Human Subjects: A Glossary of Research Words
The following definitions are useful in understanding more about research involving human subjects. These definitions have been taken from Appendix K (.pdf file) of the University of Pittsburgh's Institutional Review Board Reference Manual.
ANONYMITY - Anonymity exists when there are no identifiers on project materials which could link the data with individual subjects. Even the research investigator cannot know the identity of participants.
ASSENT - Agreement to participate in proposed research, given by an individual not competent to give legally valid informed consent (e.g., a child or mentally limited person). Mere failure to object may not be construed as assent.
ASSURANCE - A formal, written statement submitted to a federal agency attesting that an institution will comply with applicable rules governing research with human subjects.
BENEFIT - A valued or desired outcome. An advantage.
BID - Twice a day.
CHILDREN - Those who have not attained the legal age for consent to treatments or procedures
CLASS I, II, III DEVICES - Classification by the FDA of medical devices according to degree of potential risks or hazards.
CODE OF FEDERAL REGULATIONS (CFR) - A compendium of rules issued by federal agencies on a multiplicity of topics.
COGNITIVELY IMPAIRED - Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., 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.
COMPENSATION - Payment or medical care provided to subjects injured in research. Does not refer to payments (remuneration) for participation in research.
COMPETENCE - Technically, a legal term used to denote capacity to act on one's own behalf. The ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Competence may fluctuate as a function of the natural course of a mental illness, response to treatment, effects of medication, general physical health and other factors. Therefore, mental status should be reevaluated periodically. As a designation of legal status, competence or incompetence pertains to an adjudication in court proceedings that a person's abilities are so diminished that his or her decisions or actions (e.g., writing a will) should have no legal effect. Such adjudications are often determined by inability to manage business or monetary affairs and do not necessarily reflect a person's ability to function in other situations.
CONFIDENTIALITY - Right of privacy and of nonrelease of disclosed personal information. The investigator should protect subjects against invasion of privacy and loss of confidentiality. Lack of secure handling of completed personality tests, questionnaires, interview protocols or data and recorded materials augments risk and must be avoided.
CONTROL - Subjects who are not given a treatment under study or do not have a given disorder, background or risk that is the object of study, and who are comparable to subjects in the study.
CROSSOVER DESIGN - A type of clinical trial in which each subject is given, at different times, both an experimental and a control therapy.
DATA POINTS - Any text or numbers generated during a study.
DOUBLE-BLIND DESIGN - A study comparing two or more treatments in which neither the investigators nor the subjects know to which treatment group individual subjects have been assigned.
EMANCIPATED MINOR - A legal status conferred upon persons who have not yet attained the
EXPERIMENTAL - A term often used to denote a therapy (drug, device or procedure) that is unproven or scientifically unvalidated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study to evaluate its usefulness.
GUARDIAN - A person who is authorized by law to consent on behalf of a child or handicapped individuals to general medical care.
HISTORICAL CONTROLS - Control subjects (followed at some time in the past or for whom data are available through records) who are used for comparison with subjects being treated concurrently. (Note: the condition of subjects may be compared with their own condition on a prior regimen, the effectiveness of which has already been established.)
HUMAN SUBJECT - "Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.
INCAPACITY - Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information and to make a choice. Often used as a synonym for incompetence.
INCOMPETENCE - Legally, the inability to manage one's affairs. Often used as a synonym for incapacity.
INFORMED CONSENT - Informed consent means "knowing consent," the exercise of a free power of choice without undue inducement, force, fraud, deceit, duress or other form of constraint or coercion. If the subjects are minors or are not capable of giving consent, parental, guardian or other legal representative consent is required. Use of a written consent form that includes all of the basic elements of informed consent must be documented by a signature of the subject or legally authorized representative.
INSTITUTION - A residential facility that provides food, shelter and professional services (including treatment, skilled nursing, intermediate or long-term care and custodial or residential care). Examples include general, mental or chronic disease hospitals, inpatient community mental health centers, halfway houses and nursing homes, alcohol and drug addiction treatment centers, homes for the aged or dependent, residential schools for the mentally or physically handicapped, and homes for dependent and neglected children
INTERACTION - Interaction includes communication or interpersonal contact between investigator and subject.
INTERVENTION - "Intervention" includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
INVESTIGATIONAL DEVICE - A medical device which is the subject of a clinical study
INVESTIGATIONAL DEVICE EXEMPTION (IDE) - An exemption from certain rules found in the Medical Device Amendments, allowing use of a not-yet-approved devices in clinical investigators.
INVESTIGATOR - Clinician responsible for conducting the study.
