Glossary

denotes the IACUC responsible for approval of a specific animal use protocol at a given institution.

Investigational Device Exemption filed with the FDA

identifies the individual; or there is a reasonable basis to believe the information can be used to identify the individual.

a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

information about an individual that is gathered or used during biomedical, behavioral, clinical, or other research where the information is confidential and/or poses a high risk should the information be breached.

individual is identified as a prospective subject during recruitment: 1) by obtaining the results of procedures performed as part of the practice of medicine, 2) by responding to recruitment activities, or 3) referred by a provider.

UT Health San Antonio's application for disclosing outside professional activities including activities that could be Conflicts of Interest.

a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.

diminished autonomy is present when an individual has either impaired decision-making ability or is subject to undue influence or control by others.

means, in glass or test tube Ð used to refer to processes that are carried out outside the living body, usually in the laboratory.

means in the living body; processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory.

lacking the ability based on reasonable medical judgment to understand and appreciate the nature and consequences of a treatment decision, including the significant benefits and harms of and reasonable alternatives to any proposed treatment decisions.

referring to a person who is not able to manage his/her affairs due to mental deficiency (low IQ, deterioration, illness or psychosis) or sometimes physical disability and who has been appointed a guardian or conservator by a legal determination.

withholding information about the true purpose of the research.

Investigational New Drug application with the FDA.

an agreement between an Assured Institution and a collaborating investigator that permits the assured institution to extend its Federal wide Assurance to cover the investigator.

private information including demographic information collected from an individual, and (1) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (a) that identifies the individual; or (b) with respect to which there is a reasonable basis to believe the information can be used to identify the individual.

private information or specimens are individually identifiable when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.

offers that get people to do things they may not otherwise do.

a person's voluntary agreement based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic therapeutic or preventive procedure.

review of new, not previously approved research.

represents a deviation from standard medical practice.

any public or private entity or agency (including federal, state or other agencies).

provide support for interdisciplinary research that complements the academic goals of departments of instruction and research. These units are typically referenced as institutes, laboratories, or centers (e.g., Mays Cancer Center or Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases).

a federally mandated, institution-designated regulatory body empowered to oversee Human Subjects Research.

confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled.

includes but not limited to any invention, discovery, creation, know-how, trade secret, technology, scientific or technological development, research data, works of authorship and computer software regardless of whether subject to protection under patent, trademark, copyright or other laws.

any communication or interpersonal contact between investigator and subject.

adverse events and unanticipated problems experienced by subjects enrolled by investigator(s) at an institution affiliated with UTHSCSA.

all physical procedures by which information or biospecimens are gathered or manipulation of the subject or the subject's environment performed for research purposes.

applicable to interventional study, indicates intervention being tested was stopped prematurely and the follow-up procedures have been completed.

applicable to interventional study, indicates the intervention being tested was stopped pre-maturely and the participant is continuing with non-interventional procedures or other study interaction.

a clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on health-related biomedical or behavioral outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

1) Treatment: designed to evaluate one or more interventions for treating a disease, syndrome or condition
2) Prevention: designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition
3)Diagnostic: designed to evaluate one or more interventions aimed at identifying a disease or health condition
4) Supportive Care: designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease.
5) Screening: designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor).
6) Health Services Research: designed to evaluate the delivery, processes, management, organization or financing of health care.
6) Basic Science: designed to examine the basic mechanism of action of an intervention.A133

enters the body via puncture or incision or requiring numbing or sedative medication for insertion into the body.

approval by the FDA which allows an unapproved medical device to be shipped for use for research purposes.

a device not yet approved for marketing by the FDA or, any medical device, including approved or transitional devices if they are the object of a clinical investigation.

a drug in any of the clinical stages of evaluation which has not been released by the FDA for general use or cleared for sale in interstate commerce.
any commercially available drug proposed for a new use.
a new dosage form or method of administration.
a commercially available drug which contains a new component such as an excipient, coating or menstruum.
a new combination of two or more commercially available drugs.
a combination of commercially available drugs in new proportions.

(or IND) an application filed with the FDA that includes a detailed description of the planned investigation including Phase I, II and III studies.

Indicates that the study plan was developed by a local investigator and not from an external entity.

an institutional agreement where an institution agrees to rely on the IRB from the other institution for the review and continuing oversight of its human research.

denotes the IRB responsible for approval of a specific research study at a given institution.