methods of analysis that will be performed on the collected data.
- Assignment of subjects to different treatments, interventions or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics).
- A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to general knowledge.
- The probability that harm or injury (physical, psychological, social or economic) will occur as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.”
- A person or entity that initiates a clinical investigation of a drug—usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials. The drug is administered to subjects under the immediate direction of an investigator who is not also a sponsor.
- An individual who both initiates and actually conducts, alone or with others, a clinical investigation. Corporations, agencies or other institutions do not qualify as sponsor-investigators.
- Treatment intended and expected to alleviate a disease or disorder.
- Free of coercion, duress or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.