LEGALLY AUTHORIZED REPRESENTATIVE - A person authorized either by statute or by court appointment to make decisions on behalf of another person.
LONGITUDINAL STUDY - A study designed to follow subjects forward through time.
MATURE MINOR - Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor.
MEDICAL DEVICES - Diagnostic or therapeutic articles that do not interact chemically with the body. Such devices may included diagnostic test kits, crutches, electrodes, prescribed beds, pacemakers, arterial grafts, intraocular lenses and orthopedic pins.
MINIMAL RISK - 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.
MONITOR - Designated individual selected by a sponsor or contract research organization to oversee the progress of a clinical investigation.
NONSIGNIFICANT RISK DEVICE - An investigational medical device that does not present significant risk as described above. The determination that a device presents a nonsignificant risk is first made by the sponsor. If the IRB agrees with the sponsor's finding that a device presents nonsignificant risk, the device is considered a nonsignificant risk device.
NORMAL SUBJECT - Subjects used in study of normal physiology and behavior, or subjects who do not have the condition under study in a particular protocol used as comparisons with subjects who do have the condition. "Normal" does not necessarily connote normal in all respects. For example, patients with broken legs may serve as normal volunteers in studies of metabolism, cognitive development and the like. Similarly, patients with heart disease but without diabetes may be "normals" in a study of diabetes complicated by heart disease.
OPEN DESIGN - An experimental design in which both the investigator(s) and the subjects know the treatment group to which subjects are assigned.
PARENT - A child's biological or adoptive parent.
PERMISSION - The agreement of the parent(s) or guardian to the participation of the child, handicapped individual, or ward in the research.
PHYSICAL RISK - Any strenuous or unusual physical activity or procedure required of a subject, use of compounds which might alter the subject's biochemical milieu, exposure to strong stimulation or placement in a situation which could lead to violence. The investigator is responsible for anticipating circumstances which might endanger the subject's physical well-being and for bringing these circumstances to the attention of the IRB.
PSYCHOLOGICAL RISK - Any experimental condition that induces personality change or intense changes in a subject's feelings or motivations, or that may induce such changes which extend beyond the experimental or debriefing period. Subjection to deceit, to demeaning or dehumanizing procedures, to humiliation and embarrassment. The investigator has the responsibility to eliminate or minimize the effects of psychological risk to subjects and to bring these matters to the attention of the IRB.
PRISONER - An individual involuntarily confined in a penal institution, including persons (a) sentenced under a criminal or civil statute, (b) detained pending arraignment, trial or sentencing, and © detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statues or commitment procedures providing such alternatives to criminal prosecution or incarceration in penal institution [45 CFR 46.303(c)].
PRIVATE INFORMATION - "Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
PROSPECTIVE STUDIES - Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. These studies need not involve manipulation or intervention, but may be purely observational or involve only the collection of data.
QUALITY ASSURANCE - A system of activities whose purpose is to provide assurance that the
RANDOMIZATION OR RANDOMIZED CLINICAL TRIALS - Assignment of subjects to different treatments, interventions or conditions according to chance rather than with reference to some aspect of their condition, history or prognosis.
RESEARCH - "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. For example, some "demonstration" and "service" programs may include research activities.
RETROSPECTIVE STUDIES - Research conducted by reviewing records (i.e., birth and death certificates, medical records, school or employment records) or information about past events elicited through interviews with persons who have, and controls who do not have, a disease under investigation.
RISK - The probability of harm or injury (physical, psychological, social or economic) occurring 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." (See also "Minimal Risk.")
SINGLE-BLIND DESIGN - Typically, a study designed in which the investigator, but not the subject, knows the treatment assignment. Occasionally the subject, rather than the investigator, knows the assignment.
SPONSOR (of a drug trial) - The developer of a new drug who distributes it to investigators and physicians for clinical trials, and who is responsible for securing FDA clearance for trials and form reporting the results of those trials to the FDA. A sponsor may be either a private pharmaceutical manufacturer, a research institute, a clinical investigator or a federal agency.
SPONSOR - The company/person who initiates the study.
STUDY COORDINATOR - Person appointed at the institute/center where the study is being conducted.
SUBJECT - A non-patient (normal) volunteer or a patient in clinical research.
THERAPEUTIC RESEARCH - Research involving an intervention that has the likelihood of providing a therapeutic, diagnostic or preventive benefit to the subjects.
THERAPEUTIC INTENT - The research physician's intent to provide some benefit to improving a subject's condition (e.g., prolongation of life, shrinking of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected). This term is sometimes associated with Phase I drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient's condition, as well as assessing the safety and pharmacology of a drug.
Last Updated: 3-2-2006